China is accelerating early-stage development through faster clinical approvals and more flexible trial infrastructure through implementation of Investigator-Initiated Trials (IITs). The US continues to dominate capital, manufacturing scale, and commercial launches. Meanwhile, European developers are increasingly taking early-stage trials outside the region to access faster timelines, quicker data, and earlier investment opportunities, according to reporting from Fierce Biotech.
Europe’s challenge in 2026 is no longer scientific innovation. It’s execution.
Europe’s approval and trial infrastructure is struggling to keep pace with global competitors.
China recently proposed cutting novel drug clinical trial review timelines from 60 working days to 30. (Fierce Biotech) At the same time, more European biotechs are running Phase I programmes outside Europe to generate faster clinical data and unlock investment sooner.
EMA leadership has also warned that Europe is reaching a “critical point” on access to innovative medicines as global competition intensifies. Drug launches across Europe have reportedly fallen by more than a third in recent years.
For developers, slower timelines now directly impact:
Europe risks becoming the market where therapies are validated, rather than where they are first built and scaled.
So what needs to change?
Europe needs faster approvals, faster trial activation, and more coordinated clinical infrastructure.
If Europe wants to remain competitive, reducing regulatory friction and improving trial execution can no longer be long-term ambitions. They need to become immediate operational priorities.
5 key sessions at Advanced Therapies Europe 2026 addressing this market challenge:
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Panel: Europe’s ATMP rulebook reset: The 12-month pathway from fragmented rules to trusted EU execution. Featuring leaders from PrimeRA Pharma Partners and Hospital Clínic de Barcelona discussing how developers must adapt regulatory, CMC, and evidence strategies to remain competitive globally.
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Panel: Europe’s Roadmap Winning the Next Wave of ATMP R&D: What Europe must resolve to compete on speed, scale and return. With perspectives from Novo Nordisk Foundation Cellerator, Kiji Therapeutics, BIOCAT, and Alliance for Regenerative Medicine on fixing approval timelines, site readiness, and cross-border execution.
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Panel: CGT clinical trials at pace: What’s accelerating, what’s stuck and how Europe turns trials into treatments. Bringing together experts from Universitat Pompeu Fabra, Sant Joan de Déu, and Hospital Clínic de Barcelona to discuss how Europe can improve trial coordination and execution speed.
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Spotlight: Bridging proof and progress: Why promising CGTs still stall and how smarter trial infrastructure unlocks flow. Focused on why operational bottlenecks, not science, increasingly determine whether programmes progress.
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Fireside chat: Across the finish line: What FDA BLA reviews really test and where European CGT teams are most often surprised. A practical regulatory reality check for European developers preparing for global commercialisation pathways.
View the full 2026 Agenda
Advanced therapies require coordinated regulation, reimbursement, manufacturing, and delivery infrastructure. Europe still operates largely country-by-country.
Developers continue to face fragmented reimbursement systems, differing evidence expectations, and uneven hospital readiness across member states. Industry groups have warned that companies are still navigating “27 separate access and reimbursement processes” for innovative medicines, as highlighted by The Parliament Magazine.
The result:
For a sector dependent on scale and coordination, fragmentation is now a competitive disadvantage.
So what needs to change?
Europe needs more aligned regulation, reimbursement, and delivery infrastructure.
If Europe wants therapies to reach patients faster, the ecosystem needs to operate with far greater coordination across borders.
Key sessions addressing this challenge include:
View the full 2026 Agenda
The market has shifted from scientific discovery to commercial execution.
Investors are increasingly prioritising:
China’s biotech licensing market reached a record $137.7 billion last year, reflecting growing confidence in its ability to commercialise innovation quickly, according to Reuters.
Europe still produces exceptional science. But parts of the ecosystem remain optimised for research rather than industrial-scale delivery.
So what needs to change?
Europe needs to build therapies for commercial reality, not just scientific success.
That means solving manufacturing economics earlier, designing with reimbursement in mind, improving operational scalability, and building companies that investors believe can survive beyond clinical proof-of-concept.
Key sessions addressing this challenge include:
View the full 2026 Agenda
Europe still has the science, talent, and innovation to lead the next era of advanced therapies. But leadership will increasingly be defined by execution, not potential.
That's why Advanced Therapies Europe exists.
The meeting’s mission is to help Europe move faster, collaborate better, and compete more effectively on the global stage by bringing together the biotech, pharma, investor, regulatory, manufacturing, and healthcare leaders shaping the future of advanced therapies.
Taking place 7–9 September 2026 at the InterContinental Barcelona, Advanced Therapies Europe 2026’s agenda has been built around the industry’s most urgent operational and commercial challenges, from regulatory harmonisation and clinical trial acceleration to manufacturing scalability, patient access, investment strategy, and commercial readiness.
The full 2026 agenda is now live, and applications to attend are officially open.
See ticket information and apply to attend here.
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