Updated on 10 January 2014
Key findings from the study include:
• The overall success rate from Phase I to FDA approval is nearly 10 percent. This number is comprised of lead and secondary indications.
• The study also shows that large molecule drugs are twice as successful in gaining approval compared to small molecule drugs.
The BMT/BIO study examines the clinical Phase status of these development paths as of year-end 2003 through year-end 2011, which accounts for more than 5,800 Phase transitions. The study determines the percentage of drugs that advance to the next Phase of development versus those that are suspended and therefore the likelihood of a drug ultimately being approved by the FDA. The data spans all companies (Big Pharma and biotechnology, both public and private) conducting development on therapeutics for approval in the U.S.
The BMT/BIO analysis includes breakdowns by indication, disease group, size of company, molecule type, route of administration, New Molecular Entity (NME) versus Biologic versus non-NME. The data encompasses the most recent data available during a time in which FDA requirements for approval have been in flux. Included in the analysis is an in-depth look at FDA decisions and approval rates by FDA review number.