The global nucleic acid amplification testing market size is expected to reach USD 28.86 billion by 2034, according to a new study by Polaris Market Research. The report “Nucleic Acid Amplification Testing Market Size, Share, & Industry Analysis Report: By Type (PCR Tests, INAAT Tests, and LCR Tests), By Application, By End Use, and By Region – Market Forecast, 2025–2034” gives a detailed insight into current market dynamics and provides analysis on future market growth.
Nucleic acid amplification testing, or NAAT, constitutes a powerful suite of molecular techniques designed to pinpoint specific genetic material, encompassing both DNA and RNA, within a biological specimen. The fundamental principle of these tests lies in their capacity to amplify even trace amounts of target nucleic acids to detectable levels. This amplification is essential for achieving the high sensitivity required for early and accurate diagnosis, particularly when dealing with pathogens present in low concentrations or identifying subtle genetic variations that might otherwise go unnoticed. The precision and sensitivity offered by NAAT have established it as a cornerstone in modern diagnostics, playing a pivotal role in clinical decision-making across a spectrum of medical disciplines.
The persistent threat of infectious diseases, including the emergence of novel pathogens and the resurgence of existing ones, necessitates the widespread adoption of sensitive diagnostic tools such as NAAT for effective disease management and containment. Furthermore, the increasing prevalence of genetic disorders and the expanding application of molecular diagnostics in oncology are significant drivers for the market demand trends of NAAT. Ongoing advancements in molecular technologies, leading to the development of more rapid, user-friendly, and cost-effective NAAT platforms, are also broadening their applicability and accessibility, further contributing to the development of these crucial diagnostic assays.
Nucleic Acid Amplification Testing Market Report Highlights:
By type, the polymerase chain reaction (PCR) tests segment held the largest share globally in 2024 due to their high specificity, sensitivity, and broad applicability across various diagnostic areas. Isothermal nucleic acid amplification technology (INAAT) tests are anticipated to exhibit the highest growth rate during the forecast period, driven by the increasing demand for rapid and point-of-care testing solutions.
By application, the infectious disease testing segment constituted the largest application segment in 2024, fueled by the widespread use of NAAT for diagnosing and monitoring a wide array of infectious agents. Oncology testing is expected to be the fastest-growing application segment, driven by the increasing adoption of molecular diagnostics in cancer management and personalized medicine approaches.
By end use, the central and reference laboratories segment accounted for the largest share of the nucleic acid amplification testing market in 2023, attributed to the high volume of tests processed in these facilities and their role as key hubs for specialized testing. The hospitals segment is projected to demonstrate the highest growth rate, driven by the increasing integration of advanced molecular diagnostics within hospital settings for rapid and improved patient care.
By region, North America held the largest share of the market in 2024. The Asia Pacific nucleic acid amplification testing market is projected to record the highest growth rate during the forecast period.
A few of the major players actively operating in the market are F. Hoffmann-La Roche AG; Abbott Laboratories; Thermo Fisher Scientific Inc.; QIAGEN N.V.; bioMérieux S.A.; Becton, Dickinson and Company (BD); Siemens Healthineers AG; Danaher Corporation (Cepheid); Hologic, Inc.; Agilent Technologies, Inc.; and Illumina, Inc.
Polaris Market Research has segmented the nucleic acid amplification testing market report on the basis of type, application, end use, and region:
By Type Outlook (Revenue – USD Billion, 2020–2034)
PCR Tests
INAAT Tests
LCR Tests
By Application Outlook (Revenue – USD Billion, 2020–2034)
Infectious Disease Testing
Oncology Testing
Genetic & Mitochondrial Disease Testing
Others
By End Use Outlook (Revenue – USD Billion, 2020–2034)
Hospitals
Central
Reference Laboratories
Others
By Regional Outlook (Revenue – USD Billion, 2020–2034)
North America
US
Canada
Mexico
Europe
Germany
France
UK
Italy
Spain
Netherlands
Russia
Rest of Europe
Asia Pacific
China
Japan
India
Malaysia
South Korea
Indonesia
Australia
Vietnam
Rest of Asia Pacific
Middle East & Africa
Saudi Arabia
UAE
Israel
South Africa
Rest of Middle East & Africa
Latin America
Brazil
Argentina
Rest of Latin America
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Regional analysis
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Industry outlook
Competitive landscape
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- 1. Introduction
- 1.1. Report Description
- 1.1.1. Objectives of the Study
- 1.1.2. Market Scope
- 1.1.3. Assumptions
- 1.2. Stakeholders
- 2. Executive Summary
- 2.1. Market Highlights
- 3. Research Methodology
- 3.1. Overview
- 3.1.1. Data Mining
- 3.2. Data Sources
- 3.2.1. Primary Sources
- 3.2.2. Secondary Sources
- 4. North America Gaucher Disease Treatment Market Insights
- 4.1. Gaucher Disease Treatment Market – Market Snapshot
- 4.2. Gaucher Disease Treatment Market Dynamics
- 4.2.1. Drivers and Opportunities
- 4.2.1.1. Rising Prevalence of Rare Disease
- 4.2.1.2. Supportive Government Policies
- 4.2.2. Restraints and Challenges
- 4.2.2.1. High Initial Cost of Manufacturing
- 4.3. Porter’s Five Forces Analysis
- 4.3.1. Bargaining Power of Suppliers (Moderate)
- 4.3.2. Threats of New Entrants: (Low)
- 4.3.3. Bargaining Power of Buyers (Moderate)
- 4.3.4. Threat of Substitute (Moderate)
- 4.3.5. Rivalry among existing firms (High)
- 4.4. PESTEL Analysis
- 4.5. Gaucher Disease Treatment Market Trends
- 4.6. Value Chain Analysis
- 5. North America Gaucher Disease Treatment Market, by Type
- 5.1. Key Findings
- 5.2. Introduction
- 5.2.1. North America Gaucher Disease Treatment Market, by Type, 2020-2034 (USD million)
- 5.3. Type 1
- 5.3.1. North America Gaucher Disease Treatment Market, by Type 1, by Region, 2020-2034 (USD million)
- 5.4. Type 3
- 5.4.1. North America Gaucher Disease Treatment Market, by Type 3, by Region, 2020-2034 (USD million)
- 5.5. Type 2
- 5.5.1. North America Gaucher Disease Treatment Market, by Type 2, by Region, 2020-2034 (USD million)
- 6. North America Gaucher Disease Treatment Market, by Therapy
- 6.1. Key Findings
- 6.2. Introduction
- 6.2.1. North America Gaucher Disease Treatment Market, by Therapy, 2020-2034 (USD million)
- 6.3. Enzyme Replacement Therapy (ERT)
- 6.3.1. North America Gaucher Disease Treatment Market, by Enzyme Replacement Therapy (ERT), by Region, 2020-2034 (USD million)
- 6.4. Substrate Reduction Therapy (SRT)
- 6.4.1. North America Gaucher Disease Treatment Market, by Substrate Reduction Therapy (SRT), by Region, 2020-2034 (USD million)
- 6.5. Others
- 6.5.1. North America Gaucher Disease Treatment Market, by Others, by Region, 2020-2034 (USD million)
- 7. North America Gaucher Disease Treatment Market, by Distribution Channel
- 7.1. Key Findings
- 7.2. Introduction
- 7.2.1. North America Gaucher Disease Treatment Market, by Distribution Channel, 2020-2034 (USD million)
- 7.3. Hospital Pharmacies
- 7.3.1. North America Gaucher Disease Treatment Market, by Hospital Pharmacies, by Region, 2020-2034 (USD million)
- 7.4. Retail Pharmacies
- 7.4.1. North America Gaucher Disease Treatment Market, by Retail Pharmacies, by Region, 2020-2034 (USD million)
- 7.5. Online Pharmacies
- 7.5.1. North America Gaucher Disease Treatment Market, by Online Pharmacies, by Region, 2020-2034 (USD million)
- 8. North America Gaucher Disease Treatment Market, by Geography
- 8.1. Key Findings
- 8.2. Introduction
- 8.2.1. Gaucher Disease Treatment Market Assessment, By Geography, 2020-2034 (USD million)
- 8.3. Gaucher Disease Treatment Market – US
- 8.3.1. US: Gaucher Disease Treatment Market, by Type, 2020-2034 (USD million)
- 8.3.2. US: Gaucher Disease Treatment Market, by Therapy, 2020-2034 (USD million)
- 8.3.3. US: Gaucher Disease Treatment Market, by Distribution Channel, 2020-2034 (USD million)
- 8.3.4. Gaucher Disease Treatment Market – CANADA
- 8.3.4.1. CANADA: Gaucher Disease Treatment Market, by Type, 2020-2034 (USD million)
- 8.3.4.2. CANADA: Gaucher Disease Treatment Market, by Therapy, 2020-2034 (USD million)
- 8.3.4.3. CANADA: Gaucher Disease Treatment Market, by Distribution Channel, 2020-2034 (USD million)
- 9. Competitive Landscape
- 9.1. Expansion and Acquisition Analysis
- 9.1.1. Expansion
- 9.1.2. Acquisitions
- 9.2. Partnerships/Collaborations/Agreements/Exhibitions
- 10. Company Profiles
- 10.1. Amicus Therapeutics, Inc.
- 10.1.1. Company Overview
- 10.1.2. Financial Performance
- 10.1.3. Product Benchmarking
- 10.1.4. Recent Development
- 10.2. CANbridge Life Sciences Ltd.
- 10.2.1. Company Overview
- 10.2.2. Financial Performance
- 10.2.3. Product Benchmarking
- 10.2.4. Recent Development
- 10.3. Eli Lilly and Company
- 10.3.1. Company Overview
- 10.3.2. Financial Performance
- 10.3.3. Product Benchmarking
- 10.3.4. Recent Development
- 10.4. Johnson & Johnson, Inc.
- 10.4.1. Company Overview
- 10.4.2. Financial Performance
- 10.4.3. Product Benchmarking
- 10.4.4. Recent Development
- 10.5. Lingyi Biotechnology
- 10.5.1. Company Overview
- 10.5.2. Financial Performance
- 10.5.3. Product Benchmarking
- 10.5.4. Recent Development
- 10.6. Protalix Biotherapeutics Inc.
- 10.6.1. Company Overview
- 10.6.2. Financial Performance
- 10.6.3. Product Benchmarking
- 10.6.4. Recent Development
- 10.7. Sanofi
- 10.7.1. Company Overview
- 10.7.2. Financial Performance
- 10.7.3. Product Benchmarking
- 10.7.4. Recent Development
- 10.8. Spur Therapeutics
- 10.8.1. Company Overview
- 10.8.2. Financial Performance
- 10.8.3. Product Benchmarking
- 10.8.4. Recent Development
- 10.9. Takeda Pharmaceutical
- 10.9.1. Company Overview
- 10.9.2. Financial Performance
- 10.9.3. Product Benchmarking
- 10.9.4. Recent Development
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