Global Nucleic Acid Amplification Testing Market Report and Forecast 2025-2034

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.

Purchase the Regional Overview for USD 1099

If you choose to purchase the full report at a later stage, the amount already paid will be adjusted, and you will only need to pay the remaining balance.

Purchase the Regional Overview for USD 1099

If you choose to purchase the full report at a later stage, the amount already paid will be adjusted, and you will only need to pay the remaining balance.

Purchase the Regional Overview for USD 1099

If you choose to purchase the full report at a later stage, the amount already paid will be adjusted, and you will only need to pay the remaining balance.

Purchase the Regional Overview for USD 1099

If you choose to purchase the full report at a later stage, the amount already paid will be adjusted, and you will only need to pay the remaining balance.

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

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