Isothermal Nucleic Acid Amplification Technology Market

The global isothermal nucleic acid amplification technology market in terms of revenue was estimated to be worth $4.4 billion in 2023 and is poised to reach $6.8 billion by 2028, growing at a CAGR of 9.2% from 2023 to 2028. The new research study consists of an industry trend analysis of the market. The new research study consists of industry trends, pricing analysis, patent analysis, conference and webinar materials, key stakeholders, and buying behaviour in the market. The growth of the market is attributed to the cost-benefits of INAAT, rising prevalence of infectious diseases, and increasing number of blood transfusions and donations.

Attractive Opportunities in the Isothermal Nucleic Acid Amplification Technology Market

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Isothermal Nucleic Acid Amplification Technology Market Dynamics

Driver: Recent launches of INAAT consumables by prominent market players

Prominent market players have launched new kits, reagents, and systems based on INAAT in the last three years. Market players are now focusing on the increasing their R&D efforts in development of new product. For instance, in June 2022, Grifols (Spain) obtained the CE Mark for the Procleix Plasmodium Assay, a nucleic acid test (NAT) specifically validated for screening blood donors for malaria. In May 2022, Hologic, Inc. (US) received US Food and Drug Administration (FDA) approval for the Aptima CMV Quant Assay. This assay will quantify the viral load of cytomegalovirus (CMV) in patients who have had an organ or stem cell transplant.

Restraint: Unfavorable reimbursement scenario for in vitro diagnostic tests

The Centers for Medicare & Medicaid Services (CMS) reduced the Medicare reimbursement rate for COVID-19 tests based on high-throughput technology to USD 75 unless labs can process results in under two days. Medicare does not currently provide genetic testing coverage for individuals without a history of cancer. Similarly, according to MedPAC (Medicare Payment Advisory Commission), medical testing has seen a 40% decline in reimbursement over the last 40 years. This decline and additional budgetary concerns among healthcare systems will be a major obstacle to implementing novel diagnostic techniques in clinical laboratories.

Opportunity: INAAT tests as point-of-care tools

LAMP is the most used INAAT method for the development of POC tools. LAMP technology offers major advantages, such as high specificity provided by the primer design, use of a single enzyme, relatively low reaction time (<1 h), and high efficiency. The Detect COVID-19 Test (Detect Inc.) is a molecular in vitro diagnostic test for the qualitative detection of nucleic acid from the novel coronavirus SARS-CoV-2 that causes COVID-19.

Assay, kits and reagents segment accounted for the largest share of the isothermal nucleic acid amplification technology industry

Based on the product, the isothermal nucleic acid amplification technology market is segmented into assay, kits, and reagents, and systems. The assay, kits, and reagents segment accounted for the largest share in 2022. The largest share of this segment is attributed to increasing approvals of CLIA-waived tests, repeated purchase of reagents, and continuous launch of newer, faster, and more reliable POC products.

North America was the largest regional market for isothermal nucleic acid amplification technology industry in 2022.

The isothermal nucleic acid amplification technology market is segmented into five major regions—North America, Europe, the Asia Pacific, Latin America, and the Middle East & Africa. In 2022, North America accounted for the largest share of the market. Increasing number of research project on infectious disease diagnosis, rising demand for new INAAT systems and kits, and growing use of INAAT consumables are various factors projected to drive the growth of the market.

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Key players in the market include Grifols, S.A. (Spain), Hologic, Inc. (US), Abbott Laboratories (US), Becton, Dickinson and Company (US), Meridian Bioscience (US), Eiken Chemical Co., Ltd. (Japan), bioMérieux SA (France), Tecan Trading AG (Switzerland), New England Biolabs (US), QIAGEN N.V. (Germany), DiaSorin S.p.A. (Italy), General Electric (US), OptiGene Limited (UK), Quidel Corporation (US), Thermo Fisher Scientific (US), Genomtec (Poland), Mast Group Ltd. (UK), Ustar Biotechnologies (China), Jena Bioscience GmbH (Germany), Atila BioSystems (US), TwistDx Limited (UK), LGC Limited (UK), Life Sciences Advanced Technologies (US), GenoSensor Corporation (US), and PCR Biosystems (UK). 

Scope of the Isothermal Nucleic Acid Amplification Technology Industry

The study categorizes the isothermal nucleic acid amplification technology market to forecast revenue and analyze trends in each of the following submarkets:

By Product

• Assays, Kits, & Reagents
• Systems

By Technology

• Transcription Mediated Amplification (TMA)
• Loop-mediated Isothermal Amplification (LAMP)
• Strand Displacement Amplification (SDA)
• Helicase-dependent Amplification (HDA)
• Nucleic Acid Sequence-based Amplification (NASBA)
• Nicking Enzyme Amplification Reaction (NEAR)
• Single Primer Isothermal Amplification (SPIA)
• Other Technologies

By Application

• Disease Diagnosis
  • Hepatitis
  • Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG)
  • Influenza
  • Covid-19
  • Other Disease Diagnosis
• Blood Screening
• Other Applications

By End User

• Hospitals
• Reference Laboratories
• Academic & Research Institutes
• Other End Users

By Region

• North America
  • US
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • Indias
  • Rest of Asia Pacific
• Latin America
• Middle East and Africa

Recent Developments of Isothermal Nucleic Acid Amplification Technology Industry

• In May 2022, Hologic, Inc. (US) received CE marking for two new molecular assays, Panther Fusion EBV Quant Assay and Panther Fusion BKV Quant Assay, expanding its transplant pathogen monitoring menu on the Panther Fusion system.
• In December 2021, Hologic, Inc. (US) launched Panther Trax, which offers full automation to meet high-volume testing demands and will be commercially available in the US, Europe, Canada, Australia, and New Zealand.
• In September 2020, Abbott (US) received approval from Health Canada for the ID NOW rapid COVID-19 testing device for use in Canada.

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