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

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

Segmentation analysis

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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