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Forecasting Industrywide Biopharmaceutical Manufacturing Capacity Requirements

By: Thomas C. Ransohoff, Robert E. Mittendorff II, and Howard L. Levine

Among the many risks biopharmaceutical companies face is whether or not they will be able to manufacture sufficient quantities of their products to meet market demand. Recent concerns over a potential biomanufacturing “capacity crunch,” especially for monoclonal antibodies, were sparked by high-profile capacity shortages including those by Immunex and Berlex. Such shortages have led to serious consequences including loss of market share and acquisition by other companies.

Because of the enormous uncertainties associated with developing a biopharmaceutical product, the future supply and demand for manufacturing capacity continually changes as new data from clinical trials, market penetration rates for new products, and progress on construction projects emerge. Therefore, any analysis of manufacturing capacity must be updated on a regular basis providing a current picture of industrywide utilization rates with a historical perspective. A detailed analysis of manufacturing supply and demand helps companies identify capacity drivers and long-term trends in biopharmaceutical manufacturing. It can make it possible to track and validate industrywide statistics, such as probability of success at various clinical stages and commercialization. Finally, ongoing analysis of manufacturing supply and demand also enables managers to track geographical trends in manufacturing capacity.

In this chapter, we present types of analysis that improve the ability – on an industrywide or on a company-by-company basis – to forecast potential future shortages or gluts in manufacturing capacity.