Hydroxyethyl Starch Production and Sales

By Zhang Lun

Hydroxyethyl starch is an excellent plasma substitute mainly used to treat hemorrhage, trauma, infection and toxic shock. It is also used to treat diseases like hypotension that occurs after anesthesia and thromboangiitis obliterans.

Production

In the 1960s, China produced the first generation of hydroxyethyl starch products. From 1998, foreign hydroxyethyl starch products have been allowed to enter the Chinese market. In the 21st century, due to the broad market prospects of hydroxyethyl starch, domestic enterprises have developed hydroxyethyl starch product series.
At present, the domestic hydroxyethyl starch API (active pharmaceutical ingredient) producers include Sichuan Kelun Pharmaceutical Co., Ltd., China Resources Double-crane Pharmaceutical Co., Ltd., Shandong Qidu Pharmaceutical Co., Ltd., Jiangsu Lianyungang Runzhong Pharmaceutical Co., Ltd., Wuhan HUST Life Science & Technology Co., Ltd., Chengdu Bojia Pharmaceutical Co., Ltd., Chongqing Daxin Pharmaceutical Co., Ltd. of PKU International HealthCare Group, Chifeng Disheng Pharmaceutical Co., Ltd., Tianjin Shuangwei Biopharmaceutical Co., Ltd., Yichang Sanxia Pharmaceutical Co., Ltd., Hebei Guolong Pharmaceutical Co., Ltd., Huayin Pharmaceutical (Rizhao) Co., Ltd., Beijing Yimin Pharmaceutical Co., Ltd. and Mudanjiang Zhongtian Pharmaceutical Co., Ltd. Until now, CFDA (China Food and Drug Administration) has awarded 38 GMP certificates for hydroxyethyl starch production.
At present, in China’s pharmaceutical market, hydroxyethyl starch formulation products are mainly injectable, and China has dozens of hydroxyethyl starch formulation producers.  
In the domestic market, China has 27 approval numbers for imported hydroxyethyl starch, of which 6 are for API, and major API enterprises include Fresenius Kabi of Germany and B.Braun Melsungen AG of Germany. As for imported formulations, major varieties include hypertonic hydroxyethyl starch 200/0.5 and sodium chloride injection (5 approval numbers), hydroxyethyl starch 200/0.5 and sodium chloride injection (6 approval numbers), and hydroxyethyl starch 130/0.4 and sodium chloride injection (10 approval numbers). Producers are Fresenius Kabi of Germany and B. Braun Melsungen AG of Germany.

Market

In the 20th century, China mainly used hydroxyethyl starch 20 and 40 series products, and the annual sales volume once reached 40 million bottles (500ml×1). However, due to the low molecular mass and poor volume expansion effect of plasma, China’s production and clinical application of the products were restricted.
In 1998, hydroxyethyl starch 200/0.5 produced by Fresenius Kabi of Germany was approved to enter the Chinese market, and the product was quickly disseminated as soon as it entered. In 1990s, the domestic supply of blood products was becoming increasingly tense, so the price rose constantly. Artificial plasma substitutes were applied in clinics at that time, hydroxyethyl starch was quickly popularized in hospitals, and the market sales continued to rise. In 2008, China’s total sales value of plasma substitutes was RMB950 million.
In 2003, Fresenius AG and Beijing Double-crane Pharmaceutical Co., Ltd. jointly established a joint venture – Beijing Fresenius Kabi Pharmaceutical Co., Ltd. Shortly after the establishment of the joint venture, hydroxyethyl starch 130/0.4 was approved for production according to Category 4 of New Medicines. The product quickly entered the Chinese pharmaceutical market soon after being put into operation; in particular, it was widely used in major hospitals of big cities, and its sales value grew constantly.
At present, the plasma expanders commonly used in the domestic clinic include hydroxyethyl starch, dextran, gelatin and albumin. Of these, hydroxyethyl starch 130/0.4 and dextran have the most extensive application in domestic clinics and have been officially included in the National Essential Medicine List (2012 Edition).
There are many hydroxyethyl starch formulation producers in the domestic pharmaceutical market; however, a small number of varieties have trade names, and they are produced by Shanghai Changzheng Fumin Jinshan Pharmaceutical Co., Ltd., China Resources Double-crane Pharmaceutical Co., Ltd., Nanjing Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Beijing Fresenius Kabi Pharmaceutical Co., Ltd., etc. It is reported that the annual sales value for China Resources Double-crane Pharmaceutical Co., Ltd. has exceeded RMB100 million.
In 2012, China’s sales value of hydroxyethyl starch reached around RMB1.3 billion, and the consumption in clinics reached tens of millions of bags. It is expected that in the next few years, China’s annual demand for hydroxyethyl starch formulation products will reach 100 million-150 million bottles, consuming 3 500-5 000 tons of hydroxyethyl starch 130/0.4 API annually. According to the calculation based on the average price of hydroxyethyl starch 130/0.4, the scale of API and formulations will be RMB1.0 billion-2.0 billion and RMB5.0 billion-7.0 billion, respectively. At present, in the domestic pharmaceutical market, hydroxyethyl starch 130/0.4 is very well accepted, and its price is much higher than that of similar products. Hydroxyethyl starch 130/0.4 will come to occupy a larger share of the whole hydroxyethyl starch market.