The global isothermal nucleic acid amplification technology (INAAT) market is expected to register a CAGR of 10.5%, during the forecast period, (2018-2023). North America dominates the market, due to technological advancement and growing awareness regarding INAAT technique among end-user in the region.
Miniaturization of biochemical reactions leads to major advantages, where a lower amount of valuable clinical sample and reagents is just one: approximately 1/1000 of the volume used in conventional lab setups has been shown to obtain a similar result. A smaller heat capacity allows for rapid changes in temperature beneficial for the PCR time, as well as a higher parallelism of multiple genetic samples. The benefit of isothermal amplification methods compared to PCR is the constant temperature of amplification. This will result in a high potential for a simple integration in point-of-care devices and a reduction of complexity. With increasing demand of low cost and effective solutions for diagnosis of diseases and increasing demand for point of care applications, these devices are going to witness growth in the future. Also in case of laboratories the sample size required is very small which also helps in reducing the amount of reagents required. Also, the upsurge in the molecular diagnostics market, increasing incidences of chronic diseases and aging population, and increase in the adoption of INAAT over PCR are driving the market growth.
In the expanding market for medical devices and therapies, there are stringent regulatory policies in place to ensure the safety of such drugs and devices. These policies are well studied. However, while rigorous regulatory procedures guarantee the quality of the product entering the market, they delay the entry of a drug or device into the market, which could be beneficial to all patients suffering from a disease. Pre-market approval is an FDA process of scientific and regulatory review to evaluate the safety and effectiveness of drugs and devices. There have been procedures by the FDA to heighten the post-market surveillance. The FDA review process takes twice as much as time as European regulatory commissions review bodies. Hence, citizens from countries where the review process is shorter benefit more than countries with longer review processes and stringent regulations. The presence of stringent regulations is dampening the innovation in the market and hindering the growth of this market. Strict regulatory policies have resulted in a reduction of investment by drug companies in R&D of new products. Also the lack of awareness in new diagnostics technologies may induce users to stick to conventional methods, although this can be addressed with effective marketing
North America dominates the Isothermal Nucleic Acid Amplification Technology (INAAT) market, owing to high incidence of chronic diseases, technological advancement in isothermal nucleic acid amplification technology (INAAT), and increasing adoption of INAAT over conventional techniques in the region. Asia Pacific is expected to grow during the forecast period, owing to factors, such as high demand in cost effective and diagnostics, less stringent regulatory scenario, and presence of huge population base.
Major Players: Alere, Becton, Dickinson & Company, Biomeriux, Hologica, Lucigen, Quidel Corporation, New England Biolabs, Nugen, Qiagen, Ustar Biotechnologies, among others.
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