Nucleic Acid Amplification Testing Market

Nucleic Acid Amplification Testing Market by Product Type (Instruments and Reagents & Kits), Technology (Polymerase Chain Reaction (PCR) Testing, Isothermal Nucleic Acid Amplification Technology (INAAT), Transcription Mediated Amplification (TMA), CRISPER, and Others), Application (Infectious Disease Testing, Genetic Testing, Oncology Testing, and Others), End-User (Hospitals and Clinics, Diagnostic Centers, Academic and Research Institutes, and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World) is expected to grow at a steady CAGR forecast till 2032 owing to the growing prevalence of infectious and genetic diseases and rising incidence of cancer.

The nucleic acid amplification testing (NAAT) market is estimated to grow at a CAGR of 8.13% during the forecast period from 2025 to 2032. The surge in demand for nucleic acid amplification testing (NAAT) is propelled by several key factors, prominently driven by the escalating prevalence of infectious and genetic diseases. This surge is further bolstered by the rising incidence of cancer and the expanding scope of Research and Development (R&D) activities among leading industry players. These dynamics collectively underpin a positive growth trajectory for the nucleic acid amplification testing market throughout the forecast period from 2025 to 2032.

Nucleic Acid Amplification Testing Market Dynamics:

Nucleic acid amplification testing (NAAT) is a pivotal diagnostic tool that examines variations in the sequence, structure, or expression of both deoxyribonucleic acid (DNA) and ribonucleic acid (RNA). By analyzing these variations, NAAT enables the precise diagnosis of diseases, identification of infections caused by specific pathogens, and determination of genetic carrier status. This advanced testing methodology allows healthcare professionals to swiftly and accurately detect genetic abnormalities, microbial pathogens, and other molecular markers critical for informing treatment decisions and patient care strategies.

The rising incidence of infectious diseases such as HIV, hepatitis, tuberculosis, and malaria serves as a primary catalyst driving the expansion of the NAAT market. NAAT’s unparalleled sensitivity enables the detection of pathogens even at minute concentrations, making it an indispensable tool in early diagnosis. According to the World Health Organization (WHO, 2022), approximately 354 million people globally were living with hepatitis B or C infections in 2022.

Genetic testing for rare conditions also contributes to market growth. A report by the World Economic Forum (February 2023) estimated that around 475 million individuals worldwide were living with genetic rare conditions in 2021. Over the subsequent five years, approximately 15.2 million people are expected to undergo clinical genomic testing to identify such conditions.

The increasing global burden of cancer further propels the NAAT market. According to the WHO (2022), in 2020, there were approximately 2.26 million new breast cancer cases, 2.21 million lung cancer cases, 1.93 million colorectal cancer cases, 1.41 million prostate cancer cases, and 1.09 million stomach cancer cases globally. Similarly, data from the Global Cancer Observatory (2021) reported 544,352 cases of non-Hodgkin lymphoma, 83,087 cases of Hodgkin lymphoma, 474,519 leukemia cases, and nearly 176,404 cases of multiple myeloma in 2020. NAAT plays a vital role in cancer diagnosis, particularly for breast and cervical cancers, by detecting gene mutations and analyzing gene expression, thereby facilitating early intervention and targeted therapies.

Key market players are focusing on developing innovative diagnostic solutions to enhance drug research and treatment for infectious diseases. For instance, in March 2022, Thermo Fisher Scientific Inc., a U.S.-based life sciences company, launched the Invitrogen Colorimetric ReadiLAMP Kit for SARS-CoV-2 detection. This technology enables rapid and sensitive detection of viral pathogens such as SARS-CoV-2, measles, and influenza in as little as five minutes. The kit’s enhanced master mix features robust enzymes and accommodates various evaluation methods, providing flexibility for developing assays targeting different RNA and DNA concentrations.

Despite these advancements, challenges such as the occurrence of false-positive and false-negative results, along with the complexities associated with nucleic acid amplification testing, may hinder market growth.

Nucleic Acid Amplification Testing Market Segment Analysis:

Nucleic Acid Amplification Testing Market by Product Type (Instruments and Reagents & Kits), Technology (Polymerase Chain Reaction (PCR) Testing, Isothermal Nucleic Acid Amplification Technology (INAAT), Transcription Mediated Amplification (TMA), CRISPER, and Others), Application (Infectious Disease Testing, Genetic Testing, Oncology Testing, and Others), End-User (Hospitals and Clinics, Diagnostic Centers, Academic and Research Institutes, and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World)

In the technology segment, the polymerase chain reaction (PCR) testing category is projected to account for the largest revenue share in the nucleic acid amplification testing (NAAT) market in 2024. This dominance is largely attributed to the wide-ranging applications of PCR techniques, including disease diagnosis and molecular biomarker testing. PCR is extensively used for detecting specific or broad-spectrum pathogens, monitoring emerging infections, identifying biological threat agents early, and analyzing antimicrobial resistance.

The widespread utilization of PCR globally highlights its importance. For instance, according to the Australian Government Department of Healthcare (October 2021), approximately 41.5 million COVID-19 PCR tests were conducted in Australia in 2020, underscoring the technology’s critical role in the pandemic response.

Technological advancements and product launches further propel the segment's growth. In February 2023, bioMérieux, a France-based biotechnology company, launched the R-GENE PCR kit for detecting the monkeypox virus. The test is compatible with various laboratory nucleic acid extraction and amplification platforms, enhancing its accessibility and usability. Similarly, in April 2024, Bio-Rad Laboratories, Inc., a U.S.-based life sciences and clinical diagnostics company, introduced the ddPLEX ESR1 Mutation Detection Kit, marking its foray into ultrasensitive multiplexed digital PCR assays. This addition strengthens Bio-Rad’s Droplet Digital PCR (ddPCR™) portfolio, catering to oncology research. Such advanced mutation detection assays are pivotal for translational research, therapy selection, and disease monitoring.

Beyond infectious diseases, clinicians and researchers employ PCR techniques for gene cloning, sequencing, and advanced quantitative genomic studies due to their rapid turnaround and high sensitivity. Given its broad applications and continuous technological innovations, the PCR testing category is expected to significantly contribute to the growth of the nucleic acid amplification testing market during the forecast period.

North America is expected to dominate the overall Nucleic Acid Amplification Testing Market:

In 2024, North America emerged as the leading market shareholder in the nucleic acid amplification testing (NAAT) market. This dominance is primarily attributed to the rising incidence of infectious and genetic diseases in the region. Polymerase chain reaction (PCR) technology, a core component of NAAT, is a highly effective diagnostic tool for detecting such diseases, particularly those with similar clinical presentations or caused by diverse pathogens. Consequently, the increasing prevalence of infectious and genetic conditions is expected to drive the expansion of the NAAT market in North America.

According to the Centers for Disease Control and Prevention (CDC) in May 2024, approximately 5,700 babies are born with Down syndrome each year in the United States, reflecting a prevalence of about 1 in every 640 births. PCR-based genomic testing, which employs multiple primers to detect genetic abnormalities, plays a crucial role in diagnosing such conditions. As the number of genetic disease cases continues to rise, the demand for nucleic acid amplification testing is expected to grow significantly in the region.

PCR assays are also widely used in diagnosing infectious diseases like tuberculosis (TB) by detecting DNA in patient samples, including saliva. The increasing incidence of TB in North America further contributes to market growth. For example, according to the CDC in November 2023, there were 8,331 reported TB cases in the United States in 2020, marking a 5.9% increase from the previous year. The growing prevalence of infectious diseases requiring NAAT for pathogen identification is thus a key driver of the North American nucleic acid amplification testing market.

Nucleic Acid Amplification Testing Market Key Players:

Some of the key market players operating in the nucleic acid amplification testing market include 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.

Recent Developmental Activities in the Nucleic Acid Amplification Testing Market:

• 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.
• In January 2021, Thermo Fisher Scientific Inc. successfully finalized the acquisition of Mesa Biotech, Inc. for a total of USD 450 million. This strategic move significantly enriched Thermo Fisher's product portfolio, particularly enhancing its offerings in PCR-based rapid point-of-care testing. Mesa Biotech specializes in molecular diagnostics and is renowned for its pioneering work in PCR-based infectious disease testing. Through this acquisition, Thermo Fisher is poised to expand its capabilities in detecting a range of infectious diseases, including but not limited to SARS-CoV-2, Influenza A and B, respiratory syncytial virus (RSV), and Strep A.

Key Takeaways from the Nucleic Acid Amplification Testing Market Report Study

• Market size analysis for current Nucleic Acid Amplification Testing Market size (2024), and market forecast for 8 years (2025 to 2032)
• Top key product/technology developments, mergers, acquisitions, partnerships, and joint ventures happened over the last 3 years.
• Key companies dominating the global Nucleic Acid Amplification Testing market.
• Various opportunities available for the other competitors in the Nucleic Acid Amplification Testing Market space.
• What are the top-performing segments in 2024? How these segments will perform in 2032?
• Which are the top-performing regions and countries in the current Nucleic Acid Amplification Testing market scenario?
• Which are the regions and countries where companies should have concentrated on opportunities for Nucleic Acid Amplification Testing market growth in the coming future?

Target Audience Who Can be benefited from this Nucleic Acid Amplification Testing Market Report Study

• Nucleic Acid Amplification Testing product providers
• Research organizations and consulting companies
• Nucleic Acid Amplification Testing related organizations, associations, forums, and other alliances
• Government and corporate offices
• Start-up companies, venture capitalists, and private equity firms
• Distributors and Traders dealing in Nucleic Acid Amplification Testing
• Various end-users who want to know more about the Nucleic Acid Amplification Testing Market and the latest technological developments in the Nucleic Acid Amplification Testing Market.

 

Frequently Asked Questions for the Nucleic Acid Amplification Testing Market:

1. What is Nucleic Acid Amplification Testing?

• Nucleic acid amplification testing (NAAT) refers to a molecular biology method utilized for identifying and amplifying specific segments of nucleic acids (like DNA or RNA) in a sample. This technique facilitates the detection and quantification of target sequences, which could include genes, pathogens, or genetic variations linked to various diseases. NAAT techniques offer highly precise and sensitive detection of nucleic acids, making them invaluable in clinical diagnostics, infectious disease screening, genetic analysis, and scientific research.

2. What is the market for Nucleic Acid Amplification Testing?

• The nucleic acid amplification testing (NAAT) market is estimated to grow at a CAGR of 8.13% during the forecast period from 2025 to 2032.

3. What are the drivers for the global Nucleic Acid Amplification Testing market?

• The surge in demand for nucleic acid amplification testing is propelled by several key factors, prominently driven by the escalating prevalence of infectious and genetic diseases. This surge is further bolstered by the rising incidence of cancer and the expanding scope of Research and Development (R&D) activities among leading industry players. These dynamics collectively underpin a positive growth trajectory for the nucleic acid amplification testing market throughout the forecast period from 2025 to 2032.

4. Who are the key players operating in the global Nucleic Acid Amplification Testing market?

• Some of the key market players operating in the nucleic acid amplification testing market include 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.

5. Which region has the highest share in the global Nucleic Acid Amplification Testing market?

• In 2024, North America emerged as the leading market shareholder in the nucleic acid amplification testing sector. This dominance is attributed to the increasing incidence of infectious and genetic diseases within the region. PCR stands out as a formidable diagnostic instrument for detecting such diseases, especially those sharing similar clinical presentations or caused by diverse pathogens. Consequently, the escalating prevalence of infectious and genetic conditions is projected to drive the expansion of the nucleic acid amplification testing market in North America.