US Molecular Diagnostics Market

The US molecular diagnostics market is projected to reach USD 14.32 billion by 2031 from USD 8.93 billion in 2026, at a CAGR of 9.9%. Market growth is primarily driven by the increasing use of molecular testing in routine clinical workflows, the wider adoption of advanced assays for disease confirmation, and the broader application of molecular tools to monitor treatment response. Furthermore, consistent investments in modern diagnostic infrastructure, the expansion of test menus, and the transition towards more data-driven clinical decision-making are providing steady momentum to the market.

In June 2025, Danaher's (US) Xpert HIV-1 Viral Load XC test gained a medical device license from Health Canada. This next-generation test is designed to assess levels of HIV viral load that have been used in monitoring the effectiveness of antiretroviral therapy.

In May 2025, F. Hoffmann-La Roche Ltd. (Switzerland) collaborated with Broad Clinical Labs (US) to develop and pilot novel applications for the innovative next-generation sequencing technology recently launched by Roche, named “Sequencing by Expansion” or SBX.

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Companies such as DiaSorin (Italy), Myriad Genetics (US), Danaher (US), Illumina (US), Hologic (US), Roche (Switzerland), bioMérieux (France), Thermo Fisher Scientific (US), QIAGEN (Netherlands), and Becton, Dickinson and Company (US) have adopted various strategies to expand their offerings and increase their market shares. These strategies include collaborations with other companies, acquisitions, development of new products or services, and contractual agreements, among other approaches.

Danaher (US) is one of the most prominent players in the US molecular diagnostics market, driven by its strong focus on innovative diagnostic solutions and scalable laboratory systems tailored for high-throughput testing as well as decentralized settings. The company’s core strengths lie in automation, operational efficiency, and system reliability, which align well with the increasing testing volumes and evolving requirements of the region’s healthcare landscape.

Illumina, Inc. (US) is another leading player in the US molecular diagnostics market due to its strong position in next-generation sequencing technologies, which are widely used for oncology profiling, genetic testing, and advanced molecular analysis. The company’s platforms are recognized for their high accuracy, scalability, and broad assay compatibility, supporting both routine & complex diagnostic applications. In addition, Illumina’s continuous focus on innovation, the expansion of its sequencing portfolio, and strong partnerships across the diagnostics ecosystem have helped sustain its leadership and widespread adoption in the US market.

Market Ranking

bioMérieux (France), Illumina, Inc. (US), Danaher (US), Hologic, Inc. (US), and F. Hoffmann-La Roche Ltd. (Switzerland) are some of the key players in the US molecular diagnostics market, supported by their broad diagnostic portfolios and continuous technological advancements.

Danaher has a strong presence in PCR-based molecular diagnostics, supported by a broad menu of assays, automation capabilities, and a large installed base that drives recurring demand for consumables. Illumina is a key player in next-generation sequencing with platforms widely adopted for oncology profiling, genetic testing, and advanced molecular analysis. Hologic holds a strong position in molecular diagnostics for women’s health & infectious diseases with well-established assays used for screening & disease detection. Roche is recognized for its integrated solutions, ranging from advanced testing platforms to automation and companion diagnostics, across infectious diseases and oncology. bioMérieux contributes with its expertise in infectious disease diagnostics by offering molecular solutions tailored to enable the rapid and specific detection of pathogens.

Related Reports:

US Molecular Diagnostics Market by Product & Service (Kits, Instruments, Software), Test Type (Lab, PoC), Sample (Blood, Urine), Technology (PCR, NGS, ISH), Application [Infectious (Hepatitis, HIV, HAI, Flu), Cancer (Breast, Lung)] - Forecast to 2031

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