Analysis of market sales of clopidogrel in China

It is reported that three years ago, there were only two companies selling clopidogrel preparations in China's market, namely, "Plavix" produced by Sanofi in Hangzhou and "Taijia" produced by xinlitai in Shenzhen The sales ratio of the two companies was 7:3 The annual output of clopidogrel API of Shenzhen xinlitai company is 10-15 tons In addition, it is reported that the capacity of clopidogrel API of Henan xinshuaike company is up to 50 tons, and its clopidogrel preparation was officially put on the market in 2012 It is understood that in order to compete for the domestic terminal market, the external bidding price of clopidogrel tablets of xinshuaike company last year was only less than 3 yuan per tablet, at least 40% lower than that of similar drugs of Shenzhen xinlitai company People in the industry believe that the decrease in the market price of clopidogrel will promote the market popularity of the drug, and at the same time promote the increase in production and sales, so the method of price reduction is not a bad thing After all, compared with western countries, the use of clopidogrel in China has not been fully popular According to the data, at present, the capacity of clopidogrel API of Suzhou Tianma Fine Chemical Co., Ltd has reached 20 tons per year However, as the company is a pharmaceutical and chemical enterprise, although its production approval has been obtained (Note: Suzhou Tianma precision Chemical Co., Ltd is the only pharmaceutical and Chemical Factory in China that has obtained the approval for the production of clopidogrel API), the company has no tablet production Conditions of production In addition to Suzhou Tianma Jinghua, the production line of clopidogrel API of Jingxin Pharmaceutical Co., Ltd in Shangyu, Zhejiang Province was officially put into production in 2013 It is understood that the capacity of clopidogrel API of Jingxin Pharmaceutical Co., Ltd is 5600 kg per year, far lower than the scale of Suzhou Tianma Jinghua, but the factory also has the production approval of clopidogrel API and preparation This is where it is superior to Suzhou Tianma Other pharmaceutical companies that have formed the production scale of clopidogrel API include Sichuan kailihe Pharmaceutical Co., Ltd., whose capacity of clopidogrel API is 3800Kg per year It is understood that dozens of pharmaceutical and chemical plants in China are also producing clopidogrel APIs, but the products of these companies can only be exported in the name of pharmaceutical intermediates, not sold in the domestic market Based on this analysis, the total capacity of clopidogrel in China is estimated to be 80-100 tons, but the actual production as drug sales is between 30-40 tons, and most enterprises' production equipment of clopidogrel API is idle With the rapid development of China's economy and the change of people's lifestyle and diet, the incidence rate of acute coronary syndrome (ACS) has risen dramatically It has become the second cause of death in developing countries and is seriously threatening people's health Acute myocardial infarction (AM), as one of the types of coronary syndromes, has a rapid onset and serious consequences In the United States, about 1.2 million people suffer from acute myocardial infarction every year 50% of them die in the emergency room or one hour after the onset of the disease Even the surviving patients have a high disability rate In the past 10 years, the incidence of this disease has been increasing significantly in China In 2001, the number of male patients has reached 0.7% and the incidence rate of female is 0.5% Antithrombotic drugs have gradually grown from small varieties to the main drugs in the domestic pharmaceutical market However, so far, the antithrombotic treatment in China is mainly based on low-dose aspirin and other general drugs, while some internationally widely used and effective antithrombotic drugs such as low-molecular-weight heparin sodium, clopidogrel and other drugs have not been really popularized in China Every year, 12 million people are killed by cerebral thrombus, cerebral infarction, myocardial infarction, coronary heart disease, arteriosclerosis and other cardiovascular and cerebrovascular diseases in the world, nearly a quarter of the total number of deaths in the world In China, 2.6 million people die of cardiovascular and cerebrovascular diseases every year, and 75% of the surviving patients are disabled In 2006, the growth of clopidogrel sulfate was the most obvious among all kinds of antithrombotic drugs, with an annual growth rate of more than 60% and an average annual growth rate of 444.43% The growth rate of low molecular weight heparin sodium, sagrel ester and streptokinase decreased year by year The top three varieties are clopidogrel sulfate, low molecular weight heparin sodium and ozagrel sodium The market share of these three varieties is over 14%, and the growth rate of sales in 2005 compared with 2004 is higher than the overall average growth rate of antithrombotic drugs by 17.93%, which plays an important role in the antithrombotic hospital drug market Among them, clopidogrel sulfate, as the largest type of hospital drug sales in China, its sales volume has a significant growth every year According to the reports of medical journals at home and abroad, clopidogrel has been proved to be an effective antithrombotic drug so far, and it is also one of the few drugs with a sales volume of more than 10 billion US dollars in the international pharmaceutical market According to foreign consultants, the global sales volume of clopidogrel in 2013 was about 12 billion US dollars It is understood that clopidogrel's U.S patent expired in 2012, which means that this heavyweight drug has become a generic drug and must face the challenge of generic drugs As pharmaceutical manufacturers are optimistic about the market prospect of clopidogrel, there are many pharmaceutical companies in the world to produce clopidogrel preparations As a big producer of APIs, the suppliers of clopidogrel APIs in China naturally attract the attention of overseas peers Before 2011, the international market of clopidogrel was mainly monopolized by the products of two pharmaceutical companies, Bristol Myers Squibb in the United States and Sanofi in France The sales ratio of the same product of the two companies was about 7:3 Sanofi's clopidogrel preparation has entered the Chinese market as early as 10 years ago, and its sales are increasing year by year Due to the patent protection of clopidogrel APIs and preparations, this drug has become a blank in China However, after 2010, some domestic pharmaceutical and chemical plants have gradually mastered the production technology of clopidogrel API and formed large-scale production However, these chemical enterprises are unable to obtain drug production approval, so they can only sell in the name of intermediates In 2010, when the patent of clopidogrel expired, a number of domestic pharmaceutical companies that released the shackles immediately joined the list of manufacturers of the drug According to the domestic information bulletin, up to now, 13 pharmaceutical enterprises in China, including Chengdu Mingyang Pharmaceutical Co., Ltd., Tianjin Zhongrui Pharmaceutical Co., Ltd., Shenzhen xinlitai Pharmaceutical Co., Ltd., Suzhou Tianma Pharmaceutical Co., Ltd., Zhejiang shangyujing New Pharmaceutical Co., Ltd., Jiangsu Hengrui Pharmaceutical Co., Ltd., have obtained the approval documents for the production of clopidogrel APIs, of which 6 have also obtained the approval documents for the production of preparations On December 31, 2013, the production line of clopidogrel bisulfate, the API of Tianjin Zhongrui Pharmaceutical Co., Ltd., passed the new GMP certification Although there are many drugs that can be used in the field of antithrombotic drugs, the drugs with both efficacy and safety have always been a big challenge for drug researchers According to relevant aspects, the tablet making technology of clopidogrel is very complex, the technical barriers to production are hard to break, and the high threshold has kept many manufacturers out of the door, so that the market price of clopidogrel preparation has remained high The price of imported clopidogrel tablets once reached more than 20 yuan, even the price of domestic clopidogrel tablets is also 4-5 yuan, for example, the price of domestic clopidogrel tablets is high The cost of imported clopidogrel tablets is more than 50 yuan per day, and the cost of domestic drugs is 9 yuan The high price limits the promotion speed of this medicine in the domestic market The industry believes that the reason why clopidogrel tablets are difficult to popularize in the domestic market is largely related to the high price According to the statistics of relevant departments, the number of thrombotic patients and potential patients in China is comparable to that in Europe and the United States, while the sales volume of clopidogrel, a good antithrombotic drug in China, is only a fraction of that in other developed countries The reason is still related to the high retail price of clopidogrel in the domestic market Market analysts believe that with the breakthrough of production technology, there will be more manufacturers in China to join the list of clopidogrel manufacturers in the future At the same time, the optimization of production process will greatly reduce the production cost, form a benign price competition for the final product and reduce the price in the end market, which in turn will promote the production and sales of clopidogrel API, and ultimately benefit from patients and manufacturers