ABSTRACT
The innovative biopharmaceutical industry is facing unprecedented challenges as it struggles to cope with a host of factors, highlighted by new and ever-increasing economic pressures. By way of one measure as example, the rate of new molecular entity (NME) approvals (both new drug applications [NDAs] and biologics license applications [BLAs]) by the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has essentially remained flat over the past decade, hovering around 23 NME approvals per year, as has the rate of priority NDA approvals, averaging just around 21 priority approvals per year, since 2004. Paired with patent expiries, the results are declining compound annual growth rates (CAGRs) in the industry, as measured by the 14 large-cap pharmaceutical companies. Industry-wide sales CAGRs declined from 10% in the 1999 to 2004 period to 6.7% in the 2005 to 2009 period to projections of 1.2% through 2014 (Goodman, 2009).
