Key Initiatives for Achieving
Biotechnological Transformation (BX)

April 16, 2024

KEIDANREN

Contents
I.

Introduction …………………………………………………...…………………..

2

II.

Domestic and International Trends ………………………………………….….

3

III. Cross-Sectoral Key Initiatives ………………….....…….………………………
1. Creating an issue-oriented roadmap …………………………….……………
2. Visualizing and strengthening supply chains ……………………………….
3. Enhancing the pathway from basic research to application ………………..
4. Enhancing the framework for advancing biotech strategy …………………

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5
6
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IV. Key Initiatives by Sector of Application ………………………………………..
１．White Biotech (manufacturing & energy) ……………………………..…….
２．Green Biotech (food & plants) ……………………………….……….……..
３．Red Biotech (medical & healthcare) ………………………………..……….

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V.

Industry Commitment …………………………………………………..…..….... 14
Reference: Issue-Oriented Initiatives by Various Companies ………………….. 15

VI. Conclusion …………………………………………………………………………. 16

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Ⅰ. Introduction••

The bioeconomy refers to a circular economy that contributes to solving societal issues such as
decarbonization and food security.
Building on Keidanren’s March 2023 proposal “Biotechnological Transformation (BX) Strategy”,
we outline key initiatives for the government’s next Bioeconomy Strategy due in June
2024.

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Ⅱ. Domestic and International Trends••

International competition in biotechnology is intensifying.
Japan must strategically allocate resources to key initiatives.
• Biotechnology is designated as a target sector for government-wide investment
expansion in the Basic Policy on Economic and Fiscal Management andReform 2023 and as part of economic security in the K Program• Various ministries are advancing initiatives in white, green, and red biotech sectors• Issued executive order to advance domestic biotech industry (Sept 2022), set target to
replace 90% of plastics with bio-based sources within 20 years (March 2023)• Steadily advancing regulation including a policy framework for biobased,biodegradable and compostable plastics (Nov 2022) and regulation on deforestationfree products (June 2023)• Listed bio as a priority science and technology area, and released National
Vision for Engineering Biology (Dec 2023)• Released 14th Five-Year Plan for
Bioeconomy Development (May 2022)• Prioritizing biotech as abiomass resource-richcountry• First country to approve lab-grown meat
• Hosted Synthetic Biology Global Forum(Feb 2023)• Biotech industry
development under Vision
2030 plan3

Ⅲ. Cross-Sectoral Key Initiatives

Creating an issueoriented roadmap

Enhancing thepathway from basic
research toapplication

Visualizing andstrengthening
supply chains

Enhancing theframework foradvancing biotech
strategy
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Ⅲ. Cross-Sectoral Key Initiatives

1. Creating an issue-oriented roadmap•

Issues••

Efforts•

Current roadmaps framed in terms of technology andmarkets lack a clear connection to the issues thebioeconomy could potentially solve.
The 2030 target is relatively near-term, andpredictability of return on investment is low for largescale capital investments like those in white biotech.

An issue-oriented roadmap should be developed thatuses backcasting to plot technologies and markets
against the milestones necessary to solve each issue,
with a long-term target of 2040 or 2050.
Additionally, alongside identifying Japan's strategic
advantages, it is crucial to monitor and analyze global
technological trends and swiftly revise roadmaps asneeded.
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Ⅲ. Cross-Sectoral Key Initiatives

2. Visualizing and strengthening supply chains•

As with semiconductors, securing stable and costcompetitive raw materials is important from an
economic security perspective.

•

Visualizing the process from sourcing raw materials,
transport, storage, manufacturing, and going to market
to build a resilient supply chain.
Non-edible biomass such as wood or grasses are
currently the predominant sources for white and green
biotech.
For red biotechnology, it is essential to consider the risks
associated with the procurement of raw materials andcomponent supplies related to allogeneic cells andcell cultures.

Issues

Efforts••6

Ⅲ. Cross-Sectoral Key Initiatives

3. Enhancing the pathway from basic research to application
Issues

Efforts

Basic
research•

Biotechnology, which is a deep tech, faces numerous
challenges including funding and public understanding, inaddition to the challenges of technology development.

•

Strengthening the pathway from basic research to realworld application and dissemination.

Appliedresearch

Mass-production
technology
development

Manufacturing

Commercial
production

Widespread
application

Funding for biocommunities
Developing deep tech startups

Global rulemaking

Developing and securing talent for the bioeconomy
Building biodata infrastructure

Developing domestic
manufacturing infrastructure

Short-term intensive initiatives

Raising public understanding

Mid- to long-term strategic initiatives
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Ⅲ. Cross-Sectoral Key Initiatives

3. Enhancing the pathway from basic research to application
Funding to stimulate developmentof biocommunities

Developing deep-tech startups• Strengthening support systems forintellectual property and related areas
through funding for biocommunities• Enhancing presence for global investors
by attracting biotech-savvy overseas
venture capitalists, creating a continuous
funding environment tailored to eachphase

• Thorough ongoing examinations forcertifying and ensuring quality of
biocommunities• Funding to secure talent needed tosupport community management andintellectual property

Developing and securing
talent for the bioeconomy

Short-Term• Encouraging workforce mobility (from large
corporations to startups or academia): Including
loaning talent to startups, side jobs, and better pay for
intellectual property and legal positions in academia• Developing biomanufacturing talent: Expanding
government training programs, corporate internships, etc.
• Leveraging doctoral talent: Encouraging PhDs tocontribute as both researchers and venture capitalists withtech expertise• Beginning at educational stage: Integrating
biotech-related lectures and practical labs throughout theuniversity curriculum

Global rulemaking• To participate in global rulemaking, it isessential to release Japan’s biotech
strategy in English to raise internationalrecognition• Participation in major international
conferences and events, including hostingsatellite events at World Expos and similar
venues• Active participation in discussions on DSI(Digital Sequence Information) andbiosecurity

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Ⅲ. Cross-Sectoral Key Initiatives

3. Enhancing the pathway from basic research to application
Building biodata infrastructure• Government-led expansion of data
integration and development of big
data infrastructure• Companies are also promoting data
sharing and utilization incollaborative domains

Mid- toLong-Term
Raising public understanding• Japan has a deep historical connection
with biotechnology through fermented
foods, rice breed improvement, etc.
• Persistently engaging in science
communication to highlight the utility ofbiotechnology, its contribution to economic
growth, and the scientific risks involved is
vital

Developing domestic
manufacturing infrastructure• Government support is essential in thedeveloping stages of the bioeconomy• Proactive fiscal support to promoteprivate facility investments for CMOs,
CDMOs, and other organizations• Support for manufacturers ofconsumables, component materials,
analytical and measurement equipment
manufacturers• Developing an environment where
academia and startups can use
CMOs, CDMOs, etc. at low cost
CMO: Contract Manufacturing Organization
CDMO: Contract Development & Manufacturing
Organization

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Ⅲ. Cross-Sectoral Key Initiatives

4. Enhancing the framework for advancing biotech strategy•

Compared to initiatives in space development and healthcare
outlined in the Basic Policy on Economic and Fiscal
Management and Reform 2023, the government’s framework
for the promotion of biotechnology is insufficient.

•

Increasing secretariat staff, establishing an organizationalframework, and extending budgetary authority.

Issues

Efforts

Space

Healthcare

BiotechAbout 8 trillion yen*1

Over 33 trillion yen*2

About 92 trillion yen*3

Command

Strategic Headquarters forSpace Development(Dir. Gen.: Prime Minister)

Headquarters for Healthcare
Policy(Dir. Gen.: Prime Minister)Integrated Innovation Strategy
Promotion Council(Chair: Chief Cabinet Secretary)

Established by

Basic Space Act

Act on Promotion of Healthcare Policy

Cabinet decision

Dedicatedsecretariat

Yes

Yes

(Cabinet Office National Space
Policy Secretariat)(Cabinet Office National
Healthcare Policy Secretariat)(within the Secretariat of Science,
Technology and Innovation Policy,
Cabinet Office)Relatedministries andagencies

MEXT, METI, MIC, MOD, JAXA,
among others

MEXT, MHLW, METI, AMED,
among others

METI, MAFF, MHLW, MEXT,
NEDO, among others

Budget size

Around 900 billion yen*4

Around 270 billion yen*4

Around 1 trillion yen*4

Governmental framework foradvancement

Market size circa 2030

ReferenceNo*1: Early 2030s (Basic Space Plan)*2: 33 trillion yen as of 2025 (Healthcare Policy), partial overlap with the red biotech market*3: As of 2030 (Bioeconomy Strategy 2020) *4: Includes fund projects

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Ⅳ. Key Initiatives by Sector of Application

1. White Biotech (manufacturing & energy)

Developing
markets receptive
to bioproducts• Bioproducts are higher-cost compared to fossil fuel-based
products• Establishing international standards for quantifying theenvironmental impact of bioproducts (e.g., LCA, CFP),and developing regulations for translating these values into
economic terms through credits and other mechanisms• Exploring the need to mandate a specific percentage of
bioproduct adoption, alongside considering subsidies tobridge cost disparities
LCA: Life Cycle Assessment, CFP: Carbon Footprint

Securing raw
materials• Securing stable and cost-competitive raw materials isessential• Relevant ministries need to cooperate to develop plansthat address primary production, regarding securing andutilizing domestic woody biomass and other underutilized
resources• Over the medium to long term, it is essential to develop
standards and certifications for securing and tracing CO2,methane, and hydrogen11Ⅳ. Key Initiatives by Sector of Application

2. Green Biotech (food & plants)
Building a domestic
marketplace for cellbased food products

Supporting thedevelopment of
global markets forcell-based foodproducts• Cultivated meat and precision fermentation products are currently on
the market in Singapore and the US• In Japan, the market environment is underdeveloped due to stalled
discussions regarding safety and risks• Establishing safety standards and guidelines for cultivated meattasting at the 2025 Osaka-Kansai Expo is urgently needed• Immediate action is also needed to prepare the market environment for
precision fermentation products• Support for global expansion of Japan’s food tech companies is vital• Promoting rulemaking regarding the definition and safety standards
for cell-based food products (including international standardization)• Encouraging greater utilization of domestic resources is important froman economic security perspective
Promoting the use of
and accelerating therecycling of domestic
woody biomass
resources• Advancing the development, production, and adoption of wood
products (e.g., standardization of CLT panels)• Promoting cascading use• Production of domestic materials through forestry funds and creating
carbon credits
CLT: Cross Laminated Timber
Cascading use: Using wood for material, reusing for paper or other goods, and finally as fuel 12

Ⅳ. Key Initiatives by Sector of Application

3. Red Biotech (medical & healthcare)• Building a broad base of basic research as a foundation for red biotech

Strategic R&D
framework toenhance drug
discovery capabilities

Appropriate
assessment of adiverse variety ofinnovations• A clearly structured national framework is required: public funding forbroad-ranging academic research, and private funding for phases
leading to real-world implementation such as clinical trials• In academic research, extensive support is crucial to broaden thediversity of research fields nationwide• Drug discovery is a deep tech and thus high-risk, high-return• New pricing models that reflect the diverse values andcharacteristics of innovations, including their medical economic impact,
are urgently needed to ensure that returns are proportionate to the risks
involved• Improving performance of global clinical trials is essential

Strengthening
capabilities for
conducting clinical
trials swiftly andefficiently• Expediting measures such as the standardization and digitalization ofclinical trial procedures and documents, along with the promotion ofinternational regulatory alignment in pharmaceuticals• Promoting medical DX such as standardized electronic medical records,
and strengthening clinical trial networks centered on core clinicalresearch hospitals
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Ⅴ. Industry Commitment
Specific efforts
by companies

Actions to
implement key
initiatives•

Numerous companies have established ambitious objectives andinitiated targeted actions to address societal issues and foster
economic growth through biotechnology (see pp.15–16)

Considerations for real-world application of
innovation from academia•

Proposals to address barriers to the growth and expansion of
biotech and other startups emerging from domestic universities arescheduled for release in fiscal 2024

Advancing a plan for global standardization in the bioeconomy•

White: focusing on raw material standards. Green: establishingsafety standards for cultivated meat. Red: aligning global
regulations for regenerative medicine along with setting quality
standards for related industry products

Expanding the base of industry participants
and creating networking opportunities••••

Communication and dialogue with domestic andinternational stakeholders
Encouraging collaboration with biocommunities
Holding biotech-focused KIX events
Utilizing Keidanren Slack

Conducting reviews•

Periodically assessing the progress of
initiatives outlined in proposals, and issuing
additional proposals as necessary

KIX (Keidanren Innovation Crossing) is a networking event organized by Keidanren for major corporations and startups

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Reference: Issue-Oriented Initiatives by Various Companies (Part 1)
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Green
Transformation

Circular
Economy

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NaturePositive

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Food
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Ajinomoto: Aiming to achieve a 50% reduction in GHG emissions (Scope 1 & 2), zero plastic waste, and100% sustainable sourcing of key raw materials by 2030, plus a 50% reduction in food loss by 2025.
Kirin Holdings: Aiming to increase the recycled resin content in PET bottles to 50% by 2027 to promote therecycling of resources in Japan, and exploring adoption of PET bottle resin derived from non-edible plantsources to reduce reliance on petroleum resources.
Toyobo: Initiatives underway for developing a revolutionary production system to expand the use ofmannosylerythritol lipids (MELs), a microbial-derived biosurfactant selected for NEDO's Bio-Manufacturing
Project. Planning to develop new applications such as agricultural spreaders, feed additives, and sanitarymaterial coatings by around 2025.
Teijin: Selected for the NEDO Bio-Manufacturing Project for the development of bio-upcycling technology to
produce useful chemicals from unused natural resources. Developing bioprocessing technology for
manufacturing high-performance fiber materials.
Nippon Paper: Aiming to start commercial production of bioethanol from domestic sources in fiscal 2027
(tens of thousands kL/year) and obtain certification as purely domestic materials for CORSIA-compliant fuel.
Nippon Paper: Planning to register projects equivalent to 200,000 tons of forest carbon absorption credits in
its company-owned forests by fiscal 2027.
Nippon Paper: Aiming to achieve the goals for adoption of elite trees under the Green Food System Strategy
by developing production capacity for 10 million elite tree seedlings per year by fiscal 2030, strengthening thedomestic supply chain for woody resources used in green and white biotech.
Sumitomo Forestry: In 2023, established the Eastwood Climate Smart Forestry Fund I in the US and began
operations in July with 10 participating Japanese companies and assets of about 60 billion yen. Planning to
expand operations to forests in Japan, Asia, and Oceania regions (2030 target, assets of 100 billion yen). The
fund allows for significant expansion of properly managed forests, contributing to global climate change
mitigation and biodiversity conservation.
Sumitomo Forestry: Establishing a timber industrial complex (2030 target, domestic material usage of 1
million m3/year) to improve the efficiency of domestic forestry and timber production, and increase carbon
sequestration by substituting with wood-derived materials. Increasing the amount of harvested wood products(HWP) processed and produced to boost carbon sequestration.
Sumitomo Forestry: Advancing decarbonization across the industry by promoting Zero Energy Houses(ZEH), Zero Energy Buildings (ZEB), Low Carbon Construction Material (LCCM) housing, and net-zerocarbon buildings, and by establishing decarbonization design standards like One Click LCA × EPD.
Ajinomoto: Promoting the development of next-generation food systems with low environmental impact suchas plant-based foods, cultivated meat, and precision fermentation.
Nippon Paper: Expanding the cellulose livestock feed business derived from domestically sourced wood,aiming to replace imported forage with locally produced feed. Pilot projects are underway at more than 40
user sites as of April 2023.

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Reference: Issue-Oriented Initiatives by Various Companies (Part 2)
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Well-being

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Kirin Holdings: Combining insight of Kirin Group companies and Otsuka Pharmaceutical Factory to launch a
project using biotechnology to solve quality issues of raw materials in existing compounds widely circulating on
the market. Aiming for global sales of over 100 billion yen and starting construction of facilities for clinical trial
drug substances with a product launch target of 2029.
Sumitomo Pharma: Aiming to expand Japanese-originated iPS cell technology overseas and will start
corporate clinical trials of iPS cell-derived products in the US in 2024.
Sumitomo Pharma: Aiming to launch the world's first iPS cell-derived product in fiscal 2024.
Sumitomo Pharma: Aiming for global sales of over 100 billion yen in the regenerative and cellular medicine
business by fiscal 2032.
Ajinomoto: Acquired US-based Forge Biologics for roughly 82.8 billion yen in 2023 to grow its gene therapy
business.
Takeda Pharmaceutical: Developing an R&D system and advancing business strategies through a global
drug discovery ecosystem to swiftly deliver innovations to patients worldwide.
AGC: Plans to build one of the largest domestic CDMO facilities in Yokohama within Greater Tokyo Biocommunity(GTB), which can switch to vaccine production during a pandemic, and will be operational in 2026.
Daiichi Sankyo: Obtained domestic approval in August 2023 for additional immunization using a monovalentmRNA vaccine targeting the original COVID-19 strain supported by AMED and MHLW’s vaccine initiative.
Daiichi Sankyo: Obtained partial change approval for COVID-19 vaccine for the Omicron strain XBB.1.5 in
November 2023, supplying 1.4 million doses as the first domestically produced mRNA vaccine.
Daiichi Sankyo: Signed a global agreement with Merck (Rahway, NJ) for development and commercializationof DXd-ADC 3 products, aiming for rapid and widespread delivery to cancer patients worldwide.
Teijin & Mitsui Fudosan: Constructing the Kashiwanoha Regenerative Medicine Platform, which utilizes the
CDO facility adjacent to the National Cancer Center Hospital East to accelerate the development ofregenerative medicine products.
Teijin: Enhancing the global reach of Japanese-developed innovations and speeding up the development offoreign innovations in Japan by establishing a shared manufacturing platform with international CDMOs.
Teijin: Leveraging the business experience of its group company Japan Tissue Engineering to construct anautologous cell business platform at three domestic locations (Gamagori in Aichi Prefecture, Kashiwa in Chiba
Prefecture, Iwakuni in Yamaguchi Prefecture)
Chugai Pharmaceutical: Planning to double R&D output over 10 years and deliver innovative in-housedeveloped global products to the market every year. Their 2024 plan includes an investment of 171 billion yen
to bolster drug discovery technology infrastructure and related areas.
Chugai Pharmaceutical: Investing 76.7 billion yen from 2023 to 2027 in new construction and modification ofdomestic manufacturing facilities for bio drug substances and other products to double R&D output.
Astellas Pharma: Aiming for sales of over 500 billion yen by fiscal 2030 from innovative products in gene andcell therapy.
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Ⅵ. Conclusion
This proposal outlines key measures aimed at achieving
Biotechnology Transformation (BX).

BX is a key to facilitating industrial restructuring using
biotechnology and fulfilling Keidanren’s vision ofsustainable capitalism.
Keidanren is committed to achieving BX in collaboration
with stakeholders including the government, academia, andstartups.

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