The Cost to Develop an Approved New Drug Now Exceeds $2.5B

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-12-01-2014, Volume 23, Issue 12

Based on a recently completed analysis, the Tufts Center for the Study of Drug Development (Tufts CSDD) estimates that the cost to develop a new prescription medicine that gains marketing approval is now $2.6 billion. This figure includes $1.4 billion in direct out-of-pocket costs to develop the new prescription drug, plus the high cost of drug failures and the capitalized costs spent over a lengthy drug development cycle time. 

The estimated cost to develop an approved drug in 2003 is $1.04 billion (expressed in 2013 dollars). The updated $2.6 billion cost estimate represents an 8.5% compound annual growth rate over the 2003 level. Factors that have likely contributed to this high and rising cost to develop an approved drug include larger and more complex clinical trials and declining drug development success rates.


The Price of Innovation

- Tufts CSDD