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InsightAce Analytic Pvt. Ltd. announces the release of a market assessment report on the “Global Isothermal Nucleic Acid Amplification Technology Market – (By Product (Assays, Kits & Reagents, Systems), By Application (Disease Diagnosis (Hepatitis, Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Influenza, Covid-19, Other Disease Diagnosis), Blood Screening, Other Applications), 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 End User (Hospitals, Reference Laboratories, Academic & Research Institutes, Other End users).), Trends, Industry Competition Analysis, Revenue and Forecast To 2034.”

The Isothermal Nucleic Acid Amplification Technology Market Size is valued at USD 4.8 Bn in 2024 and is predicted to reach USD 12.0 Bn by the year 2034 at a 9.7% CAGR during the forecast period for 2025-2034.

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Isothermal nucleic acid amplification technology (INAAT) refers to a method for amplifying DNA sequences under constant temperature conditions, enabling the replication of specific gene segments without the need for thermal cycling. The market for INAAT is being driven by increasing demand for rapid, user-friendly, and disease-specific diagnostic solutions. Expanding healthcare infrastructure and rising healthcare expenditure in developing regions are further contributing to market growth.

Additionally, the development of gene-based therapeutics in response to the increasing prevalence of infectious and genetic diseases has created a heightened need for cost-effective diagnostic tools and therapies. Furthermore, the declining reliance on traditional nucleic acid diagnostics is reinforcing the adoption of INAAT, as stakeholders seek more efficient and accessible molecular testing methodologies.

List of Major Players in the Isothermal Nucleic Acid Amplification Technology Market:

• Abbott Laboratories
• Becton, Dickinson and Company
• Grifols, S.A.
• Hologic, Inc.
• Meridian Bioscience,
• Eiken Chemical Co., Ltd.
• BioMerieux SA
• Tecan Trading AG
• New England Biolabs
• QIAGEN N.V.
• DiaSorin Sp.A.
• General Electric
• OptiGene Limited
• Quidel Corporation
• Thermo Fisher Scientific
• Genomtec
• Mast Group Ltd.
• Ustar Biotechnologies
• Jena Bioscience GmbH
• Atila BioSystems
• TwistDx Limited
• LGC Limited
• Life Sciences Advanced Technologies
• GenoSensor Corporation
• PCR Biosystems

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Market Dynamics

Drivers:

The global isothermal nucleic acid amplification technology (INAAT) market is being propelled by increased government funding and support for pharmaceutical research and development. Various federal and regulatory agencies are implementing initiatives aimed at advancing healthcare innovation, including the development and application of INAAT for molecular diagnostics.

These programs foster the adoption of INAAT by facilitating research, accelerating clinical applications, and promoting advancements in diagnostic technologies. Consequently, public sector investment in pharmaceutical and biotechnological research is a key driver of market growth.

Challenges:

Market expansion faces several constraints, including regulatory complexities surrounding INAAT-based diagnostics. Limited awareness among patients regarding the technology, coupled with unclear legislation governing INAAT applications, restricts market penetration. The adoption of point-of-care amplification methods, such as DNA and RNA testing, is further challenged by the need for specialized equipment capable of precise temperature control and operational consistency.

Additionally, the legal frameworks regulating the development and commercialization of INAAT-based therapeutics present operational hurdles. Nevertheless, the COVID-19 pandemic has positively influenced market growth, as the urgent demand for diagnostic tests, vaccines, and therapeutics accelerated adoption and investment in amplification-based technologies.

Regional Trends:

North America is expected to secure a leading share of the INAAT market, driven by a well-established research infrastructure, rising demand for nucleic acid-based diagnostics, and increasing adoption of point-of-care testing solutions. High healthcare expenditure and strong support for innovation further reinforce regional growth.

Europe also holds a significant market share, supported by rising incidences of hereditary and chronic diseases, substantial R&D investments by key manufacturers in genome-based therapeutics, and growing awareness of affordable diagnostic solutions among aging populations. These factors collectively contribute to sustained expansion in both regions.

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Recent Developments:

• In April 2024, New England Biolabs (NEB®) announced the launch of its Monarch Mag Viral DNA/RNA Extraction Kit. This extraction kit improved the recovery of minimal quantities of viral nucleic acid to provide highly sensitive detection. The kit employed a magnetic bead-based method to extract viral RNA and DNA consistently and effectively, facilitating scalability for high-throughput automation. The kit was compatible with prevalent sample types for extracting viral nucleic acids, including saliva, respiratory swab samples, and, after an enrichment step, wastewater samples.

Segmentation of Isothermal Nucleic Acid Amplification Technology Market-

By Product-

• Assays, Kits, & Reagents
• Systems

By Application-

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

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 End User-

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

By Region-

North America-

• The US
• Canada
• Mexico

Europe-

• Germany
• The UK
• France
• Italy
• Spain
• Rest of Europe

Asia-Pacific-

• China
• Japan
• India
• South Korea
• Southeast Asia
• Rest of Asia Pacific

Latin America-

• Brazil
• Argentina
• Rest of Latin America

Middle East & Africa-

• GCC Countries
• South Africa
• Rest of the Middle East and Africa

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InsightAce Analytic is a market research and consulting firm that enables clients to make strategic decisions. Our qualitative and quantitative market intelligence solutions inform the need for market and competitive intelligence to expand businesses. We help clients gain competitive advantage by identifying untapped markets, exploring new and competing technologies, segmenting potential markets and repositioning products. Our expertise is in providing syndicated and custom market intelligence reports with an in-depth analysis with key market insights in a timely and cost-effective manner.

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