Anticoagulant Clopidogrel Hot on Chinese and Foreign Markets, with Strong Growth Momentum

As a new-generation anticoagulant, clopidogrel can selectively inhibit the binding of ADP and platelet receptor, thereby inhibiting the platelet aggregation and activation, and is used for atherosclerosis, acute coronary syndrome and thromboembolism complications, etc., with quite eye-catching performance after marketing.

Hot on international market

First marketed in the U.S. in 1997, clopidogrel thereafter entered the European, Canadian and Australian markets, etc., and had quite good performance after the marketing, with sales rising sharply for consecutive years: USD 140 million in 1998, USD 2 billion in 2001, USD 4 billion in 2003, USD 6.4 billion in 2005, USD 8.1 billion in 2007, USD 9.7 billion in 2009, and the peak USD 10 billion in 2011, becoming a global blockbuster drug and one of the few pharmaceutical products with sales exceeding USD 10 billion on the international pharmaceutical market. It has been included in the pharmacopeia of countries like the U.S., UK, Japan, India, South Korea, and that of Europe, with wide application scope and large application volume in the world.

Strong growth in China

Clopidogrel was marketed in China in 2001, and its sales have continued to rise after the marketing, with significant growth momentum in recent years. There are currently 3 enterprises selling clopidogrel tablets in China: Plavix of Sanofi, Taijia of Shenzhen Salubris, and Shuaitai and Shuaixin of Lepu Pharmaceutical. The sales of clopidogrel in China reached RMB 1.079 billion in 2011, RMB 1.448 billion in 2013, RMB 1.741 billion in 2015, and RMB 1.858 billion in 2016, with the compound annual growth rate reaching 16.37% from 2009 to 2016.

Clopidogrel is currently the main antiplatelet drug in China, with sales in sample cities of nearly RMB 1.5 billion in 2015, accounting for 81% of the entire market; the total sales of the top 5 antiplatelet drug enterprises accounted for 89% of the entire market, with the foreign enterprise Sanofi accounting for nearly 50% of the market; the 3 preparation manufacturers (Sanofi, Salubris and Lepu) of clopidogrel separately ranked first, second and fourth, and the varieties of Tide Pharmaceutical that ranked third and AstraZeneca that ranked fifth were separately beraprost and ticagrelor.

Analysis of prospects of future market

1. Growth momentum will still be strong

Cardiovascular and cerebrovascular diseases such as cerebral thrombosis, cerebral infarction, myocardial infarction, coronary heart disease and arteriosclerosis take the lives of 12 million people in the world every year, nearly one fourth of all the global death toll. The number of people who die of cardiovascular and cerebrovascular diseases is 2.60 million every year in China, and 75% of the survivors are disabled thereby. The next 2 decades will be the period witnessing the fastest growth of the aging population in China, and the aging population above 60 years old is estimated to reach 260 million by 2020, accounting for 17.8% of the total population of China, and reach 400 million around 2033, with average growth of 10 million every year, and highest growth of over 14 million in a year. Chinese and overseas demands for drugs preventing and treating thrombotic diseases are large, and the sales of global antithrombotic drug market reached USD 23.5 billion in 2013 and such sales are expected to reach USD 25.9 billion in 2018. In China, the antithrombotic drug market reached RMB 3 billion in sample cities in 2015, with a steady growth trend. The average annual growth rate of antithrombotic drugs in China exceeded 10% from 2010 to 2015, and market development prospects are good.

The number of thrombotic disease patients and potential patients in China is almost equal to that in the European and American countries, however, the antithrombotic therapy in China is based on general drugs such as small-dose aspirin, and the antithrombotic drug commonly used in the world with definite effect: clopidogrel has not been really promoted and popularized in China, with sales in China being only a fraction of those in other developed countries, and its market has large room for development in the future.

2. Market competition will be fiercer

The hot sale of clopidogrel market attracted many enterprises: after its core compound patient expired in May 2012, there was a large number of generic drugs flowing into market and the sales of original drug started to decline. The global sales of the original drug were USD 6.859 billion in 2012, down by 35% year on year; such global sales were USD 5.94 billion in 2013, down by 13.4%; and such sales declined to USD 3.4 billion in 2014, and USD 3.385 billion in 2015. It is reported that there have already been a dozen enterprises marketing generic drugs of clopidogrel on the U.S. market, to scramble for the market share.

There are mainly 9 antiplatelet varieties marketed in China. The manufacturers of aspirin exceed 100 as the primary prevention of cardiovascular diseases of aspirin has been fully proved clinically. There are 28 production approvals for clopidogrel in China: 22 for API, and 6 for tablets, with 3 tablet manufacturers: Sanofi, Salubris and Lepu. The clopidogrel sales of those 3 enterprises were separately RMB 1.11 billion, RMB 552 million, and RMB 196 million in 2016, with market share of separately 59.7%, 29.7% and 10.5%. Currently there are dozens of enterprises applying for the production in China, eyeing the market covetously, and the future competition will be quite fierce.

3. Low prices will help expand sales

Clopidogrel is expensive: the imported clopidogrel is about RMB 15 per tablet and the China-produced clopidogrel is RMB 4~5 per tablet on the Chinese market; if calculated according to 1-2 tablets taken by a hyperlipidemia patient every day, the expense for imported clopidogrel will be RMB 15 per day and RMB 450 per month, and the expense for China-produced clopidogrel will be RMB 9 per day and RMB 270 per month, and the drug needs to be taken for a long time. The excessive price of the drug limits its promotion on the Chinese market. There are many people taking antiplatelet drugs in China, however, most of them select aspirin. 22 enterprises in China have received the clopidogrel API production approvals, and there will be more manufacturers joining the production of clopidogrel tablets in China; the optimization of the productive technology will largely reduce the production cost, and eventually there will be benign price competition formed and decline of terminal market price, to promote the sales increase of clopidogrel and help expand sales.

4. Treat clopidogrel rationally

There is a view that aspirin can be fully absorbed via oral taking, without the need for activation after liver metabolism, plus the safety and economy of aspirin, therefore, it is superior to any other antiplatelet drugs. Clopidogrel has better antiplatelet effect and safety than aspirin, however, the price is higher, and clinically, clopidogrel shall be alternative in the case of aspirin allergy or intolerance, instead of the drug of first choice.