Isothermal Nucleic Acid Amplification Technology Market Size, Share & Trends Analysis Report By Product, By Technology (NASBA, HDA, LAMP, SDA, SPIA, NEAR), By Application, By End Use, By Region, And Segment Forecasts, 2022 - 2030

Report Overview

The global isothermal nucleic acid amplification technology market size was valued at USD 3.78 billion in 2021 and is anticipated to expand at a compound annual growth rate (CAGR) of 12.3% by 2030. The technology is witnessing a significant increase in demand as a molecular testing technique due to the rising prevalence of infectious diseases. Tuberculosis, hepatitis, and influenza are among the leading causes of deaths sourced by infectious diseases, especially in developing countries. As a result, demand for rapid, user-friendly, and disease-specific testing options is expected to boost the adoption of isothermal nucleic acid amplification technology (INAAT) offerings.

Furthermore, COVID-19 has positively affected the market growth by expanding demand for the rapid and accurate testing alternatives intended for the detection of the SARS-CoV-2 virus. Several key players have developed new INAAT-based COVID-19 testing products and have secured emergency use approvals for such products from the U.S. FDA. For instance, commercially available products in this domain include Grifols Diagnostic Solutions Inc.’s Procleix SARS-CoV-2 assay and Lucira Health, Inc.’s Lucira CHECK-IT COVID-19 test kit. Such strategic initiatives fueled by the COVID-19 pandemic are likely to provide a significant stimulus to market growth in the near future.

Rapid advancements in existing amplification technologies along with the introduction of novel technologies such as Single Primer Isothermal Amplification (SPIA), Loop-Mediated Isothermal Amplification (LAMP), Recombinase Polymerase Amplification (RPA), and Strand Displacement Amplification (SDA) are opening new avenues for the applications of INAAT products. For instance, a research paper published in the Analyst Journal in June 2022 demonstrated the development of a smartphone-integrated instrument that can rapidly test for Zika virus in a single blood drop using the LAMP technology. Such developments are likely to boost the market penetration of the technique in the near future.

Amplification techniques such as PCR are limited by the requirement of instrumentation, capable of thermal cycling and temperature control, which limits the applications of the technique for point-of-care applications. This creates significant growth opportunities for the isothermal amplification techniques meant for use in molecular diagnostics, as these techniques have a lower energy demand and enable assay incubation in portable battery-powered devices.

Similarly, strategic partnerships between companies that manufacture INAAT diagnostics and associated products are likely to boost market expansion prospects. For instance, Merck KGaA offers custom LAMP primers in collaboration with New England Biolabs for the applications of LAMP technologies in life sciences research and molecular diagnostics.

However, a critical factor limiting the market growth is the regulatory framework governing the development of INAAT-based diagnostics. Regulatory agencies such as the U.S.FDA, EMEA, and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, have stringent protocols for monitoring the manufacturing processes of  INAAT production, which increases the challenges associated with INAAT manufacturing.

Furthermore, lower awareness levels and uncertainty in regulations for INAAT-based diagnostics lead to restricted commercialization of INAAT products.In addition, the lack of a robust reimbursement framework in developed markets, such as the U.S., can significantly limit the purchasing power of the buyers. Such factors can impede market growth during the forecast period.

Product Insights

The reagents segment dominated the market in 2021 due to the extensive usage in hospitals and primary healthcare settings, as well as the increasing availability of polymerases with high strand displacement capabilities. Furthermore, growth in the market penetration of INAAT diagnostics is expected during  the near future, adoption of the associated reagents is projected to grow at a significant rate throughout  the forecast period.

Rise in R&D interests in the development of novel diagnostics for emerging infectious diseases such as COVID-19 are driving an increasing demand for the INAAT instruments segment. Similarly, the introduction of advanced diagnostic devices, with enhanced accuracy, portability, and speed can considerably boost the market prospects for INAAT instruments used for the prevention of disease outbreaks.

Technology Insights

Loop-mediated isothermal amplification (LAMP) accounted for the largest market share of 15.83% in 2021. The technology enables multiple modes of detection such as the use of real-time fluorescence using inter calators, or lateral flow and agarose gel detection. 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. Furthermore, demand for the technique is supported by its tolerance to inhibitors that enable the use of crude samples and minimally purified nucleic acids.

HelicaseDependent Amplification (HDA) and Transcription Mediated Amplification (TMA) are other technologies that significantly contributed to the market value in 2021. Demand for these technologies is fueled by increasing scientific awareness about their potential benefits, such as the requirement of fewer steps and lesser processing time, for blood screening and diagnostic applications. High competitive rivalry between key players such as Hologic, Inc., which offers TMA products, and Quidel Corporation, which offers HDA products, is anticipated to drive steady growth for the technology segment during the forecast period.

Application Insights

INAAT applications for infectious disease diagnostics accounted for the dominant share of 34.84% in 2021. Recent introduction of specific INAAT kits and increasing incidence of HIV, hepatitis A & B, and sexually transmitted diseases are the key factors, anticipated to fuel the segment growth. Moreover, rising concerns over antimicrobial resistance and increasing focus on the prevention of epidemic outbreaks in developing countries is expected to further propel the segment growth.

Blood screening forms an important application of isothermal amplification methods due to the rising number of blood transfusions and associated blood testing requirements across the globe. Here, INAAT is widely used for the evaluation of blood quality by screening transfused blood for the presence of any infectious organisms. Furthermore, increasing research activities for the development of INAAT devices capable of detecting molecular biomarkers and multiple blood-borne pathogens are anticipated to broaden the growth prospects for the market.

End-use Insights

Hospitals held the largest market share of 39.83% in 2021. This can be attributed to the development of miniaturized point-of-care INAAT instruments that enable single-level access for hospital-based analysis. Similarly, increasing throughput and automation offered by such technologies for the processing of a large number of samples are expected to boost segment growth.

Central and reference laboratories end-use segment is expected to exhibit significant growth throughout the forecast period due to an increasing number of reference laboratories and the rising adoption of molecular diagnostic techniques in such laboratories. In addition, increasing funding from various public agencies such as the U.S. CDC and NIH is boosting the adoption of rapid analysis technologies used for the mitigation of infectious diseases.

Regional Insights

North America held the largest market share in 2021 due to the established research infrastructure and growth in demand for nucleic acid amplification-based diagnostics intended to prevent infectious diseases in the region. Furthermore, a high per capita expenditure on healthcare and increasing focus on point-of-care diagnostic methods is anticipated to drive market growth.

INAAT market for Germany held a substantial share in 2021 due to the ageing population of the country and significant focus on the healthcare systems. According to the World Bank, the country’s population over 65 years of age was estimated to account for a 21.98% share of the total population in 2021. As a result, a such high proportion of the geriatric population is expected to lead to a high prevalence of age-related disorders that can strengthen market prospects for effective INAAT devices.

Key Companies & Market Share Insights

The INAAT market is highly competitive due to the adoption of major strategic initiatives by the key players. For instance, in May 2022, Meridian Bioscience, Inc. launched the new Lyo-Ready Direct RNA/DNA LAMP and Lyo-Ready Direct DNA LAMP Saliva Mix master mixes for isothermal applications. Some of the prominent players in the global isothermal nucleic acid amplification technology market  include:

• Alere, Inc.

• bioMerieux SA

• Eiken Chemical Co. Ltd

• Hologic Inc.(Gen-Probe)

• Lucigen

• Meridian Bioscience, Inc.

• Ustar Biotechnologies Ltd.

• QIAGEN

• Quidel Corporation

• Thermo Fisher Scientific, Inc.

• BD (Becton, Dickinson & Company)

• OptiGene Limited

Isothermal Nucleic Acid Amplification Technology Market Report Scope 

Global Isothermal Nucleic Acid Amplification Technology Market Segmentation

This report forecasts revenue growth and provides an analysis on the latest trends in each of the sub-segments from 2018 to 2030. For this report, Grand View Research has segmented the INAAT market, based on the product, technology, application, end-use, and regions.

• Product Outlook (Revenue, USD Million, 2018 - 2030)

  • Instruments

  • Reagent

• Technology Outlook, (Revenue, USD Million, 2018 - 2030)

  • NASBA

  • HDA

  • LAMP

  • SDA

  • SPIA

  • NEAR

  • TMA

  • RCA

  • RPA

  • SMAP2

  • Others

• Application Outlook (Revenue, USD Million, 2018 - 2030)

  • Blood Screening

  • Infectious Disease Diagnostics

  • Cancer

  • Others

• End-use Outlook (Revenue, USD Million, 2018 - 2030)

  • Hospitals

  • Central & Reference Labs

  • Others

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

  • Latin America

    • Brazil

    • Mexico

  • Middle East and Africa (MEA)

    • South Africa

    • Saudi Arabia

    • UAE