Nucleic Acid Amplification Testing Market Outlook - Forecast Trends, Market Size, Share and Growth Analysis Report (2025-2034)

The nucleic acid amplification testing market was valued at USD 9.46 Billion in 2024, driven by the expansion of diagnostic applications in oncology and genetic testing across the globe. The market is anticipated to grow at a CAGR of 8.10% during the forecast period of 2025-2034 to achieve a value of USD 20.61 Billion by 2034 .

Report Overview

The nucleic acid amplification testing market is expanding due to rising R&D investments in novel biotechnological diagnostic techniques that enhance detection accuracy for infectious diseases. The market growth is driven by the demand for testing alternatives that offer rapid and accurate testing methods. The increasing prevalence of diseases like the SARS-CoV-2 virus highlight the necessity for nucleic acid amplification in point-of-care testing, enabling quicker results and improved patient management. Advancements in PCR and isothermal amplification technologies continue to enhance diagnostic capabilities, with many companies focusing on innovative solutions to improve the efficiency and accessibility of molecular diagnostics.

For instance, in March 2023, Bio-Rad iQ-Check Real-Time PCR Kits received AOAC INTERNATIONAL and AFNOR approval for use with the CFX Opus Deepwell Real-Time PCR System, improving pathogen detection and DNA analysis. This technological progress strengthens the U.S. nucleic acid amplification testing market, boosting its market size and contributing to a higher growth rate. The continuous development of enhanced PCR-based assays supports market expansion, meeting the growing demand for accurate and efficient diagnostic solutions.

Companies like Abbott Laboratories have made significant contributions to the market, particularly through the Emergency Use Authorization (EUA) granted for the Abbott ID NOW COVID-19 test. This test played a crucial role during the pandemic, demonstrating the effectiveness of nucleic acid amplification methods. Additionally, market growth is being driven by strategic initiatives, such as partnerships and technological advancements, aimed at improving diagnostic speed and accuracy.

In June 2024, Roche received FDA Emergency Use Authorization (EUA) for the cobas liat SARS-CoV-2, Influenza A/B & RSV test. This RT-PCR assay provides results within 20 minutes using a single nasal or nasopharyngeal swab. This breakthrough enhances the detection of infectious agents in diagnostic applications and supports advancements in cancer research, personalized medicine, and forensics. Such innovations improve patient outcomes by enabling faster and more precise disease detection.

The emerging infectious diseases, such as the Monkeypox virus, are accelerating demand for nucleic acid amplification test products. Companies like Quest Diagnostics are expanding their diagnostic capabilities, and regulatory agencies like the U.S. FDA’s Emergency Use Authorization (EUA) continue to support the development of reliable testing solutions. These efforts ensure that diagnostic technologies remain at the forefront of combating public health challenges.

Type Insights

Polymerase chain reaction (PCR) tests remain the gold standard for nucleic acid amplification due to their high sensitivity and specificity. However, isothermal nucleic acid amplification technology (INAAT) tests are gaining traction for their rapid results without the need for thermal cycling. A key development in this field occurred in October 2024, when BARDA partnered with Sherlock Biosciences to develop the Sherlock Molecular COVID-19 + Flu A + B Test, a hand-held, battery-operated home-use molecular test utilizing isothermal amplification. This test can detect SARS-CoV-2, influenza A, and influenza B within 15 minutes using nasal swabs, highlighting the growing demand for fast and portable diagnostic solutions.

Transcription-mediated amplification (TMA) and loop-mediated isothermal amplification (LAMP) are widely used in infectious disease diagnostics. TMA provides high-throughput capability, making it ideal for large-scale screening, while LAMP is particularly useful in point-of-care settings due to its efficiency in amplifying DNA at a constant temperature. The increasing adoption of these methods reflects the industry's shift toward faster and more accessible testing technologies.

Nucleic acid sequence-based amplification (NASBA) and ligase chain reaction (LCR) tests further contribute to market expansion. NASBA is commonly used for RNA detection, particularly in viral diagnostics, while LCR enhances mutation detection and bacterial identification. As the demand for highly sensitive and specific nucleic acid testing methods continues to grow, these technologies are expected to play a crucial role in advancing molecular diagnostics.

Application Insights

Infectious disease testing remains a critical application of nucleic acid amplification technology, covering COVID-19, mosquito-borne diseases, influenza, sexually transmitted infections (STIs), hepatitis, and tuberculosis. COVID-19 testing has driven widespread adoption of molecular diagnostics, accelerating advancements in rapid and point-of-care testing. Influenza and mosquito-borne disease testing, including Zika and dengue, continue to be significant due to seasonal outbreaks. STI and hepatitis testing benefit from the high sensitivity of nucleic acid-based methods, enabling early and accurate detection. The demand for tuberculosis testing is also rising due to global eradication efforts, supporting the market’s continuous growth.

Oncology testing is another major application, leveraging nucleic acid amplification for the detection of cancer-related genetic mutations. These methods help diagnose solid tumours and haematological cancers, monitor treatment responses, and guide targeted therapies. With the increasing incidence of cancer diseases, the demand for early and precision diagnostics is growing, making molecular testing a cornerstone in oncology research and clinical applications.

Genetic and mitochondrial disease testing helps in identifying hereditary conditions, supporting newborn screening and early intervention programs. The expansion of advanced molecular diagnostics is expected to further improve healthcare outcomes and patient management.

End-use Insights

Hospitals and clinics are the primary users of nucleic acid amplification technologies, driving the demand for rapid and accurate diagnostic solutions. Hospitals rely on these tests for infectious disease diagnosis, oncology testing, and genetic screening, ensuring timely treatment decisions. Clinics process large volumes of samples, making high-throughput molecular testing essential for detecting pathogens, genetic disorders, and blood-borne infections. The increasing adoption of point-of-care molecular diagnostics in hospital emergency departments and outpatient clinics further enhances accessibility to critical healthcare services.

Central and reference laboratories play a crucial role in advancing nucleic acid amplification technologies. They focus on developing novel biomarkers, refining diagnostic methods, and enhancing precision medicine applications. Pharmaceutical and biotechnology companies integrate these technologies into drug development, clinical trials, and personalised medicine, ensuring effective therapeutic interventions. Increased R&D investments and strategic collaborations are fostering innovation, leading to improved diagnostic solutions and expanding market potential in both clinical and research settings.

Regional Insights

North America dominates the nucleic acid amplification testing market, driven by high adoption of advanced diagnostics, strong healthcare infrastructure, and government initiatives supporting infectious disease testing. The U.S. is poised to lead the region due to extensive R&D investments, regulatory approvals, and widespread use of molecular diagnostics in hospitals and laboratories. Asia Pacific is witnessing rapid growth, fueled by rising healthcare expenditure, increasing prevalence of infectious diseases, and technological advancements. Countries like China, India, and Japan are investing in molecular diagnostic research, expanding market potential.

Europe remains a key market due to stringent regulatory frameworks, strong research initiatives, and increasing demand for point-of-care diagnostics. For instance, in November 2024, Bioer Technology showcased three molecular diagnostic innovations, a digital PCR system, an automated nucleic acid analyzer, and an automatic PCR system, at MEDICA 2024, demonstrating Europe's commitment to advanced diagnostics. Meanwhile, Latin America, the Middle East, and Africa are experiencing gradual adoption of nucleic acid amplification technologies, supported by government healthcare initiatives and international collaborations.

Key Companies & Market Share Insights

The key features of the market report comprise patent analysis, grants analysis, funding and investment analysis, and strategic initiatives by the leading players. The major companies in the market are as follows:

F. Hoffmann-La Roche Ltd

F. Hoffmann-La Roche Ltd is a global leader in the nucleic acid amplification testing market, driven by substantial investments in research and development. The company offers advanced molecular diagnostic solutions, including the highly efficient cobas® PCR systems, which provide precise and reliable results for infectious disease detection. Roche’s commitment to innovation and automation enhances laboratory efficiency, making its solutions widely adopted in clinical and research settings. With a strong portfolio in molecular diagnostics, the company continues to expand its market presence by integrating cutting-edge technologies to improve diagnostic accuracy and patient outcomes.

Becton, Dickinson and Company (BD)

Becton, Dickinson and Company (BD) is at the forefront of innovative diagnostic technologies, focusing on enhancing the accuracy and efficiency of molecular testing. The company’s BD MAX™ molecular testing platform is a fully automated, user-friendly system that delivers rapid and reliable results, particularly in detecting infectious diseases. BD’s commitment to expanding its diagnostic capabilities through advanced molecular solutions and strategic partnerships strengthens its competitive position. By continuously developing high-performance diagnostic tools, BD plays a crucial role in improving clinical decision-making and streamlining laboratory workflows, driving growth in the nucleic acid amplification testing market.

Danaher Corporation

Danaher Corporation has established a significant presence in the nucleic acid amplification testing market, leveraging its diverse portfolio and subsidiary network. Through its subsidiary Cepheid, Danaher delivers industry-leading GeneXpert® systems, known for their rapid, automated PCR-based diagnostic capabilities. These systems enable real-time molecular testing with high accuracy, making them essential in infectious disease detection and antimicrobial resistance surveillance. Danaher’s strategic acquisitions and focus on continuous innovation strengthen its market leadership. By integrating advanced automation and precision technologies, the company enhances diagnostic efficiency, ensuring faster turnaround times and improved patient management in clinical settings.

Abbott

Abbott is a dominant player in the nucleic acid amplification testing market, recognised for its pioneering rapid molecular testing solutions. The company’s ID NOW™ platform offers real-time, point-of-care molecular diagnostics, widely used for COVID-19, influenza, and other infectious diseases. This compact and efficient system delivers rapid results, significantly improving clinical decision-making and outbreak control. Abbott’s strong emphasis on technological advancements and global market expansion has solidified its leadership position. By continuously innovating and expanding its diagnostic portfolio, the company contributes to improving accessibility to high-quality molecular testing solutions across healthcare settings worldwide.

Other key players in the market include Thermo Fisher Scientific Inc., Illumina, Inc., Siemens Healthineers, bioMérieux SA, Bio-Rad Laboratories, Inc. and Seegene Inc

Global Nucleic Acid Amplification Testing Market Report Segmentation

"Nucleic Acid Amplification Testing Market Report and Forecast 2025-2034" offers a detailed analysis of the market based on the following segments:

Offerings Outlook (Revenue, USD Million, 2018-2034)

• Systems
• Services

Type Outlook (Revenue, USD Million, 2018-2034)

• Polymerase Chain Reaction (PCR) Tests
• Isothermal Nucleic Acid Amplification Technology (INAAT) Tests
• Ligase Chain Reaction (LCR) Tests

Application Outlook (Revenue, USD Million, 2018-2034)

• Infectious Disease Testing
• COVID-19 Testing
• Mosquito Borne Disease Testing
• Influenza Testing
• Sexually Transmitted Infections Testing
• Hepatitis Testing
• Tuberculosis Testing
• Others
• Oncology Testing
• Genetic and Mitochondrial Disease Testing
• Others

End-use Outlook (Revenue, USD Million, 2018-2034)

• Hospitals and Clinics
• Central and Reference Laboratories
• Others

Regional Outlook (Revenue, USD Million, 2018-2034)

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East and Africa (MEA)

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