Nucleic Acid Amplification Testing Market - By Product Type (Consumables, Instruments/Systems), Technology (PCR, INAAT, LCR), Application (Infectious Disease, Oncology, Genetic & Mitochondrial Disease Testing), End-use – Global Forecast, 2024 - 2032

Nucleic Acid Amplification Testing Market - By Product Type (Consumables, Instruments/Systems), Technology (PCR, INAAT, LCR), Application (Infectious Disease, Oncology, Genetic & Mitochondrial Disease Testing), End-use – Global Forecast, 2024 - 2032

Nucleic Acid Amplification Testing Market Size

Nucleic Acid Amplification Testing Market size was valued at around USD 7.3 billion in 2023 and is estimated to reach over USD 18.8 billion by 2032. Nucleic acid amplification testing (NAAT) is a molecular technique used to amplify and detect specific sequences of nucleic acids, such as DNA or RNA, within a sample. NAAT is employed in various fields including medical diagnostics, microbiology, and genetic research.

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Infectious diseases continue to pose a significant threat to global public health. The increasing prevalence of diseases such as HIV/AIDS, tuberculosis, hepatitis, and sexually transmitted infections necessitates accurate and rapid diagnostic methods. For instance, according to World Health Organization (WHO), in 2022, tuberculosis caused 1.3 million deaths, including 167,000 co-infected with HIV, making it the second leading infectious cause of death worldwide, surpassing HIV/AIDS.

There were 10.6 million new TB cases, affecting 5.8 million men, 3.5 million women, and 1.3 million children, highlighting its global prevalence across all demographics. Therefore, NAAT offers high sensitivity and specificity in detecting various pathogens, making it a crucial tool in the diagnosis and management of infectious diseases.

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Point-of-care testing (POCT) which is estimated to reach USD 78.3 billion by 2023, with NAAT technologies allows for rapid, accurate infectious disease diagnostics even at the remote locations. With quick results and decentralized testing, POCT meets the demand for timely diagnosis, improving patient care and stimulating NAAT adoption across healthcare settings.

Nucleic Acid Amplification Testing Market Trends

Personalized medicine aims to tailor medical treatment to the individual characteristics of each patient. NAAT plays a crucial role in personalized medicine by enabling precise diagnosis and monitoring of diseases based on an individual's genetic makeup and specific pathogen characteristics. As healthcare providers and patients increasingly recognize the importance of personalized treatment approaches, the demand for NAAT as a diagnostic tool is expected to rise significantly.

• Increasing investments in research and development (R&D) aimed at developing novel biotechnological diagnostic techniques contribute to the advancement of NAAT technologies.
• These investments support the development of next-generation NAAT platforms with improved sensitivity, specificity, automation, and multiplexing capabilities.
• Innovations in NAAT technology driven by R&D efforts enhance the performance and utility of NAAT assays for a wide range of applications, including infectious disease diagnosis, cancer screening, and genetic testing.

Nucleic Acid Amplification Testing Market Analysis

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Based on product type, the market is segmented into instruments/systems and consumables. The consumables segment is estimated to account for USD 13 billion by 2032.

• Consumables such as reagents, primers, probes, and disposable plasticware are integral to NAAT assays, ensuring accurate and sensitive diagnostic testing.
• The increasing adoption of NAAT technologies across various healthcare domains, including infectious disease diagnostics, oncology, and genetic testing, fuels the demand for consumables as healthcare facilities and laboratories integrate NAAT into their diagnostic workflows.
• Technological advancements in NAAT lead to the development of more sophisticated assays, driving the need for specialized consumables with improved performance characteristics.
• Additionally, market dynamics and competition encourage the introduction of novel consumables offering enhanced performance and cost-effectiveness, stimulating market growth within the consumables segment.

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Based on technology, the nucleic acid amplification testing market is segmented into polymerase chain reaction (PCR) tests, isothermal nucleic acid amplification technology (INAAT) tests, and ligase chain reaction (LCR) tests. The polymerase chain reaction (PCR) tests segment's substantial revenue of USD 5.1 billion in 2023 within the nucleic acid amplification testing (NAAT) market reflects PCR's established technology, diverse applications, and continuous innovation.

• PCR's reliability, sensitivity, and versatility have made it a preferred choice for diagnosing infectious diseases, genetic disorders, and conducting various other clinical and research tasks.
• Moreover, the heightened demand due to the COVID-19 pandemic further propelled the adoption of PCR tests, particularly for SARS-CoV-2 detection. Regulatory approval and standardization efforts have also reinforced PCR's credibility, ensuring its quality, safety, and performance standards.

Based on application, the nucleic acid amplification testing market is segmented into infectious disease testing, oncology testing, genetic & mitochondrial disease testing, and other applications. The infectious disease testing segment is estimated to account for USD 8.9 billion by 2032.

• The global prevalence of infectious diseases and the emergence of new pathogens emphasize the need for accurate and timely diagnostics. NAAT's high sensitivity and specificity enable early detection and precise diagnosis, crucial for effective disease management and surveillance.
• The rising demand for rapid and accurate diagnostics, stimulated by global health threats and pandemics such as COVID-19, underscores the importance of NAAT technology.
• Thus, as healthcare systems worldwide prioritize infectious disease control, the demand for NAAT-based diagnostic solutions is expected to continue to rise, propelling significant growth in the infectious disease testing segment.

Based on end-use, the nucleic acid amplification testing market is segmented into hospitals, diagnostic laboratories, biotechnology companies, and other end-users. The diagnostic laboratories segment held a substantial revenue of USD 3 billion in 2023.

• Diagnostic laboratories serve as central hubs equipped with advanced instrumentation and trained personnel capable of performing accurate and reliable NAAT assays.
• They play a crucial role in disease surveillance, outbreak investigation, and patient care by providing timely diagnostic results. NAAT assays, known for their high sensitivity and specificity, are particularly valuable in diagnosing infectious diseases, genetic disorders, and cancer.
• The increasing prevalence of infectious diseases and the demand for personalized medicine, coupled with the impact of the COVID-19 pandemic, have further stimulated the utilization of NAAT assays in diagnostic laboratories.

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In 2023, North America held a significant market share of 40.8% in the global nucleic acid amplification testing market and is predicted to witness substantial market expansion.

• North America's commitment to healthcare quality and patient safety stimulates the extensive utilization of accurate and sensitive diagnostic methods such as NAAT for a range of conditions, including infectious diseases and genetic disorders.
• Proactive regulatory frameworks and robust reimbursement policies provide further impetus to the adoption of NAAT assays in clinical practice.
• The region's rapid response to public health emergencies, exemplified by its handling of the COVID-19 pandemic, has also fueled demand for NAAT testing solutions, contributing to substantial market growth.

Nucleic Acid Amplification Testing Market Share

The nucleic acid amplification testing industry is competitive in nature, with several large multinationals and small and mid-sized companies competing in the industry. The development and launch of novel advanced products and services based on different technologies is among a key market strategy. Some of the leading industry players have a notable presence in the market.

Nucleic Acid Amplification Testing Market Companies

Some of the eminent market participants operating in the nucleic acid amplification testing industry include

• Abbott Laboratories
• Becton, Dickinson and Company
• bioMerieux S.A.
• Bio-Rad Laboratories, Inc.
• Danaher Corporation
• F. Hoffmann La Roche AG
• Illumina, Inc.
• QIAGEN N.V.
• Seegene Inc.
• Siemens Healthineers AG    

Nucleic Acid Amplification Testing Industry News

• In August 2023, Becton, Dickinson and Company (BD) announced U.S. FDA clearance for its BD Respiratory Viral Panel (RVP) for BD MAX System. These single molecular diagnostics test distinguished SARS-CoV-2, influenza A, influenza B, and Respiratory Syncytial Virus (RSV) in about two hours using a single nasal or nasopharyngeal swab. This strategy increased the product portfolio and strengthened BD's market position.
• In March 2023, Bio-Rad Laboratories, Inc., announced that AOAC INTERNATIONAL and AFNOR approved the CFX Opus Deepwell Real-Time PCR System for use with Bio-Rad iQ-Check Real-Time PCR Kits. This enhanced the product capabilities of in-vitro diagnostics, thereby generating sales.

The nucleic acid amplification testing market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2018 to 2032 for the following segments

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Market, By Product Type

• Consumables
• Instruments/Systems

Market, By Technology

• Polymerase chain reaction (PCR) tests
• Isothermal nucleic acid amplification technology (INAAT) tests
• Ligase chain reaction (LCR) tests

Market, By Application

• Infectious disease testing
  • COVID-19 testing
  • Mosquito borne disease testing
  • Influenza testing
  • Sexually transmitted infections testing
  • Hepatitis testing
  • Tuberculosis testing
  • Other infectious disease testing
• Oncology testing
• Genetic & mitochondrial disease testing
• Other applications

Market, By End-use

• Hospitals
• Diagnostic laboratories
• Biotechnology companies
• Other end-users

The above information is provided for the following regions and countries

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • South Korea
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Rest of Latin America
• Middle East and Africa
  • Saudi Arabia
  • South Africa
  • UAE
  • Rest of Middle East and Africa