Beyond Market Access: Foundations for Sustaining Europe’s IVD Leadership
Europe has a substantial and globally relevant in-vitro diagnostics industry. Its manufacturing output exceeds its own market demand — the European Union produces approximately USD 49 billion of diagnostic products annually against approximately USD 33 billion of regional market demand. It serves not only European healthcare systems but global ones. This monograph examines whether the foundations sustaining that position are being adequately reinforced — and identifies where they may not be. The question is not whether European diagnostics is functioning. It is. Products are available, laboratories operate, and major manufacturers remain active across the market. The question is whether the industrial conditions that make that functioning durable over time are receiving proportionate reinforcement as the expectations placed on diagnostics expand.