China has been the world’s biggest producer and consumer of human vaccines over four decades of planned vaccination, a program that has reduced incidence of multiple vaccine-targeted infectious diseases to the lowest level.
Following the vaccine scandal of Changsheng Bio-technology Co., Ltd. in 2018, the Vaccine Administration Law of the People’s Republic of China was enacted at the Eleventh Meeting of the Standing Committee of the 13th National People’s Congress on June 29th, 2019. The Law which is due to take effect on December 1, 2019, will be a boon for better regulation on the whole vaccine market and sound development of the vaccine industry.
The National Institutes for Food and Drug Control approved supply of 276.6 million doses (37 kinds of vaccines) to the market from January to July 2019. Thereof, China National Biotech Group (including 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., Changchun Institute of Biological Products Co., Ltd. and Changchun Keygen Biological Products Co., Ltd.) boasted the largest lot release volume, or 43.4% of the total, staying far ahead of others as the bellwether in the Chinese vaccine industry.
In China, homemade vaccines lead the market, and the imported take a small share (lower than 5%), especially in the EPI vaccines market which is in the monopoly of local big-name brands. That it takes one year to five years for imported vaccines to acquire the Imported Drug License helps explain why there are just several imported vaccines such as pentavalent vaccine, 13/23-valent pneumococcal vaccine and HPV vaccine available on the Chinese vaccine market.
Chinese vaccine companies have broken the monopoly of their foreign peers on new vaccines like 13-valent pneumococcal vaccine and HPV vaccine, in their race to spend more on research and development. In current stage, Walvax Biotechnology’s 13-valent pneumococcal vaccine has been applied for GMP certificate and is expected to be the first approved homemade vaccine of such kind in China in 2019; Beijing Wantai Biological Pharmacy Enterprise’s 2-valent HPV vaccine which was applied for launch in November 2017, undergoes the quick review by National Medical Products Administration, and is expected to be the first approved homemade vaccine of such sort in China in 2019.
China’s vaccine market will have a rosy prospect. The growing demand for vaccines comes with a large population base, the aging of population, more than 15 million newborns each year and the two-child policy. As people live a better life, they also demand more extra EPI vaccines.
China Human Vaccine Industry Report, 2019-2025 highlights the following:
- China’s human vaccine industry (environment, status quo, demand, market size, import and export, and competitive pattern);
- Chinese human vaccine market segments (demand, lot release volume and competitive pattern);
- 22 human vaccine companies (operation, vaccine business);
- Summary and forecast.