The pharmaceutical industry, especially Big Pharma, has dramatically shifted its R&D focus from its historical concentration on small molecule drugs to include a rapidly increasing number of biotechnology products, according to an analysis from the Tufts Center for the Study of Drug Development (CSDD).
Tufts CSDD found biotech products, which accounted for only 7% of revenue generated by the 10 top-selling pharmaceutical-biotech products worldwide in 2001, accounted for 71% of the 10 top-selling products in 2012.
The transformation of Big Pharma has been driven as much by new technologies that have enabled development of new products that improve disease outcomes and command high prices as by the expiring patents on many top-selling small molecule drugs, said Kenneth I. Kaitin, Tufts CSDD director.
Helping to drive that evolution has been the development of novel technology platforms over the last three decades, which has spurred an extensive pipeline of products across a wide range of therapeutic areas, he said. In 1989, for example, only 13 biotechnology products were commercially available. By 2012, that number had grown to 210.
“The notion that large pharmaceutical companies primarily develop small molecule drugs no longer holds,” Kaitin said.
The analysis also found the number of biotech products in clinical trials grew 155% in 11 years, from 355 in 2001 to 907 in 2012, with Big Pharma in 2012 engaged in about 40% of all biotech products in clinical development. Financing of biotech research increased nearly 10-fold in a decade, from $10.5 billion in 2001 to $103 billion in 2012, and worldwide growth in biotechnology product sales grew 353% between 2001 and 2012, from $36 billion to $163 billion.