For most pharma and biotech companies, Europe is framed as a commercial problem to be solved later. A launch plan to be refined. A partnership discussion to be revisited. An infrastructure question that can wait until after approval.This framing is deeply misleading. Europe is not a launch choice. It is a structural commitment. Whether a company decides to go it alone, partner, or outlicense Europe does not simply shape how a product is commercialised; it fixes the organisati

There is a persistent misunderstanding about Europe that continues to quietly destroy value for first-time Pharma and Biotech entrants. Europe is not uniquely hostile. It is not inherently slow. And it does not require scale before access. What it does require is clarity. Clarity of ownership, clarity of intent, and clarity of decision-making. Where companies fail is not in execution, but in allowing responsibility for irreversible decisions to diffuse across partners, adviso

For more than two decades, European pharmaceutical launch strategy has been built on a reassuring simplification: Europe is complex, but it is ultimately manageable as a single market. Execute a coordinated EU5 launch, align pricing corridors, navigate HTA sequentially, and scale from there. That assumption is now obsolete. By 2026, Europe will no longer fail companies because it is slow or bureaucratic. It will fail them because it is structurally fragmented in ways that inv

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