Published Year: 2025
Molecular Oncology Diagnostics Market - A Global and Regional Analysis: Focus on Product, Technology
The global molecular oncology diagnostics market was valued at $2,410.9 million in 2024, and...
Market Research Report
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Table of Contents
1.1 Global Incidence and Prevalence of Cancer (by Cancer Type)
1.1.1 Europe
1.2 Trends: Current and Future Impact Assessment
1.2.1 Increasing Partnerships among Players
1.2.2 Increasing Launch of Innovative Products and Regulatory Approvals in Molecular Oncology Diagnostics Ecosystem
1.3 Regulatory Landscape
1.3.1 Legal Requirements and Framework in Europe
1.4 Impact of COVID-19 on the Molecular Oncology Diagnostics Market
1.5 Liquid Biopsy-Based Cancer Molecular Diagnostics
1.6 Laboratory-Developed Test (LDT) vs. In-Vitro Diagnostics (IVD)
1.7 Role of Companion Diagnostics in the Molecular Oncology Diagnostics Market
1.8 Market Dynamics
1.8.1 Market Drivers
1.8.1.1 Rising Incidence of Cancer Cases
1.8.1.2 Rising Technological Advancements in Molecular Diagnostics
1.8.1.3 Growth in Biomarker Identification and Transformations in Molecular Techniques
1.8.1.4 Growing Demand for Personalized Medicine
1.8.2 Market Challenges
1.8.2.1 Lack of Qualified Professionals
1.8.2.2 High Cost of Molecular Diagnostic Kits and Assays Hindering the Adoption Rate
1.8.3 Market Opportunities
1.8.3.1 Focus on Reimbursement and Medical Coverage for Molecular Oncology Diagnostics
1.8.3.2 Focus on Next-Generation Ultrasensitive Molecular Diagnostics
1.8.3.3 Increasing Growth Opportunities for Molecular Diagnostics Companies in Emerging Economies
2.1 Regional Summary
2.2 Drivers and Restraints
2.3 Europe
2.3.1 Regional Overview
2.3.2 Driving Factors for Market Growth
2.3.3 Factors Challenging the Market
2.3.4 By Cancer Type
2.3.5 By End User
2.3.6 Germany
2.3.6.1 By Cancer Type
2.3.6.2 By End User
2.3.7 France
2.3.7.1 By Cancer Type
2.3.7.2 By End User
2.3.8 U.K.
2.3.8.1 By Cancer Type
2.3.8.2 By End User
2.3.9 Italy
2.3.9.1 By Cancer Type
2.3.9.2 By End User
2.3.10 Spain
2.3.10.1 By Cancer Type
2.3.10.2 By End User
2.3.11 Rest-of-Europe
2.3.11.1 By Cancer Type
2.3.11.2 By End User
3.1 Key Strategic Development
3.1.1 Partnerships, Alliances, and Business Expansions
3.1.2 New Offerings
3.1.3 Mergers and Acquisitions
3.1.4 Regulatory and Legal Activities
3.2 Company Share Analysis
3.3 Company Profiles
3.3.1 Biocartis Group NV
3.3.1.1 Overview
3.3.1.2 Top Products
3.3.1.3 Top Competitors
3.3.1.4 Target Customers/End User
3.3.1.5 Key Personnel
3.3.1.6 Analyst View
3.3.2 bioMérieux
3.3.2.1 Overview
3.3.2.2 Top Products
3.3.2.3 Top Competitors
3.3.2.4 Target Customers/End User
3.3.2.5 Key Personnel
3.3.2.6 Analyst View
3.3.3 F. Hoffmann-La Roche Ltd.
3.3.3.1 Overview
3.3.3.2 Top Products
3.3.3.3 Top Competitors
3.3.3.4 Target Customers/End User
3.3.3.5 Key Personnel
3.3.3.6 Analyst View
3.3.4 QIAGEN N.V.
3.3.4.1 Overview
3.3.4.2 Top Products
3.3.4.3 Top Competitors
3.3.4.4 Target Customers/End User
3.3.4.5 Key Personnel
3.3.4.6 Analyst View
4.1 Data Sources
4.1.1 Primary Data Sources
4.1.2 Secondary Data Sources
4.1.3 Data Triangulation
4.2 Market Estimation and Forecast
Table 1: Market Snapshot
Table 2: Key Trends, Impact Analysis
Table 3: Molecular Oncology Diagnostics Market, Partnerships and Collaborations
Table 4: Molecular Oncology Diagnostics Market, Product Launches and Regulatory Approvals
Table 5: Molecular Oncology Diagnostics Market, New Offerings
Table 6: Biomarkers for Different Cancer Types
Table 7: Significance of Different Biomarkers in Clinical Outcomes of Various Cancer
Table 8: Cost of Liquid Biopsy-Based NGS Kits
Table 9: Europe Molecular Oncology Diagnostics Market, Reimbursement and Medical Coverage
Table 10: Molecular Oncology Diagnostics Market (by Region), $Million, 2023-2033
Table 11: Europe Molecular Oncology Diagnostics Market (by Cancer Type), $Million, 2023-2033
Table 12: Europe Molecular Oncology Diagnostics Market, Cancer Type (by Solid Tumors), $Million, 2023-2033
Table 13: Europe Molecular Oncology Diagnostics Market, Cancer Type (by Hematological Malignancies), $Million, 2023-2033
Table 14: Europe Molecular Oncology Diagnostics Market (by End User), $Million, 2023-2033
Table 15: Germany Molecular Oncology Diagnostics Market (by Cancer Type), $Million, 2023-2033
Table 16: Germany Molecular Oncology Diagnostics Market, Cancer Type (by Solid Tumors), $Million, 2023-2033
Table 17: Germany Molecular Oncology Diagnostics Market, Cancer Type (by Hematological Malignancies), $Million, 2023-2033
Table 18: Germany Molecular Oncology Diagnostics Market (by End User), $Million, 2023-2033
Table 19: France Molecular Oncology Diagnostics Market (by Cancer Type), $Million, 2023-2033
Table 20: France Molecular Oncology Diagnostics Market, Cancer Type (by Solid Tumors), $Million, 2023-2033
Table 21: France Molecular Oncology Diagnostics Market, Cancer Type (by Hematological Malignancies), $Million, 2023-2033
Table 22: France Molecular Oncology Diagnostics Market (by End User), $Million, 2023-2033
Table 23: U.K. Molecular Oncology Diagnostics Market (by Cancer Type), $Million, 2023-2033
Table 24: U.K. Molecular Oncology Diagnostics Market, Cancer Type (by Solid Tumors), $Million, 2023-2033
Table 25: U.K. Molecular Oncology Diagnostics Market, Cancer Type (by Hematological Malignancies), $Million, 2023-2033
Table 26: U.K. Molecular Oncology Diagnostics Market (by End User), $Million, 2023-2033
Table 27: Italy Molecular Oncology Diagnostics Market (by Cancer Type), $Million, 2023-2033
Table 28: Italy Molecular Oncology Diagnostics Market, Cancer Type (by Solid Tumors), $Million, 2023-2033
Table 29: Italy Molecular Oncology Diagnostics Market, Cancer Type (by Hematological Malignancies), $Million, 2023-2033
Table 30: Italy Molecular Oncology Diagnostics Market (by End User), $Million, 2023-2033
Table 31: Spain Molecular Oncology Diagnostics Market (by Cancer Type), $Million, 2023-2033
Table 32: Spain Molecular Oncology Diagnostics Market, Cancer Type (by Solid Tumors), $Million, 2023-2033
Table 33: Spain Molecular Oncology Diagnostics Market, Cancer Type (by Hematological Malignancies), $Million, 2023-2033
Table 34: Spain Molecular Oncology Diagnostics Market (by End User), $Million, 2023-2033
Table 35: Rest-of-Europe Molecular Oncology Diagnostics Market (by Cancer Type), $Million, 2023-2033
Table 36: Rest-of-Europe Molecular Oncology Diagnostics Market, Cancer Type (by Solid Tumors), $Million, 2023-2033
Table 37: Rest-of-Europe Molecular Oncology Diagnostics Market, Cancer Type (by Hematological Malignancies), $Million, 2023-2033
Table 38: Rest-of-Europe Molecular Oncology Diagnostics Market (by End User), $Million, 2023-2033
Table 39: Europe Molecular Oncology Diagnostics Market, Company Share Analysis, 2023
Figure 1 Europe Molecular Oncology Diagnostics Market, $Million, 2024, 2028, and 2033
Figure 2 Molecular Oncology Diagnostics Market (by Region), $Million, 2023, 2027, and 2033
Figure 3 Europe Molecular Oncology Diagnostics Market (by Cancer Type), $Million, 2023, 2027, and 2033
Figure 4 Europe Molecular Oncology Diagnostics Market (by End User), $Million, 2023, 2027, and 2033
Figure 5 Role of Diagnostics in Healthcare
Figure 6 Cancer Prevalence and Incidence (by Cancer Type), in Million, Europe, 2022
Figure 7 Europe In-Vitro Diagnostic Devices Regulation Regulatory Process
Figure 8 Technological Advances in Liquid Biopsy Analysis
Figure 9 List of Some Liquid Biopsy-Based Available Tests Approved by FDA/CE-IVD
Figure 10 Prominent FDA-Approved Companion Diagnostics
Figure 11 Impact Analysis of Market Navigating Factors, 2022-2033
Figure 12 Global Distribution of Cases and Deaths (by Cancer Type), 2022
Figure 13 Global Incidence for Cancer Types, 2018-2022
Figure 14 Germany Molecular Oncology Diagnostics Market, $Million, 2023-2033
Figure 15 France Molecular Oncology Diagnostics Market, $Million, 2023-2033
Figure 16 U.K. Molecular Oncology Diagnostics Market, $Million, 2023-2033
Figure 17 Italy Molecular Oncology Diagnostics Market, $Million, 2023-2033
Figure 18 Spain Molecular Oncology Diagnostics Market, $Million, 2023-2033
Figure 19 Rest-of-Europe Molecular Oncology Diagnostics Market, $Million, 2023-2033
Figure 20 Partnerships, Alliances, and Business Expansions, January 2021-July 2024
Figure 21 New Offerings, January 2021-July 2024
Figure 22 Mergers and Acquisitions, January 2021-July 2024
Figure 23 Regulatory and Legal Activities, January 2021-July 2024
Figure 24 Data Triangulation
Figure 25 Top-Down and Bottom-Up Approach
Figure 26 Assumptions and Limitations
Europe Molecular Oncology Diagnostics Market Report Coverage
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Europe Molecular Oncology Diagnostics Market |
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Base Year |
2023 |
Market Size in 2024 |
$606.0 Million |
|
Forecast Period |
2024-2033 |
Value Projection and Estimation by 2033 |
$1,523.4 Million |
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CAGR During Forecast Period |
10.78% |
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Some of the prominent key players in this market are:
• Biocartis Group NV
• bioMérieux
• F. Hoffmann-La Roche Ltd
• QIAGEN N.V.
Key Questions Answered in this Report:
• What is the estimated market size for the Europe molecular oncology diagnostics market?
• What are the different cancer types? Which one of these segments is projected to be the fastest-growing segment during the forecast period 2024-2033?
• What are the different end users? Which one of these segments is projected to be the fastest-growing segment during the forecast period 2024-2033?
• Which country holds the largest market share of the Europe molecular oncology diagnostics market, and which one of these countries is expected to be the fastest-growing segment during the forecast period 2024-2033?
• What are the key drivers, challenges, and opportunities for the Europe molecular oncology diagnostics market, and what will be their impact on the market in short-, mid-, and long-term duration?
• Who are the key players in the Europe molecular oncology diagnostics market, and what are their product offerings?
Introduction to Europe Molecular Oncology Diagnostics Market
The Europe molecular oncology diagnostics market was valued at $606.0 million in 2024, and the market is expected to grow with a CAGR of 10.78% and reach $1,523.4 million by 2033. Next-generation sequencing (NGS), digital PCR, and liquid biopsy are just a few of the technological advancements driving the European molecular oncology diagnostics market's expansion. The region's rising cancer incidence is another factor. Better patient outcomes, more accurate treatment choices, and earlier detection are made possible by these advancements.
However, there are a number of regional obstacles to market penetration. The high expense of molecular diagnostic testing remains a hurdle, especially in nations with relatively limited healthcare budgets in Central and Eastern Europe. Furthermore, wider clinical usage is constrained by a lack of qualified personnel who can operate sophisticated diagnostic tools and decipher complicated genomic data.
The European market continues to grow in spite of these challenges. The integration of molecular tools into routine oncology care is being supported and innovation is being accelerated by cooperative efforts involving biotech companies, pharmaceutical companies, diagnostic producers, and academic research centres. Unlocking the full potential of molecular diagnostics in cancer management across various European healthcare systems would require efforts to standardise payment regulations, lower test prices, and increase clinician genomic literacy.
Market Introduction
The market for molecular oncology diagnostics in Europe is changing dramatically as more healthcare systems embrace precision medicine methods for treating cancer. Molecular diagnostics is becoming more and more important in detecting genetic changes connected to different types of cancer, driven by the demand for earlier detection, more precise diagnosis, and customised therapy planning. Advanced testing systems that support targeted therapies and enhance treatment outcomes are becoming more and more in demand in the region.
Adoption is accelerating in Western Europe, especially in nations like Germany, the UK, and France, because to established healthcare systems, benevolent legal environments, and rising genomic research expenditures. Central and Eastern Europe is progressively catching up, though, as initiatives are being made to standardise cancer treatment internationally and increase access to molecular diagnostics.
The market is also benefiting from the continuous integration of digital health, as oncology centres and labs use genetic data platforms to make decisions in real time. Demand in the market is also being driven by growing applications in risk stratification, treatment monitoring, and early diagnosis as well as rising awareness among physicians and patients. Europe is positioned to become a major centre for molecular oncology diagnostics, influencing the direction of customised cancer treatment in a variety of clinical settings as long as public and private health authorities keep funding innovation and capacity-building.
Market Segmentation:
Segmentation 1: by Cancer Type
• Solid Tumors
• Hematologic Malignancies
Segmentation 2: by End User
• Hospitals and Diagnostic Centers
• Reference Laboratories
• Pharmaceutical and Biotechnology Companies
• Academic and Research Institutes
Segmentation 3: by Region
• Europe - U.K., Germany, France, Italy, Spain, and Rest-of-Europe
Europe Molecular Oncology Diagnostics Market Trends, Drivers & Challenges:
Market Trends
• Expansion of Next-Generation Sequencing (NGS) Panels: Increasing use of multiplexed NGS assays for simultaneous detection of multiple oncogenic mutations, enabling broader genomic profiling.
• Growth of Liquid Biopsy Adoption: Rising preference for minimally invasive circulating tumor DNA (ctDNA) and circulating tumor cell (CTC) assays to monitor treatment response and detect early relapse.
• Integration with Immuno-Oncology: Molecular diagnostics platforms increasingly incorporate biomarkers (e.g., PD-L1, TMB) to guide immune checkpoint inhibitor therapies.
• Emergence of Companion Diagnostics: Co?development of targeted therapies and associated diagnostic tests is accelerating regulatory approvals and market uptake.
Market Drivers
• Rising Cancer Incidence & Aging Population: Europe’s growing elderly demographic and higher cancer prevalence boost demand for precise diagnostic tools.
• Shift Toward Precision Medicine: Clinicians and payers favor personalized treatment plans, driving investment in molecular assays that predict therapy efficacy.
• Favorable Reimbursement Policies: Several European healthcare systems and HTA agencies are approving broader coverage for advanced genomic tests, reducing out-of-pocket costs.
• Technological Advancements & Cost Reductions: Continuous improvements in assay sensitivity, turnaround time, and economies of scale are making molecular tests more accessible.
Market Challenges
• High Test Development & Implementation Costs: Building validated panels and obtaining regulatory clearances remain expensive, limiting adoption in smaller hospitals.
• Fragmented Reimbursement Landscape: Inconsistent coverage policies across EU member states and varied HTA requirements create uncertainty for providers and manufacturers.
• Standardization & Quality Control Issues: Lack of uniform guidelines for assay validation, interpretation, and reporting can hamper cross?laboratory comparability.
• Data Privacy & Regulatory Complexity: Strict GDPR requirements and evolving IVDR regulations increase administrative burden and slow down clinical deployment.
Europe Molecular Oncology Diagnostics Market
Focus on Cancer Type, End User, and Country - Analysis and Forecast, 2024-2033
Some Faq's
Frequently Asked Questions
The Europe molecular oncology diagnostics market was valued at $606.0 million in 2024, and the market is expected to grow with a CAGR of 10.78% and reach $1,523.4 million by 2033.
EU member states employ varied HTA bodies and reimbursement systems—Germany’s G?BA evaluates diagnostics for SHI coverage; France’s HAS and CEESP set price recommendations; the UK’s NICE assesses cost-effectiveness; Italy’s AIFA negotiates tariffs; and Spain’s national and regional authorities define test inclusion and reimbursement rates. These frameworks dictate access and pricing.
Pan-cancer NGS panels and multi-gene assays enable comprehensive genomic profiling, identifying actionable mutations across tumor types. In Europe, they support broader patient stratification for targeted therapies, streamline clinical decision-making, and enhance enrollment in basket trials. Their versatility and cost-efficiency are accelerating precision oncology adoption in centralized and academic settings.
The companies manufacturing molecular oncology diagnostics, service providers, pharmaceutical companies, and research institutions, among others should buy this report.
• Exhaustive product portfolio, recent developments, and company share of key players in the Europe molecular oncology diagnostics market
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