Navigating Europe's Commercial Landscape: Lessons from 2025 and Expectations for 2026

2025 marked a decisive inflection point for pharmaceutical and biotech commercialisation in Europe. Long-signalled reforms moved from policy design into operational reality, forcing companies to confront not just what Europe intends to do, but how it actually behaves at launch.

Europe has not become simpler, but it has become more predictable for companies that plan properly. 2026 will reward those that treat evidence, policy, pricing, and access as a single integrated system

• The most consequential structural change in 2025 was the formal start of the EU Health Technology Assessment Regulation, with Joint Clinical Assessments applying to oncology medicines and ATMPs from January. Coverage throughout the year focused less on political intent and more on operational friction: how PICO definitions are set, what constitutes an acceptable comparator, and how EU-level conclusions intersect with national HTA expectations.

• The core insight from 2025 was not that EU HTA replaces national decision-making, but that it reshapes the narrative space within which national pricing and reimbursement discussions occur.

• Confidentiality became a commercial design issue.Public-facing EU JCA outputs raised legitimate concerns about disclosure of sensitive clinical positioning and downstream implications for international reference pricing. In 2025, sophisticated companies began to treat confidentiality not as a legal footnote, but as a launch-strategy architecture question.

• National systems still decide, despite EU-level assessment, pricing and reimbursement decisions remain national. Germany’s early work to integrate EU JCAs into AMNOG processes highlighted the need for tight alignment between EU and national value narratives.

• Rare disease optimism met feasibility constraints. For ultra-rare diseases, standardised assessment frameworks struggled with limited patient numbers and immature endpoints. The emerging consensus was pragmatic: companies must actively design around feasibility constraints using registries, external controls, early access programmes, and staged value narratives.

• Europe recalibrated innovation and access. The provisional agreement on EU pharmaceutical legislation reform during 2025 signalled a deliberate rebalancing of affordability, access speed, and innovation incentives. This introduced explicit policy risk into European launch sequencing and pipeline prioritisation.

What 2026 will demand from companies?

• EU HTA becomes a capability, not a milestone. In 2026, success will depend on Institutionalised EU HTA readiness: repeatable PICO strategy, evidence feasibility logic, and clear EU-to-national traceability.

• National divergence will persist, but tolerance will shrink

• Countries will continue to diverge on price and access, but unjustified divergence from EU clinical conclusions will become harder to sustain.

• Rare disease strategies must be explicitly adaptive

• Adaptive evidence strategies, early access, and real-world data generation will increasingly be expected components of rare disease launches.

• Europe-wide launch sequencing will be re-optimised

• With EU HTA bedding in and policy economics stabilising, many companies will revisit Europe’s role in global launch sequencing.

Europe will no longer reward isolated excellence. It will reward orchestration. Successful commercialisation in 2026 and beyond will depend on integrated thinking across evidence, access, policy, and operations.