Pharma Moving towards Biologics in the Lab and the Market

An interesting article from the April 9, 2012 issue of Genetic Engineering & Biotechnology News summarizes two studies that confirm an industry shift towards biologics over small molecule drugs. Specifically:

[The UK law firm, Withers & Rogers finds that] biologics accounted for 60% of the patents filed by the top 10 pharma companies in 2009…The number of biologic patent applications in ’09 increased by 14.5% from two years earlier, even though ’09 saw 31.5% fewer overall patent filings than ’07.

Further, this trend is paying off at the commercial level. Per KMR Group’s Pharmaceutical Benchmarking Forum:Biologics hold better prospects than traditional small molecules of advancing all the way from the lab to the clinic to the market…more than 25% of large molecules in Phase II between 2006 and 2010 reached the market compared to about 10% of small molecules…12% of biologics were calculated to advance from preclinical to clinical studies, compared with just 2% of small molecule drugs. The biologics percentage clearing each successive clinical review hurdle grows to 17% at Phase I, 27% at Phase II, leaping to 58% at Phase III, and 82% at the registration phase. For small molecule drugs, according to KMR, success was calculated to be 4% at Phase I, 9% at Phase II, 44% at Phase III, and 78% at registration.


Todd Clark
Todd Clark

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