United States Nucleic Acid Testing Market 2031 | Growth Drivers, Trends & Market Forecast, Competitive Landscape & Investment Opportunities

Market Size and Growth

Nucleic Acid Testing Market growing with a High CAGR during the forecast period 2024-2031.

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Key Development:

United States: Recent Industry Developments

✅ In January 2026, researchers demonstrated a rapid hepatitis C nucleic acid test delivering results in around 20 minutes using a point-of-care molecular platform. The system supports fast PCR-based detection without complex lab infrastructure. It strengthens decentralized infectious disease diagnostics in the U.S.

✅ In December 2025, Anbio Biotechnology launched an ultra-fast PCR system capable of delivering nucleic acid test results in approximately 15 minutes without extraction. The launch targets rapid response diagnostics during outbreaks. It supports faster clinical decision-making in decentralized settings.

✅ In November 2025, U.S. diagnostic developers accelerated adoption of isothermal nucleic acid amplification technologies for rapid testing. These platforms reduce reliance on centralized labs. They improve turnaround time for infectious disease detection.

✅ In November 2025, Co-Diagnostics initiated clinical evaluations for its multiplex PCR Flu A/B, COVID-19, and RSV nucleic acid test to support an FDA 510(k) submission. The platform is designed for near-patient testing with compact instrumentation. It advances regulatory progress for point-of-care NAAT solutions.

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Japan: Recent Industry Developments

✅ In January 2026, Japanese healthcare institutions expanded deployment of AI-enabled nucleic acid testing platforms for infectious disease screening. The systems improve workflow automation and result accuracy. They support faster diagnostics across hospitals and regional labs.

✅ In December 2025, Fujifilm initiated collaborative research with national medical institutions to advance nucleic acid-based diagnostic and therapeutic technologies. The initiative focuses on precision diagnostics and targeted applications. It strengthens Japan's molecular diagnostics ecosystem.

✅ In November 2025, Sysmex Corporation introduced an automated isothermal nucleic acid amplification device for decentralized testing environments. The system enhances rapid molecular diagnostics outside central laboratories. It expands access to NAAT in regional healthcare facilities.

✅ In November 2025, Japanese diagnostic companies increased integration of nucleic acid testing modules into multifunction clinical analyzers. These developments improve testing efficiency and scalability. They support broader adoption of molecular diagnostics nationwide.

Key Players:

=> Abbott Laboratories, Becton, Dickinson and Company, Beckman Coulter Inc, Bio-Rad Laboratories, Illumina Inc, Siemens Healthcare, bioMérieux SA, F. Hoffmann-La Roche Ltd, Novartis International AG, and Grifols, S.A.

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Key Segments:

By Product Type

Nucleic Acid Test Kits - ~65% share, driven by high demand for accurate and rapid molecular diagnostics across infectious diseases, oncology, and genetic testing.
Consumables - ~35% share, supported by recurring usage of reagents, primers, probes, and sample preparation materials in routine testing.

By Indication

Infectious Disease - ~45% share, dominant segment due to widespread use in viral and bacterial diagnostics and public health screening programs.
Cancer - ~25% share, growth driven by precision oncology, companion diagnostics, and early cancer detection.
Genetic Disorders - ~15% share, increasing adoption for inherited disease screening and prenatal testing.
Forensic Testing - ~10% share, supported by DNA profiling and criminal investigation applications.
Others - ~5% share, includes applications such as paternity testing and agricultural genomics.

By End User

Hospitals - ~40% share, primary users due to in-house diagnostic labs and high patient testing volumes.
Pathology Laboratories - ~35% share, strong demand from centralized and reference laboratories offering molecular testing services.
Research Institutes - ~15% share, driven by genomics research and clinical trials.
Others - ~10% share, includes academic labs and forensic facilities.

By Region

North America - ~35% Share
Strong molecular diagnostics infrastructure, high healthcare spending, and rapid adoption of advanced nucleic acid testing technologies.

Europe - ~25% Share
Growth supported by public healthcare systems, cancer screening programs, and regulatory support for molecular diagnostics.

Asia Pacific - ~30% Share
Fastest-growing region due to expanding diagnostic capacity, rising infectious disease burden, and government investments in healthcare infrastructure.

Latin America - ~5% Share
Gradual adoption with increasing investment in diagnostic laboratories and public health initiatives.

Middle East & Africa - ~5% Share
Emerging market driven by improving healthcare access and diagnostic modernization efforts.

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