Crunching the numbers
Biopharmaceuticals account for approximately 10% of the global prescription drug market, based on a 2007 global prescription drug market of $712 billion, according to IMS Health. Global sales of prescription biotechnology drugs increased 12.5% to more than $75 billion in 2007. This rate of growth was nearly double the rate of growth of 6.4% for the overall global pharmaceutical market in 2007, and expectations remain high. Biologics are forecast to grow 11–12% in 2009, again surpassing projections for growth in the global pharmaceutical market, which is expected to increase 4.5–5.5% in 2009, according to IMS Health (1, 2).Capacity utilization
Over the past several years, capacity for mammalian cell-culture systems has dropped significantly—from 76.4% in 2003 to 63.2% in 2008, although during the past four years, the decline in capacity utilization has moderated, according to the BioPlan survey. Since 2005, the change in capacity utilization for mammalian cell-culture systems has decreased at a compound annual growth rate (CAGR) of –2.8% (3). Capacity utilization for microbial fermentation has declined as well—from 71.0% in 2003 to 53.3% in 2008. Since 2005, however, the decrease has slowed to a CAGR of –2.9% (3).
"In 2003, the biopharmaceutical industry's utilization rates exceeded 76%," explains Langer. "This period was a capacity-crunch time that led to facility build-outs by both biotherapeutic developers and contract manufacturers. The resulting expanded capacity brought the utilization rate down so that by 2006, it appeared that a stable capacity utilization rate would be around 63%."
These results are further supported by the perception of biotherapeutic developers and CMOs as they relate to capacity constraints. In the study released in 2008, although fewer than 2% of CMOs said that they were experiencing "severe" constraints, 13.4% of drug-developer respondents and 14.6% of CMO respondents said that they were experiencing more than just "minor" capacity constraints. In the study released this year, approximately 45% of developer respondents and 43% of CMO respondents said that they were experiencing "no constraints" (3). These findings indicate "a significant relaxation in CMO capacity constraints," says Langer.