Regional biotech ecosystems as engines of Europe’s health sovereignty: from clusters to global competitiveness
By Montserrat Daban Marín, PhD, Strategy and Global Partnerships Director, Biocat, Past President of CEBR
As health innovation becomes a strategic arena shaped by geopolitics, Europe’s quest for health sovereignty is unfolding in a far more competitive global context. The United States increasingly consider biotechnology as a national security matter, while China’s bioeconomy strategy is rapidly expanding capabilities across research, clinical trials, manufacturing and industrial policy. In this increasingly competitive environment, Europe’s long-standing fragmentation across research, clinical development and industrial scale-up is becoming harder to sustain. Encouragingly, Europe is beginning to respond more coherently through an emerging life sciences policy agenda, including initiatives such as the proposed Biotech Act, aimed at strengthening translation, industrial capacity and resilience.1 2 3 4
Europe’s ambition for health sovereignty will rise or fall with the strength of its innovation ecosystems. Scientific excellence is undisputed, but translating discovery into scalable products, industrial capacity and patient access remains a structural weakness.
Regional innovation ecosystems must therefore become strategic assets, environments capable of connecting research, clinical development, manufacturing, regulation and investment in a coordinated way5. Europe has historically lost time, industrial capacity and value at the scale‑up phase — a loss that is not abstract, but visible in fragile supply chains, uneven patient access, repeated valleys of death and the relocation of companies seeking global scale.6 7
The structural challenges highlighted in competitiveness discussions, combined with a shifting global order, require new strategies to secure Europe’s leadership in biopharma as a top-tier geopolitical and economic industry. In practice, Europe has begun to change the narrative. The growing debate on European competitiveness — visible across consultations, parliamentary discussions and industry forums — reflects a broader consensus: scientific leadership alone is insufficient without industrial capacity and system-level delivery. Innovation ecosystems are increasingly recognised as the execution architecture through which the EU’s emerging policy compass can be deployed in practice.
This shift is reflected in the Commission’s current policy agenda. The “Life Sciences Strategy” places biotech at the heart of competitiveness.
The proposed Biotech Act targets simplification, scale-up and industrial deployment. The Critical Medicines Act focuses on resilience, availability and strategic production. The Pharmaceutical Package seeks to rebalance access, affordability and innovation attractiveness.
Funding instruments under Horizon Europe, the EIC and the future Multiannual Financial Framework aim to close the scale-up gap. Single Market tools, including the proposed “28th regime” and a clearer “Made in Europe” logic, aim to reduce fragmentation for innovative companies while preserving Europe’s standards in patient protection, public oversight and social cohesion.8 9
This is not a single policy intervention. It is an ecosystem of policies. To succeed, it must support the full biomedical innovation continuum, from fundamental science and translational research to clinical validation, manufacturing and market deployment. Competitiveness depends not only on industrial scale-up, but also on strong R&I institutions, innovative hospitals and long-term talent retention. With initiatives such as the proposed 28th regime, Europe is consolidating its own model for R&I‑intensive sectors: regulated, trusted, and offering greater predictability through strong public‑private coordination.
Innovation ecosystems matter because Europe’s competitiveness is often decided at the interfaces between research, hospitals, manufacturing, regulation and investment. When these interfaces are fragmented, delays and inefficiencies accumulate. When they are coordinated, ecosystems become platforms for execution, resilience and industrial capacity.
Recent EU‑level work on cluster and innovation ecosystem policy makes this transition explicit, signaling a move from cluster‑based coordination towards stronger regional ecosystem strategies; from project‑based support towards structured feedback loops to surface Single Market barriers; and towards shared infrastructures, earlier mobilisation of private capital, and a more strategic use of regulatory sandboxes.10 11 This marks a qualitative shift: from supporting innovation to organising execution at global scale.
Advanced therapies and complex biomanufacturing illustrate why this shift matters. They act as a stress test for Europe’s clinical research system, while the underlying constraints affect innovative clinical trials more broadly. Europe’s weakness in this field has not been science or clinical expertise, but the industrialisation and clinical translation wall. Limited access to pilot capacity, manufacturing bottlenecks, uneven site readiness and late regulatory engagement continue to slow down early clinical development.12
Robust and resilient ecosystems can change this trajectory. They provide shared validation environments where processes and data can be reused, enable earlier and more structured interaction with regulators, and reduce risk before major investment decisions are taken. These are precisely the conditions Europe is seeking to strengthen.13
Beyond ATMPs, Europe must also become more attractive for early‑stage clinical development. Europe already hosts some of the world’s leading clinical research regions and hospitals, with strong scientific capabilities, experienced investigators and access to patients.
The Clinical Trials Regulation was an important step towards harmonisation, but implementation still varies across Member States. This matters most in early‑phase and highly innovative trials, where approval timelines, contracting and site activation conditions shape location decisions. More consistent and better coordinated procedures, specialised early‑phase units, and stronger integration between hospitals, research centres and manufacturing infrastructures are therefore essential to reinforce Europe’s position as a leading destination for innovative clinical research.
With instruments now defined and being deployed, health sovereignty will be built through regional ecosystems capable of transforming European science into accessible innovation and resilient industrial capacity — where delivery, scale and impact are decided.
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1 https://www.lazard.com/research-insights/the-geopolitics-of-biotech/
2 https://www.bcg.com/publications/2026/reimagining-business-models-biopharma-trends
4 https://www.biotech.senate.gov/final-report/chapters/?utm_source=chatgpt.com
5 https://single-market-economy.ec.europa.eu/publications/industrial-accelerator-act_en
6 https://www.bmj.com/content/390/bmj.r1965
8 https://ec.europa.eu/commission/presscorner/detail/da/ip_25_3077
9 https://commission.europa.eu/eu-inc-new-harmonised-corporate-legal-regime_en
11 https://data.europa.eu/doi/10.2777/9535645
12 https://pubmed.ncbi.nlm.nih.gov/35186986/
13 Daban ,M 2026
