Global sales volume of medical technology (including medical apparatus and instruments, diagnostic products) will reach USD 440 billion with a growth rate of 4.4% by 2018. IVD industry holds the largest market share among all subdivided industries. It is estimated that the market share of IVD industry will reach USD 54.5 billion, accounting for 12.4% of the whole market. China’s IVD market will grow 10% in 5 years and its size will exceed USD 10 billion. However, imported instruments and reagents account for over 50% of domestic IVD market. As market demand for hospital accounts for over 90% of the total IVD demands, IVD industry will benefit from the increasing hospital visits and examination charges per capita. It is estimated that the growth rate will maintain between 16%-18%, a higher level.
At present, there are 1,199 IVD reagent producers in China. Producers of larger scale are as follows, Kehua Bio-engineering, DAAN Gene, Strong Biotechnologies, Leadman Biochemistry, Shenzhen Mindray, Sichuan Maker, Biosino Bio-technology, Fosun Long March, etc., among which Kehua Bio-engineering, DAAN Gene, Leadman Biochemistry, EPNK, etc. are the public companies.
Development Trend of IVD Reagent Technology
- Biochemical Diagnosis
Emphasis will be put on improving stability of the previous examination products and developing new examination projects brought by technological progress. The trend of substituting imported biochemical diagnostic reagents with domestic ones will be further strengthened in the future.
Chemiluminescent reagents have high technical requirements, which will be the main technology of IVD reagents in the future. At present, China depends on imported chemiluminescent reagents, therefore it is an inevitable trend that China will research and develop chemiluminescent products to replace the imported ones.
- Upstream Raw Materials
At present, China still mostly depends on imported upstream raw materials. From the long run, China must master the preparation techniques of raw materials.
In 2016, the annual consumption per capita of China’s in-vitro diagnostic products was less than USD 3, while that of developed countries reached USD 25 to USD 30.