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Isothermal Nucleic Acid Amplification Technology Market Size Analysis:

Isothermal Nucleic Acid Amplification Technology Market size was valued at USD 4.68 billion in 2023 and is expected to reach USD 13.57 billion by 2032, growing at a CAGR of 12.40% from 2024-2032.

The report offers a comprehensive analysis of target disease incidence and prevalence in 2023, providing insights into the demand for isothermal nucleic acid amplification technology for infectious disease testing, genetic testing, and oncology. It also analyzes the adoption patterns of different isothermal amplification methods by application. Moreover, the study also points towards market penetration rates of major techniques, such as LAMP, NASBA, and RCA, in the last decade and forecasted prospects. The report also tracks regulatory clearances and compliance patterns, R&D expenditures on innovation, and healthcare expenditure trends on molecular diagnostics, and offers a detailed market overview.

The U.S. Isothermal Nucleic Acid Amplification Technology Market size was USD 1.42 billion in 2023 and is expected to reach USD 4.05 billion by 2032, growing at a CAGR of 12.13% over the forecast period of 2024-2032.

The market is driven by the increasing demand for rapid and cost-effective molecular diagnostics, particularly in infectious disease detection and genetic testing. Advancements in point-of-care testing and the growing adoption of portable diagnostic devices are further fueling market growth. The rise in research activities and funding for nucleic acid-based testing solutions is also contributing to the expansion of this technology.

Isothermal Nucleic Acid Amplification Technology Market Dynamics

Drivers

  • Rising Demand for Rapid and Point-of-Care Diagnostics is propelling the market growth.

The growing demand for rapid and reliable molecular diagnostics is a major driving force for the Isothermal Nucleic Acid Amplification Technology (INAAT) market. In contrast to conventional PCR technology, INAAT provides quick, real-time pathogen identification without needing sophisticated thermal cycling, thus being well suited for point-of-care (PoC) settings. The COVID-19 pandemic also spurred the uptake of fast diagnostic technologies, with Abbott's ID NOW system being commonly employed for near-patient testing. As per the latest industry trends, the demand for PoC molecular diagnostics will continue to be robust, especially for respiratory infections, STDs, and TB. Moreover, the U.S. FDA's heightened interest in the approval of PoC molecular diagnostic assays has also driven market growth, making them widely accepted in hospitals, clinics, and decentralized healthcare environments.

  • Rising demand for rapid and point-of-care diagnostics is accelerating the market growth.

Ongoing innovations in Isothermal Nucleic Acid Amplification methods like Loop-mediated Isothermal Amplification (LAMP), Recombinase Polymerase Amplification (RPA), and Nucleic Acid Sequence-Based Amplification (NASBA) are fueling market growth. These processes are highly sensitive, have low equipment needs, and provide results more quickly than PCR-based methods. In December 2023, Eiken Chemical Co., Ltd. launched a more advanced LAMP kit that can identify multiple pathogens at once, enhancing diagnostics efficiency in medical care. Further, isothermal technologies are being appreciated as useful technologies in low-resource contexts by the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC). Increasing investment in research, coupled with governmental support in regulatory affairs, is prompting firms to design multiplex INAAT assays to open new areas of use in oncology, infectious disease, and genetic screening, leading to greater applications and utilization.                                                                                    

Restraint

  • High Cost and Limited Accessibility in Low-Resource Settings are restraining the market from growing.

One of the significant constraints of the Isothermal Nucleic Acid Amplification Technology (INAAT) market is the prohibitively expensive development of assays and restricted availability in low-resource areas. Although INAAT has advantages like quick amplification and less thermal cycling, reagent cost, assay kit cost, and proprietary enzyme formulations are still higher than those in traditional PCR-based technologies. Moreover, most INAAT-based diagnostic platforms involve specialized equipment that might not be easily accessible in developing nations or rural healthcare facilities. Low-income countries are reported to face issues of affordability, even with the need for rapid molecular diagnostics for infectious diseases, as per recent reports. In addition, regulatory barriers and reimbursement restrictions in some areas impede the use of INAAT-based diagnostics. Overcoming these cost and access impediments with government subsidies, funding, and technological developments will be essential for wider market expansion.

Opportunities

  • Expansion of INAAT in Point-of-Care and decentralized testing presents a significant opportunity for the market.

Increased need for fast, precise, and point-of-care molecular diagnostics is a great opportunity for the market of Isothermal Nucleic Acid Amplification Technology (INAAT). In contrast to classical PCR, INAAT strategies like LAMP, NASBA, and HDA do not involve sophisticated thermal cycling, which makes them perfect for point-of-care (POC) analysis, distant healthcare facilities, as well as low-resource environments. The surge in infectious disease outbreaks, antimicrobial resistance monitoring, and personalized medicine programs is fueling demand for decentralized molecular testing. For example, the growing adoption of INAAT in portable diagnostic equipment for COVID-19, tuberculosis, and sexually transmitted infections is transforming the early detection of diseases. Industry players are making significant investments in miniaturized, user-friendly INAAT platforms that can be used in pharmacies, home-testing kits, and emergency care units, opening up new market growth opportunities.

Challenges

  • Standardization and Regulatory Compliance Issues are challenging the market growth.

One of the greatest challenges for the INAAT market is the absence of standardization and rigorous regulatory barriers in various regions. In contrast to PCR, which has established regulatory standards, INAAT technologies are subject to variability in assay design, enzyme formulations, and performance characteristics, complicating validation and broad clinical acceptance. Regulatory bodies like the FDA, EMA, and WHO mandate rigorous clinical testing and performance benchmarking to confirm the accuracy and reproducibility of INAAT-based diagnostics. Variations in reimbursement policies and requirements for quality control between countries become roadblocks for market growth. Regulatory hold-ups can slow down new product launches and reduce cycles of innovation. Solving these challenges will demand the harmonization of worldwide standards, joint regulatory action, and increased investment in clinical trials to make INAAT a standard molecular diagnostic tool.

Isothermal Nucleic Acid Amplification Technology Market Segmentation Analysis

By Product

The Reagent segment dominated the isothermal nucleic acid amplification technology market with a 58.45% market share in 2023 because of the constant and high demand for nucleotides, probes, primers, and enzymes that are critical for amplification reactions. In contrast to instruments, which are used once, reagents are consumables that need to be replenished in a continuous process for research and diagnostic purposes. Widespread adoption of LAMP, NASBA, and other INAAT-based methods in infectious disease testing, oncology, and genetic screening drove demand for reagents. Improved formulations of reagents using stability of enzymes and multiplexing capabilities have also contributed to the increased accuracy and efficiency of tests and, consequently, market growth. Key industry players such as New England Biolabs, Thermo Fisher Scientific, and Eiken Chemical keep innovating and increasing reagent portfolios, further solidifying the segment's stronghold in the INAAT market.

By Technology

The Loop-mediated Isothermal Amplification (LAMP) segment dominated the market with a 15.22% market share in 2023, owing to its superior sensitivity, speed of detection, and simplicity. LAMP lacks the need for sophisticated thermal cycling, which is why it finds extensive use in point-of-care (POC) diagnostics as well as field-based applications. Its extensive usage in infectious disease diagnosis, such as COVID-19, tuberculosis, and malaria, has spurred market demand. Moreover, ongoing advancements in colorimetric and fluorescence-based LAMP assays have enhanced precision and convenience, further establishing its dominance. Industry leaders such as Eiken Chemical, New England Biolabs, and OptiGene have diversified LAMP-based product lines, making it more accessible and widely adopted globally.

The Transcription-Mediated Amplification (TMA) segment is expected to exhibit the fastest growth in the forecast period because it offers higher sensitivity in the detection of low-copy nucleic acid targets, which makes it extremely useful for infectious disease screening, such as HIV, HPV, and STIs. TMA facilitates high-throughput, automated sample processing, which makes it the first choice for centralized lab testing. The increasing need for precision molecular diagnostics and automation in clinical settings has pushed TMA's adoption. Hologic and bioMérieux, among other companies, are placing investments in growing the TMA-based diagnostic platforms, further enhancing their market penetration. As healthcare providers globally move towards early disease detection and high-volume molecular testing, TMA is poised for increased growth.

By Application

The Infectious Disease Diagnostics segment dominated the market with 35.26% market share in 2023 as a result of the heavy global burden of infectious diseases and the need for fast, accurate, and decentralized diagnostic testing solutions. INAAT methods, including LAMP, TMA, and NASBA, are now essential tools for the detection of pathogens such as SARS-CoV-2, tuberculosis, malaria, HIV, and HPV, since they provide rapid turnaround times without the requirement of advanced thermal cycling machines. The COVID-19 pandemic further brought on the increasing use of INAAT-based infectious disease testing, with firms such as Abbott, Hologic, and bioMérieux launching new products in response to growing demand. Further, government programs and funding for point-of-care (POC) testing programs and infectious disease surveillance have fortified the segment's supremacy, especially in decentralized and resource-constrained healthcare environments.

By End-Use

The Hospitals segment dominated the isothermal nucleic acid amplification technology market with a 41.25% market share in 2023 with the large number of diagnostic tests performed in hospital environments and the urgent requirement for quick and reliable molecular diagnostics. Hospitals are central to infectious disease management, cancer diagnosis, and emergency services, where rapid and dependable nucleic acid amplification tests (NAATs) are necessary to make timely decisions and plan treatments. The addition of INAAT-based testing systems like Hologic's Panther System and Abbott's ID NOW has increased on-site molecular diagnosis, with decreased turnaround times in comparison to laboratory-based PCR testing. Further supporting this segment is higher hospital investment in sophisticated point-of-care (POC) diagnostic systems, higher patient admissions, and government subsidies for infectious disease surveillance programs.

Isothermal Nucleic Acid Amplification Technology Market Regional Insights

North America dominated the isothermal nucleic acid amplification technology market with a 42.24% market share in 2023 its well-developed healthcare infrastructure, robust research environment, and high rate of molecular diagnostics adoption. The region is home to established players like Abbott Laboratories, Hologic, and Thermo Fisher Scientific, which are leading diagnostic firms and promote innovation in INAAT-based tests. The U.S. FDA's expedited approval routes for infectious disease diagnostics, coupled with high investments in point-of-care diagnostics and decentralized healthcare technologies, have further accelerated market growth. Also, increasing incidences of infectious diseases like respiratory infections and STDs have augmented demand for quick and portable INAAT-based testing solutions. Government programs, including biodefense and pandemic preparedness funding, continue to drive the use of these technologies in hospitals, labs, and home-testing applications.

Asia Pacific is experiencing the fastest growth in the market with 13.03% CAGR, fueled by increasing healthcare access, rising infectious disease burden, and demand for affordable diagnostics. China, India, and Japan are heavily investing in molecular diagnostics research, as local biotechs are innovating low-cost and scalable INAAT solutions. The increasing endemicity of tuberculosis, malaria, and new viral diseases in the region has surged the demand for field-deployable and fast diagnostic tests. In addition, government initiatives in enhancing diagnostic power in rural and resource-constrained areas have spurred the use of portable INAAT platforms. The availability of low-cost manufacturing centers and strategic partnerships among global and regional players also contributes to market growth, and hence, Asia Pacific is the region of future growth for INAAT-based molecular diagnostics.

Isothermal Nucleic Acid Amplification Technology Market Key Players

  • Abbott Laboratories (ID NOW COVID-19 Test, Alere i Influenza A & B)

  • Hologic, Inc. (Panther System, Aptima HPV Assay)

  • bioMérieux SA (BioFire FilmArray System, NucliSENS EasyQ)

  • Eiken Chemical Co., Ltd. (Loopamp MALARIA Pan Detection Kit, Loopamp SARS-CoV-2 Detection Kit)

  • New England Biolabs (NEB LAMP Master Mix, WarmStart RT-LAMP Kit)

  • Thermo Fisher Scientific, Inc. (Invitrogen LAMP Kit, TaqMan LAMP Assays)

  • Becton, Dickinson and Company (BD) (BD MAX LDT, BD Veritor Plus System)

  • Lucira Health, Inc. (Lucira COVID-19 & Flu Test, Lucira Check-It COVID-19 Test)

  • Meridian Bioscience, Inc. (Revogene C. difficile Test, illumigene Mycoplasma Detection Kit)

  • QuantuMDx Group Ltd. (Q-POC SARS-CoV-2 Test, Q-POC Multiplex Respiratory Panel)

  • Atila BioSystems (iAMP COVID-19 Detection Kit, iAMP HPV Detection Kit)

  • Twist Bioscience (TwistAmp Liquid Basic Kit, TwistAmp Liquid Exo Kit)

  • Promega Corporation (GoTaq Rapid LAMP Master Mix, LAMP RT-qPCR Detection Kit)

  • Genedrive plc (Genedrive MT-RNR1 Test, Genedrive COVID-19 Test)

  • Molbio Diagnostics (Truenat MTB Test, Truenat SARS-CoV-2 Test)

  • Ubiquitome Limited (Liberty16 Mobile qPCR Device, Ubiquitome COVID-19 Test)

  • OptiGene Limited (Genie II LAMP System, Genie HT SARS-CoV-2 Test)

  • Molecular Loop Biosciences (MLB Target Enrichment Kit, MLB Custom LAMP Panels)

  • Tetracore, Inc. (T-COR 8 Real-Time PCR Thermocycler, Tetracore Anthrax Detection Kit)

  • Jena Bioscience GmbH (LAMP Master Mix, SARS-CoV-2 LAMP Assay)

Suppliers (These suppliers provide essential raw materials, including nucleotides, enzymes (such as polymerases and reverse transcriptases), primers, and reaction buffers) in the Isothermal Nucleic Acid Amplification Technology Market

  • Merck KGaA

  • Thermo Fisher Scientific, Inc.

  • New England Biolabs, Inc.

  • Qiagen N.V.

  • Integrated DNA Technologies (IDT)

  • Takara Bio Inc.

  • Promega Corporation

  • LGC Biosearch Technologies

  • Bio-Rad Laboratories, Inc.

  • Jena Bioscience GmbH

Recent Development in the Isothermal Nucleic Acid Amplification Technology Market

  • In June 2024, Abbott launched an updated version of its ID NOW system to improve rapid detection for COVID-19, RSV, and Influenza A/B. Utilizing Isothermal Nucleic Acid Amplification Technology (INAAT), this portable and small device provides results in 15 minutes, which makes it suitable for urgent care and off-site locations.

  • In December 2023, Eiken Chemical Co., Ltd. launched a new, enhanced Loop-mediated Isothermal Amplification (LAMP) kit that can identify multiple pathogens at once. This new technology dramatically reduces diagnostic turnaround times in healthcare facilities, increasing the efficiency of respiratory infection care.

    Isothermal Nucleic Acid Amplification Technology Market Report Scope:
    Report Attributes Details
    Market Size in 2023 US$ 4.68 billion
    Market Size by 2032 US$  13.57 billion
    CAGR CAGR of 12.40% from 2024 to 2032
    Base Year 2023
    Forecast Period 2024-2032
    Historical Data 2020-2022
    Report Scope & Coverage Market Size, Segments Analysis, Competitive  Landscape, Regional Analysis, DROC & SWOT Analysis, Forecast Outlook
    Key Segments • By Product (Instruments, Reagents)
    • By Technology (NASBA, HDA, LAMP, SDA, SPIA, NEAR, TMA, RCA, RPA, SMAP2, Others)
    • By Application (Blood Screening, Infectious Disease Diagnostics, Cancer, Others)
    • By End-use (Hospitals, Central and Reference Labs, Others)
    Regional Analysis/Coverage North America (US, Canada, Mexico), Europe (Eastern Europe [Poland, Romania, Hungary, Turkey, Rest of Eastern Europe] Western Europe] Germany, France, UK, Italy, Spain, Netherlands, Switzerland, Austria, Rest of Western Europe]), Asia Pacific (China, India, Japan, South Korea, Vietnam, Singapore, Australia, Rest of Asia Pacific), Middle East & Africa (Middle East [UAE, Egypt, Saudi Arabia, Qatar, Rest of Middle East], Africa [Nigeria, South Africa, Rest of Africa], Latin America (Brazil, Argentina, Colombia, Rest of Latin America)
    Company Profiles Abbott Laboratories, Hologic, Inc., bioMérieux SA, Eiken Chemical Co., Ltd., New England Biolabs, Thermo Fisher Scientific, Inc., Becton, Dickinson and Company (BD), Lucira Health, Inc., Meridian Bioscience, Inc., QuantuMDx Group Ltd., Atila BioSystems, Twist Bioscience, Promega Corporation, Genedrive plc, Molbio Diagnostics, Ubiquitome Limited, OptiGene Limited, Molecular Loop Biosciences, Tetracore, Inc., Jena Bioscience GmbH, and other players.