| By Cindy Wu, Asia Manufacturing Pharma |
| Monday, 11 May 2009 |
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As an anti-rejection drug used in organ transplants, rapamycin, also known as Sirolimus, has witnessed speedy growth over the past few years since its launch in China. The market is expected to see further expansion with an increasing number of organ transplants such as for kidneys performed in all levels of hospitals across
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the country. Rapamycin expected to defeat ciclosporin in terms of output China’s immunosuppressant market, traditionally dominated by ciclosporin drugs including sandimmun, sandimmun neoral and cyspin, has experienced robust growth since 2000, reaching almost RMB2 billion (approx. US$295 million).
However, the State Food and Drug Administration of China has approved seven domestic drug makers as producers of rapamycin since 2001, including Zhejiang Xinchang Pharmaceutical Factory, Fujian Pharmaceutical and Hangzhou Zhongmei Huadong Pharmaceutical under the condition that US-made rapamycin would fail to get administrative protection from the government.
Accordingly, China’s rapamycin production is estimated to achieve five tons annually, higher than the two tons recorded by ciclosporin over the recent years through process innovations and breakthroughs in technology.
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In the process, Sichuan Yibin Wish Pharmaceutical has become a frontrunner in the market with an annual production capability totaling one ton.
End markets waiting for further expansion
Sales of rapamycin in Chinese domestic market are expected to be in a range between RMB500 million (US$73 million) and RMB 600 million (US$88 million), yet lower than the sales of sandimmun, mainly because most physicians are not familiar with the novel agent.
However, homegrown rapamycin has a potential to be a major category in the anti-rejection drug market due to declining costs of production and dropping selling prices. Retail price for homegrown rapamycin in the market has seen a sharp drop in recent years and now sells for RMB580 (US$85) per 100 tablets, well below the price of US$525 per 100 tablets in the United States.
Furthermore, insiders expect the selling price to see a further decline due to home-based producers having developed new zymosis technology for rapamycin which led to a large cut in production costs.
New applications boost market demand
In 2005, researchers in Western countries found that rapamycin also can be used in conjunction with coronary stents to prevent restenosis |
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in coronary arteries following balloon angioplasty.
This finding enabled the drug sales in global markets to show steep growth and potentially exceed paclitaxel over time.
Recently, surveys carried out in other countries also revealed that rapamycin can play an active role in treating cancers through enhancing the anti-cancer effects of other chemotherapy drugs and extending the survival rate of patients by 28 percent.
All the same, most domestic hospitals are not yet aware of the newly discovered applications and still take rapamycin merely as an immunosuppressant, signaling the market still has room for major expansion. Sales of rapamycin in global markets reached US$1.5 billion in 2007. As time goes by, the new applications are expected to largely boost rapamycin’s market share and make the multi-purpose drug a high growing agent in the market.
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