earticle

영어

The in vitro diagnostic reagents have become increasingly important for rapid diagnosis since the pandemic of the novel coronavirus (COVID-19). However, development status analysis based on Ministry of Food and Drug Safety approval information is insufficient. In this study, we analyze the domestic in vitro diagnostic (IVD) reagents based on all the approval information for pathogen diagnostics, classified the product group that require national research and development promotion. In addition, we provide the reference information for domestic IVD companies to develop and invest in new products. Through the approval information, it was organized and an based on imported and domestic products, single target and complex target , diagnostic methods, target pathogens, etc., and shows changes in the number of in vitro diagnostic product approvals for each infectious disease. From the results of this analysis, IVD-related domestic companies can improve their international competitiveness by innovating products based on new technologies and expanding investment in diagnostic products for novel infectious diseases. In addition, by identifying the approval information of diagnostic products targeting pathogens such as fungi, protozoa, Nematoda, and flatworms that are underdeveloped by domestic companies due to economic reasons or competition with giants foreign companies. It is possible to provide information on diagnostic products that require expanded development support at the national level and improve public health by increasing self-sufficiency of in vitro diagnostic reagents.