In Vitro Diagnostic (IVD) is a product and service that obtains clinical diagnostic information by detecting human samples (various body fluids, cells, tissue samples, etc.) outside the human body to determine disease or body function.

　　In vitro diagnosis is known as “the doctor's eye” in the medical field. It is an important part of modern laboratory medicine. The clinical application runs through the whole process of disease prevention, initial diagnosis, treatment plan selection, and efficacy evaluation.Providing doctors with a large amount of useful clinical diagnostic information,has been becoming an important part of human disease diagnosis and treatment.

　　With the increasing health needs of people, there are higher requirements for disease risk prediction, health management, and chronic disease management. In vitro diagnosis, which is an important means of disease diagnosis, has attracted more and more attention. The market of it is huge, especially in regions and countries where medical levels are underdeveloped.According to "World Preview 2018, Outlook to 2024" released by Evaluate MedTech, the global medical device market sales in 2017 were $405 billion.Among them, the IVD field is still the number one in the medical device segment, with sales reaching US$52.6 billion. It is estimated that sales in 2024 will reach US$79.6 billion, with a compound growth rate of 6.1%.

　　In China, with the deepening of reform and opening up, the living standards are constantly improving, and people's health needs are increasing day by day. In vitro diagnostic has also developed rapidly as an important means of disease diagnosis.According to estimates by the Medical Machinery Research Institute, the size of China's in vitro diagnostic market in 2017 was about 51 billion yuan, an increase of 18.78% year-on-year. It is expected that the market size will reach 60.4 billion yuan in 2018, an increase of 18.43% year-on-year.

　　In vitro diagnostic can be divided into biochemical diagnosis, immunodiagnosis, molecular diagnosis, microbial diagnosis, blood diagnosis, POCT (instant diagnosis) and other sub-divisions according to the different principles and methods. At present, biochemical diagnosis, immunodiagnosis and molecular diagnosis are the main three major areas of in vitro diagnostic.

　　In recent years, China's immunodiagnostic industry has developed rapidly. With the continuous advancement of technology, immunodiagnosis has replaced biochemical diagnosis as the largest market segment in China's in vitro diagnostic market, accounting for 38% of the market;The biochemical diagnostic market is weak, with only 19% market share; molecular diagnostics and POCT are the fastest growing, with market share rising, accounting for 15% and 11% respectively.

　　All along, the upstream raw materials, the mid-stream high-end diagnostic market and the downstream large-scale hospital market are dominated by foreign giants, and the degree of localization is low, especially in the upstream raw materials, which has caused difficulties for domestic enterprises to break through.However, in recent years, with the continuous encouragement of innovation and import substitution policies by the state, domestic leading enterprises have strengthened their industrial chain layout and R&D investment, and have made good progress in the upper, middle and lower reaches.And in many fields to reach the world's leading level, and foreign giants stand up to the court, and therefore, specialization and scale has become the best choice for domestic enterprises to break through, learn from the development experience of foreign markets, the future will also be owned Enterprises in the "industry chain" have won the market.