China’s blood product industry demonstrated a good prospect in 2016. The National Institute for Control of Pharmaceutical Biological Products inspected more than 4000 lots of blood products in total, equivalent to approximately 59 million bottles, which exhibited an upward trend. The present Chinese market is dominated by domestic products, with imported products occupying less than 5% of market shares. The lack of raw materials has an impact on the blood products. In particular, the demand volume of human serum albumin is 50% higher than the supply volume, contributing to a high demand for import human serum albumin.
Generally, the safety status of blood products remains stable. Quality problems seldom occur after strict regulations were issued in the industry. From the perspective of lot releases, only 2 lots of imported human serum albumin did not meet the prescriptions in 2016. The differences in lots of relevant manufacturers are relatively controllable.
There are 12 varieties of blood products in the present Chinese market, referring to freeze-dried intravenous human immunoglobulin (pH4), freeze-dried intravenous hepatitis B human immunoglobulin (pH4), intravenous human immunoglobulin (pH4), intravenous hepatitis B human immunoglobulin (pH4), human rabies immunoglobulin, tetanus human immunoglobulin, human immunoglobulin, human prothrombin complex, human blood coagulation factor VIII, human fibrinogen, human serum albumin and hepatitis B human immunoglobulin.
in 2016, there were 26 in 28 domestic blood product manufacturers operating in normal production and there were 12 import enterprises. Xinjiang Deyuan Bioengineering Co., Ltd. could not produce normally for not obtaining a GMP certificate. Harbin Pacific Bio-pharmaceutical Co., Ltd. has not operated in normal production until now because its GMP certificate was confiscated in the middle of 2016. The total number of plasma stations operating normally is 218, with an annual plasma volume reaching 6,212 tons.
According to CRI, China will become one of the major global blood product markets as its economy develops. Chinese government imposes strict regulations on production, sales and import of blood products.
In 2015, 8,000 tons of blood plasma was needed to meet the demand of Chinese market, and the actual supply was only 5,000 tons.