Therapy Analysis - Pharma R&D Annual Review
The 2009 pipeline - clinical surge stumbles
As we now return to reviewing today's pipeline, let's begin to break it down and analyze trends more finely. Having noted that the overall pipeline size has shown a healthy increase, we can examine it by world development status (Graph 2). This shows that virtually the entire increase can be accounted for by a rise in the number of preclinical drugs reported. This stage of development is the least strictly defined and as such is the one most prone to exhibit volatility based on improved editorial scanning procedures. It is therefore rather more concerning just how flat the trends are at the post-preclinical phases. Although there are slightly more drugs at each of the Phase I, Phase II and Phase III development stages in 2009 than there were a year ago, the increases are, bar a modest 2.6% at Phase II, almost negligible. Moving to the numbers of products nearest the market, there are actually declines at the awaiting registration and registered but awaiting launch statuses. This does not bode well for the number of drugs likely to enter the market during 2009.
However, it is the trends at the different clinical phases to which observers most often look for signs of the health or otherwise of the pipeline. And if we compare the change from 2008 to 2009 with the trend in the preceding years, we see a slightly more worrying picture emerge. Throughout the decade, there have been big year-on-year increases in the number of drugs in Phase I and Phase II, and increases also have been also seen at Phase III, albeit in only 2006 onwards. Thus the flat figures for 2009 would appear to indicate a possible end of a period of sustained growth. However, it remains to be seen whether this is the case or is just a blip - next year's data could prove very revealing.
