DUBLIN–(BUSINESS WIRE)–Mar 25, 2025–
The “United States Molecular Diagnostics Market Report Size and Share Analysis – Growth Trends and Forecast Report 2025-2033″ report has been added to ResearchAndMarkets.com’s offering.
The United States molecular diagnostics market stood at USD 4.91 billion in 2024 and is expected to reach USD 8.40 billion by 2033, growing at a CAGR of 6.15% from 2025 to 2033. This is fueled by the development of diagnostic technologies, rising demand for personalized medicine, and an increased incidence of infectious diseases and cancer, making the U.S. a leading force in the world market.
As the U.S. healthcare system focuses on the early detection of diseases and precision medicine, molecular diagnostics are increasingly being adopted across hospitals, diagnostic centers, and research centers, which is further enhancing patient outcomes and fuelling medical innovation.
Rising Infectious Disease and Cancer Incidence
The increasing prevalence of infectious diseases such as COVID-19, influenza, and HIV, and the increasing number of cancer cases are fueling demand for molecular diagnostics in the U.S. Early and accurate detection of disease is essential for successful treatment, and molecular diagnostics offers quick and accurate results. Genetic testing in oncology identifies specific biomarkers for targeted therapy. The increasing usage of liquid biopsy and next-generation sequencing (NGS) also contributes to the growth of the market.
The U.S. is expected to have 2,041,910 new cancer cases and 618,120 cancer deaths in 2025. The death rate for cancer has decreased since 1991, preventing nearly 4.5 million deaths because of declining smoking, increased early detection, and better treatments. Yet, there are still major gaps, with Native Americans having two to three times the mortality for some cancers as White people, and Black people having twice the mortality for prostate, stomach, and uterine corpus cancer.
Technological Innovation and Automation of Molecular Testing
Ongoing innovation in molecular diagnostic technologies like digital PCR, CRISPR-based diagnostics, and AI-enabled data analysis are revolutionizing the market. Automated diagnostic systems enhance efficiency, minimize human errors, and support high-throughput testing, bringing molecular diagnostics to the masses. Firms are investing in point-of-care (POC) molecular diagnostic platforms that are easy to use, portable, and affordable, which provide quicker results and improved disease management. The innovations drive acceptance across hospitals, laboratories, and research centers. Jan 2024, Diagnostics firm 3EO Health makes its low-cost COVID-19 test available to U.S. physicians and consumers.
Increasing Focus on Personalized Medicine
The American healthcare system is moving towards personalized medicine, in which treatments are individualized according to a patient’s genetic makeup. Molecular diagnostics plays an important role in pharmacogenomics, assisting in determining the right drugs and dosages for a given patient. Targeted therapies in oncology based on molecular diagnostics enhance the effectiveness of treatment and reduce side effects.
With personalized medicine gaining more popularity, the need for molecular diagnostic tests is likely to increase drastically. FDA approved 16 new personalized drugs for rare disease patients in 2023, compared to six in 2022. The new personalized drugs approved in 2023 also cover seven cancer medications and three for other diseases and conditions.
Challenges in the U.S. Molecular Diagnostics Market
High Costs and Reimbursement Issues
Molecular diagnostic tests tend to need costly equipment, reagents, and highly trained professionals, making the tests expensive. Insurance coverage has increased, but reimbursement policies by healthcare providers are still complex and variable. Medicare or private insurance does not cover many sophisticated molecular tests comprehensively, thus denying them to some patients. The cost constraint to healthcare facilities and patients hinders the widespread use of molecular diagnostics in the U.S.
Regulatory and Compliance Hurdles
The U.S. molecular diagnostics market is faced with strict FDA and other government regulatory requirements. The process for the approval of new molecular diagnostic tests is lengthy and expensive, which can cause delays in entering the market. Regulatory uncertainty concerning laboratory-developed tests (LDTs) also poses a challenge to manufacturers and clinical labs. Adhering to changing standards, quality control procedures, and data protection regulations also complicates market expansion.
Investment in the United States Molecular Diagnostics Market
Jan 2025, The DDDI FY2022 investment was $263 million for advanced product development and regulatory clearance, including diagnostics for Biothreats, Antimicrobial Resistance, Biodosimetry, Influenza, COVID-19, and Respiratory Protection Devices. DDDI invests in testing systems and medical devices appropriate for a variety of settings, such as hospitals, outpatient clinics, nursing homes, and homes. The emphasis is on products at any stage of development, from late-stage research to FDA clearance.
Top United States Molecular Diagnostics Company News
Jan 2024, ELITechGroup releases the GI Bacterial PLUS ELITe MGB Kit, expanding its diagnostic portfolio. The in vitro test is aimed at significant bacterial pathogens such as Campylobacter spp., Clostridium difficile, Salmonella spp., Shigella spp., and Yersinia enterocolitica, which are leading causes of food- and waterborne disease and hospital-acquired gastrointestinal illness.
Company Analysis: Overview, Key Persons, Recent Development, Revenue
- F Hoffmann-la Roche Ltd
- Illumina Ltd
- Hologic Corporation
- Agilent Technologies Inc.
- Qiagen NV
- Myriad Genetics
- Abbott Laboratories
- Danaher Corporation
- Becton, Dickinson and Company
Key Attributes:
| Report Attribute | Details |
| No. of Pages | 200 |
| Forecast Period | 2024 – 2033 |
| Estimated Market Value (USD) in 2024 | $16.43 Billion |
| Forecasted Market Value (USD) by 2033 | $28.83 Billion |
| Compound Annual Growth Rate | 6.4% |
| Regions Covered | United States |
Key Topics Covered:
1. Introduction
2. Research & Methodology
3. Executive Summary
4. Market Dynamic
4.1 Growth Drivers
4.2 Challenges
4.3 Opportunities
5. United States Molecular Diagnostics Market
6. Market Share Analysis
6.1 By Technology
6.2 By Application
6.3 By Product
6.4 By End User
7. Technology
7.1 Chips and Microarrays
7.2 In Situ Hybridization
7.3 Sequencing
7.4 Mass Spectrometry (MS)
7.5 PCR
7.6 Other Technologies
8. Application
8.1 Pharmacogenomics
8.2 Infectious Disease
8.3 Genetic Disease Screening
8.4 Oncology
8.5 Blood Screening
8.6 Microbiology
8.7 Human Leukocyte Antigen Typing
9. Product
9.1 Instruments
9.2 Reagents
9.3 Other Products
10. End User
10.1 Hospitals
10.2 Laboratories
10.3 Other End Users
11. Porter’s Five Forces Analysis
11.1 Bargaining Power of Buyers
11.2 Bargaining Power of Suppliers
11.3 Degree of Competition
11.4 Threat of New Entrants
11.5 Threat of Substitutes
12. SWOT Analysis
12.1 Strength
12.2 Weakness
12.3 Opportunity
12.4 Threats
13. Key Players Analysis
For more information about this report visit https://www.researchandmarkets.com/r/6s579a
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KEYWORD: UNITED STATES NORTH AMERICA
INDUSTRY KEYWORD: BIOTECHNOLOGY GENETICS HEALTH ONCOLOGY
SOURCE: Research and Markets
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PUB: 03/25/2025 01:19 PM/DISC: 03/25/2025 01:20 PM
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