Nucleic Acid Amplification Testing Market Size, Share & Trends Analysis Report By Type (Polymerase Chain Reaction (PCR) Tests, Isothermal Nucleic Acid Amplification Technology (INAAT) Tests, Ligase Chain Reaction (LCR) Tests), By Application (Infectious Disease Testing, Oncology Testing, Genetic Testing, Others), By End-User (Hospitals, Diagnostic laboratories, Others) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2025-2033

Nucleic Acid Amplification Testing Market Size

The global nucleic acid amplification testing market size was valued at USD 10.11 billion in 2024 and is projected to grow from USD 11.63 billion in 2025 to reach USD 23.74 billion by 2033, exhibiting a CAGR of 12.2% during the forecast period (2025-2033).

Nucleic acid amplification testing refers to a molecular diagnostic technique used to detect specific genetic material, such as DNA or RNA, in a sample. This is widely used in clinical diagnostics, particularly for infectious disease detection, including viruses and bacteria, as well as in genetic testing and personalized medicine.

The global market is experiencing significant growth, driven by the increasing demand for accurate and rapid diagnostics in infectious diseases, oncology, and genetic disorders. The widespread use of PCR-based tests, especially during the COVID-19 pandemic, has propelled the adoption of NAAT technologies.

Impact of COVID-19

The COVID-19 pandemic significantly impacted the global NAAT market by driving a surge in demand for rapid and accurate diagnostic solutions. The widespread implementation of PCR testing to identify COVID-19 cases accelerated the development and adoption of these technologies across various applications, including infectious disease detection, oncology, and genetic testing.

This shift not only increased market awareness but also prompted innovations in testing methods and accessibility, establishing a robust foundation for future growth in the market. While the severity of the COVID-19 pandemic has decreased, the continuous rise in cases underscores the importance of nucleic acid amplification testing.

The chart below shows COVID-19 cases in various countries in 2022.

Source: Straits Research, Johns Hopkins University & Medicine

The COVID-19 case data from 2022 highlights the United States reporting the highest number of cases at 78,348, followed by France and Japan. This variance underscores the continued need for effective diagnostic solutions, such as nucleic acid amplification testing, to accurately identify and manage outbreaks in diverse settings.

Nucleic Acid Amplification Testing Market Trends

Shift toward point-of-care testing

The shift toward point-of-care testing is transforming the diagnostic landscape by enabling rapid, on-site testing in decentralized settings such as clinics, airports, and remote areas. This trend is driven by the need for quicker, more accurate results without the delays of central lab processing. Companies like Cepheid are innovating compact, user-friendly platforms.

• For instance, in September 2024, Cepheid launched a new POC system aimed at simplifying molecular diagnostics in primary care and emergency settings, offering fast results for a wide range of pathogens, including respiratory viruses.

As technology continues to advance, the integration of point-of-care NAAT in healthcare settings is poised to play a crucial role in combating infectious diseases and streamlining patient care.

Shift towards automation and high-throughput systems

The demand for automation and high-throughput systems in NAAT is increasing as laboratories seek to improve efficiency, minimize human error, and scale operations to handle large volumes of tests. Fully automated platforms streamline workflows by integrating sample preparation, amplification, and analysis processes, allowing for faster turnaround times and more consistent results.

Companies are investing significantly in developing advanced robotic systems and software that can process multiple samples simultaneously, further enhancing throughput.

• For instance, in February 2023, Hamilton introduced the Microlab STAR automated liquid handling system, which is designed to facilitate high-throughput workflows, improving sample processing efficiency and accuracy in molecular diagnostics laboratories.

Nucleic Acid Amplification Testing Market Growth Factors

Increasing prevalence of infectious disease

The rise in infectious diseases is a significant driver for the global nucleic acid amplification testing market, as the increasing incidence of these diseases necessitates effective and rapid diagnostic solutions. With the emergence of viral outbreaks, such as COVID-19, influenza, and other respiratory infections, the demand for precise and timely detection methods has surged.

• For instance, in September 2023, according to the report of the World Health Organization (WHO), the global burden of infectious diseases remains significant, with about 17 million deaths attributed to infectious diseases in 2022.

This emerging threat from infectious diseases highlights the critical role of this testing in effective disease management, driving market growth.

Technological advancements

Technological advancements are a pivotal driver for the growth of the global market, significantly enhancing the performance and accessibility of these diagnostic tools. Innovations in amplification methods, such as rapid polymerase chain reaction (PCR) and loop-mediated isothermal amplification (LAMP), have greatly improved test speed and efficiency, allowing for quicker diagnosis and treatment decisions.

• For instance, in July 2024, Bio-Rad Laboratories launched ddPCR (digital droplet PCR) technology in August 2023, which significantly improves precision and sensitivity in detecting low-abundance nucleic acids, thereby advancing the capabilities of molecular diagnostics.

Such integration with digital health solutions, including telehealth platforms and data analytics, further enhances the utility of these tests by facilitating remote monitoring and real-time data sharing, thereby further boosting market growth.

Market Restraining Factors

Shortage of skilled personnel

The need for skilled personnel is a significant restraint on the global market, as these technologies often require specialized training and expertise for accurate test performance and result interpretation. The complexity of these testing procedures can pose challenges in clinical settings, particularly in laboratories with limited resources. A shortage of qualified personnel capable of handling these sophisticated diagnostic tools may hinder the widespread adoption and effective utilization of nucleic acid amplification testing, potentially limiting their effectiveness and reach in routine clinical practice.

Nucleic Acid Amplification Testing Market Opportunities

Expansion of personalized medicine

The expansion of personalized medicine represents a significant opportunity for the global nucleic acid amplification testing industry, as there is an increasing demand for advanced diagnostic tools that deliver precise genetic and molecular information. This testing enables the identification of specific genetic markers associated with diseases, facilitating tailored treatment plans that optimize patient outcomes.

• For instance, a 2023 report by the National Institutes of Health (NIH) highlights that nearly 75% of oncologists now utilize genetic testing to guide treatment decisions, reflecting the growing reliance on molecular diagnostics, such as nucleic acid amplification testing, in the personalized medicine landscape.

This underscores the critical role of the global market in advancing personalized healthcare initiatives and improving patient care.

Regional Insights

North America: Dominant region with 37.10% market share

North America dominates the nucleic acid amplification testing (NAAT) market, capturing the largest revenue share, largely due to its robust healthcare infrastructure and high prevalence of infectious diseases. The region has made substantial investments in advanced diagnostic technologies, ensuring access to cutting-edge solutions in clinical settings.

Moreover, the ongoing focus on improving diagnostic accuracy and speed, especially during public health crises like the COVID-19 pandemic, has propelled NAAT adoption. The presence of major biotechnology companies and continuous research initiatives further strengthen the market’s competitive landscape, fostering innovation in diagnostic methods.

Asia-Pacific: Fastest growing region with highest market CAGR

The Asia-Pacific region is witnessing the highest growth rate in the global market, driven by a combination of factors. Rapid investments in healthcare infrastructure, particularly in emerging economies, are significantly enhancing access to diagnostic technologies. The increasing prevalence of infectious diseases and genetic disorders, alongside a growing awareness of the importance of early detection, has further fueled demand for NAAT. Moreover, government initiatives to improve healthcare standards and boost diagnostic capabilities are accelerating market expansion.

Country Insights

The global market is experiencing dynamic growth and diversification across the globe, with each region contributing uniquely to the advancement of this transformative field. Below are a few countries that illustrate the diverse contributions and advancements in the global market.

• US.- The U.S. is a leader in the regional NAAT market, bolstered by advanced healthcare infrastructure and substantial research funding. The country reported over 90 million COVID-19 tests using nucleic acid amplification testing in 2021 alone, highlighting the method's critical role in diagnostics and driving market growth.
• Germany- Germany is a prominent player in the market, with a strong focus on research and development in molecular diagnostics. The country has a high per capita healthcare expenditure, approximately USD 4,500, enabling investment in advanced diagnostic technologies.Moreover, the country’s robust healthcare system and emphasis on precision medicine drive demand for nucleic acid amplification testing, particularly in infectious disease testing.
• UK- The UK has a well-established market, largely due to its advanced healthcare system and ongoing research in molecular diagnostics. The National Health Service (NHS) emphasized the use of NAAT for COVID-19 testing, leading to over 50 million tests by mid-2021. This strong emphasis on accurate diagnostics is likely to continue, fostering market growth.
• Japan- Japan is witnessing rapid growth in the market, supported by an aging population and the rising prevalence of chronic diseases. The Japanese government’s commitment to enhancing healthcare infrastructure includes investments in advanced diagnostic technologies.In 2022, approximately 60% of hospitals in Japan implemented nucleic acid amplification testing for respiratory infections, reflecting a shift towards efficient diagnostic methods and improving patient care.
• China- China is rapidly expanding its market, driven by increased healthcare spending and a rising focus on infectious disease control. The National Health Commission reported over 1.3 billion nucleic acid tests conducted during the COVID-19 pandemic.Moreover, China is investing in domestic manufacturing of NAAT technologies to enhance self-sufficiency and improve accessibility to advanced diagnostics.
• India- India's nucleic acid amplification testing market is growing quickly due to rising healthcare investments and the increasing burden of infectious diseases. The country saw a surge in testing post the pandemic, with over 300 million tests conducted by mid-2022. Moreover, government initiatives aimed at improving healthcare infrastructure are promoting the adoption of NAAT in remote areas, expanding its reach.
• Brazil- Brazil is emerging as a significant player in the global market, driven by rising healthcare investments and a growing demand for advanced diagnostic solutions. The Brazilian Ministry of Health reported a significant increase in nucleic acid amplification testing utilization for infectious disease management, especially during the COVID-19 crisis, with millions of tests conducted.

Segmentation Analysis

The global nucleic acid amplification testing market is segmented into type, application, and end-user.

By Type

Polymerase chain reaction (PCR) segment dominates the market with the highest market revenue

The polymerase chain reaction (PCR) segment dominates due to its established efficacy, sensitivity, and specificity in detecting a wide range of pathogens and genetic materials. PCR technology is widely adopted across various applications, including infectious disease diagnostics, oncology, and genetic testing, thanks to its robust performance and familiarity among healthcare professionals.

The segment's growth is further fueled by ongoing advancements in PCR technology, such as real-time PCR and digital PCR, which enhance detection capabilities and throughput.

• For instance, in June 2022, Thermo Fisher Scientific updated its Applied Biosystems QuantStudio 5 Dx Real-Time PCR System to comply with the In Vitro Diagnostic Regulation (IVDR), to support molecular diagnostic manufacturers and laboratories in meeting the new regulatory requirements, ensuring high standards for patient safety and quality results.

By Applications

Infectious disease segment holds the largest market share

The infectious disease testing segment holds a dominant position, driven by the increasing prevalence of infectious diseases worldwide. The growing need for fast, accurate, and early detection of pathogens such as viruses, bacteria, and fungi is fueling this trend. NAAT allows healthcare professionals to identify infections with high sensitivity and specificity, essential in the context of outbreaks like COVID-19, HIV, and tuberculosis.

Additionally, the growing demand for personalized medicine and precision diagnostics is expected to further boost the market. The ability of NAAT to detect infections at an early stage enables timely treatment, reducing transmission rates and improving patient outcomes, making it a critical tool in managing public health threats.

By End-Users

Hospital segment dominates the market with the highest market revenue 

Hospitals dominate the global market, driven by their need for fast, reliable, and accurate diagnostic tools, particularly for infectious disease outbreaks. Hospitals are critical in providing immediate care, and NAAT supports clinical decision-making by offering rapid results. In emergency or epidemic situations, such as during a flu season or the COVID-19 pandemic, the demand for precise diagnostics grows significantly.

NAAT systems are crucial for hospitals as they can detect a wide range of pathogens in real-time, enabling prompt treatment and infection control. Moreover, as healthcare facilities strive to improve patient care and minimize hospital-acquired infections, the growing focus on rapid testing technologies continues to make NAAT a preferred choice for hospital laboratories.

Company Market Share

Key market players are strategically investing in improving their diagnostic platforms by enhancing automation, increasing the scalability of testing, and integrating digital health solutions. These investments are aimed at boosting the efficiency and accuracy of nucleic acid amplification testing technologies while expanding their applications in areas like personalized medicine and infectious disease detection.

Visby Medical: An emerging player

Visby Medical is an emerging diagnostic company focused on developing portable, rapid PCR testing devices. Visby aims to address the need for fast, accurate, and accessible diagnostics in decentralized settings, such as clinics and remote areas. Its innovative technology has gained attention, particularly with FDA Emergency Use Authorization (EUA) for its COVID-19 and respiratory infection tests.

Recent developments at Visby Medical include:

• In January 2023, Visby Medical received FDA Emergency Use Authorization (EUA) for its rapid PCR test targeting multiple respiratory infections, including COVID-19, influenza, and RSV.

Recent Developments

• October 2024 - The World Health Organization (WHO) approved the first diagnostic test for mpox, a disease caused by the monkeypox virus. This approval is a significant step in enhancing global efforts to detect and manage the disease, which has seen a resurgence in recent years. The test is designed to be highly accurate and efficient, ensuring faster diagnosis and better containment strategies during outbreaks.

Analyst Opinion

As per our analyst, the global market is a rapidly evolving sector driven by technological advancements, the rising prevalence of infectious diseases, and the increasing demand for point-of-care diagnostics. Innovations in automation and portable platforms are expected to streamline testing processes, making nucleic acid amplification testing more accessible in decentralized settings. As the healthcare industry continues to prioritize precision diagnostics, NAAT is poised to play a crucial role in disease detection and personalized medicine, positioning it for sustained growth in both clinical and research applications.