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Isothermal Nucleic Acid Amplification Technology (INAAT) Global Market Report 2022

Isothermal Nucleic Acid Amplification Technology (INAAT) Global Market Report 2022

  • February 2022
  • 175 pages
  • ID: 6229166
  • Format: PDF
  • The Business Research Company


Table of Contents

Major players in the market are Alere, Biomeriux, Qiagen, Becton, Dickinson & Company, Hologica, Lucigen, Quidel Corporation, New England Biolabs, Nugen, Ustar Biotechnologies, Thermo Fisher Scientific, BioHelix, Meridian Bioscience, New England Biolabs Inc., Novartis Diagnostics, Sharp Corp, Sony Corp, Panasonic, Toshiba Corp, Rohm, PhilipsHologic-Gen-Probe, BetaLED, Avago technologies and Grifols.

The global isothermal nucleic acid amplification technology (INAAT) market is expected to grow from $2.91 billion in 2021 to $3.20 billion in 2022 at a compound annual growth rate (CAGR) of 10.1%. The growth is mainly due to the companies resuming their operations and adapting to the new normal while recovering from the COVID-19 impact, which had earlier led to restrictive containment measures involving social distancing, remote working, and the closure of commercial activities that resulted in operational challenges. The market is expected to reach $4.76 billion in 2026 at a CAGR of 10.4%.

The isothermal nucleic acid amplification technology (INAAT) market consists of sales of isothermal nucleic acid amplification technologies and related services.The services include only installation and maintenance services offered by equipment manufacturers.

Isothermal nucleic acid amplification technologies are used to amplify DNA sequence from two different nucleic acids segments at the constant temperature.

The main product types of isothermal nucleic acid amplification technology are instrument and reagent.A reagent is a material or compound that is added to a system to produce a chemical reaction or to determine whether or not a reaction occurred.

The various technology used are NASBA, and HAD that are applied for blood screening, infectious disease diagnostics, and cancer. The various end users include hospital, reference laboratories, and others.

The incidence of infectious diseases such as H. influenzae, S. pneumonia (respiratory tract infections), N. gonorrhoeae, C. trachomatis (genital infections), and TB are increasing and require isothermal nucleic acid amplification technology (INAAT) to diagnose them. For instance, according to World Health Organization 17 million people lose their lives to infectious diseases every year. Another report by Centers for Disease Control show that number of diseases from mosquitoes, ticks and fleas like West Nile, Zika, Malaria and Lyme disease increased three times. Similarly, as per a survey done by NCBI, around 50% of the population in the United States (approx. 157 million) was suffering from at least one chronic disease in 2020. Increase in infectious or chronic disease drives the demand for diagnosing through isothermal nucleic acid amplification technology.

The market for isothermal nucleic acid amplification technology is strictly regulated by stringent regulatory policies that govern the functioning, approvals and standards set for the manufacturers of this market.These regulations discourage companies to invest in new products for research and development or enter new markets.

For example, the administration of US food and drugs (USFDA) requires multi-laboratory validation of a loop-mediating isothermal amplification which takes twice as much time as the Commission for European regulatory to review the process. Long regulatory procedures delay the scope for further study of the safety and efficacy of devices and affects the operating cycle of the vendors thereby adversely affecting the growth of the market.

Nanostructures are being incorporated to in vitro diagnostics and in vitro rapid diagnostic tests (RDT) in order to improve existing tests and make them more effective or create innovative diagnostic test approaches that are incorporated in point?of?care applications.Nanostructures/nanotechnology uses nanoparticles to enhance the action of the drug in treatment and nanotechnology is the design, characterization, production, and application of devices, structures and systems by controlled manipulation of size and shape at the nanometer scale.

For instance, a range of RDTs have been developed to diagnose syphilis such as AccuBioTech (Accu-Tell Rapid Syphilis Test), Alere, Inc. (Alere Determine), Alere/Standard Diagnostics (SD Syphilis 3.0), The Tulip Group/Qualpro (Syphicheck - WB), Cypress Diagnostics (Syphilis Rapid Test), and Omega Diagnostics (Visitect Syphilis). These RDTs allow patients to be diagnosed at the point-of-care (POC).

The isothermal nucleic acid amplification technology market is regulated by government agencies such as European Medicines Agency (EMA), USFDA (the US food and drug ministration), and others.For instance, according to USFDA, each medical device is classified into three groups which is class 1, class 2 & class 3.

Class 1 devices require less regulatory control and class 3 requires the most.However, devices which are not been marketed before as in the case of INAAT devices, will fall under class 3 devices as per the medical device amendment.

Such devices require approval of a Pre-Market Application (PMA) under the federal law. Premarket approval (PMA) is the scientific and regulatory review process of the FDA to assess the safety and efficacy of medical devices of Class 3.

In July 2021, Sapphiros, a KKR-backed platform focused on developing the next generation of diagnostic technologies acquired Biocrucible Ltd for an undisclosed amount.With this acquisition, Sapphiros aimed to develop market-leading consumer molecular diagnostics.

Biocrucible Ltd, a biotechnology company based in the UK, is a pioneer in the acceleration and augmentation of biochemical kinetics through the use of their Molten TagsTM technology.

The regions covered in this report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.

The countries covered in the market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK and USA.

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