In vitro diagnostics (IVD) are tests done on the blood sample or tissue sample that have been taken from the human body. IVD can be used to monitor a person's overall health to help cure, treat, or prevent diseases. In vitro diagnostics are utilized to diagnose a wide range of medical disorders, such as cardiac disease, infectious disease, cancer, diabetes, autoimmune diseases, nephrology, and HIV/AIDS. In vitro diagnostic raw materials used to determine the status of a person's health. IVD products are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.
The Global IVD Raw Materials Market is estimated to account for US$ 25,618.5 Mn in terms of value by the end of 2022.
The outbreak of COVID-19 across the globe is expected to augment the growth of the global IVD raw materials market over the forecast period. COVID-19 pandemic turned the spotlight on in vitro diagnostics since there is an increasing demand for IVD kits and reagents for the rapid and accurate diagnosis of COVID-19. In October 2021, Takara Bio Europe announced the launch of an in vitro diagnostic assay for the qualitative detection of novel coronavirus from patients suspected of having COVID-19, based on real-time reverse transcriptase PCR (RT-qPCR). This CE-IVD kit complies with the Directive 98/79/EC on in vitro medical devices and is available for immediate distribution in selected countries.
Subsequent growth in the prevalence of chronic diseases and infectious diseases worldwide is expected to offer significant growth opportunities for players in the global IVD raw materials market. Chronic diseases are the leading causes of disability and death among the elderly across the world. The main types of non-communicable diseases (NCDs) are cardiovascular diseases, cancers, diabetes, and chronic respiratory diseases. Cardiovascular diseases account for most NCD deaths. According to World Health Organization (WHO), NCDs kill around 41 million people each year; 71% of all deaths worldwide.
Stringent rules/regulations regarding product approvals, variations in IVD reagents, and lower penetration of IVD devices are some major factors expected to hamper the growth of the global IVD raw materials market. For instance, the FDA classifies medical devices, including IVD products, into Class I, II, or III according to the level of regulatory control that is necessary to reasonably assure safety and effectiveness. CE Marking is required for all IVD devices sold in Europe. CE Marking indicates that an IVD device complies with the European IVD Devices Directive (IVDD 98/79/EC) and that the device may be legally commercialized in the EU.
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Global IVD Raw Materials Market- Impact of Coronavirus (Covid-19) Pandemic:
The outbreak of COVID-19 has had a positive impact on the growth of the market, as in vitro diagnostics involve the testing of various biological samples. This is expected to help in the diagnosis of infectious diseases such as COVID-19. According to the article published in April 2021, titled ' the impact of COVID-19 on the In vitro Diagnostic Industry', in vitro diagnostics tests conducted on samples from the human body, have been indispensable tools in combating COVID-19. Moreover, players in the market are focusing on launching diagnostic kits for the diagnosis of COVID-19 (SARS-CoV2 virus).
For instance, in May 2021, Defense Research and Development Organization (DRDO), India developed a COVID-19 antibody detection kit that offers result in just 75 minutes.
The global IVD raw materials market was valued at US$ 24,340.0 Mn in 2021 and is forecast to reach a value of US$ 35,895.2 Mn by 2028 at a CAGR of 5.8% between 2022 and 2028.
Among product, antibodies and antigens segment held dominant position in the global IVD raw materials market in 2022, accounting for 36.4% share in terms of value, increasing approval and launch of new products is expected to propel growth of the segment during the forecast period.
Major players operating in the global IVD raw materials market include
Aalto Bio Reagents, Fapon Biotech, Fujirebio, Merck KgaA, F. Hoffmann-La Roche, and Thermo Fisher Scientific, among others.
In October 2021, Carlyle (NASDAQ: CG) announced that Carlyle Beijing Partners Fund II has led the Series A financing for BiOligo, a Chinese IVD raw material supplier.
In July 2018, Creative Diagnostics announced the launch of varieties of IVD raw materials to the global marketplace for life science applications. Featured products such as DENV antigens of 4 distinct serotypes, Lp-PLA2 monoclonal antibody pair, & tumor markers are all available.