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European Pharmaceutical Contractor Editor's Letter
2001 was not a great year for drug development. In their latest survey, CMR International report some interesting trends. The bad news is that the launch of new molecular entities (NMEs) in 2001 was at its lowest level for 10 years - only 31. The number of products derived from biotechnology increased to 35 per cent of the total, revealing a bleak picture for traditional pharmaceutical companies with only a peripheral interest in biotech. Indeed, of the 31 products only six came from the top 10 pharma companies with two from Europe and four from the US. What did not decrease in 2001 was the expenditure on R&D by the industry - pharma alone spent an estimated US$43.6 billion, up from US$41.8 billion (an increase of four per cent). Thus the cost of NMEs approaches US$1.0 billion, however you calculate the cost. The further piece of bad news is that the cost goes up while productivity apparently goes down. With few exceptions the promise of genomics, high throughput screening and combinatorial chemistry have not yet delivered their undoubted potential and so pressure is mounting inexorably on so-called downstream activities such as clinical development, to increase their productivity, decrease costs and cut development times. As ever, I believe that outsourcing does offer major opportunities for both cost and time reduction.
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