Isothermal Nucleic Acid Amplification Technology Market by Product, Type, Application, End-User

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[196 Pages Report] The Isothermal Nucleic Acid Amplification Technology Market size was estimated at USD 3.77 billion in 2023 and expected to reach USD 4.25 billion in 2024, at a CAGR 13.64% to reach USD 9.22 billion by 2030.

The usage of isothermal nucleic acid amplification technology is increasing across hospitals and academic & research institutes, which enables the creation of DNA and RNA in the presence of a target molecule at constant temperatures. The isothermal amplification processes have greater efficiency, produce higher amplification yields, and need fewer sample preparation steps than polymerase chain reaction (PCR). This isothermal nucleic acid amplification technology is widely used as a molecular detection technique in blood screening and infectious disease diagnosis owing to its accuracy and ability to detect various molecules. Furthermore, the growing prevalence of antimicrobial and infectious diseases has increased the need to detect antimicrobial resistance genes and various pathogens, including bacteria and viruses. However, a lack of awareness and a stringent regulatory framework for isothermal nucleic acid amplification may limit their use in end-use sectors. The advancement in isothermal nucleic acid amplification techniques and approvals from healthcare regulatory authorities for innovative technologies are expected to create immense opportunities for the market.

KEY MARKET STATISTICS
Base Year [2023]	USD 3.77 billion
Estimated Year [2024]	USD 4.25 billion
Forecast Year [2030]	USD 9.22 billion
CAGR (%)	13.64%

Product: Advancements in isothermal nucleic acid amplification technology systems to scale up their operations and automate their workflows

Assays, kits, and reagents are vital in the isothermal nucleic acid amplification process, providing the necessary biochemical substances for reactions. These products typically include enzymes such as DNA and RNA polymerases that function at a constant temperature, nucleotides for amplification, buffers, and other reagents that ensure the specificity and fidelity of the amplification process. Systems in the context of isothermal nucleic acid amplification refer to the instruments and devices needed to facilitate and monitor the amplification process. These systems are engineered to maintain the constant temperature required for isothermal amplification and often come with features such as real-time monitoring of the amplification process, automated data analysis, and user-friendly interfaces. In comparison, assays, kits, & reagents are often seen as recurring spend with direct application to the technology's end-use, making them integral for routine operations and testing. On the other hand, systems are capital equipment that enables these assays to be performed, offering automation and sophisticated monitoring of the isothermal amplification processes.

Type: Growing preference for transcription-mediated amplification in clinical diagnostics for its rapid and high amplification capacity

Helicase-dependent amplification is easily integrated into simple and low-energy consumption microsystems. It helps to develop single-stranded templates for primer hybridization and subsequent primer extension by a DNA polymerase. Loop-mediated isothermal amplification (LAMP) and nucleic acid amplification testing (NAAT) methods are carried out at a constant temperature with a short reaction time and used to screen and identify a pathogen for diagnosing pathogen-based infections. Moreover, transcription-mediated amplification produces DNA and RNA amplicon from a target nucleic acid and helps detect various diseases, such as HIV-1 and Zika virus. Strand displacement amplification (SDA) is used to amplify nucleic acids, such as DNA and RNA. In comparison, LAMP is often favored for its simplicity and suitability for point-of-care diagnostics. At the same time, other methods, such as HDA and SDA, are selected for their unique advantages. Selection for a specific application is influenced by required sensitivity and specificity, the expertise needed for assay development, and equipment and reagent resources.

Application: Extensive utilization of isothermal nucleic acid amplification technology for disease diagnoses for promoting better patient outcomes

In blood screening, isothermal nucleic acid amplification technology (INAAT) is crucial in detecting pathogenic nucleic acids to ensure the safety of blood transfusions. INAAT provides high sensitivity and specificity, allowing for the rapid identification of bloodborne pathogens in donated blood products. In the context of disease diagnosis, INAAT is leveraged to detect various pathogens promptly and accurately. This technology is utilized across infectious diseases, promoting better patient outcomes through early intervention. INAAT offers rapid and simultaneous detection of sexually transmitted infections such as chlamydia and gonorrhea. INAAT's ability to work directly from clinical samples without complex processing steps significantly enhances its utility in STI screening. Identifying viral hepatitis infections (notably Hepatitis B and C) is essential for managing chronic liver diseases and preventing transmission. INAAT detects low levels of viral genetic material, facilitating early diagnosis and monitoring of viral load, which is integral to treatment decisions, and assessing response to therapy. INAAT is beneficial in early-stage HIV detection, where it may identify the virus before seroconversion. This is particularly important in scenarios such as infant testing, where maternal antibodies can interfere with traditional HIV immunoassays. For respiratory illnesses, such as those caused by influenza viruses, INAAT offers the rapid detection necessary for effective patient management and infection control measures, especially during flu seasons or outbreaks. In comparison, the isothermal nucleic acid amplification technology is widely utilized in disease diagnosis for promoting better patient outcomes through early intervention.

End-User: Significant role of isothermal nucleic acid amplification technology in hospitals for rapid and accurate diagnostics to improve patient care

Academic and research institutes utilize INAAT for basic scientific research, method development, and the study of various diseases at the molecular level. The inherent nature of academic research demands high sensitivity, specificity, and adaptability of the technology, enabling detailed and accurate detection of nucleic acids in research specimens. In the hospital sector, INAAT is utilized for various applications such as infectious disease detection, cancer diagnostics, and genetic disorder screening. Reference laboratories are specialized diagnostic facilities that conduct a wide range of complex tests, often serving as the hubs for high-throughput INAAT applications. They serve other laboratories, hospitals, and clinics, providing sophisticated testing that may not be feasible in smaller settings. In comparison, academic and research institutes focus on flexibility and cost-efficiency for in-depth research, whereas hospitals prioritize rapid diagnostics for immediate patient care. On the other hand, reference laboratories rely on the high throughput and reliability of INAAT to serve various external clients efficiently.

Regional Insights

Americas represents a highly developing landscape for the isothermal nucleic acid amplification technology market characterized by an increasing number of diagnostic procedures across hospitals and academic & research institutes and an increasing introduction of innovative isothermal nucleic acid solutions. The development in healthcare infrastructure and increasing medical tourism in various Asia-Pacific regions, such as India, Thailand, Singapore, Malaysia, and South Korea, are expanding the need for isothermal nucleic acid amplification technology to detect viral diseases. In January 2023, Peking University reported that 900 million individuals had been infected with the coronavirus in China, and has further expected to expand the usage of isothermal nucleic acid amplification for the detection of SARS-CoV-2 RNA in research laboratories and diagnostic centers. Moreover, increasing the prevalence of infectious diseases and government initiatives for improving diagnostic procedures are subsequently expanding the use of isothermal nucleic acid amplification technology in the EMEA region. Additionally, rising approvals from healthcare regulatory authorities for innovative diagnostic technologies are expected to encourage the growth of isothermal nucleic acid amplification technology worldwide.

FPNV Positioning Matrix

The FPNV Positioning Matrix is pivotal in evaluating the Isothermal Nucleic Acid Amplification Technology Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success: Forefront (F), Pathfinder (P), Niche (N), or Vital (V).

Market Share Analysis

The Market Share Analysis is a comprehensive tool that provides an insightful and in-depth examination of the current state of vendors in the Isothermal Nucleic Acid Amplification Technology Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.

Key Company Profiles

The report delves into recent significant developments in the Isothermal Nucleic Acid Amplification Technology Market, highlighting leading vendors and their innovative profiles. These include Abbott Laboratories, AtilaBiosystems, Beijing SBS Genetech Co., Ltd., bioMerieux SA, Biosearch Technologies by LGC Limited, DiaSorin S.p.A., Eiken Chemical Co., Ltd., Fortis Life Sciences, LLC, GENOMTEC S.A., GenoSensor Corporation, Grifols S.A., highQu GmbH, Hologic, Inc., Illumina, Inc., Jena Bioscience GmbH, Life Sciences Advanced Technologies, Inc., Mast Group Ltd., Meridian Bioscience Inc. by SD Biosensor, Inc., New England Biolabs, Inc., OptiGene Limited, PCR Biosystems Ltd., QIAGEN GmbH, Quidel Corporation, Tecan Trading AG, Thermo Fisher Scientific Inc., Ustar Biotechnologies (Hangzhou) Ltd, Xiamen Jiqing Biomedical Technology Co., Ltd., Zhengzhou Laboao Instrument Equipment CO., LTD, and Zhuhai Biori Biotechnology Co., Ltd..

Market Segmentation & Coverage

This research report categorizes the Isothermal Nucleic Acid Amplification Technology Market to forecast the revenues and analyze trends in each of the following sub-markets:

Product
- Assays, Kits, & Reagents
- Systems

Type
- Helicase-dependent Amplification
- Loop-mediated Isothermal Amplification
- Nucleic Acid Sequence-based Amplification
- Strand Displacement Amplification
- Transcription-mediated Amplification

Application
- Blood Screening
- Disease Diagnosis
  - CT/NG
  - Hepatitis
  - HIV
  - Influenza
End-User
- Academic & Research Institutes
- Hospitals
- Reference Laboratories

Region
- Americas
  - Argentina
  - Brazil
  - Canada
  - Mexico
  - United States
    - California
    - Florida
    - Illinois
    - New York
    - Ohio
    - Pennsylvania
    - Texas
- Asia-Pacific
  - Australia
  - China
  - India
  - Indonesia
  - Japan
  - Malaysia
  - Philippines
  - Singapore
  - South Korea
  - Taiwan
  - Thailand
  - Vietnam

Europe, Middle East & Africa
- Denmark
- Egypt
- Finland
- France
- Germany
- Israel
- Italy
- Netherlands
- Nigeria
- Norway
- Poland
- Qatar
- Russia
- Saudi Arabia
- South Africa
- Spain
- Sweden
- Switzerland
- Turkey
- United Arab Emirates
- United Kingdom

The report offers valuable insights on the following aspects:

1. Market Penetration: It presents comprehensive information on the market provided by key players.

2. Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.

3. Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.

4. Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.

5. Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.

The report addresses key questions such as:

1. What is the market size and forecast of the Isothermal Nucleic Acid Amplification Technology Market?

2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Isothermal Nucleic Acid Amplification Technology Market?

3. What are the technology trends and regulatory frameworks in the Isothermal Nucleic Acid Amplification Technology Market?

4. What is the market share of the leading vendors in the Isothermal Nucleic Acid Amplification Technology Market?

5. Which modes and strategic moves are suitable for entering the Isothermal Nucleic Acid Amplification Technology Market?

Product Code: MRR-B9334AD6C2E2

1. Preface

1.1. Objectives of the Study
1.2. Market Segmentation & Coverage
1.3. Years Considered for the Study
1.4. Currency & Pricing
1.5. Language
1.6. Stakeholders

2. Research Methodology

2.1. Define: Research Objective
2.2. Determine: Research Design
2.3. Prepare: Research Instrument
2.4. Collect: Data Source
2.5. Analyze: Data Interpretation
2.6. Formulate: Data Verification
2.7. Publish: Research Report
2.8. Repeat: Report Update

3. Executive Summary

4. Market Overview

5. Market Insights

5.1. Market Dynamics
- 5.1.1. Drivers
  - 5.1.1.1. Rising prevalence of antimicrobial and infectious diseases worldwide
  - 5.1.1.2. Increasing adoption of INAAT for accurate & rapid testing results
  - 5.1.1.3. Development of miniaturized nucleic acid-based diagnostics
- 5.1.2. Restraints
  - 5.1.2.1. High cost of reagents and implementation of technology
- 5.1.3. Opportunities
  - 5.1.3.1. Technological advancements in isothermal nucleic acid amplification
  - 5.1.3.2. Increasing adoption of digital diagnostics and rising demand for point-of-care diagnostics solutions
- 5.1.4. Challenges
  - 5.1.4.1. Limitation of isothermal nucleic acid amplification technology
5.2. Market Segmentation Analysis
- 5.2.1. Product: Advancements in isothermal nucleic acid amplification technology systems to scale up their operations and automate their workflows
- 5.2.2. Type: Growing preference for transcription-mediated amplification in clinical diagnostics for its rapid and high amplification capacity
- 5.2.3. Application: Extensive utilization of isothermal nucleic acid amplification technology for disease diagnoses for promoting better patient outcomes
- 5.2.4. End-User: Significant role of isothermal nucleic acid amplification technology in hospitals for rapid and accurate diagnostics to improve patient care
5.3. Market Disruption Analysis
5.4. Porter's Five Forces Analysis
- 5.4.1. Threat of New Entrants
- 5.4.2. Threat of Substitutes
- 5.4.3. Bargaining Power of Customers
- 5.4.4. Bargaining Power of Suppliers
- 5.4.5. Industry Rivalry
5.5. Value Chain & Critical Path Analysis
5.6. Pricing Analysis
5.7. Technology Analysis
5.8. Patent Analysis
5.9. Trade Analysis
5.10. Regulatory Framework Analysis

6. Isothermal Nucleic Acid Amplification Technology Market, by Product

6.1. Introduction
6.2. Assays, Kits, & Reagents
6.3. Systems

7. Isothermal Nucleic Acid Amplification Technology Market, by Type

7.1. Introduction
7.2. Helicase-dependent Amplification
7.3. Loop-mediated Isothermal Amplification
7.4. Nucleic Acid Sequence-based Amplification
7.5. Strand Displacement Amplification
7.6. Transcription-mediated Amplification

8. Isothermal Nucleic Acid Amplification Technology Market, by Application

8.1. Introduction
8.2. Blood Screening
8.3. Disease Diagnosis

9. Isothermal Nucleic Acid Amplification Technology Market, by End-User

9.1. Introduction
9.2. Academic & Research Institutes
9.3. Hospitals
9.4. Reference Laboratories

10. Americas Isothermal Nucleic Acid Amplification Technology Market

10.1. Introduction
10.2. Argentina
10.3. Brazil
10.4. Canada
10.5. Mexico
10.6. United States

11. Asia-Pacific Isothermal Nucleic Acid Amplification Technology Market

11.1. Introduction
11.2. Australia
11.3. China
11.4. India
11.5. Indonesia
11.6. Japan
11.7. Malaysia
11.8. Philippines
11.9. Singapore
11.10. South Korea
11.11. Taiwan
11.12. Thailand
11.13. Vietnam

12. Europe, Middle East & Africa Isothermal Nucleic Acid Amplification Technology Market

12.1. Introduction
12.2. Denmark
12.3. Egypt
12.4. Finland
12.5. France
12.6. Germany
12.7. Israel
12.8. Italy
12.9. Netherlands
12.10. Nigeria
12.11. Norway
12.12. Poland
12.13. Qatar
12.14. Russia
12.15. Saudi Arabia
12.16. South Africa
12.17. Spain
12.18. Sweden
12.19. Switzerland
12.20. Turkey
12.21. United Arab Emirates
12.22. United Kingdom

13. Competitive Landscape

13.1. Market Share Analysis, 2023
13.2. FPNV Positioning Matrix, 2023
13.3. Competitive Scenario Analysis
- 13.3.1. Polish biotech Genomtec raises EUR 2.9 million (USD 3.19 million) from share issue
- 13.3.2. Stilla Technologies and Atila BioSystems to Co-Develop High-Plex Digital PCR Kits for Oncology
- 13.3.3. Sherlock Biosciences Acquires Sense Biodetection to Commercialize Disposable CRISPR-Based Diagnostics
- 13.3.4. Sherlock Biosciences and Tolo Biotech Expand Collaboration to Advance Development and Adoption of CRISPR-based Diagnostics
- 13.3.5. Ankur Capital invests in molecular diagnostic startup D-NOME
- 13.3.6. WeTrade and Jiqing Biomedical partner to sell monkeypox tests
- 13.3.7. Recombinase Polymerase Amplification, or RPA, is the breakthrough, isothermal replacement to PCR
- 13.3.8. Mawi iSWAB Microbiome-EL Enables Prime Discoveries' Development of Rapid Extraction-Less COVID Diagnostic Assay
- 13.3.9. Thermo Fisher introduces two RT-LAMP tests to detect viral pathogens
- 13.3.10. Medix Biochemica Acquires German MDx Raw Materials Producer MyPols Biotec
13.4. Strategy Analysis & Recommendation

14. Competitive Portfolio

14.1. Key Company Profiles
14.2. Key Product Portfolio