US Molecular Diagnostics Market worth $14.32 billion by 2031
The report "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" is projected to grow from USD 8.93 billion in 2026 and to reach USD 14.32 billion by 2031, at a Compound Annual Growth Rate (CAGR) of 9.9% during the forecast period.
Browse 120 market data Tables and 44 Figures spread through 200 Pages and in-depth TOC on "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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The blood, serum, and plasma segment held the largest share of the US molecular diagnostics market, by sample type, in 2025.
On the basis of sample type, the market is segmented into blood, serum, and plasma; urine; and other sample types. In 2025, the blood, serum, and plasma segment accounted for the largest market share as these specimens are most commonly used for MDx testing across a wide range of applications. Their compatibility with multiple molecular technologies, reliable biomarker availability, and routine use in clinical testing support high sample volumes and consistent demand, contributing to the segment’s leading position.
The oncology testing segment is expected to be the fastest-growing segment during the forecast period.
By application, the market is categorized into genetic testing, oncology testing, infectious disease diagnostics, and other applications. The oncology testing segment is the fastest-growing segment, driven by the increasing burden of cancer and the growing use of MDx for tumor profiling, mutation detection, and treatment selection. Advancements in NGS and the expanding adoption of precision medicine approaches are further supporting the rapid growth of this segment.
The major players operating in this market are Danaher (US), Illumina, Inc. (US), Hologic, Inc. (US), F. Hoffmann-La Roche Ltd. (Switzerland), bioMérieux (France), Myriad Genetics, Inc. (US), Thermo Fisher Scientific Inc. (US), QIAGEN N.V. (Netherlands), Becton, Dickinson and Company (US), and DiaSorin S.p.A. (Italy).
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