After years of development, global in vitro diagnostics has become a sunrise industry with a huge market capacity of tens of billions of dollars. The in vitro diagnostic industry is an emerging industry in China. Compared with European and American countries, the industrialization development is relatively lagging behind. The size of the in vitro diagnostic market is closely related to a country's population base, per capita medical expenditure, medical security level, medical technology and service level. Due to China's large population base and high economic growth rate, medical insurance investment and per capita medical consumption expenditure have continued to grow in recent years, which has led to the continuous growth of in vitro diagnostic market demand. The market for in vitro diagnostics is extremely promising.
I. Industry Overview Instruments and test strip reagents in the field of in vitro diagnostics refer to products that obtain clinical diagnostic information by testing human blood, secretions and other samples outside the human body. Compared with traditional medical devices, they are generally digital and The characteristics of computerization are the high-tech crystallization of many industries, with certain technical content and entry threshold. According to the "Medical Device Classification Catalogue" of the State Drug Administration, in vitro diagnostic products belong to the category of clinical testing and analysis instruments, and belong to modern high-tech medical devices. The main function is to provide basic clinical test data for medical diagnosis. When applying in vitro diagnostic reagents for testing, it is generally necessary to use corresponding testing instruments. Therefore, reagents and instruments together constitute an in vitro diagnostic system. Enterprises engaged in the research, development, production and sales of these in vitro diagnostic reagents and instruments form an in vitro diagnostic industry, which will be internationally They are collectively referred to as the IVD (In-Vitro Diagnostics) industry.
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