Research Report

APRC-FY2021-RR-05

Advances and Challenges in the Emerging Technology
Field of “Synthetic Biology” in Australia, China and India

March 2024

Japan Science and Technology Agency

Established in April 2021, the Asia and Pacific Research Center (APRC) of the Japan Science and Technology Agency (JST) aims
to contribute to building a foundation for innovation in Japan by expanding and deepening science and technology cooperation in
the Asia-Pacific region based on the three pillars of research, information dissemination, and networking.
This report is compiled as part of a research that surveyed and analyzed science and technology innovation policies, researchand development trends, and associated economic and social circumstances in the Asia-Pacific region. It is being made public on
the APRC website and portal site to enable wide use by policymakers, associated researchers, and people with a strong interestin collaborating with the Asia-Pacific region; please see the websites below for more details.

APRC website:
https://www.jst.go.jp/aprc/en/index.html
Research Report:
https://sj.jst.go.jp/publications/researchreports/index.html

Research Report

Advances and Challenges in the Emerging Technology Field of“Synthetic Biology” in Australia, China and India

Executive Summary
It is obvious that synthetic biology is an important emerging technology that contributes both to economic growth andsolutions to social issues, and is extremely beneficial to Japan and humanity, despite the risks associated with biosafety
and other issues. Due to this, Japan’s position in the Asia-Pacific Region, including the United States, which is said
to be the world leader in the field in addition to Australia and India, and China, which is promoting large scale R&D
investment, is extremely important. In this study, we analyzed the impact on Japan in terms of science and technology
innovation, by comparing basic data from the U.S. with those from Australia, India, and China, which have strong
scientific and technological capabilities in the Asia-Pacific region and show great potential in the field of synthetic
biology, and then examined the direction that Japan should take regarding measures related to synthetic biology. The
report also summarizes the direction that Japan should take with respect to policies related to synthetic biology andthe possibilities for cooperation with these countries.

Science and technology policy and funding
Synthetic biology in Australia has grown from an individual, laboratory, or project-based effort, such as participationin iGEM in the late 2000s, to a large-scale network effort as announced in the National Innovation and Science
Agenda (NISA) in December 2015. In light of this, knowledge-sharing and educational hubs are being actively
formed by leveraging and strengthening the country’s existing research infrastructure networks. In August of 2021,
CSIRO (the Commonwealth Scientific and Industrial Research Organisation) published Australia’s Synthetic Biology
Roadmap, which predicted that the national market could grow to generate up to A$27 billion in annual revenue andsupply 44,000 new jobs by 2040. In November of the same year, the Department of Home Affairs released its Critical
Technology Supply Chain Principles, identifying synthetic biology as an emerging technology of strategic importancefor supply chain security purposes. In addition, in December of the same year, the government’s Critical Technology
Policy Coordination Office (CTPCO) published the Blueprint for Critical Technologies and Action Plan as a strategy
to protect and promote critical technologies. The Blueprint for Critical Technologies and the Action Plan, as a strategy
to protect and promote critical technologies, designated nine technology areas, including synthetic biology, that are
expected to increase in importance within the next 10 years. In connection to this, the Australian Defense Science andTechnology Research Summit (ADSTAR) was held in July 2022, where government officials from the United States
and the United Kingdom, along with representatives of other countries, discussed the risks of biotechnology. As aresult, Australia has been comprehensively promoting synthetic biology in recent years, viewing it as an importantfield from the perspective of basic research, industrial deployment, and national defense and security.
China, setting a milestone at the 2008 Xiangshan Science Conference (XSSC), has been investing in R&D throughcollaboration between industry, academia, and government, establishing a journal named “Synthetic Biology Journal,”
and promoting biotechnology research, including synthetic biology, with the expectation that it will solve problems
in the fields of medicine, agriculture, environmental restoration, and natural resource utilization and bring about
economic and social development in the country. The government is also working to attract human resources fromother countries and develop high-level human resources. In recent years, the “Fourteenth Five-Year Plan for National
Economic and Social Development and the Outline of Distant Objectives for 2035,” announced in 2021, mentions
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Research Reportsynthetic biology technology with keywords such as “disruptive,” “strategic needs,” “frontier technology,” and “keytechnology,” and emphasizes the need for medium- to long-term development to become a world leader. Funding is
also provided by the National Key Research Program of the Ministry of Science and Technology (MOST) for “synthetic
biology” and “green biomanufacturing ( 绿色生物制造 ),” which aims to break away from fossil fuel dependence, as
well as by the National Natural Science Foundation of China (NSFC) for its Major Research Programs. The NSFC’s
Critical Research Program also provides support for other types of research, from microbial applications to in silico
metabolic networking.
India does not have many explicit policies focused on synthetic biology or funding that leans toward basic research,
but the National Biotechnology Development Strategy 2021-2025 (NDBS2021-2025) announced in 2021 mentions
human resource development in synthetic biology among its ambitions goal of contributing to a “knowledge andinnovation-driven biotechnology economy” during the period it covers. In addition, in August 2022, the Ministry of
Science and Technology announced a new program led by the Department of Biotechnology (DBT) - Biotechnology
Industry Research Assistance Council (BIRAC) supporting interdisciplinary, high-quality, high-risk research andR&D called the “AMRIT GRAND CHALLENGE”. The program’s target areas include synthetic biology, alongwith health, agricultural biotechnology, and climate change. In addition, under the DBT’s National Biotechnology
Park Scheme, the central and state governments are working to stimulate biotechnology research in the country by
establishing biotechnology parks, incubators, and pilot projects through public-private partnerships.

R&D Trends
Australia is actively collaborating with domestic universities and research institutions through hubs as well as withoverseas collaborations; in September 2018, CSIRO established the Synthetic Biology Future Science Platform(SynBio FSP) to support innovation and create commercialization opportunities in the manufacturing, industrial
biotechnology, environmental remediation, agriculture, biosecurity and healthcare industries and focuses on threeprograms: environment and biocontrol, chemicals and fibers, and symbionts and organelles. In addition, the Australian
Research Council (ARC) Synthetic Biology COE (CoESB), headed by Macquarie University, is pioneering new
approaches to microbial design, including for wine yeast, to develop custom-designed microbial populations andnovel synthetic enzymes. The Australian Institute of Bioengineering and Nanotechnology (AIBN) at the University of
Queensland opened a new integrated design environment facility called IDEA Bio (Integrated Design Environment
for Advanced Biomanufacturing) at the end of 2021 for project design, including fermentation characterization, multiomics characterization, and cellular design.
China’s has a significant concentration of investment in Beijing, Shanghai, and the Greater Bay Area (Yuehua
Bay Area), and among the many unique institutions, the Shenzhen Institute of Advanced Technology (SIAT),
which was jointly established by the Chinese Academy of Sciences (providing personnel), the Shenzhen municipal
government (providing land and facilities), and the Chinese University of Hong Kong (the proponent) and the Tianjin
Institute of Industrial Biotechnology (TIB) of the Chinese Academy of Sciences are very active in the field. SIAT is
actively engaged in industry-academia collaboration and has cooperative relationships with many companies suchas BGI, HUAWEI, Tencent, etc. Although not limited to SIAT, it is also active in attracting talent. In 2017, Prof.
Jay D. Keasling of the University of California, Berkeley, who succeeded in the biosynthesis of a special malaria
drug (artemisinin) using yeast, opened an endowed research lab at SIAT as a visiting professor, aiming to promote
the synthesis and commercialization of Chinese herbal medicine resources at that time. TIB-Tianjin University,
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established in 2012, was approved by the Ministry of Science and Technology on November 8, 2019, to build the
National Synthetic Biology Innovation Center1 ( 國家合成生物技術創新中心 ) in the Tianjin Airport Economic Area,
and in the same year, TIB joined the Global BioFoundry Alliance (GBA) with the Shenzhen Institute of Advanced
Technology (SIAT) Shenzhen Institute of Synthetic Biology, Chinese Academy of Sciences, to lead synthetic biology
research in China. TIB’s recent notable research achievements include the publication of a paper in Science on
September 24, 2021, on the artificial starch assimilation pathway in collaboration with the Dalian Institute of Chemical
Physics, Chinese Academy of Sciences (Dalian Institute of Chemical Physics), the, inorganic-catalyzed methanol
reduction of carbon dioxide, and the world’s first realization of artificial synthesis of carbon dioxide to starch,
including enzymatic conversion of carbon dioxide to hexacharose, and was selected as one of the 10 Chinese domestic
science and technology stories (organized by Science & Technology Daily) for the year 2021.
One of India’s BIRAC flagship centers, the Center for Cellular and Molecular Platforms (C-CAMP), was establishedin 2009. It is located in Bangalore, Karnakatha, the Silicon Valley of India, which is also known as the center ofinnovation. The facility is equipped with the basic facilities necessary for drug discovery and biotechnology research,
including high-resolution 3D X-ray microscopes, mass spectrometers, electron microscopes, and recombinant modelorganisms.
It is also part of the Bangalore Life Science Cluster (BLiSC) along with the National Center for Biological Sciences(NCBS), inStem, and Tata Institute of Genetics (TIGS), and has a strong presence by funding over 330 startups, the most successful of which is Bugworks, founded in 2014, which develops novel antibiotics that can act on
Gram-negative and Gram-positive drug-resistant bacteria (Anti-microbial Resistance, AMR). Another successful
global company that has taken advantage of the global trend toward precision medicine is Strand Life Sciences,a bioinformatics-based company that takes advantage of India’s status as an IT powerhouse. While international
collaboration in basic research is lacking in India compared to other countries, global development in the industrial
field is active.

Implications for Japan
Synthetic biology has an extremely wide range of applications in the health and medical, food, environment andenergy, and chemical industries, and is expected to drive economic growth in each of these countries. Although the U.S.
and China are far ahead of the other countries in the basic and applied research phases, there are still many researchissues in the field of synthetic biology that academia is working on, including whole-cell simulation, metabolicmodeling - reverse synthetic pathway exploration (database and algorithm/modeling), and biohydrogen energy
production, bio-bricks (parts from DNA to tissue) and their design research and biofoundry infrastructure technology(bio manufacturing) as mentioned by researchers at the Australia-Japan Synthetic Biology Workshop (held on March
16, 2022).
While there are countries such as China and India that lack international collaboration in research fields, the paper
analysis in this survey suggests that collaboration with other countries in fields such as “codon optimization,” “DNAdata storage,” “gene drives,” and “bioprospecting” where Japan lacks advantage in terms of “number of papers” is apossible approach. In the fields of “global competition” and “artificial customization,” Japan has a strong competitive

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Advances and Challenges in the Emerging Technology Field of“Synthetic Biology” in Australia, China and Indiaedge.
In this field, where global competition is prominent and technological progress is rapid, as exemplified by the
emergence of new technologies such as artificial custom cells, bio-3D printers, molecular robotics, and DNA data
storage, Japan should focus on research platforms, activate joint research with top-level foreign institutions, andcollaborate with other countries in academia to develop new technologies. In this field, where technological progress
is rapid, it is expected that Japan will focus on research platforms, collaborate with top-level foreign institutions, andaccelerate collaboration between academia and industry.

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Table of Contents
Executive Summary ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・i

1 Introduction ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 1
1.1 Defining Synthetic Biology ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 1
1.2 Background・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 2
1.3 Objectives of this Research Report ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 5
1.4 Research Methodology・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 5
2 Policy and Research and Development Trends ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 7
2.1 Australia・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 7
2.1.1 Government Organizations and Systems ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 9
2.1.2 Major Policies and Key Issues ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 11
2.1.3 Funding ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 17
2.1.4 Main Research Institutions and University R&D Trends ・・・・・・・・・・・・・・・・ 21
2.1.5 Trends in Major Industries ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 24
2.2 China ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 26
2.2.1 Government Organizations and Systems ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 28
2.2.2 Major Policies & Key Issues (Central Government) ・・・・・・・・・・・・・・・・・・・・・・・・・ 29
2.2.3 Major Policies & Key Issues (Local Governments) ・・・・・・・・・・・・・・・・・・・・・・・・・・ 34
2.2.4 Funding ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 36
2.2.5 Main Research Institutions and University R&D Trends ・・・・・・・・・・・・・・・・ 39
2.2.6 Trends in Major Industries ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 44
2.2.7 Other related trends:・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 45
2.3 India ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 47
2.3.1 Government Organizations and Structures・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 49
2.3.2 Major Policies and Key Issues ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 54
2.3.3 Funding ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 62
2.3.4 Main Research Institutions and University R&D Trends ・・・・・・・・・・・・・・・・ 66
2.3.5 Trends in Major Industries ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 69
2.4 United States (Comparative Reference Information) ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 72
2.4.1 Major Policies and Key Issues ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 72
2.4.2 Main Research Institutions and University R&D Trends ・・・・・・・・・・・・・・・・ 74
3 Analysis of Scientific Papers and Patents・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 81
3.1 Population of Papers and Patents・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 81

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3.2 Global Research and Technology Areas Identified
by Paper Analysis ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 84
3.2.1 Emerging Biotechnology Field ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 84
3.2.2 Synthetic Biology Field ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 87
3.3 Global Research and Technology Areas Identified
by Patent Analysis ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 88
3.3.1 Emerging Biotechnology Field ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 88
3.3.2 Synthetic Biology Field ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 90
3.4 Research and Technology Areas Identified
by Paper Analysis by Country ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 92
3.4.1 Australia ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 92
3.4.2 India ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 94
3.4.3 Dominant Individual Areas
by Country Based on Number of Papers ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 97
4 Summary ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 99
5 APPENDIX ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 100
5.1 Main Synthetic Biology Related Keywords and Glossary・・・・・・・・・・・・・・・ 100
5.2 Japan-Australia Synthetic Biology Workshop(Held online on March 16, 2022) ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 103
5.3 Policies of Major Provinces and Cities Basedon Chinaʼs 14th Five-Year Plan ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 110
5.4 Chinaʼs National Key Research and Development Programs“Synthetic Biology” and “Green Bio-manufacturing”・・・・・・・・・・・・・・・・・・・・・・・・・ 115

List of Authors ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ 121

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1

Introduction

1.1

Defining Synthetic Biology

Synthetic biology is an interdisciplinary field that merges various disciplines such as biology, engineering, systems
biology, bioinformatics, mathematics, chemistry, and computer science to artificially design life functions andconstruct artificial biological systems.
It is said that the term was first used by the French biologist Professor Stéphane Leduc around 19102. However,modern synthetic biology is based on the idea proposed by the Polish geneticist Professor Wacław Szybalski in 1974 inresponse to advancements in analytical techniques. His definition involves devising new control elements, adding new
modules to existing genomes, or constructing entirely new genomes3.
In this research report, synthetic biology (or Engineering Biology) is defined as “a field of study that combines
molecular biology and systems biology with engineering principles to design biological systems and biofactories,”with the objective being “to create more sophisticated biological functions capable of addressing future challenges inareas such as energy generation, food production, optimization of industrial processes, and the diagnosis, prevention,and treatment of diseases.4”
Under the Biden administration, a report by the Congressional Research Service (CRS) titled “The Bioeconomy: A
Primer” states that synthetic biology is a component of biotechnology5.
- Biotechnology involves utilizing cellular and biomolecular processes to develop technologies and processes.
- Synthetic biology is one of the elements that constitutes biotechnology, specifically being the science ofredesigning organisms for useful purposes by engineering them to have new abilities. Synthetic biology focuses
not only on integrating into larger systems to solve specific problems but also on designing and constructingcore components (such as parts of enzymes, genetic circuits, and metabolic pathways) that can be modeled,understood, and fine-tuned to meet specific performance criteria.
- The bioeconomy is economic activity driven by research and innovation in the life sciences and biotechnology,
made possible through technical advancements in engineering and computer and information science.

2

S. Tirard. (2009) “Stephane Leduc (1853-1939), from medicine to synthetic biology”, Histoire des sciences medicales, 43(1):67-72

3

W. Szybalski. (1974) “In Vivo and in Vitro Initiation of Transcription”, in A. Kohn and A. Shatkay (Eds.), Control of Gene Expression , pp.
23–24, and Discussion pp. 404–405. New York: Plenum Press.

4

According to the Thermo Fisher Scientific website on “Synthetic Biology”:
https://www.thermofisher.com/jp/ja/home/life-science/cloning/synthetic-biology.html

5

N. Chaudhary, et al. (2021) “mRNA vaccines for infectious diseases: principles, delivery and clinical translation”, Nat Rev Drug Discov , p.
817–838

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1.2

Advances and Challenges in the Emerging Technology Field of “Synthetic Biology” in Australia, China and India

Background(1) The Development of Synthetic Biology
The world is entering an era of synthetic biology, driven by advances in biotechnology and computational capabilities.
Dr. Craig J. Venter, an American molecular biologist who succeeded in synthesizing the entire genome of thebacterium Mycoplasma genitalium in 2008, has stated that we are moving from being able to read genetic code tobeing able to write it.
The development of synthetic biology has been propelled by advancements in nucleic acid sequencing (reading),
genome editing, microarrays, nucleic acid synthesis (writing), and single-cell manipulation technologies. As shown in
Figure 1-1, the cost of human genome analysis, which required 10 billion yen in 2000, had decreased to about 60,000
yen by 2020, thanks to the development of next-generation sequencers and information processing technologies overthe past 20 years since the Human Genome Project6. This has been a significant driving force for the advancement ofsynthetic biology.

Figure 1-1 Cost of Human Genome Analysis(Based on “The Cost of Sequencing a Human Genome6” by NHGRI, compiled by APRC)

Recent years have seen rapid advancements in applied research in crop breeding and medicine, thanks to theemergence of genome editing technologies like CRISPR-Cas9. The development8 of synthetic RNA technologies for
COVID-19 mRNA vaccines is also seen as a significant achievement in the field of synthetic biology. In addition,
the establishment of technologies for synthesizing long-chain DNA of tens of thousands of base pairs and analyzing

6

The Human Genome Project, planned by the American DOE and HHS, aimed to analyze the entire base sequence of the human genome. It
was initiated in 1990, with a draft sequence published in 2000. The analysis was completed in 2003.

7

NHGRI Cost per genome data (2021): https://www.genome.gov/about-genomics/fact-sheets/Sequencing-Human-Genome-cost

8

Dr. Katalin Karikó and Dr. Drew Weissman faced the challenge of administered mRNA being recognized as a foreign substance in the body,which they overcame by replacing uridine with synthetically produced pseudouridine to evade immune functions, breaking through a majorbottleneck.

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their functional expression within cells is advancing research aimed at understanding the functions and principles
of genomes. Examples of research that has greatly benefited from these technological innovations include thesynthetic yeast genome project (Sc2.0) with 16 chromosomes reported in 2018 by Professor Jef D. Boeke of New York
University, and the international project known as Genome Project-Write (GP-Write), started in 2016 in the UnitedStates, led by Professor George Church of Harvard University, aiming to understand the blueprint of life through thesynthesis of human cell lines and genomes of organisms important for agriculture and public health.
Furthermore, dramatic improvements in computational power, the foundation for analysis, have rapidly advanced
the fields of systems biology and high-throughput and automation technologies, allowing for the in silico reproduction
and understanding of biological systems from molecular dynamics. With a deeper understanding of the blueprint oflife and further advancements in these technologies, the manufacturing processes for biomolecules such as DNA could
become standardized and automated in a manner similar to industrial assembly lines, envisioning a future where
gene-targeted therapies, pharmaceuticals, and food production become more efficient, environmentally friendly, andavailable at lower costs.
Many of the technologies contributing to the development of synthetic biology were developed in the UnitedStates. America’s lead in the field of synthetic biology is generally attributed to the country’s continuous support forbiotechnology research and development, regardless of scale, and a thriving ecosystem for investment in startups
leading to commercialization.

(2) The Market for Synthetic Biology
In its future outlook for synthetic biology up to 2026, Markets and Markets’ Synthetic Biology Market report
predicts that the Asia-Pacific region will experience the fastest growth, with key factors including an increase insynthetic biology research projects, enhanced collaboration with foreign companies in the Chinese market, andincreased research and development budgets in the Asia-Pacific region. The market for synthetic biology spans tools(oligonucleotides / synthetic DNA, enzymes, etc.), technology development (genome engineering, sequencing, etc.),
and applications (healthcare, pharmaceuticals, agriculture, etc.), with established companies (as seen in the STAR
section in the top-right of Figure 1-2) like Thermo Fisher Scientific (US), Novozymes (Denmark), Merck KGaA
(Germany), and Agilent Technologies (US), as well as startups centered in the United States, competing for market
share. Established companies are actively expanding into China, including by establishing research and development
departments. There are high expectations for mergers and acquisitions of high-tech startups and market expansion
in the country. For instance, the German pharmaceutical company Merck has partnered with the Zhangjiang Group(Zhangjiang High-Tech Park) to open its largest Merck Innovation Hub in Zhangjiang Science City, a national-level
key high-tech industrial development zone approved by China’s National Development and Reform Commission and
the Ministry of Science and Technology, located in the Pudong district of Shanghai. This hub is driving new projects
focused on the innovation ecosystem, healthcare, biotechnology, and electronics. Merck also has innovation centers inShanghai and Guangzhou, Guangdong Province9.

9Merck website:https://www.merckgroup.com.cn/cn-zh/innovationhub_en.html

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Figure 1-2 Synthetic Biology Market; Company Evaluation Map for 2020
(Published with permission from Markets and Markets “FIGURE 28 SYNTHETIC BIOLOGY MARKET:COMPANY EVALUATION QUADRANT, 2020“)202010(3) The Risks Inherent in Synthetic Biology
The development and application of synthetic biology encompass issues and risks related to biosafety, biosecurity,and ethics. Synthetic biology also has a dual use in military applications. The Global Risks Report 2022 published by
the World Economic Forum11 lists examples of intentional/unintentional outcomes of technology such as AI, braincomputer interfaces, biotechnology, and quantum technologies under the category of technological advancementsthat could lead to negative legacies. One example of a related research outcome is the reconstruction of the 212kbp
virus genome of horsepox—which had been considered difficult to clone due to issues surrounding its genome

10

The “STAR” companies in the top-right of In Figure 1-2 are highly evaluated for their robust product portfolios, high market share, broad
application coverage, and global presence, indicating established companies that provide innovative tools and technologies. “EMERGINGLEADERS” in the top-left are companies with innovative products and significant market presence but lack a strong growth strategy.
“PERVASIVE” in the bottom-right are companies with strong business strategies and global distribution and supply capabilities but have amarket share inferior to STAR companies. “EMERGING COMPANIES” in the bottom-left are companies offering niche products but are
expected to grow.

11

WEF Global Risk Report 2022: https://www3.weforum.org/docs/WEF_The_Global_Risks_Report_2022.pdf

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hairpin structures and telomeres—by researchers at the University of Alberta, Canada, in 2018, by combining ten
synthetic fragments12. Similar results are not limited to pathogens. For example, attempts to resurrect extinct animals(mammoths) led by Professor George Church, have garnered attention for their combination of positive and negative
aspects. While it is difficult to halt or eliminate the advancement of technology, discussions on risk and governancestructures, including the incorporation of protective and marker functions in the design process of genomes, arebeing held not only among governments but also within researcher communities like iGEM13. Additionally, the fact
sheet from the Japan-US-Australia-India leaders’ teleconference (Quad Summit), held on March 21, 2021, included
a statement about facilitating cooperation to monitor trends and opportunities in the development of critical andemerging technologies, including biotechnology, through the Critical and Emerging Technology Working Group,
which includes Japan, the United States, Australia, and India. Moreover, the joint statement from the Japan-USAustralia-India leaders’ meeting on May 24, 2022, also mentioned ongoing discussions related to biotechnology.

1.3

Objectives of this Research Report

Although it entails risks such as biosafety, synthetic biology is an extremely useful significant emerging technology
for both Japan and humanity and is internationally recognized as a key area for new industries. Major developed
countries are actively promoting it as an essential technology for securing technological sovereignty (defined as
possessing indispensable technologies within an industry and being independent from other countries’ technologies).
In this context, by gathering information on policies and research and development trends in Australia, China, andIndia, which can be said to be the leading countries in the field of synthetic biology in the Asia-Pacific region, thisresearch aims to provide meaningful suggestions on the direction Japan country should take in terms of synthetic
biology-related policies from the perspective of science and technology innovation, and the possibilities of cooperation
with these countries. Relevant information from the United States14, believed to be leading the world in this field, hasalso been surveyed for reference.

1.4

Research Methodology

Information collection and analysis in this research report primarily used the following three methods:(1) Policy and Research and Development Trends (Chapter 2)
To assess trends in policies related to science and technology innovation and research and development related tosynthetic biology in Australia, China, and India, an overview of trends in biotechnology and healthcare was acquired.
If trends focused around synthetic biology were discovered in each country, those were investigated in depth. This

12

Ryan S., et al. (2018) “Construction of an Infectious Horsepox Virus Vaccine from Chemically Synthesized DNA Fragments”, PLOS ONE
13, no. 1: https://doi.org/10.1371/journal.pone.0188453

13

iGEM (The International Genetically Engineered Machine competition) is the world’s largest synthetic biology competition, held annually.
It conceptualizes genes as blocks, combining them to imbue various functions into organisms. The most recent competition, iGEM2022, saw
participation from over 5,000 people across 346 teams and was held in a hybrid format in Paris. https://blog.igem.org/

14

Protecting U.S. Technological Advantage (2022), National Academies of Sciences, Engineering, and Medicine.
https://doi.org/10.17226/26647

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involved desktop research on national initiatives in synthetic biology, major funding agencies, and research institutionsin these countries.
For India, where no clear national initiatives in synthetic biology were uncovered (and there appears to be noflagship policy), the research report was conducted as a whole in the field of biotechnology, which includes this area.
For the United States, its policies and research and development trends were noted as reference information and wereconsidered important for fulfilling the objectives of this research report.

(2) Analysis of Scientific Papers and Patents (Chapter 3)
Clarivate’s academic literature database Web of Science was used to collect data on papers. For data on patents,
LexisNexis’s TotalPatentOne (the world’s largest patent database) was used. Data analysis was based on keywords
specific to synthetic biology, a field within emerging biotechnologies.

(3) Summary (Chapter 4)
Based on the current situation of policies and research and development in Australia, China, and India (with the UnitedStates used as reference), this chapter summarizes the direction Japan should explore in synthetic biology-related
policies from the perspective of innovations in science and technology, and the possibilities of building cooperative
relationships in various fields with these countries.

(4) APPENDIX - Overview of Japan-Australia Workshop, etc.
To provide a reference for and to complement the investigation into policy and research and development in Chapter
2, the results from a workshop attended by top researchers from Japan and Australia are included. This workshop
was held on March 16, 2022, under the co-sponsorship of the Japan Science and Technology Agency (JST) AsiaPacific Center for Research (APRC), in cooperation with JST’s International Division, the Ministry of Education,
Culture, Sports, Science and Technology (MEXT), the Australian Government’s Department of Industry, Science,
Energy and Resources (DISER), the Commonwealth Scientific and Industrial Research Organisation (CSIRO), and
the Australian Embassy in Japan. The workshop facilitated information collection and discussions and hearings onareas for cooperation between the two countries. It was chaired by Professor Akihiko Kondo (Vice President of Kobe
University) from the Japanese side and Dr. Claudia Vickers (CSO of Provectus Algae Pty Ltd.) from the Australianside and saw more than 150 participants share research outcomes and the latest information on synthetic biology, with
14 speakers presenting.
Note: The exchange rates mentioned in this report are based on the rates at the end of March 2022 (TTS). The
parentheses indicate the fiscal year of each country.
・Australian Dollar: 94 JPY/AUD (July to the following June)・Indian Rupee: 1.78 JPY/INR (April to the following March)・Chinese Yuan: 19 JPY/CNY (January to December)
・US Dollar: 123 JPY/USD (October to the following September)

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2 Policy and Research and Development
Trends2.1

Australia

Australia’s total research and development investment, according to OECD statistics, was 35.602 billion Australian
dollars (approximately 2.9532 trillion yen) in 2019, with a GDP ratio of 1.8% (2019 estimate)15, 16. Statistics from
Universities Australia also show that the funding sources for research and development expenses include thegovernment, state governments, and companies, totaling 35.6 billion Australian dollars (approximately 3.3464 trillion
yen) in 2019/20. The government’s research and development expenditure for 2021/22 was 11.8 billion Australian
dollars (approximately 1.1092 trillion yen), a decrease of 184 million Australian dollars (approximately 17.2 billion
yen) from the previous year17. 31.5% of the total research and development expenses are allocated to the higher
education sector. The government’s research and development budget for 2020/21 (estimated) was 10.647 billion
Australian dollars (2019/20, 9.328 billion Australian dollars)18.
It should be noted that not all university research and research infrastructure is funded by government expenditure,and reliance on income19 from international students (tuition fees) was not considered sustainable given the impact of
COVID-19, posing a challenge on how to bridge this gap.
Investment in the field of synthetic biology was over 80.7 million dollars in public funds (2016-2021, approximately
9.9261 billion yen) 20 and over 20 million dollars in private funds (fiscal year 2020, approximately 2.46 billion yen)21,
leading to the establishment of 10 startups. However, this is significantly smaller compared to the public fundingof 1.4 billion dollars (2005-2015, approximately 172.2 billion yen) and private funding of 5.3 billion dollars (2018,
approximately 651.9 billion yen) in the United States, which holds a market share of 33-39%, with 336 startups, andthe United Kingdom’s public funding of 550 million dollars (2009-2016, approximately 67.6 billion yen) and private

15

OECD Main Science and Technology Indicators, https://stats.oecd.org/Index.aspx?DataSetCode=MSTI_PUB

16

Private company investment, although data is from 2017, is estimated to be 17.43 billion dollars, accounting for more than two-thirds.
OECD, Gross domestic expenditure on R&D by sector of performance and source of funds,
https://stats.oecd.org/Index.aspx?DataSetCode=GERD_SOF&_ga=2.235261765.556047645.1620879487-64687999.1620879487 (Accessed
October 20, 2022)

17

Universities Australia “RESEARCH FUNDING”: https://www.universitiesaustralia.edu.au/policy-submissions/research-innovations/research-funding/ (Accessed October 6, 2022)

18“Australian Government R&D programs and activities valued at over $100 million in 2021-22”,https://www.industry.gov.au/publications/science-research-and-innovation-sri-budget-tables

19

Tuition fees are said to cover 27% of university research costs. From “University research funding: a quick guide”
https://www.aph.gov.au/About_Parliament/Parliamentary_Departments/Parliamentary_Library/pubs/rp/rp2122/Quick_Guides/
UniversityResearchFunding (Accessed October 6, 2022)

20

Total public funding budgets for ARC CoESB (37 million dollars from ARC and NSW government), CSIRO Synbio Future Science Platform
and BioFoundry (27.7 million dollars), NCRIS Biofoundry Capability (8.3 million dollars), Macquarie Biofoundry (2.5 million dollars),
QUT Mackay Renewable Biocommodities Pilot Plant (5.2 million dollars). This budget does not include specific research project funding.

21

Includes seed investments in Provectus Algae (3.25 million dollars in October 2020) and Nourish Ingredients (11 million dollars in March).

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funding of 910 million dollars (2018, approximately 111.9 billion yen), with 150 startups and a market share of 8-12%22.
The federal government’s science and technology policy includes “Australia’s Science and Research Priorities”
announced in 2015 and the “National Science Statement” in 2017. However, as mentioned later, they are expected to be
updated following the change of government in July 2022, with the Albanese administration also focusing on “Putting
science back into government” to formulate evidence-based policies.
Australia is famous for the discovery of Helicobacter pylori by Professor John Robin Warren and Professor Barry
James Marshall of the University of Western Australia, who won the Nobel Prize in Physiology or Medicine in2005. This research originated from Professor Warren’s discovery of small, curved, previously unknown bacteria(Helicobacter pylori ) in the stomach mucosa of patients with gastritis in 1979, reflecting the longevity of researchin this field. Recently, Professor Edward C. Holmes of the University of Sydney, specializing in virus research, was
one of the first to announce the genetic sequence of the virus causing COVID-19 (SARS-CoV-2) to the world, alongwith China23. This discovery contributed to the acceleration of preclinical and clinical trials for vaccine candidates inAustralia.
The contribution of the medical technology, biotechnology, and pharmaceutical sectors to the overall economy ofAustralia was $5.5 billion AUD (Gross Value Added: GVA basis, approximately 517 billion yen) in 2021, an increaseof $300 million AUD (approximately 28.2 billion yen) compared to 201924. Employment increased by a total of 5,000
people over two years. However, supply chain challenges meant that exports decreased by 18% over the same period.
Nevertheless, based on these solid efforts to date, there is a prospect of growth to $7.6 billion AUD (approximately
714.4 billion yen) by 2025, creating an additional 3,000 jobs. Various plans have been formulated by government
agencies, public institutions such as universities, and the industry for research and development and industrial
cultivation of biotechnology, with specific financial and institutional support systems being introduced to implement
them.
Synthetic biology in Australia has grown from an individual, laboratory, or project-based effort, such as
participation in iGEM in the late 2000s, to a large-scale network effort as announced in the National Innovation andScience Agenda (NISA)25 in December 2015. In light of this, knowledge-sharing and educational hubs are being
actively formed by leveraging and strengthening the country’s existing research infrastructure networks.
In August of 2021, the CSIRO (the Commonwealth Scientific and Industrial Research Organisation) published
Australia’s Synthetic Biology Roadmap, which predicted that the national market could grow to generate up to $27
billion AUD (approximately 2.538 trillion yen) in annual revenue and supply 44,000 new jobs by 2040. In Novemberof the same year, the Department of Home Affairs released its Critical Technology Supply Chain Principles,
identifying synthetic biology as an emerging technology of strategic importance for supply chain security purposes26.
Furthermore, in December, the government’s Critical Technology Policy Coordination Office (CTPCO) published

22

CSIRO “A National Synthetic Biology Roadmap”, 2021

23

Fan Wu et. al. (2020) “A new coronavirus associated with human respiratory disease in China”, Nature , Vol. 579

24

MTPConnect. (2022) “Medical Technology, Biotechnology and Pharmaceutical Sector Competitiveness Plan”, MedTech and Pharma GrowthCentre, p5, https://www.mtpconnect.org.au/images/2022_MTPConnect_SectorCompetitivenessPlan.pdf (Accessed October 20, 2022)

25

As mentioned later, NISA outlines a future vision for Australia. It states that to create high-wage employment and new waves of economic
prosperity, new ideas in the fields of innovation and science must be adopted to create new drivers of growth. It places focus on (1) culture
and capital, (2) collaboration, (3) talent and skills, and (4) government as an exemplar.

26

Commonwealth of Australia 2021 “Critical Technology Supply Chain Principles”

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the Blueprint for Critical Technologies and Action Plan as a strategy to protect and promote critical technologies,
designated nine technology areas, including synthetic biology, that are expected to increase in importance within thenext 10 years. (5G/6G, AI, cybersecurity, genomics and genetic engineering (including synthetic biology), quantum
technologies, etc.).
As a result, Australia has been comprehensively promoting synthetic biology, viewing it as an important field fromthe perspective of basic research, industrial deployment, and national defense and security. This chapter summarizes
major policies, research and development, and industry trends in the field of biotechnology, including synthetic
biology, in Australia.

2.1.1 Government Organizations and Systems
Following the federal election in May 2022, Anthony Albanese, leader of the Labor Party, became the next Prime
Minister, and on June 23, the new government’s organization was announced, with the new government officiallycoming into power on July 1.
Examining the history of Australia’s science and technology innovation policies, the Office of the Chief Scientist
was established under the Department of Industry, Science and Resources in 1989 to provide authoritative andindependent scientific advice on the government’s science and technology priorities. Additionally, in 2014, theNational Science and Technology Council was established as an advisory body to the Prime Minister and related
ministers on significant issues related to science and technology, with the Prime Minister as chair and participationfrom the Chief Scientist. The main organizations and institutions related to synthetic biology under the Albaneseadministration are outlined in Figure 2-1.

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Figure 2-1 Main Organizations and Institutions Related to Synthetic Biology in Australia

The Chief Scientist is a full-time position, also serving as the chair of the National Research Infrastructure
Advisory Group, the Australian Climate Change Science Framework Coordination Group, and a member of othersignificant domestic and international science and technology-related meetings. Reports prepared by the Office of the
Chief Scientist are submitted to the Minister for Industry and Science after consultation with the Prime Minister andrelated ministers. The current Chief Scientist, the ninth in the role, appointed in August 2018, is Dr. Cathy Foley27,
who has achieved significant accomplishments in semiconductor electronics research at the CSIRO.
The National Science and Technology Council is also an institution that advises the Prime Minister and related
ministers on important science and technology issues. Within the council, the Prime Minister serves as chair, and thescience and technology-related ministers as vice-chair. The Chief Scientist acts as the Executive Officer, and the headof the CSIRO is a permanent member. The structure also includes six scientific expert members . The council’s tasks
are to address long-term and emerging issues, policy priorities in science and technology, the science and technology
system, goals set by the National Science Statement (mentioned later), and other requests from the Prime Ministerand related ministers. It typically holds four meetings annually. Furthermore, as part of the advisory process fromthe scientific community to the parliament and members of parliament, various platforms such as the functions of the27

Dr Cathy Foley, Australia’s Chief Scientist: https://www.chiefscientist.gov.au/DrCathyFoley (Accessed October 6, 2022)

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Chief Scientist, direct dialogs with researchers, events like Science Meets Parliament28, and the Australian Council of
Learned Academies (ACOLA) have been established.
As shown in the schematic diagram in Figure 2-1, the differences compared to the Scott Morrison administration
include the renaming of the “Department of Education and Training” to the “Department of Education,” the“Department of Health” to the “Department of Health and Aged Care,” the “Department of Industry, Science,
Energy and Resources” to the “Department of Industry, Science and Resources (DISR),” and the establishment of
the “Department of Climate Change, Energy, the Environment, and Water.”29 Additionally, the Defence Science andTechnology Group (DSTG) under the Department of Defence is a research institution that uses science and technology
to protect Australia and its interests. It is one of Australia’s largest organizations, with about 2,200 staff, including
scientists, engineers, and IT specialists, led by the Chief Defence Scientist, providing expert and impartial advice andinnovative solutions for defense and national security.
The main government research funding agencies related to science and technology innovation in Australia include
two organizations that provide grants based on researchers’ scientific curiosity using a bottom-up approach: theAustralian Research Council (ARC) under the jurisdiction of the Department of Education, and the National Healthand Medical Research Council (NHMRC) under the Department of Health and Aged Care.
However, there are also examples of top-down funding, including grants for research addressing socio-economicand environmental challenges that are available from various departments and related agencies, including the
Cooperative Research Centres (CRC) Grant Program from DISR 30. Of relevance, a recent challenge in science andtechnology innovation is the recognition of research and development outcomes based on academic paper rankingsand other metrics, which don’t reach commercialization or product development31.

2.1.2 Major Policies and Key Issues
This section reviews major policies related to synthetic biology by the Australian government and related agencies inrecent years.

(1) National Innovation and Science Agenda (NISA)32
NISA, announced in November 2015, aims to expand financial support for entrepreneurs, encourage risk-taking andenhance public research, broaden cooperation between industry and research institutions to contribute to solving

28

Science Meets Parliament is a networking event between federal members of parliament and science and technology stakeholders that started
in 1999. A lecture by Professor Katalin Karikó is scheduled for March 2023. The organizer of this event is Science & Technology Australia(formerly: Federation of Australian Scientific and Technological Societies (FASTS)), an organization formed by multiple science andtechnology-related bodies.
https://scienceandtechnologyaustralia.org.au/what-we-do/science-meets-parliament/science-meets-parliament-2023/

29

Administrative Arrangements Order made on 23 June 2022,
https://www.pmc.gov.au/sites/default/files/publications/administrative-arrangements-order-23-June-2022.pdf (Accessed October 6, 2022)

30“Backing research centres to boost economic output 13 January 2023”,
https://www.minister.industry.gov.au/ministers/husic/media-releases/backing-research-centres-boost-economic-output

31

Australian Parliament Tim Brennan, “Parliamentary Library Briefing Book - Science and research”, June 2022
https://www.aph.gov.au/About_Parliament/Parliamentary_departments/Parliamentary_Library/pubs/BriefingBook47p/ScienceResearch

32

National Innovation and Science Agenda report:
https://www.industry.gov.au/publications/national-innovation-and-science-agenda-report (Accessed October 2, 2022)

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global challenges and create jobs, attract world-class researchers, and capture innovations that lead to industrial
development. The plan provides an investment of 1.1 billion Australian dollars (approximately 103.4 billion yen) overthe four years following its announcement. In relation to biotechnology, this agenda included a proposal to establish a
Biomedical Translation Fund (BTF) to commercialize promising discoveries. The government contributed 250 million
Australian dollars, and private companies provided 251.25 million Australian dollars (approximately 23.6 billion yen)
to the fund, which operates at a total scale of 501.25 million Australian dollars (approximately 47.1 billion yen)33.

(2) 2015 National Science and Research Priorities34
The Australian government (at time of writing: the Department of Industry, Science, and Resources) identified
nine priority areas in the 2015 National Science and Research Priorities, including food, soil and water, health, andmanufacturing technologies related to biotechnology. These priorities form the basic support target for ARC funding.
The Australian government also announced on September 27, 2022, that it has started a review led by the Chief
Scientist with a task force in the Department of Industry, Science, and Resources, aiming to complete an update to thepriorities within the next 12 months35.
Items (1) and (2) were established prior to facing urgent issues such as climate change, infectious disease
countermeasures, and emerging critical technologies. The Albanese government will hold discussions with thescientific and industrial communities in response to these challenges. Based upon the results of this dialog there will
be a review of priorities led by the Department of Industry, Science, Energy, and Resources over one year, starting in
2022.

(3) 2017 National Science Statement36
The National Science Statement, formulated in 2017, sets long-term national goals and aims to provide guidance tothe government. Its main content includes strengthening Australia’s science system and providing guidelines forgovernment investment and policy decisions.
The statement identifies challenges such as only 4.8% of corporate investment going towards cooperation with
universities or publicly supported institutions, and weaknesses in STEM education, making it difficult to supply askilled workforce. The statement, therefore, outlines guidelines such as basing economic development on science,focusing investment in scientific research on advanced research, stabilizing and making predictable support for
research, promoting and supporting interdisciplinary, industrial, and international cooperation, and maximizing
opportunities for all Australians to engage in science.

33

Biomedical Translation Fund: https://www.bulletpoint.com.au/biomedical-translation-fund/ (Accessed October 2, 2022)

34

Science and Research Priorities:
https://www.arc.gov.au/funding-research/apply-funding/grant-application/science-and-research-priorities (Accessed October 2, 2022)

35

Australian Government to revitalise our science priorities: https://www.industry.gov.au/news/australian-government-revitalise-our-sciencepriorities; https://www.industry.gov.au/sites/default/files/2022-09/revitalising-australias-science-priorities-terms-of-reference.pdf (Accessed
October 6, 2022)

36

National Science Statement 2017: https://nicm.edu.au/__data/assets/pdf_file/0004/1233823/National-science-statement.pdf (Accessed
October 6, 2022)

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Advances and Challenges in the Emerging Technology Field of “Synthetic Biology” in Australia, China and India(4) Synthetic Biology in Australia: An outlook to 2030 37
In 2018, the Australian Council of Learned Academies (ACOLA) published a document titled Synthetic Biology inAustralia: An outlook to 2030. The chief author was Professor Peter Gray, a fellow of the Australian Academy ofTechnological Sciences and Engineering and the inaugural director of the Australian Institute for Bioengineeringand Nanotechnology (AIBN) at the University of Queensland. Although this document does not represent the
government’s view, it involved many renowned experts from the Australian academies, such as Dr. Claudia Vickers (seeAppendix), leading to the recommendation paper by the Office of the Chief Scientist mentioned in (5). The document
highlights the following points.
・That Australia has a strong scientific foundation and advanced knowledge in agriculture, positioning it favorably
in the field of synthetic biology.
・T hrough intensive and cooperative efforts, Australia can create internationally competitive new industries andprotect the export base of its agriculture.
・Communicating the potential benefits and risks of synthetic biology to the public is extremely important.
・Australia’s regulatory system for technology related to genetic modification is one of the most effective andadvanced in the world and revising it to reflect international trends is essential for the development of synthetic
biology.
・Developing talent with knowledge in STEM and HASS (Humanities, Arts, Social Sciences), and building national
infrastructure for international competitiveness is necessary.

(5) Occasional Paper: SYNTHETIC BIOLOGY38
Based on ACOLA’s document, the Office of the Chief Scientist released a recommendation paper (occasional paper)on August 5, 2020. While it largely agrees with ACOLA’s document, it states that Australia has research capabilities
and expertise in the field of synthetic biology, a regulatory environment, access to the Asian market, and a strong
agriculture-related industry, enabling it to leverage the opportunities synthetic biology offers. The paper lists thefollowing four challenges Australia should address:
・[Bridging the Gap Between Science and Industry] Current synthetic biology tools cannot predict the outcomes ofcircuits made by combining multiple synthetic parts. Therefore, directed evolution method— which won the Nobel
Prize in Chemistry in 2018—and modularization of parts are important approaches. The paper notes it is essential
to prepare a large number of interchangeable parts, much like LEGO® bricks. To address this need, the CSIRO
is prioritizing the construction of a BioBricks library and has established the Synthetic Biology Future Science
Platform to support industrial development.
・[ Enhancing Skills and Knowledge] Australian universities and industry are particularly skilled in tool
development, circuit design, protein engineering, and bioengineering, but there is a need to strengthen theirtechnological foundation in genome design and artificial gene construction. To enable the applied developmentof synthetic biology, an interdisciplinary field, it is necessary to enhance the development of talent in IT,
artificial intelligence, engineering, robotics, and machine learning, which are the basis for design, testing, and37

Synthetic Biology in Australia: An outlook to 2030: https://acola.org/hs3-synthetic-biology-australia/

38

Clarissa Fraser, Peter Gray, Office of Australia’s Chief Scientist (2020) “Synthetic Biology Occasional Paper”:
https://www.chiefscientist.gov.au/news-and-media/occasional-paper-synthetic-biology

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manufacturing.
・[Infrastructure Investment and Construction] Commercial facilities are needed to transition research findings
to large-scale production composed of products and components derived from synthetic biology. Over the past
decade, support and investment for research and development in synthetic biology has expanded, and under the
National Collaborative Research Infrastructure Strategy, facilities such as the National Biologics Facility and the
Mackay Renewable Biocommodities Pilot Plant at Queensland University of Technology have been developed.
Additionally, the New South Wales government has supported Macquarie University with 2.5 million Australian
dollars (approximately 235 million yen) to establish a biofoundry (a genome foundry with automated DNA
assembly and evaluation facilities)39, and the CSIRO has partnered with the University of Queensland to establish
a biofoundry.
・[Regulatory Framework for Risk Management] Predicting and assessing the potential risks synthetic biology may
pose to human health, biosecurity, and the environment is crucial, necessitating a review of genetic technology
and the regulatory framework.

(6) National Synthetic Biology Roadmap 40
The National Synthetic Biology Roadmap released by the CSIRO in August 2021, based on ACOLA’s documents andrecommendations from the Chief Scientist’s office, identifies the value of synthetic biology for Australia and outlines
methods for accelerating the demonstration, expansion, and commercialization of applications.
Under predictions that synthetic biology will become a $700 billion industry globally by 2040 (approximately
65.8 trillion yen), Australia is positioned to become a competitive leader in the Asia-Pacific region by designating
the period between 2021 to 25 as one of “Building capability and demonstrating commercial feasibility” 2025 to
30 as “Early commercial successes and establishing critical mass,” and 2030 to 40 as the “Growth through scaling
market-determined application priorities.” This roadmap was jointly created based on input from over 140 individuals
representing more than 60 organizations across government, industry, and research institutions.

(7) National Research Infrastructure Roadmap 202141
The National Research Infrastructure Roadmap 2021, by the Department of Education, sets priorities for future
investments in Australia’s research infrastructure, with specific funding provided through the National Collaborative
Research Infrastructure Strategy (NCRIS) program. Compiled by an Australian expert group led by Dr. Ziggy
Switkowski, Chancellor of Royal Melbourne Institute of Technology (RMIT), it outlines the national research
infrastructure needed over the next decade for maintaining Australia’s excellence and innovation and addressing newchallenges.
In the roadmap, synthetic biology is mentioned in the eighth recommendation as a research foundation for realizing

39

According to the National Synthetic Biology Roadmap, a biofoundry is defined as “A facility containing the resources, equipment, andsoftware required for high-throughput engineering of DNA-encoded biological components and systems. Biofoundries conduct the DesignBuild-Test and Learn stages of advanced bioengineering and synthetic biology research and development (R&D)”

40

CSIRO, “Australia’s Synthetic Biology Roadmap,” 2021. https://www.csiro.au/en/work-with-us/services/consultancy-strategic-adviceservices/csiro-futures/future-industries/synthetic-biology-roadmap

41

Australian Government, Department of Education, “National Research Infrastructure”:
https://www.education.gov.au/national-research-infrastructure

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the bioeconomy and as preparation for tackling future challenges, alongside digital infrastructure, environmental
and climate research, and bridging studies. It highlights the need for a strong network that integrates various omics
research and high-performance computing for synthetic biology research. However, it emphasizes the need for theformation of a strong network tailored to synthetic biology, functioning in conjunction with these elements, as anational infrastructure for research.
・The roadmap calls for biofoundries to streamline engineering processes foundational to synthetic biology research,
enabling rapid product development across various biological systems and capacities.
・It also states that access to a variety of bioreactors for experimental research would be desirable.
・I n addition, the roadmap states that efficiency and synergies must be maximized through integration andnetworking with other national research infrastructures and existing synthetic biology platforms, includinginternational organizations.
・In the interdisciplinary field of synthetic biology, it states that virtual/physical support from experts familiar withvarious technologies is required.

(8) Biotechnology in Australia – Strategic Plan for Health and Medicine42
In March 2022, the government evolved the “Health and Medical Industry Growth Plan 2018” into the “Biotechnology
in Australia – Strategic Plan for Health and Medicine.” This plan aims for investment in the innovation ecosystemfrom basic research to application, particularly targeting the commercialization of medical products. The plan statesthat cooperation between governmental research institutes and groups such as the CSIRO, ANSTO43, and the Defence
Science and Technology Group will be vital. It establishes three pillars.
・Strategic investments in key areas will be made to support world-class research and development to promoteindustry-academia-government partnerships.
・T he international competitiveness of research capabilities, processes, and infrastructure will be enhanced toensure a high-quality and safe clinical development framework.
・Accelerating commercialization through manufacturing support for pharmaceutical and medical technology
products and industry-academia-government partnerships.
This strategic plan is coordinated with the “Medical Products Roadmap under the Modern Manufacturing Strategy(MMS)”44 announced by the Department of Industry, Science, Energy, and Resources (at the time) in October 2020,
and aims to contribute to the biotechnology sector over the next decade with more than 8 billion Australian dollars(approximately 752 billion yen) in added value, over 1,400 related companies, over 80,000 supported employment
positions, and more than 12 billion Australian dollars (approximately 1,128 trillion yen) in product exports throughsustained growth in clinical trials.

42

Biotechnology in Australia: https://www.health.gov.au/sites/default/files/documents/2022/03/biotechnology-in-australia-strategic-plan-forhealth-and-medicine.pdf

43

ANSTO’s national deuteration facility contributes to the commercialization of mRNA products by mass-producing deuterated biomolecules
for both biomedical and pharmaceutical research.

44

Modern Manufacturing Strategy (MMS): Formulated by the Department of Industry, Science, Resources, and Energy in October 2020, thisstrategy supports Australian manufacturing with a total investment of 1.3 billion Australian dollars (now increased by 146 million Australian
dollars). Medical products are one of the six priority areas along with food, recycling/clean energy, defense, and space, etc. https://www.
industry.gov.au/news/modern-manufacturing-initiative-and-national-manufacturing-priorities-announced(Accessed October 1, 2022)

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The biotechnology sector is separated into different colors and includes medical products (pharmaceuticals, red),
agricultural bio (green), industrial & energy (gray), and marine (blue) sectors. The importance of vaccine technology,
diagnostic technology, and therapeutic technology in synthetic biology is highlighted, with the “National Synthetic
Biology Roadmap” suggesting methods for demonstration, expansion, and commercialization acceleration. This
strategic plan is reviewed every five years, and priorities are redefined every two years.
In relation to this policy, the Australian Defence Science, Technology and Research Summit 2022 (ADSTAR 2022)
was held in Sydney from July 20 to 22, 2022, hosted by the Defence Science and Technology Group (on behalf of the
Department of Defence)45. This summit focused on (1) resilience in conflict environments, (2) artificial intelligence for
defense, and (3) biotechnology for defense. Regarding theme (3), keynote sessions were presented by Professor Dame
Angela McLean of the UK Ministry of Defence, Dr. Stephanie Rogers, acting principal director of biotechnology at
the US Department of Defense, and Dr. Nick Beagley, and Dr. Greg Coia of the Australian Department of Defence.
Discussions and lectures covered Synthetic/Engineering Biology, dual-use applications, initiatives by the US DARPA,
and Manufacturing USA’s BioMADE, among other topics. At the summit, Professor Tanya Monro, the Chief Defence
Scientist, presented on the efforts of the Safeguarding Australia through Biotechnology Response and Engagement
alliance (SABRE) to protect and strengthen Australia’s bioresearch. She discussed how SABRE plans to compile
opinions on biotechnology from Australian universities, research institutions, and small and medium-sized enterprises(SMEs) and connect these with the needs of the defense and national security sectors.

(9) The Action Plan for Critical Technologies
In April 2021, the Department of Foreign Affairs and Trade announced the International Cyber and Critical
Technology Engagement Strategy46. The strategy defines critical technologies as those that enhance national interests,
including Australia’s prosperity, social cohesion, and national security, and have the potential to pose risks to theseinterests. Critical technologies listed include cyberspace, artificial intelligence (AI), 5G, the Internet of Things (IoT),
quantum computing, and synthetic biology. In relation to critical technologies, the strategy continues to prioritize the
Indo-Pacific region for the diplomatic objectives of cyber and critical technologies. It aims to build new partnerships,
strengthen existing ones, and enhance activities that pursue shared democratic values. The strategy outlines afundamental policy to ensure that the supply and use of cyber and critical technologies do not endanger international
peace, security, and democratic values.
On November 17, 2021, then Prime Minister Scott Morrison announced the “Blueprint for Critical Technologies,”
consisting of four goals and seven actions.47 This document identifies synthetic biology as a technology thatsignificantly enhances Australia’s national interests or poses risks, listing it as one of the critical technologies of initial
focus.48
On the same date, the Action Plan for Critical Technologies49 was announced, detailing specific measures for

45

ADSTAR2022: https://www.dst.defence.gov.au/event/australian-defence-science-technology-and-research-summit-adstar

46

International Cyber​​and Critical Technology Engagement Strategy : https://www.internationalcybertech.gov.au/strategy

47

Critical Technologies Policy Coordination Office, “Blueprint”:
https://www.pmc.gov.au/resource-centre/domestic-policy/blueprint-critical-technologies

48

Critical Technologies Policy Coordination Office, “Critical Technologies”:
https://www.pmc.gov.au/resource-centre/domestic-policy/list-critical-technologies-initial-focus

49

The action plan for critical technologies: https://www.industry.gov.au/publications/action-plan-critical-technologies

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63 technologies across eight categories. This plan provides a specific vision for protecting and advancing criticaltechnologies in alignment with national interests. Synthetic biology is included in the “Biotechnology, Genetic
Engineering, and Vaccines” category, comprising bio-manufacturing, biomaterials, genetic technologies, genome,
and genetic sequencing, nanobiotechnology, and nanoscale robotics. Within this category, the focus is initially on
genomics and genetic engineering, emphasizing genetic engineering, genome sequencing and analysis (including nextgeneration sequencing), and synthetic biology.
Research and development programs related to biotechnology or synthetic biology are categorized into four levels:(1) No regret, (2) Responsive support, (3) Pre-emptive support, and (4) On-shoring and regulation, with individual
responses planned accordingly. Among the current biotechnology or synthetic biology programs, mRNA vaccine
manufacturing technologies (sovereign mRNA vaccine capability), highlighted due to COVID-19, are speciallymentioned as part of the fourth category.

(10) Other related safety regulations include:
The Food Standards Australia New Zealand (FSANZ) is responsible for setting and managing food standards basedon the Food Standards Australia New Zealand Act 199150. Its mission is to protect the health and safety of Australians
and New Zealanders by ensuring a safe food supply.
FSANZ sets standards that apply to both Australia and New Zealand, as well as Australia-specific standards.
Overall, food standards in Australia and New Zealand are known as the Food Standards Code.
The Australian Gene Technology Act 200051 is a national regulatory framework for genetically modified organisms.
It aims to identify risks arising from or as a result of gene technology, and by regulating certain dealings withgenetically modified organisms, it protects public health and safety as well as the country’s environment, managing
those risks.
Australia has been a party to the Convention on Biological Diversity (CBD) since 1993, committing to fulfill its
obligations under the CBD in accordance with national priorities.52 In 1996, the Australian government approved thefirst National Biodiversity Strategy and Action Plan (NBSAP) showing how CBD obligations would be implemented
domestically. After extensive reviews, Australia announced the third revised NBSAP, “Australia’s Strategy for Nature
2019-2030,”53 on November 8, 2019.

2.1.3 Funding
The following is a summary of funding related to synthetic biology covering basic to applied research.

50

Australian Government’s Health, “Food Standards Australia New Zealand”

51

Office of Parliamentary Counsel, Canberra. (2000) “Gene Technology Act 2000”

52

Under the CBD, a technical expert group on synthetic biology has been established, with its Conference of the Parties (COP) deliberating on
the matter. In December 2022, at COP15 held in Montreal, Canada, it was acknowledged that no conclusion had been reached on whether
synthetic biology constitutes a “new issue” for discussion under the Convention on Biological Diversity (agenda item 27). It was decided
that a horizon scan to analyze and interpret future prospects would be conducted, and the effectiveness of this process would be reviewed at
COP16. References: https://www.nacsj.or.jp/2022/12/33376/

53

Commonwealth of Australia. (2019) “Australia’s Strategy for Nature 2019-2030”:
https://www.australiasnaturehub.gov.au/national-strategy

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Advances and Challenges in the Emerging Technology Field of “Synthetic Biology” in Australia, China and India(1) Funding for Universities and Corporations
Competitive funding for universities is primarily distributed by the Australian Research Council (ARC) and the
National Health and Medical Research Council (NHMRC). Table 2-1 summarizes 39 cases and funding amounts
totaling 94.46 million Australian dollars (approximately 8.46 billion yen) for universities, based on data from theGrant Information System GrantConnect54 from January 2018 to January 2023, with synthetic biology as a keyword.

Table 2-1 Funding for Synthetic Biology Research by University from January 2018 to January 2023

University/ResearchInstitution

Funding Amount (2018-2023,
in thousand AUD)

University of Queensland

3,648 (including COE 3,500)

4

0

0

Macquarie University

3,593 (including COE 3,500)

2

0

0

Australian National University

378

3

0

0

Monash University

368

5

1

0

University of Western
Australia

324

3

2

0

University of Sydney

241

4

0

0

University of New South
Wales

204

3

0

0

University of Melbourne

191

3

0

0

University of Newcastle

120

3

0

0

HydGene Renewables

110

0

0

1

Walter and Eliza Hall Instituteof Medical Research

79

0

1

0

Flinders University

59

1

0

0

Curtin University

53

1

0

0

Queensland University ofTechnology

39

1

0

0

University of Technology
Sydney

34

1

0

0

Total

9,446 (about 8.46 billion yen)

34

4

1

54

Number of Projects
ARC

NHMRC

DISR

GrantConnect is a comprehensive database for registering Australian government grant information. 42 cases were analyzed that hit in the
search with the keyword “synthetic biology” and the date range “01-Jan-2018 to 01-Jan-2023”:
https://www.grants.gov.au/

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The University of Queensland’s “Centre of Excellence for Innovations in Peptide and Protein Science (CIPPS)”55
and Macquarie University’s “Centre of Excellence in Synthetic Biology (CoESB)” are major recipients of ARC
Centres of Excellence funding (support for COE establishment, with 35 million AUD (approximately 3.29 billion yen),provided over 7 years), making up a significant portion of university grants. The ARC accounts for nearly 96% of thetotal funding support (90.5 million AUD; approximately 8.5 billion yen), followed by 3% from NHMRC (2.86 million
AUD; approximately 240.64 million yen), and 1% from DISR (Business Research and Innovation Initiative, BRII, 1.1
million AUD; approximately 103.4 million yen). The total funding over five years56 amounts to 94.46 million AUD(approximately 8.46 billion yen).
ARC’s individual programs include various ones such as Discovery, similar to Japan’s Grants-in-Aid for Scientific
Research, Linkage for network formation support, and Industrial Transformation Research Hubs for industryacademia collaboration support.
NHMRC’s adopted projects include applied research such as designing new therapeutic drugs using synthetic
biology, receptor engineering to improve cancer immunotherapy, and developing FRET-based protein sensors for
localization analysis.
HydGene Renewables, receiving funding from DISR’s Business Research and Innovation Initiative (BRII), is
engaged in R&D at the Macquarie University campus to produce renewable hydrogen gas from carbohydratecontaining raw materials by manipulating the genetic functions of green algae like Chlamydomonas through asynthetic biological approach. The base of HydGene Renewables’ R&D originated from a student team at Macquarie
University winning the Best Energy Project 2017 at the iGEM, the world competition in synthetic biology, in 201757.
Macquarie University, in collaboration with the CSIRO, has bioplatforms for joint research, enabling researchers toaccess cutting-edge infrastructure through collaborations with Bioplatforms Australia, supported by the National
Collaborative Research Infrastructure Strategy (NCRIS) program, the National Biologics Facility, Phenomics
Australia, and the Australian Plant Phenomics Facility.

(2) The Medical Research Future Fund (MRFF)
The MRFF, established by the Abbott government in 2015, saw its cumulative investment reach 20 billion AUD(about 1.88 trillion yen) over five years by July 2020. During the second 10-year investment plan period from 202223 to 2031-32, 6.3 billion AUD (about 592.2 billion yen) will be invested to support research innovation in humanhealth, job creation, and strengthening regional industries, aiming to lead the world in medical research. Investment
targets include (1) Research benefiting patients, such as clinical research and innovative treatments (1.4 billion
AUD: approximately 131.6 billion yen), (2) Key research aggregating leading researchers, health professionals, andstakeholders (1.5 billion AUD; approximately 141 billion yen), (3) Support for R&D aimed at skill enhancement for of
researchers and marketization (1.3 billion AUD; approximately 122.2 billion yen), and (4) Support for evidence-basedtranslational research (2.1 billion AUD, approximately 197.4 billion yen). Recent investment amounts are summarizedin Table 2-2, with 2021-22 seeing nearly double the increase compared to 2019-21.

55

CIPPS is not mentioned in the context of synthetic biology within the National Synthetic Biology Roadmap.

56

Includes the amount of ARC-COE support over 7 years.

57

Macquarie University iGEM2017: https://2017.igem.org/Team:Macquarie_Australia

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Table 2-2 Annual investment amounts for R&D activities in the health and medical sector (in million AUD)58

Fund Name

2019-2020

2020-2021

2021-2022

NHMRC Grants

901

891

870

Medical Research Future Fund MRFF

393

580

646

Biomedical Translation Fund BTF

29

58

25

R&D Tax Incentive

246

251

267

Other

112

99

114

(3) The Cooperative Research Centres (CRC) Program59
The Cooperative Research Centres (CRC) program, established by the Australian government in 1990, provides
funding for industry-led joint research conducted between industry, university researchers, and end-users. The
program offers two types of financial support: CRC Program Grants for industry-led mid to long-term joint research
focusing on the application of research for up to 10 years, and grants supporting short-term (within 3 years) joint
research led by industry. Strategic oversight of this program is provided by Innovation and Science Australia60 and its
CRC Advisory Committee.
The CRC Program Grant provides funding to industry-led research centers (established concurrently with theinitiation of the CRC Program Grants) aiming to utilize Australian expertise for practical outcomes beneficial
to Australian businesses. This grant supports industry-led collaborative research centers for up to ten years. It iscurrently overseen by DISR. Grant applications target research fields across all industry sectors, requiring applicants
to seek at least an equal amount of cash or investment in-kind from partners, including the applicant. The 24th roundof applications started on January 13, 2023.
Since its inception, more than 5.5 billion AUD has been provided to establish 236 CRCs and 189 CRC projects,
further leveraging 16.8 billion AUD in cash and investment in-kind from partners. According to DISR, CRC Grants
provide a missing step between research and commercialization. They are evaluated to bring about 32.5 billion AUD
in economic productivity through the commercialization of products and services using new technologies by 2025.
The main synthetic biology-related CRCs that received funding focus on areas such as future fuels, digital health,future battery industries, food loss countermeasures, future food systems, and marine bioproducts.

(4) Startup Support61
The Biomedical Translation Fund (BTF) is a fund under the Department of Health and Aged Care aimed at investingin early-stage biomedical companies, announced in the 2015 NISA. The total support amount is 501 million AUD (about

58

Data reprinted from “Biotechnology in Australia - ‘Strategic Plan for Health and Medicine’”:59

Cooperative Research Centres Program impact evaluation:
https://www.industry.gov.au/publications/cooperative-research-centres-program-impact-evaluation

60

Industry Innovation and Science Australia,
https://www.industry.gov.au/science-technology-and-innovation/industry-innovation-and-science-australia

61

BTF: https://business.gov.au/grants-and-programs/biomedical-translation-fund

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47 billion yen), with 250 million AUD (about 23.4 billion yen) from government funds and 251.25 million AUD (about
23.6 billion yen) from corporate funds, supporting nearly 27 startups to date, including Blade Therapeutics Pty Ltd,
which develops treatments for idiopathic pulmonary fibrosis.

(5) R&D Tax Incentive62
Although not a support system limited to the biotechnology sector, nor a direct financial support system, the tax
incentive exists as a support system for R&D where tax deductions can be obtained for research and development
investments. The tax authorities and the Department of Health are collaborating to ensure it is an accessible system forcompanies working on clinical trials of therapeutic drugs. It has been established for over 10 years and more than 1,000
companies have received tax deductions amounting to 2.5 billion Australian dollars (approximately 235 billion yen)annually.

(6) Patent Box Initiative63
This initiative, announced in May 2022, is a discounted tax regime applicable to revenues generated from new patents
in the medical and biotechnology sectors from July 1, 2022. A 17% discount rate is applied to the corporate income ofcompanies in the medical and biotechnology sectors that meet certain eligibility criteria.

2.1.4 Main Research Institutions and University R&D Trends
As shown in Figure 2-2, Australian universities supported by ARC Centers of Excellence and the CSIRO work closely
together and participate in the Global Biofoundry Alliance. The country also has many research institutes and privatecompanies specializing in medical and agribio research, and actively participates in joint research with Europe andAmerica. The following are some major Australian research institutes.

62

R&D Tax Incentive: https://www.ato.gov.au/Business/Research-and-development-tax-incentive/

63“Patent Box - tax concession for Australian medical and biotechnology innovations”, https://www.ato.gov.au/General/Newlegislation/In-detail/Direct-taxes/Income-tax-for-businesses/Patent-Box---tax-concession-for-Australian-medical-and-biotechnologyinnovations/#:~:text=In%20the%202021%2D22%20Budget,effective%20from%201%20July%202022 (accessed on October 2, 2022)

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Figure 2-2 Australian Synthetic Biology Research Institutions.
(In parentheses is the proportion of synthetic biology research to the entire country based on Web of Science
information from 2015-2020, created based on the “National Synthetic Biology Roadmap“)(1) CSIRO Synthetic Biology Future Science Platform (SynBio FSP)64
In September 2018, the CSIRO established the Synthetic Biology Future Science Platform (SynBio FSP) to support
innovation and create commercialization opportunities in the manufacturing, industrial biotechnology, environmental
remediation, agriculture, biosecurity, and healthcare industries. In 2018, 13 million US dollars (approximately 1.599
billion yen) were invested in the SynBio FSP, focusing on three programs: environment and biocontrol, chemicals andfibers, and symbionts and organelles. According to Dr. Claudia Vickers, the founder and former Director of SynBio
FSP (currently CSO at Eden Brew), and current Director Dr. Colin Scott, SynBio FSP has trained about 100 PhD
researchers through the Future Science Fellows and SynBio FSP PhD Top-up Scholarships, across 24 laboratories(research institutions) in Australia and 17 international partner institutions65. It also has an International Advisory
Committee consisting of about ten leading researchers, such as Professor Paul Freemont from Imperial College
London, Professor John Glass from the J. Craig Venter Institute, and Professor Pamela Silver from Harvard University,
working towards effective management. The CSIRO BioFoundry (a bio-production system called a “BioFoundry”)
was established within SynBio FSP, offering contracted analysis of the design/build/test/learn (DBTL) process,including combinatorial gene design, DNA assembly, high-throughput strain construction, phenotypic analysis, anddata analysis.

64

CSIRO SynBio: https://research.csiro.au/synthetic-biology-fsp/

65

JST/APRC workshop“Future Trends and Emerging Technologies in Synthetic Biology” 2022,
https://www.jst.go.jp/aprc/en/event/2022ausjp.html

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Advances and Challenges in the Emerging Technology Field of “Synthetic Biology” in Australia, China and India(2) Macquarie University ARC Centre of Excellence in Synthetic Biology (CoESB)
The Australian Research Council (ARC) Synthetic Biology COE (CoESB), headed by Macquarie University, aims topioneer new approaches to microbial design to develop custom-designed microbial populations and novel synthetic
enzymes. According to Professor Ian Paulsen—who has led the microbial genome sequencing project at The Institutefor Genomic Research (TIGR; founded by J. Craig Venter, the representative of CoESB)—the Centre consists of
19 domestic and international research groups, 19 industrial collaborators, and 16 research partners. It has madesignificant contributions to the Yeast 2.0 international consortium (contributing to the synthesis of chromosomes 14
and 16)66 and has established a presence as a hub for genome analysis in Australia, known as the Genome Foundry. In
particular, the CoESB has partnered with the metabolomics facility of the Australian Wine Research Institute (AWRI),
supported by a bio-platform for yeast metabolism routes, focusing on research centered on functional modifications
through synthetic biology approaches. In May 2019, the Global Biofoundries Alliance (GBA) was established in
Kobe, with the University of Queensland and Macquarie University (the parent body of the CoESB)67 participating as
founding members from Australia.

(3) University of Queensland (UQ) - Australian Institute for Bioengineering andNanotechnology (AIBN)68
The UQ-Australian Institute for Bioengineering and Nanotechnology (AIBN) is a large-scale research instituteestablished in 2004 and is composed of hundreds of scientists aiming to solve challenges in energy, health, and thebioeconomy. At the end of 2021, Professor Alan Rowan, the director of the research institute, announced the launchof a new facility in the field of bioeconomy research called IDEA Bio (Integrated Design Environment for Advanced
Biomanufacturing)69. This facility, funded by NCRIS, aims to offer a comprehensive design environment for project
development, including the evaluation of fermentation characteristics of strains, multi-omics characterization, andcell design. IDEA Bio collaborates with American biotechnology company Amyris Inc, American pharmaceuticalcompany Zoetis Inc, and Dow AgroSciences Inc, to lead cutting-edge research in synthetic biology.

66

The Yeast 2.0 project is an international partnership focused on utilizing synthetic biology tools to construct the world’s first synthetic
eukaryotic genome. It includes major international leaders participating from institutions such as New York University (USA), Johns Hopkins
University (USA), the Joint Genome Institute (USA), BGI (China), Tianjin University (China), Tsinghua University (China), Imperial
College London (UK), the University of Edinburgh (UK), and Australia (hosted by Macquarie University). The results were featured in the
March 10, 2017, issue of SCIENCE magazine (Vol.355, No. 6329).

67

GBA originated from discussions in 2018 about the establishment of 15 biofoundries worldwide aiming for efficient mutual operation. As of2022, there are 30 biofoundries worldwide, with the breakdown in the Asia-Pacific region (in no particular order) being Japan (1), China (5),Australia (2), India (1), South Korea (2), and Singapore (1). The institutions are as follows: Agile BioFoundry (USA), Australian Genome
Foundry (Australia), BIOFAB, University of Washington (USA), Biofactorial (Canada), The BioFoundry at UBC (Canada), BioFoundry
India (India), Colorado Cyberbiofoundry (USA), CompuGene, TU Darmstadt (Germany), Concordia Genome Foundry (USA), CSIRO
BioFoundry (Australia), DAMP lab, Boston University (USA), DTU Biosustain BioFoundry (Denmark), Earlham DNA Foundry (UK),
Edinburgh Genome Foundry (UK), GeneMill, Liverpool (UK), iBioFAB-Illinois Biological Foundry for Advanced Biomanufacturing(USA), K-Biofoundry (KAIST KRIBB) (South Korea), Kobe Biofoundry (Japan), LARA, Laboratory Automation Robotic Assistant
Biochemistry Greifswald (Germany), Living Measurement Systems Foundry, NIST (USA), London BioFoundry ICL (UK), SIAT BiofoundShenzhen (China), SJTU (Shanghai Jiao Tong University) Synbio BioFoundry (China), SKy Biofoundry Sungkyunkwan University (South
Korea), SYNBIOCHEM, Manchester (UK), SynCTI, Singapore BioFoundry (Singapore), Tianjin BioFoundry-Tianjin Institute of Industrial
Biotechnology (China), Tianjin University BioFoundry (China), VTT Technical Research Centre of Finland (Finland), Zhejiang University(China):https://www.nature.com/articles/s41467-019-10079-2.pdf?proof=t+target%253D

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UQ-AIBN: https://aibn.uq.edu.au/

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IDEA Bio has high-throughput facilities capable of designing and testing hundreds of strains in a week.
https://www.ideabio.org.au/

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The facility cooperates with many university facilities such as BASE (a joint facility of the National Bioproducts
Facility and Protein Expression Facility)70, Metabolomics and Proteomics Facility (Q-MAP), and Protein Expression
Facility (PEF), promoting efficient research and development.
Additionally, in synthetic biology-related research, Professor David Craik, a world-leading researcher in peptide
research and protein structural analysis and the center director of ARC Centre of Excellence for Innovations in
Peptide and Protein Science (CIPPS), is discovering new proteins and peptides from Australia’s diverse flora andfauna, synthesizing novel proteins and peptides through functional analysis. One of the three flagship research pillars
highlighted is biosynthetic technology for peptide and protein engineering, utilizing technologies such as the RaPID
system developed by Professor Hiroaki Suga of the University of Tokyo, identifying novel peptides such as the SARSCoV-2 spike protein.

2.1.5 Trends in Major Industries
In 2020, Australia accounted for 15.3% of the synthetic biology market in the Asia-Pacific region, with projections
indicating growth from 275 million US dollars (approximately 33.8 billion yen) in 2021 to 863 million US dollars(approximately 106.1 billion yen) by 2026, at a compound annual growth rate (CAGR) of 25.7% during the period.71
The Australian biotechnology-related industry as a whole mainly comprises medical technology, digital health,pharmaceuticals, and food & agricultural companies. It is seeing particularly notable growth in pharmaceuticals andfood & agriculture, which are also related to synthetic biology.
According to a 2019 report72 by the Australian corporate body AusBiotech, biotechnology-related industries haveshown a 16% increase since 2017. The number of companies has grown by about 15%, with a market value estimatedat 1.7 billion US dollars (approximately 209.1 billion yen).73 These industries are relatively widely distributed but
are particularly concentrated in Victoria (707 companies in 2019) and New South Wales (652 companies in the sameyear), with 73% of all companies located in these states. Investments in research by companies have reached 2 billion
US dollars (approximately 246 billion yen) by 2020-21, mainly in genomics, translational research, brain tumors,and clinical research. The Department of Health and Aged Care (DHAC)’s Genomics Health Futures Mission aims
to invest 500 million US dollars (approximately 61.5 billion yen) over 10 years from 2018-19 in genomics research to
improve tests and diagnostics that contribute to personalized treatment. In March 2022, AusBiotech announced the“Biotechnology Blueprint: A Decadal Strategy for the Australian Biotechnology Industry 2022-2032.”74 The blueprint
was based on consultations with academia, industry, and government, and aims to make the Australian biotechnology
industry a cornerstone of the future economy. It focuses on promoting translational research and innovation creation,
supporting dual focus (universities, companies) on commercialization, implementing special projects such as scaling
up small businesses, enhancing the competitiveness of Australian researchers in the international arena, and building70

UQ-BASE: https://basefacility.org.au/

71

Markets and Markets, “Synthetic biology market - Global forecast to 2026,” 2021.

72

AusBiotech is an industry body comprising over 3,000 members in the Australian life sciences sector, including therapeutics, medical
technology (devices, diagnostics), digital health, and agricultural biotechnology, and has been active for over 35 years. Australia’s Life
Sciences Sector Snapshot 2019: https://www.ausbiotech.org/documents/item/589

73

Mainly from Synthetic Biology Market-Global Forecast to 2026.

74

Biotechnology Blueprint2022: https://www.ausbiotech.org/documents/item/703

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sovereign capabilities in biotechnology, among eight75 recommendations. These recommendations are aligned with the“Biotechnology in Australia – Strategic Plan for Health and Medicine” by the Department of Health mentioned earlier
in 2.1.2 (8).
Additionally, MTPConnect76, a non-profit organization established in 2015, aims to foster growth and academicindustry collaboration in the medical technology, biotechnology, and pharmaceutical sectors. After announcing its first
Sector Competitiveness Plan (SCP) in 2016, MTPConnect revised the plan again in 2022. The SCP plays a leading rolein clarifying the commercial research potential and outcomes of this industry. In particular, the plan’s Growth Centre
operates five MRFF programs: BioMedTech Horizons (MBTH), Biomedical Translation Bridge (BTB), Researcher
Exchange and Development within Industry (REDI), Targeted Translation Research Accelerator (TTRA), and ClinicalTranslation and Commercialisation Medtech (CTCM), enabling commercialization and support for the scaling ofstartups and small businesses77.
Notable companies here include four startups among the ten deep tech startups identified in the National Synthetic
Biology Roadmap, closely associated with ARC-CoESB and the CSIRO:(1) Bondi Bio (NSW) company 78
Established in 2018, Bondi Bio develops Cyanoworks (tm), using cyanobacteria with high metabolic efficiency as
chassis strains for producing fragrances, cosmetics, nutritional supplements, pharmaceuticals, aromatic chemicals,
and matter production. It produces astaxanthin, squalene (shark liver oil), sandalwood oil, and nootkatone (a grapefruit
fragrance component) in a carbon-neutral manner. In October 2021, it won the UN FAO’s Startup Innovation Award(UN WFF Innovator of the Year). It has partnerships with the University of Technology Sydney, the University of New
South Wales, Macquarie University, the University of Queensland, the Marine Bioproducts CRC, and ARC-CoESB.

(2) MicroBioGen (NSW) company
Founded in 2001 by Dr. Philip Bell, Dr. Paul Attfield, and four others from Macquarie University, MicroBioGen’s
strength lies in owning a library of non-genetically modified yeast strains (exempt from GM regulations). In
collaboration with Denmark’s Novozymes, it has developed strains like Innova®Drive, successfully mass-producing
first-generation bioethanol. It has also succeeded in developing an optimization process for second-generation
bioethanol production with an 8 million Australian dollar grant (ARENA) from the Australian government.
MicroBioGen develops and optimizes industrial yeast strains suitable for producing high-protein feed. The company
developed first-generation biofuel yeasts under the “Innova” brand, with Novozymes, a major partner and investor,
handling sales and marketing.

75

AusBiotech: “Industry-backed plan to navigate Australian biotech into the future”, 12 May 2022,
https://www.ausbiotech.org/news/industry-backed-plan-to-navigate-australian-biotech-into-the-future (accessed on October 2, 2022)

76

MTPConnect :https://www.mtpconnect.org.au/

77“Sector Competitiveness Plan”, MTPConnect:
https://www.mtpconnect.org.au/images/2022_MTPConnect_SectorCompetitivenessPlan.pdf (accessed on October 2, 2022)

78

Bondi Bio company: https://www.bondi.bio/about

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Advances and Challenges in the Emerging Technology Field of “Synthetic Biology” in Australia, China and India(3) PROVECTUS ALGAE (QLD) company
Founded in 2018, Provectus Algae is a startup with biotechnology manufacturing technology79 based on microalgae.
Founder and marine biotechnologist Dr. Nusqe Spanton, in cooperation with the University of the Sunshine Coast’s
Genetics Research Centre (now the Centre for Bioinnovation), developed a novel chloroplast expression system forcommercial applications, including large-scale and rapid manufacturing of genetically modified algae.
In October 2020, it successfully raised 3.25 million dollars (approximately 399 million yen) from Hong Kong’s
Vectr Ventures in a seed round to accelerate the commercialization of their in-house developed synthetic biology
platform for algae, which includes proprietary lighting equipment. In 2022, its further improved and optimized its
expression system using the CSIRO’s Innovation Connections80 program that provides support for SMEs, developing
protocols for the commercial production of peptides and proteins. The company plans to launch four commercial
products in 2023 and is aiming to expand its staff and expand into the United States.81(4) Eden Brew (NSW) company
Eden Brew, a food tech startup aiming to produce animal-free milk, was founded in 2021 with funding from Norco,
Australia’s largest dairy cooperative, and the CSIRO’s venture capital Main Sequence. Using recombined yeast
protein production technology developed by the CSIRO, it produces six common milk proteins, including casein
and β-lactoglobulin. In 2022, it hired Dr. Claudia Vickers, former director of the CSIRO’s Future Science Platform,
as Chief Science Officer (CSO). Dr. Vickers is a founder of Synthetic Biology Australasia, a member of the expert
working group on Australia’s national synthetic biology and infrastructure investment plan, and co-chair of theWorld Economic Forum’s Global Future Council on the Future of Synthetic Biology, as well as serving on advisorycommittees including Food Standards Australia New Zealand (FSANZ).

2.2 China
China’s total research and development investment for the year 2022, as announced by the National Bureau of
Statistics (preliminary figures), increased by 10.4% from 2021 to 3.087 trillion yuan (about 59 trillion yen), with thepercentage of GDP increasing by 0.12 points from 2021 to 2.55%. This marks an annual average growth rate of 8%
since the start of the 13th Five-Year Plan in 2016, exceeding the growth rate of over 7% targeted in the 14th Five-Year
Plan (2021-2025). In particular, basic research funding increased by 7.4% from the previous year to 195.1 billion yuan(about 3.7 trillion yen), making up 6.32% of the total R&D investment and maintaining a level above 6% for four

79

Their system, called Precision Photosynthesis®, adjusts gene expression through control by light, enhancing cell proliferation andbiomanufacturing productivity to produce novel compounds for food, cosmetics, and agricultural products.
https://provectusalgae.com/microalgae-biotechnology-biomanufacturing-platform/

80

Innovation Connections:
https://www.csiro.au/en/work-with-us/funding-programs/SME/Innovation-Connections/About-the-program81

CSIRO:https://www.csiro.au/en/work-with-us/funding-programs/SME/Innovation-Connections/Medical-Pharmaceuticals-Success-Stories/
Provectus-Algae?utm_source=Snapshot_October_2022&utm_medium=newsletter&utm_campaign=Snapshot_October_2022

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consecutive years82.
While the exact amount of investment in the field of synthetic biology is not specified, the 2021 annual report toCongress submitted by the U.S.-China Economic and Security Review Commission in November 2021 states that aspart of its strategy in synthetic biology, the central and local governments combined have invested over 100 billion
dollars (12.3 trillion yen) in the biotechnology sector83.
China has been investing in R&D through collaboration between industry, academia, and government andpromoting biotechnology research, including synthetic biology, with the expectation that it will solve problems
in the fields of medicine, agriculture, environmental restoration, and natural resource utilization and bring about
economic and social development in the country. The government is also working to attract human resources fromother countries and develop high-level human resources. In recent years, the “Fourteenth Five-Year Plan for National
Economic and Social Development and the Outline of Distant Objectives for 2035,” announced in 2021, mentions
synthetic biology technology with keywords such as “disruptive,” “strategic needs,” “frontier technology,” and “keytechnology,” and emphasizes the need for medium- to long-term development to become a world leader.
The starting point for China’s initiatives in synthetic biology was the 2008 Xiangshan Science Conference (“ 香山科学会议第 322 学术讨论会综述 2008”)84, held in Beijing, where “synthetic biology” was adopted as a theme forthe first time, with attendees including academician Zhang Chunting of the Chinese Academy of Sciences, callingfor enhanced government support for the field, recognizing its significant value to the future bioeconomy. Following
this conference, the “Key Laboratory of Synthetic Biology” was established by the Chinese Academy of Sciences in
2008, marking the first official government initiative in synthetic biology in China. Since then, the field has rapidly
developed in China through active research support from the Ministry of Science and Technology to the Chinese
Academy of Sciences, Chinese Academy of Engineering, and various universities under the national key research anddevelopment programs (then known as the “863 Program”, “973 Program”), and platform building through expanding
sequencing and oligonucleotide synthesis capabilities led by major companies such as the Beijing Genomics Institute(BGI)85. The Chinese government is also proactive in establishing biobanks closely related to genome analysis
information. The China National GeneBank (CNGB), established in Shenzhen by the National Development andReform Commission in 2011 (opened in 2016), is China’s first national-level gene storage bank. It features three banks:
Biorepository, Bioinformatics Data Centre, Living Biobank, and two platforms: Digitalization Platform, Synthesis andEditing Platform. The China National GeneBank DataBase (CNGBdb) works to database this information86. Currently,

82“China’s research and development investment in 2022 exceeds 3 trillion yuan”, CRIonline, January 23, 2023
https://japanese.cri.cn/2023/01/23/ARTIngCJezQjHA3nzckUTHd7230123.shtml#:~:text=%E5%9B%BD%E5%AE%B6%E7%B5%B1%E8%A8%88%E5%B1%80%E3%81%8C%E3%81%93%E3%81%AE%E3%81%BB%E3%81%A9,%EF%BC%85%E3%81%AB%E9%81%9
4%E3%81%97%E3%81%A6%E3%81%84%E3%81%BE%E3%81%99%E3%80%82

832021 REPORT TO CONGRESS of the U.S.-CHINA ECONOMIC AND SECURITY REVIEW COMMISSION, NOVEMBER 2021, https://www.uscc.gov/sites/default/files/2021-11/2021_Annual_Report_to_Congress.pdf

84

The Xiangshan Science Conference, initiated in 1993 by the Ministry of Science and Technology and supported by both the Ministry and theChinese Academy of Sciences, aims to provide a free discussion forum for academics. Supporting organizations include the National Natural
Science Foundation of China, Chinese Academy of Sciences, Chinese Academy of Engineering, Ministry of Education, Central MilitaryCommission Science and Technology Commission, China Association for Science and Technology, National Health and Family Planning
Commission, and the Ministry of Agriculture:

85

LeiPei et al. (2011) “Synthetic biology: An emerging research field in China”, Biotechnology Advances Vol 29, Issue 6, pp804-814

86

China National GeneBank DataBase (https://doi.org/10.25504/FAIRsharing.9btRvC (accessed on June 10, 2022))

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China is said to have the largest capacity for genome storage in the world.87
One iconic institution is the Institute of Synthetic Biology established by the Chinese Academy of Sciences inShenzhen in 2017. This institute began cooperating with the Shenzhen Institute of Advanced Technology (SIAT) in
2018, opening several research centers such as for Quantitative Synthetic Biology, Synthetic Genomics, Synthetic
Biochemistry, Synthetic Microbiome, Genome Engineering and Therapy, and Synthetic Immunology, becoming acentral figure in China’s synthetic biology field.

2.2.1 Government Organizations and Systems
The organization and research development system of the Chinese government is shown in Figure 2-3. The core role informulating China’s science and technology policy is played by the Communist Party of China and the State Council,
with the Ministry of Science and Technology (MOST) under its guidance.
The national budget and final accounts related to science and technology are jointly prepared by MOST and theMinistry of Finance and approved by the State Council88. China’s funding system is based on centralized managementby the central government. Specifically, under the leadership of the State Council and MOST, medium to long-termscientific development plans are established in accordance with the country’s basic policy and the needs of scienceand technology development, and these are made public as central policies. In response, local (provincial, municipal,
autonomous region) governments and various bureaus adjust their policies to the specific conditions of their regions
and bureaus and implement various measures89. Under MOST, there is the National Natural Science Foundation ofChina (NSFC), a funding organization supporting basic research. Following the plan to deepen the reform of party
and state institutions in 2018, NSFC was transferred from the State Council to the jurisdiction of MOST, becoming
an organization with greater independence than before. Amongst synthetic biology-related research and development
in China, MOST oversees major research and development projects. Moreover, while research institutions such asuniversities, the Chinese Academy of Sciences, and the Chinese Academy of Agricultural Sciences are central tonational research and development project promotion, many also receive support from local city governments andcooperate with companies. The Chinese Academy of Sciences is placed directly under the State Council and is a largeorganization with research institutes, universities, think tanks, publishing houses, and spin-off companies under its
umbrella.

87

U.S. CSET Roll Call. (2021) “China’s amassing of genomic data highlights global biotech race:
https://cset.georgetown.edu/article/chinas-amassing-of-genomic-data-highlights-global-biotech-race/

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JST Asia-Pacific Research Center “Promotion of Basic Research in China and the Future of ’Scientific Research Management’ Reform”(APRC-FY2021-RR01) pp. 33-34, partially reproduced.

89

China’s funding system is divided into three levels, starting with central-level funding including the Ministry of Science and Technology,
Ministry of Education, National Development and Reform Commission, followed by local-level funding by local provinces and cities’
science and technology agencies, finance bureaus, and finally, funding conducted independently by some private organizations andcompanies. (Ibid., APRC-FY2021-RR01, p151)

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Figure 2-3 Main organizations and institutions related to synthetic biology in China

2.2.2 Major Policies and Key Issues (Central Government)
China formulates its economic and social policies in five-year intervals. The State Council announced the “Outlineof the National Medium and Long-Term Science and Technology Development Plan (2006-2020)” in 2006, and Table
2-3 shows the main biotechnology-related items related to synthetic biology in policies since then90. According to
the 2021 annual report to Congress91 by the U.S.-China Economic and Security Review Commission, the Chinese
government (central and local governments) has invested over 100 billion dollars (about 127 trillion yen) in researchand development in the field of biotechnology, including synthetic biology. The strengthening of companies throughM&A has also become active, and in 2017, the acquisition of the Swiss pesticide company Syngenta by ChemChina
for 43 billion dollars (about 5.461 trillion yen) became the largest acquisition of a foreign company by China at thetime. China’s the increasingly active collection of human and non-human genome information in biobanks throughcooperation and support with other countries is also noteworthy.

90

JST China Comprehensive Research & Sakura Science Center (currently Asia and Pacific Research Center), “The Policy Changes andDevelopment History of Science and Technology in China,” March 2019.

91

U.S.-CHINA ECONOMIC AND SECURITY REVIEW COMMISSION, â€œ2021 REPORT TO CONGRESS of the U.S.-CHINAECONOMIC AND SECURITY REVIEW COMMISSION, ONE HUNDRED SEVENTEENTH CONGRESS FIRST SESSION, U.S.
Government Publishing Office,https://www.uscc.gov/sites/default/files/2021-11/2021_Annual_Report_to_Congress.pdf (accessed November 2021)

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Table 2-3 Changes in Policies in the National Science and Technology Five-Year Plans since 2006
(Excerpts related to Synthetic Biology)

Plan

Period11th National
Science andTechnology
Five-Year Plan

20062010

12th National
Science andTechnology
Five-Year Plan

20112015

13th National
Science andTechnology
Innovation
Five-Year Plan

92

20162020

Item

Key Areas/Fields (Excerpts)

Promotion of
Independent
Innovation

Information, life, space, ocean, nano, new materials,
etc.

Focus ondevelopmentof high-techindustries(2) Bioindustry (out of 8)

Major national
science andtechnology
projects92(8) Genetic engineering for biological breeding(9) Development of major new drugs(out of 11)

Strategic
emerging
industries(3) Bioindustry (out of 7)

Advanced
technology fields(2) Bio and pharmaceutical technology (out of 10)

Implementationof major scienceand technology
projects(7) Independent innovation in breeding technology
and seed industries (out of 15)

Improvementof international
competitivenessin industrial
technology(1) Advanced agricultural technology(7) Advanced biotechnology(out of 10)

Strengthening
basic research

Strategic basic research aimed at societal needs(1) Genetic improvement of agricultural products (outof 9)Advanced basic research(3) Protein complexes and control of life processes(8) Synthetic biology(9) Genome editing (out of 13)

Support from the 863 Program and the 973 Programs (integrated into the “National Key Research and Development Programs” in 2016),
international cooperation program on the synthesis of eukaryotic yeast genomes “Synthetic Yeast Genome Project (Sc2.0)” with Chinese
teams from Peking University, Tsinghua University, Shenzhen BGI, and the United States, etc., completed the design and total synthesis offour chromosomes: syn II , syn V , syn X , syn XII .

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Fourteenth
Five-Year Plan
for National
Economicand Social
Development
and the Outline
of DistantObjectives for2035 (Science,
Technology& Innovation)

Advances and Challenges in the Emerging Technology Field of “Synthetic Biology” in Australia, China and India

20212026(up to2035 asa distantvision)Part Two:
Adhere toinnovationdriven
development
andcomprehensively
build newadvantages indevelopment
Chapter Four:Strengthen
national strategicscience andtechnology
Section Two:
Enhancebreakthroughs
in science andtechnology
driven by original
innovation

Implement strategic science plans and science
projects in fundamental core areas related tonational security and development. Execute major
national science and technology projects targeting
frontier areas such as artificial intelligence, quantum
information, integrated circuits, life and health, brain
science, biological breeding, aerospace science andtechnology, the deep earth and deep sea.
[Key Initiatives in Science and Technology
Frontier Areas]
05 Genetics and Biotechnology
Research into and application of genomics,
technological innovations in genetic cells, genetic
breeding, synthetic biology, and biopharmaceuticals;
innovation in vaccines, research and development
into in vitro diagnostics and antibody drugs, produce
significant new varieties of crops, livestock, poultry,
aquatic products, and agricultural microorganisms,
research, and development of critical technologies forbiosafety

Section Four:
Construction ofMajor Scienceand Technology
Innovation
Platforms

Support Beijing, Shanghai, and the GuangdongHong Kong-Macao Greater Bay Area in forminginternational science and technology innovation
centers, constructing comprehensive national science
centers in Beijing Huairou, Shanghai Zhangjiang, theGreater Bay Area, Anhui Hefei, and support eligible
regions to build regional science and technology
innovation centers.
[Column 3: National Major Scientific andTechnological Infrastructure]
04 Improvement of Peopleʼs Livelihood
Translational medicine research facilities, multi-mode
trans-scale biomedical imaging facilities, phenotype
and genotype research facilities for model animals,
experiment sites for earthquake science, numericalsimulators for earth systems, etc., will be constructed.

In addition to the above, the State Council’s “Outline of the National Medium and Long-Term Science and Technology
Development Plan (2006-2020),” announced in 2006, is positioned as the cornerstone of China’s science andtechnology policy for the next 15 years. It highlights key areas such as genetic engineering, new drug development,
infectious diseases, biotechnology, protein research, and developmental and reproductive research. Furthermore, the“Made in China 2025” initiative (2015) emphasizes biopharmaceuticals and high-performance medical equipment,
and the “Outline of the National Innovation-Driven Development Strategy 2016-2030)” prioritizes health technology
as a priority effort.
The “Outline of the National Medium and Long-Term Science and Technology Development Plan (2021-2035)”
includes the construction of national laboratories in fields such as quantum information and AI, biomedicine, as
well as the restructuring of existing key national laboratories. It also focuses on strengthening basic research andpositioning AI, quantum information, integrated circuits, life and health, brain science, genetics & bio-breeding, space
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science technology, the deep earth / the deep sea as key frontier fields. This development plan outline was scheduled
for publication before March 2021, but was postponed due to prioritization of responses to the COVID-19 pandemic.
Additionally, prior to the announcement of the “Fourteenth Five-Year Plan for National Economic and Social
Development and the Outline of Distant Objectives for 2035,” on September 25, 2020, the National Development andReform Commission issued the “Guiding Opinions on Expanding Investment in Strategic Emerging Industries andCultivating Strengthened New Growth Points and Growth Poles.”93 This guidance focuses on industries designatedand invested in as strategic emerging fields since 2016, aiming to expand investment to accelerate the transformationof the industrial structure and achieve advanced and high-quality economic development. The information on
synthetic biology was taken from the source below.

Accelerating the Pace of Innovation and Development in the Bio-Industry
Key industrial projects such as innovative vaccines, in vitro diagnostics and detection reagents, and antibody
pharmaceuticals are being accelerated, and the upgrading of vaccine types and processes is being promoted. The
construction of the national bio-safety risk prevention and management system is to be systematically planned,
with increased investment in bio-safety and emergency response. The construction of a national biologicalproduct inspection and verification innovation platform is to be strengthened, and the construction of researchand development centers for genes, cells, and genetic breeding technologies, synthetic biology innovation centers,
and biopharmaceutical technology innovation centers will promote the healthy development of biotechnology.
The examination and approval mechanism for traditional Chinese medicine will be reformed and improved, andthe research and development and industrial development of traditional Chinese medicine will be promoted.
Projects will be implemented that benefit biotechnology to create markets for self-innovative pharmaceuticals,
medical devices, and other products. (Responsible departments: National Development and Reform Commission,
Health Commission, Ministry of Science and Technology, Ministry of Industry and Information Technology,
National Administration of Traditional Chinese Medicine, State Administration for Market Regulation, etc.)

On May 10, 2022, the National Development and Reform Commission issued the “14th Five-Year Plan for theDevelopment of the Bio-economy” 94 in relation to policies in the five-year plan. The development plan focuseson whole genome sequencing, systems biology, synthetic biology, and artificial intelligence (AI)-aided breeding
technologies and promotes the creation of artificial proteins and food development using synthetic biology. This isprioritized content in the aforementioned Fourteenth Five-Year Plan for National Economic and Social Development

93

国家発展改革委員会 , “ 关于扩大战略性新兴产业投资培育壮大新增长点增长极的指导意见

94

National Development and Reform Commission website: https Commentary by 徐涛・, Member of the Chinese Academy of
Sciences:https://www.ndrc.gov.cn/xxgk/jd/jd/202205/t20220509_1324432.html Commentary by 馬炎和・天津市人民代表大会常務委員
会副主任兼中国科学院天津工業研究所所長 , on the perspective of biological manufacturing:https://www.ndrc.gov.cn/xxgk/jd/jd/202205/t20220510_1324454.html

发改高技 1409 号 ,” 2020. [Online].
Available:
https://www.ndrc.gov.cn/xxgk/zcfb/tz/202009/t20200925_1239582.html?code=&state=123. [Accessed January 2022].

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and the Outline of Distant Objectives for 2035. Of note, however, the shift from the traditional “scale-oriented”
approach to a “quality-oriented” approach is a new perspective. Also, the statement regarding “establishing andimproving world-class scientific and technological facilities and innovative platforms and providing active support
to support the development of biotechnology,” citing the United States, Germany, the United Kingdom, France, andJapan, aims to generate innovation through the support of high-level national research institutions and universities,
support for innovative projects, leadership development, and the construction of high-level bio-industry clusters. (Note:
Or “highlights the importance.”) It particularly emphasizes Beijing, Shanghai, and the Guangdong-Hong Kong-Macao
Greater Bay Area as international science and technology innovation centers led by China. Although not directly
related to the policy, policies related to peak carbon and carbon neutrality (dual carbon) announced by the StateCouncil also include research and development using synthetic biology methods from the perspective of improving the
production efficiency of bioenergy and require ongoing attention.
Although not directly linked to policy, of central level interest is President Xi Jinping’s speeches at the academic
conferences of the Chinese Academy of Sciences and the Chinese Academy of Engineering, where in 2018, heused the word “synthetic biology” for the first time, and in 2021, touched on the importance of life ethics from theperspective of “synthesis and design of life.” The relevant excerpts are as follows, both in line with the national policy
at the time.
(1) May 28, 2018, 19th Academic Conference of the Chinese Academy of Sciences and the 14th Academic Conferenceof the Chinese Academy of Engineering“Since the beginning of the 21st century, the world’s technological innovation has entered an unprecedentedly
concentrated and active period, a new round of technological revolution and industrial transformation isreshaping the world’s innovation map and restructuring the world’s economic structure. New generation
infor mation tech nologies, as represented by ar tif icial intelligence, quant u m infor mation, mobile
communications, the Internet of Things, and blockchain, are accelerating revolutionary applications, andlife sciences, as represented by synthetic biology, gene editing, brain science, and regenerative medicine, arecreating new transformations.”95(2) May 28, 2021, 20th Academic Conference of the Chinese Academy of Sciences, the 15th Academic Conference of
the Chinese Academy of Engineering, and the 10th National Conference of the China Association for Science andTechnology“Humanity has entered an era of intelligent interconnection of everything, integrating humans, machines, andobjects. Basic and applied research in life sciences is rapidly developing. Through scientific and technologicalinnovation, research on biological macromolecules and genes has not only benefited humanity by enablingunderstanding of and the evolution of life but has also reached a stage of regulation as an ethical issue in life
synthesis and design.”96

95

Chinese Academy of Sciences, “ 在中国科学院第十九次院士大会、中国工程院第十四次院士大会上的讲话 ,” May 2018:https://www.cas.cn/zt/hyzt/ysdh19th/.

96

Xi Jinping: Speech at the 20th Conference of the Chinese Academy of Sciences. (2021) “ 中国工程院第十五次院士大会、中国科协第十
次全国代表大会上的讲话 ,” May 28, 2021: https://www.cas.cn/zt/hyzt/ysdh20th/yw/202105/t20210528_4790360.shtml

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2.2.3 Major Policies and Key Issues (Local Governments)
Following the “Fourteenth Five-Year Plan for National Economic and Social Development and the Outline of DistantObjectives for 2035,” various provinces and cities have published plans related to the advancement of their industries97.
In China, local governments, such as provinces and cities, are also supporting research and development throughplatform construction and startup support based on each policy. Among them, particularly in Shanghai Zhangjiangand Shenzhen, research and development plans related to synthetic biology are planned at the four major national
science centers (comprehensive national science centers: Beijing Huairou, Anhui Hefei, Shanghai Zhangjiang,
and Shenzhen) approved by the National Development and Reform Commission and the Ministry of Science andTechnology, and focused initiatives are also indicated in Zhejiang Province and Shanxi Province. Figure 2-4 provides
an overview of this. In addition, policies related to synthetic biology in various provinces and cities are compiled inappendix table A-3.

Figure 2-4 “Promotion of Synthetic Biology Research in Various Provinces and Cities Basedon the 14th Five-Year Plan“

Local science and technology development funds supporting these local government policies are intended tosupport the four areas listed in Article 5 (free exploration-type basic research, construction of science and technology

97

Ministry of Science and Technology of China, “Ministry of Science and Technology & Local Science and Technology”:
http://www.most.gov.cn/dfkj/bj/

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innovation bases, deployment of science and technology achievements and technology transfer, and construction of
innovation ecosystems) of the management measures for science and technology development funds in local regions
guided by the central government issued in November 202198.
Table 2-4 lists the top 10 provinces and cities for the 2022 budget of science and technology development funds for
local governments guided by the central government (total of 4.5 billion yuan (about 85.5 billion yen))99. According
to the “Statistical Bulletin of National Investment in Science and Technology in 2020” by the National Bureau of
Statistics, the national fiscal expenditure on science and technology in 2020 was a total of 1.95 trillion yuan (about
19.1805 trillion yen (central government 375.82 billion yuan (about 7.1495 trillion yen), local governments 633.68
billion yuan (about 12.399 trillion yen))100. Based on the same statistics, expenditure in research and development fromlocal governments in 2020, including to the private sector (experiments/development), is listed in Table 2-5. In the
breakdown, enterprises account for 76.6% of this expenditure. Regionally, there are 8 provinces and cities, including
Guangdong Province and Jiangsu Province, where investment in R&D exceeded 100 billion yuan (approximately 1.9
trillion yen). The budgets in the table are not limited to synthetic biology research, but among the budgets from thecentral government to local governments, as well as those by local governments, the budget allocation for Guangdong
Province stands out amongst the national science centers, indicating a situation that could well be described as a new
dawn of scientific research.

Table 2-4 Budget for Local Science and Technology Development Funds
Guided by the Central Government in 2022 (Top 10)

No.

Province/City

Budget (Ten Thousand Yuan)

1

Guangdong

34,5002

Sichuan

31,9003

Jiangsu

27,5004

Zhejiang

26,0005

Shandong

25,3006

Anhui

20,0007

Hubei

18,5008Henan18,0009

Shaanxi

15,70010

Hunan

14,800Total for All Provinces/Cities

450,000

98

Central People’s Government. (2021)“ 关于印发《中央引导地方科技发展资金管理办法》的通知财教 ,” No. 204, November 2021:
http://www.gov.cn/zhengce/zhengceku/2021-12/22/content_5663957.htm.

99

Ministry of Finance of the People’s Republic of China. (2022) “ 关于下达 2022 年中央引导地方科技发展资金预算的通知 ,” No. 88:
http://jkw.mof.gov.cn/gongzuotongzhi/202204/t20220429_3807720.htm

100

National Bureau of Statistics of China. (2021) “2020 年全国科技经费投入统计公报 ,” September 22. Final figures for fiscal expenditures ofcentral and local governments :http://www.stats.gov.cn/tjsj/tjgb/rdpcgb/qgkjjftrtjgb/202109/t20210922_1822388.html

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Table 2-5 Research and Development Expenditure by Local Governments in 2020

No.

Province/City

Research and Development
Expenditure (Billion Yuan)

Rate of Investment in Researchand Development (%)

1

Guangdong

3479.93.14

2

Jiangsu

3005.92.93

3

Beijing2326.6

6.44

4

Zhejiang

1859.92.88

5Shandong

1681.92.30

6Shanghai1615.74.17

7Sichuan1055.3

2.17

8

Hubei

1005.3

2.31

9

Henan

901.3

1.64

10

Hunan

898.7

2.15

Total for All
Provinces/Cities

24393.1

2.40

2.2.4 Funding
The National Natural Science Foundation of China (NSFC), which was transferred from a direct organization under
the State Council to the management of the Ministry of Science and Technology (MOST) in 2018, funds basic research
fields in China. Figure 2-5 summarizes the number of projects related to the field of synthetic biology from 2010 to2019101, 102.
Between 2010 to 2019, there was a clearly increasing trend in the number of project applications and funding in thefield of synthetic biology. Out of a total of 3,258 applications, 793 were accepted (acceptance rate of 24%), distributing
a total of 567 million yuan (about 10.7 billion yen). It should be noted that NSFC funding primarily supports basic
research, and so this does not represent overall funding trends for synthetic biology in China.

101

杜 全 生 , 洪 伟 , 祖 岩 . ( 2020) “ 2010— 2019 年 国 家 自 然 科 学 基 金 资 助 合 成 生 物 学 领 域 情 况 ” , 合 成 生 物 学 , 1( 3) : 385- 394 d o i :10.12211/2096-8280.2020-06

102

Information on individual projects is also available from the LetPub website:
https://www.letpub.com.cn/index.php?page=grant#fundlisttable

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Figure 2-5 Number of Projects in the NSFC Related to the Field of Synthetic Biology (2010-2019)

In the general program ( 面上类项目 ), the NSFC’s main funding program, 97 projects including keywords suchas genome editing and chassis cell & model animal construction (total of 45.44 million yuan (about 863.36 million
yen, approximately 9 million yen per project)) were accepted. Recent efforts in artificial genome synthesis include
4 projects (total of 1.29 million yuan (about 24.51 million yen, approximately 6 million yen per project)), gene
circuit construction includes 17 projects (8.11 million yuan (about 154.1 million yen, approximately 9 million yen
per project)), and studies related to synthetic metabolic networks include 104 projects (49.06 million yuan (about
932.14 million yen, approximately 9 million yen per project)). A significant portion of the research subjects aremicroorganisms such as E. coli and yeast (62%, 158 institutions), with others including plants such as rice, wheat, andsugar beet (62 institutions), animals such as mice and primates (45 institutions), and humans (74 institutions).
Within the talent development program ( 人才类项目 ), projects related to synthetic biology include 7 innovative
group research programs ( 创新群体研究项目 ) funded with 43 million yuan (approximately 817 million yen, about
116.71 million yen per project), 6 National Outstanding Young Scientists Fund programs ( 国家杰出青年科学基金项
目 ) with funding of 22.5 million yuan (approximately 427.5 million yen, about 71.25 million yen per project), and 15
Excellent Young Scientists Fund programs ( 优秀青年科学基金项目 ) funded with 18.8 million yuan (approximately
357.2 million yen, about 59.53 million yen per project), totaling 28 projects with 95.55 million yuan (approximately
1.81545 billion yen) in support to 11 universities and 7 research institutions.
In the innovative group research programs, the team led by Professor Yuan Yingjin ( 元英进 ), Vice President of
Tianjin University and academician, established a method for precise repair of genome defects, with some researchoutcomes published in journals such as Science. This result was selected as one of the top 10 scientific achievements (中国科学十大进展 ) in China for 2017103. The research was performed in joint with Professor Jef D. Boeke of New York103

XIE Z X, et al. (2017) ““Perfect” designer chromosome V and behavior of a ring derivative”. Science, 355(6329):

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University. Additionally, Dr. Dai Junbiao from the Shenzhen Institute of Advanced Technology (SIAT) of the Chinese
Academy of Sciences developed a method to rapidly and efficiently reconstruct (repair) sequence defects that occur
during the synthesis of yeast genomes using the SCRaMbLE method employed in the yeast Sc2.0 project104.
Within the key programs ( 重点类项目 ), the key program ( 重点项目 ) supported 12 projects related to theconstruction of model organisms, microbial drug synthesis, and artificial life systems, with funding of 32.71 million
yuan (approximately 621.49 million yen , about 51.8 million yen per project). Additionally, the major program ( 重大项目) provided support for 5 projects in the aforementioned fields with 29.92 million yuan (approximately 568.48 million
yen, about 113.69 million yen per project). Furthermore, 5 projects that came under major research programs ( 重大研究计划 ) received funding of 3.25 million yuan (approximately 61.75 million yen, about 12.35 million yen per project),which included research on constructing disease models in non-human primates.
As a significant achievement supported by the key programs, Dr. Qin Zhong Jun of the Center for Excellencein Molecular Plant Sciences of the Chinese Academy of Sciences fused 16 chromosomes of yeast, creating thefirst eukaryote with a single linear chromosome (SY14 yeast), which was published in Nature Protocols in 2019105.
This established a functional chromosome fusion method using CRISPR-Cas9, allowing for the design of novel
chromosomes, chromosome fusion, and functional verification within 18 days. Additionally, although slightly older
in 2016, Dr. Qiu Zilong’s team from the Center for Excellence in Brain Science and Intelligence Technology of theChinese Academy of Sciences established an autism animal model in non-human primates, with some results of thisresearch published in Nature106. Besides the above, NSFC funding projects include international joint research support
programs, which are omitted in this section.
Thus, NSFC funding supports basic research in synthetic biology, and is not limited to applied fields, enhancing the
momentum for creating innovation in China.
Although this research did not gather comprehensive information, as examples of non-NSFC funding, information
on “Synthetic Biology” key special projects approved by the Ministry of Science and Technology in fiscal year 2021,
as well as projects in the green bio-manufacturing field that solicit research and development using synthetic biology
techniques, is organized in Appendix Table A-4, according to “Several Opinions on Improving and Strengthening
the Management of Central Financial Research Projects and Funds” by the State Council, including “Notice on
Deepening the Management Reform Plan of the Central Financial Science and Technology Plan (Special Projects,etc.)” and “Interim Measures for the Operation of National Key Research and Development Projects.” For green biomanufacturing, the 2022 call for proposals is seeking innovative proposals from young researchers under the categoryof “bounty system ( 揭榜挂帅 )”, with a funding of 35 million yuan (about 665 million yen) for large projects overthree years. Fields for which proposals are being accepted include reduced carbon emissions through bioenergy andthe development of core technologies in energy-saving production processes.

104

Wei Liu, et al. (2018) “Rapid pathway prototyping and engineering using in vitro and in vivo synthetic genome SCRaMbLE-in methods”,
Nature Communications , 9(1): 1936.

105

SHAO Y, et al. (2019) “Creating functional chromosome fusions in yeast with CRISPR-Cas9” Nature Protocols , 14(8): 2521-2545.

106

LIU Z, et al. (2016) “Autism-like behaviours and germline transmission in transgenic monkeys overexpressing MeCP2”, Nature , 530(7588):
98-102.

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2.2.5 Main Research Institutions and University R&D Trends
Table 2-6 summarizes the number of papers (articles, reviews, and conference proceedings) as a form of output
under the National Natural Science Foundation’s support of R&D projects related to synthetic biology in the National
Science and Technology Major Specific Projects and the National Key Research and Development Programs. There isa tendency for a higher ratio of domestic co-authorship than international co-authorship among many universities andresearch institutions. Fields such as immunology, microbiology, chemical engineering, and chemistry have notable
numbers of publications.

Table 2-6 Academic Paper Numbers Output Top 10 Institutions Related to Synthetic Biology in China from 20152020107

Institution/University Name
(Main Paper Writing Organization)

Numberof
FWCI
Papers%International
CoAuthorship108%
Domestic
Coauthorship%
Institutional
Coauthorship%
Solo

Chinese Academy of Sciences( 国家合成生物技术创新中心 )

403

1.32

36.9

58.1

3.2

1.8

Tianjin University(Ministry of Education 国家合成生物技术创新中心 )

159

1.34

19.5

71.7

8.2

0.6

Tsinghua University( 清华大学合成与系统生物学中心 )

141

1.59

32.9

37.1

22.9

7.1

Shanghai Jiao Tong University( 上海交通大学生命科学技术学院 )

139

1.16

45

32.5

22.5

0

Jiangnan University( 合成与生物胶体教育部重点实验室 )

99

1.49

27.3

61.6

10.1

1

Peking University( 北京大学定量生物学中心 )

80

1.48

30.8

52.3

16.9

0

Zhejiang University( 浙江大学杭州国际科创中心、浙江大学药学院 )

76

1.11

47.5

39

13.6

0

East China University of Scienceand Technology( 华东理工大学生物反应器工程国家重点实验室 )

56

1.52

32.1

51.8

16.1

0

107

M. J. et al. (2021) “An International Comprehensive Benchmarking Analysis of Synthetic Biology in China from 2015 to 2020,” Chinese
Journal of Chemical Engineering , https://doi.org/10.1016/j.cjche.2021.05.036

108“International Co-authorship” is defined as having authors from institutions in two or more countries including China, “Domestic Coauthorship” as having authors from multiple institutions within China, “Institutional Co-authorship” as having multiple authors from thesame institution, and “Solo Authorship” as having a single author.

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Wuhan University( 武汉大学药学院 )

52

1.59

30.2

58.1

9.3

2.3

Shandong University( 山东大学微生物技术国家重点实验室 )

48

0.92

30.2

32.6

34.9

2.3

In addition to the above institutions, focusing on Guangdong Province and its surrounding provinces andautonomous regions, which have significant science budgets as outlined in section 2.3.2 (connecting China, Hong
Kong, and Macao in the “Greater Bay Area”109), the following universities and institutions should continue to be ofinterest going forward.
・The University of Hong Kong (School of Biomedical Sciences)
・Sun Yat-sen University (School of Life Sciences)
・BGI Research ( 深圳华大生命科学研究院 )・Shenzhen Bay Laboratory ( 広東生命情報生物医学研究所 )・Xiamen University (School of Life Sciences)
110・University of Science and Technology of China (School of Life Sciences and Medicine, Hefei, Anhui Province)

Among the top 10 institutions in China related to synthetic biology publications listed in Table 2-6, the Chinese
Academy of Sciences and Tianjin University, as well as Shanxi University, which is close to many chemical industryrelated plants and is working towards carbon neutrality, are outlined below for their recent notable research outcomes
and initiatives.

(1) Institute of Synthetic Biology, Shenzhen Institute of Advanced Technology (SIAT) of
the Chinese Academy of Sciences
SIAT is an institute focused on IT and biotechnology, established jointly by the Chinese Academy of Sciences(providing talent), Shenzhen Municipal Government (providing land and facilities), and The Chinese University ofHong Kong (which proposed the institute). It actively engages in industry-academia collaboration, having partnerships
with many companies such as BGI, HUAWEI, and Tencent. Shenzhen city, through initiatives like the Peacock Plan
started in 2011 to attract high-level talent from overseas, proactively provides invitations to outstanding Chinese
researchers working in the West. In 2017, Professor Jay D. Keasling of the University of California, Berkeley, who
succeeded in the biosynthesis of a special malaria drug (artemisinin) using yeast, opened an endowed research lab
at SIAT as a visiting professor, aiming to promote the synthesis and commercialization of Chinese herbal medicine
resources111.
Shenzhen city is one of the cities forming the Guangdong (Shenzhen) - Hong Kong - Macao Greater Bay Area ( 粤109At a symposium held in Tokyo on April 9, 2019, Carrie Lam, the Chief Executive of Hong Kong, Ma Xingrui, the Governor of Guangdong
Province, and the Director of the Policy Research and Regional Development Bureau of the Macao Special Administrative Region (positions
were current at the time of the symposium), visited Japan and introduced the Greater Bay Area plan:

110

Though not located in the Greater Bay Area, these universities are listed as part of the national science center area.

111

SIAT News:http://english.siat.cas.cn/News2017/SN2017/201709/t20170928_183586.html

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港澳大湾区 ), a strategic initiative pushed by the Chinese government. As the first startup area for the national science
center, the Guangming District located in the northern part of Shenzhen is constructing an industrial park specialized
in synthetic biology. Similar to Japan, in China, the majority of core research equipment and consumables in thefield of biotechnology, such as sequencers, PCR, and culture equipment, are imported, leading to high overall costs
for procurement, operation, and maintenance, and posing barriers to automation aligned with data-driven and AIdriven digital transformation and the Design/Build/Test/Learn (DBTL) flow. The synthetic biology research facility
in the Guangming District adopts red and blue routes ( 红蓝军路线 ) as a key technology development strategy. The
red route aims for collaboration amongst domestic R&D teams to develop and build control systems for automatedrobotics arms and centrifuges, starting projects entirely from scratch. The blue route, which uses existing work, isbased on absorbing advanced foreign technologies and achieving early construction of platforms through equipment
advancement to achieve open platformization. The goal is to have the combined results from both routes produce
even greater outcomes112. Additionally, a phase 2 plan aims to build platforms for translational research, including
cell synthesis and cell function detection. On February 15, 2022, the Shenzhen Institute of Synthetic Biology’s
Medical Center was opened at the Chinese Academy of Science Shenzhen Hospital in Guangming District, drawing
attention as a cutting-edge hub for clinical application research in the area.113 Furthermore, the area and its vicinity
are equipped with various research facilities, such as a brain analysis and simulation center114 capable of providing avariety of experimental animals, a multiscale imaging center115, a national supercomputing center116 contributing to
the “D (Design)” of DBTL, and the China National GeneBank (see section 2.2.6) storing a wide variety of genetic
information. The aim is to strengthen complementary relationships through mutual exchange between these facilities.
On December 23, 2021, SynBio China 2021 & Engineering Biology Innovation Forum Ⅲ (Guangming Science City
2021) was held, co-organized by the Development and Reform Commission of Shenzhen, the People’s Governmentof Guangming District, Shenzhen, the Chinese Society of Biotechnology’s Division of Synthetic Biology, Shenzhen
Institute of Advanced Technology, Chinese Academy of Sciences, and DeepTech, among others117. This event
featured many presentations on the prospects of new industries brought about by synthetic biology, discussions on
new technologies such as high-throughput techniques and storage, and the launch of synthetic biology competitions(Synbio Challenges, Synbio Hive). Following this, on January 5, 2022, the “Frontier Forum on DNA Information
Storage” was held by the same institute, and the unveiling ceremony of a DNA information storage and industry
innovation transformation center (DNA 信息存储产业创新转化中心 ) took place118. Research on DNA storage, whichis considered a next-generation frontier field that utilizes DNA as a medium for information storage, is attracting

112

张亭，冷梦甜，金帆，袁海 , (2022)“ 合成生物研究重大科技基础设施概述 ”, Synthetic Biology Journal, 3(1) 184-194 DOI:
10.12211/2096-8280.2021-077

113

深圳市光明区政府 , “ 深圳合成生物学创新研究院临床医学中心正式落户光明 ”:
http://www.szgm.gov.cn/xxgk/tt/content/post_9576684.html. (Accessed December 2022)

114脑解析与脑模拟重大科技基础设施 : http://www.braintechnews.com/nkjhy/20200828/165.html (Accessed December 2022)

115

Established in cooperation between Shenzhen City and Peking University. 多模态跨尺度生物医学成像设施深圳基地（深圳基地）：http://www.ibp.cas.cn/zhxw/2017zhxw/201803/t20180316_4976687.html (Accessed December 2022)

116

国家超级计算深圳中心 ( 深圳云计算中心 ): http://www.nsccsz.cn/ (Accessed December 2022)

117

Pharmadeer Information Technology Co., Ltd, “ 中国合成生物学学术年会暨第三届工程生物创新大会・光明科学城 2021,”:https://www.pharmadeer.com/activity/69979

118

深圳合成生物学创新研究院 , “DNA Information Storage Frontier Forum,”:
http://www.isynbio.org.cn/news-detail.aspx?detail=5687&parm=577

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significant attention for trends in development at SIAT and across China.
A recent notable research outcome from SIAT includes the efficient reduction of carbon dioxide and the synthesisof glucose and fatty acids combined with biosynthetic pathways, published in Nature Catalysis in April 2022, andfeatured on the cover 119. This work, co-authored by Professor Yu Tao among others, was highlighted in Scienceand Technology Daily as one of the top ten scientific and technological news stories in China for 2022, laying the
groundwork for artificial food synthesis research.

(2) Tianjin Institute of Industrial Biotechnology (TIB) and Tianjin University Biofoundry
TIB (established in 2012) and Tianjin University were approved by the Ministry of Science and Technology on
November 8, 2019, to construct the National Synthetic Biology Innovation Center ( 國家合成生物技術創新中心 )in the Tianjin Airport Economic Area. in the same year, TIB joined the Global BioFoundry Alliance (GBA) with
the Shenzhen Institute of Advanced Technology (SIAT) Shenzhen Institute of Synthetic Biology, Chinese Academyof Sciences, to lead synthetic biology research in China120. The GBA also includes the School of Life Sciences
and Biotechnology at Shanghai Jiao Tong University and Zhejiang University. The aforementioned TIB & Tianjin
University Biofoundry has established 16 joint ventures with companies such as “Tianjin Ringpu Bio-Technology Co.,Ltd.天津瑞普生物技术股份有限公司 ( 瑞普 -TIB Joint Research Laboratory; headquartered in the Tianjin Airport
Economic Area manufacturing food, feed, and chemical products)” in the fields of chemical industry, biomedical, andhealth food, for the rapid commercialization and market deployment of research outcomes121.
In 2018, Tianjin University received approval from the Ministry of Education for the construction of a frontierscience center for synthetic biology ( 教育部 “ 珠峰计划 ” 合成生物学前沿科学中心 ) under the “Everest Plan for Basic
Research in Higher Education Institutions” ( 教育部 “ 珠峰计划 ” 合成生物学前沿科学中心 ). Additionally, in 2019,the construction of a national synthetic biotechnology innovation center, a joint effort between the Chinese Academyof Sciences and the Tianjin Municipal People’s Government, began122.
According to Dr. Jibin Sun, Deputy Director of TIB, TIB focuses on bioproduction research such as succinic acid,herbal components such as ginseng, and improvements to vitamin-producing strains, stating that “TIB files a patent
every three days, with 53% of approved patents being utilized,” highlighting TIBs research and development and also
the application of its results in industry through corporate collaboration123. Furthermore, TIB has been developing
BioFoundry devices since 2012 to automate the process from PCR, plasmid construction, transformation to check.
These devices are capable of constructing 2,000 plasmids within two weeks.
A notable research outcome from TIB includes the world’s first artificial synthesis of starch from carbon dioxide,published in Science on September 24, 2021124. TIB, in joint research with the Dalian Institute of Chemical Physics,
Chinese Academy of Sciences, designed the Artificial Starch Anabolic Pathway (ASAP), using inorganic catalysts to

119

Tingting Zheng et al. (2022) “Upcycling CO2 into energy-rich long-chain compounds via electrochemical and metabolic engineering”,
Nature Catalysis , Volume 5 Issue 5120

Nathan Hillson, et al. (2019) “Building a global alliance of biofoundries,” Nat. Commun .

121

Tianjin University, “ 联合实验室 ”: http://www.tib.cas.cn/cgzh/lhsys/

122

中央人民政府 , “ 国家合成生物技术创新中心核心研发基地在津启动建设 ”:
http://www.gov.cn/xinwen/2019-12/27/content_5464585.htm

123

From a lecture at the Synthetic Biology Frontier Forum held in December 2020.

124

Tao Cai, et al. (2021) “Cell-free chemoenzymatic starch synthesis from carbon dioxide,” SCIENCEJST Asia and Pacific Research Center

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reduce carbon dioxide to methanol and enzymes to convert hexoses, achieving starch synthesis through 11 steps. Thismethod of starch synthesis reached a speed 8.5 times faster and an energy conversion efficiency 3.5 times higher thanthat of corn, demonstrating a higher efficiency of starch synthesis than plants. It was highlighted in the Science andTechnology Daily as one of the top ten scientific and technological news stories in China and abroad for 2021.

(3) Shanxi University & Shanxi Institute of Synthetic Biology
Although Shanxi University currently does not have any notable research outcomes, it is attracting attention for its
active efforts to link applications to carbon-neutral policies. The “Shanxi Province High-Quality Development 3-Year
Action Plan for the New Materials Industry (2019-2021)”125 outlines action plans for the development of five distinctive
new materials, including advanced metal materials, chemical materials, inorganic non-metal materials, cutting-edge
new materials, and bio-based new materials.
In July 2020, the “Shanxi Province Hundred Billion-Level New Material Industry Cluster Development Plan”126
was announced. It outlines a plan to involve local enterprises, universities, and research institutes in a majorinternational new materials science and technology cooperation project, and to encourage foreign companies andresearch institutions to establish new material research and development centers and incubation facilities for results
within the province, aiming to facilitate industry-academia collaboration and societal implementation. In Octoberof the same year, a cooperation agreement was signed between the Shanxi Transformation and Comprehensive
Reform Demonstration Zone and Cathay Biotech, a unicorn in the field of biomaterials (detailed in the next section).
Construction is underway for the Shanxi Synthetic Biology Industry Ecological Park, in collaboration with Shanxi
University’s Department of Synthetic Biology and the Shanxi Synthetic Biology Research Institute (located in
Donghuangshui Town, Yangqu County, Taiyuan, Shanxi Province)127, 128.
CathayBiotech has established the world’s first systematic synthetic biology base to promote the development of abio-based new material industry aimed at replacing petroleum products. It is carrying out ten projects including the
production of bio-based pentanediamine (annual production capacity of 500,000 tons), bio-based polyamide (annual
production capacity of 900,000 tons), and long-chain dibasic acids (annual production capacity of 80,000 tons). Basedon the “2022 Action Plan for the Synthetic Biology New Materials Industry in Shanxi Province”129 notification by the
Shanxi Provincial Department of Industry and Information Technology on February 22, 2022, it also aims to develop
new biodegradable plastic technologies, such as pelletizing calcium carbonate and biodegradable resins, as well as
develop biopesticides.

125

山西省工业和信息化厅主办 , “ 关于印发《山西省新材料产业高质量发展三年行动计划（ 2019-2021 ）》的通知 ,”:https://gxt.shanxi.gov.cn/zfxxgk/zfxxgkml/cl/202110/t20211018_2708027.shtml

126“ 山西发布千亿级新材料产业集群培育行动计划 ,”: http://www.shanxi.gov.cn/yw/sxyw/202007/t20200715_827936.shtml

127

JST Science Portal China, “Clothes made from corn and sorghum arrive,” September 8, 2021:
https://spc.jst.go.jp/news/210902/topic_3_01.html

128

山西省転換型総合改革実証区管理委員会 , “ 王一新在山西合成生物产业生态园调研 ,”https://zgq.shanxi.gov.cn/xmjs/202112/t20211222_4196504.shtml (Accessed January 2022)

129

Shanxi Provincial People’s Government, “Shanxi Province Synthetic Biology New Materials Industry 2022 Action Plan,” February 22, 2022:
http://www.sxzhb.gov.cn/onews.asp?id=58057&owen1=%CD%B6%D7%CA%D6%B8%C4%CF

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2.2.6 Trends in Major Industries
In 2020, China accounted for 30% of the synthetic biology market in the Asia-Pacific region. It is forecast to growfrom 570 million US dollars (about 70.1 billion yen) in 2021 to 2.355 billion US dollars (about 289.6 billion yen) by
2026, with a compound annual growth rate (CAGR) of 32.8% during the period.130 The entire biotechnology-relatedindustry in China is being propelled by policies such as “Made in China 2025” and “Healthy China 2030”131. For
example, the presence of foreign companies in China is expanding everywhere from basic research to industrial
deployment, such as the establishment of bases and factories in Shanghai and Hangzhou by foreign companies
like American Thermo Fisher Scientific, the opening of a logistics hub by the British Agilent Technologies, andthe establishment of an accessible partnership for genome editing tools with Germany’s Merck KGaA and Tongji
University (Shanghai).
At present, companies related to synthetic biology in China are biased towards manufacturing. Here, two ofthese companies, which are among the top in terms of operating profit in China, are introduced as a benchmark.
Although this expression may be a cliche, the key to the success of bio-manufacturing lies solely in “strain designand construction” and “scaling up the fermentation process.” The former depends on theoretical research and basic
research, while the latter depends on applied research related to the fermentation process. This section will not go
into details, but Cabio Biotech (Wuhan) Co.132, Shandong Jincheng Pharmaceutical Group Co., Ltd., Layn Corp., andRianlon are also companies active in this field, and were established around 2000133.

(1) Cathay Biotech ( 上海凯赛生物技术研发中心有限公司 )Cathay Biotech founded (registered) in 2000 by Xiucai Liu134, who returned to China from the United States,
specializes in bio-based enzyme preparations and polyamide production. Headquartered in Zhangjiang Hi-Tech
Park, Pudong, Shanghai, the company aims to develop the bio-based green new materials industry using n-alkanes,a by-product of petroleum, as raw materials and producing long-chain dibasic acids through microbial fermentation.
Recently, it has been advancing the clustering of biological production bases in collaboration with the Shanxi
provincial government. The relationship between the company and Shanxi Province is deep. In a prospectus for a loanof 830 million yuan (about 15.77 billion yen) obtained from Lu’an Group (a major coal company in Shanxi Province)in 2015, the Shanxi Provincial Finance Bureau and the Shanxi Provincial State-owned Assets Supervision and130

Markets and Markets, “Synthetic biology market - Global forecast to 2026,” 2021.

131“Healthy China 2030” is a policy published by the State Council and the Central Committee of the Communist Party of China in 2016,
aiming to align the quality standards of domestic medical devices with international standards by 2030 and enhance manufacturing
capabilities of high-end domestic medical devices. “Made in China 2025” is a policy published by the State Council in 2015, aiming toelevate China in the manufacturing industry’s value chain through productivity improvements and to make innovation the driving force ofeconomic growth.

132

A biotechnology company established in Province in 2004, specializing in the biosynthesis of β-carotene and the production of omega-6
polyunsaturated fatty acids like Carbito® ARA (arachidonic acid) and selling products such as infant formula milk powder.

133

2023 年合成生物学行业深度报告 合成生物学是 21 世纪最值得关注的行业之一、中信证券、2023 年 2 月 :https://www.vzkoo.com/read/20230201f2b8010e3eefb66ef3aa72be.html

134

Liu, born in Anhui Province, obtained his master’s degree from the University of Science and Technology of China and his PhD in Chemistryfrom the University of Wisconsin-Milwaukee. After conducting postdoctoral research at Yale University and Columbia University, he worked
as a senior researcher at Sandoz Pharmaceuticals, where he was involved in drug development. He returned to China in the 1990s where hecontributed to the vitamin C industry. He is also an American citizen.https://www.nytimes.com/2011/12/08/business/an-entrepeneurs-rivalin-china-the-state.html

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Administration Commission were reported to hold 20.30% of the shares through Shanxi Science Park Investment andLu’an Group. Cathay Biotech was listed on the Shanghai Stock Exchange STAR Market in August 2020. From the firstto the third quarter of 2022, Cathay Biotech achieved an operating profit of 1.838 billion yuan (about 34.9 billion yen),
an increase of 4.8% compared to the previous year.

(2) Anhui Huaheng Biotechnology ( 安徽華恒生物科技股份有限公司 )135

Huaheng Biotechnology, established in Anhui Province in 2005 by Heng Hua Guo and others, specializes in the
production of amino acids, vitamins, and other products using synthetic biology methods. It is headquartered in Hefei
City, Anhui Province, with Dongzhu Zhang as the managing director. The company produces a wide range of raw
materials used in food additives, health foods, feed, and many other fields, such as alanine (L-alanine, DL-alanine,β-alanine), L-valine, D-calcium pantothenate, and arbutin (α-arbutin, β-arbutin) In 2021, its production of L-valine
products through anaerobic fermentation increased, contributing significantly to revenue and profit. In 2022, from thefirst to the third quarter, it achieved an operating profit of 984 million yuan (about 18.7 billion yen) compared to thesame period last year.
Leading the company in science-based product development and production, and research and development is
Dr. Xueli Zhang136, who has served as a director of the company since November 2013 and as Chief Scientist since
January 2016. Young engineers of Dr. Zhang’s generation, such as Siqing Tang, who obtained a bachelor’s degree
in bioengineering from Hefei University, are among the executive management and have established long-termcooperative relationships with research institutions such as the Tianjin Institute of Industrial Biotechnology, Chinese
Academy of Sciences, Shanghai Institute for Biological Sciences, Chinese Academy of Sciences, and the Institute ofMicrobiology, Chinese Academy of Sciences (Beijing).

2.2.7 Other related trends:(1) Genetic Database Development
The China National GeneBank (CNGB), established in Shenzhen by the National Development and Reform
Commission in 2011 (opened in 2016), is China’s first national-level gene bank. It consists of three banks - a
Biorepository, a Bioinformatics Data Center, and a Living Biobank - and two platforms, a Digitalization Platform anda Synthesis and Editing Platform, at its core, with the China National GeneBank DataBase (CNGBdb) databasing thisinformation. China is said to possess the greatest number of genomes in the world.
At CNGB, the George Church Institute of Regenesis, named after Professor George Church of Harvard Medical
School, who has recently attempted to revive the woolly mammoth using the CRISPR system, was established in 2017

135 「安徽华恒生物科技股份有限公司」首次公开发行股票并在科创板上市招股说明书 , 福建省福州市湖东路 268 号 :http://file.finance.sina.com.cn/211.154.219.97:9494/MRGG/CNSESH_STOCK/2021/2021-4/2021-04-16/7052638.PDF
136

Dr. Xueli Zhang, born in 1981, obtained his PhD from Shanghai Jiao Tong University and conducted research on microbes at the University
of Florida and the Tianjin Institute of Industrial Biotechnology, Chinese Academy of Sciences. In 2017, he received the 14th Tianjin
Youth Science and Technology Award, and he has obtained 21 Chinese patents, and 7 international patents, including those for geneticallyengineered bacteria that produce DL-alanine, and a method for producing DL-alanine using these bacteria (patent specification 2016-503650,
among others). https://baike.baidu.com/item/%E5%BC%A0%E5%AD%A6%E7%A4%BC/24278992#reference-[1]-24721243-wrap(As of
December 2022)

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in collaboration with China’s BGI Shenzhen. It conducts research in synthetic biology and genome editing, including
efficient DNA data storage methods and the synthesis of E. coli with 57 codons137.
The National Genomics Data Center (NGDC)138, one of the centers of the China National Center for Bioinformation(CNCB) established in 2019, has focused on collecting genome data and publishing sequences of SARS-CoV-2 since
the outbreak of COVID-19. Originally aimed at collecting and publishing large-scale genomic analysis information
related to precision medicine and biodiversity, it systematically organizes resources such as raw data and metadata,
genomes and mutations, gene expression, non-coding RNA, epigenomics, single-cell omics, biodiversity andbiosynthesis, and health and disease. Additionally, its integrated database for aging research, Aging Atlas, allows forthe search of epigenomics and metabolomics data related to humans, mice, rats, and rhesus monkeys. It also maintains
other resources, such as the brain research Brainbase database, introduced as the “Monkey Kingdom”139 in Nature
magazine in 2016.
Regulations already in place in 2019 and 2020 manage sharing of genetic resources with foreign partners, including
biological samples like organs, tissues, and blood that are directly linked to producing DNA information. However,
new regulatory guidelines proposed in March 2022 indicate this management will be further strengthened. Some
researchers are concerned that such regulatory strengthening could, at the very least, affect international cooperationin this field140.

(2) Moves to Publish Science and Technology Journals
To prioritize quality over quantity and correct the tendency to rely on foreign journals, the government announced
the “China Science and Technology Journal Excellence Action Plan”141 to nurture domestic journals. The first phase(2019-2023) of the Plan142, jointly announced in 2019 by the China Association for Science and Technology, theMinistry of Education, and the Ministry of Science and Technology, defined seven categories including (1) leading
journals, (2) key journals, (3) mid-sized journals, and (4) high-quality new journals, along with programs to nurturejournals. Progress with nurturing domestic journals bearing the name of synthetic biology is gradually progressing.
In 2019, support was decided for 280 journals (180 in English, 100 in Chinese), with a total of about 200 million yuan
per year being provided, and in 2020 and 2021, 30 journals per year were supported in the high-quality category. In
the field of synthetic biology, “Synthetic and Systems Biotechnology,” launched by the Chinese Academy of Sciencesin July 2020, has been recognized as a high-quality new journal ( 高起点新刊 ). On December 12, 2020, Chemical
Industry Press, the Biological Societies of China, and SDIC Biotech Investment Co., Ltd. collaborated to launch thebimonthly Synthetic Biology Journal. The publication aims to be an international top and flagship journal of synthetic
biology in China, and is a renaming of the former “Biotechnology & Business” of the China Biotechnology. The

137

At the 12th International Conference on Genomics (ICG-12) in 2017:https://bgi-australia.com.au/news-1/f/george-church-institute-of-regenesis-in-cngb?blogcategory=2017

138

NGDC: https://ngdc.cncb.ac.cn/

139David Cyranoski. (2016) “Monkey kingdom”, Nature vol 532, pp300–302 : https://www.nature.com/articles/532300a

140

Smriti Mallapaty. (2022) “China expands control over genetic data used in scientific research”, Nature :https://www.nature.com/articles/d41586-022-01230-z

141

中央人民政府 , “ 培育世界一流科技期刊 四部门联合发文推动科技期刊改革发展 ” 2019 年 8 月 19 日 :http://www.gov.cn/xinwen/2019-08/16/content_5421699.htm

142

教育部、中国科学技術協会 , “ 关于组织实施中国科技期刊卓越行动计划有关项目申报的通知 ” 2019 年 8 月 19 日 :http://www.moe.gov.cn/s78/A16/tongzhi/201909/t20190927_401259.html.

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journal is supported organizationally and financially by BGI (Shenzhen 華大基因 ), Xuzhou Medical University(Jiangsu Province), Twist Bioscience (USA), AMYRIS (USA), Tsingke Biotechnology Co. Ltd., and others. At the
Frontiers in Synthetic Biology Forum held concurrently with the journal’s first editorial meeting in December 2020,
renowned Chinese researchers presented their outlooks for the field. In particular, Dr. Tan Tianwei, President of
Beijing University of Chemical Technology and an academician of the Chinese Academy of Engineering, emphasized
the need for innovation in response to American export restrictions on biotechnology and the transformationof the chemical industry towards achieving carbon neutrality (dual carbon goals) in his lecture titled “Green
Biomanufacturing ( 緑色生物製造 ).” He also pointed out the importance of green processes while referring to theclosure of chemical companies in Shandong and Jiangsu provinces.

2.3 India
The Indian government set a target in its “Science, Technology, and Innovation Policy 2013”143 to rapidly achieve
2% of GDP in total R&D investment. This goal was expected to be achieved by 2018 if private enterprise investment
proceeded smoothly. In reality, in 2018, government investment was 0.41% and private investment was 0.24%, totaling
0.65%, meaning this goal was not close to being met. It is not easy to obtain the latest total R&D investment figures.
However, according to statistics released by the Ministry of Science & Technology (MoST)144, it was 1.2384 trillion
rupees (about 2.2043 trillion yen) in 2018-19, showing an 8.8% increase from 1.1382 trillion rupees (about 2.026
trillion yen) in 2017-18. Contributions from private companies increased from 32.1% in 2010-11 to 36.8% in 2017-18.
Although investment in the field of synthetic biology is unclear, the budget for the Department of Biotechnology(DBT) under the Ministry of Science & Technology is, as an initial budget for the fiscal year 2021, 35.02 billion rupees(about 62.3 billion yen)145, and for the fiscal year 2022, 25.81 billion rupees (about 45.9 billion yen)146, indicating that
infrastructure for vaccine manufacturing and related pharmaceutical R&D is being established due to the influence of
COVID-19, and the biotechnology-related budget is gradually expanding.
This chapter discusses policies, R&D, and industrial trends related to biotechnology, including synthetic biology, inIndia.
The government has positioned biotechnology, from the perspective of COVID-19 vaccine manufacturing, as partof the “Atmanirbhar Bharat Abhiyaan” (Self-Reliant India Campaign)147. The Campaign is an economic stimulus plan
aimed at further opening up the Indian economy for the promotion of the “Make in India” policy advocated by Prime
Minister Modi. It aims to more closely involve India’s manufacturing with international partners to make it more

143

Science, Technology and Innovation Policy, Government of India,
http://dst.gov.in/sites/default/files/STI%20Policy%202013-English.pdf

144

RESEARCH AND DEVELOPMENT STATISTICS 2019-20, GOVERNMENT OF INDIA, MINISTRY OF SCIENCE & TECHNOLOGY,
DEPARTMENT OF SCIENCE & TECHNOLOGY, NEW DELHI-110016 (INDIA), December 2020:
https://dst.gov.in/sites/default/files/Research%20and%20Deveopment%20Statistics%202019-20_0.pdf

1452022-2023 budget, Indian Finance Ministry: https://www.indiabudget.gov.in/doc/eb/sbe90.pdf

146

On February 1, 2022, Finance Minister Nirmala Sitharaman announced the budget for India for the fiscal year 2022. Although the budget
increased by 13.3% from the previous year, the DBT budget decreased by about 10 billion rupees. The budget focused on public investment
in infrastructure (increased budget for the Ministry of Railways and the Ministry of Road Transport & Highways) and is estimated to be
adjusted based on the DBT’s budget implementation for the fiscal year 2021 (about 29.6 billion rupees).

147

INVEST INDIA: https://www.investindia.gov.in/ja-jp/%20atmanirbhar-bharat-abhiyaan

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globally competitive, sublimate India’s consumption and production into the global supply chain, foster resilience,and provide opportunities that include both investment and technology148. Through the positioning of this policy, thegovernment has prioritized budget allocation for biotechnology, simplification of procedures, preparation of investorfriendly environments, and cultivation of excellent talent.
India lacks explicit policies focused on synthetic biology, and funding for basic research is not abundant, trailingbehind Western nations and Australia in R&D. However, in August 2022, the Ministry of Science & Technology
announced a new program by the DBT-Biotechnology Industry Research Assistance Council (BIRAC), the “AMRITGRAND CHALLENGE,” which supports interdisciplinary and high-quality high-risk R&D, including synthetic
biology.
India’s biotechnology forms an important industrial base in biomolecules, biosystems, bio-manufacturing, andbio-computing, accounting for about 3% of the global biotechnology market, ranking 12th in the world and 3rd in
Asia149. The industry size was 70.2 billion dollars (approximately 8.6346 trillion yen) in 2020 and 80.12 billion dollars(approximately 9.8523 trillion yen) in 2021, showing an annual growth rate of 14.13%. It is expected to grow at anannual rate of more than 15%, reaching $150 billion (about 18.45 trillion yen) by 2025, accounting for 19% of the
global biotechnology market. Currently, the biotechnology industry consists of more than 3,500 startups, however, thisis estimated to number 10,000 by 2024/2025. Prime Minister Modi attended “Biotech Startup Expo 2022”150 in June
2022, a BIRAC 10th anniversary exhibition, showing the government’s focus on supporting this field.
India has invested 9 billion rupees (about 16 billion yen) in COVID-19 vaccine development, providing an excellent
opportunity for collaboration among scientists, researchers, medical charities, entrepreneurs, and technocrats,
with the industry expected to grow from $2 billion (about 246 billion yen) to $5 billion (about 615 billion yen). The
Ministry of Science & Technology, Indian Council of Medical Research (ICMR), Defence Research and Development
Organisation (DRDO), and private companies have focused on vaccine production, accounting for 50% of the global
vaccine demand. This movement is expected to remain a strong element in the development of the biotechnology
industry. The 18th G20 meeting is also scheduled to be held in New Delhi in September 2023, with international
discussions on health and medical issues also drawing attention.
Thus, India’s biotechnology industry is showing remarkable development, with clear governmental policy efforts
and active investment by related private enterprises. In regard to synthetic biology, despite the lack of prominent
R&D programs, as mentioned above, there is visible activity amongst industry. From the perspective of research andindustrial activities promoted by universities and private enterprises, clarification of government policies that take
into consideration international safety regulations, is expected, and the government is also working on demonstrating
policy direction and specificity.

148

Anil Wadhwa. (2020) “Partnership, a Visionary Approach,” India Perspectives, Issue 4
https://www.indiaperspectives.gov.in/en/visionary-approach/ (Accessed September 5, 2022)

149

India Brand Equity Foundation (IBEF) established by the Government of India’s Ministry of Commerce and Industry;
https://www.ibef.org/industry/biotechnology-presentation

150

Biotech Startup Expo 2022 is an event held on June 9-10, 2022, in New Delhi, commemorating the 10th anniversary of BIRAC’s
establishment. The event featured 75 startups supported by BIRAC, 75 biotech incubation centers, 21 IITs and universities, and 50 startups
supported by the Department for Promotion of Industry and Internal Trade (DPIIT), including domestic and international companies, andfacilitated exchanges with researchers from DBT, CSIR, ICAR, DST, IIT, NIPER (National Institute of Pharmaceutical Education andResearch), NISER (National Institute of Science Education and Research), and IISER. DST website:

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2.3.1 Government Organizations and Structures151
The main agencies involved in research and development related to biotechnology, including synthetic biology, inIndia, as shown in Figure 2-6, fall under the Ministry of Science and Technology (MoST): the Department of Scienceand Technology (DST), the Department of Biotechnology (DBT), and the Department of Scientific and Industrial
Research (DSIR). Other government agencies involved in research and development include the Defence Researchand Development Organisation (DRDO), the Ministry of Electronics and Information Technology (MEITY), and theMinistry of New and Renewable Energy (MNRE).
The overall budget for these government R&D institutions has nearly doubled from 265.59 billion rupees (about
464.7 billion yen) in 2009-10 to 480.45 billion rupees (about 855.1 billion yen) in 2017-18. During this period, DST’s
budget increased from 19.86 billion rupees (about 35.3 billion yen) to 35.27 billion rupees (about 62.7 billion yen),
and DBT’s budget from 7.27 billion rupees (about 12.9 billion yen) to 17.72 billion rupees (about 31.5 billion yen)152.
Overall, DBT has shown more than a doubling of growth, serving as governmental funding to support the market.
Subsequently, DBT set the initial budget for the fiscal year 2022 at 25.81 billion rupees (about 45.9 billion yen), of
which, 13.1 billion rupees (about 23.3 billion yen) for biotechnology research and development budget and 3.6 billion
rupees (about 6.4 billion yen) for industry and entrepreneurship support are planned to be provided in the fiscal year
2022.153
The office of the Principal Scientific Adviser (PSA) and its secretariat were established under the Prime Minister
as a policy advisory body in 1999, with Dr. Ajay Kumar Sood currently serving as the PSA. Additionally, the “Prime
Minister’s Science, Technology, and Innovation Advisory Council (PM-STIAC)” has been established under thePrime Minister’s Office and is chaired by the PSA. It handles policies on science, technology, and innovation, andcoordination and adjustment among ministries. Professor Krishnaswamy VijayRaghavan, who served as the third PSA(from April 2018 to April 2022), was the former director of DBT.
In addition, the Ministry of Chemicals and Fertilizers (MoC&F)’s Department of Pharmaceuticals (DoP) formulated“Pharma Vision 2020.” The government is taking the lead in making India a leading country in pharmaceuticaland medical device innovation by establishing world-class infrastructure, promoting pharmaceutical R&D withinternational competitiveness, and supporting ventures in both public and private research.

151

Mainly from Synthetic Biology Market-Global Forecast to 2026.

152

RESEARCH AND DEVELOPMENT STATISTICS 2019-20, GOVERNMENT OF INDIA, MINISTRY OF SCIENCE & TECHNOLOGY,
DEPARTMENT OF SCIENCE & TECHNOLOGY, NEW DELHI-110016 (INDIA), December 2020:
https://dst.gov.in/sites/default/files/Research%20and%20Deveopment%20Statistics%202019-20_0.pdf

153

On February 1, 2022, Finance Minister Nirmala Sitharaman announced the budget for India for the fiscal year 2022. Although the federal
budget increased by 13.3% from the previous year, the DBT budget decreased by about 10 billion Rupees. This was due to a focus on public
investment in infrastructure (increased budget for the Ministry of Railways and the Ministry of Road Transport & Highways).

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Figure 2-6 Main organizations and institutions related to biotechnology (including synthetic biology)153

Below are the details of the main ministries and funding agencies related to biotechnology in India.

(1) Department of Science and Technology (DST)
Established in 1971 under the Ministry of Science and Technology, DST organizes, coordinates, and promotes India’s
activities related to science and technology. DST’s main tasks include formulating policies related to science andtechnology, assisting the Cabinet Scientific Advisory Committee, promoting science and technology by focusing on
specific issues in emerging areas, coordinating with cross-sectoral science and technology-related organizations,financial support for technological surveys and development, and support through grants to scientific research
institutions and scientific associations. Major policies like STP (2003) and STIP (2013)155 were also compiled based on
coordination with relevant administrative bodies involved with DST. Under DST, there are several bodies and research
institutions, including the Science and Engineering Research Board (SERB), and three natural science academies:
Indian National Science Academy (INSA), Indian Academy of Sciences (IASc) founded by Nobel laureate C. V.
Raman, and National Academy of Sciences India (NASI). SERB is a research funding agency with the mission of154

DST and DBT, like ICAR, CSIR, DRDO, and ICMR, have funding functions, but here they are classified into the category of ministries.

155

STI policies will be discussed later under “Science, Technology, and Innovation Policy.”

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promoting basic research in the fields of science and engineering and providing financial support to researchers andinstitutes. In 2009, in response to the need for rapid decision-making on research challenges and demands from thescientific and technological system, a bottom-up type of research support was established. This support system aims toprovide grants based on the scientific curiosity of researchers and to support challenging research. The DST director
serves as the chairperson, with other government officials and renowned scientists as members.
DST’s main support program is the INSPIRE program (Innovation in Science Pursuit for Inspired Research
Programme), aimed at early-stage support for young researchers, providing scholarships for higher education, andensuring research career formation.

(2) Department of Scientific and Industrial Research (DSIR)
Established in 1985, DSIR aims to develop, utilize, and transfer proprietary technologies. That is, it supports thepromotion of R&D by industry, the development of commercial potential by SMEs, the early commercializationof laboratory-level outcomes, and enhancement of technological management capabilities in industry. Through the
National Research Development Corporation (NRDC), it forms a relationship of technology transfer between scientificresearch labs and industry and promotes investment.
DSIR houses the Council of Scientific & Industrial Research (CSIR), India’s largest R&D organization establishedin 1942 to return the outcomes of science and technology to the nation. The CSIR structure has the Prime Minister as
the chairman and the Minister of Science and Technology as the vice-chairman. Under its umbrella are 38 independent
research institutes, among which approximately ten are related to biotechnology. These include the Institute of
Genomics and Integrative Biology (CSIR-IGIB, Delhi), the Centre for Cellular and Molecular Biology (CSIR-CCMB,
Hyderabad), the Central Drug Research Institute (CSIR-CDRI, Lucknow), the Central Food Technological ResearchInstitute (CSIR-CFTRI, Mysuru), the Indian Institute of Chemical Biology (CSIR-IICB, Kolkata), the Institute ofIntegrative Medicine (CSIR-IIIM, Jammu), the Institute of Microbial Technology (CSIR-IMTECH, Chandigarh), andthe National Botanical Research Institute (CSIR-NBRI, Lucknow), among others.
DSIR also has a system where certified organizations (e.g., SCPL156) assist companies in applying for funding andtax incentives. This system primarily targets programs of the Biotechnology Industry Research Assistance Council(BIRAC), mentioned later. To receive public support (financial measures, preferential treatment, etc.), a form ofgovernment certification called the Industrial R&D Promotion Programme (IRDPP) is required.157 Organizations or
systems certified under this program receive support from Scientific and Industrial Research Organizations (SIRO)158.
Under the SIRO system, organizations like universities are recognized for activities that expand knowledge in naturalsciences, applied sciences, agriculture, medical, and social sciences under a governance system with clear objectives.
Organizations certified in this way can benefit from tax exemptions on the import of scientific research equipment andrelaxed procedures. Given the impact of COVID-19, DSIR has extended the SIRO certification.

156

SCPL (Scinnovation Consultants Pvt. Ltd.) is a private company established in 2005. It provides support on IP strategy, tax incentives,
etc., for startups, and also assists in accessing funding for research and development. (Reference: Accessed on the 9th of https://www.
scinnovation.in/ (Accessed on September 9, 2022)

157

IRDPP Details:https://www.indiascienceandtechnology.gov.in/programme-schemes/research-and-development/industrial-rd-promotionprogramme-irdpp

158

SIRO System Details:https://www.mondaq.com/india/patent/1108600/application-process-of-getting-siro-recognition

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Advances and Challenges in the Emerging Technology Field of “Synthetic Biology” in Australia, China and India(3) Department of Biotechnology (DBT)DBT is an agency that promotes biotechnology research oriented towards agriculture, environment, and industrial
applications. It was established in 1986 by then Prime Minister Rajiv Ratna Gandhi, in response to global trends inbiotechnology, as an independent department within MoST. It supports research and development and manufacturing,oversees its subordinate independent research institutes, promotes industry-academia collaboration, develops humanresources, and establishes infrastructure facilities.
The National Biotechnology Board (NBTB) advises on the formulation of long-term outlooks and the selection ofpriority areas for DBT’s policy formulation. NBTB is also tasked with nurturing programs in emerging fields andstrengthening unique human capabilities. DBT announced the first National Biotechnology Development Strategy in2007 and has been updating this strategy approximately every five years since 2015 (see section 2.2.2(2)). The latest
version of the Strategy is for 2021-2025159.
The budget for DBT for the fiscal year 2022 was set at 25.81 billion rupees (about 45.9 billion yen) in the federal
budget established in February 2022, allocated for basic infrastructure, genetic engineering, bioinformatics,
agricultural biotech, skill training, etc.160
Below are the main programs and systems managed by DBT.
・Undertaking Nationally Relevant Technology Innovation/Atal Jai Anusandhan Biotech Mission (UNaTI)
A program initiated by DBT on its foundation day in February 2019, aiming to reform the sectors of health,agriculture, and energy over five years. It includes the following missions161.
➡ GARBH-ini: aims to promote maternal and child health and develop tools for predicting preterm birth.

GARBH-ini (Interdisciplinary Group for Advanced Research on Birth Outcomes - DBT India Initiative)162 is
an interdisciplinary collaboration program started in 2014, conducting cohort studies on pregnant women at
a citizen’s hospital in Gurugram, Haryana.
➡ Ind-CEPI Mission: Supports Indian vaccine development in collaboration with the international initiative

Coalition for Epidemic Preparedness Innovations (CEPI) as a measure against infectious diseases throughrapid vaccine development. A program management unit was established within the non-profit corporation
established by DBT, the previously mentioned Biotechnology Industry Research Assistance Council(BIRAC).
➡ Anti-Microbial Resistance (AMR) Mission: Ensures rapidity in diagnosis, treatment, and preventive

measures against antimicrobial resistant pathogens.
163➡ UNATI Mission Clean Technologies for Swachh Bharat: Identifies ten clean technologies, such as

biomethanization, constructed wetlands, bio-toilets, and non-chemical membrane-based water purification,and demonstrates them in various locations across India in collaboration with local stakeholders like159

DBT (2021), “National Biotechnology Development Strategy2021-2025”,
https://dbtindia.gov.in/sites/default/files/NATIONAL%20BIOTECHNOLOGY%20DEVELOPMENT%20STRATEGY_01.04.pdf

160

Indian Biotechnology Industry Analysis: https://www.ibef.org/industry/biotechnology-presentation

161

MoST (2019) “Key missions launched on foundation day of DBT”, https://pib.gov.in/PressReleasePage.aspx?PRID=1566339

162

Garbh-ini (n.d.) “About us”, https://www.garbhinicohort.in/

163“Swachh Bharat” (Clean India) is a nationwide campaign started by the central government in 2014 to achieve an India without open
defecation.

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municipalities.
➡ Fortified Wheat Nutritional Improvement: Develops protein-rich fortified wheat to contribute to thegovernment’s malnutrition campaign “POSHAN Abhiyan” (Holistic Nutrition) started in 2018.
164
・Agriculture Biotechnology

A program started to reform agricultural research by incorporating technological advancements and strengthening
research infrastructure and talent development in cutting-edge areas. It supports research on the creation ofknowledge, development of technologies and products to enhance productivity, improvements in the nutritional value
and quality of crops, resilience to abiotic and biotic stress, efficiency in the use of input resources, climate resilience,and biosafety. It covers economically significant crops such as rice, wheat, corn, cotton, cereals, oilseeds, legumes,
as well as horticultural crops. Under this program, DBT has supported research and development projects throughbasic research such as molecular breeding/marker-assisted selection (MAS), identification of QTL/genes, crop quality
improvement with added functions like Vitamin A richness, disease (such as bacterial blight) and disaster resistance,international collaborations, and public-private partnerships, revising the system in recent years to meet changing
needs from farmers, consumers, and export markets.
・Biotechnology Programme for North Eastern Region

165

This program targets the North Eastern Region of India, known globally for its threatened biodiversity, to utilize its
rich biological resources spread across the ecosystem for further economic development of the region. DBT allocates
10% of its annual budget to promote and enhance biotechnology-related activities in this region, supporting solutions
to regional problems and the use of biological resources for regional development. To ensure the program is operated
efficiently, the North Eastern Region Biotechnology Programme Management Cell (NER-BPMC) was established at
the DBT Institute of Life Sciences (DBT-ILS) in Bhubaneswar.
The establishment and operation of biotechnology parks/incubators are mentioned as a major initiative of DBT for
promoting the conversion of research outcomes into products and services Here, under the National Biotechnology
Parks Scheme166, scientists and SMEs carry out technology incubation, technological demonstration, and pilot plantstudies to promote the commercial development of biotechnology DBT has established 9 biotechnology parks in India.
These parks include ecosystems that support startups to develop beyond the incubation stage and provide further
assistance in scaling up.
In addition to supporting biotechnology parks, DBT has been actively establishing centers specialized in energy
research aimed at achieving carbon neutrality in recent years. Currently, it has established the DBT-ICT Centre forEnergy Biosciences (DBT-ICT-CEB, Mumbai), established jointly with the CSIR National Chemical Laboratory(ICT), the DBT-IOC Centre for Advanced Bio-Energy Research, relocated from Mumbai to Faridabad near New

164

DBT (n.d.) “Agriculture & Plant Sciences”,
https://dbtindia.gov.in/schemes-programmes/research-development/agriculture-animal-allied-sciences/agriculture-biotechnology

165

DBT (n.d.) “North East Region (NER)”, https://dbtindia.gov.in/scientificdecisionunits/ner
Note: This page was updated on March 21, 2022, with content changed to “Under Preparation,” and the information referred to at the time of
preparing this document was deleted.

166

Biotechnology Park Plan:https://dbtindia.gov.in/sites/default/files/guidelines_biotech_Park_0.pdf

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Delhi, in collaboration with Indian Oil Corporation (IOC), and the International Centre for Genetic Engineering andBiotechnology (ICGEB, Delhi). These institutes focus on biofuel research, including biodiesel, bioethanol, biobutanol,and biohydrogen production.
Taking an overhead look at this series of initiatives by DBT, although there are few institutions explicitly conducting
synthetic biology, biotechnology research in India revolves around research clusters established within the country.
These clusters integrate the research capabilities of core facilities and core services from academies and promote
startup incubation. They also integrate core facilities and services such as genome analysis, gene phenotype analysis,genomics, and proteomics analysis. This structure is how the government has formed its platform for innovation.
Of note, DBT signed a Memorandum of Understanding with the Indian Angel Network in August 2017 to create anenvironment in which startups can easily receive investment.
From a synthetic biology perspective, DBT launched a joint funding scheme in 2018 to promote researchcooperation with the Finland Academy, known for its active biofuel research. In the same year, DBT launched training
courses aimed at providing a fundamental understanding of bioengineering for aquatic and marine organisms,
research that serves as a foundation from academia to industry, the practice of computational and experimental
synthetic biology, and knowledge on ethics/biosafety in relation to synthetic biology167.

(4) Biotechnology Industry Research Assistance Council (BIRAC)
BIRAC, a non-profit organization established by DBT, conducts strategic research and innovation, and addresses thedevelopment needs of products required by India. BIRAC’s vision is to nurture and strengthen the strategic researchand innovation capabilities of India’s biotechnology industry, aiming especially for SMEs and startups to produce
affordable products addressing broad societal needs, contributing to constructing a bio-economy.
BIRAC has supported over 3500 startups, 600 technologies/products, established 74 bio-incubation and preincubation centers, supported 344 academic organizations, with a total support amount of 40 billion rupees (about 71.2
billion yen)168.

2.3.2 Major Policies and Key Issues
According to the Science, Technology, and Innovation Policy (STIP2013), India’s science and technology policy aims
to form a Science, Research and Innovation System for High Technology-led path for India (SRISHTI), prioritizing
critical research in key sectors like agriculture, communication, energy, promoting interdisciplinary research,
supporting risk development for SMEs, establishing funds for an inclusive society, and supporting entrepreneurshipled by science and technology innovation. Its goal was to increase the total R&D investment to 2% of GDP (1% at thetime), increase the number of research personnel (FTE) by 66%, and increase the global share of papers from 3.5% toover 7% by 2020, aiming to be within the top 5 countries globally169.

167

The DBT training program in SYNTHETIC BIOLOGY,
https://syntheticbioindia.weebly.com/dbt-syn-bio-training.html(Accessed on September 24, 2022)

168

From BRIAC website: https://birac.nic.in/

169

India, which produced about 149,000 papers (fractional count) in 2020, ranked 3rd after China and the United States, achieving the plan’sgoal. From Global Note Inc.’s website: https://www.globalnote.jp/post-5275.html (Accessed on September 8, 2022)

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The draft of the successor plan, Science, Technology and Innovation Policy 2020 (STIP2020)170, aims to makeIndia the third largest science and technology powerhouse in the world over the next decade, double India’s total
R&D investment (GERD) and the number of researchers (FTE) every five years, and have outstanding individuals
and organizations receive world-class awards over the next decade. Additionally, the national project formulated in
March 2019 includes implementing support for the commercialization of innovations, including automated translation
technologies, quantum frontiers, artificial intelligence, biodiversity, electric vehicles, health care, waste utilization,and deep-sea exploration171. Various policies are being advanced based on this plan, but here the main policies related
to biotechnology, including synthetic biology, have been highlighted, specifically within DBT. Not detailed below arenational initiatives related to the industrial application of synthetic biology research, including the National Policy on
Biofuels172 by the Ministry of Petroleum & Natural Gas and the National Biopharma Mission173 by DBT.

(1) National Biotechnology Development Strategy 2015-2020 (NDBS2015-2020)
In 2000, DBT issued its first document on its vision for the future of biotechnology. In September 2007 it formulated
the first National Biotechnology Development Strategy, marking the dawn of India’s biotechnology sector andcontributing to the launch of various necessary projects. BIRAC was also established in 2012 after this strategy wasformulated, giving momentum to the development of biotechnology in the private sector. However, the full-fledged
policy was the National Biotechnology Development Strategy 2015-2020, announced by DBT in December 2015,
which was drafted with the help of experts from academia, government, and industry. It broadly covers necessary
measures from education to the promotion of bioscience research and commercialization, establishing the following
fundamental principles in the field of biotechnology:
1. Securing an excellent workforce and leadership.
2. Invigorating the intellectual environment along with the growing bio-industry.
3. Enhancing the potential for research in fundamental, academic, and interdisciplinary science.
4. Promoting new, purpose-driven research.
5. Focusing on biotechnology as a tool for comprehensive development.
6. Advancing technology-driven innovation, transfer capabilities, and commercialization.

170

The drafting of STIP2020 started in October 2019, with a schedule laid out from public and expert opinion collection in Track I in May 2020
to reporting to the Prime Minister’s Office in Track IV in November 2021. As of early 2023, there is no information on the final policy being
published.
https://thesciencepolicyforum.org/initiatives/science-technology-and-innovation-policy-stip-2020/

171

For an overview of India’s science and technology policy advancements, see “Overview of Advancing India’s Science and Technology
Policy” by Kiyoshi Kurihara, NIISTEP Horizon, 2022, Vol.8. No.2.
https://www.nistep.go.jp/wp/wp-content/uploads/NISTEP-STIH8-2-00296.pdf(Accessed September 25, 2022)

172

Announced by the Ministry of Petroleum & Natural Gas in 2018 and revised in June 2022. This policy aims to promote the production ofdomestic biofuels and support the reduction of petroleum product imports. From the International Energy Agency (IEA) website:https://www.iea.org/policies/17006-national-policy-on-biofuels-amendment-2022

173

The National Biopharma Mission, approved by the cabinet committee on the economy in 2017, titled “Innovate in India (i3),” aims toaccelerate innovation creation through the development of affordable products to improve the country’s health standards and strengthen
entrepreneurship support This mission aligns with other national missions such as Make in India and Start-up India. By investing $250
million (approximately 31.7 billion yen), it aims to introduce 5 to 7 types of biopharmaceuticals to the market over the next four years. From
the DBT website:
https://dbtindia.gov.in/sites/default/files/uploadfiles/NBM%20WEBSITE-Dr.%20Madhavi_FV.pdf

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7. R ealizing biotechnology in society with a transparent, efficient, and optimal regulatory system andcommunication strategy.
8. Engaging in international biotechnology cooperation that nurtures the country’s alliances.
9. Reconstructing governance models to enhance institutional capabilities.
Specific measures include establishing training programs for students, core facilities/equipment, special centers/commercialization centers, and national research institutes such as the National Institute of Pharmaceutical Education
and Research, the Interdisciplinary Infection Science Research Centres, and the National Institute of Ocean
Biotechnology, proposing the establishment of a knowledge environment. Furthermore, it also focuses on various
research areas in bio-design research such as human genome, vaccine development, infectious diseases, clinical,
chronic diseases, stem cells & regenerative medicine, implants & diagnostics, and biotechnology.
Synthetic biology is first noted among the basic principles for promoting research in interdisciplinary fields
alongside systems biology and nanobiotechnology as an emerging field. Specific measures include strengthening
DBT’s support for research aimed at understanding genetic diseases in human genome research, as well as enzymatic
research and biofuel-related research.
This strategy emphasizes the importance of securing a public-private partnership, establishing intellectual property
rights protection measures, setting up safety regulation measures for genetic use, and enhancing understanding
in society. Regarding international cooperation, DBT is planning to expand the cooperation systems that will be
required for this, although no special considerations for emerging critical technologies has been observed as of yet.
This strategy does not provide financial plans from the government or forecasts on the industrial scale that futurebiotechnology development may bring.

(2) National Biotechnology Development Strategy 2021-2025 (NDBS2021-2025)174
As a successor to the previous development strategy, the National Biotechnology Development Strategy 2021-2025
formulated by DBT in 2021 sets ambitious goals to contribute to a “knowledge and innovation-driven bio-economy”
during the target period. Its main strategies are as follows:・Talent Development: Strengthening production of highly skilled personnel and cutting-edge infrastructure
175
・U NATI Biotechnology Mission: Aligning with India’s and the world’s priorities

・A iming for a “Atmanirbhar Bharat (self-reliant India)” through biotechnology: Affordable products andtechnologies accessible to all・Leveraging the strengths of strategic partnerships: Domestic and international
・Measures for the future - Building a knowledge base & bringing science to society: Revitalizing the rural sector
・Effective outreach and communication: Building social trust・Global benchmarks and performance evaluation: Quality control and improvements through metrics

174

From APRC-FY2022-PD-IND03 (provisional translation):https://spap.jst.go.jp/resource/pdf/aprc-fy2022-pd-ind03.pdf

175

UNATI is an acronym for Undertaking Nationally relevant Technology Innovation (Atal Jai Anusandhan Biotech), a mission to addresscritical issues in India and around the world, such as maternal and child health, antimicrobial drug resistance (AMR), infectious diseasevaccines, food, nutrition, and clean technologies.

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The National Biotechnology Development Strategy 2021-2025176 sets a goal to position India’s biotechnology within
the top 5 nations globally and become a hub for the world’s biomanufacturing industry, achieving a bio-technology
sector economic size of $150 billion (approximately 18.45 trillion yen) by 2025. In the aforementioned strategy,
synthetic biology is highlighted as an important field within talent cultivation, UNATI, measures for the future, andpolicy implementation as outlined below. However, as of now, there are no calls for programs specifically dedicated tosynthetic biology.
・Training talent adaptable to strategic fields such as data science, synthetic biology, cell & regenerative medicine,genome editing, artificial intelligence, computational & structural biology, and quantum biology.
・Direct funding for new biological fields and blue-sky research related to synthetic biology, quantum biology,
nutrigenomics, personalized medicine, microbiome manipulation technologies, and SDGs.
・Expansion of substantial concentrated investments towards the following priority areas in emerging biotechnology
fields and cutting-edge basic research: Personalized medicine, CAR-T technology, genome editing & therapy,
CRISPR-Cas, synthetic biology, lipid biology, glycobiology, epigenetics, plant secondary metabolism, marine
biology, natural products chemistry, quantum biology, 3D bioprinting, etc.
・Develop guidelines on ethics and the use of synthetic biology and emerging technologies.
In NDBS2021-2025, various targets have been set, including the establishment of a 100 billion US dollar(approximately 12.3 trillion yen) scale international biotechnology manufacturing hub (Biomanufacturing Global
Hub) and the expansion of base initiatives such as 125 biotech incubators, 10 technology clusters, 10 biotechnology
parks and manufacturing bases, 10 biotech university-industry joint research translational clusters (UNIVERSITYRESEARCH JOINT INDUSTRY TRANSLATIONAL CLUSTER, Biotech URJIT Cluster), and 10 centers of
excellence in emerging technologies (CONEs). These targets are being closely watched for future developments.

(Reference) The 12th Five-Year Plan and Synthetic Biology (2011)
Since the first Five-Year Plan (1951-1956), India has been formulating five-year plans as national economic
programs, with the latest, the 12th Five-Year Plan, covering 2012-2017 (a 13th Five-Year Plan has not beenformulated). During the 12th Five-Year Plan period, the Task Force on Synthetic and Systems Biology Resource
Network compiled a report titled “Resource Network for Synthetic Biology and Systems Biology.” to recommend
the promotion of synthetic biology and related initiatives by the Indian government177. The report emphasizes thepotential benefits of synthetic biology in biofuels, biotherapeutics, biosensors, and food & health, hoping for India
to strongly promote technology enabling it to become a global leader in this field.

176

DBT (2021), “National Biotechnology Development Strategy2021-2025”,
https://dbtindia.gov.in/sites/default/files/NATIONAL%20BIOTECHNOLOGY%20DEVELOPMENT%20STRATEGY_01.04.pdf

177

12th FIVE YEAR PLAN, Report of the Planning Commission Constituted Task Force on Synthetic and System Biology Resource Network,https://dst.gov.in/sites/default/files/3-tsk_ssbrn-report.pdf

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In the 12th Five-Year Plan related to DBT, nanoscience, bioscience, and synthetic biology were highlighted
under the section on strengthening the biotech industry through collaboration of existing research organizations.
These fields are eligible for research funding assistance and strengthened partnership research by DBT. However,the plan had listed a CSIR institute of synthetic biology and systems biology to be established during the CSIR
plan period178, but it appears that this has not been realized.
Even after the formulation of the 12th Five-Year Plan, the parliament has not deliberated on the bill related tothe establishment of an independent regulatory authority for biotechnology since 2013, and discussions that could
affect research surrounding genetic engineering, which includes synthetic biology, have not progressed179. India
is facing challenges such as the ban on genetically modified eggplant products and lawsuits against geneticallymodified grains.

(3) Task Force Report on the Resource Network for Synthetic Biology and Systems
Biology180
When DST released this report in 2011, synthetic biology and systems biology were still in their infancy in India, andthere was no doubt that India’s potential in human resources in this field was untapped. The document states that India,
with only a limited number of players such as CSIR’s related institutes, the Indian Institute of Science (IISc), National
Centre for Biological Sciences (NCBS), Indian Institute of Technology Kharagpur (IIT-Kharagpur), Bose Institute,
University of Kerala, and a few companies, needs a “push” towards synthetic biology, requiring sufficient support
from feasible technologies to achieve practical applications. The report’s immediate goal was to build expertise andinfrastructure in synthetic biology and systems biology.
India is attempting to lead the world as a protector and supporter of open-source biological platforms by creating
the right legal environment where small biotechnology firms can compete with major pharmaceutical and petroleum
companies.
The Task Force’s recommendations include capacity building through the establishment of institutions, training
centers, and network centers, promoting human resource development, building translational capabilities, developing
multimodal and fast-track funding mechanisms, and establishing international cooperation. It also suggests elevating
the Task Force to a permanent committee with new members to create domestic documents and coordinate a national
network of synthetic biology and systems biology research.

(4) Foresight Paper of Synthetic Biology181
Since DBT’s establishment in 1986, India has long lacked consensus on how the government should address synthetic

178

Twelfth Five Year Plan (2012–2017), Faster, More Inclusive and Sustainable Growth, Volume I, 10 May, 2013,https://nhm.gov.in/images/pdf/publication/Planning_Commission/12th_Five_year_plan-Vol-1.pdf

179“India needs a policy on synthetic biology”, BusinessLine, December 16, 2019,https://www.thehindubusinessline.com/opinion/india-needs-a-policy-on-synthetic-biology/article30322176.ece

180

REPORT OF THE PLANNING COMMISSION CONSTITUTED TASK FORCE ON SYNTHETIC AND SYSTEMS BIOLOGYRESOURCE NETWORK (SSBRN) , https://dst.gov.in/sites/default/files/3-tsk_ssbrn-report.pdf

181

Foresight Paper of Synthetic Biology, DBT, https://dbtindia.gov.in/sites/default/files/uploadfiles/2.%20JNU-FLEDGE%20Project%20
Report%20on%20synthetic%20biology_updated%2008022022.pdf (Accessed September 22, 2022)

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biology, as exemplified by genetic engineering technologies. However, the development of synthetic biology has ahistory that is over 30 years long, and reducing reliance on petroleum-based products is becoming crucial for building
a sustainable and inclusive future. Therefore, it was necessary to clarify what synthetic biology is, its potential
applications, and the required regulations. While Indian industry is advancing investments in synthetic biology, there
is a lack of regulations and policies concerning this technology, creating a dilemma. The policies to be formulated are
expected to define synthetic biology, prioritize research and development in the public sector, guide policy frameworks
including intellectual property rights, and regulate environmental and socio-economic issues.
Amidst these circumstances, in December 2019, DBT commissioned a team182 led by Professor Pawan Kumar
Dhar of Jawaharlal Nehru University to analyze the prospects of synthetic biology, with Dr. Syed Shams Yazdaniof ICGEB and many researchers participating in the discussion. The project examined the current state and future
direction of public and private research and development in this field, the country’s promotion policies, domestic andinternational legal regulations, and strategies for dialoging with the public. The results presented further perspectives
for formulating national policies, emphasizing the importance of considering international legal regulatory elements
crucial for national policy formulation.
While recognizing synthetic biology as a driver of a new industrial revolution, crucial challenges for India include
appropriately evaluating the benefits and risks, accelerating scientific research, and clarifying the Indian government’s
stance on synthetic biology, conveying its benefits and enthusiasm to the international community. The findings werecompiled into the Foresight Paper of Synthetic Biology, and DBT accepted public opinions regarding the matter on its
website until March 15, 2022. As of early 2023, no information on the results of these opinions has been released.

(5) Regulations on Biotechnology or Synthetic Biology Safety
The international debate on biotechnology safety regulations began with recombinant DNA research in the 1970s
at the Asilomar Conference, and India has been building its domestic system in line with this movement since then.
Subsequently, the need for regulations on genetically modified plants or agricultural products emerged, and in the late1980s, a national biosafety framework was established, with the current regulatory framework being established in
1989183.
Concerns related to research involving synthetic biology include unintended infections of laboratory personnel,
leaks from containment areas of pathogens, lack of certification and validity for laboratories requiring Biological
Safety Level BSL2, improper handling of biological waste in drug trials or clinical trials, and intentional release ofgenetically modified organisms into the environment. India has many BSL level facilities that handle pathogens,and DBT has introduced an application system to confirm the validity of BSL3 or 4 research facilities. However,experts are concerned about the lack of national guidelines and a verification system for BSL research facilities’
certification and validity, fearing these issues could constrain research and development and entry into the market

182

Jawaharlal Nehru University serves as India’s representative node in the Global Biofoundry Alliance (GBA) as Biofoundry India. Codirectors of Biofoundry India include Professor Pawan Kumar Dhar and Professor Binay Panda, who compiled this report. Project Theme“Policy and Research Planning for Synthetic Biology,” Project ID: BT/PBD/26/SP30134/2018:https://www.syntheticbiology.in/_files/ugd/cdb456_136f7cc2a81c4ddda4d7b194ba1b3cea.pdf

183

Regulatory framework for genetically engineered plants in India: http://www.geacindia.gov.in/resource-documents/13_2-Regulatory_
Framework_for_GE_Plants_in_India.pdf (Accessed September 22, 2022)

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of synthetic biology in India184. The Carnegie Endowment185 report in 2020 also mentioned that while DBT manages
safety regulations for BSL3 and 4 facilities, measures for lower-level facilities are insufficient, raising concerns about
unintended staff contamination and foreign substances being released into the environment.
Indian legal framework of relevance to this topic includes the 1986 Environmental Protection Act, the Rules for the
Manufacture, Use, Import, Export, and Storage of Hazardous Microorganisms, Genetically Engineered Organisms
or Cells (known as the 1989 Rules), the 2002 Biological Diversity Act, the 2003 Plant Quarantine Order, the 2006
Food Safety and Standards Act, etc., overseen by the DBT, Ministry of Agriculture and Farmers Welfare, Ministry of
Health and Family Welfare, among others. Additionally, under the 1989 Rules, specific procedures are taken within
the framework of six regulatory/advisory committees such as the Review Committee on Genetic Manipulation (RCGM)(the secretariat of RCGM is the DBT)186.
The aforementioned NDBS2021-2025 states that it is necessary to establish a biotechnology regulatory authority
through appropriate legislation, which will aim to improve regulatory personnel training, guideline development,
and public understanding, as well as improve the regulatory framework including the RCGM mentioned above. In
March 2021, at the online Global Bio-India 2021187, it was stated that India’s previous system needs to be revised inlight of Western regulatory frameworks, and as seen through the foresight paper on synthetic biology (2022), this is an
important issue at present.

(6) Pharmaceutical Industry-Related Research and Development Innovation Policy
The pharmaceutical industry, as already mentioned, plays a significant role in India’s biotechnology-related industrial
activities. The Department of Pharmaceuticals of India, under the Ministry of Chemicals and Fertilizers, announced apolicy draft for the pharmaceutical and medical device-related research and development innovation sector in October
2021188. This policy draft, which was open for comment until November 21, 2021, has a significant impact on India’s
pharmaceutical industry, and it is expected that industry movements will become more active based on this policy189.
The policy draft190 is to be implemented according to an action plan that defines specific activities, goals, andschedules over the next ten years, with its basic direction being (1) simplification of the regulatory process, (2)acceleration of new drug development and promotion of medical device development innovation, (3) strengthening
motivation to invest privately and evaluation of various sources of funding, (4) enhancement of the ecosystem to184

Synthetic Biology Market-Global Forecast to 2026

185

DECEMBER 09, 2020, “Biological Risks in India: Perspectives and Analysis”, SHRUTI SHARMA, Carnegie India,
https://carnegieendowment.org/2020/12/09/biological-risks-in-india-perspectives-and-analysis-pub-83399

186

Review Committee on Genetic Manipulation https://ibkp.dbtindia.gov.in/Registration/Index,
https://ibkp.dbtindia.gov.in/Content/Commitee?AspxAutoDetectCookieSupport=1 (Accessed September 22, 2022))

187

Global Bio-India 2021 (hosted by DBT and BIRAC)
https://birac.nic.in/webcontent/1651648167_Global_Bio_India_2021_Report.pdf

188“Draft Policy to Catalyze Research & Development and Innovation in the Pharma - MedTech Sector in India”,
https://pharmaceuticals.gov.in/sites/default/files/Draft%20Policy.pdf (Accessed September 23, 2022)

189“DoP releases draft policy to catalyse R&D and innovation in pharma-MedTech”, Pharma.Biz, Gireesh Babu, New Delhi, Wednesday,
October 27, 2021, http://pharmabiz.com/ArticleDetails.aspx?aid=143514&sid=1#:~:text=The%20draft%20policy%20aims%20
to,stakeholders%20by%20November%206%2C%202021 (Accessed September 23, 2022)

190“Centre finalising policy to catalyse R&D and innovation in pharma and med-tech sectors”, PharmaBiz. Com. February 8, 2023. According
to this report, the government is currently working on finalizing a policy.
http://www.pharmabiz.com/NewsDetails.aspx?aid=156229&sid=1

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promote cooperation between industry and academia. Especially in regard to the simplification of the regulatory
process, it calls for a joint effort among regulatory bodies to make regulations more innovation-oriented, aiming toeliminate duplications in the regulatory process and clarify timelines, with goals such as halving the approval time for
new drugs within the next two years and setting the review period for medical devices within 12 months. In terms of
expanding cooperation between industry and academia, it proposes opening up academic infrastructure for industry
use and talent development, involving industry representatives in the National Institute of Pharmaceutical Education& Research (NIPER) to strengthen the training of specialists in higher education such as doctoral programs.
Furthermore, the draft proposes the establishment of inter-departmental research conferences and innovation hubs tofacilitate cooperation between the educational and industrial sectors.

(7) Relation to Economic Security Policy
The government formulated India’s National Security Strategy in March 2019. Its goal is to protect India’s sovereignty,
ensure territorial integrity, secure India’s rightful place in the international arena, guarantee a peaceful domestic
environment, and create a fair, equal, and prosperous environment for citizens, protecting them and their livelihoods
from dangers. At present, it only has a minimal relationship with synthetic biology, but India’s security strategy isoutlined here for reference.
In terms of economic security, it emphasizes the importance of financial and fiscal policies, ensuring the reductionof vulnerabilities in the Indian economy, and establishes a national “Digital Security Organization” to protect
government and civilian public facilities, power, banking, communication, computer, and internet environments.
Regarding technological development, it sees the advancement of AI, robotics, quantum computing, etc., aspotentially threatening the safety of the economy and public life, pointing out threats in cyberspace and advocating for
appropriate protective measures. It also urges measures to enhance energy security, defense industry infrastructure,and measures against nuclear, space, and cyber technologies.
However, this security policy does not include appropriate measures for technological cooperation, technology
trade, and international research and development cooperation in advanced fields that take into consideration the harshinternational environment surrounding advanced emerging technologies. In August 2022, the Ministry of Electronics
and Information Technology’s Emerging Technologies Division published a list191 of emerging technologies promoting
the adoption of advanced technologies with significant socio-economic impact, focusing on information technology,
AI, robotics, IoT, etc. However, it does not encompass comprehensive emerging technologies, such as biotechnology,
for protecting national interests.
However, India has shown deep interest in building an advanced research and development cooperation framework
related to economic security within the QUAD framework. Especially noteworthy are its specific efforts inestablishing the Centre of Excellence cooperation framework for quantum research with Australia192. The attitude andmeasures shown by India in materializing its economic security policy through bilateral and multilateral cooperation
will be of ongoing interest.

191

Emerging Technologies Division Promoting the Adoption of Cutting-edge Technologies to create Significant Economic and Societal Impact,
https://www.meity.gov.in/emerging-technologies-division

192

Strengthening our technology partnership with India Statement 17 November 2021,
https://www.foreignminister.gov.au/minister/marise-payne/media-release/strengthening-our-technology-partnership-india

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2.3.3 Funding
A large portion of the financial support for science and technology innovation, based on an analysis of bibliographic
data, is provided by federal government bodies and related agencies such as DST, SERB under its umbrella, DSIR,
with private sector bearing about 30% of the research and development funding for the country as a whole193. A
desire to perform research and development in the private sector is not widespread across the country. Additionally,as general funding bodies, there are the Council of Scientific & Industrial Research (CSIR) under DSIR, the IndianCouncil of Medical Research (ICMR) under the Ministry of Health and Family Welfare, the University Grants
Commission (UGC) under the Ministry of Higher Education, the Indian Council of Agricultural Research (ICAR)
under the Ministry of Agriculture and Farmers Welfare, the Board of Research in Nuclear Sciences (BRNS) under the
Atomic Energy Commission194, the Defence Research and Development Organisation (DRDO) under the Ministry of
Defence, and the English DBT/Wellcome Trust India Alliance195.
The government is also providing funds to encourage domestic manufacturing of pharmaceutical raw materials
amongst businesses. In November 2020, the Indian government allocated a third stimulus package of 9 billion rupees(approximately 16 billion yen) for “Mission Covid Suraksha - the Indian COVID-19 Vaccine”, accelerating vaccine
development. In April 2021, DBT provided additional funding for the clinical trial of India’s first mRNA-based
COVID-19 vaccine HGCO19, developed by Gennova Biopharmaceuticals Ltd. based in Pune196.
It is also funding various plans and programs to promote biotechnology research and development in India. Amongthese, the 2316 Biotechnology Parks promoted by DBT as ongoing projects (as of 2022), and the 60 bio-incubation
centers promoted by BIRAC serve as crucial cores, with specific details introduced below.
The primary eligibility criteria for companies to apply for funding include: over 51% of the company’s sharesmust be owned by Indian nationals, the company must have research facilities in India, must have obtained DSIR
certification (refer to the DSIR section) and must be at a TRL level 7 with commercialization potential. If the funding
is to be COVID-19 related, the research period must be within 12 months, and the intellectual property rights acquired
must be owned by the company197.

(1) National Biotechnology Park Scheme (DBT)
Under the Scheme, the central and state governments are working to stimulate biotechnology research in the countryby establishing biotechnology parks, incubators, and pilot projects through public-private partnerships. The funding
aims to provide financial support from the country to promote biotechnology product development, commercialization,and research innovation in the parks, offering scientists and SMEs opportunities for technology incubation, technology

193

From APRC-FY2021-RR-04 “Policy and R&D Trends for Science and Technology Cooperation with India”.

194

Under the Department of Atomic Energy, there is the Tata Institute of Fundamental Research (TIFR) as a national research center. In thefield of biology, there are the Department of Biological Sciences (Main Campus) in Mumbai, the National Centre for Biological Sciences in
Bangalore, and the TIFR Centre for Interdisciplinary Sciences in Hyderabad.

195

A public charity funded by the DBT and the Wellcome Trust Foundation of the UK, established in 2008. India Alliance:
https://www.indiaalliance.org/

196

DBT- S&T Interventions for COVID-19:
https://dbtindia.gov.in/sites/default/files/DBT%27s%20Response%20to%20COVID-19_September%202021.pdf

197

DSIR R&D Funding Scheme, https://www.dsir.in/rdfunding.php (Accessed September 24, 2022)

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demonstration, and research in pilot plants. The parks, centered around universities, are expected to act as effective
bridges between science and industry, and also to financially contribute to the universities. All research institutes andother corporations established by state governments are eligible to apply. Existing parks seeking support can apply by
clearly specifying the number of employees requiring advanced technology, the number of products, and the numberof patent applications. Table 2-7 summarizes the main parks and their activities.
Financial support guidelines are calculated based on the size of the park and the number of participating companies,
for example, in the case of existing facilities, this is either 50% of the lease or less than 75 rupees (about 133 yen)
per foot, whichever is lower. For new facilities, financial support from the country is 300 million rupees (about 534
million yen) per park or 75% of the project cost (90% for parks in underdeveloped regions) (the remaining 25% isborne by partners participating in the park setup), covering construction costs, management costs, machinery costs,
etc. The land is to be provided by the local government. Projects are overseen by a monitoring committee, and funds
are provided based on phase evaluations. Other detailed criteria are applied in the selection of parks.

Table 2-7 Biotechnology Parks198

Location & Name

Details of Initiative

Biotech Park (Lucknow,
Uttar Pradesh)

The first incubator, co-founded by DST, DBT, and the Governmentof Uttar Pradesh. The park hosts 18 common facilities and 27
measurement facilities, accumulates 36 startups, utilizes nearby
research facilities such as CSIR and ICAR, focuses on the developmentof agricultural products, biofertilizers, biopesticides, and contributes totalent development. It is famous for developing disease-free banana
varieties through tissue culture.

Biotechnology Incubation
Centre (Hyderabad,
Telangana)Established with the cooperation of CSIR-Indian Institute of Chemical
Technology (CSIR-IICT), DBT, and state government, owned by theSociety for Biotechnology Incubation Centre (SBTIC). It is equippedwith advanced instruments such as Fourier Transform Nuclear
Magnetic Resonance (FT-NMR) equipment (500MHz) and LC-Q-TOF/
MS/MS. This facility is characterized by conducting everything fromprocess development to quality analysis and performance evaluation ofpharmaceuticals199.

Biotech Park (BTCIF)(Chennai, Tamil Nadu)

Established by the Tamil Nadu Industrial Development Corporation(TIDCO) with support from the state government and DBT, it isequipped with a series of analytical devices like MALDI TOF/TOF andchromatography equipment, as well as biotechnology research facilities
like microbial culture devices from 5L to 100L200.

198

Biotech Parks & Incubators, DBT: Https://dbtindia.gov.in/schemes-programmes/translational-industrial-development-programmes/biotechparks-incubators (Accessed September 24, 2022)

199

The Advanced Analytical and Characterization Facility (AACR) is located in Hyderabad’s high-tech business district, Genome Valley, andfeatures cutting-edge analytical equipment: http://sbtic.org/AACR.html

200

TIDCO Centre for Life Sciences briefing materials: https://ticelbiopark.com/ticel-new/uploads/BTCIF%20Brochure-2020.pdf

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The Golden Jubilee Biotech
Park For Women (Chennai,
Tamil Nadu)

The parkʼs association was established in 2001 with the vision of
encouraging female entrepreneurs in the life sciences field, supportedby the Government of Tamil Nadu and DBT. Since its establishment, it
has nurtured 500 female entrepreneurs and engineers, with nearly 200
currently working there. It is supported by BIRAC and is equipped withgeneral research facilities, functioning as an incubation center201.

Biotech Park Technology
Incubation Centre (GBPIC)(Guwahati, Assam)

Assam is a biodiversity-rich hotspot area. The center was authorized
in 2009 and established near IIT Guwahati and Gauhati University. It
houses eight modular labs and is equipped with shared measurement
facilities for precision measurement. It aims to revitalize the stateʼs
economy through promoting employment and the development of
products utilizing natural resources202.

Biotechnology Park
(Bangalore, Karnataka)

Authorized in 2005 with contributions from Karnataka Biotechnology
and Information Technology Services (KBITS), the state government,
and DBT, serving as an innovation center for biotechnology startups,
fully equipped with various measurement devices, mammal and planttissue culture facilities, animal houses, etc.203.

Kribs Bionest (Kochi,
Kerala)Established within the Kerala Biotechnology Park. Previously known
as KINFRA Biotech Park. Its facilities are managed by the Rajiv Gandhi
Centre for Biotechnology (RGCB) and Kerala Startup Mission (KSUM).
It is equipped with cell biology and genomics research facilities suchas next-generation sequencers and cell sorters, in addition to in vivo
imaging systems in animal houses and 100L culture tanks. It houses 28
startups (with an additional two companies participating virtually), withfive companies having already graduated204.

(2) Funding by BIRAC
BIRAC, a non-profit company established by DBT, primarily targets SMEs to bridge the gap in academic-industrial
innovation research and promotes programs and platforms related to establishing and operating innovative, highquality, and affordable product development through cutting-edge technology. Table 2-8 summarizes its main
programs related to academic research.

201

Bio-NEST facility: https://www.biotechpark.co.in/bionest.htm

202

GBPIC Guwahati Biotech Park: https://gbp.assam.gov.in/portlet-innerpage/guwahati-biotech-park-incubation-centre

203

Bangalore Biotech Park: https://dbtindia.gov.in/bangalore-biotech-park-karnataka

204

RGCB BioNEST site: https://rgcb.res.in/BioNest/facilities.php

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Table 2-8 Main BIRAC Programs

Programs

Content

Bio-NEST205(Incubation)

Supports startup establishment by academia through providing
space for entrepreneurs, entrepreneur exchange, intellectual property
management, etc., aiming to promote an innovation ecosystem.
Has supported 63 universities and research institutions such as the
University of Delhi and the University of Hyderabad, resulting in thecreation of 200 products and 250 patent applications.

Promoting Academic
Research Conversion toEnterprise (PACE)206

Provides support up to proof of concept (PoC) for solving nationaland societal challenges. (1) The Academic Innovation Research (AIR)category offers support of 5 million rupees (about 8.9 million yen) for
1.5 years. It excludes basic/exploratory research or proposals withlow commercial value, requiring applicants to be the lead author of thepaper forming the basis of the PoC or to have filed a patent. (2) The
Contract Research Scheme (CRS) targets proposals above TRL-3,
requiring academia to be the applicant, while also making an industrial
partner mandatory. There is no set limit for the support duration andgrant amount.

Biotechnology Ignition Grant
Scheme (BIG)207(Idea to early stage)

BIRACʼs flagship program. Supports startups and entrepreneurs fromconception to proof stage with 5 million rupees (about 8.9 million yen)for 1.5 years. Held biannually in January and July, selected projects aremanaged through 8 national partner institutions like DBT-supported
C-CAMP and DST-supported KIIT-Technology Business Incubator.

Biotechnology Industry
Partnership Programme(BIPP)208

Supports high-risk public-private research in advanced fields.
Conducts three calls for proposals annually targeting areas like a) drugdelivery/pharmaceuticals, b) vaccines/clinical trials, c) biosimilars/stem
cells, d) devices/diagnostic technologies, e) agriculture, f) industrial
biotechnology, g) bioinformatics, following national priorities. Since its
inception in 2008, it has supported 214 projects (as of the end of fiscal
year 2020), resulting in 52 product creations.

AMRIT Grand Challenge(AMRIT GRAND
CHALLENGE)209(New in 2022)

A new program announced in 2022 to support interdisciplinary,high-quality, high-risk R&D. Targets startups, industry, academia,
and research institutions, planning to grant 1 to 1.5 billion rupees(about 1.78-2.67 billion yen) over 2-3 years. Focus areas include
addressing national priorities and positioning India as a global leader
in biotechnology, covering health, agricultural bio, climate change,
synthetic biology, and sustainable biological resource management.

205

Bio-NEST site: https://birac.nic.in/bionest.php

206

PACE: https://birac.nic.in/desc_new.php?id=286

207

BIG site: https://birac.nic.in/big.php

208

BIPP site: https://birac.nic.in/desc_new.php?id=216

209

On August 22, 2022, Minister Shin of the Ministry of Science and Technology announced the establishment of the AMRIT GRAND
CHALLENGE program to support fields such as health, agro-biotechnology, climate change, synthetic biology, and sustainablebioresource management, addressing national priorities and advancing India as a global leader in biotechnology. Reference video:
https://www.indiascience.in/videos/amrit-grants-for-biotech-initiatives-e (Accessed December 25, 2022)

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BIRAC’s synthetic biology-related R&D efforts, as of 2020, are primarily targeting research fields within the
Biotechnology Ignition Grant Scheme (BIG) as below210.
・Pathway/genome engineering in microorganisms and algae for fine chemicals, specialty chemicals, polymers, biolubricants, and hydrocarbons.
・Improved enzyme systems.
・Development of synthetic genetic parts and circuits.
This funding targets individual or team applications, focusing on innovation research for companies, consortia,
academia, and startups, and excludes basic research. The maximum support amount is 5 million rupees (about 8.9
million yen), with a maximum research period of 1.5 years. Supports domestic projects in synthetic biology, including
construction of a BioBrick library using CRISPR-Cas9 by Saha Institute of Nuclear Physics, anthocyanin production
by yeast at Central Food Technological Research Institute (CFTRI), and hyaluronic acid production by IIT Madras,
with 11 projects selected 211.
According to the announcement212 by the Minister of Science and Technology on August 22, 2022, DBT-BIRAC
established the AMRIT GRAND CHALLENGE program to support interdisciplinary, high-quality, high-risk R&D
in fields including synthetic biology by startups, industry, academia, and research institutions, preparing a grant of
1-1.5 billion rupees (about 1.78-2.67 billion yen) over 2-3 years. It is hoped it will accelerate R&D that fully utilizes thefacilities and advanced research equipment installed in existing biotechnology parks, etc.

2.3.4 Main Research Institutions and University R&D Trends
Synthetic biology research in India mainly involves national biotechnology parks and the surrounding historic
universities and research institutions listed in section 2.2.3 as main players, which are equipped with cuttingedge research infrastructure. In this section, major research institutions and universities, including those under thejurisdiction of the Department of Biotechnology (DBT), are shown in Figure 2-7. Additionally, institutions among themain players that are notably active are introduced below.

(1) Centre for Cellular and Molecular Platforms (C-CAMP)The Centre for Cellular and Molecular Platforms (C-CAMP) is one of BIRAC’s flagship centers, established in 2009.
It is positioned as a national incubator for biostartups, located in Bangalore, Karnataka, which is often referred toas India’s Silicon Valley and a center of innovation. C-CAMP houses infrastructure necessary for drug discovery
support and biotechnology research, including high-resolution 3D X-ray microscopes, mass spectrometers, electron
microscopes, and recombinant model organisms. It is also part of the Bangalore Life Science Cluster (BLiSC) alongwith NCBS, inStem, and Tata Institute for Genetics and Society (TIGS) and has produced a strong presence byfunding over 330 startups. The most successful of these startups is Bugworks, founded in 2014, which develops novel

210

R&D Proposals 2020 in Synthetic Biology by BIRAC, India: Https://researchersjob.com/rd-proposals-2020/ (Accessed September 24, 2022)

211

List of Projects Adopted in Synthetic Biology by BIRAC-BIG:
https://birac.nic.in/projects_supported.php?scheme=16&iscomplete=5 (Accessed September 24, 2022)

212

DST Press Release: https://pib.gov.in/PressReleasePage.aspx?PRID=1853621

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antibiotics that can act on Gram-negative and Gram-positive drug-resistant bacteria (anti-microbial resistance, AMR).
It is discovering first-in-class antibiotics through the ELUDEtm platform. In 2017, it was the first in Asia to be selected
for a grant by the global network CARB-X (Combating Antibiotic Resistant Bacteria Accelerator), led by Boston
University, to accelerate the development of new antimicrobials213. It has expanded to Western countries, Japan, andAustralia.
Another successful global company that has taken advantage of the global trend toward precision medicine is
Strand Life Sciences, a bioinformatics-based company that takes advantage of India’s status as an IT powerhouse.
C-CAMP is actively fostering partnerships for funding and collaboration with international institutions like
Swissnex, the Indian government, domestic universities, and the industrial sector. In November 2022, Principal
Scientific Adviser Ajay Kumar Sood (former professor at the Indian Institute of Science, IISc), announced theestablishment of the Bangalore Science and Technology Cluster (BeST) in the area. This cluster is a collaborative
effort involving the Indian Institute of Science (IISc) and C-CAMP, aiming to strengthen research and development inareas such as health, precision agriculture, urban transport, monsoons and climate change, quantum technology, androbotics.

(2) Jawaharlal Nehru University - Biofoundry India
The university that compiled the “Foresight Paper” mentioned in section 2.3.2, it is the sole Indian member of the
Global Biofoundries Alliance (GBA). Operating as an open platform, it offers talent development and analyticalsupport. Equipped with various advanced measurement and analysis instruments, including laser microscopes capableof live imaging and facilities for protein X-ray crystallography analysis. It is co-represented by Professor Binay
Panda214 of Jawaharlal Nehru University and Professor Pawan Kumar Dhar, who was previously mentioned. Professor
Panda also serves as the Indian contact for the international project known as Genome Project-Write (GP-Write).

213

CARB-X https://carb-x.org/partners/global-accelerator-network/

214

Professor Panda earned his Ph.D. from Oxford University and has postdoctoral experience at the Scripps Research Institute in the US. He
also has experience as a visiting researcher at the Technical University of Denmark (DTU) and the University of Tokyo Institute of Medical
Science. In Nature India (2016), he raised issues regarding open access to papers and the use of clinical big data in India.
https://www.nature.com/articles/nindia.2016.71

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Figure 2-7 Major Research Institutions Related to Synthetic Biology in India

In addition to the two institutions mentioned above, the following autonomous research institutions are also present
under DBT215.
・National Institute of Immunology, New Delhi
・National Centre for Cell Science (on the campus of Pune University), Maharashtra
・National Brain Research Centre, Haryana
・Centre for DNA Fingerprinting and Diagnostics (CDFD), Hyderabad
・National Institute of Plant Genome Research, New Delhi
・Institute of Life Sciences, Bhubaneswar, Odisha
・Institute of Bioresources and Sustainable Development (IBSD), Imphal, Manipur
・Rajiv Gandhi Centre for Biotechnology (RGCB), Kerala

215

Autonomous research institutions under DBT:
https://dbtindia.gov.in/about-us/organization-structure/autonomous-institution

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・Institute for Stem Cell Science and Regenerative Medicine (inStem), Bangalore・Translational Health Science and Technology Institute, NCR Biotech Science Cluster, Gurgaon
・National Institute of Animal Biotechnology (NIAB), Hyderabad

2.3.5 Trends in Major Industries
India’s primary biotechnology industries are categorized into biopharmaceuticals, bioindustrials, bioagriculture, bioIT,
and the bioservices sector (manufacturing, research, and clinical trial outsourcing). The biotechnology sector’s skilledworkforce is believed to exceed 1 million people. Segment contributions are as follows: vaccines 17.8%, bio IT/medical
research 15%, COVID bioeconomy 7.8%, diagnostics/medical devices 25.6%, BT cotton 216 14.4%, biofertilizers/
biopesticides 1.4%, enzymes 3.7%, biofuels 3.6%, biologics/therapeutics 10.7%217, with vaccines218 and diagnostics/
medical devices leading the way.
Particularly in the field of biopharmaceuticals, India plays a crucial role globally in vaccine manufacturing,
significantly contributing to the supply of DPT, BCG vaccines, and biosimilars.219 India operates 665 factories
approved by the FDA, second only to the USA, with over 1,400 manufacturing facilities meeting WHO standards, andaccounts for 44% of new drug applications worldwide220. According to SynBioBeta221, a US-based company, India,
which has a high prevalence of genetic disorders like beta-thalassemia and sickle cell anemia, is expected to produce
developments in effective treatments using genome editing technologies.
The growth of the industry is attributed domestically to the government’s Make in India and Startup India policies,
and internationally to the strong demand for Indian vaccines222 and biopharmaceuticals. Additionally emphasized are
the draft of the “National Policy on Research & Development & Innovation in Pharma-MedTech Sector”223 announced
at the end of 2021, the industrial nurturing measure known as PLI 224and clinical trial rules225, support for foreign

216

India is the world’s largest cotton producer, cultivating Bt cotton (genetically modified cotton with insecticide-resistant genes) introduced by
Monsanto (at the time) in the 2000s.

217“India’s Biotechnology Sector: How India is Reinventing the Future” , Ajjay Kumar Guputa, NIIR PROJECT CONSULTATION SERVICE,
April 19, 2022:
https://www.linkedin.com/pulse/indias-biotechnology-sector-how-india-reinventing-future-gupta

218

India’s Serum Institute and America’s Novavax have partnered to produce COVID vaccines. The world’s first DNA vaccine was developedby Zydus Cadila, based in Ahmedabad.

219

The biosimilar market is growing at 22% annually and is expected to reach $25 billion by 2025.
https://www.investindia.gov.in/sector/biotechnology(Accessed September 22, 2022)

220

Biotechnology industry in India , https://www.ibef.org/industry/biotechnology-india

221

SynBioBeta, a media company based in California, USA (founded and CEO by John Cumbers), provides information related to synthetic
biology and hosts events such as the Global Synthetic Biology Summit for scientists, engineers, inventors, entrepreneurs, and investors.
URL:
https://www.synbiobeta.com/read/jugaad-epitomized-a-deep-dive-into-indias-synthetic-biology-scene

222

India exports vaccines to over 150 countries (same as above).

223“Draft policy to catalyse R&D and innovation in pharma-MedTech sector”
https://pharmaceuticals.gov.in/sites/default/files/Draft%20Policy.pdf (Accessed September 22, 2022)

224

PLI: An initiative started by the Government of India to not only encourage foreign companies to find workforce in the country and thereby
generate employment, but also encourage domestic and local production to create micro jobs
https://cleartax.in/g/terms/pli-scheme (Accessed September 22, 2022)

225

The new drug/clinical trial regulations of 2019 are perceived to reduce costs, shorten approval times, and simplify procedures for thepharmaceutical market.

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investment in the pharmaceutical/medical device industry, and India’s epidemiologically unique background 226. The
strong support by BIRAC for strategic projects that advance ideas to commercialization amongst biotechnologyrelated technologies and products is also crucial.
The pharmaceutical industry, the largest segment of the biotechnology industry, accounted for 62% of the total (in2020), with its size projected to reach 65 billion US dollars (about 8.255 trillion yen) by 2024, and further expected
to reach 120 to 130 billion US dollars (about 16.51 trillion yen) by 2030227. The export value of pharmaceuticals is
23.04 billion US dollars (about 2.921 trillion yen), accounting for 5.92% of the global pharmaceutical demand 228, withformulations and biologics making up the majority (73.31%) of India’s export value229.
In the synthetic biology-related industries, India accounted for 8.9% of the Asia-Pacific synthetic biology market in
2020, not reaching Australia’s 15.3%. This market is predicted to grow from 163 million US dollars (about 20.7 billion
yen) in 2021 to 567 million US dollars (about 72 billion yen) by 2026, with an annual growth rate of 28.3% during theforecast period.
The following section will discuss two companies that dominate sales in India as pharmaceutical companies andtwo companies that have garnered attention for their R&D activities introduced in section 2.2.4(1).

(1) Sun Pharmaceutical Industries Limited230
Sun Pharma, founded in 1983, is the world’s fourth-largest generic pharmaceutical manufacturer, boasting annual
sales of 5.1 billion US dollars (about 627.3 billion yen). With over 40 manufacturing facilities, it produces high-quality,
affordable medicines, earning the trust of medical professionals and supplying to over 100 countries worldwide. The
company focused on technological differentiation through early investment in R&D, addressing complex productdevelopment through talent development and the establishment of pharmaceutical development strategy teams.
Its products range from generics to specialty pharmaceuticals targeting both chronic and acute diseases, sensitively
responding to the demands of trading countries’ regions. The importance of science in pharmaceutical development iscentral to the company; it has a research team comprising over 2700 researchers based in six research centers in India,
Israel, and the USA. It holds over 1400 patents.

(2) Aurobindo Pharma Limited231
Aurobindo Pharma Limited began its operations in 1992 and was listed on the stock market in 1995, becoming thesecond-largest pharmaceutical company in the Indian market. Initially, the company specialized in semi-synthetic
penicillin, later expanding its performance in areas such as psychiatry, cardiovascular, antiretrovirals, diabetes, thegastrointestines, and antibiotics. In 2020/21, it recorded sales of $3.3 billion, exporting to over 150 countries, with
90% of its revenue derived from exports.

226

The patient pool in India is expected to grow by more than 20% over the next decade due to population growth. Indian Biotechnology
Industry Analysis https://www.ibef.org/industry/biotechnology-presentation (As above)

227

IBEF Posters on Indian economy and business https://www.ibef.org/mediaevents/posters(Accessed September 22, 2022)

228

Pharmaceutical export from India: https://www.ibef.org/industry/biotechnology-india

229

India Brand Equity Foundation “Indian Biotechnology Industry Analysis” 2021,
https://www.ibef.org/industry/biotechnology-india (Accessed September 22, 2022)

230

https://sunpharma.com/

231

Excerpt from https://www.aurobindo.com/

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It is India’s largest research facility, with five domestic research centers spanning a total area of 16,000 square
meters. It also has three research and development centers in the USA. The company employs over 1,700 scientists
and analysts. In particular, its research and development center in Hyderabad is equipped with the latest technology,
houses an interdisciplinary research team of over 700 people across more than 13,000 square meters, fosters a creativeenvironment, and supports its new drug development team with complex in vitro analysis and bioanalytical methods.

(3) Strand Life Sciences
Strand Life Sciences was the first company to spin off from the India Institute of Science in 2000. Focused on
genomics-based research and diagnostics, the company aims to decipher genetic information contained within the
genome to enhance global health.
Its powerful genomics solutions contribute to accelerating drug discovery research for pharmaceutical andbiotechnology companies. Through access to genomics data along with clinical and phenotypic data, it enables
insights at the genetic and molecular levels for complex diseases, promoting research in personalized medicine.
Its partnerships with Strand Life Sciences enable large-scale genomics research. The company collaborates withthousands of scholars and physicians, applying next-generation genomics to generate valuable insights in disease areas
such as cancer, cardiovascular and metabolic diseases, eye, and neurological disorders.
It enables targeted treatments and preventive medicine for diseases through accurate diagnostics and genetic testing
using next-generation sequencers. With the latest technology and its proprietary analysis and interpretation platform,
it provides quick and reliable guidance on optimal treatment and prevention options. Strand Life Sciences is a testing
facility accredited by CAP (College of American Pathologists) and NABL (National Accreditation Board for Testing
and Calibration Laboratories), being the first in India to receive both prestigious certifications for NGS testing. It has
an interdisciplinary team of over 220 pathologists, scientists, and engineers, with about 50% of scientists holding PhDs
from leading research institutions worldwide, and engineers from top domestic universities providing computational
capabilities for complex analyses. For nearly 20 years, it has developed robust and sophisticated bioinformatics
solutions through GeneSpring, and Strand NGS, which are based on its proprietary platforms Ramanujan and Avadis.
Strand Life Sciences operates the highest number of three CAP-accredited central labs among lab providers in India.
Its tests cover a wide range from rapid point-of-care tests to the most specialized molecular level tests for cancer,
genetics, infertility, maternal and child health, infectious diseases, and algorithm-based wellness.

(4) Bugworks232
Bugworks was established in 2014 and was incubated at C-CAMP. Its core team of scientists has over 200 yearsof drug discovery experience, partnering with several globally renowned partners to drive groundbreaking broadspectrum activities. The company started as a small group of dedicated and skilled scientists aiming to tackle solutions
before the global challenge and severity of global health issues worsen. It is currently headquartered in the USA, withsubsidiaries in India and Australia. Over the years, the company has diversified its expertise in the areas of cancer
biology and immunology, developing new classes of broad-spectrum antimicrobials and immunotherapies needed for
critical care in infectious diseases and cancer.

232

Excerpt from https://bugworksresearch.com/

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The most recent class of novel antibiotics was discovered in 1987, but antimicrobial resistance (AMR) remains amajor contemporary challenge with devastating and long-term impacts. The company has been continuously engaged
in the research and development of new antimicrobial therapies, ensuring both patients and society can benefit from
effective AMR strategies. It is also working on evolving immunotherapy to new stages. The company’s research
program is focused on the discovery of affordable, differentiated small molecule therapeutics for high-density, hypoxic
tumors. It emphasizes the extremely important role adenosine plays in creating an immunosuppressive and tumorpromoting environment. It believes a deep understanding of the medicinal chemistry and the tumor microenvironment
can provide a kickstart to initiate and maintain a strong anti-cancer response by the immune system, and that this has
the potential to make current immunotherapies more effective. In April 2021, it announced receiving funding fromthe US Defense Threat Reduction Agency (DTRA) to support the development of a novel broad-spectrum antibiotic,
BWC0977, to counter the most critical bacterial biothreats233.

2.4 United States (Comparative Reference Information)
2.4.1 Major Policies and Key Issues
Many of the technologies and tools that enabled the development of synthetic biology were developed in the
United States. The United States continues to lead the field due to substantial and ongoing support for research anddevelopment in biotechnology, the presence of a high number and quality of startups, and a functioning innovation
ecosystem through academia-industry-government collaboration. On January 20, 2021, President Biden, in a letter
to Dr. Eric S. Lander, the Presidential Science Advisor and Director of the White House Office of Science andTechnology Policy (OSTP) at a cabinet-level post, stated, “From artificial intelligence to synthetic biology, newtechnologies that can alter our lives are emerging at an ever more rapid pace.”
He posed questions about how the US can remain a global leader in future technologies and industries essential for
economic prosperity and national security, with a focus on competition with China234.
Recent US presidential administrations have focused on promoting and regulating biotechnology and its
foundational research and development from a national security and defense strategy perspective. However, significant
policies related to biotechnology date back to the 1980s, the dawn of biotechnology, as shown in Table 2-9, including
the development of PCR methods and genome sequencers.

233

Referenced https://kyodonewsprwire.jp/release/202104264129

234

The White House, “A Letter to Dr. Eric S. Lander, the President’s Science Advisor and nominee as Director of the OSTP,” January 15, 2021:
https://www.whitehouse.gov/briefing-room/statements-releases/2021/01/20/a-letter-to-dr-eric-s-lander-the-presidents-science-advisor-andnominee-as-direct

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Table 2-9 Overview of Recent Biotechnology-Related Policies

Administration

Overview

ReaganAdministration

・In 1986, the OSTP announced the “Coordinated Framework for the Regulation of
Biotechnology,” outlining a comprehensive federal regulatory policy to ensure theObama
Administration

・Focused on updating the aforementioned framework and its accompanying

Trump
Administration

・Hosted the Bioeconomy Summit 237,238, conducting outreach to industry andsafety of biotechnology products.

guidance. Clarified the roles and responsibilities of federal agencies in biotechnology
regulation.
・The National Science and Technology Council (NSTC) published numerous
reports during Obamaʼs second term (2013-2017), focusing on various aspects ofbiotechnology, including biosecurity/biosafety and biosurveillance235, 236.
focusing on updating the regulatory approval process for agricultural biotechnology
products.
・In September 2019, the OSTP issued a “Request for Information (RFI) on the
Bioeconomy,” soliciting community input on how the US government can support
the promotion of the bioeconomy, highlighting needs such as sustained and longterm federal investment in research and development in the bio sector, including
synthetic biology239, 240.
・It identified biotechnology as one of the emerging technology areas emphasizedalongside AI, quantum information science, 5G/advanced communications, andadvanced manufacturing as “industries of the future,”241 although no major policies
related to the promotion of research and development were issued.

235

U.S. Environmental Protection Agency, “National Strategy for Modernizing the Regulatory System for Biotechnology Products,” September
2016: https://www.epa.gov/sites/default/files/2016-12/documents/biotech_national_strategy_final.pdf

236

T h e W h i t e H o u s e , “ T h e H o m e l a n d B i o d e f e n s e S c i e n c e a n d Te c h n o l o g y C a p a b i l i t y R e v i e w ( 2016) , ” D e c e m b e r 2016:
https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/NSTC/biodefense_st_report_final.pdf

237

The White House, “SUMMARY OF THE 2019 WHITE HOUSE SUMMIT ON AMERICA’S BIOECONOMY,” October 7, 2019:https://trumpwhitehouse.archives.gov/wp-content/uploads/2019/10/Summary-of-White-House-Summit-on-Americas-BioeconomyOctober-2019.pdf

238

George B. Frisvold. (2021) “Understanding the U.S. Bioeconomy: A New Definition”, Sustainability , 13, 1627

239

Office of Science and Technology Policy (OSTP), “Request for Information on the Bioeconomy,” 9 2019:https://www.federalregister.gov/documents/2019/09/10/2019-19470/request-for-information-on-the-bioeconomy240

As an example of RFI responses, the Biotechnology Innovation Organization (BIO), representing the biotechnology industry, seeks sustainedfederal funding for basic biotechnology research and strong public-private partnerships in biosciences. They also emphasize the necessityof robust STEM education policies to secure a domestic workforce capable of leveraging “increasing high-paying science jobs.” Other
respondents included the American Society for Microbiology (ASM), the American Society for Biochemistry and Molecular Biology(ASBMB), and university associations.

241

The White House, “ADVANCING AMERICA’S GLOBAL LEADERSHIP IN SCIENCE & TECHNOLOGY -TRUMP ADMINISTRATIONHIGHLIGHTS: 2017-2020,” October 2020. [Online]. Available:
https://trumpwhitehouse.archives.gov/wp-content/uploads/2020/10/Trump-Administration-ST-Highlights-2017-2020.pdf

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・The Bureau of Industry and Security (BIS) of the US Department of Commerce

listed biotechnology (nanobiology, synthetic biology, genetic engineering, neuroengineering) as an example of the 14 emerging technologies subject to regulation
under the Export Control Reform Act (ECRA) and its subordinate regulations,
the Export Administration Regulations (EAR). In addition, in conjunction with its
participation in the Australia Group, a multilateral export control regime focused on
dual-use items related to biological and chemical weapons, the Bureau of Industry
and Security (BIS) has added several items to the Export Control Classification
Numbers (ECCN) used in the Commerce Control List (CCL) for the purpose ofidentifying dual-use items subject to export controls242.

Biden
Administration

・Identified biotechnology as a priority research and development area for federal

agencies, focusing on the development of biomedical technologies to address
COVID-19 and related threats.
・From a national security and defense strategy perspective, the 2021 U.S.-China
Economic and Security Review Commission annual report recommended measures
such as the collection and protection of non-human genome data, considering
Chinaʼs enhanced national support for emerging technologies, including synthetic
biology.

2.4.2 Main Research Institutions and University R&D Trends
The US leads in almost all areas of life sciences and bioengineering related to the genome, including genome
sequencing, genome editing, and genome synthesis. As a leading country, it has countless institutions contributing toresearch and development in biotechnology, including synthetic biology, across academia, industry, and government.
Below, is a list of key federal agencies involved in basic to applied research and security-related activities.

Table 2-10 Main Federal Agencies Advancing Biotechnology Research, Including Synthetic Biology

AgencyUS
Departmentof Agriculture(USDA)

242

Sub-division

Main Responsibilities and Activity Overview

National Instituteof Food andAgriculture (NIFA)

NIFA provides federal funding to academia and privatecompanies for research and development in the biotechnology
fields of animals, plants, microbes, and insects.

Agricultural
Research Service(ARS)

ARS, USDAʼs principal research agency, conducts much of its
research at the Animal Biosciences & Biotechnology Laboratory(ABBL).

For instance, in June 2020, considering the potential use of the MERS coronavirus as a biological weapon, it was added to ECCN 1C351Human and Animal Pathogen and Toxins, along with the addition of culture chambers to the technical note of ECCN 2B352-Equipment
Capable of Use in Handling Biological Materials. In October 2021, nucleic acid assembler/synthesizer software capable of designing andconstructing functional genetic elements from digital sequence data was added (classified under ECCN 2D352-’Software’ for Nucleic Acid
Assemblers/Synthesizers).

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Departmentof Defense(DOD)

Departmentof Energy
(DOE)

243

Advances and Challenges in the Emerging Technology Field of “Synthetic Biology” in Australia, China and India

Defense Advanced
Research Projects
Agency (DARPA)

DARPAʼs Biological Technologies Office (BTO) undertakes
initiatives to enhance military benefits through biosciences,including areas such as biomanufacturing and synthetic biology.

Army ResearchLaboratory (ARL)The ARL collaborates with universities like the University ofTexas, UCSB-Institute for Collaborative Biotechnologies (ICB),
and companies like Lockheed Martin, aiming for operational
improvements in the Army through the TRANSFORME(Transformational Synbio for Military Environments ) programusing synthetic biology for custom material manufacturing.

Naval ResearchLaboratory (NRL)

NRLʼs Center for Bio/Molecular Science and Engineering
conducts various biotechnology research and development
projects, including synthetic biology surfactants.

Manufacturing
USA

Two manufacturing institutes sponsored by DOD, BioFabUSA
and BioIndustrial Manufacturing and Design Ecosystem(BioMADE), support DOD-related biotechnology research anddevelopment.

Office of Scienceʼs(DOE SC)
Biological andEnvironmental
Research (BER)
Program

The DOE SCʼs BER program provides substantial funding forthe development of novel bioimaging technologies for microbialinteractions using quantum technology, as well as for research
into synthetic biology approaches for plants and microbes.
BER collaborates with national laboratories to advance genome
science and bioenergy science, funding four Bioenergy ResearchCenters (BRCs)243.
In February 2022, Dr. Pamela Ronald, Feedstocks Division
Director at the Joint BioEnergy Institute (JBEI) and biologist in theEnvironmental Genomics and Systems Biology Division (EGSB),
won the Wolf Prize in Agriculture for her research on rice disease
resistance and environmental stress resilience.

National Virtual
Biotechnology
Laboratory (NVBL)

NVBL is a consortium of DOE national laboratories conducting
biotechnology research and development in response to
COVID-19.

DOE Bioenergy Research Centers (BRC): (1) The Great Lakes Bioenergy Research Center (GLBRC), led by the University of WisconsinMadison and Michigan State University, focuses on biofuel and bioproduct manufacturing from lignocellulose, (2) The Center for
Bioenergy Innovation (CBI), led by Oak Ridge National Laboratory, focuses on plant science and genome engineering research, bio-process
improvements, and bio-product development from lignin residue, working towards realizing a bio-economy society, (3) The Joint BioEnergy
Institute (JBEI), led by Lawrence Berkeley National Laboratory, conducts research on bioenergy crop improvement, biomass glycation
process development, and microbial enhancement for industrial use, (4) The Center for Advanced Bioenergy and Bioproducts Innovation(CABBI), led by the University of Illinois Urbana-Champaign, focuses on improving feedstock and energy crops like miscanthus, sorghum,
and sugarcane, and has many fields. Designated by DOE as a BRC in July 2017.

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US
Department
of Health& HumanServices(HHS) National
Institutes of
Health (NIH)

National
ScienceFoundation(NSF)

Advances and Challenges in the Emerging Technology Field of “Synthetic Biology” in Australia, China and India

National Instituteof Biomedical
Imaging andBioengineering(NIBIB)NIBIB researchers provide research and development grants inthe biomedical field for external researchers to conduct studies
in synthetic biology, among other areas, through the Synthetic
Biology Consortium. Additionally, in 2021, they supported a
conference at the Keystone Symposium244 on the theme ofSynthetic Biology: At the Crossroads of Genetic Engineering andHuman Therapeutics.

National Human
Genome ResearchInstitute (NHGRI)NHGRI leads NIHʼs genomic research, including novel nucleic
acid synthesis technology development and follow-up studies ofthe Human Genome Project. In the Analysis, Visualization, andInformatics Lab-space (AnVIL) program245, they operate a cloudbased genomic data sharing and analysis platform developedin collaboration with numerous research institutions anduniversities, including the Broad Institute and UC Santa Cruz.

Biosciences Office(BIO)

BIO is the primary office providing funding for biological researchand development projects, supporting various synthetic biology
projects.

The following table details notable research and development programs that it supports based on its long-term
strategies.

(1) DARPA Biological Technologies Office (BTO)
DARPA-BTO leads DARPA’s efforts to leverage biosciences for American military interests. Recent topics under the
BTO’s “Syn-Bio” tag are covered below246.
・B-SURE (Biomanufacturing: Survival, Utility, and Reliability beyond Earth)：
The Biomanufacturing: Survival, Utility, and Reliability Beyond Earth (BSURE) program is a program thatcollaborates with partners to explore the possibilities of biomanufacturing activities in space. The 2021 call for
applications (HR001122S0010) outlines projects on the use of microbes for alternative materials in space, optimizationof microbial growth under varying gravity, and mitigating the specific effects of galactic cosmic radiation on microbial
growth and bioproduction.
・Bio-INC (Bio-Inorganic Nanoparticle Control):The “Bio-Inorganic Nanoparticle Control (Bio-INC)” program involves research using microbes and biomolecules
to synthesize tunable rare ear th element (R EE)-containing optical and magnetic inorganic nanopar ticles(HR001121S0025, under the biotechnology category).

244

Keystone Symposia: A symposium for molecular and cell biology researchers, held annually in North America. Prominent researchers ineach field plan the program, and researchers conducting the most current research are invited.

245

NHGRI , “Analysis Visualization and Informatics Lab-space,”: https://anvilproject.org/ (Accessed February 2022)

246

DARPA, “Biological Technologies Office (BTO),”:https://www.darpa.mil/about-us/offices/bto#OfficeProgramsList (Accessed February 2022)

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・Living Foundries:
In December 2021, a decade after its launch in 2010, the Living Foundries program, which aims to program basic
biological metabolic processes to produce precursors for over 1,000 molecules and materials across a wide range ofdefense-related applications, including industrial chemicals, fuels, coatings, and adhesives, announced that it had
successfully manufactured over 1,630 molecules. Additionally, it announced it had successfully transferred thesesynthetic biomanufacturing technologies to five research laboratories of the Army, Navy, and Air Force247. Amongthe approximately 1630 molecules are compounds with interesting molecular properties for advanced polymer
development, and potential uses include durable adhesives for vehicle structural purposes such as armored vehicles,
and high-performance composite materials for aircraft and missile applications. The following are some development
examples in this program.
・A team led by Dr. Ben Harvey at the Naval Air Warfare Center Weapons Division (NAWCWD), in collaboration
with Amyris and Zymergen, developed tools and technologies for manufacturing high-performance chemicals
and materials useful for various military applications. NAWCWD succeeded in converting precursor molecules
into high-energy-density fuels, energy materials, heat-resistant polymers, and high-performance composite
materials. These technologies are planned for further development through the Naval Research Laboratory (ONR)
Bioengineering and Biomanufacturing Program, ONR Advanced Energy Manufacturing Pipeline, Wright Brothers
Institute/Air Force Research Laboratory (AFRL) Synthetic Biology Challenge, and Bioindustrial Manufacturing
and Design Ecosystem (BioMADE).
・T eams led by Dr. Greg Peterson, Dr. Jared DeCoste, and Dr. Vipin Rastogi at the Army’s Combat Capabilities
Development Command Chemical Biological Center (DEVCOM CBC) are developing filters, fabrics, anddecontamination wipes to counter chemical and biological warfare agents using biological template materials
provided by MIT. This technology is slated for further testing and development at DEVCOM CBC as part of the
Defense Threat Reduction Agency’s multifunctional materials program.

(2) Army Research Laboratory (ARL)As the Army’s leading research institution, ARL conducts the TRANSFORME (Transformational Synbio for
Military Environments) program in collaboration with numerous universities (Texas A&M University, MIT, Tufts
University, etc.) and companies (Lockheed Martin, Ginkgo Bioworks, etc.) as one of its foundational programs.
Recent achievements include the development of a method for synthesizing fully symmetrical oligomers248 using
the Supercharged Protein Assembly (SuPrA) technique by the University of Texas at Austin, and the developmentof efficient and inducible DNA introduction tools249 into bacteria in non-culturable environments by a team led byProfessor Christopher Voigt of MIT, among others.

(3) Manufacturing USA BioFabUSA
Established in 2016. Operated by the Advanced Regenerative Manufacturing Institute (ARMI) in New Hampshire.

247

DARPA, “OUTREACH@darpa.mil,” 8 12 2021: https://www.darpa.mil/news-events/2021-12-08

248

AJ Simon et al. (2019) “Supercharging enables organized assembly of synthetic biomolecules,” Nature Chemistry249

JAN Brophy et al. (2018) “Engineered integrative and conjugative elements for efficient and inducible DNA transfer to undomesticatedbacteria,” Nature Microbiology

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With approximately $300 million in funding from the federal government and private sources, it integrates cell andtissue culture with biofabrication, automation, robotics, and advanced analytical technologies to create disruptive
R&D tools and manufacturing processes.
Key projects include:・Supporting the automated production of β cells for diabetes treatment. Received $2 million in funding from theJuvenile Diabetes Research Foundation.
・T hrough an automated manufacturing project for bones, ligaments, and muscles, in collaboration with STELTechnologies, it developed an automated process for tissue manufacturing (Tissue Foundry).

(4) DOE Advanced Research Projects Agency-Energy (ARPA-E) ARPA-E ）ARPA-E, modeled after the Department of Defense’s DARPA, is a high-risk, high-reward funding program in theenergy sector. Recent synthetic biology-related projects include the Energy and Carbon Optimized Synthesis for
the Bioeconomy (ECOSynBio) program 250. It aims to facilitate the use of advanced synthetic biology tools for new
biomass conversion platforms and system designs, focusing on (1) carbon-optimized fermentation strains that reduce
CO2 emissions, (2) artificial organisms that mix different energy and carbon sources to curb CO2 production, (3)biomass-derived sugar and carbon dioxide gas fermentation technologies, (4) cell-free carbon-optimized biocatalysts
for biomass conversion and CO2 utilization, and (5) other technologies, with 17 projects led primarily by companies
and universities starting from 2021.

(5) Manufacturing USA BioMADE
The newest institution within the Manufacturing USA network. On October 20, 2020, the DOD announced itentered into a $87 million, 7-year contract with BioMADE251. It collaborates with 31 companies, 57 universities,
and 6 non-profit organizations to accelerate research and development. BioMADE is led by members from the nonprofit Engineering Biology Research Consortium 252 (EBRC) and is hosted by the University of Minnesota. Over the
next seven years, BioMADE intends to develop industry standards, tools, and measurement technologies, cultivatea resilient bioindustrial manufacturing ecosystem, and nurture core companies within the supply chain crucial for
propelling the bioeconomy in the United States. It will also place a strong emphasis on addressing societal challenges
such as biosafety and ELSI.
As of February 2022, it had launched 10 innovation projects253, including the development of a pilot-scale prototype
manufacturing device for in situ removal of toxins (and their microbial sources) (Amyris) and large-scale fermentation
production of succinic acid at pH 3.0 or lower (University of Illinois Urbana-Champaign), and plans to continue
soliciting project proposals as needed. In the future, it aims for the industrial-level production of new bio-products

250

DOE-APRA-E, “ECOSynBio,”: https://arpa-e.energy.gov/technologies/programs/ecosynbio

251

DOD, “IMMEDIATE RELEASE DOD Approves $87 Million for Newest Bioindustrial Manufacturing Innovation Institute,” 20 10 2020.:
https://www.defense.gov/News/Releases/Release/Article/2388087/dod-approves-87-million-for-newest-bioindustrial-manufacturinginnovation-insti/

252

EBRC: Members of the SynBERC (Synthetic Biology Research Center) program, supported by NSF for ten years, established to evolve andgrow a broader synthetic biology community, including industry and international members. They are creating policy recommendations,research ethics ELSI (security), and education, along with a technology roadmap for priority areas of basic research over the next 20 years inmicrobiome and material science.

253

BioMADE, “Technology & Innovation Projects,”: https://www.biomade.org/projects (Accessed February 2022)

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such as chemicals, solvents, detergents, plastics, fabrics, agricultural materials, and food additives.
A list of major universities with research centers related to synthetic biology, serving as key players from basic
to applied research can be found in Table 2-11. Additionally, notable research centers specializing in biotechnology
centered around the West Coast (which hosts many synthetic biology-related companies) include Stanford University(Bio-X), the University of California’s Center for Complex Biological Systems (CCBS), the University of Pennsylvania(Center for Cell and Developmental Biology, Center for Engineering Mechanobiology, Institute for Biomedical
informatics, Nano/Bio Interface Center), the University of Wisconsin-Madison (Biotechnology Center), and Purdue
University (Laboratory of Renewable Resources Engineering (LORRE), Biotechnology Innovation and Regulatory
Science Center (BIRSC)).
According to the 2022 Technology Trends Report254 by the New York City-based consulting firm Future Today
Institute (CEO Amy Webb), notable universities and researchers emerging in synthetic biology255, from perspectivesof equipment development, CRISPR technology, and applications in medicine and food, include the Broad Institute,
Dr. Drew Endy of Stanford University256, and Professor Jay Keasling’s lab at DOE Lawrence Berkeley National
Laboratory (also affiliated with the University of California, Berkeley).

Table 2-11 Main Universities Advancing Biotechnology Research, Including Synthetic Biology

Universities

Center Name

Overview

Johns Hopkins
University (JHU)

Institute for
NanoBioTechnology

Engineering approaches for cancer treatment, stem cellresearch, early diagnostic tools, and nano-scale processengineering.

Institute for
Basic Biomedical
Sciences

Has a Center for Cell Dynamics studying cell andmolecular dynamics using biosensors, an Epigenetics
Center developing tools for exploring epigenetic factors
in normal development and disease, and a Center for
Metabolism & Obesity Research.

Center for Synthetic
Biology

Conducts synthetic biology research under four themes:
cell-free systems, mammalian systems, technology
platforms (such as high-throughput technologies), andethical and social impact. Advisory members include
Nobel laureate Professor Frances Arnold, who developed
directed evolution methods, and Professor James J.
Collins from MIT.

Northwestern
University

254

The Future Today Institute. (2022) “Synthetic Biology, AgTech & Biotech”:
https://futuretodayinstitute.com/mu_uploads/2022/03/FTI_Tech_Trends_2022_Book12.pdf

255

Outside of academia and researchers, names such as ERS Genomics, CRISPR Therapeutics, Caribou Biosciences, Editas Medicine, Bayer,
Ginkgo Bioworks, Twist Bioscience, Benchling, GenScript, BGI Group, Built with Biology (formerly SynBioBeta), J.C. Venter Institute(JCVI), Synthace, Codexis, Zymergen, Amyris, Viridos, and Sherlock Biosciences, mainly from the West, are mentioned as unicorns andmajor companies.

256

Chairperson of the Biobricks Foundation and co-founder of iGEM. The Biobricks Foundation, established by researchers including Dr. Tom
Night, who moved from MIT to GinkgoBioworks, and Dr. Drew Endy, aims to standardize and standardize genetic information as “parts” ina library for free use.

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Harvard University

Massachusetts
Institute ofTechnology (MIT)University of
Illinois UrbanaChampaign

Simpson Querrey
Institute for
BioNanotechnology

Led by Professor Samuel I. Stupp, renowned for his
research in self-assembling materials and supramolecularchemistry, the center focuses on regenerative medicine,targeted nanotherapeutics, biomimetic materials, andelectrically active biomaterials. It is equipped with peptide
synthesis devices.

Wyss Institute for
Biologically Inspired
Engineering

Aims to develop technologies for health, energy,
architecture, robotics, and manufacturing based on
biological design principles. Members of the institute
who developed a strong hydrogel adhesion technology
and soft robotic glove technology received the Harvard
Presidentʼs Innovation Challenge in 2022. An applicationoriented institute, it is developing sensors with
biofunctional chips and micro-sized robots produced
using 3D printing technology. Its members include
Professor George Church, mentioned in the section on
China.

Harvard Chan
Microbiome in
Public Health Center(HCMPH)

Conducts basic research in epidemiology, nutrition,
cancer biology, immunology, etc., to deepen
understanding of the microbiome and link it to thetreatment of lifestyle-related diseases.

Broad InstituteFeatures prominent figures performing cutting edgeresearch in synthetic biology, including Professor Eric
Lander, former director of OSTP; Professor Christopher
Voigt, who devised a programming language for bacteria;
Professor Feng Zhang, known for applying CRISPR-Cas9
to mammals; and Professor David Liu, who is aiming todevelop treatment methods for progeria through singlebase modification.

Whitehead InstituteConducts basic research on cancer, cell mechanics, cell
development and regeneration, genetics and genomics,
infectious diseases, metabolism, neurodevelopment,
plant biology, and the structure and function of proteins.

Lincoln Laboratory

Located within Hanscom Air Force Base, Lincoln
Laboratory is funded by MIT and the DOD to develop awide range of advanced technologies addressing national
security needs. The Biotechnology and Human Systems
Division conducts research and development aimed
at enhancing the health and performance of military
personnel and dependents through enhanced disaster
response capabilities, climate change adaptations,improved defense against biological and chemical
threats, and the construction of artificial gut devices(enterobacterial flora research).

Roy J. Carver
Biotechnology
CenterA core research analysis facility supporting six categories
of research: genomics, proteomics, metabolomics,
bioinformatics, flow cytometry, and translational medicine.

Center for
Computational
Biotechnology and
Genomic Medicine(CCBGM)

An NSF-supported center promoting medical researchusing data analysis, artificial intelligence, machinelearning, and high-performance computing. Works incollaboration with companies such as IBM and Infosys,
along with Sandia National Laboratories.

Note: CABBI, a DOE-supported facility mentioned above, is excluded from this table.

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3 Analysis of Scientific Papers andPatents
This chapter provides an overview of the research and development trends in synthetic biology in India, Australia,and, for reference, Japan, China, and the United States. This overview is based on common understandings that leadto the analyses in each chapter, drawing from information in academic journals and published patent data. Emerging
biotechnology fields and synthetic biology-related keywords were extracted based on various papers, and a method
to gain an overview of paper and patent information using natural language processing text analysis techniques was
adopted.
For details, a separate report “Data landscape of emerging biotechnology articles and patents in major Asia and thePacific regions (APRC-FY2021-RR-05 (reference material)),” was referred to, and the summary is provided below.

3.1

Population of Papers and Patents

Synthetic biology is an interdisciplinary field. With the intention of comprehensively collecting data, this analysis
supplements the field’s trends since 2000 through bibliometric studies of prior articles, including those summarizing
the trends of synthetic biology in the Asian region based on keywords mentioned in the articles, as well as panoramicview reports257 from the JST Center for Research and Development Strategy (CRDS). A wide range of search
keywords and formulas were set, targeting not only the technology but also the products utilizing the technology. Thisapproach initially frames it as an “emerging biotechnology field” and subsequently focuses specifically on synthetic
biology to compile the findings.
Clarivate’s academic literature database Web of Science was used to collect data on papers. For data on patents,
LexisNexis’s TotalPatentOne (the world’s largest patent database) was used. The final population was collected without
specifying countries, regions, or languages to assess the global picture.

257

Ning Mao et al. (2021) “Future trends in synthetic biology in Asia”, Advanced Genetics, https://doi.org/10.1002/ggn2.10038
P. Shapira, S. Kwon , J. Youtie. (2017) “Tracking the emergence of synthetic biology,” Scientometrics, 1439-1469
JST/CRDS Panoramic View of the Life Science and Clinical Research Field (2021)

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Table 3-1 Target Scope for Emerging Biotechnology Field Search

Item

PapersPatents

Database Used

Clarivateʼs Web of Science

LexisNexisʼs TotalPatentOne

Type

Article OR Proceedings

Publication

Year Extracted

2010-2020

Examples of
Search Formulas& Keywords

As per “Analysis of Paper and Patent Trends in the Emerging Biotechnology Fieldin Major Asia-Pacific Countries (APRC-FY2021-RR-05 (reference material)).” For
reference, an example of a paper search formula is excerpted below. The patent
analysis is synonymous with the above.

Primary
Population

153,862

71,442

Final Population(After Noise
Removal)146,92957,603

Number of Items
by Country in the
Final Population(Percentage ofTotal Population)

Australia
India
Japan
United States
China

4157( 2.8%)7545( 5.1%)
10632( 7.2%)
43374(29.5%)
30632(20.8%)

Australia
India
Japan
United States
China

206( 0.4%)274( 0.5%)2760( 4.8%)
14968(26.0%)31500(54.7%)

The results of the search are shown in Figures 3-1 and 3-2 for the number of papers published and patentapplications by each country, respectively. Papers are classified by the country of the author’s affiliated institution, andpatents are classified by the country claiming priority.
Regarding the number of papers, while Australia and India do not reach the levels of the United States, China, andJapan, they have been consistently publishing in recent years. The recent ratio of the number of papers [from 2018 to2020 / total number over the entire period] is 30-32% for each country, showing no significant differences between
countries, indicating a similar trend. Moreover, in terms of the total number of papers worldwide, the United States
is followed by China, with Japan ranking fourth after Germany. India ranks sixth after the United Kingdom, andAustralia is twelfth, following South Korea and Spain, in the number of published papers.
On the other hand, the number of patent applications from Australia and India is overwhelmingly lower compared to
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the three countries. Also, the recent ratio for Australia is lower, indicating that it is significantly behind other countries
in terms of patents. Furthermore, the recent ratio for China is higher compared to other countries, clearly showing aproactive stance towards patent applications in the emerging biotechnology field, similar to other technology fields.

Figure 3-1 Annual trend and recent ratio of published papers in the five countries

Figure 3-2 Annual trend and recent ratio of published patents in the five countries

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Advances and Challenges in the Emerging Technology Field of “Synthetic Biology” in Australia, China and India

Global Research and Technology Areas Identified by Paper
Analysis3.2.1 Emerging Biotechnology Field
The final population of papers in the emerging biotechnology field was evaluated for similarity using topic modeling258
and mapped onto a two-dimensional plane259 through manifold learning260. As a global structure, Table 3-2 illustrates
that based on characteristic words, names, summaries, and abstracts, the research was broadly divided into nineresearch and technology categories (excluding others): Informatics, Pathology, Infectious Diseases, Cell-Related,
Protein Engineering, Biosensors, Metabolic Networks, Gene Function Analysis, and Gene Editing. Based on
similarity, 74 individual areas (clusters) were identified.

Table 3-2 Nine Research and Technology Categories and 74 Individual Areas

Research and Technology
Category

Individual Areas (Clusters)

Informatics

Machine learning, evaluation models, systematic studies, signal detection& processing

Pathology

Muscle formation & function, bone formation, lifestyle diseases, immune
abnormalities & inflammation, neurological diseases & cognitive
functions, tumors, heart-related diseases, miRNA and diseases, genetic
factors, target proteins, interferons, germ cells

Infectious Diseases

HIV, HCV, dengue fever, influenza and other viruses, virus replication,
tuberculosis, immune response

Cell-Related

Stem cell preparation, cell culture & preparation methods, cell culture
related materials

Protein Engineering

Fusion proteins, recombinant protein expression, cell-free protein
synthesis, fluorescent probes, receptor ligand binding, domain structure,translation initiation factors, ribosome biosynthesis, functional peptides(antimicrobial, etc.), antigen peptides, vaccines

Biosensors

DNA detection & construction, DNA methylation & demethylation, metal
ion adsorption, nanoparticles

Metabolic Networks

Culture environment, biosynthetic pathways & control, E. coli & Bacillus
subtilis, enzyme activity optimization, terpene biosynthesis, secondary
metabolism biosynthetic genes

258

Topic Model (LDA: Latent Dirichlet Allocation) is a type of probabilistic model that estimates the “probability of word occurrence” indocuments, evaluating documents with similar words as similar using basic natural language processing techniques.

259

The absolute position of the plot has no meaning; only the relative positions of each are important.

260

Manifold learning is a method of extracting lower-dimensional data from higher-dimensional data, for example, reducing 3D data to 2D toreduce computational complexity.

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Gene Function Analysis

Gene expression regulation, sequencing, plasmids & vectors, aptamers,
molecular markers, methanol-utilizing yeast, plant-related genes, insectrelated genes

Genome Editing & Gene
Modification

Primers, nucleic acid preparation, chromosome preparation, CRISPRCas

Other

Others include information processing of images & sounds, feed &environmental impact, microbial diversity & environmental purification,
mitochondrial function, DNA damage & repair, DNA replication, parasites,
gene interactions & complexes, tRNA synthetase, natural extracts,
compound synthesis & applications, probiotics & prebiotics, fatty acids,
antibodies, traditional Chinese medicine

Figure 3-3 is a map showing the temporal changes in paper information from 2010 to 2020. Each point in the map
represents paper information, and clusters (individual areas) were identified by red dotted lines based on similarity.
The map visualizes the density of paper data, with areas of high density (where data accumulates) indicated by colors
from red, yellow, green, blue, to black (no data).
From 2010 to 2013, papers were distributed across a wide range of fields, with strong concentrations in individual
areas such as “microbial diversity & environmental purification,” “muscle formation & function,” “fusion proteins,”“enzyme activity optimization,” “gene interactions & complexes,” and “tRNA synthetase.” During the period from2014 to 2017, strong concentrations were observed in new individual areas like “evaluation models,” “signal detection& processing,” “CRISPR-Cas,” indicating a period of increased interest in the “Informatics” category and CRISPRCas, a breakthrough technology in genome editing. From 2018 to 2020, strong concentrations were seen in “machinelearning” and “secondary metabolism biosynthetic genes.” In “machine learning,” papers related to synthetic biology
were seen, utilizing omics data for machine learning & predictive models, and in “secondary metabolism biosynthetic
genes,” papers related to metabolic engineering and the exploration of useful secondary metabolites were observed.

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Figure 3-3 Temporal changes in the research & technology map of papers

To understand the temporal changes in paper information in more detail, the number of papers from 2010 to 2020
and the recent ratio (the ratio of the number of papers published from 2018 to 2020 to the number of papers publishedfrom 2010 to 2020, hereinafter referred to as the recent ratio) for each research & technology category are shown in
Figure 3-4. The category with the highest number of papers is “Pathology,” followed by “Gene Function Analysis” and“Protein Engineering.” These categories have a wide distribution on the research & technology map, suggesting thatthey include a variety of themes with different contents.
On the other hand, the category with the highest recent ratio is “Informatics,” which is supported by “Machine
Learning.” This is followed by “Metabolic Networks” and “Genome Editing & Gene Modification,” driven bytechnological advances in CRISPR-Cas, indicating an increase in activity in these areas. Excluding “Informatics,”
there is no significant difference in the recent ratio between categories, but the categories with a high number of papers
mentioned above generally have a relatively low recent ratio. The three categories with a high recent ratio, althoughhaving a small number of papers, may see an increase in the future.

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Figure 3-4 Number and recent ratio of papers by each research & technology category

3.2.2 Synthetic Biology Field
Based on the data and analysis of the previous section, the temporal changes in papers containing keywords specific
to synthetic biology were analyzed. Figure 3-5 shows the transition of papers containing keywords related to synthetic
biology published from 2010 to 2013, from 2014 to 2017, and from 2018 to 2020.

Figure 3-5 Temporal changes in the distribution of papers with synthetic biology-related keywords

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In the period from 2010 to 2013, the areas where papers were strongly concentrated were “cell-free protein
synthesis” and “chromosome preparation,” with other areas sparsely distributed. During the period from 2014 to2017, strong concentrations were newly observed in categories such as “biosynthetic pathways & control,” “E. coli
& Bacillus subtilis,” “enzyme activity optimization” in the Metabolic Networks category, and “DNA detection &construction” in the Biosensors category, as well as in “CRISPR-Cas” and “signal detection & processing” areas.
The strong concentrations continued into the period from 2018 to 2020, especially in “cell-free protein synthesis,”“biosynthetic pathways & control,” “E. coli & Bacillus subtilis,” “CRISPR-Cas,” “DNA detection & construction”
areas, indicating ongoing research and technology related to synthetic biology in these areas.
Figure 3-6 shows the number of papers containing synthetic biology-related keywords and their recent ratio (limited
to those with more than 20 papers). Some papers that include keywords related to synthetic biology, such as DNA data
storage, CRISPR-Cas, and multiplexed genome editing, show an increasing trend based on the recent ratio. Especiallyfor keywords with fewer data entries, an increase is expected in the future.

Figure 3-6 Number and recent ratio of papers with synthetic biology-related keywords

3.3

Global Research and Technology Areas Identified by Patent
Analysis

3.3.1 Emerging Biotechnology Field
Similar to the analysis method for papers, Figure 3-7 shows the temporal changes in patents related to research andtechnology transitions in the emerging biotechnology field from 2010 to 2020.
During the period from 2010 to 2013, patents were distributed across a wide range of fields, with a characteristic
strong concentration in the “Genome Editing & Gene Modification” category. In addition to technologies related
to “Genome Editing & Gene Modification” such as “Primers” and “Nucleic Acid Preparation,” there was also a
concentration of patents related to emerging biotechnology products, such as “Antibodies.”
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From 2014 to 2017, in addition to the concentration in the “Genome Editing & Gene Modification” category,new concentrations were seen in the individual areas of “Metabolic Networks,” “CRISPR-Cas,” “E. coli & Bacillus
subtilis,” and “Traditional Chinese Medicine”. In the “CRISPR-Cas” and “E. coli & Bacillus subtilis” areas, many
patents related to genome editing technology were observed. From 2018 to 2020, excluding the “Informatics” area, thedistribution of concentrations was similar to the period from 2014 to 2017, with no significant overall differences.

Figure 3-7 Temporal changes in the patent research & technology map

To understand the temporal changes in patent information in more detail, the number of patents by each research& technology category and their recent ratio are shown in Figure 3-8. The category with the most patents is “GeneFunction Analysis,” followed by “Protein Engineering” and “Genome Editing & Gene Modification.” These categories
have a wide distribution on the research & technology map, indicating that they include various themes with slightly
different contents.
On the other hand, like papers, the category with the highest recent ratio is “Informatics,” followed by “Cell-Related”
and “Pathology.” The “Informatics” technology area is mainly supported by “Machine Learning,” with a high recent
ratio but still a small number of patents. Although there are not many patents for “Informatics” technologies that serveas the foundation for high-throughput automation or systems biology, this category is considered likely to accelerate
towards practical applications in the future. Meanwhile, “Cell-Related” and “Pathology” involve many research andtechnology fields related to medicine, such as “Cell Culture Materials & Preparation” technologies and “miRNA andDiseases,” suggesting that materials and sensing-related technologies may be driving growth, making technology
commercialization particularly important in these categories.

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Figure 3-8 Number and recent ratio of patents by each research & technology category

3.3.2 Synthetic Biology Field
Following the same flow as the previous paper analysis, Figure 3-9 shows the results of analyzing the trends of patents
related to synthetic biology (limited to patents containing keywords in the title or summary) within the emerging
biotechnology field.
Patents containing synthetic biology-related keywords are mostly distributed in “Gene Function Analysis” and its
surrounding categories (“Biosensors,” “Metabolic Networks,” “Genome Editing & Gene Modification (CRISPR-Cas)”),but unlike papers, there is hardly any distribution in “Informatics” and “Protein Engineering” categories. Patents
containing synthetic biology-related keywords include many related to metabolic engineering and protein engineeringin the “Gene Function Analysis” and “Metabolic Networks” categories, and in the “Biosensors” category, patents
related to DNA detection technologies, such as DNA sequencing, similar to papers.
From 2010 to 2013, the area with the strongest concentration of patents was “DNA Detection & Construction,” withhardly any distribution in other areas. From 2014 to 2017, new concentrations were seen in “CRISPR-Cas” and “E. coli
& Bacillus subtilis,” and the same applies to the period from 2018 to 2020.

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Figure 3-9 Temporal changes in the distribution of patents with synthetic biology-related keywords

Figure 3-10 shows the number of patents containing synthetic biology-related keywords and their recent ratio.
Although the numbers are small, patents containing keywords such as DNA data storage, CRISPR-Cas, andmultiplexed genome editing also show an increasing trend in the patent analysis, similar to papers, suggesting an
increase in research and technology related to synthetic biology from the perspective of patents.

Figure 3-10 Number and recent ratio of patents with synthetic biology-related keywords

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Advances and Challenges in the Emerging Technology Field of “Synthetic Biology” in Australia, China and India

Research and Technology Areas Identified by Paper
Analysis by Country

In this section, the number of papers (relative values) for each individual area from 2010 to 2020, as well as the recent
ratios, were organized to assess the dominant research and technology areas, their characteristics, and the main
research institutions for each individual area261.

3.4.1 Australia(1) Relative Dominance in Research and Technology Estimated from Papers
The scatter plot on the left side of Figure 3-11 plots individual areas based on the ratio of Australian paper numbers
to the global total on the x-axis and the recent ratio on the y-axis for each individual area. The x-axis serves as anindicator of relative competitive strength, showing the share of paper numbers relative to the global total, while they-axis serves as an indicator of relative focus, showing the recent number of papers. Individual areas rated above acertain level in both relative competitive strength and focus are considered dominant research and technology fields,
and individual areas included in the area (red frame in the scatter plot) with values above the average for all Australianpapers are extracted and organized.
“Pathology” and “Protein Engineering,” among others, as well as individual areas related to plant biosynthesis in the“Metabolic Networks” and “Gene Function Analysis” categories, are suggested as dominant research and technology
fields. Additionally, in terms of relative values for papers specialized in synthetic biology keywords, “High-Throughput
Screening and Automation” and “Gene Drive” had particularly high ratios, suggesting a high proportion of themes
related to gene mutation and screening. Meanwhile, “Bioprospecting” and “Directed Evolution” had particularly highrecent ratios and considering the increasing number of papers in the “Metabolic Networks” category, there may be a
growing interest in metabolic engineering through genome editing.

261

Both Australia and India generally have a low number of patents, making it difficult to identify areas of technological advantage, thus thisanalysis was excluded. Additionally, detailed information on China’s relative research and technology advantages is omitted.

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Figure 3-11 Relative dominance in research and technology estimated from the number (relative value) andrecent ratio of papers by individual area

(1) Major Institutions with Dominance in Research and Technology Based on Paper
Information
Table 3-3 shows Australian institutions with a high number of papers in dominant research and technology fields.
Among the major institutions, the University of Melbourne, the University of Queensland, the University of Western
Australia, and the CSIRO have many papers in the field of synthetic biology. Based on the proportion of papers since
2018, the University of New South Wales is also a noteworthy institution. The University of Melbourne has many
papers in the “Informatics” category and “Mitochondrial Function” category, while the University of Queensland
has many paper publications in the “Cell-Related” category and “Fusion Protein” area. Although not listed in thetable, Macquarie University’s COE (2020-) is actively working on synthetic biology for engineering control of wine
fermentation tanks, including crowd control and aroma control of wine yeast using synthetic biology and functional
analysis of non-Saccharomyces yeast (NSY) as co-culture partners for wine yeast. Their future activities appear
promising.

Table 3-3 Major institutions with the highest number of papers in the field of emerging biotechnology& synthetic biology

Name

Total number of papers(number with synthetic biology
keywords)

Proportion of papers since
2018 (proportion with synthetic
biology keywords)

University of Melbourne

132 (26)

49% (50%)

University of Queensland

112 (44)

41% (45%)

Monash University

89 (11)36% (45%)

University of Western Australia

88 (22)

42% (41%)

University of Sydney

87 (14)36% (50%)

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CSIRO

83 (34)37% (50%)

University of New South Wales

55 (13)49% (54%)

Australian National University

41 (11)39% (45%)

Table 3-4 organizes the proportion of co-authored papers between researchers from major Australian institutions
with high numbers of papers in the emerging biotechnology field and researchers from institutions in the UnitedStates, China, and Japan, showing that Japan has a lower proportion of co-authored papers compared to the other two
countries. Of particular note, the CSIRO (Commonwealth Scientific and Industrial Research Organisation) and theAustralian National University have co-authored many papers with China.

Table 3-4 Co-authorship status of major Australian institutions

Total number of
papers (proportion of
papers since 2018)

Name

Proportion of co-authored papers withJapan, the United States, and China(2010-2020)
Japan

UnitedStates

China

University of Melbourne

132 (49%)

5%

36%

8%

University of Queensland

112 (41%)

4%

26%

13%

Monash University

89 (36%)

8%

19%

13%

University of Western Australia

88 (42%)

2%

16%

11%

University of Sydney

87 (36%)

2%

25%

8%

CSIRO

83 (37%)

2%

6%

16%

University of New South Wales

55 (49%)

2%

27%

9%

Australian National University

41 (39%)

7%

29%

20%

3.4.2 India(1) Relative Dominance in Research and Technology Estimated from Papers
Similar to Australia, individual areas rated above a certain level in both relative competitive strength and focus are
considered dominant research and technology fields, and individual areas included in this area (red frame in the scatterplot) with values above the average for all papers in India are extracted and listed in the right table. “Biosensors” andareas such as “Compound Synthesis & Application” could be seen as dominant research and technology fields.
Additionally, in terms of relative values for papers specialized in synthetic biology keywords, “Bioprospecting” and“Codon Optimization” had high ratios, while “DNA Data Storage,” “Multiplexed Genome Editing,” and “Synthetic
Chromosomes” had particularly high recent ratios, suggesting a gathering interest in DNA construction throughgenetic engineering.
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Figure 3-12 Relative dominance in research and technology estimated from the number (relative value)
and recent ratio of papers by individual area(2) Major Institutions with Dominance in Research and Technology Based on Paper
Information
Table 3-5 shows Indian institutions with a high number of papers in dominant research and technology fields.
The Council of Scientific & Industrial Research (CSIR), the Indian Council of Agricultural Research (ICAR), theDepartment of Biotechnology (DBT), and the Indian Institutes of Technology (IITs) are among the top institutions inboth emerging biotechnology and synthetic biology fields. The analysis shows that these institutions have publishedpapers across a wide range of fields from 2010 to 2020, but particularly many in the “Gene Interactions & Complexes”
area. Limited to papers published from 2018 to 2020, the Indian Institutes of Technology have many papers in the“Informatics” category, specifically in the “Machine Learning” area, as part of DNA data storage research, developing
efficient algorithms for storing large amounts of data with few bases, while the Council of Scientific & Industrial
Research has papers in areas such as pharmaceutical research using modified yeast and “Plant-Related Genes.”
Besides the institutions listed in Table 3-5, specifically for synthetic biology papers, the Academy of Scientific &Innovative Research (AcSIR) has 10 papers (70%), the Centre for DNA Fingerprinting and Diagnostics (CDFD) has 8
papers (13%), and the Central Food Technological Research Institute (CFTRI-CSIR) has 8 papers (63%)

Table 3-5 Major institutions with the highest number of papers in the emerging biotechnology &synthetic biology field

Total number of papers(number with synthetic
biology keywords)

Name

Proportion of papers since
2018 (proportion withsynthetic biology keywords)

Council of Scientific and Industrial
Research (CSIR)

264 (52)

31% (37%)

Indian Council of Agricultural
Research (ICAR)

137 (25)

41% (40%)

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Indian Institutes of Technology (IITs)262

110 (25)

45% (36%)

Department of Biotechnology (DBT)

110 (31)32% (45%)

National Institutes of Technology(NIT)263

62 (-)

50% (-)

Banaras Hindu University (BHU)

58 (-)

47% (-)

Department of Science andTechnology (DST)

54 (-)

28%（-)

International Centre for Genetic
Engineering and Biotechnology(ICGEB)49 (9)

24% (33%)

Indian Institute of Science, Bangalore(IISC)

44(11)

23% (45%)

Table 3-6 organizes the ratio of co-authored papers between researchers from major Indian institutions in the fieldof emerging biotechnology and researchers from institutions located in the United States, China, and Japan. India,
compared to Australia, tends to have a lower ratio of international co-authorship, with Japan being on a similar levelto China in terms of the low ratio of co-authored papers.

Table 3-6 Co-authorship status of major Indian institutions

Proportion of co-authored papers withJapan, the United States, and China(2010-2020)

Total number of
papers (proportion of
papers since 2018)

Name

Japan

UnitedStatesChina

Council of Scientific and Industrial
Research (CSIR)

264 (31%)

1%

6%

3%

Indian Council of Agricultural
Research (ICAR)

137 (41%)

1%

3%

0%

Indian Institutes of Technology(IIT)264

110 (45%)

3%

8%

1%

Department of Biotechnology(DBT)

110 (32%)

2%

7%

0%

262

The Indian Institutes of Technology (IIT) are the premier institutes of engineering education in India, encompassing 23 universities such as
IIT Kharagpur and IIT Bombay.

263

The National Institutes of Technology (NIT) are public technical research institutes owned by the Ministry of Education of the Governmentof India.

264

The Indian Institutes of Technology (IIT) are the premier institutes of engineering education in India, encompassing 23 universities such as
IIT Kharagpur and IIT Bombay.

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National Institutes of Technology(NIT)265

62 (50%)

0%

6%

2%

Banaras Hindu University (BHU)

58 (47%)

0%

5%

0%

Department of Science andTechnology (DST)

54 (28%)

2%

6%

2%

International Centre for Genetic
Engineering and Biotechnology(ICGEB)49 (24%)

4%

4%

2%

Indian Institute of Science,
Bangalore (IISC)

44 (23%)

0%

14%

2%

3.4.3 Dominant Individual Areas by Country Based on Number of Papers
So far, the analysis of each country has involved both paper and patent information, but the number of patents inAustralia and India is very limited, making it difficult to assess and compare dominant research and technology froma patent perspective. Therefore, themes are organized in Table 3-7 based on the results of the dominance assessment
obtained from “number of papers” information.
Comparing Australia, India, and Japan, there are themes such as “CRISPR-Cas,” “cell-free systems,” and “directed
evolution” where all three countries have dominance, suggesting they could further enhance this advantage bycollaborating. Also, if there are themes where Japan and either Australia or India is dominant, collaboration between
the two countries could also potentially enhance their advantage. However, when considering a collaborative
relationship that complements the respective dominant fields between Australia and Japan or India and Japan, an
approach of collaborating with Australia or India in fields they have dominance in like “codon optimization,” “DNAdata storage,” “gene drives,” and “bioprospecting” where Japan does not, is a possibility. Assessing and organizing
themes related to synthetic biology in which each country has dominance is an important perspective when
considering collaborative strategies.

265

The National Institutes of Technology (NIT) are public technical research institutes owned by the Ministry of Education of the Governmentof India.

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Table 3-7 Themes Related to Synthetic Biology Where Each Country is Dominant Based on Number of Papers266

Dominance by Country( ◎ indicates a competitive dominance and focus, 〇 indicates adominance in either)

Theme

Australia

India

○

Wide-host-range plasmids
Genome miniaturization

Japan

UnitedStates

◎

◎

○

◎

◎

Codon optimization
DNA assembly○

CRISPR-Cas○

Multiplexed genome editing

China

○
○

○

◎

○

○

◎

◎

○

○

◎

◎

○

○

○

◎

◎

Synthetic chromosomes○

Gene drives◎

Cell-free systems

○

○

○

◎

○

Directed evolution

○

○

○

◎

○

Synthetic organelles

○

○

○

○

High-throughput screening andautomation

◎

○

○

DNA data storage
Bioprospecting

○

○

◎

○

◎

○

◎

○

Xenobiology

266○“Dominant” here simply refers to assigning ◎ or ○ based on the number of papers, without considering the weight of the authors (First/Lastauthor, etc.). Themes without ○ are those with a low number of papers, such as single digits.

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Advances and Challenges in the Emerging Technology Field of “Synthetic Biology” in Australia, China and India

Summary

There are still many growth areas and abundant opportunities in the field of synthetic biology and other emerging
biotechnologies. However, they require long-term research and development investment and early engagement inresearch and development. In this environment, the United States, and more recently China and Australia, havebeen intensively working on policy and strategy formulation and funding in the field of synthetic biology and otheremerging biotechnologies, as revealed in this research report.
In all countries researched, the establishment of biotechnology research platforms and clusters, including synthetic
biology research, is evident, especially in China, where significant investments are concentrated in Beijing, Shanghai,
and the Greater Bay Area. Australia and India also have many policies focused on startup support, opening up wellequipped facilities to research institutions and startups to strongly promote domestic and international collaboration.
Japan’s various ministries are also actively engaging in initiatives under the names of bioeconomy andbioproduction.
However, to acquire research and development capabilities that are on par with the United States, and China, which
has rapidly increased its investment in the field of synthetic biology, selective concentration and cooperation strategies
with major countries are essential, especially in Japan’s areas of strength, including research equipment and talentdevelopment. Furthermore, in the context of pharmaceutical development, which is critical also from the perspectiveof ensuring supply chain resilience, it is imperative not to overlook the efforts to link research achievements withclinical applications through a clinical testing framework that integrates research results into societal implementations.
Specifically, Japan is known for some outstanding technologies, such as cell-free protein synthesis, but apart from
Kobe University, it has no prominent research platforms, and industrial application examples are limited. In a field
where global competition is so striking, and the pace of technological advancement is so fast, as demonstrated by the
emergence of new technologies such as artificial custom cells, bio 3D printers, molecular robotics, and DNA storage, it
is hoped that Japan will focus on strengthening research platforms and intensify joint research with top-level research
institutions abroad in mutually beneficial areas.

<References>
・“Saibo o tsukuru / seimei system o tsukuru ” [Creating Cells, Creating Life Systems] Experimental Medicine Special
Number 2011 Vol. 29-No.7, Shoji Takeuchi, Hiroki Ueda (Editors)
・“Ima, seimei kagaku to igaku kenkyu no ashita o kangaeyo - Breakthrough wa anata no nakani! ” [Thinking about
the Current Future of Life Sciences and Medical Research - The Breakthrough is Within You!] Experimental
Medicine 2017 Vol. 35, No.13
・“Dr. Kitano no zero kara hajimero system biology” [Dr. Kitano’s Introduction to Systems Biology ] 2015, Hiroaki
Kitano (Planning & Writing), Yodosha
・“Cho seibutsugaku - tsugi no X ” [Superbiology - The Next X] Experimental Medicine Supplement 2021, Nozomu
Yachie (Editor)
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5

APPENDIX

5.1

Main Synthetic Biology Related Keywords and Glossary

Based on various materials, the JST Asia and Pacific Research Center has organized and summarized the main
keywords related to synthetic biology in Table A-1. These keywords serve as basic information for paper and patent
searches.

Table A-1 Main Synthetic Biology Related Keywords and Glossary

Classification

Synthetic Biology Related
Keywords

Overview

Targets & Tools

BioBrick(BioBrick)Standardized synthetic DNA parts (components)
with certain functions and structures. Proposed byProfessor Tom Knight, a synthetic biologist from the
USA (Ginkgo Bioworks). Catalogs of each part areavailable on the iGEM website.

Broad-host-range
plasmids(Broad-host range
plasmid)

Plasmids are circular DNA found in bacteria. Broadhost-range plasmids play an important role inhorizontal gene transfer. In addition, their replicons
are suitable for vector construction.

Minimal genome(Minimal genome)

A streamlined genome that is minimized to theessentials necessary for maintaining life functions.

Synthetic cells(Synthetic cell)

Synthetic cells refer to entities assembled frommolecules that have been either broken down
and extracted from biological cells or syntheticallycreated, incorporating new blueprints that do notexist in nature.

Synthetic chromosomes(Synthetic chromosome)A representative example of synthetic chromosomes
is the research on yeast chromosome reconstitution
using the SCRaMbLE system in the yeast genome
synthesis project (Sc2.0) reported by Professor Jef
Boeke of New York University in 2018.

Synthetic organelles(Synthetic organelle)

Artificially created cell organelles such as nuclei,
mitochondria, and Golgi bodies. It is hoped they
will have practical applications in fields such as celltherapy.

3D Bioprinting(3D Bioprinting)A technology that uses 3D printer technology to
mimic the structure of proteins, cells, or threedimensional tissues and organs and construct similarfunctions and structures. Used in medical and tissue
engineering fields.

Modificationand synthesis
technologies

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Biofabrication(Biofabrication)

Synonymous with 3D bio-printing.

Bioprospecting(Bioprospecting)

The process of finding useful genetic resources
for pharmaceuticals, chemicals, food, etc., from
biological resources.

Codon optimization(Codon optimization)

Designing an introduced gene sequence
appropriately to improve production yield when
producing proteins not originally present, such as byintroducing genes from different host species.

Cell-free systems(Cell-free systems)

Cell-free protein synthesis systems are efficienttechnologies for synthesizing recombinant proteins.
They are based on cell extracts from E. coli, wheat
germ, human cell lines, etc., performing RNA
transcription to protein synthesis.

CRISPR-Cas

A genome editing technology that artificially modifies
the genome of organisms, awarded the 2020 Nobel
Prize in Chemistry. Development of nucleases
different from Cas9 is progressing due to issues with
PAM sequence specificity and vector size. Professor
Jennifer Doudna at UC Berkeley is working on
genome editing using the small Cas Φ .

DNA origami(DNA origami)

A molecular design and fabrication method thatmixes one long single-stranded DNA with a vast
number of short single-stranded DNAs to create
various nanostructures.

Directed evolution(Directed evolution)

An experimental method of the 2018 Nobel Prize in
Chemistry, mimicking natural evolution and selection,changing the function of proteins, DNA, etc., through
PCR.

Genome miniaturization(Genome miniaturization)

A method to improve gene manipulation efficiency
and enable high-throughput screening by retaining
only the minimal genome necessary for maintaining
functions.

Genetic logic circuits(Genetic logic circuits)

Research incorporating various artificial circuits into
cells like electrical circuits. In 2007, groups including
Professor Christopher Voigt of UCSF (at the time)and Dr. Adam Arkin of Lawrence Berkeley National
Laboratory demonstrated circuits that accurately
switch genes using AND gates in E. coli. In 2013,
Professor Timothy Lu of MIT and Dr. Drew Endy ofStanford University developed logic gates using sitespecific recombinases, showing significant progress.

Gene drives(Gene drives)

A technique that introduces the CRISPR/Cas9
genome editing system itself into the genome tocompletely modify all offspringʼs target genes.

Metabolic engineering(Metabolic engineering)

A field of study related to the modification andanalysis of biological metabolic pathways.

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Design/Evaluation
Technologies

Applied andrelated terms

Multiplexed genome
editing(Multiplexed genome
editing)

A multiplex CRISPR technology that expresses
numerous gRNAs and Cas enzymes at once. Greatly
improves the scope and efficiency of genome editing
and transcriptional regulation.

Microbiome engineering(Microbiome engineering)Engineering modifications to the microbiome to alter
the structure (bacterial species balance) and functionof microbial communities within the gut flora andecosystems.

Protein Engineering(Protein engineering)

Artificially modifying and creating new proteins basedon natural substances.

Riboswitch(Riboswitch)

Sequences in the untranslated region of mRNA that
regulate the expression of the genes they carry.

Self-organizing
multicellular structures(Self-organizing
multicellular structure)

The process in the fabrication of biomaterials or
artificial tissues where single cells autonomously
organize (self-organize) over time to form multicellular
3D structures.

DNA sequencing(DNA sequencing)

Determining the sequence of bases (adenine (A),thymine (T), guanine (G), cytosine (C)) in DNA.

DNA assembly(DNA assembly)

In bioinformatics, computer processing thatreconstructs genome sequences by connecting alarge number of DNA fragment sequences.

High-throughput
screening and automation(High-throughput
screening andautomation)

Automating the testing of the utility of compounds
in experiments and drug discovery processes using
robots, etc.

Modeling, machinelearning(Modelling, machinelearning)

Promising sequence detection, statistical learning,
reinforcement learning, structure prediction, optimal
pathway calculation, and structured/quantitative
design of life dynamics, etc.

Organ-on-a-chip
Organs-on-Chips

Microfluidic chips/devices that mimic organs.
Contribute to accelerating drug discovery, etc.

Biofoundry(Biofoundry)

A bio-production system for culture, transport, andcontract manufacturing.

Bioeconomy(Bioeconomy)

The concept of utilizing biotechnology and renewablebiological resources to expand a sustainable,
renewable circular economy.

DNA data storage(DNA data storage)

A technology that uses DNA as an information
storage medium. Expected to allow for high-density,
long-term data storage. The idea was originallyproposed by a group at Mount Sinai School of
Medicine in the USA in 1999.

Engineering biology(Engineering biology）

Synonymous with synthetic biology. Refers to aninterdisciplinary field that enables the prediction ofmodifications to life systems, their components, andbiological processes.

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Advances and Challenges in the Emerging Technology Field of “Synthetic Biology” in Australia, China and India

Systems biology(Systems Biology)

Research that views the networks of genes, proteins,metabolites, and cells as life systems, exploring
how their functions are regulated and how they
respond to perturbations. Also synonymous with life
dynamics.

Xenobiology(Xenobiology)

A field aimed at designing artificial life forms notfound in nature, such as by replacing parts of nucleic
acids with synthetic polymers. Said to intersect theorigins of life, astrobiology, synthetic biology, andsystems chemistry

Japan-Australia Synthetic Biology Workshop (Held online on
March 16, 2022)

On March 16, 2022, the JST Asia and Pacific Research Center (JST APRC), in cooperation with JST’s International
Division, the Ministry of Education, Culture, Sports, Science and Technology (MEXT), the Australian Government
Department of Industry, Science, Energy and Resources (DISER), the Commonwealth Scientific and Industrial
Research Organisation (CSIRO), and the Australian Embassy in Japan, hosted a workshop titled “Future Trends andEmerging Technologies in Synthetic Biology - Connecting Australia and Japan through science and technology.”
This workshop aimed to provide networking opportunities for researchers in the field of synthetic biology from Japanand Australia, hoping to lead to future international joint research. In this workshop, chaired by Professor Akihiko
Kondo (Vice President of Kobe University) from the Japanese side and Dr. Claudia Vickers (CSO of Provectus Algae
Pty Ltd.) from the Australian side, more than 150 participants shared research outcomes and the latest information on
synthetic biology, with 14 speakers presenting.
Keynote speeches included a lecture from Professor Aleksandra Filipovska, Deputy Director of the Australian
Research Council Centre of Excellence in Synthetic Biology (ARC Synthetic Biology COE), on mitochondrial RNA
editing tools and their medical applications, and a presentation by Professor Hiroyuki Noji from the University ofTokyo on artificial cell reactor technology and on-chip cell-free systems. In the three sessions, 12 researchers fromJapan and Australia gave lectures on the construction of artificial cells and fundamental technologies of synthetic
biology, systems biology and protein translation systems, and applied research in synthetic biology. These sessions
were followed by energetic Q&A sessions.
The final discussion session focused on metabolic engineering, systems biology & modeling, data science andbioinformatics, artificial cells, and genome engineering, bioproducts and biomaterials, cell-free systems, protein
engineering, and biocatalysis. Speakers and participants divided into three groups discussed the characteristics anddeficiencies of research in Japan and Australia, and discussed potential areas for future joint research, summarized inTable A-2.

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Table A-2 Areas of Expected Joint Research Discussed in the Workshop

Expected Applications/
Industrial Fields

Country

Strengths

Weaknesses- Despite having a uniquecommunity, tends tobe isolated from otherregions, lacking visibility ininternational major projects- Synthetic biology perceived
merely as “synthesis”,
whereas in the US it isstrongly associated withinformation science- Cross-disciplinary efforts
are lacking compared to
the West

Genetically modified
crop field trials or edible
chemical production

Japan- Artificial cell simulation- Genome reconstruction- In vivo tissue engineering- Enzyme engineering, such as
fermentation- Artificial membranes- Exploration of metabolic
pathways- Plant hormone research(RIKEN Center for Sustainable
Resource Science, CSRS)- Lab automation (strengths inbasic research)

Australia- Systems biology- Protein simulation in drug
discovery (AI platforms)- Molecular docking dynamics(applied research-oriented)- Protein engineering (enzyme
engineering and sensors)- Exploration of metabolic
pathways- Research developmentusing AI

Sustainable agriculture
Medical fields
Metabolic engineering
for industrial material
discovery
Gene editing in plants●

Primary Areas and Challenges Proposed for Joint Research in the Discussion Session✓

Whole-cell simulation✓

Biohydrogen energy production✓

Biomaterials (biocompatible materials, biomimetic materials)✓

Artificial membrane & protein research✓

Bioparts (BioBricks, etc., from DNA to tissues) and their design research✓Non-membrane organisms - Control of rotation centered on ATP✓

Biofoundry foundational technologies (biomanufacturing)✓

Metabolic modeling - Reverse synthetic pathway search: databases, algorithms/modeling

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Research report●

Workshop Program & Abstracts

Future Trends and Emerging Technologies in Synthetic Biology

Connecting Australia and Japan through science and technology
1.

Date: Wednesday, 16th March 2022, 10:00 ~ 16:00 (AEST) / 9:00 ~ 15:00 (JST)2.

Zoom Meeting

3.

Language: English

4.	Target Audience: Aust ralian and Japanese representatives of research perfor ming organizations,researchers, students in the field of synthetic biology, policymakers, etc.
5.

Co-chaired by:
Akihiko Kondo, Vice President, Kobe University
Claudia Vickers, Chief Scientific Officer, Provectus Algae; Adjunct Professor, Queensland University ofTechnology; Adjunct Professor, Griffith University

6.

Program

10:00 AEST
/ 09:00 JST

Welcoming Remarks
・Hiroya YAMANOUCHI, Director, Office for Strategic Research Promotion,
Strategic Planning, Research and Development Division, Science andTechnology Policy Bureau, MEXT
・Steph Gorecki Natik, General Manager of the International and Astronomy
Branch, DISER

10:15 AEST
/ 09:15 JSTPart 1: Morning part
Chair: Akihiko Kondo, Vice President, Kobe University
Keynote speech “Medicinal Synthetic Biology”
Aleksandra Filipovska, Deputy Director, the ARC Centre of Excellence inSynthetic Biology; Professor, University of Western Australia
Keywords: energy metabolism, mitochondria, gene editing

10:35 AEST Session A: Artificial cell construction, Basic technology/ 09:35 JST ・Yuki Goto, Associate Professor, the University of Tokyo
Artificial in vitro biosynthesis of backbone-modified peptides toward
development of pseudo-natural products
Keywords: In vitro translation, posttranslational modification, macrocyclic
peptides, natural products, in vitro selection, mRNA display
・Hirohide Saito, Professor, the Center for iPS Cell Research and Application,
Kyoto University
RNA and RNP synthetic biology to expand the possibility of synthetic living
systems
Keywords: RNA and RNP synthetic biology, cell programming, microRNA,
mRNA, translation
・Wenlong Cheng, Professor, Monash University
Gold electronic skins and tattoos for connected healthcare
Keywords: Electronic skin, wearable sensors, bioelectronics, gold nanowires
・Ian Paulsen, Director, ARC Centre of Excellence in Synthetic Biology;
Macquarie University
The ARC Centre of Excellence in Synthetic Biology- Inspired by Nature,
Designed by Science

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11:35 AEST Session B: Systems biology, Protein translation systems/ 10:35 JST ・Colin Jackson, Professor, the Australian National University
How the study of protein evolution can aid protein engineering
Keywords: Protein Engineering, Molecular Evolution, Biocatalysis, Computational
Protein Design, Bioremediation.
・Kirill Alexandrov, Professor, Queensland University of Technology
Artificial protein allostery and construction of synthetic logic networks
Keywords: protein allostery, protein biosensors, signaling networks, protein ligand
interactions, directed evolution
・Yutetsu Kuruma, Associate Professor, Earth-Life Science Institute, Tokyo
Institute of Technology
Cell-free construction of cellular functions towards artificial cell
construction
Keywords: Artificial cell, Cell-free system, Giant vesicle, Membrane proteins,
Origin of life
・Nozomu Yachie, Associate Professor, Canada Research Chair (Tier 2) in
Synthetic Biology, University of British Columbia
HD Video Recorder of the Cell
Keywords: DNA event recording, cell lineage tracing, genome editing, baseediting, high-performance computing
12:35 AEST
/ 11:35 JST

Lunch

13:30 AEST
/ 12:30 JST

Part 2: Afternoon part
Chair: Claudia Vickers, Chief Scientific Officer, Provectus Algae
Keynote speech 2 “Perspectives on building of autonomous cell systems
based on femtoliter reactor technology”
Hiroyuki Noji, Professor, The University of Tokyo
Keywords: Femtoliter reactor technology, On-chip cell-free systems

13:50 AEST Session C: Application/ 12:50 JST ・Keiji Nishida, Deputy Director, Research Center for Advanced Bioengineering,
Kobe University; Bio Palette Inc.
Development and application of base editing technologies
Keywords: Genome editing, Base editing, CRISPR, Breeding・Toshiya Muranaka, Professor, Osaka University
Towards development of new varieties of plants with medicinal properties
by synthetic biology
Keywords: Convention on Biological Diversity (CBD), genome editing, plant
specialized metabolites, medicinal plants, synthetic biology
・Colin Scott, Synthetic Biology Future Science Platform Leader, CSIRO
Artificial metabolic pathways in continuous-flow
Keywords: Enzyme fusion, modified cofactors, continuous flow biocatalysis
・Claudia Vickers, Chief Scientific Officer, Provectus Algae; Adjunct Professor,
Queensland University of Technology; Adjunct Professor, Griffith University
Synthetic biology tools to understand and control subcellular biocatalysis
conditions
Keywords: Isoprenoids, nanotechnology, virus-like particles, biosensors,
metabolic engineering

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Discussion Session
Session 1
14:50 AEST ・Metabolic engineering/ 13:50 JST ・Systems biology andmodeling, Data scienceand bioinformatics
・Application

Session 2
・Artificial cells andgenome engineering
・Synbio tools andnanotechnology
・Application

Session 3
・Bio-products and bio-materials

・Cell-free systems,

Protein engineering,
Biocatalysis
・Application

15:35 AEST
/ 14:35 JST

Wrap-up session by co-chairs: Akihiko Kondo, Claudia Vickers

16:00 AEST
/ 15:00 JST

Close

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DISCUSSION SESSION
1. Discussion session’s length: approx 45mins. There are chair and co-chair for each session. Chair will moderate thesession and co-chair will do the summarize at the end.
2. Questions
・W hat are the strengths in the discussion fields in Australia and Japan? What are the weaknesses?
・W here are the obvious areas for collaboration? – i.e. a strength in one country that compliments a weakness inanother country・W hat are the strategic and exciting new technical directions these technologies will move in?
・W hat application areas are strategic priorities for each country? How can we help support technology developmentin these areas?
・G iven the various international frameworks and the fact that some countries, such as Europe and the UnitedStates, are becoming more active in research, what issues need to be addressed to stimulate joint research between
Japan and Australia further?

Session 1
・Metabolic engineering
・Systems biology andSession 2

Session 3

・Artificial cells and genome

・Bio – products and bio –modeling, data science andbioinformatics
・Applicationengineering
・Synbio tools andnanotechnology
・Application

Chair: Claudia Vickers
Co-chair: Nozomu Yachie

Chair: Hiroyuki Noji,
Co-chair: Ian Paulsen

Chair: Colin Scott
Co-chair: Yuki Goto

Toshiya Muranaka
Nozomu Yachie
Yutetsu Kuruma
Claudia Vickers

Hiroyuki Noji
Keiji Nishida,
Hirohide Saito
Ian Paulsen
Aleksandra Filipovska

Akihiko Kondo
Yuki Goto
Colin Scott
Kirill Alexandrov
Colin Jackson

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materials

・Cell - free systems, Protein

engineering, Biocatalysis
・Application

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Policies of Major Provinces and Cities Based on Chinaʼs
14th Five-Year Plan

5.3

Table A-3 Promotion of Synthetic Biology Research in Various Provinces and Cities Based on Chinaʼs“14th Five-Year Plan”

Date

Province/
City

Policy Name

Descriptions Related to Synthetic Biology in the Policy(Excerpt)

June 11,
2021

Zhejiang
Provincial
Peopleʼs
Government

The 14th
Five-Year
Plan for theDevelopmentof ScientificandTechnologicalInnovationin Zhejiang
Province267

Further implement innovation-driven development
strategies and accelerate the construction of higher
education facilities.
2. Tackle fierce competition in the development of key
core technologies(1) Main Issues
Focus on basic research in intelligent computing, newgeneration communication networks, new generation
smart chips, quantum information, precision medicine,
new drug creation and medical devices, cutting-edge
new materials, precision manufacturing, low-carbon
energy, green chemicals, environmental governance,
biological characteristics of agriculture, marine resource
development and disaster prevention, mathematicalmechanics, etc.

August 4,
2021

Shanxi
Provincial
Peopleʼs
Government

Shanxi
Province 14.5
14 Strategic
EmergingIndustries268

III. Overall Requirements(III) Development Goals
By 2025, to have industrial clusters with high market
share and strong competitiveness, among which 3 to
5 strategic emerging industry clusters such as big dataand semiconductors will become the new economic
pillars of the province, complete national-level researchand development manufacturing bases for carbon-based
new materials, special metal materials, and synthetic
biology industries, significantly improving the provinceʼs
industrial base capability and the modernization level ofthe industrial chain. [...]
IV. Development Focus(VIII) A New Materials Industry Based on Biotechnology
Advance basic research in synthetic biology anddeveloping applied technologies based on biotechnology,
such as high-performance new polymers andbiomimetic materials. Accelerate the construction of
key projects like synthetic biology industrial ecology
parks and biodegradable polyesters while focusing
on the development of products such as bio-basedpolyamides, biodegradable polyesters, and bio-carbon
fiber composite materials.

267

浙江省人民政府 , “ 浙江省科技创新发展 “ 十四五 ” 规划 ,”:http://kjt.zj.gov.cn/art/2021/8/6/art_1229247517_4698825.html. [Accessed January 2022].

268

山西省人民政府 , “ 山西省「14・5」14 の戦略的新興産業計画 ,”: http://www.shanxi.gov.cn/sxszfxxgk/sxsrmzfzcbm/sxszfbgt/flfg_7203/
szfgfxwj_7205/202107/t20210706_926554.shtml [Accessed January 2022].

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Tianjin
Municipal
Peopleʼs
Governmentof Hebei
Province

The 14th FiveYear Plan for
Science andTechnology
Innovation in
Tianjin269

Chapter 1.1 Assessing New Trends in TechnologicalInnovation and Development(1) Current Situation
Since the 13th Five-Year Plan, the city has actively
implemented the innovation-driven development strategy,
and support for scientific and technological innovation
has achieved remarkable results in promoting social andeconomic development. [...] Major platforms such aslarge-scale earthquake engineering simulation researchfacilities and the national synthetic biology innovation
center were constructed, and achievements were madein key areas such as artificial intelligence, biomedical,
new materials (such as precise customization synthesisof yeast chromosomes).
Chapter 2
1. Active Deployment of Applied Facilities and CuttingEdge Technologies- Promote collaborative innovation in Beijing-TianjinHebei (e.g., “Cell Valley”, “Bio-Manufacturing Valley”)
2. Efforts to Promote Core Technology Research(2) Biotechnology and Modern Medicine
Focus on the development of synthetic biology, newgeneration DNA synthesis, gene editing, artificial designof protein modules, genetic network design, digital cell
modeling and simulation, design optimization of chassis
cells, artificial gene synthesis and assembly, and othertechnological research. Emphasize supporting thedesign and construction of high-value compound andnatural product biosynthesis pathways, bio-sensing
and environmental restoration, biological utilization ofCO2, diagnosis/treatment of major diseases, and thedevelopment of synthetic biology-based DNA information
storage technology.

September Guangdong
22, 2021
Provincial
Peopleʼs
Government

The 14th FiveYear Plan for
Science andTechnology
Innovation in
Guangdong
Province270

Chapter 2
2. Promoting the Construction of Major Science andTechnology Infrastructure and Clusters
In the field of life sciences, the construction of thesecond phase of the National Gene Bank, a major
scientific and technological infrastructure for synthetic
biology research, is being accelerated, and in the fieldsof brain analysis and material science, the second phase
construction of the China (Dongguan) Spallation Neutron
Source is being accelerated.
Chapter 3.2 Strengthening Research on Frontier andDisruptive Technologies
Special projects on cutting-edge and disruptive
technologies in key areas will be implemented.
Synthetic Biology

August 8,
2021

269

天津市人民政府 , “ 天津市科技创新 “ 十四五 ” 规划 ,”:http://www.tj.gov.cn/zwgk/szfwj/tjsrmzfbgt/202108/t20210812_5532506.html [Accessed January 2022].

270

広東省人民政府 , “ 广东省科技创新 “ 十四五 ” 规划 ,”:http://dara.gd.gov.cn/attachment/0/467/467916/3577549.pdf [Accessed January 2022].

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Research will be conducted on the design of artificial
life forms at the intracellular, single-cell, and multicellularlevels, improving the quantitative and predictable
design capabilities of synthetic biological systems.
Research will be conducted on artificial genome design,
optimized synthesis and design techniques, gene editing
technologies, etc., and high-throughput, automated, andstandardized synthetic biotechnology systems will bebuilt.
Major artificial biological systems will be constructed topromote disruptive advanced technologies, innovations,and engineering applications of synthetic biology inindustrial biointelligence, diagnostics and therapeutics,
environmental conservation, energy security, and national
security sectors.
Research and development will be conducted on
the creation and application of industrial enzymes,
construction of industrial microbial strains forbiomanufacturing, and the application of raw materials
for biomanufacturing.
September Jiangsu
2, 2021
Provincial
Peopleʼs
Government

The 14th FiveYear Plan for
Scientific andTechnologicalInnovationin Jiangsu
Province271

Implement an innovation-driven development strategy
and accelerate the building of a province strong inscience and technology towards realizing the new
mission and requirements of “setting an example andleading the front.” According to the plan, establish
an industrial technology innovation center with global
influence.
The following are excerpts specifically related tosynthetic biology:(1) Strengthen basic research and innovation: Strategic
key research topic No.13 Synthetic Biology(3) Develop high-efficiency, safe, and ecological modern
agricultural technologies[...] Strengthen research in synthetic biology, smart
agriculture, and bottleneck technologies, accelerate thedevelopment of key technologies for green agriculture,promote the construction of agricultural high-techindustry demonstration zones, improve agricultural
system services, and enhance quality, efficiency, andcompetitiveness.

September Shanghai
28, 2021
Municipal
Peopleʼs
Government

The 14th FiveYear Plan for
Building a
Science andTechnology
Innovation
Center inShanghaiwith Global
Influence272

The construction of a science and technology
innovation center with global influence is an importanttask and strategic mission given by the Central
Committee of the Communist Party to Shanghai, serving
as a significant driving force for accelerating high-quality
socio-economic development and enhancing the cityʼsenergy level and core competitiveness, with science andtechnology being a crucial support.
(4) Strengthening Basic Research
4. Synthetic Biology and the Creation of Life271

江蘇省人民政府 , “ 江苏省 “ 十四五 ” 科技创新规划 :,”: http://kxjst.jiangsu.gov.cn/art/2021/9/15/art_83527_10030709.html.

272

上海市人民政府 , “ 上海市建设具有全球影响力的科技创新中心 “ 十四五 ” 规划 ,”:https://www.shanghai.gov.cn/nw12344/20210928/5020e5fdf5ac4c6fb4b219da6bb4b889.html.

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Achieve breakthroughs in artificial biosynthesis systems
and build biomanufacturing science and technology andinnovative strategic emerging industries, significantly
strengthening the international competitiveness ofsynthetic biology.
- Promote interdisciplinary research, including thedesign of artificial life, biosynthesis of drugs, efficientsynthesis of drugs with new structures and functions,and breakthroughs in bioremediation.
- Develop unique technologies in gene editing, DNAassembly, and directed evolution to build efficientartificial biological manufacturing systems.
- Explore new directions such as semiconductor
synthetic biology and functional microbial robots.
(5) Implement Strategic Projects in Frontier Areas
14. Cell-Electronic Hybrid Systems
Research and development of semiconductor synthetic
biology technologies, self-driven chip intelligent sensor
systems (ISS), promote the development of intelligent
electronic diagnostic and therapeutic systems, early
detection of drugs and high-throughput screening,
personalized medicine, new microbiological drivers(robots), and other applied research.
Note: In addition to vaccine manufacturing, organ 3D
printing, etc.
October
18, 2021

Shenzhen
Guangming
District
Government

Measures for
the Integrated
Developmentof a Synthetic
BiologyInnovation
Chain Industryin Shenzhen
Guangming
New District273

Support the construction of the synthetic biology
industry chain by providing temporary incentives tonational high-tech enterprises, enhancing the nurturingof high-tech enterprises, rent subsidies, entrepreneurshipspace support, etc. Additionally, support the constructionof the synthetic biology industryʼs ecology by providing
event subsidies covering 50% of the costs, supporting
journals in the field of synthetic biology selected for“Double High Journals,” associations, think tanks, etc.

October
20, 2021

Hubei
Provincial
Peopleʼs
Government

The 14th FiveYear Plan for
Science andTechnology
Innovationin Hubei
Province274

Chapter 4 Establishing Unique Domestic Sources ofInnovation
4. Enhancing the Support and Guarantee Capacity of
Basic Research Platforms
Promote the construction of research bases in basic
fields. [...] Focus on transformative technologies suchas neuroscience research, synthetic biology, magnetic
confinement fusion, etc., conduct cutting-edge crossdisciplinary basic research, and promote disruptive
technological innovation.

273

深圳市光明区政府 , “ 深圳市光明区关于支持合成生物创新链产业链融合发展的若干措施 ,”:http://www.szgm.gov.cn/xxgk/xqgwhxxgkml/zcfg_116521/qgfxwj/content/post_9261919.html.

274

湖北省人民政府 , “ 湖北省科技创新 “ 十四五 ” 规划 ,: http://www.hubei.gov.cn/zfwj/ezf/202110/t20211020_3818129.shtml

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Strengthen the construction of science and technology
facility platforms. Emphasize ecosystem conservation,
modern agriculture, climate change, disaster prevention
and management, establish numerous state-level outdoor
scientific observation research bases, and promote theestablishment of national outdoor scientific observation
research bases. [...] Collect, classify, preserve, and utilize
human genes, microbial strains, plant strains, viruses,
and other resources, and operate high-level naturalscience and technology resource banks such as the
Wuhan National Human Genetic Resources Bank, a
germplasm resources bank, and a microbial bacterium(toxin) species collection center, among others.
November
3, 2021

Beijing
Municipal
Peopleʼs
Government

Beijingʼs
14.5 Period
International
Science andTechnology
Innovation
CenterConstruction
Plan275

4. Strengthen unique cutting-edge scientific andtechnological research, and bravely undertake
important tasks relating to major core technologies(2) Promoting Cutting-Edge Technologies in Key Areas
Support research and development in cutting-edge
biotechnology fields. Generate unique discoveries in thefields of nucleic acid and protein detection, detectionof cell functions and pathological change, novel in vivointervention technologies, new antibody technologies,
gene editing, novel cell therapies, stem cells, andregenerative medicine. Establish accurate diagnostics
and groundbreaking treatments for major epidemics andchallenging, rare diseases.
(4) Promotion of Other Frontier Areas
Promote innovative research in biological breeding.
Centered on multi-dimensional omics research, acquire
key genes and genetic resources. Focus on the researchand development of many important technologies suchas efficient genetic transformation technology, precise
gene editing, synthetic biology, etc., build the latest
biological breeding systems, cultivate (culture) many
major new species and varieties, ensuring food security.

February22, 2022

Anhui
Provincial
Peopleʼs
Government

14.5
Science andTechnology
Innovation
Plan of Anhui
Province276

Chapter 3: Supporting Science and Technology for
Improving Quality of Life
Item 7: Major Technical Projects and Key Topics in the
Field of Social Development
Key Topic 5: Protein Cell Engineering Technology
Focus on the development of key technologies suchas AI design of protein structures, efficient expressionof fusion protein pharmaceuticals, screening, andhumanization of nanobodies, synthetic biology
and cell factories, targeted delivery of nucleic acid
pharmaceuticals by liposomes, stem cell therapy,organoid construction, 3D printing of biological tissues,
etc.

275

北京市人民政府 , “ 北京市 “ 十四五 ” 时期国际科技创新中心建设规划 ,:http://www.beijing.gov.cn/zhengce/zhengcefagui/202111/t20211124_2543346.html

276

安徽省人民政府 , “ 安徽省 “ 十四五 ” 科技创新规划 ,”: http://fzggw.ah.gov.cn/public/7011/146472951.html.

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5.4

Advances and Challenges in the Emerging Technology Field of “Synthetic Biology” in Australia, China and India

Chinaʼs National Key Research and Development Programs“Synthetic Biology” and “Green Bio-manufacturing”

According to “Several Opinions on Improving and Strengthening the Management of the State Council’s Central
Financial Research Projects and Funds,” “Notice of the State Council on Deepening the Reform Plan for theManagement of Central Financial Science and Technology Plans (Special Projects, etc.),” “Interim Measures for the
Operation of National Key Research and Development Projects,” etc., the list of key special projects in the field ofsynthetic biology approved in the fiscal year 2021 is as follows 277278. In the field of green bio-manufacturing279, as partof the 2022 call for proposals, the category of “bounty system ( 揭榜挂帅 )” is soliciting innovative proposals fromyoung researchers, with a large project budget of 35 million yuan (about 665 million yen) over three years. Fields forwhich proposals are being accepted include reduced carbon emissions through bioenergy and the development of coretechnologies in energy-saving production processes.
A review of the program shows that the Shenzhen Institute of Advanced Technology (SIAT) of the Chinese
Academy of Sciences has been approved for seven out of 25 projects in the synthetic biology field, accounting for aquarter of all projects. Additionally, when including institutions such as universities in Guangdong Province where
SIAT is located (Guangdong Institute of Microbiology, Shenzhen University, Sun Yat-sen University), nearly half ofthe total, 11 out of 25 cases, are occupied by research institutions in Guangdong Province. The approved fields include
foundational research such as artificial chromosomes, artificial phages, and the construction of artificial cells based on
genetic modification.
Meanwhile, in the green bio-manufacturing field, the adoption of research institutions in major cities of theBohai Economic Rim such as Tianjin and Beijing is notable. The adopted fields are mostly application-oriented
issues directly linked to applications such as the construction of industrial microbial genomes and efficient enzyme
production, although some appear to overlap with the synthetic biology project selections.

277		
中国生物技术发展中心「合成生物学」：https://www.ncsti.gov.cn/kjdt/tzgg/202111/t20211115_51308.html
278

The evaluation committee for the synthetic Biology project consists of Group 1 “Design and Construction of Special Microbial Chassis
Cells” with 7 members including Professor Zhang Ya Ping of Shihezi University (Xinjiang Uygur Autonomous Region) and Group 2“Synthetic Biosensor Systems for Food Safety Detection” with 7 members including Researcher Chen Yan of the National Center for Food
Safety Risk Assessment ( 国家食品安全风险评估中心 ).
https://www.ncsti.gov.cn/kjdt/tzgg/202106/t20210608_33993.html

279“Green Bio-Manufacturing” field: https://www.ncsti.gov.cn/kjdt/tzgg/202106/P020210621622063947151.pdf

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Table A-4 List of Projects Adopted in Chinaʼs National Key Research and Development Program:
Synthetic Biology and Green Bio-manufacturing

No.

Programs

Leading ResearchInstitution

Projects

Duration(Years)Design, construction, andfunctional research of artificial
chromosomes in eukaryotes

Peking University

Design, synthesis, andfunctional research of
unnatural bases and unnatural
cells

Institute of Basic
Medical Sciences
for Chinese
Academy of
Sciences

3

Design and construction of
microbial foundational cells
for special environments

Shanghai Jiao Tong
University

4

Rational design and systemmodification of microalgaebased cells

Henan University

Rational design and systemmodification of microalgaebased cells

Qingdao Instituteof Bioenergy
and Bioprocess
Technology,
Chinese Academyof Sciences

Construction of nano artificial
hybrid biological systems
and their application in tumor
immunotherapy

Zhejiang University

7

Nano artificial hybrid biologicalsystems for early diagnosis
and treatment of pancreaticcancerEast China
University of
Science andTechnology

8

Biosensing system foraccurate diagnosis andmonitoring of serious
diseases such as malignant
tumorsZhejiang Cancer
Hospital

9

Research on synthetic biology
sensor systems for foodsafety inspections

Guangdong
Institute ofMicrobiology

5

10

Efficient treatment system
for landfill leachate based onsynthetic microbial flora

Guangdong
Institute ofMicrobiology

5

Design and construction ofhigh-energy glucose batteries

Chinese Academyof Sciences, Tianjin
Institute of Industrial
Biotechnology

5

1

2

5

6

11

Synthetic
Biology

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5

5

5

5

5

5

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55

Budget(10,000 Yuan)
Total of 25
projects: 350
million yuan(about 6.65
billion yen,approximately
14 million
yuan (about
266 million
yen) perproject)

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12

13

14

15

16

17

18

19

20

21

Advances and Challenges in the Emerging Technology Field of “Synthetic Biology” in Australia, China and India

Combinatorial biosynthesis forconstructing artificial productswith new skeletons

Huazhong
University of
Science andTechnology

Chromosome engineering ofspecial yeast-based cells

Fudan University

Synthetic biology research on
the fundamental principles of
biological pattern formation
and artificial control

Shenzhen Instituteof Advanced
Technology,
Chinese Academyof Sciences

5

Design, construction, andapplication of unnatural
photosynthetic autotrophic
organisms

Shenzhen Instituteof Advanced
Technology,
Chinese Academyof Sciences

5

Design and synthesis ofpathogen tracer compound
marker systems

Shenzhen Instituteof Advanced
Technology,
Chinese Academyof Sciences

5

Design and constructionof biological carbon chain
extension and energy storage
cells

Shenzhen Instituteof Advanced
Technology,
Chinese Academyof Sciences

5

Design and synthesis of
unnatural artificial phages

Shenzhen Instituteof Advanced
Technology,
Chinese Academyof Sciences

5

Synthesis and application ofhigh-efficiency preparationsof bacteriophages targeting
Pseudomonas aeruginosa

Third Military
Medical Universityof the Chinese
Peopleʼs Liberation
Army

5

Design and synthesis ofgenetic circuits for diagnosis
and treatment of drugresistant bacteria

Shenzhen Instituteof Advanced
Technology,
Chinese Academyof Sciences

5

Design of biochemical
reactions and construction ofefficient biosynthesis systems
for new nitrogen-containing
molecules

Fudan University

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22

Design of biochemical
reactions and construction ofefficient biosynthesis systems
for new nitrogen-containing
molecules

Chinese Academyof Sciences, Tianjin
Institute of Industrial
Biotechnology

23

DNA information
preservation in the immune
microenvironment of bladdercancerShenzhen
University

Design and mechanism
study of tumor environmenttargeted immunotherapy
targeting T helper cells

Shenzhen Instituteof Advanced
Technology,
Chinese Academyof Sciences
Sun Yat-sen
University

25

Research on novel
combination immunotherapyof oncolytic virus bispecificantibodies for “secondary
reprogramming of tumor
microenvironment”

1Intelligent design and catalytic
application of industrial
enzymes

Hubei University

Construction of a general
high-efficiency expression
system for industrial enzymes

Institute ofAnimal Sciences,
Chinese Academyof Agricultural
Sciences3

3

Enzyme production
and catalyst action inpharmaceutical and foodindustries

East China
University of
Science andTechnology

3

4

Molecular design of core
enzymes and intelligent
manufacturing of enzyme
preparations in light industry

Tianjin Universityof Science andTechnology

5

Design principles andmethods for efficient microbial
cell factories

Shandong
University

6

Foundation construction andadaptability optimization in
the microbial pharmaceuticalindustry

Shanghai Jiao Tong
University

7

Construction and applicationof next-generation networkmodels for pathogenic
microorganisms andbiomanufacturing of important
industrial chemicals

Beijing Universityof Chemical
Technology

24

2

Green Biomanufacturing

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5

5

5

5

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3

3

3

3

3

Budget is
declared byrequest, but inthe 2022 callfor proposals,a large projectbudget of 35
million yuan(about 665
million yen)over three
years wassolicited in
the categoryof “bounty
system ( 揭榜挂帅 )”Research report

Advances and Challenges in the Emerging Technology Field of “Synthetic Biology” in Australia, China and India

8

Artificial dislocation
technology for industrial
pathogenic microorganisms

Tianjin University

Jiangnan University

9

Modifications to and industrial
demonstration of importantamino acid industrial
pathogenic microbial systems

Zhejiang Universityof Technology

10

Demonstration of coretechnology and industry
for the modification ofpathogenic microorganisms in
the pharmaceutical ingredientindustry.
Bioreactors and smart
biomanufacturing

East China
University of
Science andTechnology

12High-efficiency membrane
separation technology andintegrated equipment forbioethanol production

Nanjing Tech
University

13

Key technologies for
efficient production andcomprehensive utilization ofsugars from lignocellulosic
biomass

Shanghai Jiao Tong
University

14

High-efficiency
biomanufacturing technology
for artificial meat

Jiangnan University

15

Biomanufacturing technology
for products containing
natural enzymes

Northwest
University

Cellulosic ethanol biorefineryand industrial demonstration

South China
Agricultural
University

17

Green manufacturing andindustrial demonstrationof complete biosynthetic
biological polymers

Nanjing Tech
University

18

Efficient green production
and industrial demonstrationof bio-based polyamide
monomers and materials

Institute ofMicrobiology,
Chinese Academyof Sciences
Nanjing Tech
University

19

Development andindustrialization
demonstration of new biobased polyurethane polyols
and technology for green
manufacturing

11

16

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3

4

4

3

3

3

3

3

4

4

4

4

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Green biomanufacturing andindustrial demonstration ofchiral chemicals

Chinese Academyof Sciences, Tianjin
Institute of Industrial
Biotechnology

21

Industrial demonstration of
API biomanufacturing for theprevention and managementof major diseases

Zhejiang Universityof Technology

Jiangnan University

22

Efficient treatment andresource recovery technology
demonstration for high-saltorganic wastewater

Tianjin University

23

Creation and catalyst actionof industrial enzymes forfunctional carbohydrates inmedicine and foodMolecular design andefficient production of key
oxidoreductases for lightindustry

Institute ofAnimal Sciences,
Chinese Academyof Agricultural
Sciences

Design principles andoperation methods for large
DNA fragments of industrial
microbial genomes

Tianjin University

Adaptation and optimizationof industrial foundation
for and important drug
biosynthesis pathways infilamentous bacteria

Qingdao Instituteof Bioenergy
and Bioprocess
Technology,
Chinese Academyof Sciences

20

24

25

26

4

4

4

3

3

3

3

Source: National Science and Technology Management Information Systemʼs Public Service Platform（国家科技管理信息系統公共服務平台）280（As of December 15, 2021）

280

The National Science and Technology Management Information System’s public service platform is constructed and operated by the Instituteof Scientific and Technical Information of China

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List of Authors
Pham Thi Nu , Fellow at the JST Asia and Pacific Research Center (at the time)
Yoshihide Kobayashi, Chief at the JST Asia and Pacific Research Center
Mikiko Azuma, Manager at the JST Asia and Pacific Research Center
Takayuki Shirao, Deputy Director at the JST Asia and Pacific Research Center[Acknowledgments]
In preparing this report, valuable advice was received from Hidekazu Chayama, Director, and Satoshi Yokoyama,
Deputy Director, of the JST International Division’s Beijing Office, and from the office staff. Yuko Tsuda, Deputy
Director of the Washington Office, provided support for collecting information in the United States, and Yuna
Matsuda, a fellow at the Asia-Pacific Research Center (APRC), supported the collection of information in China. In
addition, the staff of the Center for Research and Development Strategy (CRDS) Life Science and Clinical Research
Unit provided useful advice on search keywords for papers, and APRC staff Manami Ishiro and Yoko Sasaki provided
translation and editorial support. We would like to express our deep gratitude to all those involved.
For the analysis of papers and patents in Chapter 3, data from the research report “Analysis of Trends in Papers
and Patents in the Emerging Biotechnology Field in Major Countries of the Asia-Pacific Region” commissioned to
VALUENEX, Inc. in the fiscal year 2021, has been reproduced (including some modifications).

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Advances and Challenges in the Emerging Technology
Field of “Synthetic Biology” in Australia, China and India

Published March 2024
ISBN 978-4-88890-916-7

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