The Cost to Develop an Approved New Drug Now Exceeds $2.5B
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
Driving Diversity with the Integrated Research Model
October 16th 2024Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and challenges with achieving greater diversity in clinical trials, how integrated research organizations are bringing care directly to patients, and more.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
Zerlasiran Achieves Significant Sustained Reduction in Lipoprotein(a) Levels with Infrequent Dosing
November 20th 2024Zerlasiran, a novel siRNA therapy, demonstrated over 80% sustained reductions in lipoprotein(a) levels with infrequent dosing in the Phase II ALPACAR-360 trial, highlighting its potential as a safe and effective treatment for patients at high risk of cardiovascular disease.
