Isothermal Nucleic Acid Amplification Technology Market Size Report, 2024-2033
The global isothermal nucleic acid amplification technology (INAAT) market size was exhibited at USD 4,235.35 million in 2023 and is projected to hit around USD 13,753.54 million by 2033, growing at a CAGR of 12.5% during the forecast period of 2024 to 2033.
Key Takeaways:
Isothermal Nucleic Acid Amplification Technology Market Report Scope
| Report Coverage | Details |
| Market Size in 2024 | USD 4,235.35 Million |
| Market Size by 2033 | USD 13,753.54 Million |
| Growth Rate From 2024 to 2033 | CAGR of 12.5% |
| Base Year | 2023 |
| Forecast Period | 2024-2033 |
| Segments Covered | Product, Technology, Application, End-use, Region |
| Market Analysis (Terms Used) | Value (US$ Million/Billion) or (Volume/Units) |
| Regional Scope | North America; Europe; Asia Pacific; Central and South America; the Middle East and Africa |
| Key Companies Profiled | Alere, Inc.; bioMerieux SA; Eiken Chemical Co. Ltd; Hologic Inc.(Gen-Probe); Lucigen; Meridian Bioscience, Inc.; Ustar Biotechnologies Ltd.; QIAGEN; Quidel Corporation; Thermo Fisher Scientific, Inc; BD (Becton, Dickinson & Company); OptiGene Limited |
The Isothermal Nucleic Acid Amplification Technology (INAAT) is experiencing a notable surge in demand as a molecular testing technique, primarily attributed to the growing prevalence of infectious diseases. Tuberculosis, hepatitis, and influenza are among the leading causes of deaths caused by infectious diseases, especially in the developing countries. As a result, demand for rapid, user-friendly, and disease-specific testing options is expected to boost the adoption of INAAT offerings.
Furthermore, the COVID-19 pandemic has positively affected the market growth by expanding the demand for rapid and accurate testing alternatives for the detection of the SARS-CoV-2 virus. Several key players have developed new INAAT-based COVID-19 testing products and have secured emergency use approvals for such products from the U.S. FDA. For instance, commercially available products in this domain include Grifols Diagnostic Solutions Inc.’s Procleix SARS-CoV-2 assay and Lucira Health, Inc.’s Lucira CHECK-IT COVID-19 test kit. Such strategic initiatives fueled by the COVID-19 pandemic are likely to provide a significant stimulus to the market growth in the near future.
Rapid advancements in existing amplification technologies along with the introduction of novel technologies such as Single Primer Isothermal Amplification (SPIA), Loop-Mediated Isothermal Amplification (LAMP), Recombinase Polymerase Amplification (RPA), and Strand Displacement Amplification (SDA) are opening new avenues for applications of INAAT products. For instance, a research paper published in the Analyst Journal in June 2023 demonstrated the development of a smartphone integrated instrument that can rapidly test for Zika virus in a single blood drop using the LAMP technology. Such developments are likely to boost the market penetration of the technique in the near future.
Amplification techniques such as PCR are limited by requirement of instrumentation capable of thermal cycling and temperature control, which limits the applications of the technique for point-of-care applications. This creates significant growth opportunities for isothermal amplification techniques for use in molecular diagnostics, as these techniques have a lower energy demand and enable assay incubation in portable battery-powered devices. Similarly, strategic partnerships between companies that manufacture INAAT diagnostics and associated products are likely to boost market expansion prospects. For instance, Merck KGaA offers custom LAMP primers in partnership with New England Biolabs for applications of LAMP technologies in life sciences research and molecular diagnostics.
However, a critical factor limiting the market growth is the regulatory framework governing the development of INAAT-based diagnostics. Regulatory agencies such as the U.S. FDA, EMEA, and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, have stringent protocols for monitoring the manufacturing processes for INAAT production, which increases the challenges associated with INAAT manufacturing. Furthermore, lower awareness levels and uncertainty in regulations for INAAT-based diagnostics lead to restricted commercialization of INAAT products. In addition, the lack of a robust reimbursement framework in developed markets, such as the U.S., can significantly limit the purchasing power of the buyers. Such factors can impede market growth in the over the forecast period.
Segments Insights:
Product Insights
The reagents segment captured market share of 61.62% in 2023 due to their extensive usage in hospitals and primary healthcare settings, as well as increasing availability of polymerases with high strand displacement capabilities. Furthermore, with growth in the market penetration of INAAT diagnostics expected in the near future, adoption of associated reagents is projected to grow at a significant rate over the forecast period.
Instrument segment is estimated to register considerable CAGR owing to rising investments for R&D in development of novel diagnostics for emerging infectious diseases such as COVID-19 are driving an increasing demand for INAAT instruments segment. Similarly, introduction of advanced diagnostic devices with enhanced accuracy, portability, and speed can considerably boost the market prospects for INAAT instruments for prevention of disease outbreaks.
Technology Insights
Loop-mediated isothermal amplification (LAMP) accounted for the largest market share of 16.10% in 2023. The technology enables multiple modes of detection such as use of real-time fluorescence using intercalators, or lateral flow and agarose gel detection. As a result, the technique can detect a broad range of RNA and DNA targets, such as Zika virus and SARS-CoV-2 virus, in human samples. Furthermore, demand for the technique is supported by its tolerance to inhibitors that enables use of crude samples and minimally purified nucleic acids.
The transcription mediated amplification (TMA) technology segment is projected to register fastest CAGR during the forecast period. Demand for this technology is fueled by increasing scientific awareness about its potential benefits, such as requirement of fewer steps and lesser processing time, for blood screening and diagnostic applications. Further, technological advancements along with growing investments by market players are expected to offer favorable environment for segment growth by 2033.
Application Insights
Infectious disease application segment accounted for the dominant share of 35.25% in 2023. Recent introduction of specific INAAT kits, and increasing incidence of HIV, hepatitis A & B, and sexually transmitted diseases are key factors anticipated to fuel the segment growth. Moreover, rising concerns over antimicrobial resistance and increasing focus on prevention of epidemic outbreaks in developing countries is expected to further propel the segment growth.
Blood screening segment is projected to register considerable CAGR during the forecast period. Certain factors such as rising number of blood transfusions and associated blood testing requirements across the globe are likely to have positive impact on the segment growth by 2033. Here, INAAT is widely used for evaluation of blood quality by screening of transfused blood for presence of any infectious organisms. Furthermore, increasing research activities for development of INAAT devices capable of detecting molecular biomarkers and multiple blood-borne pathogens are anticipated to broaden the growth prospects for the market.
End-use Insights
Hospitals segment held the largest market share of 42.0% in 2023. This can be attributed to the development of miniaturized point-of-care INAAT instruments that enable single-level access for hospital-based analysis. Similarly, increasing throughput and automation offered by such technologies for processing of a large number of samples are expected to boost the segment growth.
Central and reference laboratories end-use segment is expected to exhibit significant growth over the forecast period due to an increasing number of reference laboratories and rising adoption of molecular diagnostic techniques in such laboratories. In addition, increasing funding from various public agencies such as the U.S. CDC and NIH is boosting the adoption of rapid analysis technologies for the mitigation of infectious diseases.
Regional Insights
North America held the largest market share in 2023 with revenue share of 43.0% due to the established research infrastructure and growth in demand for nucleic acid amplification-based diagnostics for prevention of infectious diseases in the region. Furthermore, a high per capita expenditure on healthcare and increasing focus on point-of-care diagnostic methods is anticipated to drive the market growth.
Asia Pacific is expected to register the fastest CAGR during the forecast period. The increasing prevalence of chronic conditions, growing involvement of market players in the region and rising investments for research & development are estimated to play a major role in growth of Asia Pacific market during the forecast period.
Some of the prominent players in the isothermal nucleic acid amplification technology (INAAT) market include:
Segments Covered in the Report
This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the global isothermal nucleic acid amplification technology (INAAT) market.
Product
Technology
Application
End-use
By Region
Chapter 1. Methodology And Scope
1.1 Market Segmentation And Scope
1.1.1 Segment Definitions
1.1.1.1 Test Segment
1.1.1.2 Service Provider Segment
1.1.1.3 Application Segment
1.2 Regional Scope
1.3 Estimates And Forecast Timeline
1.4 Objectives
1.4.1 Objective - 1
1.4.2 Objective - 2
1.4.3 Objective - 3
1.5 Research Methodology
1.6 Information Procurement
1.6.1 Purchased Database
1.6.2 Internal Database
1.6.3 Secondary Sources
1.6.4 Primary Research
1.7 Information Or Data Analysis
1.7.1 Data Analysis Models
1.8 Market Formulation & Validation
1.9 Model Details
1.9.1 Commodity Flow Analysis
1.10 List Of Secondary Sources
1.11 List Of Abbreviations
Chapter 2. Executive Summary
2.1. Market Snapshot
2.2. Segment Snapshot
2.3. Competitive Landscape Snapshot
Chapter 3. Market Variables, Trends, & Scope
3.1. Market Segmentation And Scope
3.2. Market Lineage Outlook
3.2.1 Parent Market Outlook
3.2.2. Related/Ancillary Market Outlook
3.3. Market Trends And Outlook
3.4. Market Dynamics
3.4.1 Increasing Incidences Of Chronic Diseases And Rise In The Aging Population Across The Globe
3.4.2 Upsurge In The Molecular Diagnostics Market
3.4.3 Rise In Demand For Low Cost And Effective Diagnostics Procedures
3.4.4 Increase In The Available Disposable Income In The Developing Economies
3.4.5 Increase In The Adoption Of Inaat Over Pcr Is Boosting The Market
3.4.6 Rise In The Miniaturization Of Nucleic Acid-Based Diagnostics
3.5. Market Restraint Analysis
3.5.1 Stringent Regulatory Framework
3.5.2 Lack Of Awareness Over New Diagnostics Technologies
3.6. Business Environment Analysis
3.6.1. Swot Analysis; By Factor (Political & Legal, Economic And Technological)
3.6.2. Porter’s Five Forces Analysis
3.7. Covid-19 Impact Analysis
Chapter 4. Product Business Analysis
4.1. Isothermal Nucleic Acid Amplification Technology Market: Product Movement Analysis
4.2. Instruments
4.2.1 Instruments Market, 2021 - 2033
4.3. Kits & Reagents
4.3.1 Kits & Reagents Market, 2021 - 2033
Chapter 5. Technology Business Analysis
5.1. Isothermal Nucleic Acid Amplification Technology Market: Technology Movement Analysis
5.2. NASBA
5.2.1 NASBA Market, 2021 - 2033
5.3. HDA
5.3.1 HDA Market, 2021 - 2033
5.4. LA MP
5.4.1 LA MP Market, 2021 - 2033
5.5. SDA
5.5.1 SDA Market, 2021 - 2033
5.6. SPIA
5.6.1 SPIA Market, 2021 - 2033
5.7. NEAR
5.7.1. NEAR Market, 2021 - 2033
5.8. TMA
5.8.1. TMA Market, 2021 - 2033
5.9. RCA
5.9.1 RCA Market, 2021 - 2033
5.10. RPA
5.10.1 RPA Market, 2021 - 2033
5.11. SMAP2
5.11.1 SMAP2 Market, 2021 - 2033
5.12. Others
5.12.1. Others Market, 2021 - 2033
Chapter 6. Application Business Analysis
6.1. Isothermal Nucleic Acid Amplification Market: Application Movement Analysis
6.2. Blood Screening
6.2.1 Blood Screening Market, 2021 - 2033
6.3. Infectious Disease Diagnosis
6.3.1 Infectious Disease Diagnosis Market, 2021 - 2033
6.4. Cancer
6.4.1. Cancer Market, 2021 - 2033
6.5. Others
6.5.1 Others Market, 2021 - 2033
Chapter 7. End-Use Business Analysis
7.1. Isothermal Nucleic Acid Amplification Market: End-Use Movement Analysis
7.2. Hospital
7.2.1 Hospital Market, 2021 - 2033
7.3. Central And Reference Laboratories
7.3.1 Central And Reference Laboratories Market, 2021 - 2033
7.4. Others
7.4.1. Others Market, 2021 - 2033
Chapter 8. Regional Business Analysis
8.1. Isothermal Nucleic Acid Amplification Technology Market: Regional Movement Analysis, 2022 & 2030
8.2. North America
8.2.1 North America Isothermal Nucleic Acid Amplification Technology Market Estimates And Forecasts, 2021 - 2033
8.2.2 U.S.
8.2.1.1. Key Country Dynamics
8.2.1.2. Competitive Scenario
8.2.1.3. Prevalence Insights
8.2.1.4. Regulatory Framework
8.2.1.5. U.S. Isothermal Nucleic Acid Amplification Technology Market Estimates And Forecasts, 2021 - 2033
8.2.3 Canada
8.2.3.1 Key Country Dynamics
8.2.3.2 Competitive Scenario
8.2.3.3 Prevalence Insights
8.2.3.4 Regulatory Framework
8.2.3.5 Canada Isothermal Nucleic Acid Amplification Technology Market Estimates And Forecasts, 2021 - 2033
8.3. Europe
8.3.1 Europe Isothermal Nucleic Acid Amplification Technology Market Estimates And Forecasts, 2021 - 2033
8.3.2 Uk
8.3.2.1 Key Country Dynamics
8.3.2.2 Competitive Scenario
8.3.2.3 Prevalence Insights
8.3.2.4 Regulatory Framework
8.3.2.5 Uk Isothermal Nucleic Acid Amplification Technology Market Estimates And Forecasts, 2021 - 2033
8.3.3 Germany
8.3.3.1 Key Country Dynamics
8.3.3.2 Competitive Scenario
8.3.3.3 Prevalence Insights
8.3.3.4 Regulatory Framework
8.3.3.5 Germany Isothermal Nucleic Acid Amplification Technology Market Estimates And Forecasts, 2021 - 2033
8.3.4 France
8.3.4.1 Key Country Dynamics
8.3.4.2 Competitive Scenario
8.3.4.3 Prevalence Insights
8.3.4.4 Regulatory Framework
8.3.4.5 France Isothermal Nucleic Acid Amplification Technology Market Estimates And Forecasts, 2021 - 2033
8.3.5 Italy
8.3.5.1 Key Country Dynamics
8.3.5.2 Competitive Scenario
8.3.5.3 Prevalence Insights
8.3.5.4 Regulatory Framework
8.3.5.5 Italy Isothermal Nucleic Acid Amplification Technology Market Estimates And Forecasts, 2021 - 2033
8.3.6 Spain
8.3.6.1 Key Country Dynamics
8.3.6.2 Competitive Scenario
8.3.6.3 Prevalence Insights
8.3.6.4 Regulatory Framework
8.3.6.5 Spain Isothermal Nucleic Acid Amplification Technology Market Estimates And Forecasts, 2021 - 2033
8.3.7 Denmark
8.3.7.1 Key Country Dynamics
8.3.7.2 Competitive Scenario
8.3.7.3 Prevalence Insights
8.3.7.4 Regulatory Framework
8.3.7.5 Denmark Isothermal Nucleic Acid Amplification Technology Market Estimates And Forecasts, 2021 - 2033
8.3.8 Sweden
8.3.8.1 Key Country Dynamics
8.3.8.2 Competitive Scenario
8.3.8.3 Prevalence Insights
8.3.8.4 Regulatory Framework
8.3.8.5 Sweden Isothermal Nucleic Acid Amplification Technology Market Estimates And Forecasts, 2021 - 2033
8.3.9 Norway
8.3.9.1 Key Country Dynamics
8.3.9.2 Competitive Scenario
8.3.9.3 Prevalence Insights
8.3.9.4 Regulatory Framework
8.3.9.5 Norway Isothermal Nucleic Acid Amplification Technology Market Estimates And Forecasts, 2021 - 2033
8.4. Asia Pacific
8.4.1 Asia Pacific Isothermal Nucleic Acid Amplification Technology Market Estimates And Forecasts, 2021 - 2033
8.4.2 Japan
8.4.2.1 Key Country Dynamics
8.4.2.2 Competitive Scenario
8.4.2.3 Prevalence Insights
8.4.2.4 Regulatory Framework
8.4.2.5 Japan Isothermal Nucleic Acid Amplification Technology Market Estimates And Forecasts, 2021 - 2033
8.4.3 China
8.4.3.1 Key Country Dynamics
8.4.3.2 Competitive Scenario
8.4.3.3 Prevalence Insights
8.4.3.4 Regulatory Framework
8.4.3.5 China Isothermal Nucleic Acid Amplification Technology Market Estimates And Forecasts, 2021 - 2033
8.4.4 India
8.4.4.1 Key Country Dynamics
8.4.4.2 Competitive Scenario
8.4.4.3 Prevalence Insights
8.4.4.4 Regulatory Framework
8.4.4.5 India Isothermal Nucleic Acid Amplification Technology Market Estimates And Forecasts, 2021 - 2033
8.4.5 Australia
8.4.5.1 Key Country Dynamics
8.4.5.2 Competitive Scenario
8.4.5.3 Prevalence Insights
8.4.5.4 Regulatory Framework
8.4.5.5 Australia Isothermal Nucleic Acid Amplification Technology Market Estimates And Forecasts, 2021 - 2033
8.4.6 Thailand
8.4.6.1 Key Country Dynamics
8.4.6.2 Competitive Scenario
8.4.6.3 Prevalence Insights
8.4.6.4 Regulatory Framework
8.4.6.5 Thailand Isothermal Nucleic Acid Amplification Technology Market Estimates And Forecasts, 2021 - 2033
8.4.7 South Korea
8.4.7.1 Key Country Dynamics
8.4.7.2 Competitive Scenario
8.4.7.3 Prevalence Insights
8.4.7.4 Regulatory Framework
8.4.7.5 South Korea Isothermal Nucleic Acid Amplification Technology Market Estimates And Forecasts, 2021 - 2033
8.5. Latin America
8.5.1 Latin America Isothermal Nucleic Acid Amplification Technology Market Estimates And Forecasts, 2021 - 2033
8.5.2 Brazil
8.5.2.1 Key Country Dynamics
8.5.2.2 Competitive Scenario
8.5.2.3 Prevalence Insights
8.5.2.4 Regulatory Framework
8.5.2.5 Brazil Isothermal Nucleic Acid Amplification Technology Market Estimates And Forecasts, 2021 - 2033
8.5.3 Mexico
8.5.3.1 Key Country Dynamics
8.5.3.2 Competitive Scenario
8.5.3.3 Prevalence Insights
8.5.3.4 Regulatory Framework
8.5.3.5 Mexico Isothermal Nucleic Acid Amplification Technology Market Estimates And Forecasts, 2021 - 2033
8.5.4 Argentina
8.5.4.1 Key Country Dynamics
8.5.4.2 Competitive Scenario
8.5.4.3 Prevalence Insights
8.5.4.4 Regulatory Framework
8.5.4.5 Argentina Isothermal Nucleic Acid Amplification Technology Market Estimates And Forecasts, 2021 - 2033
8.6. Middle East & Africa
8.6.1 Middle East & Africa Isothermal Nucleic Acid Amplification Technology Market Estimates And Forecasts, 2021 - 2033
8.6.2 South Africa
8.6.2.1 Key Country Dynamics
8.6.2.2 Competitive Scenario
8.6.2.3 Prevalence Insights
8.6.2.4 Regulatory Framework
8.6.2.5 South Africa Isothermal Nucleic Acid Amplification Technology Market Estimates And Forecasts, 2021 - 2033
8.6.3 Saudi Arabia
8.6.3.1 Key Country Dynamics
8.6.3.2 Competitive Scenario
8.6.3.3 Prevalence Insights
8.6.3.4 Regulatory Framework
8.6.3.5 Saudi Arabia Isothermal Nucleic Acid Amplification Technology Market Estimates And Forecasts, 2021 - 2033
8.6.4 UAE
8.6.4.1 Key Country Dynamics
8.6.4.2 Competitive Scenario
8.6.4.3 Prevalence Insights
8.6.4.4 Regulatory Framework
8.6.4.5 UAE Isothermal Nucleic Acid Amplification Technology Market Estimates And Forecasts, 2021 - 2033
8.6.5 Kuwait
8.6.5.1 Key Country Dynamics
8.6.5.2 Competitive Scenario
8.6.5.3 Prevalence Insights
8.6.5.4 Regulatory Framework
8.6.5.5 Kuwait Isothermal Nucleic Acid Amplification Technology Market Estimates And Forecasts, 2021 - 2033
Chapter 9. Competitive Landscape
9.1. Company Categorization
9.2. Strategy Mapping
9.2.1 New Product Launch
9.2.2 Partnerships
9.2.3 Acquisition
9.2.4. Collaboration
9.2.5 Funding
9.3. Key Company Market Share Analysis, 2022
9.4. Company Profiles
9.4.1 Alere, Inc.
9.4.1.1 Company Overview
9.4.1.2 Financial Performance
9.4.1.3 Product Benchmarking
9.4.1.4 Strategic Initiatives
9.4.2 Biomerieux Sa
9.4.2.1 Company Overview
9.4.2.2 Financial Performance
9.4.2.3 Product Benchmarking
9.4.2.4 Strategic Initiatives
9.4.3 Eiken Chemical Co. Ltd
9.4.3.1 Company Overview
9.4.3.2 Financial Performance
9.4.3.3 Product Benchmarking
9.4.3.4 Strategic Initiatives
9.4.4 Hologic Inc.(Gen-Probe)
9.4.4.1 Company Overview
9.4.4.2 Financial Performance
9.4.4.3 Product Benchmarking
9.4.4.4 Strategic Initiatives
9.4.5 Lucigen
9.4.5.1 Company Overview
9.4.5.2 Financial Performance
9.4.5.3 Product Benchmarking
9.4.5.4 Strategic Initiatives
9.4.6 Meridian Bioscience, Inc.
9.4.6.1 Company Overview
9.4.6.2 Financial Performance
9.4.6.3 Product Benchmarking
9.4.6.4 Strategic Initiatives
9.4.7 Ustar Biotechnologies Ltd.
9.4.7.1 Company Overview
9.4.7.2 Financial Performance
9.4.7.3 Product Benchmarking
9.4.7.4 Strategic Initiatives
9.4.8 Qiagen
9.4.8.1 Company Overview
9.4.8.2 Financial Performance
9.4.8.3 Product Benchmarking
9.4.8.4 Strategic Initiatives
9.4.9 Quidel Corporation
9.4.9.1 Company Overview
9.4.9.2 Financial Performance
9.4.9.3 Product Benchmarking
9.4.9.4 Strategic Initiatives
9.4.10 Thermo Fisher Scientific, Inc.
9.4.10.1 Company Overview
9.4.10.2 Financial Performance
9.4.10.3 Product Benchmarking
9.4.10.4 Strategic Initiatives
9.4.11 Bd (Becton, Dickinson & Company)
9.4.11.1 Company Overview
9.4.11.2 Financial Performance
9.4.11.3 Product Benchmarking
9.4.11.4 Strategic Initiatives
9.4.12 Optigene Limited
9.4.12.1 Company Overview
9.4.12.2 Financial Performance
9.4.12.3 Product Benchmarking
9.4.12.4 Strategic Initiatives
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