The biotechnology industry continues to show its strength in bringing new drugs to market. A recent analysis by the Tufts Center for the Study of Drug Development shows that over the decade so far, big pharma’s share of new molecular entity approvals has declined, giving way to innovative products offered by small and midsized pharmaceutical and biotechnology companies.
Tufts CSDD’s report also documents the rise in collaborations between big pharma and small or midsized biopharmaceutical manufacturers that potentially have viable products in development. These joint ventures seem to be paying off — the number of new drugs that entered clinical testing between 2003 and 2005 increased 52 percent over the period from 1998 to 2002.
Approvals increasingly are for “special designation” medications — orphan or fast-track products. U.S. Food and Drug Administration policies has supported this emphasis on patients with serious or rare illnesses through programs that hasten the development and review of specialty products.
SOURCE: OUTLOOK 2007, TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT, BOSTON