R&D costs and number of registered new molecular entities (NMEs). The costs of R&D (yellow bars) rise in an exponential-like fashion, whereas the number of FDA NME approvals declines. The figure is coloured and reprinted from FDA (2008), under FDA copyright policy. Lagging 5 year average includes new chemical entities (NCEs) and licensed products (BLAs). BLAs included 1986 onward; biologic approvals in prior years assumed negligible. Sources: NME data for 1966–1971 from Peltzman (1973). NME data for 1972–1979 as reported in Hutt (1982). NME data for 1980–2007 from Parexel's Pharma R&D Statistical Sourcebook 2009/2010, FDA and PhRMA. Industry R&D spend data from PhRMA Annual Membership Survey, 2008 and Parexel 2009/2010.