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Biomanufacturing capacity for biosimilars: Is there enough?

The impending patent cliff for many high-value innovator biopharmaceutical products offers significant opportunities for biosimilar companies, whose market is estimated to grow from $243 million in 2010 to $3.7 billion by 2015 in the United States, Europe, and Japan1. One primary success factor for individual companies will be access to biopharmaceutical development and manufacturing capacity, and determining the overall demand and the corresponding capacity requirements for emerging biosimilars can be difficult. In order to decrease cost of goods and maximize returns on investment, biosimilar companies must determine whether to invest in their own manufacturing capacity or outsource the manufacturing to a contract manufacturing organization (CMO). This presentation will explore the effect of biosimilar development on overall manufacturing capacity and will evaluate strategic options for individual biosimilar companies.

1 Datamonitor. Pharmaceutical key trends 2011 – biosimilar market overview [Internet]. London (GB): Datamonitor; 2011 Feb [cited 2011 Jun 28]. 6 p. Available from: