Bionumbers, LLC announced top-line figures from the second report in its Parameters of Performance series: "DD09 - Drug Delivery Product Success Rates, Development Times, Costs and Marketing Exclusivity."
The report evaluated the impact of multiple product development parameters on success rates and development times for more than 600 drug delivery enabled products in development between 1993 and the end of 2008.
The Bionumbers report estimates the current overall clinical development and FDA regulatory success rate for drug delivery enabled products to be 24%. This is a drop from last year's estimate of 26%. Success rates for defined subsets ranged from single-digits to more than 50%.
The average time for clinical development and regulatory product approval was 5.8 years, with an individual product range of 2 to 16 years. This is an increase of 0.1 years over last year.
The report also estimates the average direct clinical development and regulatory costs for an approved drug delivery enabled product to be in excess of $80 million in 2009 dollars. This figure reflects only out-of-pocket costs and does not factor in success rates or the cost of capital.