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Biotechnology

Biotechnology is pushing forward science and revolutionising industry. It is crucial for advancing public health and spurring economic growth.

The European Commission aims to position the EU as a leader in biotechnology by advancing R&D, fostering an ecosystem where biotech innovation can thrive and boosting the growth potential of biotech companies in the EU.

Of the almost 40 billion euros that the biotechnology sector adds to the EU’s economy, more than 80% comes from health biotechnology.

Health biotechnology in the EU – figures

  • Over the last decade, the sector grew more than twice as fast as the overall EU economy.
  • Since 2012, almost 35% of centrally authorised medicines were either manufactured using biotechnology methods or classified as Advanced Therapeutic Medicinal Products (ATMPs).
  • In 2024, 95 billion euros was spent on biological medicines sales in the EU, equal to 41% of total pharmaceutical spending.
  • 21% of top biotechnology scientific publications come from the EU, comparable to US and China.

And yet…

  • The EU is lagging behind in venture-capital investment in health biotech, with a 7% global share versus 63% precent for the US and 14% for China.
  • Many EU biotechnology start-ups choose to grow elsewhere, with 66 out of 67 EU biotechnology firms choosing to list on non-EU stock exchanges from 2019-2025.
  • The global share of commercial clinical trials in the European Economic Area has halved, from 22% in 2013 to 12% in 2023. During the same period, China’s share tripled from 5% to 18%.
  • China and the US approve clinical trial applications within 60 days, while EU multinational trials average 113 days — delaying time-to-market, patient access and returns on investment.

Factsheet - Revolutionising clinical trials 

Clinical trials

Draghi report – future of EU competitiveness (2024)

2025 – Proposal for a Biotech Act

Commission President von der Leyen announced the Biotech Act in the political priorities for 2024-2029. The act:

  • forms an integral part of the EU’s efforts to close the so-called ‘innovation gap’
  • proposes a comprehensive framework to increase competitiveness by creating the necessary conditions for the health biotechnology sector to thrive
  • strengthens and streamlines the regulatory environment in areas such as clinical trials and cell and gene therapies
  • will be central to strengthening the sector in Europe and ensuring it remains at the forefront of global innovation.

Key objectives

Include:

  • boosting and connecting the industrial ecosystem, manufacturing and R&D
  • easing access to funding, especially for start-ups and SMEs
  • facilitating the use of AI, data and digital solutions
  • decreasing time-to-market by simplifying and future-proofing the regulatory environment
  • introducing biosecurity safeguards to prevent misuse of biotechnology and set a level playing field.

These objectives are all interconnected. A more-competitive biotechnology sector will offer patients timely and broader access to treatments and products, improved healthcare and a better quality of life.

In 2026, the Commission will address the wider biotech ecosystem beyond health, to ensure a competitive internal market for all areas of biotechnology.

Public consultation

To support preparation of the Biotech Act, the Commission consulted stakeholders and the general public: