The United States molecular diagnostics market was valued at USD 6.72 Billion in 2025 and is expected to grow at a CAGR of 4.82%, reaching USD 10.76 Billion by 2035. The market is supported by technological advancements in molecular testing and increasing adoption of precision medicine.
Base Year
Historical Period
Forecast Period
Following the COVID19 pandemic, public awareness of the risks of infectious disease has increased. The enhanced infectious disease prevalence has been the major driver for the molecular diagnostics market, since many such illnesses require fast and accurate diagnosis. Cancer prevalence too is on the rise alongside the increased personalization of cancer treatments which has further driven up the demand for molecular diagnostics in oncology.
Molecular diagnostics have seen impressive medical advancements like real-time PCR and the powerful next-generation sequencing (NGS) technology, both of which have served to make diagnosis more sensitive and accurate. Methods of molecular analysis have been increasingly easy to use, improving the accessibility and efficiency of diagnostics.
The market for molecular diagnostics has also been helped by beneficial reimbursement policies and state support for both development of such tools and their deployment. State funding and favorable initiatives have been responsible for ensuring steady market expansion.
Compound Annual Growth Rate
4.82%
Value in USD Billion
2026-2035
*this image is indicative*
The market is growing quickly due to rising demand for faster and more accurate disease detection. It plays a major role in diagnosing infections, cancers, and genetic disorders. Factors like increasing awareness, technological advancements, and the need for personalized medicine are driving the market. COVID-19 testing boosted growth significantly. Companies are investing in research to develop innovative tests.
Increased Government Funding and Investment in R&D
The various forms of government support that the molecular diagnostics market receives, in terms of initiatives, schemes, and funding, has encouraged systematic research and precise development of molecular diagnostic products. These sustained and sizable investments have brought about the development of advanced diagnostic technologies and the infrastructure necessary to both develop, assess, and deploy them. Take for instance, the Bill and Melinda Gates Foundations’ recent funding of LumiraDX for T.B point of care testing. This is vital support at a time when T.B may be returning in novel forms exacerbated by climate change.
Medical Advancements have Supplemented the Increasing Demand for Early Detection in the United States Molecular Diagnostics Market
PCR, DNA probes, and next-generation biosensors are some key examples of novel advanced medical technologies in diagnostics. They serve as the foundation for the development of even more sensitive and accurate tools. The advent of COVID19, the persistence of HIV, and annual toll of influenza has pushed up the demand for early and accurate detection of deleterious infections. Personalized medicine has become the center piece of the discussion alongside companion diagnostics, with healthcare professionals increasingly customizing treatments to individual preferences, needs, and genetic profiles. This too has provided a growth boost to the U.S molecular diagnostics market. For example, in April 2025, Veravas, an important player in the clinical diagnostics market, has developed and made commercially available the VeraBIND Tau, a blood-based test designed to detect Alzheimer's disease (AD) and other tau-related neurodegenerative disorders.
Some major market trends include the shift toward personalized medicine and companion diagnostics, rising adoption of point-of-care testing, accelerated rapid diagnostics post-COVID-19, and the continued high burden of infectious diseases.
The market report offers a detailed analysis of the market based on the following segments:
Market Breakup by Product and Service
Market Breakup by Technology
Market Breakup by Application
Market Breakup by End User
Reagents and Kits Dominates the United States Molecular Diagnostics Market by Product and Service
In the U.S molecular diagnostics market, reagents and kits are expected to hold the largest chunk of the market by a significant margin. Reagents and kits are adaptable, widely applicable, and the already high demand for them was magnified by the pandemic and the need for rapid POC diagnostic testing. Reagents and kits are flexible, can diagnose a large subset of infectious diseases with great sensitivity, they can also test cancer biomarkers in patient blood to both diagnose the disease and ascertain disease progression, a range of genetic tests take advantage of their ease of use and accuracy. Their high demand is also explained by the need for repeated replenishment. They respond well to different testing environments and their manufacturers have benefited immensely from the increased need for early disease diagnosis.
Polymerase Chain Reaction to Lead the United States Molecular Diagnostics Market Segmentation by Technology
PCR technology prevails over others in terms of market share thanks to its pin-point accuracy, high sensitivity, and the ability to detect and quantify a range of nucleic acid molecules. It has been the benchmark diagnostic tool across applications from infectious disease detection to genetic examination. PCR’s success can be attributed to its ability to amplify target DNA sequences to precisely detect even miniscule amounts of genetic material. PCR is used by various biomedical professionals to diagnose infectious diseases, to check for genetic abnormalities, and for forensic examination of evidence. Innovations like qPCR and dPCR have positively augmented PCR’s capabilities for greater precision in quantification. It’s fast, easy to use, reliable and direly needed with rising cases of infectious disease.
Infectious Disease Diagnostics Leads the United States Molecular Diagnostics Market by Application
The largest share in the U.S molecular diagnostics market is infectious disease diagnostics. Its hold over this share is explained by the enormous increase in the incidence of infectious diseases, the advent of COVID19 and other respiratory illnesses, the resurgence of tuberculosis (a significant global killer), the potential reemergence of certain infectious diseases due to increasing global temperatures, lifestyle issues enfeebling immune systems, higher prevalence of STDs etc. The ubiquity of infectious disease necessitates accurate and timely detection of microbial pathogens. The U.S in particular experiences a significant caseload.
Hospitals to Hold a Significant Share of the United States Molecular Diagnostics Market by End-User
Hospitals are major healthcare providers, and the large amount of patient testing takes place in hospital settings. Hospitals are often well-resourced with diagnostic equipment, tools, high-skilled personnel, along with a focus on precision medicine. Hospitals maintain steady and sizable stocks of molecular diagnostic kits to be used by trained healthcare professionals with the requisite domain knowledge to effectively examine the results of the tests. A great number of patients also prefer a hospital environment for any kind of health evaluation despite the convenience of home-based tests, since they trust the expertise and the appreciate the close patient monitoring. The U.S has a mature healthcare system with high quality healthcare infrastructure, its hospitals are excellent and have kept abreast of the healthcare needs of its citizenry. Their increased usage of various molecular diagnostic tools is explained by this proactiveness.
In North America, the United States hold a major share of the molecular diagnostics market. This is attributed to their advanced medical technology, robust clinical research, significant fundamental innovation in the healthcare sector, a mature healthcare system, ethical and well-functioning regulatory bodies like the FDA that ensure that only safe and effective treatment solutions, whether they be drugs, supplements, vaccines, etc. are allowed access to American consumers. Major market players that develop molecular diagnostic tools are well-entrenched within the country and the region, allowing them to observe and examine biomedical research trends, lifestyle trends, and disease trends closely. They then respond with consumer-centric products that mitigate the country’s disease burden. U.S has a great prevalence of both cancers and infectious diseases with COVID19 alone killing several thousand Americans every year. Therefore, the demand for molecular diagnostic solutions in the region is soaring.
The key features of the market report comprise patent analysis, funding and investment analysis, and strategic initiatives by the leading players. The major companies in the market are as follows:
A notable global player in the domain, it has a diverse product portfolio comprising of assays and instruments for molecular diagnostics. These tools are broadly applicable for the diagnosis of cancers, infections, or in genetic testing. A sizable portion of their molecular diagnostics enterprise is focused on testing infectious diseases with particular focus on developing quick detection, early identification, and prompt treatment for such illnesses. They also offer completely integrated, automated molecular diagnostic systems for laboratories. Abbott is a market leader with over 450 products in offering and it has developed the first genetic test to detect the HER-2 breast cancer gene. This is in addition to receiving FDA approval for the Vysis ALK Break Apart FISH Probe Kit used to identify ALK gene rearrangements. Abbott Molecular received FDA approval recently (2023) for molecular human papillomavirus (HPV) screening assay, with a new addition to the Alinity m family of diagnostic assays. Abbott aims to remain at the forefront of molecular diagnostics technology.
An important participant in the U.S markets, Bio-Rad focuses on life science research products and clinical diagnostics. Some of their solutions pertain clinical quality control and information systems, which help confirm the validity of clinical test results. It is a leading provider of in-vitro diagnostics supplies and their diagnostics products and systems. These products and systems utilize several technologies to provide valuable clinical data across markets: transfusion medicine, glycemic monitoring, autoimmune, and infectious disease. Bio-Rad has developed Digital Droplets Technology which segregates samples into thousands of microfluidic droplet test tubes to quantify nucleic acid molecules with incomparable precision. In addition, they develop real-time PCR kits and cancer diagnostics with the help of biomarker detection assays. Bio-Rad impressively launched 50 new ddPCR Methylation Detection Assays in July 2024.
A prominent presence in the U.S molecular diagnostics market, Becton, Dickinson, and Company (BD), develop and distribute rapid POC instruments and assays. Their molecular diagnostic tests for infectious diseases lay special emphasis on STIs. Take for instance, the VIASURE Monkeypox Virus Real-Time PCR Reagents, which has received FDI approval for the identification of Monkeypox. It contributes to cancer diagnosis too with molecular diagnostic solutions for early detection, personalized treatment, and treatment monitoring of various cancers. It has made strategic partnerships with firms like CerTest Biotec to improve its market reach. BD introduced the COR GX System, in the U.S. market in 2022, designed testing infectious disease. It can handle a large sample volumes including tests for women's health and STIs.
Agilent Technologies Inc. has a strong presence in the United States molecular diagnostics market. The company offers advanced instruments, reagents, and software for genetic analysis, cancer diagnostics, and infectious disease testing. Agilent focuses on precision and innovation, helping labs deliver fast and accurate results. Their partnerships with clinical labs and research institutions strengthen their market position. By investing in next-generation sequencing and expanding diagnostic capabilities, Agilent continues to play a key role in the growing molecular diagnostics field.
*Please note that this is only a partial list; the complete list of key players is available in the full report. Additionally, the list of key players can be customized to better suit your needs.*
Other significant players in the market include Hologic Inc., Danaher Corporation, Illumina Inc., Johnson and Johnson, and QIAGEN.
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*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*
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| REPORT FEATURES | DETAILS |
| Base Year | 2025 |
| Historical Period | 2019-2025 |
| Forecast Period | 2026-2035 |
| Scope of the Report |
Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:
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| Breakup by Product and Service |
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| Breakup by Technology |
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| Breakup by Application |
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| Breakup by End User |
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| Market Dynamics |
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| Supplier Landscape |
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| Companies Covered |
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