The European CGT Commercialisation Gap

Europe is home to some of the most advanced research in cell and gene therapy.

Clinical pipelines are growing. Scientific progress is accelerating. There are now more than 250 ongoing advanced therapy medicinal product (ATMP) clinical trials across the region (The Lancet Regional Health – Europe, 2026).

But when it comes to commercialisation, the picture looks very different.

Only 31 ATMPs had been authorised by the European Medicines Agency by the end of 2025 (EMA, 2025). Across 23 EU countries, the average availability of those therapies sits at just 26% (Springer ATMP availability study, 2025).

Therapies reach clinical success, then stall.
Approvals happen, but access is delayed.
Investment flows in, but returns take longer to materialise.

The result is a widening gap between what is scientifically possible and what is commercially viable in Europe.

This gap is becoming more visible over time. Europe’s share of global CGT trial starts has dropped significantly, falling from around 25% in 2013 to just 10% in 2023 for industry-sponsored trials (IQVIA data cited by EFPIA, 2024).

This isn’t a pipeline problem. It’s a translation problem.

Where therapies break down
Reimbursement and HTA complexity

Even after regulatory approval, therapies must navigate a fragmented landscape of country-by-country HTA processes, inconsistent pricing frameworks, and long negotiation timelines.

On average, EMA approvals lag the US Food and Drug Administration by 252 days (EFPIA WAIT Indicator Report, 2024). The real delay comes after approval.

Across Europe, the average time to patient access now sits at 578 days (EFPIA WAIT Indicator Report, 2024). When looking specifically at reimbursed access, the gap becomes even more pronounced. In the US, access can be achieved in as little as four weeks, compared to 32 weeks in Germany, 79 weeks in the UK, and up to 91 weeks in Spain (EU4/UK vs US CGT access analysis, 2023).

What works in one market often doesn’t translate to another. Commercial success is not scalable by default.

Scaling CGT production is no longer just a technical challenge. It is a commercial one.

Cost of goods accounts for between 55% and 70% of the total cost of a therapy (Frontiers in Medicine, 2025). For CAR-T treatments, manufacturing costs alone can exceed €60,000 per patient depending on production model (CGT manufacturing cost analysis, 2025). At the same time, global manufacturing capacity is estimated to fall dramatically short of demand, with a projected 500% shortfall (BioPlan / Frontiers in Medicine, 2025).

Even when manufacturing is technically feasible, it is not always economically viable within European healthcare systems.

Automation, decentralised manufacturing, and hospital-based production models are beginning to emerge as solutions. They are not yet widely implemented, and the economics remain fragile.

Unlike the US, Europe does not operate as a single market.

Each country brings its own regulatory frameworks, reimbursement models, and clinical infrastructure. The result is significant variation in access across the region.

Germany achieves close to 89% availability of ATMPs, while France and Italy sit around 61%. Across the EU, the average is just 26%, with some countries having no access at all (Springer ATMP availability study, 2025).

Even after centralised regulatory approval, Europe behaves like a collection of smaller, disconnected markets rather than a unified launch environment.

This fragmentation slows rollout, limits adoption, and restricts patient access.

Even when therapies are approved and reimbursed, access is not guaranteed.

Treatment centres may lack the infrastructure to deliver complex therapies. Logistics, particularly for autologous treatments, remain highly complex. Patient pathways are often unclear or underdeveloped (Transplant International, 2024).

Across Europe, there is a median of just five qualified CAR-T centres per 10 million people (European CAR-T Map, 2026). In some countries, patients face delays of up to 53 months before gaining access (European CAR-T Map, 2026).

The consequences are stark. Studies show that between 58% and 83% of eligible patients do not receive commercially available CAR-T therapies (DLBCL access study, EU4, 2024).

The final mile, getting therapies to patients, is often the hardest.

This gap is no longer theoretical. It is becoming urgent.

Investment trends reflect growing caution. Gene therapy funding has dropped sharply, from $8.2 billion in 2021 to $1.4 billion in 2024 (Reuters, 2024). Europe already attracts less capital than North America, with significantly lower quarterly funding levels (Alliance for Regenerative Medicine, 2024).

Biotechs are under increasing pressure to demonstrate not just scientific success, but commercial viability. Pharma companies are re-evaluating where and how they invest.

At the same time, more therapies are progressing into late-stage development, and expectations around patient access are rising.

Companies are already making difficult decisions. Several therapies have been withdrawn from the European market for commercial reasons, including Glybera, Zynteglo, and Skysona (EMA; Reuters reporting on uniQure; EU4/UK analysis, 2023), in some cases after treating very few or no patients.

Europe is reaching a turning point.

The question is no longer whether these therapies can be developed.
It is whether they can be delivered at scale.

Closing the commercialisation gap requires a shift from innovation to execution.

Access strategy must be integrated earlier in the development process. Reimbursement and HTA considerations can no longer be treated as downstream challenges.

New manufacturing and delivery models will play a critical role. Automation, decentralisation, and hospital-based production offer pathways to improving both cost and scalability.

Greater cross-border alignment is essential. Consistency in regulatory frameworks, pricing approaches, and access pathways will determine whether Europe can function more like a unified market. The introduction of EU joint clinical assessments for ATMPs is an important step in that direction (European Commission HTA Regulation, 2025).

Collaboration across stakeholders must also improve. Biotech companies, pharma, regulators, investors, and healthcare providers need to operate as part of a connected system rather than in isolation.

Right now, many therapies are surviving the scientific “valley of death” only to fall into a second, economic one (De Luca & Cossu, advanced therapies commentary).

These challenges are not new. The way the industry is responding is evolving.

Across Europe, leaders are rethinking commercial models, testing new approaches to access, and building partnerships that accelerate delivery.

The most valuable insights are no longer theoretical. They are coming from real-world execution.

Advanced Therapies Europe is designed around the realities of commercialisation in Europe.

Not as a high-level discussion, but as a working environment focused on market access, manufacturing and scale-up, investment, and cross-border strategy.

It brings together therapeutic developers, investors, pharma, and solution providers. These are the people actively working to solve these challenges in practice.

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• 250+ CGT clinical trials in Europe (The Lancet Regional Health – Europe, 2026)
• 31 ATMPs approved by EMA (EMA, 2025)
• 26% average availability across EU countries (Springer, 2025)
• 578 days average time to access (EFPIA WAIT, 2024)
• 4 weeks vs up to 91 weeks for reimbursement timelines (EU4/UK vs US analysis, 2023)
• 55 to 70% of therapy cost driven by manufacturing (Frontiers in Medicine, 2025)
• Up to 83% of eligible patients not treated (EU4 DLBCL study, 2024)
• $8.2bn to $1.4bn drop in gene therapy investment (Reuters, 2024)