Europe Molecular Diagnostics Market Size, Growth, Share & Trends Analysis
Europe Molecular Diagnostics Market by Product & Service (Kits, Instruments, Software), Test Type (Lab, PoC), Sample (Blood, Urine), Technology (PCR, NGS, ISH), Application [Infectious (Hepatitis, HIV, HAI, Flu), Cancer (Breast, Lung)] - Forecast to 2031
OVERVIEW
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
The Europe molecular diagnostics market is estimated to reach USD 10.15 billion by 2031 from USD 6.05 billion in 2026, growing at a CAGR of 10.9%. Market growth in Europe is driven by the integration of molecular diagnostic (MDx) techniques into the healthcare infrastructure, a strong emphasis on early diagnosis, and the development of advanced diagnostic tools for cancer and infectious diseases. Additionally, investments in European healthcare, a focus on quality, and collaborations between public healthcare centers and diagnostic companies are further contributing to the growth of this market.
KEY TAKEAWAYS
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By CountryBy country, Germany held the largest share of the molecular diagnostics market in Europe in 2025.
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By Product & ServiceBy product & service, the reagents & kits segment is expected to register the highest CAGR of 11.8% during the forecast period.
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By Test TypeBy test type, the lab tests segment accounted for the largest market share of 75.0% in 2025.
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By Sample TypeBy sample type, the blood, serum, and plasma segment accounted for the largest market share of 66.1% in 2025.
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By TechnologyBy technology, the PCR segment accounted for the largest share of the market in 2025.
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By ApplicationBy application, the infectious disease diagnostics segment is expected to dominate the market.
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By TechniqueBy technique, multiplex testing accounted for the largest market share in 2025.
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Clinical ApplicationBy clinical application, the diagnostics segment is expected to dominate the market.
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By End UserBy end user, the diagnostic labs segment is expected to register the highest CAGR.
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Competitive LandscapeIllumina (US), QIAGEN (Netherlands), bioMérieux (France), Danaher (US), and Roche (Switzerland) were identified as star players in the market, which is reflected in their strong market presence and extensive product portfolios.
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Competitive LandscapeVela Diagnostics (Singapore), Savyon Diagnostics (Israel), and Uniogen OY (Finland) have distinguished themselves among startups and SMEs by securing strong footholds in specialized niche areas.
The Europe molecular diagnostics (MDx) market is expected to witness growth as healthcare providers increasingly rely on molecular methods to support clinical decision-making. The shift toward earlier diagnosis, combined with the greater use of molecular tools in managing chronic & complex diseases, is increasing test utilization across multiple applications. In addition, the alignment of regulatory frameworks across European countries and the growing availability of advanced diagnostic platforms are supporting the broader uptake of MDx across the region.
TRENDS & DISRUPTIONS IMPACTING CUSTOMERS' CUSTOMERS
The Europe molecular diagnostics market is evolving as healthcare systems increasingly adopt molecular testing to improve diagnostic accuracy & disease management. Greater use of advanced molecular techniques, particularly in oncology and infectious disease testing, is supporting more targeted and informed clinical decisions. In parallel, the adoption of automated platforms, expanded testing panels, and improved data integration is streamlining diagnostic workflows and shaping how MDx products & services are used across European countries.
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
MARKET DYNAMICS
Level
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Rising incidence of infectious diseases and cancer
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Surge in technological advancements
Level
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High costs associated with molecular diagnostic instruments
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Limited reimbursement coverage
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Increasing importance of companion diagnostics
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Growing adoption of automation and digital solutions
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Operational challenges and shortage of skilled workforce
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Evolving regulatory and compliance requirements
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
Driver: Surge in technological advancements
Advancements in technology are supporting the wider adoption of molecular diagnostics across hospitals & clinics, diagnostic labs, home care settings, and others. Continuous improvements in assay sensitivity, turnaround time, automation, and data interpretation are making molecular tests more reliable and efficient. These advancements are enabling broader test menus and improved result accuracy, which encourages the greater use of MDx across multiple disease areas.
Restraint: High costs associated with molecular diagnostic instruments
The substantial capital costs associated with the use of molecular diagnostic instruments remain a key restraint, especially in smaller facilities. Apart from capital expenditures, additional costs in terms of maintenance, supplies, and upgrades can also limit growth. This may also slow the adoption rate of advanced platforms despite an increasing need within clinical settings.
Opportunity: Increasing importance of companion diagnostics
The expanding use of companion diagnostics offers a considerable opportunity for the market. With the growing use of targeted therapies, molecular diagnostics is increasingly being used to identify patients who could benefit from the therapy. This integrated use of diagnostics and therapeutics is thus increasing the relevance of molecular diagnostics and offering opportunities for the development of molecular assays in the field of precision medicine.
Challenge: Operational challenges and shortage of skilled workforce
Operational complexity and a shortage of trained professionals continue to challenge the effective use of molecular diagnostic products. Advanced testing requires specialized skills for assay handling, data interpretation, and quality management, which are not uniformly available. Addressing workforce gaps and streamlining operational workflows remains critical to ensuring consistent and efficient molecular testing delivery.
EUROPE MOLECULAR DIAGNOSTICS MARKET: COMMERCIAL USE CASES ACROSS INDUSTRIES
| COMPANY | USE CASE DESCRIPTION | BENEFITS |
|---|---|---|
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Integrated molecular diagnostic systems for infectious disease testing, cancer diagnostics, and companion diagnostics in centralized labs. | Delivers high test accuracy, standardized results, and seamless integration across laboratory workflows. |
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Application of rapid PCR-based molecular platforms for high-throughput infectious disease testing & decentralized diagnostic workflows. | Supports faster test turnaround, improves scalability, and enables efficient deployment across diverse testing environments. |
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Use of next-generation sequencing (NGS) technologies for oncology profiling, genetic analysis, and large-scale genomic testing programs. | Delivers deep genomic insights, supports precision medicine strategies, and enables scalable high-throughput analysis. |
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MDx solutions for rapid identification of pathogens & monitoring of healthcare-associated infections (HAIs). | Enables timely detection, supports infection control strategies, and improves disease management outcomes. |
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MDx workflow solutions, including sample preparation, nucleic acid extraction, and PCR-based molecular assays for infectious disease, oncology, and genetic testing. | Ensures reliable sample-to-result workflows, improves assay performance, and supports consistent and scalable molecular diagnostic testing. |
Logos and trademarks shown above are the property of their respective owners. Their use here is for informational and illustrative purposes only.
MARKET ECOSYSTEM
The Europe molecular diagnostics ecosystem consists of key stakeholders and components across the entire value chain, including products & services, test types, sample types, technologies, applications, techniques, clinical applications, and end users. The stakeholders include manufacturers engaged in developing and introducing products, distributors who sell via third parties or e-commerce platforms, and R&D partners offering outsourced development and manufacturing support. End users include hospitals & clinics, diagnostic laboratories and other end users that apply MDx solutions in carrying out diagnostics. These constitute the key stakeholders in the Europe molecular diagnostics supply chain.
Logos and trademarks shown above are the property of their respective owners. Their use here is for informational and illustrative purposes only.
MARKET SEGMENTS
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
Europe Molecular Diagnostics Market, By Product & Service
Based on product & service, the market is segmented into reagents & kits, instruments, and services & software. In 2025, reagents & kits accounted for the largest share, supported by their routine and repeat usage across molecular testing workflows. Continuous assay consumption, expanding test menus, and a steady demand across infectious disease & oncology applications contribute to the segment’s leading position.
Europe Molecular Diagnostics Market, By Test Type
By test type, the market is categorized into lab tests and PoC tests. In 2025, lab tests held the largest share, driven by their extensive use for complex molecular analyses and higher testing volumes. Centralized testing environments in Europe continue to rely on laboratory-based molecular diagnostics for standardized and high-throughput testing.
Europe Molecular Diagnostics Market, By Sample Type
Based on sample type, the market is segmented into blood, serum, and plasma; urine; and other sample types. In 2025, blood, serum, and plasma held the largest share, as these samples are most commonly used in molecular diagnostics. Their consistent availability, ease of collection, and suitability for a wide range of assays support reliable testing outcomes, making them the preferred sample type across routine & specialized diagnostic applications.
Europe Molecular Diagnostics Market, By Technology
By technology, the market is segmented into polymerase chain reaction, isothermal nucleic acid amplification technology, DNA sequencing & next-generation sequencing, in situ hybridization, DNA microarrays, and other technologies. In 2025, PCR dominated the market, reflecting its established use, reliability, and broad application across routine molecular diagnostics in Europe.
Europe Molecular Diagnostics Market, By Application
Based on application, the market is divided into infectious disease diagnostics, oncology testing, genetic testing, and other applications. In 2025, infectious disease diagnostics accounted for the largest share, supported by consistent testing demand for respiratory infections, sexually transmitted diseases, and other communicable conditions across European healthcare systems.
Europe Molecular Diagnostics Market, By Technique
By technique, the market includes multiplex testing and singleplex testing. In 2025, multiplex testing held the largest share as it enables the simultaneous detection of multiple targets from a single sample, improving testing efficiency and resource utilization in routine molecular diagnostics.
Europe Molecular Diagnostics Market, By Clinical Application
Based on clinical application, the market is segmented into diagnostics and screening. In 2025, the diagnostics segment accounted for the largest share, driven by the widespread use of molecular tests for disease confirmation, clinical decision support, and ongoing disease management.
Europe Molecular Diagnostics Market, By End User
By end user, the market is categorized into hospitals & clinics, diagnostic laboratories, and other end users. In 2025, diagnostic laboratories represented the largest share, reflecting their role in handling high test volumes and performing specialized molecular diagnostic procedures.
REGION
Rest of Europe is fastest-growing country
The Rest of Europe segment is expected to register the highest CAGR due to the gradual expansion of molecular diagnostics adoption across emerging and less-saturated European markets. Increasing investments in healthcare infrastructure, improving access to advanced diagnostic technologies, and growing focus on early disease detection are driving demand in these countries.
EUROPE MOLECULAR DIAGNOSTICS MARKET: COMPANY EVALUATION MATRIX
F. Hoffmann-La Roche Ltd. (Star) is a leading player in the Europe molecular diagnostics market due to its strong and well-established molecular diagnostics portfolio and long-standing presence across European healthcare systems. The company offers a broad range of molecular testing solutions covering infectious diseases, oncology, and companion diagnostics supported by reliable platforms and integrated workflows. Roche’s close alignment with clinical needs and focus on high-quality & standardized testing have enabled the widespread adoption of its molecular diagnostic solutions.
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
KEY MARKET PLAYERS
MARKET SCOPE
| REPORT METRIC | DETAILS |
|---|---|
| Market Size in 2025 (Value) | USD 5.60 Billion |
| Market Forecast in 2031 (Value) | USD 10.15 Billion |
| Growth Rate | CAGR of 10.9% from 2026–2031 |
| Years Considered | 2024–2031 |
| Base Year | 2024 |
| Forecast Period | 2026–2031 |
| Units Considered | Value (USD Million/Billion) |
| Report Coverage | Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
| Segments Covered |
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| Countries Covered | Germany, UK, France, Italy, Spain, Russia, Switzerland, Rest of Europe |
WHAT IS IN IT FOR YOU: EUROPE MOLECULAR DIAGNOSTICS MARKET REPORT CONTENT GUIDE
DELIVERED CUSTOMIZATIONS
We have successfully delivered the following deep-dive customizations:
| CLIENT REQUEST | CUSTOMIZATION DELIVERED | VALUE ADDS |
|---|---|---|
| Product Analysis | Product matrix, which provides a detailed comparison of the product portfolio of each company in the Europe molecular diagnostics market | Enables the easy comparison of competitors’ offerings, helping identify gaps, overlaps, and differentiation opportunities |
| Company Information | Additional five company profiles of players operating in the Europe molecular diagnostics market | Provides insights into competitors’ strategies, innovation focus, and partnerships, supporting strategic planning |
RECENT DEVELOPMENTS
- April 2025 : Cepheid [a subsidiary of Danaher (US)] and Oxford Nanopore Technologies Plc (UK) announced a strategic collaboration to develop a joint Research-Use-Only workflow that integrates Cepheid’s GeneXpert system with Oxford Nanopore’s sequencing platform. The collaboration aims to enable rapid, in-house infectious disease analysis, delivering results within hours.
- December 2024 : F. Hoffmann-La Roche Ltd. (Switzerland) announced the CE marking approval for its new cobas 6800/8800 systems version 2.0. The new version of the cobas 6800/8800 systems will improve the efficiency of lab procedures by optimizing resource and reducing the downtime.
- November 2024 : QIAGEN N.V. (Netherlands) launched two new tools, a design tool for custom dPCR microbial assays and QIAseq xHYB custom microbial panels (custom test kits). These tools enable researchers to design and order custom assays and panels for microbial analysis of bacterial, fungal, and viral targets and are compatible with the QIAcuity digital PCR system as well as third-party next-generation sequencing platforms.
- January 2024 : Illumina, Inc. (US) entered into an agreement with Janssen Research & Development, LLC, through Janssen Global Services, LLC (Belgium), for the development of Illumina’s novel molecular residual disease (MRD) assay. The collaboration focuses on a whole-genome sequencing (WGS) multi-cancer research solution designed to detect circulating tumor DNA (ctDNA) to better understand disease persistence or recurrence following clinical intervention.
Table of Contents
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Methodology
The study involved major activities in estimating the current market size for the global Europe Molecular Diagnostics Market. Exhaustive secondary research was done to collect information on the Europe Molecular Diagnostics Market. The next step was to validate these findings, assumptions, and sizing with industry experts across the value chain using primary research. Different approaches, such as top-down and bottom-up, were employed to estimate the total market size. After that, the market breakup and data triangulation procedures were used to estimate the market size of the segments and subsegments of the Europe Molecular Diagnostics Market.
The four steps involved in estimating the market size are as follows:
Secondary Research
In the secondary research process, various secondary sources such as annual reports, press releases & investor presentations of companies, white papers, certified publications, articles by recognized authors, gold-standard & silver-standard websites, regulatory bodies, and databases (such as D&B Hoovers, Bloomberg Business, and Factiva) were referred to, to identify and collect information for this study.
Primary Research
In the primary research process, various sources from the supply and demand sides were interviewed to obtain qualitative and quantitative information for this report. Primary sources mainly include industry experts from the core and related industries and preferred suppliers, manufacturers, distributors, service providers, technology developers, researchers, and organizations related to all segments of this industry’s value chain. In-depth interviews were conducted with primary respondents, including key industry participants, subject-matter experts, C-level executives of key market players, and industry consultants, to obtain and verify critical qualitative and quantitative information and assess prospects.
Market Size Estimation
The top-down and bottom-up approaches were used to estimate and validate the Europe Molecular Diagnostics Market’s total size. These methods were also used extensively to estimate the size of various subsegments in the market.
- The key players in the industry have been identified through extensive secondary research.
- Primary and secondary research have determined the revenues generated by leading players operating in the Europe Molecular Diagnostics Market.
- All percentage share, splits, and breakdowns have been determined using secondary sources and verified through primary sources.
Data Triangulation
After arriving at the overall market size by applying the process mentioned above, the total market was split into several segments and subsegments. To complete the overall market engineering process and arrive at the exact statistics for all segments and subsegments, data triangulation and market breakdown procedures were employed, wherever applicable. The data was triangulated by studying various factors and trends from both the demand and supply sides.
Market Definition
Molecular diagnostics is a technique used to identify and analyze nucleic acids or proteins at a molecular level. This technique assesses an individual’s genetic makeup to identify a predisposition to any particular disease or condition and diagnose it.
Stakeholders
- Senior Management
- End Users
- Finance/Procurement Department
- R&D Department
Report Objectives
- To define, describe, segment, and forecast the global Europe Molecular Diagnostics Market by product & service, test type, sample type, technology, application, technique, clinical application, end user, and region
- To provide detailed information regarding the major factors (such as drivers, restraints, opportunities, and challenges) influencing market growth
- To analyze the micromarkets1 concerning individual growth trends, prospects, and contributions to the overall Europe Molecular Diagnostics Market
- To analyze market opportunities for stakeholders and provide details of the competitive landscape for key players
- To forecast the size of the market with respect to five regions, namely North America, Europe, the Asia Pacific, Latin America, and the Middle East & Africa
- To profile the key players and comprehensively analyze their product portfolios, market positions, and core competencies2
- To track and analyze company developments, such as product launches & approvals, partnerships, acquisitions, agreements, and other developments
- To benchmark players within the Europe Molecular Diagnostics Market using the Company Evaluation Matrix framework, which analyzes market players on various parameters within the broad categories of business strategy, market share, and product offerings
- To study the impact of AI/Gen AI on the Europe Molecular Diagnostics Market, along with the macroeconomic outlook for each region
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Growth opportunities and latent adjacency in Europe Molecular Diagnostics Market