Dallas, TX (PRWEB) December 31, 2013
Plasma is a key raw material of the blood product industry. In August 2011, China shut down 16 plasma stations in Guizhou, resulting in a decrease of 15% in the plasma volume of the year. However, due to the implementation of favorable policies, widening gap between supply and demand, rising product prices and other factors, more than 150 plasma stations in China produced about 3,600 tons of plasma in 2012, up 14.2% year on year. From 2012 to mid-2013, new plasma stations of some Chinese enterprises have started plasma collection or obtained plasma collection permits, such as Yuechi plasma station of Jiangxi Boya Bio-Pharmaceutical, Changyuan plasma station of Hualan Bio, and Caoxian plasma station of China Biologic Products. It's expected that China's plasma supply tension will be further eased after 2013.
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According to the lot release statistics of National Institutes for Food and Drug Control, in the first ten months of 2012, China's total lot release volume of blood products was about 36.13 million bottles, an increase of 7.1% compared with the full year of 2011. In addition, except human coagulation factor VIII with a decreased lot release volume, other products saw growing release volume. In particular, human immunoglobulin, tetanus immunoglobulin, human fibrinogen, imported human serum albumin witnessed higher growth rates of 321%, 95%, 79%, 45% respectively in the first ten months of 2012. However, Chinese blood product enterprises have weak R&D capability, low plasma utilization and fewer product varieties. The domestic market is still dominated by technically undemanding human serum albumin and human immunoglobulin (ph4) for intravenous injection, which accounted for more than 60% of the lot release volume in 2012.
In order to ease the domestic shortage of blood products, China has allowed the import of human serum albumin and recombinant coagulation factor VIII in recent years. Human serum albumin imports have grown rapidly due to low prices. The lot release volume was 8.51 million bottles in the first ten months of 2012, occupying 47.5% of the lot release volume of such products (43.3% in 2011); Behring, Baxter, Instituto Grifols and Octapharma were top four companies by lot release volume. However, due to high prices and national policy restrictions, the import of recombinant coagulation factor VIII is very small, only Bayer and Baxter products were allowed to be imported as of the end of 2012.
China Blood Product Industry Report, 2012-2015 covers the followings:
As of the end of 2012, there were about 30 enterprises passing GMP certification and in normal operation, among them, only Hualan Bio, Tiantan Biological Products (including Chengdu Ronsen), Shanghai RAAS, Yuanda Shuyang Pharmaceutical, China Biologic Products have an annual plasma volume of over 300 tons. In 2012, the five enterprises accounted for 56.1% of China's total plasma volume, and about 30% of China's blood product market revenue.
Guangdong Shuanglin Bio-pharmacy, the sixth place holder, had nine plasma stations (three under construction) in 2012, with a plasma volume of about 247 tons and blood product revenue of RMB 431 million. The company has held the largest lot release volume of rabies immunoglobulin in recent years. Jiangxi Boya, though occupying a small market share (1.8% in 2012 by sales), has seven plasma stations, with output and sales volume expected to be further enhanced in the future.
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