US In Vitro Diagnostics Market

The US in vitro diagnostics market is projected to reach USD 57.18 billion by 2031 from USD 40.15 billion in 2026, at a CAGR of 7.3% during the forecast period. Market growth is largely driven by the increasing demand for early disease detection, the rising prevalence of chronic and infectious conditions, the wider adoption of molecular and point-of-care diagnostics, continuous advancements in testing technologies, and ongoing investments in laboratory automation and healthcare infrastructure.

In August 2025, Thermo Fisher Scientific Inc. (US) opened a new, innovative Manufacturing Center of Excellence in the US. This carbon-neutral facility is capable of producing a minimum of 40 million laboratory pipette tips each week.

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In March 2025, Danaher (US) received 510(k) clearance for the DxC 500i Clinical Analyzer, an integrated system for clinical chemistry and immunoassays. The platform offers high throughput of up to 800 clinical chemistry tests per hour and 100 immunoassay tests per hour, supporting accurate and timely diagnostic results.

The key players in this market Danaher Corporation (US), F. Hoffmann-La Roche Ltd. (Switzerland), Abbott (US), Siemens Healthineers AG (Germany), Thermo Fisher Scientific Inc. (US), bioMérieux (France), Sysmex Corporation (Japan), QuidelOrtho Corporation (US), Becton, Dickinson and Company (US), and QIAGEN (Netherlands), among others. These players have employed various organic and inorganic growth strategies, including collaborations, acquisitions, product launches, partnerships, agreements, and expansions, to enhance their international footprint and increase their share in the US in vitro diagnostics market.

Danaher Corporation (US) is a leading player in the US in vitro diagnostics market, supported by a broad portfolio spanning biotechnology, life sciences, and diagnostics. The company’s global manufacturing and distribution network provides strong operational scale. Danaher continues to strengthen its diagnostics business through targeted acquisitions and regulatory approvals. Notably, the acquisition of Abcam Plc (UK) in December 2023 for approximately USD 5.6 billion further enhanced its capabilities across the diagnostics and life sciences markets.

F. Hoffmann-La Roche Ltd. (Switzerland) is one of the leading players in the US in vitro diagnostics market, supported by robust research & development capabilities and a strong focus on innovation. The company’s combined strengths in diagnostics and laboratory automation, along with its growing emphasis on personalized healthcare, have enabled it to secure a prominent market position. Roche maintains a diversified portfolio across infectious diseases, tissue diagnostics, oncology, and diabetes management. In line with its strategy to expand its advanced therapy capabilities, F. Hoffmann-La Roche Ltd. entered into a definitive agreement in November 2024 to acquire Poseida Therapeutics, Inc. (US), a clinical-stage biopharmaceutical company specializing in donor-derived CAR-T cell therapies, strengthening its cell & gene therapy portfolio.

Market Ranking

In the US in vitro diagnostics market, leading companies such as Danaher Corporation (US), F. Hoffmann-La Roche Ltd. (Switzerland), Abbott (US), Siemens Healthineers AG (Germany), and Thermo Fisher Scientific Inc. (US) play pivotal roles through their broad diagnostic portfolios and continuous technological innovation.

Roche is recognized for its strong capabilities in molecular diagnostics, laboratory automation, and personalized healthcare solutions across infectious diseases, oncology, and diabetes testing. Danaher provides a comprehensive range of diagnostic instruments, reagents, and workflow solutions, backed by an extensive global manufacturing and distribution network. Abbott maintains a strong presence across immunoassays, point-of-care testing, and clinical chemistry platforms used in hospitals and laboratories. Siemens Healthineers offers advanced diagnostic imaging and in vitro testing systems, with strengths in immunoassays, hematology, and automation solutions that enhance laboratory efficiency and productivity. Thermo Fisher Scientific provides FDA-cleared molecular diagnostic systems and in vitro diagnostic assay solutions widely used in healthcare settings for infectious disease testing, genetic screening, and other regulated diagnostic applications.

Related Reports:

US In Vitro Diagnostics Market by Product & Service (Kits, Instruments), Technology (Immunoassay, Hematology, Glucose Monitoring), Specimen (Blood), Site of Testing, Application (Endocrinology, Cardiology, Infectious Diseases) - Forecast to 2031

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