[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.
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., bioM?rieux 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
- Americas
The report offers valuable insights on the following aspects:
- Market Penetration: It presents comprehensive information on the market provided by key players.
- Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.
- Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.
- 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.
- Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.
The report addresses key questions such as:
- What is the market size and forecast of the Isothermal Nucleic Acid Amplification Technology Market?
- Which products, segments, applications, and areas should one consider investing in over the forecast period in the Isothermal Nucleic Acid Amplification Technology Market?
- What are the technology trends and regulatory frameworks in the Isothermal Nucleic Acid Amplification Technology Market?
- What is the market share of the leading vendors in the Isothermal Nucleic Acid Amplification Technology Market?
- Which modes and strategic moves are suitable for entering the Isothermal Nucleic Acid Amplification Technology Market?
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