Clinical Development Success Rates and Contributing Factors 2011-2020: Download the Report
Clinical Development Success Rates and Contributing Factors 2011-2020
Biologics have 9.1% likelihood of making it through the clinic to approval, compared to 5.7% for new molecular entities, according to this analysis of 10 years of Biomedtracker drug development data by BIO, Informa Pharma Intelligence and QLS, available for download here.
Biologic products advance through clinical development with a higher success rate than traditional small molecules, a new analysis of clinical development success from Informa Pharma Intelligence, the Biotechnology Industry Organization and the Quantitative Life Sciences shows.
“Biological complexity in drug modalities generally leads to higher LOA,” or likelihood of approval, the analysis concludes. New molecular entities – conventional small molecules – have a 5.7% chance of moving through all three phases of clinical trials to US Food and Drug Administration approval, while biologics had a 9.1% probability. Vaccines – with 10 times fewer candidates than other biologics – clocked in with a 9.7% chance of a Phase I candidate eventually gaining approval.
Informa and BIO analyzed a decade of data collected by Informa’s Biomedtracker database, identifying 12,728 clinical phase transitions, which mark a program’s movement out of a clinical phase, commonly by advancement or suspension. QLS Advisors applied machine learning to “uncover underlying drivers of success” in the 9,704 clinical drug development programs included in the study, “Clinical Development Success Rates and Contributing Factors, 2011-2020,” published 17 February 2021.
Overall, for all modalities, the LOA from Phase I was 7.9% for the 2011-2020 period.