Of the 33 advanced therapy medicinal products (ATMPs) that received positive opinions from the European Medicines Agency between 2009 and May 2026 nine subsequently had their marketing authorisations withdrawn or not renewed. These figures, published by EMA in June 20261, reflect different circumstances and should not be interpreted as evidence of a single underlying problem. They nevertheless highlight the challenges of turning scientific advances into viable therapies that can reach patients and remain available over time.
Regulatory approval is essential, but manufacturing capacity, financing, reimbursement and commercial viability also determine what happens next. Advanced therapies make these challenges particularly visible. Their development often requires highly specialised knowledge, complex manufacturing processes and substantial investment, sometimes for relatively small patient populations. Their progress depends on decisions taken by researchers, hospitals, technology transfer offices, investors, industry and healthcare systems, frequently working under different priorities and constraints. This raises a broader question: how effectively can Europe's innovation systems support the transition from scientific discovery to industrial development and patient access?
Europe has considerable strengths on which to build, from excellent research institutions and clinical centres to pharmaceutical companies and specialised infrastructures. However, these capabilities are spread across organisations and regions, and access to them remains uneven. The European Commission has identified fragmented governance, limited coordination and gaps in scale-up financing among the barriers affecting Europe's biotechnology sector. An academic team may have strong clinical expertise but limited access to manufacturing facilities, industrial partners or investors familiar with advanced therapies. The capabilities exist, but bringing them together can be difficult, particularly during the early stages of development.
This is where technology transfer has an important role to play. Intellectual property protection, licensing agreements and spin-off creation remain essential ways of bringing research results into commercial development. However, for complex technologies, a successful transfer involves more than establishing ownership and negotiating an agreement. The potential industrial partner also needs to understand the maturity of the technology, the evidence supporting it and the resources required to move forward. The earlier these questions are considered, the better informed the choices available to researchers and potential partners.
Technology transfer offices play an important role in assessing and commercialising research results, but they cannot address every challenge involved in developing complex therapies. Their effectiveness also depends on access to complementary expertise, from regulatory advice and manufacturing to investment and industrial development. Stronger connections with these capabilities can help institutions identify potential obstacles earlier and prepare more credible development opportunities. Pharmaceutical companies assess scientific potential alongside development risks, manufacturing feasibility and investment requirements. Earlier dialogue with industry can help research institutions better understand these expectations and identify the expertise needed to prepare promising technologies for further development.
These challenges also have a European dimension, as innovation capabilities are concentrated in regional ecosystems with different areas of expertise. Some have established pharmaceutical manufacturing industries; others specialise in clinical research, advanced therapies, entrepreneurship or investment. These differences offer opportunities for collaboration, but institutional boundaries and uneven access to resources can make them difficult to realise. Europe's challenge is now to make existing capabilities more accessible.
Addressing these barriers requires a more connected approach to technology transfer, involving research institutions, hospitals, industry, investors and specialised intermediaries. Regional innovation organisations and clusters can help identify complementary strengths, facilitate partnerships and connect institutions with expertise beyond their immediate networks. Their contribution is particularly relevant when a technology requires expertise that its institution of origin cannot provide. Cross-border collaboration can also help emerging ecosystems participate in development opportunities that would otherwise remain beyond their reach.
Recent European policy proposals are also addressing some of these barriers. The European Biotech Act2, proposed in December 2025, seeks to improve the conditions for biotechnology development, financing and manufacturing. The European Innovation Act proposal3, presented in September 2026, includes measures concerning intellectual property valuation, commercialisation support and access to innovation assets. Both reflect growing recognition that research excellence needs to be supported by an environment in which companies can develop and scale.
These initiatives offer an opportunity to look beyond individual funding instruments or regulatory measures. Their impact will also depend on how effectively they connect with existing regional ecosystems and institutional practices. Better financing conditions will have limited value if promising technologies cannot access the expertise required to mature. Equally, improved commercialisation tools will be more useful when institutions can identify suitable partners and development opportunities. European policies should therefore help research institutions and companies access the expertise, investment and industrial capabilities available across different regions, making it easier for promising technologies to progress towards commercial development.
This broader perspective should also inform how technology transfer is evaluated. Patents, licences and spin-offs provide useful information, but they capture only part of the process. Industrial partnerships, follow-on investment, progression into clinical development and access to manufacturing expertise can offer further evidence of how innovations advance. Understanding why projects stop is equally important. Scientific limitations, manufacturing barriers, financing gaps and commercial decisions require different responses, and distinguishing between them can help improve support mechanisms.
Advanced therapies provide a useful case through which to examine these questions, but the lessons extend to other complex health technologies. If we want a stronger European pharmaceutical pipeline, we need to make better use of existing capabilities, bring industrial expertise into development earlier and create more opportunities for collaboration across regions.
For European industry, this means access to better-defined development opportunities and a wider network of potential partners. For research institutions, it means better support in navigating the route from discovery to application. For policymakers, it means a better understanding of where intervention can make a difference.
Improving technology transfer means helping scientific knowledge find the expertise, investment and industrial capacity needed to become products and services that reach patients. It also means making better use of Europe's Single Market, connecting capabilities across regions and allowing more European innovations to progress, scale and create value for society.
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