By Vivian Ni, GBI Analyst
China remains a high-risk environment for rabies, with the number of related deaths being second only to India in recent years. A 2009 MOH report, entitled “Present Situation of Human Rabies Control in China”, notes that since the 1950s, rabies infections have peaked three times, sending reported deaths to 1,900 in the mid-50s, 7,037 in 1981, and 3,300 in 2007. The latest reemergence has surged most notably in southern and eastern provinces such as Guangdong, where in 2008 alone, as many as 1.5 million people were bitten by suspect animals. The World Health Organization has stated that while more than 99% of new human rabies cases occur in developing countries, the number in Europe has dwindled to single digits, mostly due to animal control and vaccination programs.
The usual suspects are to blame for the latest outbreak: First is the large number of infected animals, mainly dogs and cats, coupled with correspondingly low immunization rates. In 2009, the mostly free-range canine and feline populations in rural southern China were approximately 15-20 dogs and 5-10 cats per 100 humans. Second, post-exposure prophylaxis is often not introduced immediately and treatments are not standardized. Surveys show that in some rural areas, only 50% of residents know that rabies is almost invariably fatal if post-exposure prophylaxis is not administered prior to the onset of severe symptoms. In addition to rural residents, who represent one third of the high-prevalence population, boys under 15 years of age and the elderly are at higher risk.
Chinese human rabies vaccine market
According to 2009 MOH statistics, China administers 12-15 million rabies vaccine doses annually at a cost of RMB 3.5-5 billion, making it the world's largest market. The typical post-exposure vaccination regimen costs approximately RMB 1,500 per person - beyond the reach of most rural residents. By extrapolating population and prevalence ratios, the total market for rabies exposure treatments could be pegged at more than RMB 24.5 billion annually, including RMB 17 billion for rural areas and RMB 7.5 billion for the cities.
In China, where Sanofi and Novartis respectively registered human rabies vaccines in 1999 under the brand names Verorab and Rabipur, human rabies vaccines have mainly been cultured in vero cells, chick embryo cells, and hamster kidney cells. There are presently 18 registered manufacturers, 3 new applicants (1 approved) and 7 IND applicants (5 approved). The rabies antiserum, for which there are five registered manufacturers, has been added to the National Essential Drug List. Human Rabies Immunoglobulin was first registered in 1994 and currently has 14 registered manufacturers and one new approved applicant.
In recent years, the custom of keeping dogs and cats as pets has grown rapidly in China, leading to a slight uptick in annual vaccinations. While immunization remains the most effective means of rabies prevention, expanded awareness has reinforced the importance of post-exposure prophylaxis. The Hangzhou municipal government has also proposed adding the rabies vaccine to the local reimbursement drug list- an unusual and significant move for a (non national immunization program) vaccine. Clearly, the rabies vaccine market continues to merit close attention from pharmaceutical manufacturers.