Thursday, February 11, 2010

The cost and time of developing and bringing a drug to market !

The cost and time of developing and bringing a drug to market is over $900 million and often takes as long as 15 years, if not longer. The cost is mainly attributed to extensive failure rate of clinical trials, 80 % of the drugs fail to clear this stage. A recent study from the Tufts Center for Drug Development concluded that 75% of the drugs that enter phase I move forward to phase II, however, only 42% of those progress to phase III. Of those phase III drugs, only 64% successfully make it through to FDA approval.

In some ways investing in a drug trial is like betting you r money in a casino, of course after analyzing which compounds have a better chance of success. The Food Drug Administration (FDA) estimates that it takes approximately eight and- a-half years to study and test a new drug before it can be approved for the general public. This estimate includes clinical trials using human subjects through the FDA approval process. Preclinical testing can take 6.5 years to complete.

In contrast, the amount paid to market these products is minimalistic compared to the overall cost. It would be interesting to study how much influence does marketing have on the doctors decision as compared to the therapeutic effect of the drug ?