A report published on 1 July by the European Parliament takes stock of the European biotechnology sector and analyses the main issues surrounding the future European Biotech Act I regulation. The draft of the regulation was presented by the European Commission in December 2025 and the European Parliament’s Committee on Industry, Research and Energy (ITRE) and Committee on Public Health (SANT) have begun examining the relevant draft report (see EUROPE 13899/17), while Member States have already held an initial policy debate (see EUROPE 13889/7).
The study, which was produced for the ITRE Committee, examines the regulatory framework, the European market, financing conditions and competitiveness issues linked to the development of health biotechnologies.
Regarding the sector’s economic significance, the analysis highlights that, according to the data presented, biotechnology accounted for an economic footprint of €75.1 billion in the European Union in 2022 and nearly one million jobs. European companies’ investments in health research and development, meanwhile, reached €46 billion in 2024, making it the second-largest sector for private investment in research and development in the EU.
Clinical trials. The study also reports that the European Economic Area’s share of commercial clinical trials fell from 22% in 2013 to 12% in 2023, while China’s rose from 5% to 18% over the same period.
The analysis also indicates that access to financing remains one of the main factors likely to affect the sector’s development. In that respect, it notes that the funding gap with the United States, particularly for investments at an advanced stage of research and development, is encouraging young European companies to launch on the stock market across the Atlantic.
According to the document, financing difficulties weigh more heavily on the sector’s competitiveness than regulatory obstacles.
These findings echo the discussions held on 29 June within the European Parliament’s ITRE and SANT (public health) Committees, during which MEPs notably debated clinical trials, financing for biotechnology companies and simplification of the procedures provided for in the future regulation. Amendments to the draft report could be tabled until 7 July.
The study: https://aeur.eu/f/mr4 (Original version in French by Nithya Paquiry)