Isothermal Nucleic Acid Amplification Technology Market Size Report, 2030

Name: Isothermal Nucleic Acid Amplification Technology Market Size Report, 2030
Creator: Mordor Intelligence
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Isothermal Nucleic Acid Amplification Technology Market Size and Share

Market Overview

Study Period	2019 - 2030
Market Size (2025)	USD 5.36 Billion
Market Size (2030)	USD 8.19 Billion
Growth Rate (2025 - 2030)	8.87% CAGR
Fastest Growing Market	Asia Pacific
Largest Market	North America
Market Concentration	Medium
Major Players *Disclaimer: Major Players sorted in no particular order Image © Mordor Intelligence. Reuse requires attribution under CC BY 4.0.

Isothermal Nucleic Acid Amplification Technology Market (2025 - 2030) — Image © Mordor Intelligence. Reuse requires attribution under CC BY 4.0.

Isothermal Nucleic Acid Amplification Technology Market Analysis by Mordor Intelligence

The Isothermal Nucleic Acid Amplification Technology Market size is estimated at USD 5.36 billion in 2025, and is expected to reach USD 8.19 billion by 2030, at a CAGR of 8.87% during the forecast period (2025-2030).

Growth is fuelled by constant-temperature amplification, which removes the need for bulky thermal cyclers and supports rapid point-of-care testing. Hospitals deploy INAAT platforms in emergency units to cut result turnaround from hours to minutes, while reagent suppliers benefit from steady, high-margin consumable sales. Manufacturers are integrating microfluidics, lyophilised reagents and colourimetric detection that lower per-test costs and broaden use in non-laboratory settings. Asia-Pacific adoption accelerates as streamlined device approvals shorten time-to-market, whereas North America leads on revenue owing to established reimbursement frameworks.

Key Report Takeaways

By technology, Loop-Mediated Isothermal Amplification (LAMP) led with 44.34% revenue share in 2024 and is projected to record a 13.36% CAGR through 2030.
By product, reagents and consumables accounted for 63.56% of 2024 revenue, while instruments are expected to expand at an 11.24% CAGR to 2030.
By application, infectious-disease testing held 53.56% of the Isothermal Nucleic Acid Amplification Technology market share in 2024; oncology and liquid biopsy are forecast to grow at a 16.11% CAGR.
By end user, hospitals and reference laboratories held 56.78% share in 2024; point-of-care sites are projected to grow at an 11.64% CAGR.
By region, North America captured 35.67% revenue in 2024, whereas Asia-Pacific is set to log a 15.64% CAGR through 2030.

Global Isothermal Nucleic Acid Amplification Technology Market Trends and Insights

Drivers Impact Analysis

Driver	(~) % Impact on CAGR Forecast	Geographic Relevance	Impact Timeline
Point-of-Care Infectious-Disease Adoption	+2.1%	Global, with early gains in North America & EU	Medium term (2-4 years)
Aging Population & Chronic-Disease Burden	+1.8%	Global, concentrated in developed markets	Long term (≥ 4 years)
Workflow Shift from PCR to INAAT	+1.5%	APAC core, spill-over to MEA	Medium term (2-4 years)
Lower Per-Test Cost Economics	+1.3%	Global, accelerated in emerging markets	Short term (≤ 2 years)
Microfluidic Battery-Powered Cartridges	+0.9%	North America & EU, expanding to APAC	Long term (≥ 4 years)
CRISPR-Enhanced Assay Specificity	+0.7%	Global, led by research institutions	Long term (≥ 4 years)

Source: Mordor Intelligence

Point-of-care infectious-disease adoption

Emergency departments now rely on INAAT respiratory panels that deliver lab-quality answers in minutes, boosting patient throughput and antibiotic stewardship. FDA clearance of Cepheid’s Xpert HCV in June 2024 allows same-visit hepatitis C diagnosis from a fingertip blood sample, a milestone that removes multi-visit loss to follow-up.^{[1]U.S. Food and Drug Administration, “FDA Authorizes First Point-of-Care Hepatitis C Test,” fda.gov} Result accuracy remains on par with PCR while constant-temperature reactions suit battery-powered, portable devices useful in resource-limited settings.

Aging population & chronic-disease burden

Populations over 65 years demand regular biomarker checks for infections and cancer recurrence. INAAT-based liquid-biopsy systems can detect minimal residual disease with 94.1% sensitivity, enabling home or community clinic monitoring.^{[2]Nature Communications, “Portable Dragonfly Platform Enables Field Molecular Diagnostics,” nature.com} Integration with telemedicine platforms streamlines result review, curbing unnecessary hospital visits and lowering system costs.

Workflow shift from PCR to INAAT

Clinical labs that transition to LAMP report 60% less hands-on time because extraction steps are simplified and reactions run at a single 60-65 °C setting.^{[3]Frontiers in Cellular and Infection Microbiology, “Automation-Compatible LAMP Workflows Reduce Hands-On Time,” frontiersin.org} Lyophilised reagent cups ship at ambient temperature and slot into existing automation lines, keeping throughput high while cutting maintenance needs typical of thermal cyclers.

Lower per-test cost economics

Instrument capital costs fall by roughly 40% when constant-temperature heaters replace multi-zone cyclers. Colourimetric readouts remove expensive optics, pushing high-volume per-test costs below USD 5 for respiratory targets. Room-temperature reagent stability trims 20-30% from cold-chain spend in emerging economies, accelerating deployment.

Restraints Impact Analysis

Restraint	(~) % Impact on CAGR Forecast	Geographic Relevance	Impact Timeline
Competition From PCR & DCR Platforms	-1.9%	Global, strongest in established markets	Medium term (2-4 years)
Awareness And Reimbursement Gaps	-1.4%	North America & EU primarily	Short term (≤ 2 years)
Enzyme-Supply Volatility for Bst Reagents	-0.8%	Global, acute in supply-constrained regions	Short term (≤ 2 years)
Stringent CLIA-Waiver / IVDR Evidence Hurdles	-1.1%	North America & EU regulatory domains	Long term (≥ 4 years)

Source: Mordor Intelligence

Competition From PCR & DCR Platforms

Established PCR infrastructure represents significant switching costs for laboratories that have invested in thermal cycling platforms, automated sample handling systems, and technician training programs optimized for traditional amplification workflows. Digital PCR platforms further intensify competition by offering absolute quantification capabilities that INAAT currently cannot match, particularly in applications requiring precise viral load monitoring or copy number variation analysis. Laboratory directors cite workflow disruption concerns when evaluating INAAT adoption, as existing quality control procedures, regulatory validations, and staff competencies align with PCR methodologies.

Awareness and Reimbursement Gaps

Healthcare payer recognition of INAAT clinical utility lags behind technology capabilities, creating reimbursement uncertainties that limit adoption in cost-sensitive healthcare environments. Medicare's MolDX program requires extensive clinical evidence demonstrating diagnostic accuracy and patient outcome improvements before establishing coverage policies for novel molecular diagnostic technologies. The evidence generation process typically requires 18-24 months of clinical data collection, during which INAAT developers must fund studies without guaranteed reimbursement outcomes. Physician awareness of INAAT capabilities remains limited outside infectious disease specialties, with many clinicians defaulting to familiar PCR-based testing despite potential advantages in turnaround time and point-of-care deployment.

Segment Analysis

By Technology: LAMP Dominance Drives Innovation

LAMP captured 44.34% of the Isothermal Nucleic Acid Amplification Technology market in 2024 and is forecast to grow at 13.36% CAGR to 2030. The methodology targets six gene regions, conferring high specificity without thermal cycling. Complementary approaches like HDA and NEAR address low-temperature use cases, while TMA retains value in blood screening where RNA detection matters.

Detection innovation is reshaping the Isothermal Nucleic Acid Amplification Technology market as developers pair LAMP with CRISPR–Cas systems to reach attomolar sensitivity in 30 minutes. Colourimetric lateral-flow strips integrate directly into cartridges, widening adoption in clinics lacking fluorescence readers.

Market Share by Technology — Image © Mordor Intelligence. Reuse requires attribution under CC BY 4.0.

By Product: Reagent Revenues Fund Instrument Innovation

Reagents and consumables generated 63.56% of 2024 revenue, providing recurring cash flow that subsidises R&D. Bst polymerase supply resilience remains critical because it underpins most INAAT kits. Instruments are set to expand 11.24% annually as vendors embed microfluidics and one-step extraction, evidenced by iPonatic’s 30-minute cartridge achieving full workflow automation.

Instrument innovation focuses on integration and miniaturization, with manufacturers developing portable platforms that combine sample preparation, amplification, and detection in single-use cartridge formats. The iPonatic system exemplifies this trend, delivering complete nucleic acid testing within 30 minutes using room-temperature extraction and integrated detection capabilities. Microfluidic integration enables precise fluid handling and thermal control while reducing reagent consumption and contamination risks, though manufacturing complexity and cost considerations limit adoption to high-value applications.

By Application: Oncology Emergence Challenges Infectious-Disease Dominance

Infectious-disease testing retained 53.56% revenue in 2024 yet will lose relative share as oncology earns a 16.11% CAGR. The FDA’s 2024 clearance of Geneoscopy’s ColoSense stool-RNA test confirms INAAT’s role in non-invasive cancer screening. Blood centres also rely on TMA to shorten viral-window periods, underscoring broad pathogen focus.

Oncology traction exemplifies the Isothermal Nucleic Acid Amplification Technology market’s capacity to address continuous surveillance, detecting circulating tumour DNA before imaging modalities can confirm relapse. Food-safety and veterinary segments add diversity by exploiting INAAT tolerance for complex matrices, supporting field diagnoses where culture labs are scarce.

Market Share by Application — Image © Mordor Intelligence. Reuse requires attribution under CC BY 4.0.

By End User: Point-of-Care Adoption Accelerates

Hospitals and reference labs together held 56.78% revenue in 2024, leveraging existing molecular infrastructure. Emergency units use thirty-minute respiratory panels to triage patients quickly, improving bed management. Reference labs add INAAT for STAT testing to differentiate from routine PCR competitors.

Decentralised clinics and urgent-care chains are set to grow at 11.64% CAGR, aided by cartridge-based analyzers that need minimal training. The Dragonfly portable station demonstrated reliable outbreak response in remote regions with no mains power. Academic centres continue to seed breakthroughs that commercial partners scale, reinforcing the innovation cycle across the Isothermal Nucleic Acid Amplification Technology market.

Geography Analysis

North America leads with 35.67% revenue in 2024, underpinned by FDA pathways such as CLIA waiver rules that bring fifteen-minute respiratory panels into clinics fda.gov. Extensive insurance coverage permits hospitals to adopt INAAT without budget disruption. Research funding and robust venture capital accelerate domestic device launches.

Asia-Pacific is the growth engine, forecast at 15.64% CAGR. China’s NMPA shortened review timelines from 24 to 12 months, attracting multinationals to localise production nmpa.gov.cn. Japan’s senior population spurs home-based diagnostics, while India’s public-health programmes source affordable INAAT kits for tuberculosis and dengue surveillance. Local manufacturing dampens currency risk and secures supply during global disruptions.

Europe grows steadily as the IVDR harmonises standards, though smaller innovators face higher evidence hurdles for CE marking. Germany and the United Kingdom anchor demand through strong hospital networks and translational research output. Cost-containment policies favour constant-temperature systems that save energy and labour compared with PCR.

Growth Rate by Region — Image © Mordor Intelligence. Reuse requires attribution under CC BY 4.0.

Competitive Landscape

The market remains moderately fragmented. Abbott, Roche and Qiagen leverage installed customer networks to cross-sell INAAT cartridges, while pure-play specialists like Meridian Bioscience and Molbio Diagnostics focus on assay breadth. Bio-Rad’s USD 105 million stake in Geneoscopy illustrates the trend of large firms partnering to accelerate oncology assay roll-out.

Acquisitions expand point-of-care capabilities: bioMérieux bought SpinChip Diagnostics in January 2025 for EUR 111 million, adding a 10-minute cardiac marker platform that complements its respiratory test suite. Competitive advantage hinges on regulatory prowess because payers demand robust clinical-utility dossiers before reimbursements flow.

White-space opportunities persist in ultra-rapid field diagnostics and in low-infrastructure regions where constant-temperature assays outperform PCR. Vendors pairing INAAT with CRISPR or AI-enabled result interpretation could secure premium niches before incumbents re-engineer their portfolios.

Isothermal Nucleic Acid Amplification Technology Industry Leaders

Becton Dickinson and Company
BioMerieux SA
Quidel Corporation
Qiagen N.V.
Tecan Genomics Inc.
*Disclaimer: Major Players sorted in no particular order

INAAT Market — Image © Mordor Intelligence. Reuse requires attribution under CC BY 4.0.

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Recent Industry Developments

January 2025: bioMérieux completed acquisition of SpinChip Diagnostics for EUR 111 million (USD 116 million), gaining access to innovative immunoassay diagnostics platform designed for point-of-care testing with 10-minute result delivery from whole blood samples. The acquisition strengthens bioMérieux's point-of-care portfolio with technology targeting cardiac markers for myocardial infarction diagnosis, with first product launch expected in 2026 following CE marking under IVDR.
January 2025: Geneoscopy closed USD 105 million Series C funding round led by Bio-Rad Laboratories to support commercialization of ColoSense colorectal cancer screening test and advance inflammatory bowel disease diagnostic pipeline. The investment leverages Bio-Rad's Droplet Digital PCR technology to enhance test sensitivity and specificity while expanding market access through established distribution channels.
June 2024: FDA granted marketing authorization to Cepheid for Xpert HCV test and GeneXpert Xpress System, establishing first point-of-care hepatitis C RNA test capable of detecting HCV RNA from fingertip blood samples with approximately 60-minute turnaround time. The authorization enables test-and-treat approaches that address multi-step testing barriers resulting in untreated infections.
May 2024: FDA approved Geneoscopy's ColoSense device for qualitative detection of colorectal neoplasia-associated RNA markers and occult hemoglobin in stool samples, marking first RNA-based stool test for adults aged 45 and older at average risk for colorectal cancer. The approval includes post-market study requirements with 12,500 subject enrollment over 36 months to confirm clinical effectiveness.

Table of Contents for Isothermal Nucleic Acid Amplification Technology Industry Report

1. Introduction

1.1 Study Assumptions & Market Definition
1.2 Scope of the Study

2. Research Methodology

3. Executive Summary

4. Market Landscape

4.1 Market Overview
4.2 Market Drivers
- 4.2.1 Point-of-Care Infectious-Disease Adoption
- 4.2.2 Aging Population and Chronic-Disease Burden
- 4.2.3 Workflow Shift from PCR to INAAT
- 4.2.4 Lower Per-Test Cost Economics
- 4.2.5 Microfluidic Battery-Powered Cartridges (UTR)
- 4.2.6 Crispr-Enhanced Assay Specificity (UTR)
4.3 Market Restraints
- 4.3.1 Competition From PCR and DCR Platforms
- 4.3.2 Awareness and Reimbursement Gaps
- 4.3.3 Enzyme-Supply Volatility for Bst Reagents
- 4.3.4 Stringent CLIA-Waiver / IVDR Evidence Hurdles (UTR)
4.4 Porter’s Five Forces Analysis
- 4.4.1 Threat of New Entrants
- 4.4.2 Bargaining Power of Buyers
- 4.4.3 Bargaining Power of Suppliers
- 4.4.4 Threat of Substitutes
- 4.4.5 Competitive Rivalry

5. Market Size & Growth Forecasts (Value in USD)

5.1 By Technology
- 5.1.1 Helicase-Dependent Amplification (HDA)
- 5.1.2 Nicking Enzyme Amplification Reaction (NEAR)
- 5.1.3 Loop-Mediated Isothermal Amplification (LAMP)
- 5.1.4 Strand Displacement Amplification (SDA)
- 5.1.5 Nucleic Acid Sequence-Based Amplification (NASBA)
- 5.1.6 Transcription-Mediated Amplification (TMA)
- 5.1.7 Single-Primer Isothermal Amplification (SPIA)
- 5.1.8 Other Technologies
5.2 By Product
- 5.2.1 Instruments
- 5.2.2 Reagents & Consumables
5.3 By Application
- 5.3.1 Infectious-Disease Diagnostics
- 5.3.2 Oncology and Liquid Biopsy
- 5.3.3 Blood-Screening and Transfusion Safety
- 5.3.4 Food- & Water-Safety Testing
- 5.3.5 Veterinary and Agricultural Diagnostics
5.4 By End-User
- 5.4.1 Hospitals & Reference Labs
- 5.4.2 Point-of-Care / Decentralised Clinics
- 5.4.3 Academic & Research Institutes
5.5 By Geography
- 5.5.1 North America
- 5.5.1.1 United States
- 5.5.1.2 Canada
- 5.5.1.3 Mexico
- 5.5.2 Europe
- 5.5.2.1 Germany
- 5.5.2.2 United Kingdom
- 5.5.2.3 France
- 5.5.2.4 Italy
- 5.5.2.5 Spain
- 5.5.2.6 Rest of Europe
- 5.5.3 Asia-Pacific
- 5.5.3.1 China
- 5.5.3.2 Japan
- 5.5.3.3 India
- 5.5.3.4 Australia
- 5.5.3.5 South Korea
- 5.5.3.6 Rest of Asia-Pacific
- 5.5.4 Middle East & Africa
- 5.5.4.1 GCC
- 5.5.4.2 South Africa
- 5.5.4.3 Rest of Middle East & Africa
- 5.5.5 South America
- 5.5.5.1 Brazil
- 5.5.5.2 Argentina
- 5.5.5.3 Rest of South America

6. Competitive Landscape

6.1 Market Concentration
6.2 Market Share Analysis
6.3 Company Profiles (includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products & Services, and Recent Developments)
- 6.3.1 Abbott Laboratories
- 6.3.2 Amplifica Labs
- 6.3.3 Becton, Dickinson & Co.
- 6.3.4 BioMérieux SA
- 6.3.5 DiaSorin SpA
- 6.3.6 Eiken Chemical Co., Ltd.
- 6.3.7 Genomera Inc.
- 6.3.8 Hologic Inc.
- 6.3.9 Lucigen (LGC Biosearch)
- 6.3.10 Meridian Bioscience
- 6.3.11 Molbio Diagnostics
- 6.3.12 New England Biolabs
- 6.3.13 OptiGene Ltd.
- 6.3.14 Qiagen N.V.
- 6.3.15 QuidelOrtho Corp.
- 6.3.16 Roche Diagnostics
- 6.3.17 Tecan Genomics Inc.
- 6.3.18 Thermo Fisher Scientific
- 6.3.19 TwistDx Ltd.
- 6.3.20 Ustar Biotechnologies

7. Market Opportunities & Future Outlook

7.1 White-Space & Unmet-Need Assessment

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Global Isothermal Nucleic Acid Amplification Technology Market Report Scope

As per the scope of the report, nucleic acid amplification technologies are used in the field of molecular biology and recombinant DNA technologies. These techniques are used as leading methods in detecting and analyzing a small number of nucleic acids. Isothermal nucleic acid amplification technology protocols are varied, and have many advantages, as it is extremely fast and does not require thermocyclers. The Isothermal Nucleic Acid Amplification Technology (INAAT) Market is segmented By Technology(Helicase-dependant Amplification(HDA), Nicking Enzyme Amplification Reaction(NEAR), Loop-mediated Isothermal Amplification(LAMP), Strand Displacement Amplification (SDA), Nucleic Acid Sequence-based Amplification(NASBA), Transcription Mediated Amplification (TMA), Single Primer Isothermal Amplification(SPIA), Other Technologies), By Product(Instruments and Reagent), By End-User (Hospital, Research laboratories, Other End-Users), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The market report also covers the estimated market sizes and trends for 17 different countries across major regions, globally. The report offers the value (in USD million) for the above segments.

By Technology	Helicase-Dependent Amplification (HDA)
	Nicking Enzyme Amplification Reaction (NEAR)
	Loop-Mediated Isothermal Amplification (LAMP)
	Strand Displacement Amplification (SDA)
	Nucleic Acid Sequence-Based Amplification (NASBA)
	Transcription-Mediated Amplification (TMA)
	Single-Primer Isothermal Amplification (SPIA)
	Other Technologies
By Product	Instruments
	Reagents & Consumables
By Application	Infectious-Disease Diagnostics
	Oncology and Liquid Biopsy
	Blood-Screening and Transfusion Safety
	Food- & Water-Safety Testing
	Veterinary and Agricultural Diagnostics
By End-User	Hospitals & Reference Labs
	Point-of-Care / Decentralised Clinics
	Academic & Research Institutes

By Geography	North America	United States
		Canada
		Mexico

	Europe	Germany
		United Kingdom
		France
		Italy
		Spain
		Rest of Europe

	Asia-Pacific	China
		Japan
		India
		Australia
		South Korea
		Rest of Asia-Pacific

	Middle East & Africa	GCC
		South Africa
		Rest of Middle East & Africa

	South America	Brazil
		Argentina
		Rest of South America

By Technology

Helicase-Dependent Amplification (HDA)

Nicking Enzyme Amplification Reaction (NEAR)

Loop-Mediated Isothermal Amplification (LAMP)

Strand Displacement Amplification (SDA)

Nucleic Acid Sequence-Based Amplification (NASBA)

Transcription-Mediated Amplification (TMA)

Single-Primer Isothermal Amplification (SPIA)

Other Technologies

By Product

Instruments

Reagents & Consumables

By Application

Infectious-Disease Diagnostics

Oncology and Liquid Biopsy

Blood-Screening and Transfusion Safety

Food- & Water-Safety Testing

Veterinary and Agricultural Diagnostics

By End-User

Hospitals & Reference Labs

Point-of-Care / Decentralised Clinics

Academic & Research Institutes

By Geography

North America	United States
	Canada
	Mexico
Europe	Germany
	United Kingdom
	France
	Italy
	Spain
	Rest of Europe
Asia-Pacific	China
	Japan
	India
	Australia
	South Korea
	Rest of Asia-Pacific
Middle East & Africa	GCC
	South Africa
	Rest of Middle East & Africa
South America	Brazil
	Argentina
	Rest of South America

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Key Questions Answered in the Report

What is driving recent growth in the Isothermal Nucleic Acid Amplification Technology market?

Rapid point-of-care adoption, lower instrument costs and continuous regulatory support in North America and Asia-Pacific are propelling an 8.87% CAGR through 2030.

Which technology segment leads the market?

Loop-Mediated Isothermal Amplification holds 44.34% revenue and is also the fastest-growing segment at 13.36% CAGR.

What regions are expanding the fastest?

Asia-Pacific is forecast to grow at 15.64% CAGR due to streamlined approvals and infrastructure investment.

Which applications offer the highest future growth?

Oncology and liquid-biopsy tests are set to expand at 16.11% CAGR as non-invasive cancer screening gains medical and payer acceptance.

What are the main barriers to wider INAAT adoption?

Incumbent PCR infrastructure, reimbursement gaps and enzyme supply volatility remain the key restraints affecting uptake over the next two to four years.