Isothermal Nucleic Acid Amplification Technology (INAAT) Market - By Technology (Loop-mediated Isothermal Amplification (LAMP), Strand Displacement Amplification (SDA), Helicase-dependent Amplification (HDA)), By Product, By Application, By End-use & Forecast, 2022-2028

Isothermal Nucleic Acid Amplification Technology Market Size

Isothermal Nucleic Acid Amplification Technology Market size surpassed USD 1.3 billion in 2021 and is expected to witness an 11.8% CAGR from 2022 to 2028 due to technological developments, surging ageing population, and foreign financing for R&D. Additionally, rising demand for point-of-care (PoC) testing and growing demand for quick diagnostics will add to market expansion.
 

COVID-19 pandemic positively impacted isothermal nucleic acid amplification technology (INAAT) market. Since INAAT offers simple operation, rapid detection, and accurate results. As a result, it becomes more ideal for primary testing centers in urban as well as rural areas. INAAT is in high demand since PCR-based nucleic acid detection technology is time-consuming and requires specialist equipment.
 

Moreover, it is difficult to work with PCR in primary-level medical institutions. Antibody-based detection has limitations because of the late appearance of antibodies, that makes early diagnosis of virus difficult, whereas antigen-based detection has low sensitivity, that often result a high false-negative rate.
 

Isothermal nucleic acid amplification technology (INAAT) methods allow for the rapid, exponential detection of a nucleic acid target sequence. This process is not limited by the constraint of thermal cycling. Isothermal amplification, when integrated into microsystems or portable devices, improves nucleic acid-based on-site diagnostics and increases sensitivity. In addition, using different enzymatic approaches to separate the two DNA strands prior to replication, INAAT can achieve amplification in 15-16 minutes.
 

Isothermal Nucleic Acid Amplification Technology Market Trends

The growing incidence of infectious diseases across the globe is anticipated to drive the market expansion considerably throughout the forecast timeframe. Rise in number of infectious diseases such as influenza, HIV, tuberculosis, etc. has increased the demand for better diagnostic and treatment approaches in healthcare facilities.
 

According to the WHO report 2021, a total of 1.5 million people died in 2020 due to tuberculosis. Globally, tuberculosis is the 13^th leading cause of death and the second leading infectious killer after COVID-19 (above HIV/AIDS). Moreover, in 2020, nearly 10 million people got infected with tuberculosis worldwide. Out of which 5.6 million were men, 3.3 million women and 1.1 million were children. Tuberculosis is present in all countries and age groups.
 

The conventional option to diagnose such diseases is PCR. However, with advancements in INAAT, the diagnosis can be performed quickly and in cost-effective manner. Thus, the demand of diagnostics for these diseases has surged the need for INAAT solutions. Hence, the increasing prevalence of chronic diseases has stimulated demand for INAAT diagnostic services, thereby fueling overall isothermal nucleic acid amplification technology market growth.
 

Isothermal Nucleic Acid Amplification Technology Market Analysis

Based on technology, the isothermal nucleic acid amplification technology market is categorized into Loop-mediated Isothermal Amplification (LAMP), Strand Displacement Amplification (SDA), Nucleic Acid Sequence-based Amplification (NASBA), Helicase-dependent Amplification (HDA) and others. The loop-mediated isothermal amplification (LAMP) segment accounted for around 47% market share in 2021. As loop-mediated isothermal amplification (LAMP) test is most widely used approach for amplification of DNA, RNA, and identification of genetically modified organisms.
 

Additionally, compared to PCR technology, this approach has important competitive advantages over the PCR test. The LAMP test is resistant to PCR inhibitors, making it ideal for direct sample analysis. Also, the test it is done at a constant temperature, there is no need for a thermocycler.
 

By product, the isothermal nucleic acid amplification technology market is bifurcated into instruments and reagents. Out of these, reagents segment accounted for around USD 950 million revenue size in 2021. The increasing number of diagnostic tests for infectious diseases has opened new growth opportunities.
 

Accessibility to different reagents, increased approvals of CLIA-waived tests, the continuous launch of faster, newer, and more reliable POC solutions, and rising infectious disease prevalence are also serving as important elements fueling growth avenues in the next years. Similarly, the expanding use of regents in assay development, fundamental research, and treatments, as well as repeated reagent purchases, will boost growth prospects in the forthcoming years.
 

Based on application, the industry is categorized into infectious disease, oncology, blood screening and others. Infectious disease is further divided into HIV, influenza, malaria, and tuberculosis.  The blood screening segment is projected to witness over 12% CAGR through 2022 to 2028. Blood screening test help to understand overall blood health, metabolism, liver function, mineral levels, and various other biomarkers according to the specific tests.
 

Blood screening is done for various conditions such as cancer and other infections. Different technologies are used in the blood screening such as next generation sequencing, western blot assay, enzyme-linked immunosorbent assay, nucleic acid test and others. People prefer blood screening as it provides a comprehensive data of their current state of health. It can catch potential health problems in the early stages when they can be managed most effectively. Furthermore, companies are launching several blood screenings kits for diagnosis. Such scenarios contribute towards the isothermal nucleic acid amplification technology market progression.
 

Based on end-use, the isothermal nucleic acid amplification technology (INAAT) market is divided into hospitals, diagnostic laboratories, and others. The hospital segment accounted for over USD 628 million in 2021. Hospitals are well equipped with fully automated INAAT instruments that offer quick test results as compared to laboratories.
 

Besides this, the most complex and sensitive diagnostic procedures are performed in hospitals by the skilled staff to minimize the chances of error. Furthermore, with rapid growing healthcare industry, the number of hospitals has also increased thereby fueling its isothermal nucleic acid amplification technology market growth. Owing to these factors, the demand for INAAT test in hospitals is higher than the other end-use segments.
 

North America isothermal nucleic acid amplification technology (INAAT) industry captured over 43% market share in 2021 and is poised to grow substantially during the forthcoming years. The regional growth is attributed to advances in isothermal nucleic acid amplification technology (INAAT) and a growing preference in the region for INAAT testing over traditional diagnostic procedures.
 

Surging prevalence of chronic diseases in the region will also positively influence the market expansion. For instance, according to the Centers for Disease Control and Prevention (CDC) report, in the U.S. in 2018, 1,708,921 new cancer cases were reported and 599,265 people died of cancer. For every 100,000 people, 436 new cancer cases were reported and 149 people died of cancer. In addition, the increasing number of new products launches as well as the high penetration of key market competitors in North America, are further driving the market.
 

Isothermal Nucleic Acid Amplification Technology Market Share

Some of the key market players operating in the isothermal nucleic acid amplification technology (INAAT) industry include

• BD
• Abbott (Alere)
• BioMerieux SA
• Eiken Chemical Co. Ltd
• Hologic Inc. (Gen-Probe)
• Lucigen
• Meridian Bioscience, Inc.
• OptiGene Limited
• Qiagen NV
• Quidel Corporation
• Grifols
• S.A.
• Tecan Genomics Inc.
• Thermo Fisher Scientific Inc.
• Ustar Biotechnologies Ltd.

These industry participants are implementing various growth strategies with continued innovations and technology improvements to sustain in the isothermal nucleic acid amplification technology market.
 

Some of the recent industry developments:

• In March 2022, Thermo Fisher Scientific has launched two new reverse transcription loop-mediated isothermal amplification (RT-LAMP)-based solutions. This isothermal RT-LAMP nucleic-acid-based amplification provides a rapid and low-cost option for viral pathogen detection. Such product launches will help company in widening its product portfolio, thereby propelling its market growth.
   
• In March 2020, Abbott announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for the fastest available molecular point-of-care test for the detection of novel coronavirus (COVID-19), delivering positive results in as little as five minutes and negative results in 13 minutes. The test runs on the company's ID NOW platform, providing rapid results in a wide range of healthcare settings such as physicians' offices, urgent care clinics and hospital emergency departments. This launch has helped to improve the company’s product portfolio and escalate its market position.
   

The isothermal nucleic acid amplification technology (INAAT) market report includes in-depth coverage of the industry with estimates & forecast in terms of revenue in USD from 2022 to 2028, for the following segments:

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By Technology

• Loop-mediated Isothermal Amplification (LAMP)
• Strand Displacement Amplification (SDA)
• Nucleic Acid Sequence-based Amplification (NASBA)
• Helicase-dependent Amplification (HDA)
• Others

By Product

• Instruments
• Reagents

By Application

• Infectious Disease 
  • HIV
  • Influenza
  • Malaria
  • Tuberculosis
• Oncology
• Blood Screening
• Others

By End-use

• Hospitals
• Diagnostic Laboratories
• Others

The above information is provided for the following regions and countries:

By Region

• North America 
  • U.S.
  • Canada
• Europe 
  • Germany
  • UK
  • France
  • Spain
  • Italy
• Asia Pacific 
  • Japan
  • China
  • India
  • Australia
• Latin America 
  • Brazil
  • Mexico
• Middle East & Africa 
  • Saudi Arabia
  • South Africa