Who dominates the domestic 8-billion-Heparin market?

　　The global economic outlook for 2016 is not optimistic. The weak external demand and the broader economic downturn have a significant impact on exports of sodium heparin API. According to analysts from Shanghai Shiyi Technology, specialists in the heparin field, exports of low-molecular-weight heparin remained generally stable in 2016, showing a positive trend.
　　Driven by the robust demand for high-end products, the domestic heparin preparation market is showing a sustained growth trend. With the introduction of national policies, it has become an inevitable trend to set high standards and stringent requirements for product quality. Following the implementation of the 2015 edition of the Chinese Pharmacopoeia, the assay methods for heparin’s potency have been fully aligned with those of the US Pharmacopeia, making it imperative to enhance product quality.
　　According to Chinese customs statistics, in 2015, China's exports of heparin products totaled 138.08 tons, an increase of 31.98% over the previous year, with sales reaching US$547 million. The overall market for domestic heparin formulations has reached nearly 8 billion yuan. It is worth noting that the market position of low-molecular-weight heparin products has significantly improved.
　　To date, cardiovascular and cerebrovascular diseases remain the leading cause of death worldwide. In July 2016, the “China Cardiovascular Disease Report 2015,” compiled by the National Center for Cardiovascular Diseases, was released in Shanghai. The report indicated that China now has 290 million people living with cardiovascular diseases, and the number is rapidly increasing. The incidence of stroke accounts for 2.42%, while the incidence of myocardial infarction stands at 0.86%. These conditions have become major contributors to disability from cardiovascular disease, seriously impacting the quality of life of this population.
　　Currently, therapeutic drugs for cardiovascular and cerebrovascular diseases mainly consist of three major categories: antithrombotic, anticoagulant, and antiplatelet agents. The 2009 edition of the National Basic Medical Insurance Catalogue lists a total of 19 chemical compounds belonging to these three categories—antithrombotic, anticoagulant, and antiplatelet agents. Among them, heparin, low-molecular-weight heparin, rivaroxaban, warfarin, and kinase-based drugs are the primary ones used in clinical practice and play an irreplaceable and crucial role.
　　According to comprehensive data from the China Pharmaceutical Industry Information Center’s PDB, In 2015, the global market for anticoagulant and antithrombotic therapies in the world’s seven major pharmaceutical markets totaled US$19.738 billion, representing a year-on-year increase of 6.88%. The average annual growth rate over the decade from 2005 to 2015 was 5.12%.

　　In the late 1970s, low-molecular-weight heparin—a antithrombotic and anticoagulant drug—entered clinical practice. This formulation boasts superior efficacy compared to conventional heparin, with fewer bleeding side effects in patients, high bioavailability, a long half-life, and excellent anticoagulant performance. As a result, it has come to dominate most of the anticoagulant market.
　　 In 2015, the global heparin market reached US$12.58 billion, representing an 11.10% increase over the previous year. Among them, the original research heparin products from the world’s seven major pharmaceutical markets account for one-quarter of the market. Enoxaparin from Sanofi and Sandoz, as well as dalteparin sodium from Pfizer, Eisai, Janssen, and GlaxoSmithKline (GSK), account for the major share.

　　 Upgrading product status is important.
　　Among antithrombotic and anticoagulant medications used in hospitals, heparin and low-molecular-weight heparin remain widely prescribed in China. These drugs work by reducing the concentration of coagulation factors, thereby decreasing blood clotting tendency or hypercoagulability and preventing thrombus formation or halting its progression. As the clinical use of these drugs continues to expand, heparin-based products have shown a steadily increasing trend year after year, which has also boosted the market for heparin raw materials.

　　Statistical data shows: In 2015, the antithrombotic market in hospitals in China’s key cities reached 3.115 billion yuan, representing a year-on-year increase of 9.45%. Among these, heparin-based drugs—comprising eight products—accounted for 21.76% of the market share. In 2015, the sales volume for these heparin-based drugs was 678 million yuan, up 8.75% from the previous year.
　　Among domestic heparin products, low-molecular-weight heparin calcium ranks first, accounting for 44.64%; followed by enoxaparin sodium, which accounts for 26.55%; while ordinary sodium heparin accounts for only 11.98%, and other types account for 16.83%.

　　According to data from the CFDA official website: In 2016, there were 63 domestic manufacturers of heparin, collectively holding 165 production licenses. Seven imported companies held 40 production licenses. In 2015, there were 32 competing manufacturers of heparin products in hospitals, including four foreign-invested companies: Sanofi, GlaxoSmithKline, Pfizer, and Alfa Wassermann. There were 28 domestic manufacturers. In 2014, there were only 22 such companies. The six domestic enterprises that entered the market in 2015 are Nanjing Jianyou, Suzhou Er Ye, Yantai Beifang, Hainan Pharmaceutical, North China Pharmaceutical, and Hunan Kangpu.
　　 The top 10 vendors in terms of sales at public hospitals are Sanofi, GlaxoSmithKline, Changshan Biochemical, Anhui Zhaokew, Pfizer, Alphawessman, Changzhou Qianhong, Qilu, Hangzhou Jiuyuan, and Wanbang Biochemical. Sales of the low-molecular-weight heparin series by foreign-invested companies account for... 51.76% , local share 48.24% , basically a close contest. The top 10 vendors account for... 88.47% the market, while the other 22 companies accounted for a share of 11.53%.

　　Low-molecular-weight heparin calcium is a product developed and launched by GlaxoSmithKline. It has already been approved for sale in China under the trade name “Xubilin.” In 1998, domestically produced low-molecular-weight heparin calcium was first launched on the market by Hefei Zhaokewei Pharmaceutical. Currently, six manufacturers—Hebei Changshan, Zhaokewei (Hefei), Tianjin Hongri, Shenzhen Saibaoer, Guangdong Tianpu, and Jiangsu Dalianmeng—are authorized to produce and market this formulation.
　　In 2015, domestic sample hospitals spent 303 million yuan on low-molecular-weight calcium heparin, representing a year-on-year increase of 4.37%. This accounted for 44.64% of the heparin market. Both low-molecular-weight calcium heparin and low-molecular-weight sodium heparin are classified as low-molecular-weight heparins; they differ only in their manufacturing processes, but their mechanisms of action are essentially the same.
　　After subcutaneous injection of low-molecular-weight heparin calcium, there is no reduction in the pericytic matrix of intercellular capillaries, nor is vascular permeability altered. This essentially overcomes the side effect of easy bleeding associated with subcutaneous injections of sodium heparin. This product also exhibits significant activity against renin and aldosterone. Low-molecular-weight heparin calcium enjoys substantial market demand. Among domestically produced low-molecular-weight heparin calcium products entering the hospital market, those made in China account for 64.55%, an increase of 6.27 percentage points compared to the previous year.
　　In 2015, GlaxoSmithKline’s Xarelto accounted for 35.45%, a decrease of 11.31% compared to the previous year. Driving... Low-molecular-weight heparin calcium products made in China are experiencing rapid growth. Among them, Wanmaishu from Hebei Changshan Biochemical accounts for 31.93%, while Limaiqing from Hefei Zhaokewang holds a 21.33% share. The other four companies—Bopoqing from Tianjin Hongri, Unishu from Tongmeng Pharmaceutical, Cybori from Shenzhen Saibaoer, and Tempuronin from Tianpu Biochemical—collectively account for 11.29% of the market.
　　In the low-molecular-weight heparin calcium market, GlaxoSmithKline’s Fragmin was launched abroad in 1985 for hemodialysis indications, followed by its use for surgical thromboprophylaxis in 1987 and entry into the coronary syndrome market in 1998. Fragmin was registered in China in 1992 and officially launched in 1995. Shubilin had been experiencing rapid growth until, following the GSK incident, it saw a decline in the Chinese market in 2014 and continued to languish in 2015. This created development opportunities for domestic low-molecular-weight heparin calcium products, which experienced sustained growth from 2013 to 2015, with growth rates of 24.71%, 30.85%, and 15.59% respectively. It is estimated that domestic hospital usage has now exceeded 1 billion yuan.