CHICAGO, Illinois, February 28, 2012 – Although industry’s large molecule success rates in Development have recently declined, they continue to be significantly higher than that of small molecules. Over one-fourth of large molecules in Phase II are calculated to reach market, compared to about 10% of small molecules, for example.
This analysis is based on detailed data from the Pharmaceutical Benchmarking Forum (PBF) -- which consists of the leading pharmaceutical companies -- and offers the most reliable foundation for understanding rates of success. It covers all therapy areas and examines industry performance over the most recent 5 years.
“The difference between large and small molecule attrition rates is being carefully scrutinized across the Industry,” according to Scott Martin of KMR Group, the firm facilitating the analysis, “There has been considerable attention given to the reasons for this variance, as well as the implications of this for future portfolios. One of the most intriguing issues is whether large molecule success rates will decline to the point where they resemble small molecule rates and, if so, how soon this will occur.”
Founded in 1997, the PBF is the Industry’s premier source for R&D analytics. In 2011 the following submitted data for this analysis: Abbott, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Johnson & Johnson, Merck Research Labs, Novartis, Pfizer, Roche, and Sanofi. The PBF examines performance for areas within R&D as well, with potential detailed studies of Pharmaceutical Development and Biomarkers this year, for example.
Notes to Analysis:
“Small” refers to chemical molecules; “Large” refers to biologics (including peptides); vaccines are excluded
“Industry” means all data from contributing companies for given molecule size is combined into single analysis (as if they were a single company)
Pure method employed: for given molecule size, all in-licensed/acquired NMEs excluded from calculation for the phase in which they entered, but included for all subsequent phases
Method to calculate Success Rate for small molecules: (number of small molecule successes in phase) / ((number of small molecule terminations in phase) + (number of small molecule successes in phase)); same method applied for large molecules
Percent calculated to achieve 1 Approval for small molecules: apply multiplier method for each phase for small molecules (e.g., Phase 2 rate starts with industry portrait Phase 2 success rate and multiplies all subsequent phase success rates to obtain 9%); “portrait” means all Industry data treated as a single company
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KMR has been working exclusively in the biopharmaceutical R&D industry since the early 1990s. KMR is a leader in benchmarking, analytics and performance management. With an exclusive focus on biopharmaceutical R&D and unrivaled commitment to data quality, KMR provides industry with the experience and knowledge to produce clear and uncompromising results in the form of reports, tools and presentations. We use our extensive, unparalleled datasets and experience within the industry to add value to the most pressing business questions. Please visit our website at https://www.kmrgroup.com