Market Size

The United States Molecular Diagnostics Market stood at USD 4.91 billion in 2024 and is projected to reach USD 8.40 billion by 2033, expanding at a CAGR of 6.15% between 2025 and 2033. The growth is driven by the rising incidence of infectious diseases and cancer, advancements in diagnostic technologies, and the increasing adoption of personalized medicine. With its world-class healthcare infrastructure and extensive research ecosystem, the U.S. continues to lead the global molecular diagnostics market.

Market Overview

Molecular diagnostics is a transformative field of medical testing that focuses on analyzing DNA, RNA, and proteins to detect diseases, identify genetic mutations, and guide treatment decisions. Unlike traditional diagnostic methods, molecular diagnostics offers unparalleled accuracy, speed, and sensitivity, revolutionizing patient care through early detection, personalized therapies, and improved disease management.

In the U.S., molecular diagnostics has become the backbone of infectious disease testing, oncology screening, genetic testing, pharmacogenomics, and prenatal diagnostics. The COVID-19 pandemic accelerated adoption by highlighting the need for rapid, scalable, and precise testing solutions, which led to widespread use of PCR and next-generation sequencing (NGS). Post-pandemic, the market continues to evolve as laboratories, hospitals, and point-of-care (POC) facilities increasingly rely on these technologies.

Additionally, the shift toward precision medicine has positioned molecular diagnostics at the center of healthcare strategies. Personalized medicine, which tailors treatments to individual genetic profiles, relies heavily on molecular testing to ensure accurate drug selection, optimal dosage, and minimized side effects. With increasing FDA approvals of targeted therapies and companion diagnostics, the U.S. market is poised for robust expansion.

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Growth Drivers of the U.S. Molecular Diagnostics Market

Rising Burden of Infectious Diseases and Cancer

The U.S. continues to face a high prevalence of infectious diseases, including COVID-19, influenza, hepatitis, and HIV. Molecular diagnostics enables rapid and reliable detection of pathogens, making it essential for disease control and management. Moreover, the growing cancer burden significantly drives adoption. The American Cancer Society projects that in 2025, the U.S. will report 2,041,910 new cancer cases and 618,120 deaths.

While overall cancer mortality has decreased due to better screening and therapies, disparities remain:

·        Native Americans have 2–3 times higher mortality rates for certain cancers compared to Whites.

·        Black Americans have double the mortality rate for prostate, stomach, and uterine cancers.

Molecular oncology testing — including liquid biopsy, NGS, and biomarker-based therapies — is critical in addressing these challenges.

Technological Advancements and Automation

Continuous innovation is shaping the U.S. molecular diagnostics industry. Technologies such as:

·        Digital PCR for high sensitivity

·        CRISPR-based diagnostics for rapid pathogen detection

·        AI-powered data analysis for predictive insights

Automation also plays a pivotal role. High-throughput systems reduce human error, increase efficiency, and enable faster turnaround times. Companies are increasingly developing portable, user-friendly POC molecular platforms, expanding accessibility beyond hospital labs.

Example: In January 2024, 3EO Health launched an affordable COVID-19 test available to U.S. physicians and consumers, marking a significant step in decentralizing molecular testing.

Expansion of Personalized Medicine

The U.S. healthcare system is rapidly embracing personalized medicine, where treatments are tailored based on patient-specific genetic profiles. Molecular diagnostics underpins this shift by enabling:

·        Pharmacogenomics testing for drug compatibility

·        Companion diagnostics to match patients with targeted therapies

·        Rare disease identification

In 2023, the FDA approved 16 personalized drugs (up from six in 2022), including seven cancer drugs and three for rare conditions. This trend ensures rising demand for molecular diagnostics in oncology and beyond.

Challenges in the U.S. Molecular Diagnostics Market

Despite robust growth potential, several barriers persist:

1.     High Costs and Reimbursement Issues

o   Advanced molecular tests require expensive equipment, reagents, and skilled professionals.

o   Medicare and private insurers offer inconsistent reimbursement policies, limiting patient access to many advanced tests.

o   Cost burdens remain a barrier, especially in smaller healthcare settings.

2.     Regulatory and Compliance Hurdles

o   Stringent FDA approval processes slow down the market entry of new diagnostics.

o   Uncertainty around laboratory-developed tests (LDTs) complicates commercialization.

o   Laboratories must comply with evolving quality control, data security, and patient privacy regulations.

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United States Molecular Diagnostics Market Segmentation

By Technology

1.     PCR (Polymerase Chain Reaction) – Gold standard for infectious disease and cancer biomarker detection. Digital and multiplex PCR are gaining adoption for high sensitivity.

2.     Sequencing (NGS & Sanger) – Growing use in oncology, genetic disease screening, and pharmacogenomics.

3.     Chips and Microarrays – Useful in large-scale gene expression profiling and mutation detection.

4.     In Situ Hybridization – Key in oncology and cytogenetic studies.

5.     Mass Spectrometry (MS) – Expanding role in microbiology and pharmacogenomics.

6.     Other Technologies – Includes CRISPR-based diagnostics and AI-driven platforms.

By Application

·        Infectious Disease – Remains the largest segment, driven by COVID-19, HIV, and influenza testing.

·        Oncology – Rapidly expanding with biomarker-based therapies and liquid biopsy adoption.

·        Genetic Disease Screening – Includes newborn screening, carrier testing, and prenatal diagnostics.

·        Pharmacogenomics – Supports personalized medicine and drug optimization.

·        Blood Screening & Microbiology – Ensures safety in transfusions and hospital-acquired infections.

·        HLA Typing – Used in transplantation compatibility testing.

By Product

1.     Instruments – PCR machines, sequencers, microarray systems. High demand for automated, high-throughput platforms.

2.     Reagents – Largest revenue contributor, given recurring demand. Includes primers, probes, and assay kits.

3.     Other Products – Software, consumables, and ancillary tools.

By End User

·        Hospitals – Major adopters for oncology and infectious disease diagnostics.

·        Laboratories – Central testing hubs, especially for high-throughput sequencing.

·        Other End Users – Includes research centers, academic institutes, and POC facilities.

Key Market Insights and Investment Trends

·        In January 2025, the Division of Chemical, Biological, Radiological, and Nuclear Defense (DDDI) invested USD 263 million into diagnostics for biothreats, antimicrobial resistance, and respiratory infections.

·        Investment emphasis is on technologies adaptable for hospitals, outpatient clinics, nursing homes, and home-based testing.

·        Public-private partnerships are accelerating innovation and FDA approvals of diagnostic systems.

Competitive Landscape

The U.S. molecular diagnostics market is highly competitive and innovation-driven, with players focusing on new product launches, FDA approvals, partnerships, and acquisitions.

Key Players

1.     F. Hoffmann-La Roche Ltd – Leading in oncology and infectious disease diagnostics with a strong PCR and sequencing portfolio.

2.     Illumina Inc. – Global leader in next-generation sequencing, focusing on oncology and personalized medicine.

3.     Hologic Corporation – Strong in women’s health and infectious disease testing.

4.     Agilent Technologies Inc. – Known for sequencing and research-focused diagnostics.

5.     QIAGEN N.V. – Expanding its companion diagnostics and PCR solutions.

6.     Myriad Genetics – Specialized in hereditary cancer and genetic testing.

7.     Abbott Laboratories – Strong portfolio in infectious disease molecular testing.

8.     Danaher Corporation (Cepheid) – Market leader in point-of-care PCR testing.

9.     Becton, Dickinson and Company (BD) – Expanding its molecular test kits portfolio.

Recent Developments

·        Jan 2024: ELITechGroup launched GI Bacterial PLUS ELITe MGB® Kit for gastrointestinal pathogens.

·        Aug 2023: QIAGEN received FDA clearance for Therascreen PDGFRA RGQ PCR Kit for gastrointestinal stromal tumors (GIST).

·        Jan 2023: FDA granted EUA for BD and CerTest Biotec’s Monkeypox Virus PCR test.

·        Mar 2023: Lucira Health launched the first U.S.-approved at-home COVID-19 & flu test.

Future Outlook

The future of the U.S. molecular diagnostics market will be shaped by:

·        Greater integration of AI and big data analytics in diagnostics.

·        Expansion of home-based molecular testing kits.

·        Wider adoption of companion diagnostics in oncology.

·        Increased government and private sector investments in pandemic preparedness and antimicrobial resistance.

·        Rising role of liquid biopsy and genomic sequencing in precision medicine.

By 2033, the U.S. is expected to maintain its position as the global leader in molecular diagnostics, setting standards for innovation, accessibility, and patient outcomes.

Final Note

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