US In Vitro Diagnostics Market worth $57.18 billion by 2031
The report "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", is valued at an estimated USD 40.15 billion in 2026 and is projected to reach USD 57.18 billion by 2031, at a CAGR of 7.3% during the forecast period.
Browse 91 market data Tables and 44 Figures spread through 200 Pages and in-depth TOC on "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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The US in vitro diagnostics market is experiencing robust expansion, driven by increasing healthcare demand for early and accurate disease detection across a wide range of clinical conditions. Rising testing volumes, driven by chronic illnesses, infectious diseases, and routine health screening programs, are fueling consistent market activity. Rapid advancements in molecular diagnostics, next-generation sequencing, automated laboratory systems, and point-of-care platforms are transforming testing workflows and improving operational efficiency. Meanwhile, increased industry collaboration, regulatory clearances for new platforms, and strong R&D investments are accelerating product innovation. Together, these factors continue to strengthen growth momentum within the US IVD market.
In 2025, the blood, serum, and plasma specimens segment held the largest share of the US in vitro diagnostics market, by specimen.
Based on specimens, the US in vitro diagnostics market is segmented into blood, serum, and plasma specimens, saliva specimens, urine specimens, and other specimens. Among these, the blood, serum, and plasma specimens segment held the largest market share in 2025, driven by the extensive use of blood-based testing across a wide range of diagnostic applications, including infectious diseases, chronic disease monitoring, and oncology. The high clinical reliability, standardized collection procedures, and compatibility with multiple diagnostic platforms further support the dominance of this specimen category.
In 2025, the laboratory tests segment held the largest share of the US in vitro diagnostics market, by site of testing.
Based on the site of testing, the US in vitro diagnostics market is segmented into laboratory tests and point-of-care tests. In 2025, the laboratory tests segment accounted for the largest market share, supported by the widespread presence of centralized and hospital-based laboratories, high testing volumes, and extensive use of automated, high-throughput diagnostic systems. The segment enables comprehensive testing across infectious diseases, oncology, cardiology, and chronic conditions, delivering consistent accuracy and standardized quality. Continued investment in laboratory automation and workflow optimization is further supporting the growth of laboratory testing across the US.
The major players operating in this market are Danaher Corporation (US), F. Hoffmann-La Roche Ltd. (Switzerland), Abbott (US), Siemens Healthineers AG (Germany), Thermo Fisher Scientific Inc. (US), Becton, Dickinson and Company (US), bioMérieux (France), Illumina, Inc. (US), QuidelOrtho Corporation (US), and Hologic, Inc. (US).
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