Productivity continued to decline, with a total of only 18 new molecular entities approved, just four of which were biologics. On average for 2004–2006, the 15 largest pharmaceutical firms garnered 19 new product approvals, compared with 26 for biotech. With the drop in productivity, not only has pharma spending steadily increased but biotech firms also saw a jump in R&D. The good news is that Investigational New Drug submissions and New Drug Applications continue to be above average, with the latter hitting a high not seen since 1999.

Biotech and big pharma productivity

Geographic origin of FDA applicants

Number of drugs in clinical trials in Europe

FDA approval times for NMEs

Approvals of small- and large-molecule therapeutics

Number of FDA applications