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The Protein Production Challenge

Executive Summary

Growth of the biopharmaceutical market is going to create critical shortages in protein manufacturing capacity with severe consequences for pharmaceutical companies' ability to deliver products and meet rising market expectations. Companies whose pipelines are heavily reliant on expression systems with limited capacity are particularly vulnerable and should now be making strategic make/buy/collaborate decisions. Indeed, in the short term as capacity tightens, contract manufacturing organizations will gain greater leverage, enabling them to negotiate more strategic business relationships with higher financial returns. In the longer term, however, innovator companies are looking beyond cell culture to alternative technologies such as transgenic animals as a future production platform, in part, because they provide greater flexibility.

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ProteomTech Inc.

ProteomTech Inc. has developed a protocol for speeding up the protein refolding process so it can be completed in 24-to-48 hours. It's strategy for generating revenues includes contract manufacturing for the research market, a service business that may one day grow to include manufacture of protein drugs

What's Driving Amgen?

Despite its CEO's professed distaste for biotech acquisitions, Amgen was willing to pay $16 billion for Immunex, in a bold move that ensures its growth momentum even as its key product, EPO, ages and its newly launched replacement faces uncertain prospects. Immunex makes a blockbuster rheumatoid arthritis drug, Enbrel, which it forecast will have sales of $4 billion by 2005. Amgen thinks it can drive Enbrel sales further, even though it is projecting a smaller market of $3 billion for the drug by 2005.

Shortfall Happens

The dark side of outsourcing is coming into view: worldwide capacity for biological manufacturing is currently maxed out. Firms with biological products still in clinical development could find their progress to market delayed, if they can't make enough protein for trials. Others unable to meet demand for approved products will have to reconcile themselves to lost sales. Demand will likely exceed capacity for several years to come--putting companies that do have manufacturing capacity in strong bargaining positions.

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