The Administrative Measures for the Clinical Use of Antibacterial Drugs issued by the National Health and Family Planning Commission of the People's Republic of China (NHFPC) in 2012 has been called the strictest restriction order of antibiotics usage in the history of China because of the three-level administrative measures for antibiotics and serious punishment of doctors who violate rules proposed therein. NHFPC introduced some provisions in succession thereafter. Under the restriction order of antibiotics usage, many antibiotics have been listed in the scope of "restricted drugs" and "special drugs", and the market development has been subject to large restrictions, with sales shrinking and market reshuffled. With several years past, how are the trends of the antibiotic market of China is worth noting.

The total volume steady and going up

Affected by many factors like restriction order of antibiotics usage, the anti-infective drug market of China has undergone phases including rise, sharp fall, picking up, and normalized development, etc. in recent years. Seen from the data, the antibiotics usage restriction resulted in the antibacterial drugs to have negative growth in 2011-2012, however, they started to pick up in 2013. According to relevant data, the market size of the anti-infective drugs in China has shown a growing trend overall in recent years, with the sales of anti-infective drugs in hospitals of key cities of China separately being RMB 19.16 billion, RMB 19.35 billion, RMB 20.11 billion and RMB 22.22 billion in 2011-2014. The market size of anti-infective drugs in sample hospitals of key cities in 22 regions of China reached RMB 23.25 billion in 2015, growing by 4.6% year on year. Furthermore, seen from the annual growth of antibacterial drugs for systemic use in sample hospitals of China in recent years, only 2013 had negative growth (-1.0%), the growth in 2014 was 9.8%, in 2015 was 4.0%, and in 2016 was 7.5%.

NHFPC and some provinces have introduced some new measures for the administration of anti-infective drugs in recent years, including restriction of outpatient intravenous infusion of anti-infective drugs and 2015-edition guidelines for clinical use of anti-infective drugs, etc. Currently, hospitals’ use of anti-infective drugs has tended to be normalized after the previous round of antibiotics usage restriction, the marginal effect of the new administration for antibiotics usage restriction on the anti-infective drug market is decreasing, and the anti-infective drug market still maintains a relatively stable growth situation.

Market starting to become fragmented

The antibiotic market shows the fragmentation trend under the situation that the overall market is stable and upward: firstly, use of antibiotics in big hospitals of big cities shows a downtrend, while that in grass-roots hospitals and community hospitals gradually rises; secondly, the proportion of antibiotics of unrestricted use level continues to grow in the market, especially in grass-roots hospitals and community hospitals, while the proportion of antibiotics of restricted use level continues to decline in the market. Data show that among the use frequency statistics of antibacterial drugs in different levels of hospitals in China in 2016, the proportions of antibacterial drugs of unrestricted use level separately reached 69.4%, 72.9% and 87.2% in tertiary general sample hospitals, secondary general hospitals and community health centers, while that of the antibacterial drugs of restricted use level separately reached 28.6%, 25.9% and 12.8%.

Outlook of future trend

According to the analysis, the antibiotic market of China will step into a new normal in future, showing the steady and going up trend: not to rise greatly, nor decline sharply, because:

China now divides antibacterial drugs into restricted use level, unrestricted use level and special use level, similar to the new standard of the World Health Organization, and there is a strict restriction on doctors’ right to prescribe those 3 levels of antibacterial drugs. The proportion of purchase quantity of antibacterial drugs in total purchase quantity of pharmaceutical products has been declining year by year in big hospitals of big cities in China, already from the previous 35%-40% to 15%-20%, and will gradually decline in the future, with slim chance of sharp rise.

The chance of sharp rise is slim, however, that of sharp decline is also not likely, because: firstly, the pharmaceutical market of China has been developing at top speed since the reform and opening up. According to data, the compound annual growth rate of the pharmaceutical product consumption in 2002-2013 reached nearly 20%, showing good growth. The total size of the entire pharmaceutical product consumption market of China was RMB 208 billion in 2002, it exceeded RMB 1 trillion in 2013, and reached RMB 1.5 trillion in 2015, with the growth generally remaining at about 16% in recent years.

Secondly, China has a very huge population of 1.4 billion. In recent years, China has been further promoting the social security system reform and accelerating universal social security coverage plan, and governments at all levels have also been increasing the investment in medical insurance. Currently, there have been more than 1.3 billion people participating in various medical insurances in China, with the security level rising continuously with the economic development. Such a huge market will facilitate the antibacterial drug market to keep steady growth for some time to come.

Thirdly, the phenomenon of abuse of antibiotics has long been quite serious in China, with antibacterial drugs prescribed for many diseases like cold and fever which are mostly treated by infusion. The long-term use has become a habit, something seems missing if antibacterial drugs are not prescribed when seeing a doctor, and many people store antibacterial drugs as common pharmaceutical products of the family. Such using habit of the Chinese people is expected to last for some time, which plays a role in the antibiotic market.

By Zhang Lun