U.S. Molecular Diagnostics Market Opportunity, Growth Drivers, Industry Trend Analysis, and Forecast 2025 - 2034

U.S. Molecular Diagnostics Market was valued at USD 10.4 billion in 2024 and is estimated to grow at a CAGR of 4.2% to reach USD 15.6 billion by 2034.

This consistent expansion is supported by the growing burden of chronic and infectious conditions, steady improvements in molecular testing technologies, increasing federal initiatives, higher healthcare spending, and a rapidly aging population. The rising number of older adults in the country continues to elevate demand, as individuals 65 and above face a greater risk of multiple long-term illnesses requiring frequent diagnostic evaluation. Molecular diagnostics involves analyzing biological markers across DNA, RNA, and proteins to detect, track, and understand numerous diseases. This method plays a crucial role in identifying genetic abnormalities, infectious pathogens, and oncology-related indicators with strong accuracy. It has become a cornerstone of modern clinical practice, enabling specialists to investigate diseases at a deeper molecular level. Advances in testing systems have contributed to faster result turnaround, more precise diagnoses, and improved personalization of medical care. As early detection and targeted treatment approaches grow increasingly important, the adoption of molecular diagnostic technologies continues to accelerate across oncology, infectious disease management, and genetic testing applications.

The instruments category reached USD 2.9 billion in 2024 and is projected to reach USD 4.5 billion by 2034 at a 4.4% CAGR. Molecular diagnostics relies on highly specialized equipment capable of amplifying, detecting, and evaluating nucleic acids and other biomolecules. These devices form the backbone of laboratory operations, supporting reliable identification of disease markers, genetic evaluation, and personalized medical assessments. They remain essential to sample processing, genetic profiling, and accurate test interpretation across clinical laboratories, medical centers, and research-focused environments.

The polymerase chain reaction (PCR) segment held a 70.4% share in 2024. PCR technology enables the amplification of targeted DNA or RNA sequences, allowing precise analysis of extremely small genetic samples. Digital PCR enhances this capability by dividing each sample into numerous individual reactions, improving accuracy when detecting genetic material found in minimal concentrations.

The hospitals and clinics segment held a 45.9% share in 2024. These healthcare settings maintain extensive lab capacity and skilled personnel, allowing them to perform a wide range of molecular tests for diverse medical needs. Their ability to integrate molecular diagnostics into routine and urgent-care workflows ensures continuous demand and widespread adoption throughout patient care settings.

Prominent companies operating in the U.S. Molecular Diagnostics Market include Sysmex Corporation, Thermo Fisher Scientific, Agilent Technologies, Qiagen, Abbott Laboratories, Siemens Healthineers, Biocartis, Illumina, Hologic, Becton, Dickinson and Company, Bio-Rad Laboratories, F. Hoffmann-La Roche, Danaher Corporation, bioMerieux, and QuidelOrtho Corporation. Companies in the U.S. Molecular Diagnostics Market are enhancing their competitive presence by expanding assay portfolios, improving automation, and investing in next-generation sequencing and high-throughput testing platforms. Many firms emphasize R&D to introduce faster, more sensitive tests aligned with the growing demand for precision medicine. Strategic collaborations with healthcare systems, biotech firms, and research institutions help broaden clinical adoption and accelerate product innovation.