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The global nucleic acid amplification testing market attained a value of about USD 5.52 billion in 2023. The market is further expected to grow in the forecast period of 2024-2032 at a CAGR of 8.87% to reach nearly USD 11.21 billion by 2032. The growth is driven by the expansion of diagnostic applications in oncology and genetic testing across the globe.
Nucleic acid amplification testing is a molecular diagnostic technique used to detect DNA or RNA in a sample from the human body leading to accurate diagnoses of diseases. The sample may include blood, urine, or tissue. Nucleic acid amplification is highly sensitive and precise. It is a vital component of sample preparation, used for testing viruses or pathogens in patient samples making it a fundamental element in healthcare. It pinpoints the disease from diagnosis, leading to an effective treatment process.
Nucleic acid amplification testing is used to diagnose many ailments, including malaria, HIV/AIDS, TB, COVID-19, STDs, and respiratory tract infections (RTIs). Techniques like PCR are commonly used in diagnosis, making it possible to see the target nucleic acid even in tiny amounts. It also improves the accuracy of diagnosis.
Rising Prevalence of HIV Cases Drive the Market Growth
The market for nucleic acid amplification testing is expected to witness growth, owing to the increasing cases of human immunodeficiency virus (HIV) across the globe. Nucleic acid amplification testing is used to screen for RNA or DNA strands. The strands are specific to the human immunodeficiency virus, which attacks immune cells. Most people get HIV involuntarily, through contact with the affected person's body fluids. It can also get transmitted through sexual contact or by using contaminated syringes. The World Health Organization (WHO) reports that around 39 million people worldwide had HIV. Awareness and use by sexually active people have driven historical growth. The availability of NAAT kits has enhanced market development recently.
COVID-19 Outbreak Elevated the Nucleic Acid Amplification Testing Market Demand Significantly
COVID-19 caused a significant hike in nucleic acid amplification testing worldwide. The sudden outbreak created a high demand for instant and accurate tests along with high-throughput testing. This led to a surge in nucleic acid amplification procedures, including PCR tests. These changes have made NAAT technology more available and credible. They applications are expected to grow beyond the pandemic as well, driven by the emphasis on infectious disease presentation and pandemic preparedness.
Advancements in Genetic Testing Likely to Boost the Market Growth
Nucleic acid amplification testing (NAAT) techniques are expanding into genetic testing as well. It offers precise, faster, and more efficient. This has led to improvements in the diagnosis of genetic ailments. Early detection of genetic diseases can lead to precise treatment, shaped on a patient’s genes. Modern genetic testing is also being conducted for multiple purposes. It can include prenatal diagnosis, which is exclusively tailored for inherited conditions during fetal development. Pharmacogenomics, which selects proper medications for patients based on their genetics is also employing nucleic acid amplification testing (NAAT) techniques. This is mainly because of the growing need for such genetic analysis. The increasing use of such technologies is projected to boost the market value in coming years. Moreover, surge in investments, fundings and infrastructure enhancements to promote medical research and development is expected to become a major catalyst in the market growth in coming years.
Key Trends | Impact |
Development of Innovative Products | The NAAT market is witnessing constant innovation with manufacturers making new and better technologies. These include portable devices for point of care (POC) testing, with multiple benefits such as portability and high sensitivity to detect almost all diseases. These innovations are crucial as they address the rising need for better and more precise diagnostic solutions. This need has been much stressed in recent years, especially due to COVID-19. |
Geographic Expansion Strategies | Manufacturers are constantly expanding their product portfolios into new markets, intended to gain more customers and provide solutions to consumers in underserved areas. It is generally done by forming relationships with domestic distributors, setting up regional branches, and expanding their global network to raise revenues. |
Focus on Customer Needs | Emphasis on customer needs is amongst key trends in the nucleic acid research market. Manufacturing companies are engaged in careful market analysis to identify niches and seek customer opinions so as to improve their products. Such market surveys can help in development of specific to the needs of patients battling rare diseases. |
Expanding Applications | Nucleic acid amplification is finding its applications in multiple domains, including critical areas such as cancer diagnostics. This is due to earmarked developments in molecular diagnostics. It allows the spotting of gene mutations and biomarkers, relating to different types of cancer. It also helps in targeting treatment and assessing its efficacy for each patient. With broadening applications in oncology, NAAT is boosting the adoption of precision medicine in several countries. |
In March 2023, Bio-Rad iQ-Check Real-Time PCR Kits received AOAC INTERNATIONAL and AFNOR approval. Designed to be used in combination with the CFX Opus Deepwell Real-Time PCR System, it enhances the product’s ability to find pathogens and its DNA. The CFX Opus Deepwell System integrates new real-time PCR technology and is designed for operational excellence in healthcare facilities. Being more compatible with iQ-Check kits, Bio-Rad can increase test use, boosting the outlook for in-vitro diagnostics sigificantly.
In May 2022, Meridian Bioscience, Inc., expanded its isothermal amplification product line by adding two new master mixes, namely, Lyo-Ready Direct DNA LAMP Saliva Mix and Lyo-Ready Direct RNA/DNA LAMP Saliva Mix. Both products use isothermal amplification. Meridian’s new master mixes refine the sensitivity and selectivity, helping in the detection of nucleic acids in saliva. With sudden COVID-19 outbreak, the demand for this technology has risen, especially in point-of-care molecular diagnosis. These methods have several merits, such as giving faster results.
In Sept 2022 - Mylab Discovery Solutions introduced the PathoDetect HPV detection tests to ascertain high-risk HPV strains in patients. This test recommended by the regulatory authorities, isolated two HPV types, which are linked to most cervical cancer types. Based on diagnostic technology that detects and differentiates high-risk HPV strains with high sensitivity and specificity in clinical samples, this test led to early detection of high-risk human papilloma virus (HPV) types.
Market Breakup by Technique
Market Breakup by Application
Market Breakup by End User
Market Breakup by Region
Market Segmentation Based on Technique Poised for Growth
The market segmentation based on technique, includes polymerase chain reaction (PCR), transcription-mediated amplification (YMA), loop-mediated isothermal amplification (LAMP), nucleic acid sequence-based amplification (NASBA), and others. Among this polymerase chain reaction (PCR) is leading the market. This is due to innovations in molecular diagnostics. It has exceptional sensitivity and specificity in finding DNA and RNA, leading to more accurate results. It speeds up workflows and enables fast disease identification.
Market Breakdown by Applications Set to Drive Nucleic Acid Amplification Testing Market Growth
The market report also offers an insight into market breakup based on applications. It is segmented into infectious diseases, cancer, genetic testing, blood screening, and others. Among these applications, the infectious diseases segment is expected to dominate the market in the forecast period. This market value is mainly spurred by the urgent need to identify infectious agents in real-time, especially after the COVID-19 pandemic. With NAAT’s sensitivity and specificity, it is quite effective in diagnosing many infections, including new viruses like HIV and hepatitis and other unknown diseases. Cancer diagnosis is another major segment, likely to hold a significant market value in coming years. Nucleic acid amplification testing can help in finding genetic mutations and relevant biomarkers. These are crucial for early diagnosis and care plans. Another key segment is genetic testing with many applications, including prenatal testing and finding inherited diseases. Blood screening segment also demands NAAT application as it detects pathogens precisely in the blood stream.
Market Breakup by End Users to Boost Market Growth
The market segmentation based on end users includes hospitals, diagnostic laboratories, research institutes as well as pharmaceutical and biotechnology companies. Diagnostic laboratories are projected to hold a substantial market share in the forecast period. It plays a critical role in conducting many genetic tests and use advanced NAAT technologies. Research institutes also hold a significant market value, driven by high application of nucleic acid amplification testing technology in studies, drug development, genetic research, and pharmacogenomics.
North America, Europe, Asia Pacific, Latin America, the Middle East, and Africa are included in the regional market analysis. Among these, North America is expected to lead the market share in the forecast period. With a well-developed healthcare infrastructure, the region has elaborate labs and great diagnostic services. This infrastructure the adoption of superior technologies, resulting in aggressive research on technology innovations. Also, the increasing incidence of diseases like AIDS, hepatitis, and COVID-19 have increased the need for early and accurate detection methods, promoting market growth for NAATs. The presence of regulatory agencies, such as the Food and Drug Administration (FDA), ensure the quality of products and equipment. It plays a favourable role to bring new and innovative devices to the market.
Europe also has a substantial market value, driven by the presence of an effective healthcare system which promotes the use of advanced tests to identify diseases. Also, the presence of several research institutes and biotech companies in Europe offers a fertile ground for boosting the use of diagnostic technologies in the region.
Asia Pacific is likely to witness significant growth in the forecast period, driven by high demand for NAAT in the region. The demand is especially high in the Chinese and Indian markets, as these countries are meticulously investing into their healthcare systems. Rising incidence of infections, along with the growing understanding of the need for timely infection detection also adds to the high nucleic acid amplification testing market demand.
Latin America, the Middle East, and Africa are identified to have small market share. Growing spending on medical equipment and diagnostic centres is helping market growth. NAAT is witnessing high demand to improve public health and control the spread of diseases like HIV, tuberculosis, and malaria.
The key features of the market report include strategic initiatives including partnerships, and collaborations analysis by the leading key players. The major companies in the market are as follows:
Centre Testing International Group Co., Ltd.
Found in 2003, and based in Shenzhen, the company provides testing, inspection, and certification services for many industries. It emphasizes on guaranteeing quality and compliance.
SYNGENE INTERNATIONAL LIMITED
It is a global contract research organization based in Bangalore, India. It was founded in 1993 and provides a range of services in drug discovery and development. Syngene’s niche is offering more evidence on services for pharmaceutical organizations, while focusing on research and production.
NCIMB Ltd.
NCIMB was established in 1982, and is based in Aberdeen, Scotland. The organization offers services in microbial identification, preservation, and consulting. The products span across multiple domains including environmental, industrial, and healthcare.
Apollo Global Management, Inc.
Apollo Global Management was established in 1990 and is headquartered in New York. Apollo invests in many sectors of the economy, including health and technology. The technology sector owns stakes in firms that develop NAAT technologies through their investments.
Other companies in the market include Vitality Urgent Care and Max Lab Limited.
Kindly note that this only represents a partial list of companies, and the complete list has been provided in the report.
REPORT FEATURES | DETAILS |
Base Year | 2023 |
Historical Period | 2017-2023 |
Forecast Period | 2024-2032 |
Scope of the Report |
Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:
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Breakup by Technique |
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Breakup by Application |
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Breakup by End User |
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Breakup by Region |
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Market Dynamics |
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Supplier Landscape |
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Companies Covered |
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*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.
1 Preface
1.1 Objectives of the Study
1.2 Key Assumptions
1.3 Report Coverage – Key Segmentation and Scope
1.4 Research Methodology
2 Executive Summary
3 Global Nucleic Acid Amplification Testing Market Overview
3.1 Global Nucleic Acid Amplification Testing Market Historical Value (2017-2023)
3.2 Global Nucleic Acid Amplification Testing Market Forecast Value (2024-2032)
4 Vendor Positioning Analysis
4.1 Key Vendors
4.2 Prospective Leaders
4.3 Niche Leaders
4.4 Disruptors
5 Global Nucleic Acid Amplification Testing Market Landscape*
5.1 Global Urinalysis: Developers Landscape
5.1.1 Analysis by Year of Establishment
5.1.2 Analysis by Company Size
5.1.3 Analysis by Region
5.2 Global Urinalysis: Product Landscape
5.2.1 Analysis by Technique
6 Global Nucleic Acid Amplification Testing Market Dynamics
6.1 Market Drivers and Constraints
6.2 SWOT Analysis
6.2.1 Strengths
6.2.2 Weaknesses
6.2.3 Opportunities
6.2.4 Threats
6.3 PESTEL Analysis
6.3.1 Political
6.3.2 Environmental
6.3.3 Social
6.3.4 Technological
6.3.5 Ethical
6.3.6 Legal
6.4 Porter’s Five Forces Model
6.4.1 Bargaining Power of Suppliers
6.4.2 Bargaining Power of Buyers
6.4.3 Threat of New Entrants
6.4.4 Threat of Substitutes
6.4.5 Degree of Rivalry
6.5 Key Demand Indicators
6.6 Key Price Indicators
6.7 Industry Events, Initiatives, and Trends
6.8 Value Chain Analysis
7 Global Nucleic Acid Amplification Testing Market Segmentation (2017-2032)
7.1 Global Nucleic Acid Amplification Testing Market (2017-2032) by Technique
7.1.1 Market Overview
7.1.2 Polymerase Chain Reaction (PCR)
7.1.3 Transcription-Mediated Amplification (TMA)
7.1.4 Loop-Mediated Isothermal Amplification (LAMP)
7.1.5 Nucleic Acid Sequence-Based Amplification (NASBA)
7.1.6 Others
7.2 Global Nucleic Acid Amplification Testing Market (2017-2032) by Application
7.2.1 Market Overview
7.2.2 Infectious Disease Diagnosis
7.2.3 Cancer Diseases
7.2.4 Genetic Testing
7.2.5 Blood Screening
7.2.6 Others
7.3 Global Nucleic Acid Amplification Testing Market (2017-2032) by End User
7.3.1 Market Overview
7.3.2 Hospitals
7.3.3 Diagnostic Laboratories
7.3.4 Research Institutes
7.3.5 Pharmaceutical and Biotechnology Companies
7.4 Global Nucleic Acid Amplification Testing Market (2017-2032) by Region
7.4.1 Market Overview
7.4.2 North America
7.4.3 Europe
7.4.4 Asia Pacific
7.4.5 Latin America
7.4.6 Middle East and Africa
8 North America Nucleic Acid Amplification Testing Market (2017-2032)
8.1 North America Nucleic Acid Amplification Testing Market (2017-2032) by Technique
8.1.1 Market Overview
8.1.2 Polymerase Chain Reaction (PCR)
8.1.3 Transcription-Mediated Amplification (TMA)
8.1.4 Loop-Mediated Isothermal Amplification (LAMP)
8.1.5 Nucleic Acid Sequence-Based Amplification (NASBA)
8.1.6 Others
8.2 North America Nucleic Acid Amplification Testing Market (2017-2032) by Application
8.2.1 Market Overview
8.2.2 Infectious Disease Diagnosis
8.2.3 Cancer Diseases
8.2.4 Genetic Testing
8.2.5 Blood Screening
8.2.6 Others
8.3 North America Nucleic Acid Amplification Testing Market (2017-2032) by End User
8.3.1 Market Overview
8.3.2 Hospitals
8.3.3 Diagnostic Laboratories
8.3.4 Research Institutes
8.3.5 Pharmaceutical and Biotechnology Companies
8.4 North America Nucleic Acid Amplification Testing Market (2017-2032) by Country
8.4.1 United States of America
8.4.2 Canada
9 Europe Nucleic Acid Amplification Testing Market (2017-2032)
9.1 Europe Nucleic Acid Amplification Testing Market (2017-2032) by Technique
9.1.1 Market Overview
9.1.2 Polymerase Chain Reaction (PCR)
9.1.3 Transcription-Mediated Amplification (TMA)
9.1.4 Loop-Mediated Isothermal Amplification (LAMP)
9.1.5 Nucleic Acid Sequence-Based Amplification (NASBA)
9.1.6 Others
9.2 Europe Nucleic Acid Amplification Testing Market (2017-2032) by Application
9.2.1 Market Overview
9.2.2 Infectious Disease Diagnosis
9.2.3 Cancer Diseases
9.2.4 Genetic Testing
9.2.5 Blood Screening
9.2.6 Others
9.3 Europe Nucleic Acid Amplification Testing Market (2017-2032) by End User
9.3.1 Market Overview
9.3.2 Hospitals
9.3.3 Diagnostic Laboratories
9.3.4 Research Institutes
9.3.5 Pharmaceutical and Biotechnology Companies
9.4 Europe Nucleic Acid Amplification Testing Market (2017-2032) by Country
9.4.1 United Kingdom
9.4.2 Germany
9.4.3 France
9.4.4 Italy
9.4.5 Others
10 Asia Pacific Nucleic Acid Amplification Testing Market (2017-2032)
10.1 Asia Pacific Nucleic Acid Amplification Testing Market (2017-2032) by Technique
10.1.1 Market Overview
10.1.2 Polymerase Chain Reaction (PCR)
10.1.3 Transcription-Mediated Amplification (TMA)
10.1.4 Loop-Mediated Isothermal Amplification (LAMP)
10.1.5 Nucleic Acid Sequence-Based Amplification (NASBA)
10.1.6 Others
10.2 Asia Pacific Nucleic Acid Amplification Testing Market (2017-2032) by Application
10.2.1 Market Overview
10.2.2 Infectious Disease Diagnosis
10.2.3 Cancer Diseases
10.2.4 Genetic Testing
10.2.5 Blood Screening
10.2.6 Others
10.3 Asia Pacific Nucleic Acid Amplification Testing Market (2017-2032) by End User
10.3.1 Market Overview
10.3.2 Hospitals
10.3.3 Diagnostic Laboratories
10.3.4 Research Institutes
10.3.5 Pharmaceutical and Biotechnology Companies
10.4 Asia Pacific Nucleic Acid Amplification Testing Market (2017-2032) by Country
10.4.1 China
10.4.2 Japan
10.4.3 India
10.4.4 ASEAN
10.4.5 Australia
10.4.6 Others
11 Latin America Nucleic Acid Amplification Testing Market (2017-2032
11.1 Latin America Nucleic Acid Amplification Testing Market (2017-2032) by Technique
11.1.1 Market Overview
11.1.2 Polymerase Chain Reaction (PCR)
11.1.3 Transcription-Mediated Amplification (TMA)
11.1.4 Loop-Mediated Isothermal Amplification (LAMP)
11.1.5 Nucleic Acid Sequence-Based Amplification (NASBA)
11.1.6 Others
11.2 Latin America Nucleic Acid Amplification Testing Market (2017-2032) by Application
11.2.1 Market Overview
11.2.2 Infectious Disease Diagnosis
11.2.3 Cancer Diseases
11.2.4 Genetic Testing
11.2.5 Blood Screening
11.2.6 Others
11.3 Latin America Nucleic Acid Amplification Testing Market (2017-2032) by End User
11.3.1 Market Overview
11.3.2 Hospitals
11.3.3 Diagnostic Laboratories
11.3.4 Research Institutes
11.3.5 Pharmaceutical and Biotechnology Companies
11.4 Latin America Nucleic Acid Amplification Testing Market (2017-2032) by Country
11.4.1 Brazil
11.4.2 Argentina
11.4.3 Mexico
11.4.4 Others
12 Middle East and Africa Nucleic Acid Amplification Testing Market (2017-2032)
12.1 Middle East and Africa Nucleic Acid Amplification Testing Market (2017-2032) by Technique
12.1.1 Market Overview
12.1.2 Polymerase Chain Reaction (PCR)
12.1.3 Transcription-Mediated Amplification (TMA)
12.1.4 Loop-Mediated Isothermal Amplification (LAMP)
12.1.5 Nucleic Acid Sequence-Based Amplification (NASBA)
12.1.6 Others
12.2 Middle East and Africa Nucleic Acid Amplification Testing Market (2017-2032) by Application
12.2.1 Market Overview
12.2.2 Infectious Disease Diagnosis
12.2.3 Cancer Diseases
12.2.4 Genetic Testing
12.2.5 Blood Screening
12.2.6 Others
12.3 Middle East and Africa Nucleic Acid Amplification Testing Market (2017-2032) by End User
12.3.1 Market Overview
12.3.2 Hospitals
12.3.3 Diagnostic Laboratories
12.3.4 Research Institutes
12.3.5 Pharmaceutical and Biotechnology Companies
12.4 Middle East and Africa Nucleic Acid Amplification Testing Market (2017-2032) by Country
12.4.1 Saudi Arabia
12.4.2 United Arab Emirates
12.4.3 Nigeria
12.4.4 South Africa
12.4.5 Others
13 Regulatory Framework
13.1 Regulatory Overview
13.2 US FDA
13.3 EU EMA
13.4 INDIA CDSCO
13.5 JAPAN PMDA
13.6 Others
14 Strategic Initiatives
14.1 Analysis by Partnership Instances
14.2 Analysis by Type of Partnership and Collaborations
14.3 Analysis by Joint Ventures
14.4 Analysis by Leading Players
14.5 Analysis by Geography
15 Supplier Landscape
15.1 Market Share Analysis, By Region (Top 5 Companies)
15.1.1 Market Share Analysis: Global
15.1.2 Market Share Analysis: North America
15.1.3 Market Share Analysis: Europe
15.1.4 Market Share Analysis: Asia-Pacific
15.1.5 Market Share Analysis: Others
15.2 Centre Testing International Group Co., Ltd .
15.2.1 Financial Analysis
15.2.2 Product Portfolio
15.2.3 Demographic Reach and Achievements
15.2.4 Mergers and Acquisitions
15.2.5 Certifications
15.3 SYNGENE INTERNATIONAL LIMITED
15.3.1 Financial Analysis
15.3.2 Product Portfolio
15.3.3 Demographic Reach and Achievements
15.3.4 Mergers and Acquisitions
15.3.5 Certifications
15.4 NCIMB Ltd .
15.4.1 Financial Analysis
15.4.2 Product Portfolio
15.4.3 Demographic Reach and Achievements
15.4.4 Mergers and Acquisitions
15.4.5 Certifications
15.5 Apollo Global Management, Inc .
15.5.1 Financial Analysis
15.5.2 Product Portfolio
15.5.3 Demographic Reach and Achievements
15.5.4 Mergers and Acquisitions
15.5.5 Certifications
15.6 Vitality Urgent Care
15.6.1 Financial Analysis
15.6.2 Product Portfolio
15.6.3 Demographic Reach and Achievements
15.6.4 Mergers and Acquisitions
15.6.5 Certifications
15.7 Max Lab Limited
15.7.1 Financial Analysis
15.7.2 Product Portfolio
15.7.3 Demographic Reach and Achievements
15.7.4 Mergers and Acquisitions
15.7.5 Certifications
16 Global Nucleic Acid Amplification Testing Market – Distribution Model (Additional Insight)
16.1 Overview
16.2 Potential Distributors
16.3 Key Parameters for Distribution Partner Assessment
17 Key Opinion Leaders (KOL) Insights (Additional Insight)
*Additional insights provided are customisable as per client requirements.
* The coverage of the Market Landscape section depends on the data availability and may cover a minimum of 80% of the total market. The EMR team strives to make this section as comprehensive as possible.
**The supplier list is not exhaustive. Moreover, we can provide analysis of companies as per custom requests.
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