Beyond Market Access: Foundations for Sustaining Europe’s IVD Leadership

IVD Industry Monograph No. 3 — Persodia Research, May 2026 Miguel Oliveira

The central finding

Five signs point to conditions beneath visible market continuity that deserve closer attention. The IVD market’s share of total European healthcare expenditure has declined monotonically from 0.80 percent in 2009 to 0.60 percent in 2023 — every anchor year, without interruption. Real IVD growth over the 2014–2023 reference period was approximately minus 0.13 percent annually on a reported basis. Diagnostic use is rising while supplier revenue capture remains constrained. Capital takes longer to return as institutional gates multiply. Regulatory, digital and evidence obligations fall proportionally harder on smaller suppliers — the firms that carry much of the industry’s renewal and plurality potential.

One finding cuts across all five: the industry cannot make its case coherently because it cannot fully measure itself. The established reporting framework captures less than half the full European diagnostics economy. A reporting framework that captures only part of the industry’s economic scale weakens the visibility of its contribution and limits the quality of the debate around its future.

---

Structure

The monograph is organised around four questions, each examined through five structural lenses.

Chapter 1 — Europe’s Diagnostics Capacity What diagnostic capacity does Europe actually have? Covers population health need, diagnostic access infrastructure across the patient journey, the European IVD industry definition and scope, Europe’s position in the global IVD market, and the European manufacturer base and trade position.

Chapter 2 — Five Societal Expectations for Diagnostics What is healthcare now expecting from diagnostics? Covers earlier and more accurate clinical decisions, more efficient healthcare delivery, precision medicine and innovative care, system resilience and public-health readiness, and digital, regulatory and evidence infrastructure.

Chapter 3 — Five Signs of Insufficient Reinforcement Where are the signs that reinforcement may be insufficient? Covers declining participation in healthcare expenditure, weak real reinforcement, diagnostic use growing faster than supplier revenue, capital-duration stress, and participation-burden asymmetry.

Chapter 4 — Five Structural Gaps Beyond Market Access What structural gaps remain beyond the reach of market access alone? Covers competitiveness and procurement, fixed-burden absorption, value capture and investment returns, scale-up and market entry, and industrial plurality and resilience.

Each chapter reads in under ten minutes. The argument builds across all four but every section stands on its own.

---

Field observation

The analytical framework was tested against field observation at MedTech Forum Stockholm 2026, where the same diagnosis surfaced repeatedly across formal sessions, corridor conversations and closed-door exchanges — among executives, policymakers, investors and clinical leaders arriving from different directions and converging on the same concern. The monograph was substantially shaped by what was heard there.

---

Analytical basis

The monograph applies the structural framework developed in Inside the Clinical Diagnostics Industry: Constraints Shaping Strategy — Towards Health Intelligence (Oliveira, 2026) to the specific question of European IVD industrial sustainability. It draws on Persodia Research market studies, public institutional sources including Eurostat System of Health Accounts data, MedTech Europe market statistics, and professional observation at MedTech Forum Stockholm 2026, ESCMID Global Munich 2026 and Analytica Munich 2026.

This is the third publication in the IVD Industry Monograph series — the primary analytical output of Persodia Research.

---

About the series

Each monograph in the IVD Industry Monograph series examines a single structural question at the intersection of industry organisation, clinical deployment and market economics. The series is observational rather than prescriptive, cumulative rather than episodic.

Monograph No. 1 — Crossing from Analytical to Diagnostics: The Difficulty is the Moat examined the structural distance between the analytical and diagnostics industries and the conditions required to cross from one to the other.

Monograph No. 2 — Earning Position: How Evidence Becomes Authority examined the evidence architecture required to convert market entry into clinical adoption and durable position.

---

Assumed knowledge

The monograph assumes familiarity with the IVD industry and with the institutional conditions of European healthcare markets. Readers without direct commercial or technical experience in the sector will find the structural argument accessible but will benefit from prior reading of Inside the Clinical Diagnostics Industry.

---

Access

This monograph is available without charge. Access requires a brief declaration of context and intended use — Persodia Research wishes to understand who engages with the material and in what context. Full copyright is retained by the author. The material may be read, cited and discussed freely. It may not be reproduced or repurposed without prior written permission.

miguel@persodia.org · linkedin.com/in/migoli · persodia.org