COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS Building the future with nature: Boosting Biotechnology and Biomanufacturing in the EU
Date: 2024-03-27
Institutions: European Commission, Secretariat-General
Subjects: EU financing, adaptation to climate change, biotechnology, clean technology, competitiveness, digital transformation, green economy, industrial development, renewable resources, research and development

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 27.3.2024  COM(2024) 137 final/2  CORRIGENDUM This document corrects COM(2024)137 final of 20.3.2024 Concerns the EN version only. Minor editing correction of footnote 4. The text shall read as follows: COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS Building the future with nature: Boosting Biotechnology and Biomanufacturing in the EU  
 
 
1. Introduction  

Biotechnology1 and its application to manufacturing bio-based products, biomanufacturing2 
can be part of the solution to address many societal and environmental challenges, such as 
climate mitigation and adaptation, access to and sustainable use of natural resources, restoration 
of  vital  nature  systems,  food  supply  and  security,  and  human  health.  Biotechnology  and 
biomanufacturing are key for the competitiveness and the modernisation of our economy due 
to their high growth potential and increased labour productivity. They also strongly enhance 
the  EU’s  open  strategic  autonomy  and  resilience  by  reducing  industry’s  dependency  on 
fossil-based  input  and  other  sources  of  raw  materials,  and  increase  circularity.  They  help 
advance the European Health Union and achieve the European Green Deal objectives. 

Biotechnology has also been identified as a critical technology from the economic security 
perspective3, given its cross-cutting nature. It is also one of the technologies prioritised in the 
Strategic Technologies for Europe Platform (STEP) regulation4. 

Biotechnology  and  biomanufacturing  are  important  enablers  for  the  bioeconomy  at  large, 
which  cover  all  sectors  and  systems  that  rely  on  biological  resources,  their  functions  and 
principles  (ecosystems,  animals,  plants,  micro-organisms  and  derived  biomass,  wood, 
including organic waste). At the same time, biotechnology and biomanufacturing depend on 
the wider bioeconomy for their inputs, and to some extent as an outlet for their products. They 
also have strong links with healthcare and especially the pharmaceutical industry. 

The EU has an innovative and competitive biotech industry, whilst AI is set to accelerate many 
biotech innovations and developments. At the same time, the potential of biotechnology and 
biomanufacturing has also been recognised by other countries5. Moreover, the EU has a strong 
domestic supply of renewable raw materials, such as wood. Today, the EU is well-endowed 
with human talent, research and innovation results and capacities to further develop bio-based 
manufacturing and biotechnologies.  

However, to promote EU industrial competitiveness and its sustainability,  greater efforts are 
needed  to  create  the  right  environment  for  this  sector  to  grow.  European  biotech  and 

1  According  to  the  OECD,  biotechnology  is  defined  as  the  application  of  science  and  technology  to  living 
organisms, as well as parts, products and models of them, to alter living or non-living materials for the production 
of knowledge, goods and services. Advanced biotechnologies are geared towards various application areas, being 
the  main  ones  medical  and  pharmaceutical  (“red”  biotechnology),  agri-food  (“green”  biotechnology),  and 
industrial and environmental (“white” biotechnology), with the marine biotechnology (so-called “blue”) gaining 
increased attention. 
2 The use and conversion of biotechnology and biological resources into chemicals, products and energy. 
3 Commission Recommendation (EU) 2023/2113 of 3 October 2023 on critical technology areas for the EU’s 
economic security for further risk assessment with Member States.  
4 Proposal for a Regulation of the European Parliament and the Council establishing the Strategic Technologies 
for  Europe  Platform  (‘STEP’)  and  amending  Directive  2003/87/EC,  Regulations  (EU)  2021/1058,  (EU) 
2021/1056, (EU) 2021/1057, (EU) No 1303/2013, (EU) No 223/2014, (EU) 2021/1060, (EU) 2021/523, (EU) 
2021/695, (EU) 2021/697 and (EU) 2021/241, COM/2023/335 final. 
5 With the publication of their “Bold goals for US biotechnology and biomanufacturing” report, the US has defined 
an  industrial  strategy  for  biotechnology  and  biomanufacturing,  setting  goals  in  five  fields:  climate,  food  and 
agriculture, supply chains, health and cross-cutting. China has also identified biotechnology as a key sector in its 
Made in China 2025 strategy. India, which is growing robustly in biotechnology, has unveiled a Biotechnology 
strategy as part of its own “Make in India” campaign, and the UK, with its “Life Science Strategy”, intends to 
give a new push to its biotechnology sector. 

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biomanufacturing  companies  need  a  supportive  regulatory  framework  and  more  financing 
opportunities to thrive in Europe6.  

This  Communication  summarises  the  current  challenges  and  barriers  for  biotechnology  and 
biomanufacturing and proposes actions to address these challenges in a timely manner, in line 
with the Communication on the Long-term competitiveness of the EU7. It also explores ways 
to  foster  engagement  and  collaboration,  including  through  international  dialogue  and 
cooperation.  

2. Overview of the sector  

The overall global biotechnology market size8 was EUR 720 billion in 2021 with a growth rate 
of more than 18% annually. The US dominates this market by contributing 60% of the global 
value9, followed by the EU (12%) and China (11%). It is characterised by intense technological 
competition, with a R&D intensity that is higher than in other R&D-intensive fields such as 
pharmaceuticals  or  digital  products  and  services10. The  sector  is  inherently  research-driven, 
often involving cutting-edge equipment, technologies, techniques and knowledge11 that require 
substantial and continuous investments to stay at the forefront of scientific and technological 
advancements.  The  development  of  biotechnological  products  often  involves  lengthy  and 
complex processes, and additional investments before the products reach the market to secure 
the intellectual property protection and fulfil the regulatory requirements.   

In 2018 in  the EU12, biotechnology  contributed directly EUR 31 billion  to  its  overall GDP, 
created 210,700 direct jobs in healthcare, industry and agriculture, as well as supported 625,700 
jobs (indirect and induced) in the overall economy. Between 2008 and 2018, the biotechnology 
industry  grew  more  than  twice  as  fast  as  the  overall  economy,  making  it  one  of  the  fastest 
growing innovative industries in the EU. Its labour productivity is very high. The products and 
solutions  that  biotechnology  and  biomanufacturing  companies  are  creating  can  have  a 
significant impact in different areas of application. For example, enzyme technology allows 
creation  of  lactose-free  and  sugar-reduced  dairy  products  while  laundry  detergents  contain 
enzymes, which break down fats, oils and protein chains. This allows washing clothes at lower 
temperatures, therefore reducing energy consumption.  

Biotechnology also contributes to enhance economic security by providing substitute products 
and  materials  in  critical  sectors. This  Communication  complements  the  Communication  on 

6 In the EU, the latest strategy focusing exclusively on biotechnology dates back to 2002: Communication from 
the Commission to the European Parliament, the Council, the Economic and Social Committee and the Committee 
of the Regions, Life sciences and biotechnology - A Strategy for Europe, 2002/C 55/03. 
7  Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  Economic  and  Social 
Committee  and  the  Committee  of  the  Regions,  Long-term  competitiveness  of  the  EU:  looking  beyond  2030, 
COM(2023) 168 final.  
8 https://www.biospace.com/article/biotechnology-market-size-to-worth-around-us-3-44-trillion-by-2030/  
9 https://www.statista.com/statistics/1246614/top-countries-share-of-global-biotech-value/  
10 https://www.oecd.org/innovation/inno/keybiotechnologyindicators.htm 
11 Such as gene editing, synthetic biology, bioprinting and bioinformatics. 
12 EU27 adjusted values, EuropaBio study: “Measuring the economic footprint of the biotechnology industry in 
Europe”, December, 2020, https://www.europabio.org/wp-
content/uploads/2021/02/201208_WifOR_EuropaBIO_Economic_Impact_Biotech_FINAL.pdf  

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Advanced Materials for Industrial Leadership13 in the production of advanced materials with 
renewable resources and responds, among others, to the need to facilitate the substitution of 
Critical Raw Materials (CRMs) with alternative advanced materials. Materials derived from 
biotechnology are included as one of the potential solutions for this challenge. 

2.1.  Biotech for health  

Biotechnology has revolutionised healthcare since the first biotechnologically manufactured 
medicines in the 1980s, such as synthetically produced insulin. Today, many biotechnological 
medicines are on the market and bring life-saving therapies to patients.  

As  well  as  being  a  key  sector  for  investment  and  competitiveness,  a  thriving  EU  biotech 
ecosystem is of strategic importance for the effectiveness of healthcare and resilience of health 
systems in times of strain such as public health emergencies. It can help to address challenges 
linked to ageing (such as disease prevention, personalised medicines, regenerative medicine 
and chronic illness) and antimicrobial resistance. A robust EU biotech ecosystem can contribute 
to the security of supply of both innovative and generic  medicines in line with the objectives 
of the Communication on addressing medicine shortages in the EU14. 

2.2.  Biotech applications in food and feed - biotech for food security 

Biotechnology  can  help  reduce  the  EU's  external  dependencies  including  in  the  agri-food 
sector.  It  can  also  contribute  to  a  better  protection  of  health  and  the  environment  by,  for 
example,  reducing  crop  and  food  losses  and  enabling  a  more  efficient  and  reduced  use  of 
natural resources and input materials (chemical synthetic pesticides or mineral fertilisers). It 

13  Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  Economic  and  Social 
Committee and the Committee of the Regions: “Advanced Materials for Industrial Leadership”, COM(2024) 98 
final. 
14  Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  Economic  and  Social 
Committee and the Committee of the Regions “Addressing medicines shortages in the EU”, COM(2023) 672 final. 

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also allows for feed and foodstuffs with improved environmental and health traits (e.g., with 
reduced saturated fats or allergens or with increased disease fighting nutrients). Innovation in 
biotechnology  can  be  an  important  building  block  in  the  efforts  to  reduce  the  overall 
environmental  footprint  of  agri-food  production  systems  making  them  more  resilient  and 
supportive to reach the EU’s climate neutrality goal and to provide more sustainable and some 
healthier foodstuffs.  

2.3.  Biotech and manufacturing for more added value with less resources in the 

sustainable wood-based sector  

Biotechnology  can  strengthen  the  resilience  of  forests15  to  the  effects  of  climate  change, 
including severe droughts and forest fires. In the case of biomanufacturing, the forest sector 
offers sustainably produced, renewable and recyclable raw materials that can be used for high-
value  innovative  products,  such  as  batteries  or  healthcare  and  pharmaceuticals  applications 
(e.g., nanocellulose-based wound dressings). Furthermore, wood can be used to replace fossil-
based or non-renewable materials, for example, in the production of construction materials and 
textiles and to substitute chemicals. 

2.4.  Marine biotech applications responding to global challenges 

Marine biotech has led to several pharma innovations by providing medicines treating cancer, 
cardiovascular  diseases,  pain  and  viral  infections  and  by  contributing  to  environmental 
remediation solutions such as cleanup of oil spills, plastic pollution, or wastewater treatment. 
Other market segments of interest for marine biotech include cosmetics, enzymes, chemicals, 
and bio-fertilisers. Hundreds of new compounds from the marine realm are being found every 
year that open up new biotechnical pathways, with the algae sector having a particularly broad 
spectrum of application16.   

EXAMPLES OF BIOTECH APPLICATION IN DIFFERENT AREAS 

•  Biotech for clean water: Based on modified enzymes, PFS17 is the first patented enzyme-
carrying filtration system capable of removing a large range of organic pollutants from 
wastewater.  It  can  be  easily  installed  in  most  of  wastewater  treatment  facilities. 
Compared to alternative purification methods, PFS is very cost-efficient and requires no 
energy to run.  

•  Biorefineries for sustainable batteries: Biorefineries can nowadays transform wood into 
innovative high value-added products in several sectors: biochemicals, insulation foams, 
bio composites, engineered foams etc. One European company18 is developing batteries 
made from hard carbon powder (refined lignin19) with a scalable model for commercial 
production.  

15  Examples  of  biotechnologies  used  in  the  forestry  sector  more  commonly  involve  genomic  tools  to  identify 
networks of genes that produce the most robust phenotypes for specific environmental conditions, with proposed 
benefits including increased fire resistance in trees and assisting trees to better adapt to changing climates. 
16 Towards a Strong and Sustainable EU Algae Sector, COM(2022) 592 final. 
17 PFS has been developed by Pharem Biotech, with the support of Horizon 2020. 
18 Stora Enso: from trees to batteries: https://www.storaenso.com/en/products/lignin/lignode 
19 Lignin is a type of polymer found in the cell of terrestrial plants, from 20% to 30% of a tree composition and it 
can be a component for a broad range of innovative products. 

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•  Biotech for greener and more productive agriculture: Biocontrol agents (BCA) provide 
alternative solutions to chemical pesticides. They rely on natural means to control pests, 
such as parasitism, predations, or other mechanisms to protect crops. Biotech can help to 
produce more effective and cost-efficient BCA enhancing the properties of organisms, 
such as fungi. One of its applications is increasing natural plant defences for vineyards. 
Microalgae-based  biorefineries  are  already  being  developed  to  extract  nutrients  from 
wastewater to produce biostimulants, biopesticides, and biofertilisers. It is expected to 
increase crop yield compared to existing cultivation cases with chemical inputs. 

•  Biotech  for  health:  Based  in  part  ongroundbreaking  research  in  Europe,  mRNA 
therapeutics  allowed  the  discovery  of  mRNA-based  vaccines  for  COVID-19  saving 
millions of lives. In addition to vaccines against infectious diseases, RNA therapeutics 
are being developed to treat cancer as well as rare and cardiovascular diseases.  

•  Biotech  and  sustainable  carbon  sources:  In  the  chemical  industry  more  than  90%  of 
annual  carbon demand  (about  450 million  tonnes CO2)  is  supplied by fossil carbon20. 
Alternative feedstocks, like sustainable biomass, recycled waste and CO2 captured from 
biogenic  sources  could  instead  be  used  for  the  manufacturing  of  polymers,  plastics, 
solvents,  paints,  detergents,  cosmetics  and  pharmaceuticals,  contributing  to  emission 
reduction, resource efficiency and strategic autonomy. 

The 2012 EU Bioeconomy strategy, updated in 2018, set the foundation for a more innovative, 
resource-efficient and competitive society that reconciles food security with the sustainable use 
of renewable resources for industrial purposes, while ensuring environmental protection. Given 
its important role in supporting the green transition, the bioeconomy will continue to be key for 
ensuring the EU’s competitiveness and resilience. Therefore, there is a need to adjust the EU 
policy on bioeconomy taking into account the current societal, demographic and environmental 
challenges,  reinforcing  its  industrial  dimension  and  its  links  to  biotechnology  and 
biomanufacturing  to  contribute  to  a  stronger  EU  economy.  In  that  sense,  in  2025,  this 
Communication will be complemented by a review of the EU Bioeconomy Strategy. 

3. Challenges  

The  EU  biotech  and  biomanufacturing  sector  is  facing  several  challenges  that  need  to  be 
addressed for it to realise its full potential. 

3.1.  Research and technology transfer to the market 

Europe  is  strong  in  life  sciences21  and  leads  on  high-quality  publications  covering  health, 
agriculture, and industrial biotech22. However, many research results are not developed further 
for the market. In the case of health-related and blue biotech, the of cutting-edge-research into 
products and treatments is less successful in the EU compared to the US and China. Worldwide 

20 https://renewable-carbon.eu/publications/product/the-renewable-carbon-initiatives-carbon-flows-report-pdf/ 
21 World University Rankings 2022 by subject: life sciences | Times Higher Education (THE) 
22 “CWTS Leiden Ranking 2022,” CWTS Leiden Ranking, accessed October 2022. 

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growth in health biotech R&D (which concentrates most of the investments in biotech) since 
2012 can be largely attributed to the entry and activity of US firms23. 

Biotech research is scattered across Member States and only a limited number of centres of 
excellence ranking among the top worldwide have emerged24. Additionally, professionalised 
mechanisms for the technology transfer from universities and research centres to the market 
are  not  well  developed  or  systematic.  This  makes  the  use  of  their  biotech  discoveries  and 
advances by EU companies more challenging.   

3.2.  Regulatory complexity 

Innovative biotechnologies and products may encounter regulatory obstacles at both Member 
State and EU levels when entering the market. Biorefineries that do not meet the requirements 
outlined  in  the  Net-Zero  Industry  Act25  often  face  lengthy  permitting  and  authorisation 
procedures  (e.g.,  building  permits,  environmental  authorisations,  industrial  risk  analyses) 
before  they  can  become  operational.  Biotechnologies  and  products  that  fulfil  these 
requirements will benefit from the streamlined administrative and permit-granting processes 
under that regulation. Investing in and building new modern/innovative biorefineries is a long-
term and capital-intensive undertaking. Another example is the approval of a biological plant 
protection product in the EU which takes up to three times as long as in  the US. Similarly, 
developers  of  biotech  health  products  have  difficulties  in  navigating  the  complex  EU  and 
national-level  regulatory  environment  and  the  intrinsic  complexity  characterising  those 
innovative treatments.  

3.3.  Access to finance 

Access to finance is key for the development of a vibrant biotech industry. Given the long-term 
financing  needs  of  biotech  companies,  and  uncertainty  surrounding  the  return  on  their 
investments, traditional, loan-based bank financing (which is prevalent in the EU) is in most 
cases not suitable to meet the needs of this industry. Biotech companies need to look to capital 
markets for the funds they need, and would thus benefit from further progress on the Capital 
Markets Union. 

At the earliest stages of development, biotech firms need venture capital financing to get their 
ideas off the ground. The great uncertainty as to the feasibility and success of novel products 
means that investments into biotech firms carry high risk as well as long investment horizons.  

The scale-up stage of financing is the most problematic for biotech firms in the Union. The 
fragmentation of EU capital markets results in many small-to-medium sized equity funds that 
invest  mostly  nationally.  Early-stage  venture  capital  at  smaller  amounts  has  become  more 
available in the EU but still lags behind other main economic regions, while access to larger 
amounts  of  later-stage  venture  capital  in  the  growth  phase  remains  a  major  obstacle.  To 

23 EU Industrial R&D Investment Scoreboard (2023), p. 50, Table 17 as well as Section 3.2.2 Health industries. A 
similar, albeit less pronounced US dominance is observed for the (non-biotech) pharmaceutical sector. 
24  See  https://www.nature.com/nature-index/institution-outputs/generate/all/global/all  (key  words:  region: 
“global”, sector: “all”; subject or journal group: biological sciences). 
25  Proposal  for  a  Regulation  of  the  European  Parliament  and  of  the  Council  on  establishing  a  framework  of 
measures for strengthening Europe’s net-zero technology products manufacturing ecosystem (Net Zero Industry 
Act), COM(2023) 161 final. 

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adequately  fund  later-stage  biotech  firms,  the  EU  is  in  dire  need  of  larger  and  deeper  pan-
European funds which can facilitate large rounds of private investment.  

Finally,  at  later  stages  of  their  development,  biotech  companies  could  seek  financing  by 
accessing  public  stock  markets.  However,  these  markets  are  still  dispersed  across  Member 
States which leads to fragmented liquidity and consequently higher cost of capital for listing 
companies. 

3.4. 

Skills 

European  biotech  and  biomanufacturing  companies  face  rapidly  evolving  skills  needs. 
Compared  to  other  products,  biotech  products  are  more  complex  to  develop  and  their 
manufacturing  requires  highly  specialised  equipment  and  a  highly  qualified  and  multi-
disciplinary  workforce.  In  light  of  this  and  in  the  context  of  the  European  Year  of  Skills, 
continuing  training,  up-  and  re-  skilling  are  particularly  important  to  meet  the  constantly 
evolving industry needs, in line with the EU target that 60% of adults participate in training 
each year by 203026. Deep expertise is required in life sciences-related fields but also in digital 
technologies (AI, big data, robotics), in regulatory frameworks and in quality assurance and 
control. For some biotech products, especially in the field of medicines, centres of excellence 
and specific skills are needed for the final administration of the product to patients. 

In  addition,  the  EU  is  at  risk  of  losing  these  skills  because  researchers  and  companies  are 
attracted to other parts of the world with more supportive environments to develop their biotech 
projects. 

3.5.  Value chain obstacles  

Businesses  encounter  value  chain  obstacles,  and  struggle  to  find  sufficient  sustainable 
feedstock to move from fossil to renewable raw materials on a larger scale. EU industrial bio-
based  systems  rely  heavily  on  imports  such  as  oilseeds,  cork,  pulp,  algae,  (intermediate) 
chemicals,  textile fibres, as well as animal  and vegetable oils. At the same time,  some EU-
sourced alternatives may be available that are not yet fully exploited, such as organic waste and 
by-products. Whilst  the  demand  for  biomass  is  increasing  it  is  estimated  that  the  supply  of 
sustainable  biomass  falls  40-70%27  short  compared  with  projected  demand  by  205028. This 
makes  the  use  of  additional  renewable  carbon  sources  such  as  recycled  waste  or  captured 
carbon necessary.  

3.6. 

Intellectual property 

Intellectual property (IP) allows biotech innovators to protect research results and to recover 
the  large  upfront  capital  investments  needed.  It  is  also  frequently  a  critical  asset  which 
emerging biotech start-up companies can offer to secure financing.  

26 This is one of the three EU headline targets for 2030 of the European Pillar of Social Rights Action Plan. 
https://op.europa.eu/webpub/empl/european-pillar-of-social-rights/en/  
27 depending on the projected demand scenarios 
28 “The European biomass puzzle – Challenges, opportunities and trade-offs around biomass production and use 
in the EU”: https://www.eea.europa.eu/en/newsroom/news/biomass-in-europe  

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Biotech patents represent about 5% of total IP529 patents filed between 2001 and 202030. The 
vast majority of the biotech patents are related to industrial and medical applications combining 
more  than  96%  of  all  patents  analysed. The  USA  is  leading  in  the  development  of  biotech 
patents (39.6% of total biotech patents in 2020) followed by the EU with 18.3% and China 
catching up quickly (10.4%). 

3.7.  Public acceptance 

In spite of their many benefits,  public  awareness  and acceptance  of  biotechnology  and bio-
manufactured products in the EU needs further attention. Relevant frameworks need to give 
robust assurances to citizens about responsible use, safety and sustainibility. This will be a key 
objective  of  the  possible  EU  Biotech Act.  It  also  calls  for  well-informed  engagement  and 
discussion with civil society.  

Moreover, biotechnology and bio-manufactured products are usually more expensive than their 
fossil-based competitors and, at the same time, their societal and sustainability benefits are not 
apparent for many consumers.  

3.8.  Economic security 

Biotechnology was identified as one of the ten critical technology areas for European economic 
security, based on its enabling and transformative nature, the potential risk of civil and military 
fusion of some biotechnologies, and the risk of their misuse for human rights violations. It is 
currently subject to an ongoing assessment of the risks to technology security and technology 
leakage conducted jointly by the Commission and the Member States. The assessment has been 
mapping out strengths to protect and vulnerabilities to address across the main application areas 
and identified priority risk scenarios, including possibilities of misuse of biotech. Based on this 
exercise, the Commission and the Member States will identify precise and proportionate risk 
mitigation measures to ensure that the EU remains at the forefront of technological innovation 
in  biotech,  safeguards  its  economic  security,  and  maintains  strong  cooperation  with  the 
broadest possible range of like-minded partners.  

4. Opportunities and way forward 

4.1.  Leveraging research and boosting innovation  

A  more  integrated  approach  to  the  technology  transfer  process  in  Member  States  can 
significantly benefit biotech and biomanufacturing companies. This  implies actions in  three 
interconnected domains: (i) technology transfer capacity building (including through training, 
knowledge  development  and  sharing),  (ii)  technology  transfer  financing  and  (iii)  design  of 
innovation  ecosystems  through  research  organisations,  technology  transfer  offices  and 

29 IP5 includes: the European Patent Office (EPO), the Japan Patent Office (JPO), the Korean Intellectual Property 
Office  (KIPO),  the  US  Patent  and  Trademark  Office  (USPTO)  and  the  National  Intellectual  Property 
Administration of People’s Republic of China (NIPA). 
30 Grassano, N., Napolitano, N., et al. (2024). Exploring the global landscape of biotech Innovation: preliminary 
insights from patent analysis. Luxembourg: Publications Office of the European Union (forthcoming). 

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Research31 and Technology Infrastructures32. Technology centres33 are a key tool to accelerate 
technology transfer reducing the time-to-market for innovative products. In the EU there are at 
least 130 mapped technology centres active in biotechnology and biomanufacturing34. 

The  approach  could  build  upon  the  experience  of  regions  in  designing  their  innovation 
strategies, ‘smart specialisation strategies’. Several EU regions have identified biotechnology 
in  their  smart  specialisation  strategies.35 As  a  result,  the  strategies  enhance  close-to-market 
research and innovation capacities in biotechnology and develop the necessary skills. 

To  help  to  identify  drivers  and  bottlenecks  of  innovation  and  of  technology  adoption,  the 
Commission has launched a study to investigate the EU’s position compared to other global 
leaders in emerging biotechnology generation and transfer to the biomanufacturing industry.  

To facilitate a more productive use of Research Infrastructures, the Commission will explore 
ways to accelerate the development and use of  the Industrial Biotechnology Innovation and 
Synthetic  Biology  Accelerator  (EU  IBISBA)36  as  a  trusted  digital  repository  and  service 
network for the sector. 

Artificial Intelligence and use of data 

There  is  an  unprecedented  amount  of  data  available  in  biotechnology  today.  Artificial 
intelligence (AI) applied to bio-based industry allows companies to automate a wide range 
of processes helping them to streamline and scale up their operations. AI image analysis or 
deep learning can be used to analyse microbiomes, screen phenotypes, and develop rapid 
diagnostics  in  a  vast  range  of  applications.  The  use  of AI-based  systems  to  predict  best 
metabolic  pathways  for  biosynthesis  and  virtually  test  several  variables  can  speed  up 
bioprocesses’ development. The application of AI allows personalized healthcare solutions 
enabling the development of customized treatments and diagnostics. 

Generative AI  holds  a  particular  promise.  For  example,  it  can  generate  new  or  analyse 
existing  gene  sequences  to  help  understand  complex  genetic  diseases  or  facilitate  drug 
discovery and support protein and peptide engineering for biotechnological and therapeutic 
purposes and synthetic biology applications, such as the production of sustainable fabrics. 
For instance, one significant contribution37 AI has made to advancing scientific knowledge 
to date is the creation of the most complete database of predicted 3D structures of human 

31 Research Infrastructures are facilities that provide resources and services for research communities to conduct 
research  and  foster  innovation.  They  include  major  scientific  equipment  or  sets  of  instruments,  collections, 
archives or scientific data, computing systems and communication networks. 
32 Technology infrastructures are facilities, equipment, capabilities and support services where industrial players 
can find support to commercialise new products, processes and services, in full compliance with EU regulations. 
33  Technology  Centres  are  public  or  private  organisations  carrying  out  applied  research  and  close-to-market 
innovation. Technology Centres typically provide the following services to SMEs: access to technology expertise 
and facilities for validation, demonstration, proof of concept / lab testing, prototype development and testing, pilot 
production and demonstration/ pilot lines / pre-series, product validation / certification. 
34 Technology Centre Mapping tool launched by the Commission through the European Monitor of Industrial 
Ecosystems (EMI) project: https://monitor-industrial-ecosystems.ec.europa.eu/technology-centre/mapping. 
35 S3 CoP Observatory (europa.eu): https://ec.europa.eu/regional_policy/assets/s3-observatory/index_en.html 
36 IBISBA provides a single access point to researchers from academia and industry to integrated services for end-
to-end  bioprocess  development  (e.g.,  process  optimization,  data  services,  analytics  or  protein  discovery  and 
engineering). 
37 This is a result of a collaboration between the European Molecular Biology Laboratory and Deep Mind. 

9 

 
 
 
 
 
proteins and the prediction of a protein’s shape computationally rather than determining it 
experimentally through years of laborious and often costly techniques.  

Companies  applying  AI  to  biotechnology  and  biomanufacturing  can  benefit  from  the 
measures proposed in the AI package38, especially from the setting up of AI Factories which 
will  give  privileged  access  to  supercomputers  to AI  startups  and  the  broader  innovation 
community.  Companies could also benefit from the strengthened support to the Common 
European  Data  Spaces,  and  the  launch  of  “GenAI4EU”,  a  landmark  initiative  that  has 
earmarked approximately EUR 500 million to stimulate the uptake of generative AI across 
all of the Union’s fourteen industrial ecosystems, including biotechnology.  

The European Health Data Space Regulation (EHDS) once applicable will standardise health 
data across the EU to allow for better use for research, innovation, and public health policies 
(the “secondary use of health data”). While protecting patients’  fundamental right to privacy,  
the EHDS will facilitate access to and use of health data, including their use for the purposes 
of R&D for health biotech in particular, in a secure and trustworthy setting.   

The '1+ Million Genomes' (1+MG) initiative39 aims to enable secure access to genomics and 
the corresponding clinical  data across Europe for better research,  personalised healthcare 
and health policy making. Its Genomic Data Infrastructure will establish a federated data 
infrastructure for genomic and clinical data across Europe. Since November 2023, the 1+MG 
initiative  is  in  its  second  (scale-up  and  sustainability)  phase,  implementing  the  technical 
infrastructure, initial infrastructure operation with research pilots in clinical use-cases, and 
connection of the infrastructure to EHDS.  By 2026, 15 countries will have an operational 
infrastructure in place. An integrated cross-country data infrastructure can be used to expand 
to collection of new biomarkers (e.g.  lifestyle/environment biomarkers beyond health, such 
as air quality, labour characteristics)  and more comprehensive datasets needed for precision 
medicine and longevity research.  

The Commission will take the following actions to foster the application of big data and AI 
in biotech and biomanufacturing companies:  

• 

In  the  context  of  the  GenAI4EU  initiative,  support  structured  exchanges  with 
stakeholders to accelerate the uptake of AI, and in particular Generative AI, in biotech 
and biomanufacturing and raise awareness with those stakeholders of facilitated access 
to  the  EuroHPC  supercomputers  for  AI  startups  and  the  science  and  innovation 
community.  

•  Support  the  development  of  advanced  Generative  AI  models  for  healthcare, 
leveraging data and tools such as multi-modal data and human health 'Virtual Human 
Twin'40  modelling,  existing  cross-border  data  infrastructures41  and  other  relevant  data 
sources, supported under the Horizon Europe and Digital Europe programmes and using 
Euro HPC supercomputing capacities.  

38 Commission launches AI innovation package: 
https://ec.europa.eu/commission/presscorner/detail/en/ip_24_383 
39 European '1+ Million Genomes' Initiative: https://digital-strategy.ec.europa.eu/en/policies/1-million-genomes  
40 European Virtual Human Twins Initiative: https://digital-strategy.ec.europa.eu/en/policies/virtual-human-twins 
41  Such  as  1+  Million  Genomes 
Initiative:  https://digital-
strategy.ec.europa.eu/en/policies/cancer-imaging 

Initiative;  European  Cancer 

Imaging 

10 

 
 
 
 
 
4.2. 

Stimulating market demand 

To  succeed  on  the  market,  bio-based  products  need  to  prove  their  sustainability  and  lower 
environmental impact when compared, for instance to petrochemical products. The Life Cycle 
Assessment  (LCA)  is  the  key  methodology  for  assessing  the  environmental  impacts  of 
products. While different LCA approaches have been developed, the Commission recommends 
the Product Environmental Footprint (PEF) approach which was last reviewed in 2021. In its 
next  periodical  revision  (in  2025-2026),    in  light  of  recent  scientific  developments,  the 
Commission will review the assessment of fossil-based and bio-based products to ensure 
equivalence  of  treatment  and  incorporate  methodologies  for  carbon  storage  in 
construction materials.  

To accelerate the substitution of fossil feedstock and to stimulate the demand and market uptake 
of bio-manufactured products, the Commission will conduct an in-depth impact assessment of 
the  feasibility  of  bio-based  content  requirements  in  specific  product  categories  and  in 
public  procurement.  Such  requirements  could  be  established,  in  line  with  the  EU’s 
international commitments, through delegated acts under the new Ecodesign for Sustainable 
Products  Regulation.  In  addition,  the  Commission  will  explore  how  bio-manufactured  non-
food products could profile themselves better through labelling of bio-based products. In the 
growing movement towards sustainability and eco-friendly choices, labelling and certification 
of  bio-manufactured  non-food  products  play  a  pivotal  role  in  building  consumer  trust. 
Voluntary labelling, based on objective sustainability criteria for bio-based feedstock, would 
allow  biotech  and  biomanufacturing  industries  to  reliably  inform  consumers  about  the  bio-
based content and sustainability of their products42. 

This  can  be  done  by  supporting  the  circular  bioeconomy  model  and  stimulating  the  use  of 
captured  CO2  as  a  new  carbon  resource,  as  recognised  in  the  Communication  towards  an 
ambitious  Industrial  Carbon  Management  for  the  EU43. The  Innovation  Fund,  for  example, 
supports projects capturing CO2 from the atmosphere or from mixed waste and turning it into 
a valuable resource. Furthermore, the Sustainable Carbon Cycles Communication has set out 
the goal of at least 20% of the carbon used in the chemical and plastic products to come from 
sustainable non-fossil sources by 2030. 

Providing  a  stable,  predictable,  and  balanced  IP  framework  for  protecting  and  valorising 
biotech innovation and facilitating access to it, especially to smaller actors across the value 
chain such as primary producers and SMEs, is crucial for ensuring a vibrant biotech ecosystem 
in the EU. The launch of the unitary patent (‘UP’) system in 2023, as well as the upgrade of 
the current EU regime for supplementary protection certificates (SPCs), proposed in the context 
of the Commission’s ‘patent package’ of 202344, will support ground-breaking innovation in 
biotechnology. Innovators across the EU, including in biotech, need to reap the full benefits of 
these initiatives, therefore the swift adoption of the ‘patent package’ is essential. 

42 Any future sustainability criteria for bio-based feedstock beyond energy should be consistent with the 
sustainability criteria for energy products included in the recast Renewable Energy Directive 2018/2001. 
43 Communication from the Commission to the European Parliament, the Council, the Economic and Social 
Committee and the Committee of the Regions, Towards an ambitious Industrial Carbon Management for the 
EU, COM(2024) 62 final. 
44 Intellectual property: harmonised EU patent rules: 
https://ec.europa.eu/commission/presscorner/detail/en/ip_23_2454 

11 

 
 
 
 
 
4.3. 

Streamlining regulatory pathways, including permitting and authorisation 

Further  action  at  EU  level  is  needed  to  improve  conditions  for  moving  from  “lab  to  fab” 
creating a level playing field for companies in the internal market for the commercialisation of 
mature biotech innovation.  

The Commission will assess how EU legislation and its implementation could be further 
streamlined to  reduce  any  fragmentation,  explore potential simplification, and shorten 
the time for biotech innovations to reach the market; as well as regulatory obstacles that 
arise at national or other governance levels which impede an effective single market. To 
this end, the Commission will launch a study that will map key current industrial bio-based 
value  chains,  analyse  the  regulatory  framework  and  the  impact  of  relevant  legislation,  and 
thereby lay the foundations for a possible EU Biotech Act45. 

In that context, targeted simplifications to the regulatory framework, focusing on specific areas 
such  as  harmonized  requirements  for  low-risk  biotechnologies  and  streamlining/simplifying 
approval processes for certain product categories, will be explored. Issues of implementation will 
also be considered, for instance, to ensure clarity about applicable regulatory frameworks in fast 
developing areas or products or technologies that do not easily fit an existing category. This would 
foster innovation in the EU by improving clarity and predictability for the industry and help to 
upscale relevant biomass production in the EU. In addition, the adoption of the new Regulation 
on plants produced by certain new genomic techniques is essential for the EU to benefit from 
the biotechnology potential in the agri-food area. 

The Commission will further promote the establishment of regulatory sandboxes that allow 
to test novel solutions in a controlled environment for a limited amount of time under the 
supervision of regulators as a way of bringing more of them quickly to the market. This has 
already  been  proposed  for  breakthrough  therapies  under  the  reform  of  the  pharmaceutical 
legislation. 

To respond to current needs and to help biotech companies bringing innovative products to the 
market, the  Commission  will  make  full  use  of  existing  structures  such  as  the  European 
Enterprise Network to work towards establishing an EU Biotech Hub, an operational tool 
for  biotech  companies  to  navigate  through  the  regulatory  framework  and  identify 
support to scale up. 

45 One possible question would be the possible generalisation to non-medical biotech of approaches under the 
Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health 
technology assessment, OJ L 458, 22.12.2021, p. 1. 

12 

 
 
 
 
 
European leadership for health biotech  

In  the  last  30  years,  biotech  transformed  the  pharmaceutical  industry  and  enabled  the 
development of breakthrough therapies that are lifesaving or that significantly improve the 
quality  of  life  of  patients  and  their  families. The  development  of  biotech  in  Europe  also 
continues to positively contribute to the region’s economic well-being. In 2018, healthcare 
biotech’s total direct GDP contribution was EUR 29.0 billion, and the sector contributed to 
over 175,000 direct jobs in the EU46. However, the existing regulatory framework governing 
the  development  and  use  of  biotech-based  medicinal  products  (“biopharmaceuticals”)  is 
complex  and  can  include  multiple  legislations  covering  medicinal  products,  advanced 
therapies, medical devices and in vitro diagnostics, substances of human origin, genetically 
modified organisms, and clinical trials, both at the national and EU level.   

Reform of the pharmaceutical legislation 

The Commission proposed a revision of the EU pharmaceutical legislation47 that includes 
the  necessary  elements  to  ensure  that  the  EU  regulatory  system  is  flexible  enough  to 
accommodate new innovative biotechnological medicines that are safe and effective. At the 
same time, the reform aims to create a regulatory environment in which the EU can continue 
to innovate and be a global leader in pharmaceutical biotechnology, including in Advanced 
Therapy Medicinal Products (ATMPs)48 by proposing new provisions, such as regulatory 
sandboxes;  providing  clarifications  on  the  interface  and  interaction  with  other 
legislative frameworks to help developers navigate the regulatory requirements, especially 
for  combination  products;  exploring  new  possibilities  for  scaling  up  or  scaling  out  of 
biomanufacturing  capacities;  proposing  clearer  rules  on  the  use  of  the  hospital 
exemption49 for ATMPs. In parallel, a study is currently taking stock of the application of 
the hospital exemption under the ATMP regulatory framework and the practical experiences 
across  the  EU  with  developing  and  making  available  innovative  biotech  products  in  the 
hospital setting.  

Swift  adoption  of  the  proposals  for  the  reform  of  the  pharmaceutical  legislation  is 
therefore key to facilitating health biotechnology in Europe.  

Adding  to  the  support  of  biomanufacturing  in  Europe,  the  Commission  is  supporting  the 
development  of  innovative  manufacturing  technologies  through  the  EU4Health  Work 
Programme 2024. In addition, the Commission will launch a study to identify how best to 
leverage  existing  assets  and  infrastructures  for  health  biotechnology,  including  those 

46 WiFOR Institute (2020), Measuring the Economic Footprint of Biotechnology in Europe: 
https://www.wifor.com/uploads/2021/03/201215_WifOR_EuropaBIO_Economic_Impact_Biotech_FINAL.pdf 
47https://health.ec.europa.eu/medicinal-products/pharmaceutical-strategy-europe/reform-eu-pharmaceutical-
legislation_en 
48  Regulation  (EC)  No  1394/2007  of  the  European  Parliament  and  of  the  Council  of  13  November  2007  on 
advanced  therapy  medicinal  products  and  amending  Directive  2001/83/EC  and  Regulation  (EC)  No 
726/2004 provides the overall framework on ATMPs.  
49 The hospital exemption allows for the use of an ATMP without a central marketing authorization. The ATMP 
should  be  prepared  on  a  non-routine  basis  according  to  specific  quality  standards,  and  used  within  the  same 
Member State in a hospital under the exclusive professional responsibility of a medical practitioner, in order to 
comply with an individual medical prescription for a custom-made product for an individual patient. 

13 

 
 
 
 
 
developed under Joint Undertakings, with the aim to boost biomanufacturing capacity within 
the EU.  

Collaboration on national responsibilities 

Before  any  medicine  can  be  authorised,  evidence  needs  to  be  generated  through  clinical 
trials.  Clinical trials on biopharmaceuticals and ATMPs are still hindered by differences in 
national  requirements and additional national  regulations.   The  Clinical Trial  Regulation 
(CTR)50 entered in application in 2022; with transition to the new framework still ongoing, 
it is yet to realise its full potential in terms of harmonising and facilitating the conduct of 
clinical trials in the EU. In close partnership with Member States, the European Medicines 
Agency and relevant stakeholders, the Commission is working on the further harmonisation, 
improvement and streamlining of the clinical trial processes in the EU under the Accelerating 
Clinical Trials in Europe (ACT EU) initiative51. By the end of 2024, the Commission will 
launch  a  study  on  the  implementation  of  the  CTR  in  order  to  assess  its  impact  on 
European  clinical  research  and  to  prepare  the  required  report  on  the  CTR’s 
functioning. The Commission will assess whether a revision of the legislation is necessary 
and consider any further necessary steps, such as clinical trial hubs to help overcome cross-
border fragmentation and build capacity.  

Based on the objective of affordability set in the EU pharmaceuticals strategy and developed  
in  the  group  of  National  Competent Authorities  on  Pricing  &  Reimbursement  and  public 
healthcare  payers,  the  Commission  will  further  encourage  voluntary  collaboration  on 
effectiveneess analysis,  pricing and reimbursement of medicines. This may include biotech 
products and biosimilars with a view to ensure that these products address the needs of the 
health systems. 

4.4.  Fostering public and private investments  

The  EU  has  a  broad  range  of  financing  instruments  to  support  biotechnology  and 
biomanufacturing  such  as  Horizon  Europe,  including  the  Circular  Bio-based  Europe  Joint 
Undertaking  (CBE  JU)  and  the  Innovative  Health  Initiative  Joint  Undertaking  (IHI  JU); 
EU4Health; the Innovation Fund; and now also the Strategic Technologies for Europe Platform 
(STEP). Cohesion Policy alone has funded about 3 700 close-to-market biotech research and 
innovation projects in various regions since 201452. In terms of availability of information on 
funding opportunities, the Sovereignty Portal established under the STEP Regulation, will 
include  information  on  the  ongoing  and  upcoming  calls  for  proposals  and  calls  for  tender 
available under 11 EU funding programmes including for biotech. 

To develop and scale up innovations with the potential to create new markets, the Commission 
will advocate the inclusion of specific challenges on biotech and biomanufacturing in the 
co-creation  and  comitology  process  for  the  European  Innovation  Council  (EIC) 
accelerator Work Programme 2025. Further targeted support for breakthrough technologies 

50 Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical 
trials on medicinal products for human use, and repealing Directive 2001/20/EC 2 
51 Actions include methodology guidance, improving data analytics and the creation of a Union level group of 
ethics committees enabling cooperation to work towards alignment of national requirements. 
52 Projects co-funded by the EU (europa.eu): https://kohesio.ec.europa.eu/en/projects  

14 

 
 
 
 
 
under  the  European  Innovation  Council,  including  through  equity  investments,  will  also  be 
explored. As and when climate-relevant biotech and biomanufacturing innovation approaches 
high  technology  readiness  levels  at  sufficient  scale  and  variety,  the  Commission  will  also 
examine whether and how the Innovation Fund can support its deployment and take-up on the 
market, notably by using the Fund as a service to leverage national funds. 

An  InvestEU  blending  operation,  HERA  Invest,  supported  by  the  EU4Health  programme, 
supports  research  and  development  (R&D)  related  to  the  most  pressing  cross-border  health 
threats.  HERA  Invest  provides  a  financing  mechanism  to  promote  advanced  research  and 
development of medical  countermeasures and related technologies. It fills a vital gap in the 
field with EUR 100 million to support innovative SMEs with loans in the early and late phases 
of clinical trials. 

The low number of specialist investors in the EU compared with other regions of the world is 
often  perceived  as  a  hurdle  for  the  development  and  scale-up  of  European  biotech.  In  that 
regard, the Commission will explore possibilities to support the EIB Group in expanding 
the  European Tech  Champions  Initiative,  leveraging  additional  Member  State  funds  and 
attracting  new  investment  players  to  provide  competitive  high-risk  public  investment  in 
promising health biotech, focusing on the late-stage growth funding challenge and on strategic 
areas such as health security. 

In line with the recent Eurogroup statement on Capital Markets Union, the Commission will 
launch  a  study  by  the  end  of  2024  to  identify  barriers  and  ways  to  support  the 
consolidation  of  investment  funds,  stock  exchanges  and  post-trading  infrastructure  in 
order to enable the development of the necessary scale, enhance the knowledge base, create 
deeper pools of liquidity and help lower the cost of financing for companies. Depending on the 
barriers and solutions identified, this could underpin action at Union level and/or initiatives by 
(subsets of) Member States or market players. 

The forthcoming study of the European Investment Bank (EIB) on bioeconomy will quantify 
funding gaps, assess market needs and barriers and identify emerging innovative projects. On 
the  basis  of  the  study,  the  Commission  will  analyse  whether  improvements  to  the  existing 
instruments can be made to better provide financial support to solutions based on biotechnology 
and biomanufacturing53. 

Due to the long innovation timelines, tax credits, which are compliant with State aid rules and 
coherent  with  other  EU  initiatives  in  the  field  of  direct  taxation,  can  incentivise  private 
investment in biotechnology. This measure has already been adopted by some Member States; 
for example, in France a company can get a 30% tax credit for its R&I investments up to EUR 
100 million and 5% for investments above EUR 100 million. The Commission will explore the 
effectiveness of introducing general or targeted tax credits for R&I activities.   

At  international  level,  external  financing  instruments  such  as  the  European  Fund  for 
Sustainable Development Plus (EFSD+) Open Architecture offer guarantee schemes to de-risk 
investments of European companies in Africa and Latin-America and the Caribbean.  

53 Under State aid rules, the Risk Finance Guidelines, the General Block Exemption Regulation (Article 21 on 
risk  finance  aid)  and  the  research  and  development  and  innovation  (R&D&I)  framework  provide  ample 
opportunities for financial support to biotechnology and biomanufacturing. 

15 

 
 
 
 
 
4.5. 

Strengthening Biotech-related skills  

The 'Pact for Skills', under the EU Skills Agenda, addresses the most pressing industry skills 
gaps with active involvement of industry and key actors in education and training. Large-Scale 
and  Regional  Skills  Partnerships  can  play  a  significant  role  in  providing  upskilling  and 
reskilling  opportunities  on  biotech  and  biomanufacturing  related  topics  for  the  working-age 
population,  especially  in  the  agri-food  health  and  textile  sectors,  where  Large-Scale  Skills 
Partnerships  are  already  in  place54.  A  specific  large-scale  partnership  for  the  biotech  and 
biomanufacturing could also be explored, taking into account the particular skills challenges of 
an area in very rapid  evolution. Such partnerships can be co-financed through the Blueprint 
Alliances activity of the Erasmus+ programme.  

Moreover, the expanding number of dynamic European Universities alliances  and Erasmus+ 
partnerships  and  alliances  for  innovation  can  also  strengthen  the  development  of  high-level 
skills and competences required by the biotech sector. 

Biotech  industrial  clusters  and  Regional  Innovation  Valleys  can,  thanks  to  the  close 
collaboration centres, allow industry to advise universities on the design of the curricula and 
content for biotech related higher education courses, so that they can better adjust to the needs 
of EU biotechnology and biomanufacturing companies. 

The STEP is a new budgetary tool with the objective to support the development of critical 
technologies and to address shortages of labour and skills in the three STEP sectors, including 
in  the  biotech  sector.  In  the  context  of  cross-industry  labour  and  skills  shortages,  skills 
development is key and can be done through various education and training projects with the 
support of different stakeholders, especially social partners55. 

To grow and retain talent within the EU, attracting skilled third country nationals to work in 
the biotech sector can also help address skills gaps. Once operational, the EU Talent Pool will 
provide the first EU-wide platform to help match employers with skilled third country nationals 
needed on the EU labour market.56    

In addition, the New European Bauhaus Academy will support upskilling linked to circularity 
and  biotech  and  biomanufacturing  in  the  built  environment.  The  Commission  will  explore 
expanding the concept to other sectors that have a direct impact on the life of the citizens such 
as textiles. 

54 https://pact-for-skills.ec.europa.eu/about/industrial-ecosystems-and-partnerships/health_en, https://pact-for-
skills.ec.europa.eu/about/industrial-ecosystems-and-partnerships/agri-food_en 
55 Communication from the Commission to the European Parliament, the Council, the European Economic and 
Social  Committee and The Committee of the  Regions: Labour and skills shortages in the EU: an action plan, 
COM(2024) 131 final. 
56  Proposal  for  a  Regulation  of  the  European  Parliament  and  of  the  Council  establishing  an  EU Talent  Pool, 
COM(2023) 716 final. 

16 

 
 
 
 
 
 
Promoting circularity, sustainable sourcing of materials and depollution – biotech for 
green transition  

Production of renewable bio-based materials and energy carriers from waste and biomass in 
an innovative, sustainable and circular way with the help of biotechnology can significantly 
contribute  to  the  climate  neutrality  target  by  2050,  create  green  jobs  and  sustainable 
economic growth in regions across Europe.  

Industrial  biotechnology  that  uses  microorganisms  or  their  biological  components  will 
enable  new  processes  that  use  less  resources  and  energy  and  produce  less  waste  and 
polluting emissions. Enzymatic or other biotechnology-based processes are also crucial for 
novel recycling technologies.   

Environmental  biotechnology  can  more  effectively  depollute  waste  streams,  remediate 
contaminated  soils.  Environmental  biotechnology  may  also  help  to  reduce  microplastics 
pollution. 

Other  types  of  biotechnology,  combined  with  the  application  of  our  knowledge  on 
microbiomes57, can contribute to the fight against climate change. For example, bio-based 
systems  can  improve  the  detection  and  monitoring  of  chemical  pollutants.  Such  systems 
could also lead to the development of alternative energy sources by engineering marine algae 
or  bio-hybrid  artificial  photosynthesis  systems  and  by  providing  an  innovative  carbon-
capture solution while at the same time caring for biodiversity. The reduction of emissions 
can  be  further  strengthened  with  the  conversion  of  biomass  and  waste  feedstocks  into 
sustainable fuels.  

To  accelerate  the  application  of  biotechnology  for  climate  and  sustainability,  the 
Commission will explore how to accelerate market approval of sustainable, low-risk bio-
pesticides and bio-based fertilisers. Some of the living labs under the EU Mission “A Soil 
Deal for Europe” could be testbeds for such substances and their impact on soils and the 
results obtained could feed further actions58. 

4.6.  Developing standards 

Standards  are  of  utmost  importance  for  biotechnology,  biomanufacturing  and  the  bio-based 
industries in general. Even though they are most often voluntary, they facilitate market access 
and innovation by influencing industry practices, guiding policies and by ensuring products or 
processes  meet  recognised  benchmarks  for  quality,  safety,  and  sustainability.  It  is  therefore 
essential to further update and develop missing and outdated standards. The Commission will 
continue  to  encourage  the  elaboration  and  updating  of  European  standards  for 
biotechnology  and  biomanufacturing,  with  support  of  the  European  standardisation 
organisations and in compliance with EU competition rules. In this regard, the Commission in 
its Annual Union Work Programme for European Standardisation for 2024 has  indicated its 

57 Microbiomes are defined as complex microbial communities from various environments and ecosystems such 
as soils, marine, gut etc.  
58  EU  Mission:  A  Soil  Deal  for  Europe:  https://research-and-innovation.ec.europa.eu/funding/funding-
opportunities/funding-programmes-and-open-calls/horizon-europe/eu-missions-horizon-europe/soil-deal-
europe_en 

17 

 
 
 
 
 
intention  to  request  the  European  standardisation  organisations  to  develop  and  revise 
standardisation deliverables on biomaterials, bio-based, and wood-derived products. 

4.7.  Collaboration and synergies 

As a way forward, the Commission will encourage the deployment of technologies related to 
biotechnological  processes  and  biomanufacturing  across  EU  regions  through  Regional 
Innovation Valleys (RIVs)59. These RIVs could become sectoral centres of biotech excellence 
in the EU on specific issues, such as biotech health security and biotech for food systems. The 
Commission  would  support  authorities  in  charge  of  public  national,  regional,  or  local 
innovation  policies  and  programmes  to  implement  joint  activities  towards  innovation, 
development  and  deployment  in  the  area  of  biotech  and  biomanufacturing.  This  would  be 
accompanied by the participation of the private sector and research and innovation actors. 

Moreover, the Commission has in place important fora for collaboration such as the Enterprise 
Europe Network (EEN) and the European Cluster Collaboration Platform (ECCP), which can 
complement these efforts with advisory and matchmaking activities. The ECCP has at least 159 
cluster organisations active in biotech which can be involved in these activities60.  

Additionally,  bio-based  value  chains  would  benefit  from  a  deeper  integration  of  primary 
producers (e.g., farmers and foresters) as they are at the beginning of most bio-based value 
chains. At present, primary producers (farmers and forest managers) often only play the role of 
biomass suppliers, and do not always get sufficient benefits to guarantee their interest in long-
term business relations. 

4.8.  Fostering engagement and international cooperation 

International  cooperation  can  leverage  the  EU’s  strengths  in  biotech  through  knowledge 
sharing  and  industrial  collaboration.  The  Commission  will  explore  the  possibility  of 
launching 
international  biotech  and  biomanufacturing  partnerships  with  key 
international partners, such as the US, India, Japan, and South Korea, to collaborate on 
research  and  technology  transfer,  and  to  explore  possibilities  for  a  strategic  cooperation  on 
regulatory and market access-related topics. Such cooperation could also address health and 
global food security aspects. Through the Global Gateway and in line with its Global Health 
Strategy, the Commission will advance existing partnerships with Africa, Latin America and 
the  Caribbean  on  manufacturing  health  products  aiming  to  diversify  global  supply  chains, 
overcome shortages of critical health products and reduce the global burden of disease. More 
generally,  the  Commission  will  examine  the  level  of  trade  barriers  to  biotech  and 
biomanufactured products and the potential to lower them through its trade agreements. 

Furthermore, the EU and the US will step up the work in the EU-US Trade and Technology 
Council  and  under  the  Science  and  Technology  agreement  to  explore  the  opportunities  of 
innovative  and  sustainable biotechnology  and  biomanufacturing  solutions to  address  global 
challenges,  such  as  climate  change  mitigation  and  adaptation,  protecting  biodiversity, 

59 One of the five flagship of the European Commission Communication “New European Innovation Agenda” 
(NEIA), COM(2022) 332 final 
60  These  cluster  organisations  are  mapped  on 
https://reporting.clustercollaboration.eu/industry . 

the  European  Cluster  Collaboration  Platform: 

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improving  health  outcomes,  and  to  partner  up  in  addressing  economic  security  risks  on 
biotechnology.   

The EU will continue working with its partners in the global UN policy frameworks such as 
the  World  Health  Organisation,  the  Convention  on  Biological  Diversity  and  its  Cartagena 
Protocol on Biosafety, as well as the Kunming-Montreal Global Biodiversity Framework to 
ensure safe and sustainable use of biotechnology globally.  

5. Conclusions 

The  extraordinary  advances  in  life  sciences,  supported  by  digitalisation  and  AI,  and  the 
potential  of  solutions  based  on  biology  for  solving  societal  issues  make  biotechnology  and 
biomanufacturing one of the most promising technological areas of this century. They can help 
the EU to modernise its primary sector and industry, boost circularity and be more competitive 
and resilient, provide better healthcare to our citizens and succeed in its green transition.  

A more coordinated approach for biotechnology and biomanufacturing policies will help realise 
their  full  potential.  Strengthening  our  biotechnology  and  biomanufacturing  competitiveness 
requires measures in the regulatory, industrial, economic and social dimensions. This includes 
significant investment in infrastructure and know-how and ensuring that it can reap the benefits 
of the EU single market.  

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The Commission will continue to follow-up and strengthen the EU level framework along the 
main actions: 

•  Action 1: Simplified regulatory framework and faster access to market: to prepare for 
this the Commission will launch a study analysing how the legislation that applies to 
biotech  and  biomanufacturing  could  be  further  streamlined  across  EU  policies, 
exploring targeted  simplifications  to  the  regulatory  framework,  including  for  faster 
approval and bringing to the market. The study will be finalised by mid-2025 and could 
lay the foundations for a possible EU Biotech Act.  

•  Action  2:  Better  support  for  scale-up  and  ease  of  navigating  regulations:  the 
Commission will work towards establishing an EU Biotech Hub, an operational tool for 
biotech companies to navigate through the regulatory framework and identify support 
to scale up, by end of 2024.  

•  Action  3:  Use  of  AI  and  generative  AI:  the  Commission  will  support  structured 
exchanges with stakeholders to accelerate the uptake of AI, and in particular Generative 
AI, in biotech and biomanufacturing (in the context of GenAI4EU). The Commission 
will also raise awareness of facilitated access to the EuroHPC supercomputers for AI 
startups and the science and innovation community, in the course of 2024.  

•  Action  4:  Encourage  more  private  investments:  in  order  to  remove  obstacles  to 
investments,  the  Commission  will  complete  a  study  to  identify  barriers  and  ways  to 
support  the  consolidation  of  investment  funds,  stock  exchanges  and  post-trading 
infrastructure, by mid-2025.  

•  Action 5: More public investments to encourage private investments in the sector: the 
Commission will advocate the inclusion of biotech and biomanufacturing as part of the 
European Innovation Council (EIC) accelerator Work Programme 2025 to develop and 
scale-up innovations.  

•  Action  6:  Enable  fair  comparison  with  fossil-based  products:  the  Commission  will 
further  develop  methodologies  to  ensure  a  fair  comparison  between  fossil-based  and 
bio-based  products,  in  2025. This  will  include  reviewing  the  Product  Environmental 
Footprint (PEF) to assess the environmental impact of products.  

•  Action 7: Bigger market for biotechnology and biomanufacturing: the Commission will 
deepen  cooperation  with  international  partners,  such  as  the  US,  on  biotechnology 
research, under the Science and Technology Agreements, by end 2024.  

•  Action 8: The Commission will review the EU Bioeconomy Strategy by end 2025. The 
review  will  take  into  account  the  current  societal,  demographic  and  environmental 
challenges,  reinforcing  the  bioeconomy’s  industrial  dimension  and  its  links  to 
biotechnology and biomanufacturing to contribute to a stronger EU economy. 

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