The molecular diagnostics market is experiencing strong growth, driven by advances in genomic technologies and the rising demand for early and accurate disease detection.
WESTFORD, Mass., July 29, 2025 /PRNewswire/ -- SkyQuest Technology Consulting published a report, titled, Molecular Diagnostics Market - Global Opportunity Analysis and Industry Forecast, 2025-2032", valued at USD 19.1 Billion in 2024. With a projected CAGR of 7.3% from 2025 to 2032, the market is expected to reach USD 33.7 Billion by the end of 2032. The rising use of point-of-care (POC) diagnostics, especially in decentralized and remote healthcare settings, is enhancing access to molecular testing.
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Molecular Diagnostics Market Dynamics:
One of the key drivers is the increasing prevalence of infectious diseases and various forms of cancer, which has led to a surge in demand for precise and rapid diagnostic tools. Additionally, the market is propelled by the growing adoption of personalized medicine, as healthcare providers shift toward tailored treatment plans based on individual genetic profiles. Technological advancements such as real-time PCR, next-generation sequencing (NGS), and microarray technology have significantly improved the speed, sensitivity, and specificity of molecular tests, further fueling their clinical adoption.
Recent Developments in Molecular Diagnostics Market
- In July 2024, Illumina completed the acquisition of Fluent BioSciences, a pioneer in single-cell analysis technology. The deal strengthens Illumina's portfolio in high-resolution genomic tools, expanding its capabilities in research and clinical diagnostics, particularly in oncology and immunology.
- In May 2024, Bruker Corporation completed the acquisition of ELITechGroup for €870 million in cash excluding ELITech clinical chemistry business. A molecular diagnostics MDx, biomedical systems/specialty IVDs, Microbiology solutions and services provider ELITech posted near about EUR 150 million of FY 2023 revenues and over 80% by Consumable. The acquisition by Bruker is impressive since it brings changes and expansion to the company and situates it as an innovative infectious disease company in the IVD industry.
- In April 2024, Abbott launched the Alinity m molecular diagnostics analyzer and the GLP Systems Track automation platform across several countries, including India. These innovations aim to significantly reduce manual laboratory work and enhance diagnostic throughput and accuracy.
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Major Challenges in Molecular Diagnostics Industry
The molecular diagnostics market faces several key challenges that hinder its full potential. One major obstacle is the high cost of advanced molecular testing technologies, such as next-generation sequencing (NGS) and digital PCR, which limits accessibility, especially in low- and middle-income countries. The complexity of test development and validation also poses a barrier, as it requires significant investment in R&D, specialized expertise, and adherence to strict regulatory standards. These factors can slow down product approvals and market entry for new players.
Another significant challenge is the lack of standardized protocols and infrastructure, particularly in decentralized and point-of-care settings. Variability in test results due to differences in equipment, sample handling, and operator proficiency can affect diagnostic accuracy and reliability.
Competitive Landscape
The competitive landscape of the molecular diagnostics market is shaped by a mix of well-established diagnostics giants (e.g., Roche, Abbott, Thermo Fisher, Danaher, QIAGEN) and fast-growing tech innovators. These organizations sustain their lead through strategic investments in R&D, targeted acquisitions, and international expansion.
For instance, Bruker's €870 million acquisition of ELITechGroup in May 2024 added niche molecular diagnostic platforms and assays, enhancing its infectious disease offerings.
The major players in the molecular diagnostics industry include,
- F. Hoffmann-La Roche Ltd. (Switzerland)
- Hologic, Inc. (US)
- Abbott Laboratories (US)
- Illumina, Inc. (US)
- Thermo Fisher Scientific Inc. (US)
- bioMerieux (France)
- QIAGEN (Netherlands)
- Becton Dickinson And Company (US)
- Grifols S.A. (Spain)
- Bio-Rad Laboratories, Inc. (US)
- Sysmex Corporation (Japan)
- Quidel Corporation (US)
- Biocartis (Belgium)
- DiaSorin (Italy)
- Myriad Genetics (US)
- Revvity (US)
- MDxHealth (Belgium)
- OncoCyte Corporation (US)
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Molecular Diagnostics Market Segmental Analysis
- By test type, lab tests dominate when providing high-throughput processing, improved accuracy and the ability to perform complex and multiplexed assays, making them ideal for large-scale disease screening and research applications.
- By sample type, blood segment dominates the market, as it is highly accessible, minimal invasive and rich in clinical biomarkers such as DNA, RNA and protein.
- By technology, the polymerase chain reaction dominates due to its position as standard for gold in molecular diagnosis, especially by detection of infectious disease, and provides high sensitivity, specificity and rapid amplification of genetic material.
- By application, infectious disease diagnostics dominate owing to the global rise in infectious diseases such as COVID-19, HIV, tuberculosis, and influenza, driving demand for rapid, accurate, and scalable testing solutions.
- By end user, diagnostic laboratories dominate as they are equipped with advanced instruments, trained professionals, and high-capacity systems to perform large volumes of complex molecular tests with precision and regulatory compliance.
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Regional Outlook
North America dominates the molecular diagnostics market, which is driven by the presence of actors in the prominent industry as advanced diagnostic technologies, a strong infrastructure for the health care system and Rosh, Thermo Fisher and Abbott.
The Asia Pacific is the fastest growing region, which is fueled with increasing population, and expands the increased incidence of chronic and infectious diseases and the health system's investments. Countries such as China, India, Japan and South Korea invest heavily in laboratory infrastructure and genomic research.
Europe holds a significant share in the market, supported by a well-established regulatory framework, including CE-IVD marking and GDPR-compliant diagnostics.
LAMEA is an emerging molecular diagnostics market, leading to gradual progress in clinical awareness, the health care investment and infrastructure development. Countries such as Brazil, South Africa and UAE show increasing molecular testing in both public and private health areas.
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