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Molecular Diagnostics Market Across Europe: Regulatory Push and Technological Innovation Reshape Care

12-11-2025 07:48 AM CET | Health & Medicine

Press release from: MarketGenics Research

Molecular Diagnostics Market Across Europe: Regulatory Push and Technological Innovation Reshape Care

Molecular Diagnostics Market Across Europe: Regulatory Push and Technological Innovation Reshape Care

Europe stands at the center of a medical transformation. With the continent accelerating toward personalized, preventative healthcare, molecular diagnostics has become the backbone of early detection, targeted therapy selection, and precision-driven patient management.

The global molecular diagnostics market is valued at USD 16.5 billion in 2025, growing at a CAGR of 6.6% through 2035. Europe-home to advanced laboratories, strict regulatory frameworks, and massive cancer screening programs-is emerging as one of the most dynamic adopters of genomic and molecular testing.

Get the Detailed Industry Analysis (including the Table of Contents, List of Figures, and List of Tables) - from the Molecular Diagnostics Market Research Report: https://marketgenics.co/reports/molecular-diagnostics-market-21235

Why Molecular Diagnostics Is Surging in Europe
Europe offers the perfect intersection of clinical need, strong regulation, and leading innovation:

1. Rising Cancer and Chronic Disease Burden
Breast cancer, colorectal cancer, lung cancer, leukemia, diabetes, and autoimmune disorders are all growing rapidly in Europe. This has increased demand for:

NGS-based oncology panels

Liquid biopsies

Pharmacogenomic tests

Genetic screening programs

2. Government-Driven Screening Programs
European nations run some of the most extensive screening programs for:

Breast cancer

Colorectal cancer

Cervical cancer

Genetic disorders

Infectious diseases

These programs rely heavily on PCR, NGS, ISH, and digital pathology-all components of molecular diagnostics.

To know more about the Molecular Diagnostics Market - Download our Sample Report: https://marketgenics.co/download-report-sample/molecular-diagnostics-market-21235

3. Rapid Adoption of At-Home Molecular Tests
Europe is seeing strong growth in:

Home COVID/flu PCR kits

STI molecular test kits

At-home cancer screening kits

Genetic wellness and ancestry tests

This trend exploded post-pandemic and continues to grow.

4. Precision Medicine Becomes a Mandate
Europe's shift toward personalized therapy selection-especially in oncology and rare diseases-has positioned molecular diagnostics as a clinical necessity, not a luxury.

Segmental Insights: Europe Mirrors Global Trends with a Stronger Oncology Focus
Reagents & Kits Dominate (~63%)
In Europe, reagent adoption is even higher due to:

A surge in automated PCR systems in hospitals

Large-scale NGS-based screening programs

Increased adoption of multiplex infectious disease panels

Rapid digitization of pathology labs

Technology Favorites in Europe
PCR and real-time PCR: still the gold standard

Next-Generation Sequencing (NGS): fastest-growing segment

Liquid biopsy assays: rising due to demand for non-invasive cancer testing

Isothermal amplification tests: widely used in POCT

Demand Trends Reshaping Europe
1. Liquid Biopsy Adoption Skyrockets
Companies such as Guardant Health, Roche, Qiagen, and Exact Sciences are expanding their European cancer detection pipelines.
Europe sees liquid biopsy as a tool for:

Early cancer detection

Cancer recurrence monitoring

Non-invasive diagnostic workflows

2. At-Home Molecular Diagnostics Expand Rapidly
Post-COVID Europe now embraces home-based testing:

Home PCR kits

Saliva-based biomarker kits

Women's health molecular tests

Fertility and genetic screening

Cue Health's expansion of home-based flu and COVID PCR tests reflects this structural shift.

Buy Now: https://marketgenics.co/buy/molecular-diagnostics-market-21235https://marketgenics.co/buy/molecular-diagnostics-market-21235

3. Precision Oncology Moves to the Frontline
European hospitals increasingly rely on:

AI-driven histopathology

NGS-based tumor profiling

Companion diagnostics for immunotherapy

Hereditary cancer gene panels

Competitive Landscape in Europe
The Europe molecular diagnostics market is moderately consolidated, dominated by:

Leading players
Roche Diagnostics (Europe's dominant force)

Qiagen N.V. (Netherlands/Germany)

Danaher (Cepheid)

Abbott Laboratories

Thermo Fisher Scientific

Hologic, bioMérieux, Illumina

These companies command over 50% of the market share.

Europe-based leaders
bioMérieux (France)

Qiagen (Germany/Netherlands)

Oxford Nanopore Technologies (UK)

Roche Diagnostics (Switzerland)

These companies give Europe a strategic edge in global leadership.

Key Strategic Developments Impacting Europe (2024-2025)
• Danaher × AstraZeneca - AI-Powered Precision Diagnostics (May 2025)
Establishes "Centers for Enabling Precision Medicine"-accelerates companion diagnostics for oncology.

• Roche Expands navify Digital Pathology (June 2025)
Integration of 20+ new AI algorithms enhances:

cancer detection

tumor grading

treatment recommendation pathways

Europe is a core adopter of navify across major cancer centers.

Europe's Regulatory Advantage
Europe's molecular diagnostics adoption is enhanced by:

IVDR compliance frameworks

GDPR-driven secure digital pathology systems

government-funded national cancer screening

AI-regulation guidelines for medical imaging and digital pathology

Europe's strict frameworks actually accelerate adoption by ensuring standardization and safety.

Future Outlook for Europe
By 2035, Europe will remain one of the most attractive molecular diagnostics markets, driven by:

A rising chronic disease burden

Early-stage cancer detection programs

Expansion of NGS labs

AI integration across pathology

Rapid uptake of point-of-care and home testing

Strong government backing for precision medicine

Opportunity Size (2025-2035): USD 16.8 Billion
Europe will contribute significantly to this global opportunity.

Get the complete market breakdown - statistics, insights, and future outlook: https://marketgenics.co/press-releases/molecular-diagnostics-market-21235

Conclusion: Europe Is Building a New Era of Molecular, AI-Driven Healthcare
The European molecular diagnostics market is transforming healthcare delivery across hospitals, labs, and home-based settings. With rising adoption of:

AI-driven diagnostics

Digital pathology

Liquid biopsy

NGS screening

Precision oncology

POCT and home testing

Europe is emerging as one of the world's most advanced molecular diagnostics ecosystems.

Molecular diagnostics is not just a medical tool in Europe-it's becoming a strategic pillar of future healthcare, enabling earlier detection, personalized treatments, and long-term disease management.

Mr. Debashish Roy

MarketGenics Research

800 N King Street, Suite 304 #4208, Wilmington, DE 19801, United States

USA: +1 (302) 303-2617

Email: sales@marketgenics.co

Website: https://marketgenics.co

MarketGenics is a global market research and management consulting company empowering decision makers across healthcare, technology, and policy domains. Our mission is to deliver granular market intelligence combined with strategic foresight to accelerate sustainable growth.

We support clients across strategy development, product innovation, healthcare infrastructure, and digital transformation.

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