As global pharma grapples with shifting regulations, rising geopolitical tensions, and fractured supply chains, Europe is finding fresh momentum as a resilient hub for drug development. Once seen as a stepping stone to larger markets, the region is positioning itself as a launchpad for advanced therapies and a stronghold for long-term investment. Leaders from ReiThera, NextCell Pharma, and eXmoor Pharma say the time is now for Europe to redefine its global role—but only if it can overcome long-standing hurdles in funding, regulatory agility, and manufacturing scale.

A platform for stability and science

“Europe offers stability, scientific excellence, and a predictable regulatory environment,” says Claudio Panzarella, head of business development at ReiThera. In an industry where clarity is everything, the European Medicines Agency (EMA) remains a pillar of science-driven regulation, giving confidence to developers navigating complex pipelines.

Thomas De Maria, ReiThera’s head of business development for the US, adds that Europe’s integrated academic and biotech ecosystem is also driving growth. “We benefit from access to top-tier talent, EU-level funding like Horizon Europe, and growing support for advanced therapies and strategic manufacturing,” he says.

This sentiment is echoed by Lindsay Davies, CSO at NextCell Pharma. She points to Europe’s globally recognised research institutions, cost-effective manufacturing infrastructure, and commitment to fostering cross-border academic-industrial collaboration.

Gillian Lewis, chief consultant at eXmoor Pharma, agrees. “Europe, including the UK, is appreciated for its stability and well-established regulatory pathways,” she says. “Programmes like Horizon Europe and Innovate UK provide significant funding.”

From public investment to coordinated manufacturing networks, Europe’s assets make it a natural home for innovation—and a potential antidote to rising uncertainty elsewhere.

US policy shifts spark regional realignment

Recent shifts in US policy—from trade tensions to regulatory unpredictability—are forcing European companies to rethink their global strategies. According to Panzarella, the result has been a push for greater European autonomy: “It’s no longer just about innovation—it’s about control, security, and resilience.”

“We’re seeing increased interest from global partners seeking EU-based solutions that de-risk development,” De Maria adds. ReiThera’s integrated model, which spans R&D through to GMP production, is designed to meet that growing demand.

Davies notes that these geopolitical shifts have given Europe new leverage. “US policy changes have created uncertainty. There is now greater value placed on Europe’s stable market. We’re also seeing interest shift to APAC as an alternative to North America.”

For Lewis, this recalibration is prompting board-level conversations. “The evolving landscape is influencing serious strategic thinking. Companies are reassessing where to allocate future investments,” she says.

Local confidence grows, but challenges remain

One of the clearest trends across the interviews is a resurgence of confidence in Europe as a place to build and scale advanced therapy programmes. “We’re seeing more companies investing in Europe not just for proximity, but for quality, expertise, and regulatory clarity,” says Panzarella.

Davies acknowledges this optimism but highlights persistent structural hurdles. “For preclinical and early clinical programmes, Europe is a powerhouse. But exporting centrally manufactured therapies to the US and APAC presents challenges with donor material and compliance.”

Lewis adds that while full localisation is not yet universal, the tide is turning. “It may be too early to call it a trend, but high-level discussions are happening across the sector.”

Staying competitive: speed, scale, and simplification

With the US and Asia advancing rapidly in areas like cell and gene therapy (CGT), what must Europe do to compete? The answer, it seems, lies in scale and speed.

“The science is here. What’s needed is faster translation from research to market,” says Panzarella. That means accelerating manufacturing capacity, streamlining regulatory approvals, and simplifying go-to-market pathways.

“Europe should champion regulatory agility,” De Maria adds, especially for emerging modalities like cell and gene therapies. “We also need stronger incentives for biotech growth and continued investment in advanced therapy infrastructure.”

Davies believes regulatory science must evolve to keep pace with technological advances. “We’re strong in early-phase development, but must ensure that companies in late-stage development stay in Europe.”

Lewis points out that Europe’s size means it must compete differently. “We can’t match Asia on cost, but our stability, quality output, and long-term investment make us attractive.”

From crisis response to regulatory readiness

For ReiThera, recent global health crises have accelerated its capabilities. “Our experience responding to health threats has shaped a regulatory culture grounded in agility and proactive engagement,” says Panzarella.

“From early scientific advice to rolling submissions, we understand how to navigate accelerated pathways without compromising quality,” De Maria adds.

The company’s internal systems, including quality assurance and GMP manufacturing, have been strengthened to ensure ongoing compliance with EMA and global regulations.

Viral vector expertise with global reach

As a European CDMO, ReiThera combines regional excellence with global ambition. Its single-site model reduces coordination risk and accelerates development timelines. “We offer fully integrated services from early development through GMP manufacturing,” says Panzarella. “Our expertise in scaling complex viral vector technologies sets us apart.”

De Maria notes that flexibility is key to serving international clients. “Whether supporting startups or global pharma, we bring deep regulatory knowledge and a commitment to quality.”

Navigating evolving regulations across borders

When it comes to managing potential regulatory changes in the US and EU, ReiThera focuses on preparedness. “We consistently evaluate whether our quality systems and procedures align with the latest FDA and EMA guidelines,” says De Maria.

“We assess what updates are needed—be it revised documentation or additional SOP training—to ensure clients’ projects remain compliant,” Panzarella adds.

A new voice for Europe’s cell and gene therapy sector

Davies has also played a key role in establishing the ISCT European Industry Committee, a new body aimed at shaping the future of advanced therapies in Europe.

“The committee recognises that the challenges faced by advanced therapy developers are region-specific,” she explains. “We need better regulatory harmonisation, more strategic funding, and greater education and partnership opportunities.”

The group, which launched in April 2025, brings together voices from academia, startups, large pharma, service providers, and regulators to coordinate on regional challenges.

Breaking bottlenecks through collaboration

Funding gaps and regulatory delays are still major roadblocks to CGT advancement in Europe, Davies warns. “Manufacturing costs and downstream testing remain steep barriers. We need financial models that reflect the longer return timelines of advanced therapies.”

She believes active collaboration is the only way forward. “There’s no quick fix. We’re building the framework as we go. Education and open dialogue with regulators are key.”

Cross-Atlantic partnerships are gaining momentum

eXmoor’s collaboration with Kincell Bio in the US shows how strategic alliances can help bridge geographic gaps.

“It helps UK and EU clients expand trials into the US, and gives US clients local European support,” says Lewis. “The model is flexible and personalised, and shows that no one can do everything alone.”

Lewis adds that clear communication and coordination are essential for success. “Above all, partnerships must be adaptable to keep pace with the shifting regulatory and commercial landscape.”

The rise of global CDMO networks

CDMOs in Europe are increasingly under pressure to build global reach. Lewis sees this as a positive evolution. “The traditional acquisition model is giving way to collaborative partnerships. It preserves innovation while offering the reliability of larger networks.”

This is especially vital in rare diseases, where multinational access is often necessary to reach enough patients. “Global CDMO networks will be key to getting products to market efficiently, wherever patients are.”

Staying aligned in a fragmented world

To keep pace with shifting regulation, eXmoor relies on a global team of consultants and active engagement with agencies.

“Our consultants understand both US and EU requirements. We also participate in consultations and review draft guidance to stay ahead of changes,” says Lewis.

“Partnering with organisations like Kincell Bio gives us real-time insight into US regulation, while helping us serve clients expanding across regions.”

Conclusion

From viral vectors to cell therapies, and from clinical manufacturing to regulatory strategy, Europe is stepping into a new phase of biopharma leadership. The foundations are strong: scientific excellence, public funding, and regulatory depth. But to realise its full potential, the region must accelerate innovation timelines, modernise regulation, and invest in scalable infrastructure.

For companies like ReiThera, NextCell, and eXmoor, the opportunities are there. So are the challenges. The question is not whether Europe can lead in the next era of pharma innovation—but whether it will move fast enough to secure that role before others do.