Simplified Chinese
In 2018, China’s vaccine industry saw a surge in batch release volumes and market share, as numerous blockbuster products were launched one after another, ushering in a golden period of growth.
Release date:
2018-08-31
Author:
Article/Excerpt, China Report Network
Source:
Abstract
China is the world’s largest producer of human vaccines. According to data released by the National Institute for Food and Drug Control, the country issues batch releases for 500 million to 1 billion vaccine vials (doses) annually, ranking first globally. From 2012 to 2015, due to the absence of any blockbuster products entering the market, the vaccine industry’s output value remained stable at around RMB 15 billion, with growth stalling.
According to data released by the National Institute for Food and Drug Control, in 2015 there were a total of 43 domestic enterprises authorized to issue batch release certificates for vaccines. Among them, five were foreign‑owned and 38 were Chinese‑owned—seven affiliated with China National Biotec Group and 31 other domestic companies. The 38 domestic manufacturers were distributed across 14 provinces and municipalities directly under the central government. Excluding China National Biotec Group, more than half of the remaining domestically licensed vaccine producers could manufacture only a single product. Meanwhile, from 2012 to 2015, the proportion of companies capable of producing three or more products showed an upward trend, increasing from 20% to 36%.
Vaccines in China are broadly classified into Category I vaccines and Category II vaccines. Category I vaccines are those provided free of charge by the government to citizens, who are required to receive them in accordance with government regulations. These include vaccines specified in the National Immunization Program, vaccines added by provincial people’s governments when implementing the National Immunization Program, and vaccines used in emergency vaccinations or mass preventive vaccinations organized by people’s governments at or above the county level or their health administrative departments. Category II vaccines are other vaccines that citizens obtain at their own expense and receive voluntarily.
Category‑I vaccines have been expanded three times—in 1992, 2008, and 2016—and currently comprise 14 types, including BCG, DPT, and hepatitis B vaccines, with coverage rates all exceeding 90%. In addition, in response to the avian influenza outbreak, the state temporarily included the H1N1 vaccine in the Category‑I vaccine list in 2009. The manufacturers of Category‑I vaccines are predominantly state-owned enterprises, such as the China National Biotech Group.
Category II vaccines primarily include the Haemophilus influenzae type b (Hib) conjugate vaccine, the meningococcal serogroups A and C conjugate vaccine, the meningococcal serogroups A, C, Y, and W‑135 polysaccharide vaccine, the oral rotavirus vaccine, the rabies vaccine, and the influenza vaccine. Because these vaccines are not included in the national immunization program, their costs are borne by the individuals receiving them, resulting in relatively lower vaccination rates. In addition, certain Category I vaccines—such as the hepatitis B and hepatitis A vaccines—require booster doses or adult vaccinations, with the associated costs also falling on the recipient; thus, they are likewise classified as Category II vaccines. Most manufacturers of Category II vaccines are private enterprises.
The domestic vaccine market remains dominated by Class I vaccines, though their share has been declining year by year. The Class I vaccine segment is primarily led by state-owned enterprises—namely the six major research institutes and the Kunming Institute—with these entities accounting for approximately 79% of the Class I vaccine market in 2015, while Class I vaccines represented 59% of the overall vaccine market in terms of volume. Meanwhile, the Class II vaccine market is largely driven by private companies, which held about 41% of the total market in 2015 and have shown a steady year-over-year growth trend.
Previously, the domestic vaccine market remained relatively stagnant, primarily because several blockbuster products had yet to enter the Chinese market, holding back overall growth. Since 2013, with the approval and launch of the DTaP‑Hib quadrivalent vaccine; in 2014, the AC‑Hib trivalent vaccine; in 2016, the EV71 vaccine and the bivalent HPV vaccine; in 2017, the quadrivalent HPV vaccine and the 13-valent pneumococcal conjugate vaccine; and in 2018, the nine-valent HPV vaccine, the pentavalent oral rotavirus vaccine, and the quadrivalent influenza vaccine—coupled with the anticipated gradual introduction of other major domestically developed vaccines over the next few years—the Chinese Class II vaccine market is poised for a new phase of expansion.
As evidenced by the top 20 domestically produced vaccines by output value in 2017, on the one hand, newly launched novel vaccines and multivalent combination vaccines—due to their short time on the market and the lingering impact of the 2016 Shandong vaccine incident—have seen a slower ramp-up in sales, with most still absent from the rankings. However, they are expected to enter a phase of rapid volume expansion starting in 2018, thereby boosting the Class II vaccine market. On the other hand, markets for rabies vaccines, inactivated influenza vaccines, and oral rotavirus vaccines are already substantial; with the introduction of upgraded products such as human diploid cell–derived rabies vaccines and pentavalent oral rotavirus vaccines, there remains significant potential for substitution within the existing market base. Consequently, driven by these two factors, China’s Class II vaccine market is poised for a revitalization and is set to enter a golden period of growth in the coming years.
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