So now that you have a deeper sense of the complexity and time required to develop a new drug, what do you think the odds are that a new drug makes it all the way to your pharmacy’s shelf?
If you said “not high!” you’re right! Fewer than 10% of drugs that enter preclinical testing even make it into clinical trials. From there, approximately 63% of drugs that enter Phase I trials move on to Phase II, and about 30% of *those* drugs progress to Phase III. Once in Phase III, the success rate is higher; 58% of drugs at this stage win FDA approval. (Source: Clinical Development Success Rates 2006-2015 )
So when we think about the entire process, the overall success rate for a drug from discovery to FDA approval is only around 1%!
The FDA created this comprehensive summary infographic of the whole process. Take a look.
In addition to the time involved, every stage in drug development costs a mind-boggling amount of money. The biopharmaceutical industry invests significant resources and time into this process while knowing that any one drug candidate is highly unlikely to make it all the way to patients. There’s a lot of risk and uncertainty involved. And as a result, successful drugs that make it to the end represent substantial scientific and financial achievements for the scientists and companies involved.