Europe In Vitro Diagnostics Market Set to Reach USD 49.49 Billion by 2031

The Europe in vitro diagnostics (IVD) market is entering a decisive growth phase as healthcare systems, policymakers, and life sciences leaders intensify investments in early detection, automation, and precision medicine. Valued at USD 31.43 billion in 2025 and USD 33.83 billion in 2026, the market is projected to expand at a resilient CAGR of 7.9% from 2026 to 2031, reaching USD 49.49 billion by the end of the forecast period.

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This expansion raises strategic questions for healthcare executives and industry leaders: What is driving this acceleration? Why is Europe emerging as a critical battleground for diagnostics innovation? And how should manufacturers, investors, and healthcare providers position themselves now?

Growth is being fueled by rising diagnostic test volumes across national healthcare systems, broader adoption of population-based screening programs, and a growing emphasis on standardized disease monitoring. At the same time, laboratory automation and advanced molecular diagnostic technologies are improving testing efficiency and helping healthcare providers manage persistent workforce shortages. These developments are reinforced by ongoing investments in healthcare infrastructure modernization across the region, strengthening long-term demand for scalable, high-throughput IVD solutions.

From a market structure perspective, Germany accounted for the largest share of the European IVD market in 2025, while the UK is expected to register the fastest growth during the forecast period. By product and services, reagents and kits are forecast to grow at the highest CAGR of 8.4%, reflecting their recurring consumption and central role in routine and advanced diagnostics. By technology, immunoassays led market share in 2025, while molecular diagnostics is projected to expand at the fastest rate as infectious disease surveillance, oncology testing, and next-generation sequencing gain traction.

Blood, serum, and plasma specimens continue to dominate clinical usage due to standardized collection protocols and broad clinical applicability. Laboratory-based testing remains the primary site of care, holding the largest share in 2025, supported by Europe’s established centralized diagnostic infrastructure and reliance on automated analyzers. Infectious diseases represent the largest application segment, while clinical laboratories are expected to be the fastest-growing end-user group as outsourcing, consolidation, and high-volume testing models expand.

The competitive landscape is anchored by global leaders including F. Hoffmann-La Roche Ltd., Abbott, Siemens Healthineers AG, Danaher Corporation, and Thermo Fisher Scientific Inc., each leveraging extensive product portfolios and strong regional distribution networks. At the same time, specialized innovators such as Devyser (Sweden) and Boster Biological Technology (US) are securing defensible positions in niche diagnostic segments, underscoring the market’s dual structure of scale-driven incumbents and agile technology specialists.

Beyond scale, structural healthcare trends are reshaping demand. Europe’s aging population, the growing burden of chronic and infectious diseases, and expanding preventive healthcare initiatives are increasing the frequency and scope of routine testing. Governments are actively supporting timely diagnosis, while clinicians are prioritizing early detection and personalized treatment pathways. Together, these factors are translating into sustained growth in testing volumes and accelerating adoption of advanced IVD platforms.

Several technology-driven disruptions are redefining how diagnostics are delivered and monetized. Laboratory automation and digital workflow solutions are now strategic imperatives as providers seek to improve productivity and mitigate workforce shortages. Molecular diagnostics and next-generation sequencing are expanding test menus in oncology and infectious diseases, while point-of-care testing is gaining momentum in decentralized and near-patient settings where rapid clinical decisions are critical. Large-scale screening programs across Europe are further stabilizing long-term demand.

Market dynamics highlight both opportunity and constraint. The rapid uptake of point-of-care diagnostics and automated analyzers is reducing turnaround times and improving consistency across hospitals, clinics, and clinical laboratories. However, high capital investment requirements for advanced diagnostic equipment, combined with installation, maintenance, compliance, and training costs, continue to slow adoption among smaller facilities. At the same time, companion diagnostics are emerging as a high-impact growth opportunity as pharmaceutical and diagnostics companies collaborate to support targeted therapies, particularly in oncology and autoimmune diseases. Operational complexity, regulatory compliance, and data privacy risks remain ongoing challenges for multi-site laboratory operators.

Commercial deployment of IVD platforms is already delivering measurable returns across industries. High-throughput molecular platforms are enabling large-scale viral load testing in centralized laboratories, automated analyzers are accelerating HIV, HBV, and HCV detection in medium- and high-volume facilities, and integrated chemistry and immunoassay systems are streamlining hospital laboratory workflows. Cartridge-based molecular systems are extending rapid diagnostics into decentralized and low-resource environments, reinforcing the strategic role of IVD technologies across the full continuum of care.

The market ecosystem spans manufacturers, third-party distributors, e-commerce channels, R&D partners, hospitals, clinics, clinical laboratories, blood banks, pharmaceutical and biotechnology companies, and academic institutions. This interconnected value chain underscores why the IVD sector is no longer a supporting function but a core infrastructure layer for modern healthcare delivery in Europe.

Recent developments highlight the pace of innovation and partnership across the region. In December 2025, F. Hoffmann-La Roche Ltd. received CE Mark approval for its cobas BV/CV assay for accurate identification of bacterial vaginosis and candida vaginitis. In February 2024, HemoCue AB, a Danaher subsidiary, partnered with Novo Nordisk A/S to expand access to point-of-care diagnostics for children with type 1 diabetes in low- and middle-income countries. In May 2023, Abbott collaborated with Real Madrid and the Real Madrid Foundation under the “Beat Malnutrition” campaign to deploy malnutrition screening tools, while Siemens Healthineers launched its Atellica HEMA 570 and 580 Hematology Analyzers to support high-throughput laboratory environments.

For C-suite leaders, the implications are immediate. The convergence of automation, molecular diagnostics, preventive care, and regulatory momentum is reshaping competitive advantage in healthcare and life sciences. Organizations that invest early in scalable diagnostic platforms, data integration, and companion diagnostics are positioned to capture outsized value as healthcare systems transition toward precision medicine and population-scale screening.

Executives, investors, and strategic planners seeking a deeper view into market sizing, competitive positioning, technology adoption, and regional growth opportunities are encouraged to evaluate comprehensive market intelligence on the Europe in vitro diagnostics market.