Amid the unsafe domestic vaccine events, China’s human vaccine lot release volume in 2015 fell by 17.9% year on year to only 650 million doses,touching a 5-year low. Moreover, with the improvements in domestic vaccine supply capacity and vaccine circulation safety, China’s human vaccine import volume has showed a year-by-year decline in recent years, with the imports for 2015 totaling 173.9 tons, down 17.5% year on year.
Affected by China’s less-developed economy, existing national vaccine prevention policies and people’s awareness of epidemic prevention, free EPI vaccines prevail in China. But the market share is falling, with the free EPI vaccine lot release volume in 2015 accounting for about 74.3% of the total. The Chinese free human vaccine market is still dominated by the subsidiaries of China National Biotec Group—including Beijing Tiantan Biological Products, Chengdu Institute of Biological Products Co., Ltd., Shanghai Institute of Biological Products Co., Ltd., Lanzhou Institute of Biological Products Co., Ltd., Wuhan Institute of Biological Products Co., Ltd., and Changchun Institute of Biological Products Co., Ltd.—and state-owned enterprises like Institute of Medical Biology under Chinese Academy of Medical Sciences. In 2015, the EPI vaccine lot release volume of Chinese state-owned enterprises made up 72.6% of the total.
However, as China gradually relaxes controls on the vaccine market, private companies have unexpectedly emerged in extra EPI vaccine market segment in recent years, with the proportion increasing constantly. In 2015, their lot release volume accounted for 70% in this market segment. Furthermore, these enterprises hold a dominant position in haemophilus influenza B (Hib), human rabies vaccine, varicella vaccine, influenza vaccine, and other market segments.
Being upbeat about China’s human vaccine demand market and exports, many vaccine producers are stepping up vaccine R&D or expanding capacity.
So far, there are four enterprises in China, namely Walvax Biotechnology, Beijing Minhai Biotechnology, SINOVAC BIOTECH, and Lanzhou Institute of Biological Products, whose 13-valent pneumococcal conjugate vaccine (PCV13) have entered clinical research stage; recombinant HPV vaccines, developed by Shanghai Zerun Biotechnology, a subsidiary of Walvax Biotechnology, and Xiamen Innovax Biotech, have entered phase III clinical research phase.
In 2015, CFDA approved the production and registration application of the world's first inactivated Sabin strain polio vaccine, which was developed by the Institute of Medical Biology of the Academy of Medical Sciences. The vaccine was brought to market on June 30, 2015. Over the same year, the inactivated enterovirus 71 (EV71) vaccines (for hand-foot-mouth disease prevention), also developed by the Institute of Medical Biology of the Academy of Medical Sciences was made available after the approval from CFDA; SINOVAC BIOTECH and Wuhan Institute of Biological Products are applying for drug production license of inactivated enterovirus 71 (EV71) vaccines; Hualan Bio and Beijing ZhifeiLvzhu Biopharmaceutical (a subsidiary of Chongqing Zhifei Biological Products) have submitted the application of clinic trial of inactivated enterovirus 71 (EV71) vaccines.
China Human Vaccine Industry Report, 2016-2020 highlights the following: Operating environment, overall situation, sales channel, etc. of China human vaccine industry; Supply & demand, competitive landscape, import & export, and development forecast of the Chinese human vaccine market; Supply & demand, competitive landscape, and market prices of 10 vaccine product segments in China, including hepatitis B vaccine, influenza vaccine, rabies vaccine, and pneumococcal vaccine; Operation, vaccine business, and development prospects of 16 Chinese human vaccine companies.
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