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September 20, 2004
Drug Development: The Current Odds
Posted by Derek
The August issue of Nature Reviews: Drug Discovery has an alarming article on the attrition rates in drug development. I often get questions about these figures, and it's good to have a fresh look at the data. Among the ten largest pharma companies, in the period 1991-2000, here's the breakdown:
38% of the drugs taken in the the clinic dropped out in Phase I (safety / blood levels.)
60% of those remaining failed in Phase II (basic efficacy.)
40% of the remaining candidates failed in Phase III (big, expensive efficacy.)
And 23% of the ones that made it through the clinic failed to be approved by the FDA.
You can do the math as quickly as I can: that translates to about a 11% success rate from starting in the clinic. And consider that for someone like me, back in the research labs, a successful program is one that makes it to Phase I. It's no wonder that so few medicinal chemists have ever worked on a drug that's made it all the way to market!
The other thing to keep in mind, in light of last Friday's post, is that the money spent on these things grows terribly along the way. A failure in Phase I isn't pretty, considering the time and money spend in the preclinical period (aka: what I spend all my working life doing.) But a failure in Phase III or at FDA time is a financial disaster.
Comments (3)
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1. hound on September 20, 2004 12:02 PM writes...
You would thiunk that would translate into a huge market for some software which could help screen the efficacy according to molecular structure of the drug and the target enzyme or metabolite.
Permalink to Comment2. Derek Lowe on September 20, 2004 1:46 PM writes...
Yes indeed. There has been a huge amount of money and effort dropped over the years on attempts to do just that, from which one can infer that it ain't easy. To pick an analogy from another industry, there would be a huge market for a method to forecast interest rate swings, too, but no one's come up with that one, either.
You'd think that drug development would be more amenable to such a technological fix, though, and I think that it is. But that just makes it a hideously difficult problem, rather than an impossible one. The first outfit that can truly screen out losers in silico, either on the basis of pharmacokinetics, efficacy, or toxicology, will be able to name their price.
Permalink to Comment3. jeet on September 21, 2004 5:20 PM writes...
these numbers wouldn't surprise anyone who is involved in late stage clinical development, product in-licensing or the financial community.
I view it as part of the reason why drugs are priced so much higher than costs (usually). Part of the cost is the "failure cost" of all the other molecules that you paid for but have 0 return, another part is how the inherent difficulty and long, long product development times set up a very effective barrier to entry.
I don't believe that the industry has much, if any, monopoly power. If you have a drug that is sucessful every other drug company in the world is allowed to launch competitors, target the same doctors, target the same consumers and target the same payers that the orignial company targets. Of course this is easier said than done.
There has been a lot of different efforts to increase the sucess rates in various phases with both software and other technologies. Every one starts with the promise, but usually ends with an incremental increase in knowledge. That's pretty much the story with the entire industry (and science in general really).
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