<h2><strong>United States Molecular Diagnostics Market Trends &amp; Summary</strong></h2>
<p>The molecular diagnostics market in the United States was valued at USD 4.91 billion in 2024 and is projected to reach USD 8.40 billion by 2033, growing at a compound annual growth rate (CAGR) of 6.15% from 2025 to 2033. This growth is driven by advancements in diagnostic technologies, an increasing demand for personalized medicine, and a rising incidence of infectious diseases and cancer, establishing the U.S. as a leading player in the global market.</p>
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<h3><strong>Outlook for the U.S. Molecular Diagnostics Market</strong></h3>
<p>Molecular diagnostics is an emerging field of medical testing that analyzes DNA, RNA, and proteins to identify diseases, detect genetic mutations, and guide treatment decisions. This field utilizes advanced technologies such as polymerase chain reaction (PCR), next-generation sequencing (NGS), and microarrays to provide highly accurate and rapid results, thereby transforming disease management and enabling personalized medicine.</p>
<p>In the U.S., molecular diagnostics plays a crucial role in the detection of infectious diseases, including COVID-19, HIV, and influenza. It is also extensively used in oncology for identifying cancer biomarkers, which facilitates targeted therapies for conditions such as breast and lung cancer. Additionally, molecular diagnostics is essential in genetic screening, prenatal testing, and pharmacogenomics, which customizes medications based on a patient's genetic profile. As the U.S. healthcare system increasingly emphasizes early disease detection and precision medicine, the adoption of molecular diagnostics across hospitals, diagnostic centers, and research institutions is enhancing patient outcomes and driving medical innovation.</p>
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<h2><strong>Major Trends in the Market</strong></h2>
<ol>
<li><strong>Adoption of Point-of-Care Molecular Diagnostics</strong> &ndash; Rising focus on rapid diagnostics in emergency and decentralized settings is driving the use of compact, user-friendly devices.</li>
<li><strong>Rising Application in Oncology</strong> &ndash; Increasing use for biomarker-based personalized cancer treatments, including EGFR, KRAS, and BRAF.</li>
<li><strong>Increased Demand for Multiplex Panels</strong> &ndash; Shift towards multiplex molecular panels for respiratory, gastrointestinal, and sexually transmitted infection testing.</li>
<li><strong>Integration of AI and Machine Learning</strong> &ndash; Advanced analytics are improving interpretation of complex sequencing data.</li>
<li><strong>Consumer Genomics and Direct-to-Consumer Testing</strong> &ndash; Expansion of at-home molecular testing kits due to consumer interest in personal health data.</li>
<li><strong>Technological Advancements in PCR and NGS</strong> &ndash; Faster, cheaper, and higher-throughput testing capabilities.</li>
<li><strong>Shift Toward Syndromic Testing</strong> &ndash; Comprehensive pathogen detection in single tests for respiratory and gastrointestinal illnesses.</li>
<li><strong>Growth in Liquid Biopsy Adoption</strong> &ndash; Increasing popularity of non-invasive cancer detection and monitoring methods.</li>
</ol>
<h2><strong>Key Market Driver: Expansion of Infectious Disease Testing</strong></h2>
<p>A major growth driver is the heightened focus on infectious disease diagnostics post-pandemic. COVID-19 demonstrated the critical value of molecular testing in rapid, accurate detection. This has prompted significant institutional investment in preparedness for future outbreaks. The U.S. CDC has partnered with diagnostic manufacturers to develop tests for conditions such as monkeypox, dengue, and antimicrobial-resistant organisms. Multiplex respiratory panels that detect SARS-CoV-2, influenza, RSV, and other pathogens are now standard tools in many labs.</p>
<h3><strong>Key Market Restraint: High Cost of Advanced Tests</strong></h3>
<p>The high cost of molecular diagnostics remains a barrier, particularly in low-resource or outpatient settings. Complex regulatory requirements, sophisticated equipment, and R&amp;D expenses push up costs, making some tests less accessible. Variations in insurance reimbursement further contribute to disparities in availability.</p>
<h3><strong>Key Market Opportunity: Growth of Decentralized Testing</strong></h3>
<p>Advances in microfluidics, lab-on-a-chip technology, and portable platforms are enabling decentralized molecular testing in physician offices, urgent care centers, retail health clinics, and homes. CLIA-waived devices from companies like Cepheid and Abbott are already transforming diagnostics by providing rapid, accurate results outside traditional laboratories.</p>
<h3><strong>U.S. Molecular Diagnostics Market By Disease Insights</strong></h3>
<p>The respiratory disease segment dominated in 2024 due to ongoing testing for influenza, RSV, and emerging threats like avian influenza. Syndromic respiratory panels are widely deployed to support outbreak management with quick turnaround times.</p>
<h3><strong>United States Chips and Microarrays Molecular Diagnostics Market</strong></h3>
<p>Used for gene expression profiling, mutation detection, and disease screening, chips and microarrays are essential for oncology, pharmacogenomics, and infectious disease applications. High-throughput capabilities make them key to personalized medicine advances.</p>
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<h3><strong>United States PCR Molecular Diagnostics Market</strong></h3>
<p>PCR remains the cornerstone technology for detecting infectious diseases, cancer biomarkers, and genetic disorders. The pandemic accelerated adoption, with digital PCR and multiplex PCR enhancing accuracy and throughput.</p>
<h3><strong>United States Molecular Diagnostics Infectious Disease Market</strong></h3>
<p>Demand for rapid pathogen detection continues to rise for diseases like COVID-19, HIV, hepatitis, and hospital-acquired infections. Increased government funding and private investments are fueling technological innovations in this segment.</p>
<h3><strong>United States Molecular Diagnostics Oncology Market</strong></h3>
<p>Molecular oncology supports precision medicine with tools like liquid biopsies, NGS, and biomarker testing. These enable early detection, treatment monitoring, and tailored therapies, driving strong growth as cancer incidence rises.</p>
<h3><strong>United States Instruments Molecular Diagnostics Market</strong></h3>
<p>This segment includes PCR machines, sequencing platforms, and microarray systems. There is growing demand for automated, high-throughput instruments that can process large volumes of tests quickly in clinical and research settings.</p>
<h3><strong>Investment in the United States Molecular Diagnostics Market</strong></h3>
<p>In January 2025, the DDDI FY2022 announced $263 million in funding for advanced diagnostics targeting biothreats, antimicrobial resistance, influenza, COVID-19, and respiratory protection devices, supporting both hospital and point-of-care applications.</p>
<h3><strong>Top United States Molecular Diagnostics Company News</strong></h3>
<ul>
<li><strong>Jan 2024</strong> &ndash; ELITechGroup launched the GI Bacterial PLUS ELITe MGB&reg; Kit for detecting major bacterial pathogens.</li>
<li><strong>Aug 2023</strong> &ndash; QIAGEN gained FDA clearance for Therascreen PDGFRA RGQ PCR Kit for detecting gastrointestinal stromal tumors.</li>
<li><strong>Jan 2023</strong> &ndash; BD and CerTest Biotec received EUA for VIASURE Monkeypox Virus Real-Time PCR Reagents.</li>
<li><strong>Mar 2023</strong> &ndash; Lucira Health introduced the first at-home COVID-19 and flu test with EUA approval.</li>
</ul>
<h2><strong>United States Molecular Diagnostics Market Segments</strong></h2>
<ul>
<li><strong>Technology</strong>
<ul>
<li>Chips and Microarrays</li>
<li>In Situ Hybridization</li>
<li>Sequencing</li>
<li>Mass Spectrometry (MS)</li>
<li>PCR</li>
<li>Other Technologies</li>
</ul>
</li>
<li><strong>Application</strong>
<ul>
<li>Pharmacogenomics</li>
<li>Infectious Disease</li>
<li>Genetic Disease Screening</li>
<li>Oncology</li>
<li>Blood Screening</li>
<li>Microbiology</li>
<li>Human Leukocyte Antigen Typing</li>
</ul>
</li>
<li><strong>Product</strong>
<ul>
<li>Instruments</li>
<li>Reagents</li>
<li>Other Products</li>
</ul>
</li>
<li><strong>End User</strong>
<ul>
<li>Hospitals</li>
<li>Laboratories</li>
<li>Other End Users</li>
</ul>
</li>
</ul>
<h3><strong>Key Players Analysis</strong></h3>
<p>Assessed by: Overview, Key Persons, Recent Developments, and Revenue.</p>
<p><strong>Key Players Include</strong></p>
<ul>
<li>F Hoffmann-La Roche Ltd</li>
<li>Illumina Ltd</li>
<li>Hologic Corporation</li>
<li>Agilent Technologies Inc.</li>
<li>Qiagen NV</li>
<li>Myriad Genetics</li>
<li>Abbott Laboratories</li>
<li>Danaher Corporation</li>
<li>Becton, Dickinson and Company</li>
</ul>
<p>&nbsp;</p>
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