Key players in the isothermal nucleic acid amplification technology (INAAT) market are Alere, Biomeriux, Qiagen and Becton, Dickinson and Company. Global Isothermal Nucleic Acid Amplification Technology (INAAT) market is expected to grow from $ 2.
New York, September 28, 2021 (GLOBE NEWSWIRE) – Reportlinker.com Announces the Release of Isothermal Nucleic Amplification Technology (INAAT) Global Market Report 2021: COVID-19 Growth And Change To 2030 – https://www.reportlinker.com/p06151577/?utm_source=GNW
$ 36 billion in 2020 to $ 2.62 billion in 2021, assuming a compound annual growth rate (CAGR) of 11%. The growth is mainly due to companies resuming operations and adjusting to the new normal while recovering from the effects of COVID-19 that previously resulted in restrictive containment measures involving social distancing, remote working and the closure of commercial activities had operational challenges. The market is expected to reach $ 4.03 billion in 2025 at a CAGR of 11.4%.
The Isothermal Nucleic Acid Amplification Technology (INAAT) market consists of the sale of isothermal nucleic acid amplification technologies and related services. The services only include installation and maintenance services offered by equipment manufacturers.
Isothermal nucleic acid amplification technologies are used to amplify DNA sequences from two different nucleic acid segments at constant temperature.
The Isothermal Nucleic Acid Amplification Technology (INAAT) Market covered in this report is segmented into Instruments and Reagents by product. It is also divided into hospitals, reference laboratories, etc, according to end users; through technology in NASBA, HAD and through application to blood tests, diagnosis of infectious diseases, cancer.
The regions covered in this report are Asia Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, and Africa.
The isothermal nucleic acid amplification technology market is strictly regulated by strict regulatory guidelines that govern the operation, approvals, and standards for manufacturers in this market. These regulations prevent companies from investing in new products for research and development or from entering new markets.
For example, US Food and Drug Administration (USFDA) requires multiple laboratory validation of loop-mediated isothermal amplification, which takes twice as long as the European regulator’s review of the process by the Commission. Long regulatory proceedings delay the scope for further study of the safety and effectiveness of devices and affect the vendors’ operating cycle, thereby hampering market growth.
Nanostructures are integrated into in-vitro diagnostics and in-vitro rapid diagnostics (RDT) in order to improve existing tests and make them more effective or to create innovative diagnostic test approaches that flow into point-of-care applications. Nanostructures / Nanotechnology uses nanoparticles In order to improve the effectiveness of the drug in treatment and in nanotechnology, the design, characterization, manufacture and application of devices, structures and systems is through controlled manipulation of size and shape in the nanometer range.
For example, a number of RDTs have been developed to diagnose syphilis, such as AccuBioTech (Accu-Tell Rapid Syphilis Test), Alere, Inc. (Alere Define), 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 enable patients to be diagnosed at the point of care (POC).
In 2018, Tecan, a provider of laboratory instruments and solutions, acquired Nugen Technologies for $ 54.5 million. The acquisition helps Tecan expand into a new market segment of next-generation sequencing reagents (NGS). Nugen Technologies is a biotech company founded in 2000. The US-based company, headquartered in California, manufactures molecular biology reagents for next-generation sequencing genome analysis.
Infectious diseases such as H. influenzae, S. pneumonia (respiratory infections), N. gonorrhoeae, C. trachomatis (genital infections), and TB are increasing in incidence and require isothermal nucleic acid amplification technology (INAAT) to diagnose them. For example, according to the World Health Organization (WHO), 17 million people lose their lives every year to infectious diseases. Another report from the Centers for Disease Control shows that the number of diseases caused by mosquitoes, ticks and fleas like West Nile, Zika, malaria and Lyme disease has increased threefold. Similarly, in 2020, about 50% of the population in the United States (approximately 157 million) had at least one chronic illness, according to a survey conducted by NCBI. The increase in infectious or chronic diseases is driving the demand for diagnosis by isothermal nucleic acid amplification technology.
The isothermal nucleic acid amplification technology market is regulated by government agencies such as the European Medicines Agency (EMA), the USFDA, and others. For example, according to the USFDA, every medical device is divided into three groups, which is Class 1, Class 2 & Class 3.
Class 1 devices require fewer regulatory controls and Class 3 requires the most. However, devices that, as in the case of INAAT devices, have not yet been placed on the market are class 3 devices according to the medical device amendment.
Such devices require the approval of a Pre-Market Application (PMA) according to federal law. The Premarket Approval (PMA) is the FDA’s scientific and regulatory review process for evaluating the safety and effectiveness of Class 3 medical devices.
The countries covered in the market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA.
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