DELRAY BEACH, Fla., Sept. 3, 2025 /PRNewswire/ -- The global Point-of-Care Molecular Diagnostics Market, valued at US$4.01 billion in 2024, stood at US$4.30 billion in 2025 and is projected to advance at a resilient CAGR of 10.5% from 2025 to 2030, culminating in a forecasted valuation of US$7.09 billion by the end of the period. The market is experiencing strong growth due to increasing demand for timely and accessible testing solutions. A major factor is the rising prevalence of infectious diseases and cancer, which has created a growing need for fast and reliable diagnostics. Additionally, the move toward decentralized testing is gaining momentum, supported by increased research and development funding to make diagnostics more accessible to patients. This is especially crucial in remote or resource-limited areas.
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By technology, the point-of-care molecular diagnostics market, by technology, is segmented into RT-PCR, INAAT, and other technologies. RT-PCR held the largest share of the market in 2024. Its extensive clinical utility, high sensitivity, and quick turnaround time have driven its widespread adoption across various healthcare environments. The integration of compact, user-friendly RT-PCR systems into decentralized locations like hospitals and emergency care units has further boosted their use. Increasing demand for rapid detection of infectious diseases continues to propel this technology's growth. Additionally, ongoing product development focused on enhancing workflow efficiency and result accuracy is expected to maintain its market leadership in the near future.
By end user, the point-of-care molecular diagnostics market, by end user, is segmented into physicians' offices/clinics, hospitals, research institutes, and other end users. In 2024, hospitals held the largest market share. This dominance is mainly driven by their high patient volumes and the need for rapid, accurate diagnostic solutions. The increasing burden of infectious diseases and the rising demand for timely clinical decisions in emergency and critical care settings have sped up the adoption of point-of-care molecular diagnostics in hospitals. These platforms enable quicker diagnosis and treatment initiation, helping to shorten hospital stays and improve patient outcomes. Additionally, hospitals are increasingly investing in decentralized testing capabilities to streamline workflows and ease pressure on centralized labs, increasing demand for point-of-care molecular diagnostics solutions.
By geography, the point-of-care molecular diagnostics market is segmented into five regions: North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. In 2024, North America held the largest market share. This is due to the region's well-developed healthcare infrastructure, which features advanced diagnostic tools, specialized cancer treatment centers, and a highly trained medical workforce. These elements collectively promote the widespread adoption of point-of-care molecular diagnostics technologies and their integration into routine clinical practice, ensuring greater patient access across various healthcare settings.
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The key players in this market are Danaher Corporation (US), bioMérieux (France), F. Hoffmann-La Roche Ltd. (Switzerland), Abbott Laboratories (US), QIAGEN N.V. (Netherlands), QuidelOrtho Corporation (US), Co-Diagnostics, Inc. (US), Biocartis Group NV (Belgium), SD Biosensor, INC. (South Korea), genedrive plc (UK), Binx Health, Inc. (US), Molbio Diagnostics Pvt. Ltd. (India), Genomadix (Canada), Visby Medical, Inc. (US), QuantuMDx Group Ltd. (UK), DetectaChem (US), Labsystems Diagnostics Oy (Finland), Akonni Biosystems, Inc. (US), Ubiquitome Limited (New Zealand), Credo Diagnostics Biomedical Pte. Ltd. (Singapore), OpGen, Inc. (US), Nuclein, LLC (US), Genes2Me (India), Axxin (Australia), and Huwel Lifesciences (India).
Danaher Corporation (US):
Danaher Corporation maintains a strong position in the point-of-care molecular diagnostics market, supported by its broad diagnostics portfolio and global operational scale. Leveraging the capabilities of its subsidiary Cepheid, the company delivers rapid molecular testing solutions across diverse clinical areas, including respiratory conditions and women's health, among others. Its extensive distribution network and service infrastructure ensure dependable product availability worldwide, even in dynamic healthcare environments. To reinforce its leadership in the point-of-care molecular diagnostics space, Danaher actively engages in strategic partnerships and collaborations to enhance its technology base and expand its presence in high-growth diagnostic segments. In June 2025, Cepheid, a subsidiary of Danaher, announced that Health Canada issued Cepheid a medical device license for Xpert HIV-1 Viral Load XC, a next-generation extended-coverage (XC) test intended to help assess HIV viral load levels, which are used to monitor the effectiveness of antiretroviral therapy treatment.
bioMérieux (France)
bioMérieux is a key player in the point-of-care molecular diagnostics market, supported by its expansive global operations and strong manufacturing and research infrastructure. The company operates in over 150 countries across the Americas, Europe, the Middle East & Africa, and the Asia Pacific, with 18 production facilities and 20 R&D centers worldwide. With 43 subsidiaries globally, it maintains a well-integrated international presence. bioMérieux offers a robust portfolio of molecular testing solutions, which enables syndromic testing for infections in near-patient settings. Its strategic focus on innovation, especially expanding its test menu and improving automation and user-friendliness, has reinforced its position in decentralized diagnostics.
F. Hoffmann-La Roche Ltd. (Switzerland)
F. Hoffmann-La Roche Ltd. holds a prominent position in the point-of-care molecular diagnostics market, driven by its extensive global reach and well-established distribution infrastructure. With a presence across North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa, the company effectively balances both direct and indirect distribution channels to ensure broad and consistent market coverage. This diversified approach enables Roche to navigate regional demand variability efficiently. The company continues to strengthen its position in the market through targeted acquisitions and strategic collaborations, aimed at enhancing its diagnostic capabilities and expanding access to its molecular testing solutions worldwide. In January 2025, F. Hoffmann-La Roche Ltd. announced that the US Food and Drug Administration (FDA) had granted 510(k) clearance and a Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver for its cobas liat sexually transmitted infection (STI) multiplex assay panels that diagnose sexually transmitted infections at the point-of-care.
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