FDA Breakthrough Therapy Designation And Oncology Statistics
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.
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