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| home > pmps > spring 2003 > contract manufacturing of biopharmaceuticals: the regulatory framework |
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Pharmaceutical Manufacturing and Packing Sourcer
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Currently there is a significant shortfall in biopharmaceutical manufacturing. At present, biopharmaceuticals account for some five per cent of global health care sales. However, it is anticipated that this figure will increase significantly in the coming years. In 2001 biopharmaceuticals comprised around 29 per cent of new FDA approvals. It is estimated that there are approximately 350 biologics in late stage clinical trials and a further 1,000 in late stage development.
The global microbial fermentation capacity may need to double by 2005 and demand would therefore exceed capacity by a factor of four for GMP processing. The total world market size for biopharmaceutical manufacture is likely to grow from $780 million in 1998 to around $1,600 million for 2002. The US currently accounts for 58 per cent of the total market and Europe for 37 per cent.
Currently the requirement for microbial fermentation significantly exceeds that for mammalian cell culture, although it is likely that the cell culture market will grow more rapidly than will microbial fermentation. For many small companies, the use of contract manufacturing facilities is the only available option for producing materials for clinical trials and market.
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