Isothermal Nucleic Acid Amplification Technology (INAAT) Market Size Report by Product (Instruments, Consumables), Technology (TMA, LAMP, SDA, HDA, NASBA, NEAR, SPIA), Application (Blood Screening, Disease Diagnosis), End User (Hospitals, Diagnostic Centers, Reference Laboratories, Academic & Research Institutes) - Global Industry Growth Forecast to 2030

Isothermal Nucleic Acid Amplification Technology Market Overview

The global isothermal nucleic acid amplification technology market generated revenue of USD 4,425.5 million in 2023, which is expected to witness a CAGR of 9.4% during 2024–2030. This is owing to the significant increase in its usage as a molecular testing technique due to the rising prevalence of infectious diseases. Tuberculosis, hepatitis, and influenza are among the leading causes of death traceable to infectious diseases, especially in developing countries.

Moreover, the cost benefits associated with this amplification technology and the growing number of blood donations and transfusions propels this market. This is because these factors lead to an increase in the demand for quick, easy-to-use diagnostic alternatives, such as isothermal nucleic acid amplification, for specific diseases.

Primarily, the growing number of diagnostic tests and Emergency Use Authorizations for CLIA-waived tests are contributing to the growth of the isothermal nucleic acid amplification technology market. This is because these tests are simple to use, carry a lower probability of errors, and help adjust the medicine dosage for patients.

• Applications for these technologies include recombinant DNA and molecular biology.
• This method is used to detect and analyze tiny amounts of nucleic acids.
• The polymerase chain reaction (PCR) method is also based on isothermal nucleic acid amplification.
• PCRs are widely utilized for DNA buildup, detection and identification of infectious diseases, genetic disorders, and research.
• The thermocycling machine used in PCR makes it easier to separate and amplify DNA strands.

Moreover, COVID-19 has positively impacted this market’s growth by augmenting the demand for the rapid and accurate testing alternatives. Isothermal techniques have been widely used as a foundational technology for the diagnosis of SARS-COV-2 RNA in homes and clinical facilities during the epidemic. Many major players secured Emergency Use Approvals for INAAT-based COVID-19 tests from the U.S. FDA. Commercially available products include Grifols S.A.’s Procleix SARS-CoV-2 assays and Lucira Health Inc.’s Lucira CHECK-IT COVID-19 test kit.

• In March 2020, Abbott Laboratories received the U.S. FDA approval for the emergency use of ID NOW COVID-19, a rapid isothermal, instrument-based system for the qualitative analysis of diseases.

Thus, the increasing initiatives of these types by the key players during the pandemic and the product approvals for the same, to deal better with future pandemics, are expected to accelerate the growth of the market during the forthcoming period.

Moreover, the growing pace of advancements in technologies along with the introduction of novel ones, such as LAMP, SPIA, SDA, and RPA are creating new opportunities for the use of INAAT products.

• A research paper published in the Analyst Journal of Royal Society of Chemistry in June 2022 mentioned a smartphone-integrated instrument that can rapidly test for the Zika virus in a single blood drop using the LAMP technology.

High Prevalence of Infectious Diseases

Globally, infectious diseases have been a major cause of mortality and morbidity throughout human history. This is why the rising prevalence of infectious diseases across the globe is a major factor behind the growth of this market. It is due to the utilization of INAAT-based kits for their detection. According to the World Health Organization (WHO), there have been approximately 760 million cases of COVID-19 across the world and approximately 7 million deaths.

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Consumables Hold Larger Market Share

The consumables category accounted for the larger isothermal nucleic acid amplification technology market revenue share, of 70%, in 2023, and it is further expected to maintain its dominance during the forthcoming period.

• This is due to the extensive usage of reagents in diagnostic laboratories and primary healthcare settings, as well as the rising availability of polymerases with high strand displacement capabilities.
• Seeing the rising demand, a variety of reagents are being created by the players to detect infectious diseases, which are increasing in prevalence.
• The rising cases of cardiovascular disorders, diabetes, and cholesterol-related illnesses are resulting in the development of POC diagnostic devices, which are convenient and give quick results.

Moreover, with the frequent utilization of reagents in the INAAT equipment to determine and diagnose diseases, their stock depletes, which is why they have to be purchased regularly and, many times, in bulk.

The instruments category is expected to showcase the fastest growth in forthcoming period.

• This is owing to the rise in R&D investments for the development of novel diagnostic techniques for infectious diseases, such as COVID-19.
• Moreover, the market prospects for INAAT instruments could significantly improve with the advent of upgraded diagnostic devices with improved accuracy, mobility, and speed.

Loop-Mediated Amplification (LAMP) Technology Dominates Industry

By technology, the loop-mediated amplification category accounted for the largest revenue share, of 40%, in 2023, and it is further expected to maintain its dominance during the forthcoming period. This is owing to the advancements in this technology for disease detection and diagnosis by building up DNA with high specificity, efficiency, and speed under isothermal conditions. This technology employs a DNA polymerase and a set of four specially designed primers, which recognize a total of six distinct sequences on the target DNA.

• Additionally, it features a variety of detection methods, including lateral flow, agarose gel detection, and real-time fluorescence employing intercalators.
• Furthermore, the demand for this technique is supported by its tolerance to inhibitors that enable the use of crude samples and minimally purified nucleic acids.
• As a result, the technique can detect a broad range of RNA and DNA targets, such as Zika virus and SARS-CoV-2 virus, in human samples.

Helicase-dependent amplification (HDA) is witnessing significant growth in this market. This is owing to the increasing awareness about the benefits of this technology, such as the requirement for fewer steps and shorter processing times for blood screening and diagnostic applications. Further, the highly competitive rivalry between key players, such as Hologic Inc. which offers TMA products; and Quidel Corporation, which offers HDA products, is expected to drive steady growth in this category during the forecast period.

Hospitals Held Largest Revenue Share

The hospitals category accounted for the largest share of 60%, in 2023, and it is further expected to maintain its dominance in the future.

• This is due to the expanding usage of miniaturized POC INAAT instruments, which enable hospital-based analysis with single-level access.
• Moreover, the rising hospital expenditure and network across the globe are driving the market in this category.
• Moreover, the adoption of this technology is rapidly increasing due to the large patient pool and the growing incidence of infectious diseases, which have led to a rise in the demand for diagnosis procedures.
• Similarly, increasing throughput and automation offered by such technologies for the processing of a large number of samples are expected to boost segment growth.

Diagnostic centers will have the highest CAGR over the forecast period. This will be owing to the rising number of diagnostic laboratories and their increasing adoption of molecular techniques here for the early detection and diagnosis of disease. In addition, the increasing funding from various public agencies is boosting the adoption of rapid analysis technologies for the mitigation of infectious disease transmission.

North America Is Prime Revenue Contributor

Geographically, North America held the largest share, of around 45%, in 2023, and it is expected to grow at a robust pace during the review period.

• This will be due to the established research infrastructure and surge in the demand for nucleic-acid-amplification-based diagnostics to prevent pandemics in the region.
• Additionally, the high per capita healthcare spending and growing interest in point-of-care diagnostic methods will propel the market expansion.
• In the same way, the region's rapid adoption of new and advanced technologies in light of the rising prevalence of infectious diseases supports the expansion of the regional trade.

Moreover, the rising number of research studies being conducted to come up with better diagnostic tests for infectious diseases, surging demand for INAAT kits and systems, and growing use of such consumables in the region drive the growth of the market.

Moreover, the market in Germany holds a substantial share in Europe due to the growing geriatric population and significant focus on the healthcare infrastructure.

• According to the World Bank, the country’s population over 65 years of age was approximately 19 million in 2021.
• Such a large geriatric population is expected to lead to a high prevalence of age-related disorders and infectious diseases. which would strengthen the market prospects for effective INAAT devices and reagents.

Top Isothermal Nucleic Acid Amplification Technology Providers Are:

• Becton, Dickinson and Company
• QIAGEN N.V.
• Quidel Corporation
• bioMérieux SA
• Abbott Laboratories
• Meridian Bioscience Inc. 
• Thermo Fisher Scientific Inc.
• Atila Biosystems 
• Grifols S.A.
• Eiken Chemical Co. Ltd.

Market Breakdown

The study uncovers the biggest trends and opportunities in the isothermal nucleic acid amplification technology (INAAT) market, along with offering segmentation analysis at the granular level for the period 2017 to 2030.

Segment Analysis, By Product

• Instruments
• Consumables

Segment Analysis, 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)

Segment Analysis, By Application

• Blood Screening
• Disease Diagnosis

Segment Analysis, By End User

• Hospitals
• Diagnostic Centers
• Reference Laboratories
• Academic & Research Institutes

Region/Countries Reviewed for this Report

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • U.K.
  • France
  • Italy
  • Spain
• Asia-Pacific
  • Japan
  • China
  • India
  • South Korea
  • Australia
• Latin America
  • Brazil
  • Mexico
• Middle East and Africa
  • Saudi Arabia
  • South Africa
  • U.A.E.