The nucleic acid amplification testing market size is estimated to be USD 6,452.6 million in 2022 and is expected to witness a CAGR of 12.93% during the forecast period 2023-2033. Rise in the demand for advanced fast diagnostics, increase in new product launch by key market players, surge in R&D expenditures for the development of cutting-edge biotechnology diagnostic methods are factors contributing to the market growth. Additionally, higher prevalence of infectious diseases worldwide and the demand for extremely effective testing alternatives for the effective management of disease outbreaks have fuelled demand for a variety of nucleic acid amplification testing technologies. However, high price of testing is expected to hinder the growth.

Higher prevalence of infectious diseases worldwide is expected propel the market growth. The introduction and regulatory approval of nucleic acid amplification test products for such diseases is indication that new emerging infectious diseases, such as the monkey pox virus, are opening up new opportunities for market expansion. For instance, Quest Diagnostics was received the U.S. Quest Monkey pox PCR test’s FDA Emergency Use Authorization (EUA) became effective in July 2022. Similar to this, Todos Medical Ltd. introduced its Monkey Pox PCR-based diagnostic commercially in the United States in August 2022. Therefore, it is anticipated that the industry will continue to rise with such new infections.

Increase in new product launch by key market players is projected to spur the market growth. Major manufacturers are partnering together with numerous research organisations to co-develop cutting-edge test kits and support research initiatives in the area of molecular biology. It is also projected that many start-up companies would enter this market to develop new products and address the soaring medical needs. For instance, in December 2021, Roche, a global healthcare company with headquarter in Switzerland, released its most recent testing for infectious diseases using the cobas 5800 System, a cutting-edge molecular laboratory instrument.

Segmentation

By Type

The market is categorized into isothermal nucleic acid amplification (INAAT) tests, polymerase chain reaction (PCR) tests, and ligase chain reaction (LCR) tests. In 2022, the polymerase chain reaction (PCR) tests segment accounted for the highest revenue share due to the fact that the technology allows for the quick and accurate detection of a wide variety of target nucleic acid molecules. It can also be used to detect particular infections that can be difficult to culture in vitro. The broad adoption of PCR technology has also enabled it to use the method for the identification, quantification, and genotyping of several bacteria and viruses from a variety of clinical specimens, including plasma, serum, semen, cerebrospinal fluid, and others. the isothermal nucleic acid amplification technology (INAAT) tests segment is anticipated to grow at a rapid CAGR during the forecast period. This is attributed to development of novel technologies, including loop-mediated isothermal amplification (LAMP), strand displacement amplification, and recombinase polymerase amplification, among others, that are expanding the scope of the applications for nucleic acid-based test products.

By Application

The market is categorized into oncology testing, infectious disease testing, genetic & mitochondrial disease testing, and others. In the global market, the infectious disease testing segment accounted for the largest revenue share in 2022 owing to widespread prevalence and increasing incidence rate of infectious diseases, including the flu, STDs, and others. For instance, the Empower DX SARS CoV 2 RT PCR test from Euro fins Central Laboratory with the option for at-home sampling was introduced in October 2020. Such product introductions are anticipated to boost PCR test market penetration and fuel segment expansion. The oncology testing segment is projected to grow at the quickest CAGR during the forecast period due to increase in R&D interest in the development of novel cancer diagnostic alternatives and the rapid advancement in cancer research. For instance, researchers from Queen Mary University of London announced the development of the first PCR test for the identification of oral cancer in March 2022.

By End User

The market is segmented into central & reference laboratories, hospitals, and others. In 2022, the central & reference laboratories segment accounted for the largest revenue share owing to their wide range of tests and coverage across various healthcare settings. The testing capacities of such institutions are also being expanded due to helpful government schemes. For instance, the Department of Health and Human Services (HHS) increased the capacity of monkey pox testing for five lab organizations in June 2022, including Lab Corp., Quest Diagnostics, Mayo Clinic Laboratories, Aegis Science, and Sonic Healthcare. The hospital segment is predicted to experience the fastest CAGR due to rising use of nucleic acid amplification techniques for disease surveillance and pandemic prevention on a global scale.

Regional Markets

In 2022, North America region accounted for the highest revenue in the nucleic acid amplification testing market and is expected to maintain its dominance during the forecast period. This is attributed to the high incidence of chronic diseases and the availability of a well-established research and healthcare infrastructure. High level of disease preventive efforts in the area and the growing emphasis on point-of-care diagnostic procedures are driving demand for nucleic acid amplification tests. Asia Pacific to grow at the quickest rate during the projected period owing to a huge population and a growing emphasis on healthcare systems. The market prospects for nucleic acid amplification testing may be strengthened by the high prevalence of new infectious diseases such Japanese encephalitis, Hendra, and Nipah virus infections.

Competitor Insights

Some of the key players operating in the nucleic acid amplification testing market are Novartis AG, Bio-Rad Laboratories, Inc., Illumina, Inc., F. Hoffmann-La Roche Ltd, Becton, Dickinson and Company, Siemens Healthineers, Danaher Corporation, Abbott Laboratories, bio Mérieux SA, and See gene Inc.

To achieve a competitive edge, these businesses are implementing a variety of growth strategies. Strategic partnerships, alliances, and agreements with different businesses and research institutions are seen to be the main strategies used by companies in this sector.

• For instance, My Lab Discovery Solutions introduced their Patho Detect HPV Detection PCR Test in September 2022 to identify human papillomaviruses (HPV) in high-risk patients.

This comprehensive research report focuses on the global and regional market size and forecasts of diverse segments including type, application, and end user from 2023 to 2033.

Report Scope:

Segmentation: Nucleic Acid Amplification Testing Market Report 2022 – 2033

Type (Revenue, USD Million), 2022 – 2033

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

Application (Revenue, USD Million), 2022 – 2033

• Oncology Testing
• Infectious Disease Testing
• Genetic & Mitochondrial Disease Testing
• Others

End user (Revenue, USD Million), 2022 – 2033

• Central & Reference Laboratories
• Hospitals
• Others

By Region (Revenue, USD Million), 2022 – 2033

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