United States Molecular Diagnostics Market Size, Share & Forecast Report 2025–2033
Market Overview:
The United States molecular diagnostics market was valued at USD 4.91 Billion in 2024 and is projected to reach USD 8.40 Billion by 2033, growing at a CAGR of 6.15% from 2025 to 2033. This remarkable growth is driven by the increasing prevalence of infectious diseases and cancer, the rising adoption of personalized medicine, and rapid advancements in diagnostic technologies.
Key Market Highlights
- Base Year: 2024
- Forecast Period: 2025–2033
- Market Size in 2024: USD 4.91 Billion
- Forecast Market Size by 2033: USD 8.40 Billion
- CAGR (2025–2033): 6.15%
- Segments Covered: Technology, Application, Product, End User
- Delivery Format: PDF & Excel (PPT/Word available on request)
- Customization: 20% Free Customization
- Post-Sale Support: 1-Year Analyst Support
Market Drivers
📈 Rising Incidence of Infectious Diseases and Cancer
- Surge in COVID-19, influenza, HIV, and cancer cases necessitates precise diagnostics.
- In 2025, the U.S. is projected to record over 2 million new cancer cases and more than 618,000 cancer-related deaths.
- Technologies like NGS, liquid biopsy, and biomarker testing enable early detection and personalized treatment.
⚙️ Technological Innovation & Automation
- Adoption of digital PCR, CRISPR diagnostics, and AI-driven analysis.
- Investments in portable, user-friendly, and high-throughput instruments are making diagnostics more accessible.
- Example: 3EO Health launched a low-cost COVID-19 test for both physicians and consumers in Jan 2024.
🧬 Growing Focus on Personalized Medicine
- Personalized treatments based on a patient’s genetic profile are becoming mainstream.
- Molecular diagnostics plays a pivotal role in pharmacogenomics and companion diagnostics in oncology.
- The FDA approved 16 personalized drugs in 2023, including 7 for cancer and 3 for rare diseases.
Market Challenges
💰 High Costs & Reimbursement Complexity
- Advanced instruments and trained personnel contribute to high operational costs.
- Insurance reimbursements remain inconsistent across providers, limiting access to advanced diagnostics.
🧾 Regulatory Barriers
- Stringent FDA approval processes and uncertain policies around Laboratory Developed Tests (LDTs).
- Changing standards and compliance protocols create entry barriers for new players.
Related Report
Europe In-Vitro Diagnostics Market
Italy In-Vitro Diagnostics Market
Segmental Insights
🧪 By Technology:
- PCR: Gold standard for infectious diseases and cancer detection. Digital and multiplex PCR gaining traction.
- Microarrays & Chips: Widely used in cancer diagnostics, gene expression profiling, and pharmacogenomics.
- Sequencing & MS: Powering precision medicine with real-time genetic insights.
💡 By Application:
- Infectious Diseases: Rapid molecular tests critical for COVID-19, HIV, hepatitis, etc.
- Oncology: Biomarker testing and liquid biopsies transforming cancer care.
- Pharmacogenomics & Genetic Screening: Facilitating personalized treatment protocols.
🔧 By Product:
- Instruments: High demand for automated and portable systems.
- Reagents: Essential for molecular workflows across all settings.
- Other Products: Software, accessories, and consumables.
🏥 By End User:
- Hospitals & Laboratories: Major users due to demand for rapid and accurate testing.
- Other End Users: Research institutes, academic centers, and point-of-care setups.
Key Investments
- Jan 2025: USD 263 million invested under DDDI FY2022 for diagnostics in biothreats, AMR, influenza, and respiratory diseases.
- Focus on R&D to FDA clearance across hospitals, clinics, nursing homes, and even at-home care.
Recent Industry Developments
- Jan 2024: ELITechGroup launches GI Bacterial PLUS ELITe MGB® Kit for foodborne pathogens.
- Aug 2023: QIAGEN receives FDA approval for Therascreen PDGFRA RGQ PCR kit for gastrointestinal tumors.
- Jan 2023: BD & CerTest Biotec gain EUA for Monkeypox PCR test.
- Mar 2023: Lucira Health introduces the first U.S. at-home combo COVID-19 and flu test.
Key Players Covered
- F Hoffmann-La Roche Ltd
- Illumina Ltd
- Hologic Corporation
- Agilent Technologies Inc.
- Qiagen NV
- Myriad Genetics
- Abbott Laboratories
- Danaher Corporation
- Becton, Dickinson and Company
(Each company is profiled on: Overview, Key Persons, Recent Developments, and Revenue)
Key Questions Answered
- What was the market size of the U.S. molecular diagnostics market in 2024?
- What is the expected market value by 2033?
- What is the CAGR from 2025 to 2033?
- Which technologies are leading in the U.S. molecular diagnostics industry?
- What are the key application areas driving market growth?
- Which technology or application segment will dominate by 2033?
- Who are the major players in the U.S. molecular diagnostics market?
- What are the major investment trends and product launches?
- What challenges does the U.S. market face in terms of reimbursement and regulation?
- How is innovation shaping the molecular diagnostics landscape in the U.S.?
