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    Isothermal Nucleic Acid Amplification Market

    ID: MRFR/HC/20264-HCR
    128 Pages
    Rahul Gotadki
    October 2025

    Isothermal Nucleic Acid Amplification Market Research Report Information By Product (Assays, Kits, & Reagents, and 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), and Other Technologies), By Application (Disease Diagnosis, Blood Screening, and Other ...

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    Isothermal Nucleic Acid Amplification Market Infographic
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    Isothermal Nucleic Acid Amplification Market Summary

    The Global Isothermal Nucleic Acid Amplification Market is projected to grow significantly from 6.04 USD Billion in 2024 to 16.39 USD Billion by 2035.

    Key Market Trends & Highlights

    Isothermal Nucleic Acid Amplification Key Trends and Highlights

    • The market is expected to achieve a compound annual growth rate (CAGR) of 9.5 percent from 2025 to 2035.
    • By 2035, the market valuation is anticipated to reach 16.4 USD Billion, indicating robust growth potential.
    • in 2024, the market is valued at 6.04 USD Billion, reflecting a strong foundation for future expansion.
    • Growing adoption of isothermal nucleic acid amplification technology due to its efficiency in diagnostics is a major market driver.

    Market Size & Forecast

    2024 Market Size 6.04 (USD Billion)
    2035 Market Size 16.39 (USD Billion)
    CAGR (2025-2035) 9.50%

    Major Players

    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)

    Isothermal Nucleic Acid Amplification Market Trends

    Increasing incidences of chronic diseases, an aging population, and a rise in demand for low-cost and effective diagnostics procedures are driving the market growth

    Market CAGR for Isothermal Nucleic Acid Amplification is being driven by the increasing incidences of chronic diseases and an aging population, as well as a rise in demand for low-cost and effective diagnostics procedures. According to a World Health Organization report released in February 2022, cancer stands out as a major global cause of mortality. The report highlights that annually, approximately 400,000 children are diagnosed with cancer, with cervical cancer being the most prevalent in 23 countries.

    A report published by the International Agency for Research on Cancer (IARC) in December 2020 underscores the global cancer burden, which has surged to 19.3 million cases. Consequently, the escalating prevalence of cancer worldwide has spurred an increased demand for effective therapeutic interventions, driving market growth.

    Nucleic acid amplification technology finds diverse applications across the healthcare industry, spanning from research to clinical settings. Historically, polymerase chain reaction (PCR) has been the predominant amplification technique worldwide. PCR necessitates a thermal cycler to maintain various temperatures at distinct stages of the amplification process. Furthermore, the removal of contaminants is imperative for successful amplification via this technology. The thermal cycler itself incurs a significant cost, and the process of sample preparation to eliminate contaminants adds to the overall expense and duration of the procedure.

    As a result, it is anticipated that throughout the projection period, demand for the Isothermal Nucleic Acid Amplification Market will increase due to the Increasing incidences of chronic diseases and an aging population and a rise in demand for low-cost and effective diagnostics procedures. Thus, driving the Isothermal Nucleic Acid Amplification Market revenue.

    The increasing demand for rapid and accurate diagnostic tools in various sectors appears to drive the growth of the isothermal nucleic acid amplification market, reflecting a broader trend towards decentralized and point-of-care testing solutions.

    U.S. National Institutes of Health

    Isothermal Nucleic Acid Amplification Market Drivers

    Market Growth Projections

    The Global Isothermal Nucleic Acid Amplification Market Industry is projected to witness substantial growth in the coming years. With an estimated market value of 6.04 USD Billion in 2024, the industry is expected to expand at a compound annual growth rate (CAGR) of 9.5% from 2025 to 2035. This growth trajectory reflects the increasing adoption of isothermal amplification technologies across various applications, including clinical diagnostics, food safety, and environmental monitoring. The rising demand for rapid and accurate testing solutions is likely to drive investments and innovations in the field, further solidifying the market's position as a critical component of modern diagnostic practices.

    Expansion of Point-of-Care Testing

    The expansion of point-of-care testing (POCT) is transforming the Global Isothermal Nucleic Acid Amplification Market Industry. POCT allows for immediate diagnostic results at the site of patient care, which is particularly advantageous in rural and underserved areas. The convenience and efficiency of POCT are driving its adoption among healthcare providers. Isothermal amplification technologies are well-suited for POCT due to their simplicity and rapid turnaround times. As healthcare systems increasingly prioritize accessible and timely diagnostics, the market is poised for growth, potentially reaching a valuation of 16.4 USD Billion by 2035. This trend underscores the importance of integrating advanced diagnostic solutions into everyday healthcare practices.

    Increasing Demand for Rapid Diagnostics

    The Global Isothermal Nucleic Acid Amplification Market Industry experiences a surge in demand for rapid diagnostic tools, particularly in the fields of infectious diseases and genetic testing. The ability to provide results in a timely manner is crucial for effective patient management and treatment. For instance, isothermal amplification techniques can yield results within an hour, significantly reducing the time compared to traditional methods. This rapid turnaround is particularly beneficial in clinical settings, where timely decisions can impact patient outcomes. As the market is projected to reach 6.04 USD Billion in 2024, the emphasis on rapid diagnostics is likely to drive further growth in the industry.

    Rising Prevalence of Infectious Diseases

    The Global Isothermal Nucleic Acid Amplification Market Industry is significantly influenced by the rising prevalence of infectious diseases worldwide. The increasing incidence of diseases such as tuberculosis, HIV, and other viral infections necessitates the development of efficient diagnostic tools. Isothermal amplification methods offer a rapid and accurate means of detecting these pathogens, which is crucial for public health responses. The World Health Organization has reported a steady rise in infectious disease cases, further emphasizing the need for innovative diagnostic solutions. This growing demand is likely to propel the market forward, aligning with the projected CAGR of 9.5% for the period from 2025 to 2035.

    Growing Investment in Research and Development

    Investment in research and development is a key driver for the Global Isothermal Nucleic Acid Amplification Market Industry. Increased funding from both public and private sectors aims to enhance the capabilities of nucleic acid amplification technologies. This investment fosters innovation, leading to the development of more efficient and user-friendly diagnostic tools. For example, research initiatives focusing on point-of-care testing are gaining traction, as they promise to deliver results in non-laboratory settings. As the market evolves, these advancements are expected to attract further funding, thereby supporting the industry's growth trajectory and expanding its applications across various sectors.

    Technological Advancements in Amplification Techniques

    Technological innovations play a pivotal role in shaping the Global Isothermal Nucleic Acid Amplification Market Industry. Advances in amplification techniques, such as loop-mediated isothermal amplification (LAMP) and recombinase polymerase amplification (RPA), enhance sensitivity and specificity, making these methods more appealing for various applications. These technologies enable the detection of low-abundance targets, which is essential in fields like pathogen detection and genetic analysis. As these techniques continue to evolve, they are expected to attract investments and research, contributing to the market's anticipated growth to 16.4 USD Billion by 2035. This trajectory indicates a robust interest in improving diagnostic capabilities.

    Market Segment Insights

    Isothermal Nucleic Acid Amplification Market Product Insights

    The Isothermal Nucleic Acid Amplification Market segmentation, based on Product, includes Assays, Kits, & Reagents and Systems. The assays, kits, & reagents segment dominated the market, accounting for 58% of market revenue. The increasing need for molecular diagnostic methods stems from their precise, sensitive, and swift detection capabilities for infectious diseases, genetic disorders, and cancer biomarkers. Isothermal nucleic acid amplification techniques are preferred over conventional PCR methods due to their simplicity, rapidity, and cost-effectiveness. This surge in demand is driving the expansion of assays, kits, and reagents utilized in isothermal amplification methods.

    Figure 1: Isothermal Nucleic Acid Amplification Market, by Product, 2023 & 2032 (USD Billion)

    Source: Secondary Research, Primary Research, Market Research Future Database and Analyst Review

    Isothermal Nucleic Acid Amplification Market Technology Insights

    The Isothermal Nucleic Acid Amplification Market segmentation, based on Technology includes 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), and Other Technologies. The loop-mediated isothermal amplification (LAMP) segment dominated the market, accounting for 58% of market revenue. The LAMP technique presents two key competitive advantages over PCR technology. Firstly, it exhibits tolerance towards PCR inhibitors, enabling direct sample analysis. Secondly, it operates at a fixed temperature, eliminating the need for a thermocycler.

    These benefits position it favorably for point-of-care diagnostics, a segment witnessing notable growth. As per the World Ageing 2020 report, the global population aged 65 years and older is projected to reach 1.5 billion by 2050. Additionally, by 2050, one in six individuals worldwide will be over 65 years of age. These demographic trends suggest potential proportional growth in the studied LAMP market segment.

    Isothermal Nucleic Acid Amplification Market Application Insights

    The Isothermal Nucleic Acid Amplification Market segmentation, based on Application, includes Disease Diagnosis, Blood Screening, and Other Applications. The blood screening segment dominated the market, accounting for 60% of market revenue. Due to the increasing, continuously rising demand for blood screening and analysis resulting from the rates of blood donation and transfusions globally, this segment has emerged as a crucial application area for isothermal amplification techniques in recent times.

    Isothermal Nucleic Acid Amplification Market End-User Insights

    The Isothermal Nucleic Acid Amplification Market segmentation, based on Users, includes Hospitals, Reference Laboratories, Academic & Research Institutes, and Other End Users. The hospital segment dominated the market, accounting for 60% of market revenue. The hospital sector is poised to lead the market due to the growing utilization of INAAT kits in disease treatment. Moreover, the majority of diagnostic procedures are conducted under supervision, minimizing the likelihood of errors and ensuring accurate results, thus positively influencing revenue growth throughout the forecast period.

    Additionally, the escalating demand for nucleic acid amplification technology within hospitals, compared to other end-use industries, is propelling growth in this segment.

    Figure 2: Isothermal Nucleic Acid Amplification Market Share By Region 2023 (USD Billion)

    By region, the study provides market insights into North America, Europe, Asia-Pacific, and Rest of the World. North America has secured the largest market share, primarily due to its well-established research infrastructure and the rising demand for nucleic acid amplification-based diagnostics aimed at preventing infectious diseases in the region. Moreover, the region's high per capita healthcare expenditure and increasing emphasis on point-of-care diagnostic techniques are projected to propel market growth. The per capita healthcare expenditure in North America is also expected to bolster market expansion.

    According to data released by the United States Department of Commerce in 2021, healthcare spending in Canada is forecasted to reach USD 308 billion, accounting for approximately 12.7% of the country's GDP.

    Further, the major countries studied in the market report are the US, Canada, Germany, France, the UK, Italy, Spain, China, Japan, India, Australia, and South Korea.

    Figure 2: Isothermal Nucleic Acid Amplification Market Share By Region 2023 (USD Billion)

    Get more detailed insights about Isothermal Nucleic Acid Amplification Market Research Report — Global Forecast till 2034

    Key Players and Competitive Insights

    Leading market players are investing heavily in research and development to expand their product lines, which will help the Isothermal Nucleic Acid Amplification market grow even more. Market participants are also undertaking a variety of strategic activities to expand their global footprint, with important market developments including new product launches, contractual agreements, mergers and acquisitions, higher investments, and collaboration with other organizations. To expand and survive in a more competitive and rising market climate, the Isothermal Nucleic Acid Amplification industry must offer cost-effective items.

    Manufacturing locally to minimize operational costs is one of the key business tactics used by manufacturers in the global Isothermal Nucleic Acid Amplification industry to benefit clients and increase the market sector. In recent years, the Isothermal Nucleic Acid Amplification industry has offered some of the most significant advantages to the entertainment and music production sectors.

    Major players in the Isothermal Nucleic Acid Amplification Market, including 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) are attempting to increase market demand by investing in research and development operations.

    Abbott Laboratories engages in the discovery, development, manufacturing, and distribution of a diverse portfolio of healthcare products, spanning branded generic pharmaceuticals, diagnostic systems, pediatric and adult nutritional products, medical devices, minerals and nutrition products, and dietary supplements. Its medical device offerings include heart failure, electrophysiology, rhythm management, vascular and structural heart devices, and neuromodulation devices. The company operates research and development facilities across the United States, Colombia, India, Singapore, Spain, and the United Kingdom, with manufacturing facilities worldwide. Abbott markets its products across North America, Latin America, the Middle East, Europe, Asia-Pacific, and Africa.

    Headquartered in Abbott Park, Illinois, United States, Abbott gained approval from Health Canada for its ID NOW rapid COVID-19 testing device for Canadian use in September 2020.

    Becton Dickinson and Company is a leading medical technology company specializing in the manufacture and distribution of medical devices, reagents, and instruments. Its extensive product line includes syringes, intravenous catheters, infusion pumps, automated medication dispensing systems, pre-fillable drug delivery systems, respiratory ventilation equipment, diagnostic equipment, and consumables for diagnostic specimen collection. BD also offers instruments and reagent systems for detecting various infectious diseases and cancers, as well as clinical research tools.

    Serving life science researchers, healthcare institutions, clinical laboratories, the pharmaceutical industry, and the general public, BD markets its products across the Americas, Europe, the Middle East, Africa, and the Asia-Pacific region. Headquartered in New Jersey, United States, BD remains a key player in the medical technology sector.

    Key Companies in the Isothermal Nucleic Acid Amplification Market market include

    Industry Developments

    • Q2 2024: Twist Bioscience Launches New Isothermal Amplification Assay for Infectious Disease Detection Twist Bioscience announced the commercial launch of a new isothermal nucleic acid amplification assay designed for rapid detection of infectious diseases, expanding its molecular diagnostics portfolio.
    • Q2 2024: Abbott Receives CE Mark for ID NOW 2, Next-Generation Isothermal Molecular Platform Abbott announced it has received CE Mark for its ID NOW 2 platform, an upgraded isothermal nucleic acid amplification device for point-of-care molecular testing, enabling faster and more accurate diagnostics in Europe.
    • Q2 2024: Molbio Diagnostics Announces Strategic Partnership with Roche for Isothermal NAAT Distribution in Asia Molbio Diagnostics entered a strategic partnership with Roche to distribute its isothermal nucleic acid amplification technology-based diagnostic kits across select Asian markets, aiming to expand access to rapid molecular testing.
    • Q3 2024: QuantuMDx Raises $30 Million in Series C Funding to Advance Isothermal NAAT Platform QuantuMDx secured $30 million in Series C funding to accelerate development and commercialization of its proprietary isothermal nucleic acid amplification technology for decentralized molecular diagnostics.
    • Q3 2024: BioFire Diagnostics Opens New Manufacturing Facility for Isothermal NAAT Reagents in Utah BioFire Diagnostics, a subsidiary of bioMérieux, inaugurated a new manufacturing facility in Utah dedicated to producing reagents for its isothermal nucleic acid amplification tests, aiming to meet growing global demand.
    • Q3 2024: Lucira Health Appoints New CEO to Drive Expansion of Isothermal Molecular Testing Portfolio Lucira Health announced the appointment of a new Chief Executive Officer, focusing on scaling up its isothermal nucleic acid amplification-based molecular testing solutions for infectious diseases.
    • Q4 2024: Atila BioSystems Receives FDA Emergency Use Authorization for Isothermal COVID-19 Test Atila BioSystems received FDA Emergency Use Authorization for its isothermal nucleic acid amplification-based COVID-19 test, enabling broader deployment in clinical and point-of-care settings in the United States.
    • Q4 2024: Eiken Chemical and Thermo Fisher Scientific Announce Co-Development Agreement for LAMP-based Diagnostics Eiken Chemical and Thermo Fisher Scientific entered a co-development agreement to create new loop-mediated isothermal amplification (LAMP) diagnostic assays for infectious disease detection.
    • Q1 2025: Genomtec Secures $15 Million in Series B Funding to Scale Isothermal NAAT Platform Genomtec raised $15 million in Series B funding to expand manufacturing and commercialization of its portable isothermal nucleic acid amplification technology for rapid diagnostics.
    • Q1 2025: Meridian Bioscience Launches New Isothermal Amplification Test for Food Safety Applications Meridian Bioscience launched a new isothermal nucleic acid amplification test targeting foodborne pathogens, expanding its product offerings in the food safety diagnostics market.
    • Q2 2025: HiberGene Diagnostics Announces Partnership with Siemens Healthineers for Global Distribution HiberGene Diagnostics partnered with Siemens Healthineers to distribute its isothermal nucleic acid amplification-based diagnostic products globally, aiming to increase market penetration.
    • Q2 2025: Cue Health Receives Health Canada Approval for Isothermal Molecular COVID-19 Test Cue Health received regulatory approval from Health Canada for its isothermal nucleic acid amplification-based COVID-19 test, allowing commercial sales in the Canadian market.

    Isothermal Nucleic Acid Amplification 

    Future Outlook

    Isothermal Nucleic Acid Amplification Market Future Outlook

    The Isothermal Nucleic Acid Amplification Market is projected to grow at a 9.50% CAGR from 2025 to 2035, driven by advancements in molecular diagnostics and increasing demand for rapid testing solutions.

    New opportunities lie in:

    • Develop portable isothermal amplification devices for point-of-care testing.
    • Invest in automation technologies to enhance laboratory efficiency and throughput.
    • Create partnerships with biotech firms to expand product offerings and market reach.

    By 2035, the market is expected to exhibit robust growth, positioning itself as a leader in molecular diagnostics.

    Market Segmentation

    Regional Outlook

    • US
    • Canada
    • Germany
    • France
    • UK
    • Italy
    • Spain
    • Rest of Europe
    • China
    • Japan
    • India
    • South Korea
    • Australia
    • Rest of Asia-Pacific
    • Middle East
    • Africa
    • Latin America

    Isothermal Nucleic Acid Amplification Market Product Outlook

    • Assays, Kits, & Reagents
    • Systems

    Isothermal Nucleic Acid Amplification Market End-User Outlook

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

    Isothermal Nucleic Acid Amplification Market Regional Outlook

    • US
    • Canada
    • Germany
    • France
    • UK
    • Italy
    • Spain
    • Rest of Europe
    • China
    • Japan
    • India
    • South Korea
    • Australia
    • Rest of Asia-Pacific
    • Middle East
    • Africa
    • Latin America

    Isothermal Nucleic Acid Amplification Market Technology Outlook

    • 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

    Isothermal Nucleic Acid Amplification Market Application Outlook

    • Disease Diagnosis
    • Blood Screening
    • Other Applications

    Report Scope

    Report Attribute/Metric Details
    Market Size 2024    6.04 (USD Billion)
    Market Size 2025    6.61 (USD Billion)
    Market Size 2035 16.39 (USD Billion)
    Compound Annual Growth Rate (CAGR) 9.50% (2025 - 2035)
    Report Coverage Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
    Base Year 2024
    Market Forecast Period 2025 - 2035
    Historical Data 2020 - 2024
    Report Coverage Revenue Forecast, Market Competitive Landscape, Growth Factors, and Trends
    Segments Covered Product, Technology, Application, and End-User, and Region
    Geographies Covered North America, Europe, Asia Pacific, and the Rest of the World
    Countries Covered The US, Canada, Germany, France, UK, Italy, Spain, China, Japan, India, Australia, South Korea
    Key Companies Profiled 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)
    Key Market Opportunities ·         Increasing approvals from healthcare regulatory authorities for innovative technologies
    Key Market Dynamics ·         Rising disposable income and development in healthcare infrastructure

    FAQs

    How much is the Isothermal Nucleic Acid Amplification Market?

    The Isothermal Nucleic Acid Amplification Market size was valued at USD 5.0 Billion in 2023.

    What is the growth rate of the Isothermal Nucleic Acid Amplification Market?

    The Isothermal Nucleic Acid Amplification Market is projected to grow at a CAGR of 9.50% during the forecast period 2025-2034.

    Which region held the largest market share in the Isothermal Nucleic Acid Amplification Market?

    North America had the largest share of the global market.

    Who are the key players in the Isothermal Nucleic Acid Amplification Market?

    The key players in the market are 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), and others.

    Which Product led the Isothermal Nucleic Acid Amplification Market?

    The Assays, Kits, & Reagents segment dominated the market in 2023.

    Which Application had the largest market share in the Isothermal Nucleic Acid Amplification Market?

    The Blood Screening segment had the largest share in the global market.

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