The market outlook remains highly favorable, with demand supported by persistent needs in respiratory infections, tuberculosis, hepatitis, and emerging pathogen surveillance. Beyond infectious diseases, NAAT is gaining traction in oncology for mutation profiling, minimal residual disease detection, and companion diagnostics, further broadening its clinical footprint.
Technological advancements are transforming the segment, with innovations such as isothermal amplification methods, cartridge-based automated systems, multiplex PCR panels, and CRISPR-based diagnostics enabling faster, more portable, and cost-effective solutions. The growing preference for decentralized and ambulatory testing settings is accelerating the shift toward compact, user-friendly POC platforms that expand access to molecular testing globally.
Leading diagnostic companies are intensifying their investments in next-generation NAAT platforms, integrating AI-driven workflows and digital reporting to enhance clinical decision-making and streamline surveillance programs. Emerging players are also leveraging novel chemistries and portable device architectures to target unmet needs in low-resource and high-throughput testing environments.
As a result, the NAAT market is projected to grow steadily at a CAGR of ~8.13% through 2032, reaching multi-billion-dollar valuations. Growth will be sustained by favorable epidemiology, continued R&D investments, expanding oncology applications, and strong public health funding for molecular diagnostics.
DelveInsight’s Nucleic Acid Amplification Testing Market Insights report offers a comprehensive evaluation of current and forecasted market dynamics, growth drivers, challenges, regulatory landscape, and competitive positioning, alongside detailed profiles of leading players shaping the future of the NAAT industry.
Key Takeaways from the Nucleic Acid Amplification Testing Market Report
• The nucleic acid amplification testing (NAAT) market is projected to grow at an 8.13% CAGR from 2025 to 2032.
• As per DelveInsight estimates, North America is anticipated to dominate the global nucleic acid amplification testing market during the forecast period.
• Notable nucleic acid amplification testing companies such as Abbott Laboratories, Agilent Technologies, Inc., Thermo Fisher Scientific Inc., F. Hoffmann-La Roche Ltd, Merck & Co., Inc., PerkinElmer Inc., Sysmex Corporation, Bio-Rad Laboratories, Inc., Seegene Inc., QIAGEN, bioMérieux, BD, Hologic, Inc., SHERLOCK BIOSCIENCES, Siemens Healthineers AG, Illumina, Inc., Danaher Corporation, Grifols, Meridian Bioscience, Inc., QuidelOrtho Corporation, and several others are currently operating in the nucleic acid amplification testing market.
• In July 2025, the FDA granted clearance to the cobas® HIV-1 Quantitative nucleic acid test, designed for precise quantification of HIV-1 RNA across a broad range, further expanding the utility of Roche’s molecular testing portfolio.
• In June 2025, the FDA cleared Roche’s cobas® HIV-1/HIV-2 Qualitative nucleic acid test for use on the cobas® 5800/6800/8800 systems, enabling the qualitative detection and differentiation of HIV-1 and HIV-2 RNA.
• In March 2025, Abbott submitted its Alinity m BKV nucleic acid amplification test to the FDA under the 510(k) pathway, demonstrating strong concordance and analytical performance for detecting BK virus in plasma and urine specimens.
• In May 2024, bioMérieux forged a strategic collaboration with AnaBioTec, an esteemed analytical service provider catering to the pharmaceutical, biopharmaceutical, and cell-based drug sectors across all stages of development. Together, these entities aim to revolutionize and elevate Mycoplasma testing standards within the biopharmaceutical and Cell & Gene Therapy (CGT) industries, specifically in Europe.
To read more about the latest highlights related to the nucleic acid amplification testing market, get a snapshot of the key highlights entailed in the Global Nucleic Acid Amplification Testing Market Report
Nucleic Acid Amplification Testing Overview
Nucleic Acid Amplification Testing (NAAT) is a highly sensitive molecular diagnostic technique used to detect the presence of specific genetic material (DNA or RNA) from pathogens such as viruses and bacteria. NAAT works by amplifying small amounts of nucleic acids in a sample to detectable levels, enabling early and accurate diagnosis of infectious diseases. Common methods under NAAT include Polymerase Chain Reaction (PCR), Transcription-Mediated Amplification (TMA), and Loop-Mediated Isothermal Amplification (LAMP).
NAAT is widely used in clinical diagnostics for conditions like COVID-19, HIV, tuberculosis, chlamydia, and gonorrhea, among others. Its high specificity and sensitivity make it a preferred choice over traditional culture methods, especially in early-stage infections or when dealing with low pathogen loads. While NAAT typically requires specialized equipment and trained personnel, ongoing advancements are making point-of-care NAAT systems more accessible for rapid, on-site testing.
Nucleic Acid Amplification Testing Market Insights
In 2024, North America led the nucleic acid amplification testing (NAAT) market, driven by the rising prevalence of infectious and genetic diseases. The widespread use of PCR technology, a key NAAT method, supports early and accurate diagnosis of conditions like tuberculosis and Down syndrome. According to the CDC, around 5,700 babies are born with Down syndrome annually in the U.S., and TB cases rose by 5.9% in 2020. This growing disease burden, combined with the effectiveness of PCR-based testing, continues to fuel demand for NAAT across the region.
To know more about why North America is leading the market growth in the nucleic acid amplification testing market, get a snapshot of the Nucleic Acid Amplification Testing Market Outlook
Nucleic Acid Amplification Testing Market Dynamics
Nucleic acid amplification testing (NAAT) is a powerful diagnostic tool used to detect genetic abnormalities and infectious diseases by analyzing DNA and RNA variations. Its high sensitivity makes it essential for the early detection of infections such as HIV, hepatitis, tuberculosis, and malaria, contributing significantly to its market growth. According to WHO, 354 million people were living with hepatitis B or C in 2022. NAAT also supports the diagnosis of rare genetic conditions and cancers, with millions expected to undergo genomic testing in the years to come. The technology is widely used in cancer diagnostics—especially for breast and cervical cancers—by identifying gene mutations and expression patterns. Key players, such as Thermo Fisher, are advancing rapid NAAT solutions, like the Invitrogen Colorimetric ReadiLAMP Kit, which can detect viral pathogens within minutes. However, challenges such as false results and technical complexity may limit broader adoption.
Get a sneak peek at the nucleic acid amplification testing market dynamics @ https://www.delveinsight.com/report-store/nucleic-acid-amplification-testing-market
Coverage: Global
Study Period: 2022 to 2032
Nucleic Acid Amplification Testing Market CAGR: ~8.13%
Key Nucleic Acid Amplification Testing Companies: Abbott Laboratories, Agilent Technologies, Inc., Thermo Fisher Scientific Inc., F. Hoffmann-La Roche Ltd, Merck & Co., Inc., PerkinElmer Inc., Sysmex Corporation, Bio-Rad Laboratories, Inc., Seegene Inc., QIAGEN, bioMérieux, BD, Hologic, Inc., SHERLOCK BIOSCIENCES, Siemens Healthineers AG, Illumina, Inc., Danaher Corporation, Grifols, Meridian Bioscience, Inc., QuidelOrtho Corporation, and others.
Nucleic Acid Amplification Testing Market Segmentation
Market Segmentation By Product Type: Instruments and Reagents & Kits.
Market Segmentation By Technology: Polymerase Chain Reaction (PCR) Testing, Isothermal Nucleic Acid Amplification Technology (INAAT), Transcription Mediated Amplification (TMA), CRISPR, and others.
Market Segmentation By Application: Infectious Disease Testing, Genetic Testing, Oncology Testing, and others.
Market Segmentation By End User: Hospitals and Clinics, Diagnostic Centers, Academic and Research Institutes, and others.
Market Segmentation By Geography: North America, Europe, Asia-Pacific, and Rest of the World.
Which MedTech key players in the nucleic acid amplification testing market are set to emerge as the trendsetters? Explore @ Nucleic Acid Amplification Testing Companies
Table of Contents
1. Electrophysiology Devices Market Report Introduction
2. Electrophysiology Devices Market Executive Summary
3. Competitive Landscape
4. Regulatory Analysis
5. Electrophysiology Devices Market Key Factors Analysis
6. Electrophysiology Devices Market Porter’s Five Forces Analysis
7. Electrophysiology Devices Market Layout
8. Electrophysiology Devices Market Company and Product Profiles
9. KOL Views
10. Project Approach
11. About DelveInsight
12. Disclaimer & Contact Us
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