Molecular Diagnostics Market 2026-2035
Description
Molecular Diagnostics Market Size, Share & Trends Analysis Report by Technology (Polymerase Chain Reaction (PCR), In Situ Hybridization (ISH), DNA Microarray, Next-Generation Sequencing (NGS), Isothermal Nucleic Acid Amplification, and Other Technologies), By Product(Testing Equipment, Diagnostic Reagents & Kits, and Services & Software), By Applications (Infectious Diseases, Cancer, Cardiovascular Disease (CVD), Genetic Testing, Neurological Disease, and Other), Forecast Period (2025-2035)
Industry Overview
Molecular diagnostics market was valued at $19.2 billion in 2025 and is projected to reach $48.0 billion by 2035, growing at a CAGR of 8.9% during the forecast period (2026-2035). The global molecular diagnostics market is expanding rapidly as healthcare systems increasingly prioritize early and precise disease detection. Rising incidences of infectious and chronic diseases are driving the demand for advanced diagnostic solutions. Continuous innovation in molecular technologies, such as high-throughput sequencing and automated testing platforms, is enhancing testing efficiency and accuracy. Additionally, growing awareness among clinicians and patients about personalized medicine is supporting market growth. Expanding government initiatives and funding for diagnostic research further bolster adoption. The integration of molecular diagnostics into routine clinical workflows is expected to sustain this growth trajectory over the coming years.
Market Dynamics
Rising Adoption of PCR-Based Testing
The global molecular diagnostics market is witnessing a steady increase in the adoption of polymerase chain Reaction (PCR) technology owing to its high sensitivity and accuracy in detecting infectious agents. PCR continues to dominate diagnostic workflows, particularly in infectious disease testing, including emerging pathogens. Growing awareness among healthcare providers and patients, along with increasing government initiatives for early disease detection, is further driving its use. Technological advancements are also enabling faster and more cost-effective PCR platforms.
Expansion of Reagents & Kits Segment
The demand for diagnostic reagents and kits is expanding rapidly, reflecting their central role in molecular diagnostic testing. Reagents and kits offer standardized and reliable solutions for laboratories, supporting diverse applications such as cancer, genetic testing, and cardiovascular disease diagnostics. Increased investments by key market players in research and development are enhancing the availability and variety of kits. Additionally, the shift toward point-of-care testing and rapid diagnostics is boosting the segment’s market share. This growth trajectory is anticipated to remain strong due to continuous innovation and rising disease prevalence.
Market Segmentation
The global molecular diagnostics market is witnessing significant expansion driven by the increasing demand for high-quality diagnostic reagents and kits. These products provide laboratories with standardized, reliable, and efficient solutions for testing a wide range of diseases. Continuous advancements in reagent formulations are improving sensitivity and reducing turnaround times. Moreover, the availability of diverse kits tailored for specific applications, including genetic and infectious disease testing, is supporting broader adoption. Rising investments by key manufacturers in research and development are further enhancing product offerings.
Infectious Disorders: A Key Segment in Market Growth
The prevalence of infectious disorders is playing a pivotal role in expanding the global molecular diagnostics market. Rapid and accurate detection of pathogens has become essential for effective disease management and outbreak control. Molecular diagnostic technologies offer precise identification of infections, enabling timely therapeutic interventions. Increased public health awareness and government-led screening initiatives are further boosting demand. The ongoing emergence of new infectious agents has intensified the need for advanced testing platforms. As a result, infectious disease diagnostics are increasingly contributing to sustained market growth worldwide.
Regional Outlook
The global molecular diagnostics market is further divided by geography, including North America (the US and Canada), Europe (the UK, Germany, France, Italy, Spain, Russia, and the Rest of Europe), Asia-Pacific (India, China, Japan, South Korea, Australia and New Zealand, ASEAN Countries, and the Rest of Asia-Pacific), and the Rest of the World (the Middle East & Africa, and Latin America).
Growing Investments And Improving Diagnostic Infrastructure in Asia-Pacific
The Asia-Pacific molecular diagnostics market is expanding rapidly, supported by increasing healthcare investments and improving diagnostic infrastructure. Growing prevalence of chronic and infectious diseases has amplified the need for early and precise testing. Rising government initiatives, along with awareness programs for preventive healthcare, are contributing to higher market adoption. Expanding access to advanced molecular technologies in emerging economies is driving demand for diagnostic services. Collaborations between local and international diagnostic companies are further strengthening market penetration.
North America Region Dominates the Market with Major Share
The North American molecular diagnostics market is experiencing steady growth due to widespread adoption of advanced testing technologies. High healthcare expenditure and well-established laboratory infrastructure facilitate rapid integration of innovative molecular diagnostic solutions. The region also benefits from strong government support for research and early disease detection programs. Rising awareness among clinicians and patients regarding personalized medicine further drives demand. Investments in next-generation sequencing and automated testing platforms are enhancing testing accuracy and efficiency.
Market Players Outlook
The major companies operating in the global molecular diagnostics market include Abbott Laboratories, Danaher Corp. (Cepheid), F. Hoffmann‑La Roche Ltd. (Roche Diagnostics), QIAGEN N.V., Thermo Fisher Scientific, Inc., among others. Market players are leveraging partnerships, collaborations, mergers and acquisition strategies for business expansion and innovative product development to maintain their market positioning.
Recent Developments
Industry Overview
Molecular diagnostics market was valued at $19.2 billion in 2025 and is projected to reach $48.0 billion by 2035, growing at a CAGR of 8.9% during the forecast period (2026-2035). The global molecular diagnostics market is expanding rapidly as healthcare systems increasingly prioritize early and precise disease detection. Rising incidences of infectious and chronic diseases are driving the demand for advanced diagnostic solutions. Continuous innovation in molecular technologies, such as high-throughput sequencing and automated testing platforms, is enhancing testing efficiency and accuracy. Additionally, growing awareness among clinicians and patients about personalized medicine is supporting market growth. Expanding government initiatives and funding for diagnostic research further bolster adoption. The integration of molecular diagnostics into routine clinical workflows is expected to sustain this growth trajectory over the coming years.
Market Dynamics
Rising Adoption of PCR-Based Testing
The global molecular diagnostics market is witnessing a steady increase in the adoption of polymerase chain Reaction (PCR) technology owing to its high sensitivity and accuracy in detecting infectious agents. PCR continues to dominate diagnostic workflows, particularly in infectious disease testing, including emerging pathogens. Growing awareness among healthcare providers and patients, along with increasing government initiatives for early disease detection, is further driving its use. Technological advancements are also enabling faster and more cost-effective PCR platforms.
Expansion of Reagents & Kits Segment
The demand for diagnostic reagents and kits is expanding rapidly, reflecting their central role in molecular diagnostic testing. Reagents and kits offer standardized and reliable solutions for laboratories, supporting diverse applications such as cancer, genetic testing, and cardiovascular disease diagnostics. Increased investments by key market players in research and development are enhancing the availability and variety of kits. Additionally, the shift toward point-of-care testing and rapid diagnostics is boosting the segment’s market share. This growth trajectory is anticipated to remain strong due to continuous innovation and rising disease prevalence.
Market Segmentation
- Based on technology, the market is segmented into polymerase chain reaction (PCR), in situ hybridization (ISH), DNA microarray, next-generation sequencing (NGS), isothermal nucleic acid amplification, and other technologies.
- Based on the product, the market is segmented into testing equipment, diagnostic reagents & kits, and services & software.
- Based on the application, the market is segmented into infectious diseases, cancer, cardiovascular disease (CVD), genetic testing, neurological disease, and other.
The global molecular diagnostics market is witnessing significant expansion driven by the increasing demand for high-quality diagnostic reagents and kits. These products provide laboratories with standardized, reliable, and efficient solutions for testing a wide range of diseases. Continuous advancements in reagent formulations are improving sensitivity and reducing turnaround times. Moreover, the availability of diverse kits tailored for specific applications, including genetic and infectious disease testing, is supporting broader adoption. Rising investments by key manufacturers in research and development are further enhancing product offerings.
Infectious Disorders: A Key Segment in Market Growth
The prevalence of infectious disorders is playing a pivotal role in expanding the global molecular diagnostics market. Rapid and accurate detection of pathogens has become essential for effective disease management and outbreak control. Molecular diagnostic technologies offer precise identification of infections, enabling timely therapeutic interventions. Increased public health awareness and government-led screening initiatives are further boosting demand. The ongoing emergence of new infectious agents has intensified the need for advanced testing platforms. As a result, infectious disease diagnostics are increasingly contributing to sustained market growth worldwide.
Regional Outlook
The global molecular diagnostics market is further divided by geography, including North America (the US and Canada), Europe (the UK, Germany, France, Italy, Spain, Russia, and the Rest of Europe), Asia-Pacific (India, China, Japan, South Korea, Australia and New Zealand, ASEAN Countries, and the Rest of Asia-Pacific), and the Rest of the World (the Middle East & Africa, and Latin America).
Growing Investments And Improving Diagnostic Infrastructure in Asia-Pacific
The Asia-Pacific molecular diagnostics market is expanding rapidly, supported by increasing healthcare investments and improving diagnostic infrastructure. Growing prevalence of chronic and infectious diseases has amplified the need for early and precise testing. Rising government initiatives, along with awareness programs for preventive healthcare, are contributing to higher market adoption. Expanding access to advanced molecular technologies in emerging economies is driving demand for diagnostic services. Collaborations between local and international diagnostic companies are further strengthening market penetration.
North America Region Dominates the Market with Major Share
The North American molecular diagnostics market is experiencing steady growth due to widespread adoption of advanced testing technologies. High healthcare expenditure and well-established laboratory infrastructure facilitate rapid integration of innovative molecular diagnostic solutions. The region also benefits from strong government support for research and early disease detection programs. Rising awareness among clinicians and patients regarding personalized medicine further drives demand. Investments in next-generation sequencing and automated testing platforms are enhancing testing accuracy and efficiency.
Market Players Outlook
The major companies operating in the global molecular diagnostics market include Abbott Laboratories, Danaher Corp. (Cepheid), F. Hoffmann‑La Roche Ltd. (Roche Diagnostics), QIAGEN N.V., Thermo Fisher Scientific, Inc., among others. Market players are leveraging partnerships, collaborations, mergers and acquisition strategies for business expansion and innovative product development to maintain their market positioning.
Recent Developments
- In May 2025, Danaher Corp. announced a partnership with AstraZeneca to develop and commercialize novel diagnostic tools and tests intended to help clinicians better determine which patients would most benefit from precision medicine treatments. This partnership will utilize the newly opened Danaher Centers for Enabling Precision Medicine to support a more streamlined, end-to-end development process.
- In September 2024, Roche announced the launch of the cobas Respiratory flex test, the first to use Roche’s novel and proprietary TAGS (Temperature-Activated Generation of Signal) technology. TAGS technology, developed by Roche scientists, uses multiplex polymerase chain reaction (PCR) testing, combined with colour, temperature, and data processing, to identify as many as 15 pathogens in a single PCR test.
- Market value data analysis of 2025 and forecast to 2035.
- Annualized market revenues ($ million) for each market segment.
- Country-wise analysis of major geographical regions.
- Key companies operating in the global molecular diagnostics market. Based on the availability of data, information related to new products and relevant news is also available in the report.
- Analysis of business strategies by identifying the key market segments positioned for strong growth in the future.
- Analysis of market-entry and market expansion strategies.
- Competitive strategies by identifying ‘who-stands-where’ in the market.
Table of Contents
293 Pages
- 1. Report Summary
- Current Industry Analysis and Growth Potential Outlook
- Global Molecular Diagnostics Market Sales Analysis – Technology | Product | Application ($ Million)
- Molecular Diagnostics Market Sales Performance of Top Countries
- 1.1. Research Methodology
- Primary Research Approach
- Secondary Research Approach
- 1.2. Market Snapshot
- 2. Market Overview and Insights
- 2.1. Scope of the Study
- 2.2. Analyst Insight & Current Market Trends
- 2.2.1. Key Molecular Diagnostics Market Trends
- 2.2.2. Market Recommendations
- 3. Market Determinants
- 3.1. Market Drivers
- 3.1.1. Drivers For Global Molecular Diagnostics Market: Impact Analysis
- 3.2. Market Pain Points and Challenges
- 3.2.1. Restraints For Global Molecular Diagnostics Market: Impact Analysis
- 3.3. Market Opportunities
- 3.3.1. Opportunities For Global Molecular Diagnostics Market: Impact Analysis
- 4. Competitive Landscape
- 4.1. Competitive Dashboard – Molecular Diagnostics Market Revenue and Share by Manufacturers
- Molecular Diagnostics Product Comparison Analysis
- Top Market Player Ranking Matrix
- 4.2. Key Company Analysis
- 4.2.1. Abbott Laboratories
- 4.2.1.1. Overview
- 4.2.1.2. Product Portfolio
- 4.2.1.3. Financial Analysis
- 4.2.1.4. SWOT Analysis
- 4.2.1.5. Business Strategy
- 4.2.2. Danaher Corp. (Cepheid)
- 4.2.2.1. Overview
- 4.2.2.2. Product Portfolio
- 4.2.2.3. Financial Analysis
- 4.2.2.4. SWOT Analysis
- 4.2.2.5. Business Strategy
- 4.2.3. F. Hoffmann‑La Roche Ltd. (Roche Diagnostics)
- 4.2.3.1. Overview
- 4.2.3.2. Product Portfolio
- 4.2.3.3. Financial Analysis
- 4.2.3.4. SWOT Analysis
- 4.2.3.5. Business Strategy
- 4.2.4. QIAGEN N.V.
- 4.2.4.1. Overview
- 4.2.4.2. Product Portfolio
- 4.2.4.3. Financial Analysis
- 4.2.4.4. SWOT Analysis
- 4.2.4.5. Business Strategy
- 4.2.5. Thermo Fisher Scientific, Inc.
- 4.2.5.1. Overview
- 4.2.5.2. Product Portfolio
- 4.2.5.3. Financial Analysis
- 4.2.5.4. SWOT Analysis
- 4.2.5.5. Business Strategy
- 4.3. Top Winning Strategies by Market Players
- 4.3.1. Merger and Acquisition
- 4.3.2. Product Launch
- 4.3.3. Partnership And Collaboration
- 5. Global Molecular Diagnostics Market Sales Analysis by Technology ($ Million)
- 5.1. Polymerase Chain Reaction (PCR)
- 5.2. In Situ Hybridization (ISH)
- 5.3. DNA Microarray
- 5.4. Next-Generation Sequencing (NGS)
- 5.5. Isothermal Nucleic Acid Amplification
- 5.6. Other Technologies
- 6. Global Molecular Diagnostics Market Sales Analysis by Product ($ Million)
- 6.1. Testing Instruments
- 6.2. Diagnostic Reagents and Kits
- 6.3. Services & Software
- 7. Global Molecular Diagnostics Market Sales Analysis by Application ($ Million)
- 7.1. Infectious Disorders (including COVID-19)
- 7.2. Cancer
- 7.3. Cardiovascular Disease (CVD)
- 7.4. Genetic Testing
- 7.5. Neurological Disease
- 7.6. Other
- 8. Regional Analysis
- 8.1. North American Molecular Diagnostics Market Sales Analysis – Technology | Product | Application | Country ($ Million)
- Macroeconomic Factors for North America
- 8.1.1. United States
- 8.1.2. Canada
- 8.2. European Molecular Diagnostics Market Sales Analysis – Technology | Product | Application | Country ($ Million)
- Macroeconomic Factors for Europe
- 8.2.1. UK
- 8.2.2. Germany
- 8.2.3. Italy
- 8.2.4. Spain
- 8.2.5. France
- 8.2.6. Russia
- 8.2.7. Rest of Europe
- 8.3. Asia-Pacific Molecular Diagnostics Market Sales Analysis – Technology | Product | Application | Country ($ Million)
- Macroeconomic Factors for Asia-Pacific
- 8.3.1. China
- 8.3.2. Japan
- 8.3.3. South Korea
- 8.3.4. India
- 8.3.5. Australia & New Zealand
- 8.3.6. ASEAN Countries (Thailand, Indonesia, Vietnam, Singapore, And Other)
- 8.3.7. Rest of Asia-Pacific
- 8.4. Rest of the World Molecular Diagnostics Market Sales Analysis – Technology | Product | Application | Country ($ Million)
- Macroeconomic Factors for Rest of the World
- 8.4.1. Latin America
- 8.4.2. Middle East and Africa
- 9. Company Profiles
- 9.1. Abbott Laboratories
- 9.1.1. Quick Facts
- 9.1.2. Company Overview
- 9.1.3. Product Portfolio
- 9.1.4. Business Strategies
- 9.2. Agilent Technologies, Inc.
- 9.2.1. Quick Facts
- 9.2.2. Company Overview
- 9.2.3. Product Portfolio
- 9.2.4. Business Strategies
- 9.3. Becton, Dickinson and Company
- 9.3.1. Quick Facts
- 9.3.2. Company Overview
- 9.3.3. Product Portfolio
- 9.3.4. Business Strategies
- 9.4. Biocartis Group NV
- 9.4.1. Quick Facts
- 9.4.2. Company Overview
- 9.4.3. Product Portfolio
- 9.4.4. Business Strategies
- 9.5. bioMérieux SA
- 9.5.1. Quick Facts
- 9.5.2. Company Overview
- 9.5.3. Product Portfolio
- 9.5.4. Business Strategies
- 9.6. Bio‑Rad Laboratories, Inc.
- 9.6.1. Quick Facts
- 9.6.2. Company Overview
- 9.6.3. Product Portfolio
- 9.6.4. Business Strategies
- 9.7. Bruker Corp.
- 9.7.1. Quick Facts
- 9.7.2. Company Overview
- 9.7.3. Product Portfolio
- 9.7.4. Business Strategies
- 9.8. Danaher Corp. (Cepheid)
- 9.8.1. Quick Facts
- 9.8.2. Company Overview
- 9.8.3. Product Portfolio
- 9.8.4. Business Strategies
- 9.9. DiaSorin S.p.A.
- 9.9.1. Quick Facts
- 9.9.2. Company Overview
- 9.9.3. Product Portfolio
- 9.9.4. Business Strategies
- 9.10. F. Hoffmann‑La Roche Ltd. (Roche Diagnostics)
- 9.10.1. Quick Facts
- 9.10.2. Company Overview
- 9.10.3. Product Portfolio
- 9.10.4. Business Strategies
- 9.11. Grifols, S.A.
- 9.11.1. Quick Facts
- 9.11.2. Company Overview
- 9.11.3. Product Portfolio
- 9.11.4. Business Strategies
- 9.12. Hologic, Inc.
- 9.12.1. Quick Facts
- 9.12.2. Company Overview
- 9.12.3. Product Portfolio
- 9.12.4. Business Strategies
- 9.13. Illumina, Inc.
- 9.13.1. Quick Facts
- 9.13.2. Company Overview
- 9.13.3. Product Portfolio
- 9.13.4. Business Strategies
- 9.14. Myriad Genetics, Inc.
- 9.14.1. Quick Facts
- 9.14.2. Company Overview
- 9.14.3. Product Portfolio
- 9.14.4. Business Strategies
- 9.15. QIAGEN N.V.
- 9.15.1. Quick Facts
- 9.15.2. Company Overview
- 9.15.3. Product Portfolio
- 9.15.4. Business Strategies
- 9.16. Quidel Ortho Corp.
- 9.16.1. Quick Facts
- 9.16.2. Company Overview
- 9.16.3. Product Portfolio
- 9.16.4. Business Strategies
- 9.17. Seegene, Inc.
- 9.17.1. Quick Facts
- 9.17.2. Company Overview
- 9.17.3. Product Portfolio
- 9.17.4. Business Strategies
- 9.18. Siemens Healthineers AG
- 9.18.1. Quick Facts
- 9.18.2. Company Overview
- 9.18.3. Product Portfolio
- 9.18.4. Business Strategies
- 9.19. Sysmex Corp.
- 9.19.1. Quick Facts
- 9.19.2. Company Overview
- 9.19.3. Product Portfolio
- 9.19.4. Business Strategies
- 9.20. Thermo Fisher Scientific, Inc.
- 9.20.1. Quick Facts
- 9.20.2. Company Overview
- 9.20.3. Product Portfolio
- 9.20.4. Business Strategies
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