Drop in current clinical development and success rate for drug delivery enabled products

Oct 13 2009

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.

"DD09 updates and expands our analysis of the development times and success rates for drug delivery enabled products," stated Josef Bossart, Ph.D., author of the report and managing director of Bionumbers. "This year's report also includes estimates of development costs and exclusivity periods enjoyed by drug delivery enabled products. The data provided in this report can help companies estimate and improve the development and approval performance of their drug delivery enabled products. A number of strategies and technologies are identified that can provide for much shorter development times and higher approval rates. Some success rates exceeded 60%, while average clinical development and approval times for selected product groups were as low as 3.5 years."

In addition to overall figures, the report provides an in-depth analysis of the impact of a wide range of variables on product approval success rates, and clinical development and approval times. The report includes an easy-to-use algorithm that permits companies to estimate their own product development and approval times based on the report findings.

The report, "DD09 - Drug Delivery Product Success Rates, Development Times, Costs and Marketing Exclusivity," is available from Bionumbers, (512) 535-3613 or http://www.bionumbers.com.