Another Annual Report

Recently, I was sent an Annual Review conducted by Citeline Intelligence Solutions. This concise report offers readers a brief summation of pharmaceutical R&D trends and an analysis of industry wide product development strategies and clinical trial success rates. There were not too many talking points amongst the majority of findings presented, however there was the odd statistic that buckled recent trends & a couple of surprise ones that I could not have predicted. Following is a rapid-fire synopsis of their findings:

* A total of 9605 drugs in active development for 2008, a 4.3% increase from the previous year.
* An above average 32 market entrants (New Active Substances) globally, although none of them seem to be really big sellers.
* The US remains the premier market with 15 of 32 debuts.
* Six new biotech product launches for the year.
* In 2007, anticancer drugs accounted for a third of the total launches. In 2008? Despite oncology being the biggest area of R&D, the grand total is a big Zero!
* CNS, the next big R&D area also had a laggardly year with 3 new drugs (but none first in class).
* Cardiovascular & Blood/Clotting disorder drugs had the greatest success with 10 new market entrants. Gastrointestinal drugs come in second with 5 product launches.
* Innovation levels remained discouragingly low with only 1 new market entrant for HIV/AIDS and 2 new anti-infectives.
* At the clinical stage, virtually the entire 4.3% increase in drug candidates is at the preclinical stage. The trends for post-preclinical phases remain flat, with a modest 2.6% increase at Phase II being the only noteworthy statistic.


* More disturbing is the decrease in the number of drugs at the pre-registration and registered but awaiting launch phases.
* 28% of all drugs in development have an anticancer therapeutic activity. 19.8% of the total pipeline has a neurological activity.
* The gradual ascent of biotech continues with 23.7% of the drugs placed under a biotechnology therapeutic category.
* Some positive news is a 6.2% increase in the number of drug protein targets under investigation.
* The J&J Empire, GSK and Genzyme enjoyed the most first launches in 2008.
* GSK remains the biggest company in R&D terms (240 drugs), but looks to surrender this position with the recent mega-mergers.
* The trend seems to be for the biggest companies to have shown slight declines in pipeline sizes, indicating that further segmentation and specialization seems to be the new motto of the industry.
* Despite the financial climate, it is encouraging to see a 6% rise (a total of 2084 companies) in the number of companies involved in pharma R&D. The recession does not seem to have dampened the spirits of start-ups & small companies with 836 of them listing one or two drugs in their portfolios.