Biotechnology at scale: Europe’s next competitiveness test

Biotechnology's growing significance to Europe's healthcare, food security, industrial decarbonization, and strategic autonomy has generated €75.16 billion in gross value added by 2022. The EU demonstrates strong scientific capabilities, yet faces challenges in translating research into successful companies, manufacturing, commercial value, and societal benefits. Three key factors will determine Europe's ability to bridge this innovation translation gap.

Firstly, streamlining regulations across various aspects of biotechnology, including medicines, clinical trials, data, agriculture, intellectual property, and trade, will be crucial. The European Biotech Act aims to enhance coordination, but its effectiveness relies on whether implementation reduces fragmentation among Member States rather than adding new structures to an already complex regulatory landscape.

Secondly, while Europe possesses scientific prowess, it lags behind in late-stage financing, accounting for only 7 percent of global health-biotech venture capital, compared to 14 percent for China and 63 percent for the United States. To address this, specialized manufacturing, testing infrastructure, high-quality data, and AI are becoming increasingly vital to biotechnology commercialization.

BioTechEU and the European Competitiveness Fund may bolster these conditions, but Europe risks missing out on significant value from its research if companies continue to finance, manufacture, and scale operations elsewhere.

Thirdly, successful innovation hinges on access as well as commercialization. Advanced therapies have shown that EU authorization does not necessarily guarantee patient access; out of 32 authorized advanced therapies since 2009, seven have been withdrawn, and two were not renewed. Moreover, manufacturing, reimbursement, and treatment capacity remain significant constraints.

Non-governmental trials present a different challenge: regulatory predictability alone will not secure uptake without workable intellectual property, licensing conditions, financing, farmer and supply-chain acceptance, and access for smaller actors.

The distribution of biotechnology's benefits will also influence public legitimacy. Three possible trajectories emerge by 2035. Coordinated regulation, investment, and industrial capacity could bolster Europe's scientific strengths and foster biotechnology leadership. Partial progress may maintain research excellence without closing the scale-up gap.

Conversely, weaker investment conditions and policy coherence could accelerate capital, company, talent, and production movement to other regions. Ultimately, Europe's biotechnology challenge lies not in scientific capability but in translation: connecting research to regulation, capital, industrial scale, and access. The European Biotech Act will serve as an early test of whether Europe can effectively build these connections to retain the economic and societal value of the innovations it generates.