Tufts Report Shows Dramatic Shift from Small Molecule to Biologic Drugs

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Tufts CSDDLast week, the Tufts Center for the Study of Drug Development (CSDD) at Tufts University released a report showing that the pharmaceutical industry has dramatically shifted its focus from a historical concentration on small molecule drugs to include an increasing number of biotechnology drugs.  In a press release announcing the release of the Tufts CSDD Impact Report, the independent, academic, non-profit research group noted that biotech products, which in 2001 accounted for 7% of the revenue top 10 selling biopharm products worldwide, accounted for 71% of the top 10 selling products in 2012.  Tufts CSDD Director Dr. Kenneth Kaitin explained that "[t]he 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."

The transformation of the pharma pipeline can be seen in the number of commercially available biotech drugs, which the report indicates rose from only 13 in 1989 to 210 by 2012, with worldwide sales growing by 353% from $36 billion in 2001 to $163 billion in 2012.  The industry's R&D focus also shows evidence of the shift, with clinical trials of biotech products rising 155% from 355 in 2001 to 907 in 2012.  The report indicates that in 2012, the 21 largest pharmaceutical companies had 429 biotech drugs in clinical development, and that 58% of these products were monoclonal antibodies.  The report also notes that Big Pharma was involved in nearly 40% of biotech drug clinical development in 2012.

Biotech financing also showed a significant increase between 2001 and 2012, increasing from $10.5 billion to $103 billion over this period.  Finally, the report compares biotech company acquisitions by Big Pharma in the 1998-2002 and 2008-2012 time frames, and notes that such acquisitions increased five-fold from 15 in the earlier time frame to 75 in the later time frame.

In view of the report's findings, Dr. Kaitin concluded that "[t]he notion that large pharmaceutical companies primarily develop small molecule drugs no longer holds."

 


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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