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
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Full Phase IIIb BATURA Trial Results Show Airsupra Cuts Severe Exacerbations by 47% in Mild Asthma
May 20th 2025Results from the pivotal BATURA trial show that Airsupra (albuterol/budesonide) significantly outperformed albuterol monotherapy in reducing severe asthma exacerbations and systemic corticosteroid exposure, reinforcing its role as a next-generation, anti-inflammatory rescue therapy for mild asthma patients.
