PUBLISHER: AnalystView Market Insights | PRODUCT CODE: 1901531
PUBLISHER: AnalystView Market Insights | PRODUCT CODE: 1901531
The Molecular Diagnostics Market size was valued at US$ 25,456.89 Million in 2024, expanding at a CAGR of 4.1% from 2025 to 2032.
The molecular diagnostics market is experiencing strong growth driven by rising demand for precise, rapid, and early disease detection. Technologies such as PCR, NGS, ISH, microarrays, and isothermal amplification are widely used for diagnosing infectious diseases, cancer, genetic disorders, and for blood screening. Increasing prevalence of conditions like HIV, COVID-19, tuberculosis, and various cancers continues to boost test adoption. Growing applications in companion diagnostics, personalized medicine, and pharmacogenomics further strengthen market expansion. However, the Molecular diagnostics market faces restraints such as high test and equipment costs, complex regulatory approvals, and others.
Molecular Diagnostics Market- Market Dynamics
Rising prevalence of infectious diseases and cancers
Molecular diagnostics, especially PCR, real-time PCR, and isothermal amplification, allow early identification of pathogens, even at very low viral or bacterial loads. This supports timely treatment decisions, outbreak control, and effective patient management. Additionally, new variants of viruses and antimicrobial resistance trends further increase dependence on molecular-level testing. The rising prevalence of infectious diseases and cancers is a major force driving the growth of the molecular diagnostics market. Infectious diseases such as HIV, hepatitis B and C, tuberculosis, influenza, respiratory infections, and emerging viral threats require rapid, accurate, and sensitive detection methods. According to the data published by the World Health Organization, at the end of 2024, an estimated 40.8 million people worldwide were living with HIV, including 39.4 million adults and 1.4 million children. In that year, about 1.3 million people acquired HIV globally. Additionally, around 630,000 people died from AIDS-related illnesses in 2024, marking a 54% reduction in AIDS-related deaths since 2010. Thus, growing disease burden, need for early detection, and expanding precision medicine applications are significantly accelerating the adoption of molecular diagnostics worldwide.
The Global Molecular Diagnostics Market is segmented on the basis of Product, Technology, Application, End User, and Region.
The market is divided into three categories based on Product: Reagents & Kits, Instruments & Systems, and Software & Services. Reagents & kits dominate due to high testing frequency, while instruments & systems support automation and accuracy, and software & services enable efficient data analysis, workflow management, and integration.
The market is divided into six categories based on Technology: PCR, Next-Generation Sequencing (NGS), In Situ Hybridization, Chips & Microarrays, Mass Spectrometry, and Other Technologies. NGS enables genomic profiling; In situ Hybridization offers spatial analysis; microarrays and mass spectrometry enhance multiplexing and precision, while other technologies support specialised and emerging diagnostic applications.
Molecular Diagnostics Market- Geographical Insights
North America leads the market due to advanced healthcare infrastructure, high adoption of PCR and NGS technologies, strong presence of major companies, and robust reimbursement systems. Europe follows closely, driven by rising cancer diagnostics, infectious disease testing, and government support for precision medicine. Asia-Pacific is the fastest-growing region, supported by expanding healthcare access, rising chronic disease burden, large patient populations, and increasing investments in genomics and laboratory automation in countries like China, India, and Japan. Latin America shows moderate growth, driven by improving diagnostic capacity and expanding public health programs. Middle East & Africa remain emerging markets, with growth limited by cost constraints but supported by gradual improvements in healthcare infrastructure and infectious disease screening initiatives.
Molecular Diagnostics Market- Country Insights
The United States molecular diagnostics market was reflecting a significant CAGR. This growth is primarily driven by advancements in diagnostic technologies, increasing demand for personalised medicine, and a rising incidence of infectious diseases and cancer in the country. The U.S. healthcare system's focus on early disease detection and precision medicine contributes to the widespread adoption of molecular diagnostics across hospitals, diagnostic centres, and research institutions. Key technologies such as liquid biopsy and next-generation sequencing (NGS) are increasingly utilised to enhance diagnostic accuracy and targeted therapy selection, especially in oncology. Additionally, the rising prevalence of infectious diseases like COVID-19, influenza, and HIV fuels demand for rapid and accurate molecular testing.
The molecular diagnostics market's competitive landscape in 2025 is led by several major global players that drive innovation and market growth through robust product portfolios, technological advancements, and strategic expansions. For instance, in August 2024, Sysmex Corporation expanded its strategic alliance with QIAGEN to deepen collaboration in genetic testing, covering research and development, production, clinical trials, and global sales and marketing. This alliance builds upon their initial 2021 partnership focused on cancer companion diagnostics using ultra-sensitive liquid biopsy NGS technology. Additionally, the market players are actively engaged in regulatory approvals, acquisitions, and partnerships to enhance their market presence. Moreover, the collaborative efforts of market players, coupled with continuous R&D, enable the molecular diagnostics market to grow robustly, addressing diverse clinical needs globally.
In March 2025, Danaher Corporation, through subsidiaries like Beckman Coulter, is investing in automated and high-throughput molecular diagnostic solutions to support diverse clinical needs.
In February 2023, Becton Dickinson (BD) received FDA Emergency Use Authorisation (EUA) for a molecular diagnostic test capable of detecting and differentiating COVID-19, influenza A/B, and respiratory syncytial virus (RSV). This test, designed for use on the BD MAX Molecular Diagnostic System, uses a single nasal or nasopharyngeal swab sample.