“This groundbreaking study highlights the depth and breadth of risk inherent in the drug development process more comprehensively than any other previous study,” said
The study builds on the findings from previous studies and uses a broader, deeper, and larger sample than previous reviews of clinical trials and approvals data using the BioMedTracker (BMT) proprietary database of close to 4,500 drugs and over 7,300 unique development paths.
"Having an up-to-date and detailed picture of clinical success rates, and ultimately how likely a drug is to be approved, is vital to our clients when making investment and business decisions. We believe that this study provides the market with an accurate and comprehensive picture of the relative difficulty of achieving product approval in the U.S.," remarked
Using clinical trial data from the past nine years, the analysis examines the most recent probability of success by treatment type, phase of development and therapeutic area. Before new therapies hit the market, they have to pass a number of hurdles – meeting regulatory thresholds for efficacy and safety as well as maintaining a competitive internal corporate profitability and marketability profile.
Key findings from the study include:
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
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
The paper is available to Nature Biotechnology subscribers.
BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across
BioMedTracker (www.biomedtracker.com) is an independent research service that offers proprietary clinical assessments and patient-based revenue forecasts of developmental drugs within a comprehensive and intuitive web-based platform. Clients from the pharmaceutical, biotech, and investment industries rely on BioMedTracker for its insight on the likelihood of approval, commercial potential, and future data and regulatory catalysts for drugs within the competitive landscape of every important disease and indication.
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