Surge in Isothermal Nucleic Acid Amplification Technology: Market Size Projected to Reach USD 17.26 Billion by 2034

Isothermal Nucleic Acid Amplification Technology Market Size and Forecast 2025 to 2034

The isothermal nucleic acid amplification technology market had a valuation of USD 5.39 billion in 2024. It’s set to grow from USD 6.06 billion in 2025 to around USD 17.26 billion by 2034. This growth represents an annual increase of 12.34%. A key factor driving this market is the rising demand for point-of-care testing. More healthcare professionals are turning to molecular diagnostics because they allow for quicker and more accurate results.

Isothermal Nucleic Acid Amplification Technology Market Key Takeaways

• North America held the largest market share at 44% in 2024.
• Asia Pacific is expected to grow at the fastest rate, with a CAGR of 13.52% during the forecast period.
• The reagents segment represented the biggest market share of 63% in 2024.
• The instrument segment is also anticipated to grow significantly.
• Loop-mediated isothermal amplification (LAMP) secured the largest share by technology at 18% in 2024.
• Transcription-mediated amplification (TMA) is projected to see rapid growth in the next decade.
• Infectious diseases accounted for 37% of the market share in 2024.
• The blood screening sector is expected to grow the quickest.
• Hospitals made up 42% of the market in 2024, making them the leading end-use segment.
• Central and reference laboratories are expected to expand rapidly.

Artificial Intelligence (AI) in the Isothermal Nucleic Acid Amplification Technology Market

AI is transforming the isothermal nucleic acid amplification market. By integrating AI, companies are making systems that are faster, more accurate, and cost-effective. This technology is crucial for the development of portable devices. The push for advanced diagnostic tools and better patient outcomes is fueling AI’s role in amplification technologies.

AI algorithms help analyze data in real time, enabling quicker and more precise results. The combination of AI and isothermal nucleic acid amplification enhances diagnostics, making them faster and more accessible.

U.S. Isothermal Nucleic Acid Amplification Technology Market Size and Growth 2025 to 2034

The U.S. market for isothermal nucleic acid amplification technology was valued at USD 2.18 billion in 2024 and is expected to reach approximately USD 7.07 billion by 2034, growing at a CAGR of 12.48% from 2025 to 2034.

North America leads the global market thanks to its robust R&D infrastructure and major pharmaceutical firms. Increased healthcare spending is pushing the adoption of new technologies, including isothermal nucleic acid amplification. The rise of diseases such as HIV and tuberculosis is also driving this advancement.

Strong government support for research adds to this growth. The U.S. has fast-tracked approvals for innovative technologies, along with a high adoption of molecular diagnosis in its hospitals.

Asia Pacific is projected to grow at the quickest rate between 2025 and 2034, aided by a growing healthcare system and investments in pharmaceuticals. Issues such as the rising rates of infectious diseases in the aging population emphasize the need for these technologies.

Countries like China, India, Japan, and South Korea are key players in this growth. For instance, China is notable for its large aging population and the prevalence of chronic diseases, while Japan is similarly advancing due to its own health challenges. Government investment in tech adoption is crucial across these nations.

• In September 2024, researchers in South Korea introduced new assays to detect gastric cancer exosomal miRNA.

Market Overview

The rising adoption of molecular testing mirrors the increasing incidence of chronic diseases. This trend is driving the need for efficient nucleic acid amplification technologies. Research in biotechnology and molecular biology fuels this demand, pushing developers to create more effective and sensitive tests.

Isothermal nucleic acid amplification technologies can amplify DNA or RNA at a steady temperature, allowing for quick and accurate diagnostics. The popularity of point-of-care testing is spurring innovation in these technologies, with advancements like loop-mediated amplification (LAMP) and others offering rapid, efficient solutions.

Isothermal Nucleic Acid Amplification Technology Market Growth Factors

• Rise of molecular diagnostics: As chronic diseases keep increasing, there’s a higher demand for fast and accurate diagnostic tools.
• Demand for personalized medicine: More people want tailored treatments, boosting the adoption of molecular diagnostics.
• Technological advancements: Innovations are enhancing sensitivity, speed, and accuracy, driving market growth.
• Government funding: Financial support for research is accelerating the development of new amplification technologies.
• Broadening applications: New uses in oncology, food safety, and veterinary medicine are emerging.

Market Scope

Market Dynamics

Driver

Increase in chronic diseases: The rise in chronic illnesses is pushing the need for advanced diagnostic tests, highlighting isothermal nucleic acid amplification technology.

The market is also seeing a demand for personalized medicines and easier point-of-care testing options for early diagnostics. Stakeholders in this space are increasingly focused on creating user-friendly, cost-effective solutions.

Restraint

Regulatory challenges: Strict regulations can hinder growth. Requirements for diagnostics in clinical trials increase costs and slow development, posing challenges for manufacturers.

Opportunity

Technological innovation: New developments in isothermal nucleic acid amplification present significant market opportunities, especially as more people look for user-friendly solutions.

Innovations like microfluidic chips in LAMP technology enhance its sensitivity and efficiency. Furthermore, advanced point-of-care solutions are improving accuracy and diagnostic speed.

Product Insights

The reagents segment dominated the isothermal nucleic acid amplification market in 2024, driven by their extensive use in healthcare. Reagents enable effective tests for various conditions, fueling their demand.

• New isothermal nucleic acid amplification reagents were launched in November 2024 to improve diagnostic capabilities.

The instrument segment is also set for growth. Companies are investing in cost-effective and portable tools, making them more appealing to healthcare staff.

Technology Insights

In 2024, the loop-mediated isothermal amplification (LAMP) method garnered the largest share of the market. Its rapid DNA amplification (30-60 minutes) meets growing needs for point-of-care diagnostics effectively.

• A team developed a new method in 2024 to detect the Delta variant of SARS-CoV-2 using LAMP.

The transcription-mediated amplification (TMA) segment is also expected to grow, favored for its efficiency and rapid tests for various conditions.

Application Insights

The infectious disease segment dominated the market in 2024, driven by the need for quick testing solutions against various infectious agents. Technologies like LAMP and TMA are valuable tools in this area.

• In November 2024, a handheld platform for HIV detection utilizing real-time isothermal amplification was introduced.

The blood screening sector is poised for the fastest growth, driven by a push for safe blood transfusion methods and new technologies in screening for various illnesses.

End-Use Insights

Hospitals led the market share in 2024 due to rising patient numbers and demands for advanced diagnostic technologies. Point-of-care instruments are becoming more successful in these settings.

The central lab segment is also expected to grow quickly as molecular diagnostic techniques become more common. Quick results and user-friendly features enhance their suitability for lab use.

Isothermal Nucleic Acid Amplification Technology Market Companies

• Alere, Inc.
• bioMerieux SA
• Meridian Bioscience, Inc.
• Ustar Biotechnologies Ltd.
• Eiken Chemical Co. Ltd
• Lucigen
• QIAGEN
• Quidel Corporation
• Hologic Inc. (Gen-Probe)
• OptiGene Limited
• Thermo Fisher Scientific, Inc.
• BD (Becton, Dickinson & Company)

Leader’s Announcements

• In March 2024, BD announced the first patient enrolled in a new study aimed at providing important solutions for treating Peripheral Arterial Disease.

Recent Developments

• In March 2024, BD began an important study on new vascular technology.
• Thermo Fisher Scientific unveiled a new clinical registry in March 2024 for a specific skin condition.
• In February 2023, the FDA authorized a new at-home test for detecting influenza A and B and SARS-CoV-2.

Segments Covered in the Report

By Product 

By Technology 

• Nucleic Acid Sequence-based Amplification (NASBA)
• Helicase-dependent Amplification (HDA)
• Loop-mediated Isothermal Amplification (LAMP)
• Strand Displacement Amplification (SDA)
• Single Primer Isothermal Amplification (SPIA)
• Nicking Enzyme Amplification Reaction (NEAR)
• Transcription Mediated Amplification (TMA)
• RCA
• RPA
• SMAP2
• Others

By Application 

• Blood Screening
• Infectious Disease Diagnostics
• Cancer
• Others

By End-use 

• Hospitals
• Central and Reference Labs
• Others

By Regions

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East and Africa