China's Antihistamines Market Grows Vigorously
COLUMN:PHARMACEUTICALS AND BIOCHEMICALS
China's Antihistamines Market Grows Vigorously
By Cai Deshan
In the global wave of upgrading antihistamines, the competition among multinational pharmaceutical companies in the field of anti-allergic rhinitis and OTC drugs becomes increasingly fierce. The use of classic drugs like loratadine, the academic promotion of desloratadine and L-cetirizine and the development of new drugs such as rupatadine, olopatadine, bilastine and bepotastine have further improved the product structure worldwide and enabled this market to thrive.
In China, along with the constantly expanding coverage of the basic medical insurance system and the implementation of a new round of medical and health system reform programs, the huge potential of the domestic market for consumer medicine is becoming increasingly prominent.
1. Overall outlook
Antihistamines are mainly used for the desensitization in treating allergic diseases of the human body's immune system. With constant upgrading, antihistamines have developed from the first generation to the third generation. In the past two years, because typical first-generation antihistamines, such as chlorpheniramine, diphenhydramine and promethazine, have a strong inhibitory effect on the central nervous system, their market shares are decreasing. In the same time, the second-generation antihistamines, such as astemizole and terfenadine, were found to have obvious toxicity to the heart, so they have exited from the market. At present, the market is dominated by some second-generation antihistamines like loratadine, fexofenadine and mizolastine as well as the third-generation ones like desloratadine, L-cetirizine and setastine.
So far, the Chinese State Food & Drug Administration (SFDA) has approved the entry of over 30 types of China-made and imported antihistamines in China's market. The latest "National Drug List for Basic Medical Insurance, Industrial Injury Insurance and Maternity Insurance" released by the national government in 2009 includes 15 classic anti-allergic drugs, eliminating astemizole and terfenadine but adding hydrochloride decloxizine, L-cetirizine and ebastine. These 15 drugs include major varieties of alkyl amines, monoethanolamines, phenothiazines, piperazines and piperidines that have been sold in China.
In recent years, the consumption of antihistamines in China is growing. According to statistics made by the Chinese Pharmaceutical Association in 2008, the sales value of more than 20 kinds of antihistamines at 22 sample hospitals in China's key cities amounted to RMB247 million, increasing by 21.23% year on year, accounting for 0.42% of these hospitals' total medicine sales revenues. The top 10 varieties of antihistamines with the largest sales values were loratadine, cetirizine, desloratadine, L-cetirizine, mizolastine, azelastine, ebastine, epinastine, fexofenadine and ketotifen. The consumption of these top 10 drugs together accounted for 89.42% of the total consumption of antihistamines. The three fastest-growing varieties in 2008 were epinastine, azelastine and L-cetirizine, with a growth rate of 85.25%, 62.08% and 44.61%, respectively. But the consumption of astemizole, terfenadine, triprolidine, dimenhydrinate and decloxizine each has declined year by year. In the first half of 2009, loratadine, cetirizine, desloratadine and L-cetirizine led the market share.
2. Loratadine leads the domestic market
Loratadine began to be sold in China in 1993. In March 1994, Schering-Plough obtained 7.5-year-long administrative protection in China for its loratadine product, with the trade name of Clarityne. Shanghai Schering-Plough Pharmaceutical Co., Ltd. is responsible for the sales of the imported drug in China. So far, SFDA has issued loratadine production licenses to 112 Chinese enterprises, of which 35 are active pharmaceuticals ingredients producers and 77 are formulation manufacturers.
In 2008, the sales value of loratadine at the above 22 sample hospitals was RMB73.33 million, up 15.52% year on year, accounting for 29.69% of the total sales value of antihistamines at these hospitals. In 2008, Schering-Plough occupied 77.16% of China's loratadine market, and the remaining 22.84% market share was occupied by Chinese generic drug manufacturers. The market competition is very fierce.
3. Domestic company-made cetirizine accounts for nearly half of China's cetirizine market
Cetirizine was developed by Pfizer Inc. of the United States and UCB S.A. of Belgium. Its patent expired in December 2007. So far, SFDA has approved 21 Chinese enterprises to produce cetirizine. In 2008, the sales value of cetirizine at the 22 sample hospitals was RMB34.63 million, up 12.35% year on year, accounting for 14.04% of the total sales value of antihistamines at these sample hospitals. In China's cetirizine market, imported products from UCB, India Sun Pharmaceutical Industries Limited and Dr. Reddy's Labs occupied a market share of 51.91%, and China-made products seized 48.09%.
4. The growth of mizolastine is promising
In 1996, mizolastine was put on the market for the first time in the United States. In 2002, Janssen Pharmaceutical (Xi'an) Ltd. began to import mizolastine into China and distribute it in the Chinese market. Before the imported drug was registered in China, Chinese companies had conducted clinical trials on mizolastine. In 2002, through its R & D efforts, Beijing Jialin Pharmaceutical Co., Ltd. obtained a new drug certificate and production license for the active ingredients and tablets of mizolastine. Currently, China's domestic mizolastine formulation market is dominated by Janssen Pharmaceutical (Xi'an) Ltd. and Sanjiu Medical & Pharmaceutical Co., Ltd.
According to statistics, in 2008, the sales value of mizolastine at the 22 sample hospitals only ranked 5th among antihistamines, falling from the 4th position in 2007. Its market share declined a little, accounting for 7.17% of the antihistamines market in China. In 2008, the sales value of mizolastine at the 22 sample hospitals was RMB17.785 million, up 13.37% year on year.
5. The localization of epinastine
Epinastine is a clemastine and was developed by Germany's Boehringer Ingelheim. In 1994, it was put onto the market for the first time in Japan. Its trade name was Alesion. In June 2000, SFDA approved the entry of imported epinastine into the Chinese market. In 2004, Chongqing Carelife Pharmaceutical Co., Ltd successfully developed epinastine and was allowed to produce it. Later, SFDA approved that the epinastine tablet developed by Beijing Laneva Pharmaceutical Co., Ltd. was put into the market.
In 2008, the sales value of epinastine at the 22 sample hospitals reached RMB12.15 million, up 85.25% year on year, having the highest growth rate in China's antihistamines market. Chinese-made epinastine occupied 98.58% of China's epinastine market, of which epinastine hydrochioride capsules produced by Chongqing Carelife Pharmaceutical Co., Ltd. occupied 66.76%, and epinastine tablets produced by Beijing Laneva Pharmaceutical Co., Ltd. accounted for 31.79%.