Biotechnology at scale: Europe’s next competitiveness test

Key findings

• Biotechnology is increasingly important to Europe’s healthcare, food security, industrial decarbonization and strategic autonomy, generating €75.16 billion in gross value added in 2022. The EU retains major scientific strengths, but struggles to translate research into companies, manufacturing capacity, commercial value and broad societal benefits. Three factors will determine whether Europe can close this innovation translation gap.
• First, regulatory simplification will need to extend across the innovation pathway. Biotechnology increasingly cuts across rules governing medicines, clinical trials, data, agriculture, intellectual property and trade. The European Biotech Act seeks to improve coordination, but its impact will depend on whether implementation reduces fragmentation across Member States rather than adding new structures to an already complex regulatory landscape.
• Second, scientific strength must be matched by the capacity to scale. Europe remains comparatively weak in late-stage financing, attracting only 7 percent of global health-biotech venture capital, compared with 14 percent for China and 63 percent for the United States. Specialized manufacturing, testing infrastructure, high-quality data and AI are increasingly critical to commercialization. BioTechEU and the European Competitiveness Fund could strengthen these conditions, but Europe will capture limited value from its research if companies continue to finance, manufacture and scale elsewhere.
• Third, successful innovation depends on access as well as commercialization. Advanced therapies demonstrate that EU authorization does not guarantee patient access: of 32 ATMPs authorized since 2009, seven have been withdrawn and two were not renewed. Manufacturing, reimbursement and treatment capacity remain important constraints. NGTs present a parallel challenge: regulatory predictability alone will not ensure uptake without workable intellectual property and licensing conditions, financing, farmer and supply-chain acceptance, and access for smaller actors. How widely biotechnology’s benefits are distributed will also shape public legitimacy.
• These factors point to three possible trajectories toward 2035. Coordinated regulation, investment and industrial capacity could reinforce Europe’s scientific strengths and support biotechnology leadership. Partial progress could preserve research excellence without closing the scale-up gap. Weaker investment conditions and policy coherence could instead accelerate the movement of capital, companies, talent and production elsewhere.
• Europe’s biotechnology challenge is therefore not primarily one of scientific capability, but of translation: connecting research to regulation, capital, industrial scale and access. The European Biotech Act will be an early test of whether Europe can build those connections strongly enough to retain the economic and societal value of the innovation it creates.