In-vitro diagnostics is a diagnostic method through detecting samples (blood, body fluid, tissues, etc.) taken out from human bodies so as to judge diseases and organism functions. In most cases, the detection system composed of detection instruments and reagents are applied in in-vitro diagnostics.
In-vitro diagnostic reagents are used to carry out in-vitro detection on human samples. In Chinese market, there are mainly three categories including biochemical diagnostic reagents, immune diagnostic reagents and molecule diagnostic reagents.
The global in-vitro diagnostic market is mature and the concentration rate is high. Top 5 manufacturers of global in-vitro diagnostic industry are Roche, Siemens, JNJ, Abbott and Beckman with an aggregate market share of over 60% in the globe as monopolies. The market size of in-vitro diagnostics is closely related to the population base, medical treatment expenses per capita, medical care level and medical technology together with service levels of a country. At present, the demand market of global in-vitro diagnostics is mainly distributed in developed economies such as North America, Europe and Japan.
Meanwhile, emerging economies such as China, India and Brazil are increasing in medical care investment and medical treatment expenses per capita in recent years with large population base and high economic growth rate, leading to the pull for in-vitro diagnostic market demand.
The history of China in-vitro diagnostic industry is less than 40 years with a high growth rate, which is shorter than that of developed countries. The market size of China in-vitro diagnostic reagents reached about CNY 26 billion (USD 3.9 billion) in 2016, of which the leading three were immune, biochemical and molecular products. In terms of industry regulatory policies, laws and regulations together with industry policies concerning China in-vitro diagnostic industry are gradually consistent with international conventions. CFDA started to implement strict supervision on the IVD industry from 2014. A series of policies were issued to supervise various links including R&D, production, registration, clinics, circulation and sales, and large-scale shuffle was carried out on the IVD industry through strict industry access and operation requirements.
In China, major consumption demand for in-vitro diagnostic reagents derives from medical testing and blood screening. Medical testing is the major consumer of in-vitro diagnostic reagents including hospital clinical laboratory, physical examination center, independent laboratory and epidemic prevention station. Meanwhile, blood screening is mainly applied in blood collection and supply departments including various blood stations and blood product manufacturers. Presently, hospitals are major demand markets of in-vitro diagnostic reagents in China.
Before 2003, medium and high-end diagnostic products in China were monopolized by imports, but the improvement of domestic manufacturers' production levels of detection reagents leads to the significant transfer of market pattern. In the primary market, the share of domestic reagents is increasing rapidly, while foreign enterprises still dominate the instrument market. Currently, Chinese domestic enterprises are gradually expanding from diagnostic reagents to instruments and occupying the market with advantages of instrument prices to promote the reagent sales.
According to CRI, China's population accounts for more than 20% of the world, while the market share of in-vitro diagnostics is less than 10%. 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. Therefore, there is a wide increase space for China's in-vitro diagnostic market. It is estimated that from 2017 to 2021, the market scale of China's in-vitro diagnostic market will develop at a growth rate exceeding that of the average global level to about CNY 49 billion with the CAGR of over 10%. Meanwhile, major shares will be occupied by immune and biochemical products, and molecular products will grow with a higher proportion.
Through this report, readers can acquire the following information or even more:
- Status of Global and China In-vitro Diagnostic Reagents
- Governmental Policies Faced by China In-vitro Diagnostic Reagent Industry
- Status of Market Competition in In-vitro Diagnostic Reagent Industry
- Major In-vitro Diagnostic Reagent Manufacturers in Global and China Markets
- Major Driving Forces and Market Opportunities in China In-vitro Diagnostic Reagent Industry
- Risks and Challenges in China In-vitro Diagnostic Reagent Industry
- Prediction on Development of In-vitro Diagnostic Reagent Industry in China, 2017-2021