Molecular Diagnostics Market Introduction and Overview
According to SPER Market Research, the Global Molecular Diagnostics Market is estimated to reach USD 39.08 billion by 2034 with a CAGR of 4.26%.
The market is expanding due in large part to technological advancements, an aging population, and a growing need for accurate and effective genetic testing. Additionally, increased patient awareness of the advantages of quicker diagnostic results and a growing need for self-diagnostic tools are driving the growing popularity of Point-of-Care (POC) testing. Businesses are being encouraged by this trend to create and launch new testing products. Additionally, the market for molecular diagnostics is expanding due to the increased prevalence of infectious diseases and different types of cancer. Further propelling market expansion are developments in biomarker discovery and heightened understanding and acceptance of personalized medicine. However, Due to their high cost, only reference labs and major hospitals with substantial capital budgets can afford to buy molecular diagnostic technologies. Lacking adequate funding, many smaller labs, medical practices, and private practitioners could not be able to purchase these pricey, massive analyzers. Therefore, the high prices may prevent the market for molecular diagnostics from expanding.
Recent Developments:
- In 2024: The FDA approved Danaher's (US) dual-target molecular diagnostic test, Xpert Xpress GBS, in March 2024 for the qualitative intrapartum detection of Group B Streptococcus (GBS).
- The BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel from bioMérieux (France) received US FDA 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver approval in March 2024.
By Product: Based on product, reagents segment dominated the market.
The reagents segment held the largest market share in 2024, driven by the increasing demand for accurate and efficient diagnostic tools across various healthcare sectors. Reagents, including enzymes, probes, primers, and buffers, are crucial for molecular diagnostic tests. Continuous innovation and new product launches by key players further contribute to the segment's growth.
By Test Location: The central laboratories segment held the largest market share in 2024
The central laboratories segment dominated the market in 2024, holding the largest revenue share at 78.8%. This dominance stems from advancements in laboratory technology, such as automation and integration, which significantly improve testing efficiency and throughput. Central laboratories excel at handling high-volume testing, facilitating faster and more accurate diagnoses. Their crucial role in disease detection, monitoring, and personalized medicine continues to drive market growth. Secondly, the self-test or OTC segment is projected to experience the most rapid growth during the forecast period. This growth is primarily driven by a rising consumer preference for at-home health monitoring solutions
By Technology: Based on technology, the PCR segment led the market with the largest revenue.
The PCR segment led the market, holding the largest revenue share in 2024. PCR encompasses various methods, including quantitative PCR, reverse transcription PCR, and multiplex PCR, with multiplex PCR gaining popularity due to its ability to detect multiple targets simultaneously. Real-time PCR has become crucial for cancer marker analysis, driving the increased use of high-throughput PCR techniques in cancer detection. Further driving segment expansion has been the advancement of digital PCR technologies.
By Application: The infectious disease segment led the market with the largest revenue share
The infectious disease segment held the largest market share in 2024, driven by the increasing demand for rapid and accurate pathogen detection. Molecular diagnostic techniques like PCR and next-generation sequencing have revolutionized infectious disease identification, allowing healthcare providers to diagnose conditions like tuberculosis, HIV, and various viral infections more efficiently than traditional methods. Key market players contribute to the growth of the infectious disease segment by developing innovative, rapid, and accurate diagnostic technologies.
By Region: The greatest market share for Molecular Diagnostics Market is held by the North America region.
North America led the molecular diagnostic market in 2024, holding the largest revenue share. This dominance is attributed to the increasing adoption of molecular diagnostics, recognized for their superior accuracy, sensitivity, and specificity. The rising demand for genetic testing, particularly for personalized healthcare in conditions like diabetes and cancer, is expected to drive market growth. Furthermore, increasing regulatory support for advanced solutions further contributes to market expansion.
Market Competitive Landscape
The Global Molecular Diagnostics Market is highly consolidated. Some of the market players are Abbott, Agilent Technologies, Inc., BD, Bio-Rad Laboratories, Inc., BIOMÉRIEUX, Danaher, F. Hoffmann-La Roche, Ltd., Grifols, Hologic Inc. (Gen Probe), Illumina, Inc., QIAGEN, Siemens Healthineers AG, Sysmex Corporation, Others.
Scope of the Report:
| Report Metric | Details |
| Market size available for years | 2021-2034 |
| Base year considered | 2024 |
| Forecast period | 2025-2034 |
| Segments covered | By Product, By Test Location, By Technology, By Application.
|
| Regions covered | North America, Asia-Pacific, Latin America, Middle East & Africa and Europe. |
| Companies Covered | Abbott, Agilent Technologies, Inc., BD, Bio-Rad Laboratories, Inc., BIOMÉRIEUX, Danaher, F. Hoffmann-La Roche, Ltd., Grifols, Hologic Inc. (Gen Probe), Illumina, Inc., QIAGEN, Siemens Healthineers AG, Sysmex Corporation, Others. |
Key Topics Covered in the Report:
- Global Molecular Diagnostics Market Size (FY’2025-FY’2034)
- Overview of Global Molecular Diagnostics Market
- Segmentation of Global Molecular Diagnostics Market By Product (Instruments, Regards, Others)
- Segmentation of Global Molecular Diagnostics Market By Test Location (Point of care, Self-test or OTC, Central laboratories)
- Segmentation of Global Molecular Diagnostics Market By Technology (Polymerase Chain Reaction, Isothermal Nucleic Acid Amplification Technology, DNA Sequencing & Next-Generation Sequencing, In Situ Hybridization, DNA Microarrays, Other)
- Segmentation of Global Molecular Diagnostics Market By Application (Oncology, Pharmacogenomics, Infectious disease, Genetic Testing, Neurological disease, Cardiovascular disease, Microbiology, Others)
- Statistical Snap of Global Molecular Diagnostics Market
- Expansion Analysis of Global Molecular Diagnostics Market
- Problems and Obstacles in Global Molecular Diagnostics Market
- Competitive Landscape in the Global Molecular Diagnostics Market
- Details on Current Investment in Global Molecular Diagnostics Market
- Competitive Analysis of Global Molecular Diagnostics Market
- Prominent Players in the Global Molecular Diagnostics Market
- SWOT Analysis of Global Molecular Diagnostics Market
- Global Molecular Diagnostics Market Future Outlook and Projections (FY’2025-FY’2034)
- Recommendations from Analyst
1. Introduction
1.1. Scope of the report
1.2. Market segment analysis
2. Research Methodology
2.1. Research data source
2.1.1. Secondary Data
2.1.2. Primary Data
2.1.3. SPERs internal database
2.1.4. Premium insight from KOLs
2.2. Market size estimation
2.2.1. Top-down and Bottom-up approach
2.3. Data triangulation
3. Executive Summary
4. Market Dynamics
4.1. Driver, Restraint, Opportunity and Challenges analysis
4.1.1. Drivers
4.1.2. Restraints
4.1.3. Opportunities
4.1.4. Challenges
5. Market variable and outlook
5.1. SWOT Analysis
5.1.1. Strengths
5.1.2. Weaknesses
5.1.3. Opportunities
5.1.4. Threats
5.2. PESTEL Analysis
5.2.1. Political Landscape
5.2.2. Economic Landscape
5.2.3. Social Landscape
5.2.4. Technological Landscape
5.2.5. Environmental Landscape
5.2.6. Legal Landscape
5.3. PORTERs Five Forces
5.3.1. Bargaining power of suppliers
5.3.2. Bargaining power of buyers
5.3.3. Threat of Substitute
5.3.4. Threat of new entrant
5.3.5. Competitive rivalry
5.4. Heat Map Analysis
6. Competitive Landscape
6.1. Global Molecular Diagnostics Market Manufacturing Base Distribution, Sales Area, Product Type
6.2. Mergers & Acquisitions, Partnerships, Product Launch, and Collaboration in Global Molecular Diagnostics Market
7. Global Molecular Diagnostics Market, By Product (USD Million) 2025-2034
7.1. Instruments
7.2. Regards
7.3. Others
8. Global Molecular Diagnostics Market, By Test Location (USD Million) 2025-2034
8.1. Point of care
8.2. Self-test or OTC
8.3. Central laboratories
9. Global Molecular Diagnostics Market, By Technology (USD Million) 2025-2034
9.1. Polymerase Chain Reaction
9.2. Isothermal Nucleic Acid Amplification Technology
9.3. DNA Sequencing & Next-Generation Sequencing
9.4. In Situ Hybridization
9.5. DNA Microarrays
9.6. Other
10. Global Molecular Diagnostics Market, By Application (USD Million) 2025-2034
10.1. Oncology
10.1.1. Breast Cancer
10.1.2. Prostate Cancer
10.1.3. Colorectal Cancer
10.1.4. Cervical
10.1.5. Kidney
10.1.6. Liver
10.1.7. Blood
10.1.8. Lung
10.1.9. Other
10.2. Pharmacogenomics
10.3. Infectious disease
10.3.1. MRSA
10.3.2. Clostridium difficile
10.3.3. Vancomycin-resistant enterococci
10.3.4. Carbapenem-resistant bacteria testing
10.3.5. Flu
10.3.6. Respiratory syncytial virus (RSV)
10.3.7. Candida
10.3.8. Tuberculosis and drug-resistant TB
10.3.9. Meningitis
10.3.10. Gastro-intestinal panel testing
10.3.11. Chlamydia
10.3.12. Gonorrhea
10.3.13. HIV
10.3.14. Hepatitis C
10.3.15. Hepatitis B
10.3.16. Other Infectious Diseases
10.4. Genetic Testing
10.4.1. Newborn screening
10.4.2. Predictive and presymptomatic testing
10.4.3. Others
10.5. Neurological disease
10.6. Cardiovascular disease
10.7. Microbiology
10.8. Others
11. Global Molecular Diagnostics Market Forecast, 2025-2034 (USD Million)
11.1. Global Molecular Diagnostics Market Size and Market Share
12. Global Molecular Diagnostics Market, By Region, 2025-2034 (USD Million)
12.1. Asia-Pacific
12.1.1. Australia
12.1.2. China
12.1.3. India
12.1.4. Japan
12.1.5. South Korea
12.1.6. Rest of Asia-Pacific
12.2. Europe
12.2.1. France
12.2.2. Germany
12.2.3. Italy
12.2.4. Spain
12.2.5. United Kingdom
12.2.6. Rest of Europe
12.3. Middle East and Africa
12.3.1. Kingdom of Saudi Arabia
12.3.2. United Arab Emirates
12.3.3. Qatar
12.3.4. South Africa
12.3.5. Egypt
12.3.6. Morocco
12.3.7. Nigeria
12.3.8. Rest of Middle-East and Africa
12.4. North America
12.4.1. Canada
12.4.2. Mexico
12.4.3. United States
12.5. Latin America
12.5.1. Argentina
12.5.2. Brazil
12.5.3. Rest of Latin America
13. Company Profile
13.1. Abbott
13.1.1. Company details
13.1.2. Financial outlook
13.1.3. Product summary
13.1.4. Recent developments
13.2. Agilent Technologies, Inc.
13.2.1. Company details
13.2.2. Financial outlook
13.2.3. Product summary
13.2.4. Recent developments
13.3. BD
13.3.1. Company details
13.3.2. Financial outlook
13.3.3. Product summary
13.3.4. Recent developments
13.4. Bio-Rad Laboratories, Inc.
13.4.1. Company details
13.4.2. Financial outlook
13.4.3. Product summary
13.4.4. Recent developments
13.5. BIOMÉRIEUX
13.5.1. Company details
13.5.2. Financial outlook
13.5.3. Product summary
13.5.4. Recent developments
13.6. Danaher
13.6.1. Company details
13.6.2. Financial outlook
13.6.3. Product summary
13.6.4. Recent developments
13.7. F. Hoffmann-La Roche, Ltd.
13.7.1. Company details
13.7.2. Financial outlook
13.7.3. Product summary
13.7.4. Recent developments
13.8. Grifols
13.8.1. Company details
13.8.2. Financial outlook
13.8.3. Product summary
13.8.4. Recent developments
13.9. Hologic Inc. (Gen Probe)
13.9.1. Company details
13.9.2. Financial outlook
13.9.3. Product summary
13.9.4. Recent developments
13.10. Illumina, Inc.
13.10.1. Company details
13.10.2. Financial outlook
13.10.3. Product summary
13.10.4. Recent developments
13.11. QIAGEN
13.11.1. Company details
13.11.2. Financial outlook
13.11.3. Product summary
13.11.4. Recent developments
13.12. Siemens Healthineers AG
13.12.1. Company details
13.12.2. Financial outlook
13.12.3. Product summary
13.12.4. Recent developments
13.13. Sysmex Corporation
13.13.1. Company details
13.13.2. Financial outlook
13.13.3. Product summary
13.13.4. Recent developments
13.14. Others
14. Conclusion
15. List of Abbreviations
16. Reference Links