| By Liu Yuanyuan, Asia Manufacturing Pharma |
| Wednesday, 24 June 2009 |
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At the 62th API China & INTERPHEX China, the pharmaceutical excipient sector took up more booth space than at last year’s show, with more exhibitors attending. Industry insiders attributed the increase to the fast development of the pharmaceutical industry, which contributed to the growth of the excipient sector. China’s pharmaceutical excipient market is highly fragmented. According to preliminary statistics, the market’s total production value was approximately RMB5 billion (approx. US$732 million) in 2008, with a year-on-year growth of approximately 25 percent.
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The global market for pharmaceutical excipients is experiencing fast growth. Factors such as globalization are promoting the development of China’s pharmaceutical excipient market.
As China has cost advantage, enough technology professionals, rich production experience and huge market potential, international drug |
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makers are moving their research and development and production centers to the country. Expanded production of preparations will certainly drive the demand for pharmaceutical excipients.
However, the absence of uniform standards and low industry concentration hinders the development of China’s excipient sector. Currently China has more than 500 pharmaceutical excipients, only 26.9 percent of which meet national drug standards. A majority of China’s excipient producers are small and medium-sized enterprises, with a low level of competence in research and development.
Advisors have suggested that the Chinese government close down those excipient manufacturers with outdated production processes. In addition, China’s State Food and Drug Administration is considering the establishment of a drug master file (DMF) system this year, which will encourage drug makers to improve product quality.
According to China Pharmaceutical
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Research and Development Association deputy director Kong Zhenyu, China’s pharmaceutical .
excipient market will be dominated by a few manufacturers with strong brands, high-quality products, innovative technologies and standardized operation. Meanwhile, foreign manufacturers will set up wholly-owned production bases or joint ventures in China, bringing the competition in the local pharmaceutical excipient market to a higher level.
Given the booming business in preparations for biological engineering and insoluble drugs, the outlook for China’s pharmaceutical excipient sector is promising.
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