With the passage of the FDA Safety and Innovation Act of 2012 (FDASIA), the Breakthrough Therapy Designation (BTD) was introduced as the newest mechanism to facilitate expedited development and review. Here we provide an overview of the BTD pathway and its evolution over the past three years.

This concise analysis examines:

• Therapeutic breakdown
• Insights on approval timing
• Industry players
• Licensing and investment
• Upcoming approvals

This report is a collaborative effort between Medtrack and BioMedTracker. Medtrack’s integrated platform offers insights into pharmaceutical pipelines, sales, epidemiology, patents and more, to give a comprehensive view of the biopharmaceutical business landscape. For more information about Medtrack, please visit Medtrack here.

An accompanying infographic summarizing the details of this report can be viewed here.

For our disclosures, please read the BioMedTracker Research Standards.