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A Method for Forecasting Industry-wide Biopharmaceutical Manufacturing Capacity Requirements

By: Thomas C. Ransohoff and Howard L. Levine, Ph.D.
Reprinted with permission of Advances in Large Scale Biopharmaceutical Manufacturing and Scale-Up Production, 2nd ed., ASM Press Nov 2007

The ability of biopharmaceutical companies to manufacture sufficient quantities of their products to meet market demand is a critical risk factor. Concern over capacity forecasting has been a driving force, leading to a number of analyses on the topic of supply and demand for manufacturing capacity. Because of the enormous uncertainties associated with development of a biopharmaceutical product, the estimates for future supply and demand for manufacturing capacity is continually changing as new data from clinical trials, market penetration rates for new products, and progress on construction projects emerge. Any analysis of manufacturing capacity must be updated on a regular basis in order to provide a current and accurate picture of industry-wide utilization rates with a historical perspective. Finally, recognizing that the biopharmaceutical industry is a global one, ongoing analysis of manufacturing supply and demand enables tracking of geographical trends in manufacturing capacity.