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FDA Breakthrough Therapy Designation And Oncology Statistics

December 11, 2014

As reported widely in the media and the literature, oncology indications make up a significant percentage of FDA Breakthrough Therapy (BTD) Designations. The IMS Institute for Healthcare Informatics publishes in November 2014 the report, “Global Outlook For Medicines Through 2018”. This report takes a look at medicines and global spending levels through 2018.

Here are a few observations for global drug trends from the IMS November report:

•   Global drug spending is forecast to reach nearly $1.3 trillion by 2018 – a 30% increase over 2013

•   Increase in the # of Orphan Drug Designation (ODD) & Breakthrough Therapy Designation (BTD) applications and steady approval rates are the expected trend

•   In 2014, as of this IMS Report publication date, there are 12 drugs approved in the US that have a FDA BTD

•   1st FDA BTD biologic (Meningococcal Group B vaccine) is approved

•   Increase in the # of immunotherapy oncology treatments – with many receiving the FDA BTD, with potential for multiple follow-on indications

•   Acceleration of oncology medications, with many getting FDA BTD

•   46% of FDA BTDs are for an oncology indication

•   New immunotherapies, PD-1 & CDK inhibitors, are becoming a strong growth trend for oncology indications

•   Globally, oncology is 31% of the total drug pipeline, with biologics making up 45% of the late stage oncology pipeline

•   Spending on oncology medicines globally is expected to grow by over 50% to exceed $100 bllion in 2018.


The Orphan Druganaut Blog has supplied the following statistics for oncology products:

•    53 % of the FDA BTDs receiving approval are for an oncology indication (as of 12/03/14)

•    Of the 58 FDA BTDs reported by sponsor companies (as of 12/01/14), 43% are for an oncology indication.

Thus the FDA Breakthrough Therapy Designation is playing an important role in helping to accelerate drug development and the approval process for oncology indications.

Please Note: “3D Bar Graph Meeting” by “The Gold Guys Blog” [CC-BY-SA-2.0] via Wikimedia Commons.

Copyright © 2012-2014, Orphan Druganaut Blog. All rights reserved.

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