Number of Global Drug Projects by Phase

The Wall Street Journal ran a recent article about liability issues involving research subjects enrolled in clinical trials (see: When Drug Trials Go Wrong, Patients Have Little Recourse). Read the whole thing if you are so inclined -- it's well worth your time. However, this particular note is about another related topic -- the number of yearly clinical drug projects on a global basis.

Embedded in the WSJ article was this graph (source: IMS Health) illustrating the number of  projects organized by the five phases. I was impressed by the fact that there were nearly 8,000 of them in 2007 across the various stages. I have posted a number of previous notes about the involvement of contract research organizations (CROs) such as Covance and Charles River in clinical drug trials. As you might expect, laboratory testing is a very important part of these endeavors. In fact and regarding its lab capabilities, Covance make the following claim on its web site: the largest central laboratory in the world dedicated exclusively to outsourced drug development.

I must admit to being surprised by one aspect of these numbers. I have read a number of articles recently speculating that the number of drugs in the pharmaceutical "pipeline" was low. Below is a quote from an article that makes this point with boldface emphasis mine (see: 2008 Pharmaceutical Pipeline Is Not Expected to Produce Blockbuster Drugs).

The 2008 pipeline looks "extremely dry right now, possibly worse than 2007," says Mark Gruenhaupt, clinical consultant at Argus Health Systems. "A rash of late-stage trial failures along with increased scrutiny by the FDA have combined to really slow down new drug development" .... "Several products that were expected to be big sellers have either been scrapped or delayed because of negative decisions by the FDA or safety concerns during the clinical trials. The oncology pipeline continues to produce, but there are very few drugs in late stages in other categories."

The graph shows a relatively large increase in the number of global projects in the preclincal/discovery phase for the years 2004-2007 and what appears to be modest increases in the number of trials in phases 1 and 2. Of course, many of the preclincal/discovery phase projects will be abandoned. Also, these rough numbers have relatively little bearing on the number of successful drugs that will emerge from this pipeline. And yet the total of 8,000 projects strikes me as evidence of a large amount of resources devoted to new drug discovery and also would seem to bode well for the CRO industry.

Comments

I wonder whether the comparisons you are making are apples to apples here. The graphic you display--is it number of drugs? number of trials? It states number of projects, although I'm not quite sure what that refers to. Quite often (particularly in main stream media and blogs) I see a comparison of trials activity to number of drug candidates. While that ratio is an interesting stat--how robustly is a drug being developed--it's not meant for direct comparison.

For example, you can have one drug that is actively being developed in 100 trials, all phases, many diseases. (This is particularly true in oncology.) So here you would have 1 drug-->100+ trials. Similarly, you can have 1 drug being actively investigated in only 2 or 3 very focused indication trials. So here you have 1 drug-->2 or 3 trials. In both scenarios you have 1 drug--but would you say that the development activity of each is the same because each is one drug? Of course not. It's the number of trials that indicates the development intensity. The number of drugs is a reflection of the pipeline diversity, not development intensity.

Having said that, drugs-->trials is an interesting stat indeed. As that multiple increases, you are theoretically looking at a landscape where the companies are trying to get the biggest bang for the buck with the drugs they have (same number of drugs; more trials). When the multiple decreases, you are theoretically looking at 2 possible scenarios: 1) a landscape where the number of number of drug candidates is increasing (ie., increasing pipeline diversity); or 2) the number of drug candidates is constant, but number of trials is decreasing (ie., failed/abandoned development OR more focused indication development).