New medicine approvals slumped to record low in 2010
pharmafile | June 29, 2011 | News story | Research and Development, Sales and Marketing | drug sales, new drug approvals, research
There was a major slide in medicine approvals last year, compounding a difficult and ominous period for the industry.
Only 21 new molecular entities (or NMEs) were launched on the global market in 2010 – a decrease from 26 in the previous year, according to a new report from Thomson Reuters R&D Factbook, representing the lowest number of new drug approvals by big pharma in the past decade.
This is partly due to tougher regulator processes, but pharma is also seeing its drug success rates continuing to decline.
The report illustrates the extent of the problem, showing that there were 55 late-stage drug terminations during 2008-2010 – more than double the number of terminations during 2005-2007.
In addition, the number of drugs entering phase III clinical trials fell by over a half last year, making the future landscape uncertain for new medicines.
The trend is behind a growing dilemma for pharma, which faces higher clinical failure rates and fewer new drug approvals, even though in the first decade of the new millennium it spent more on R&D at any other time.
Moreover, the industry is now having to rein in its R&D costs, with major companies such as Pfizer, Merck and AstraZeneca cutting thousands of jobs from across their research centres in the past year.
This has seen R&D spend reach its lowest level in three years, down to $68 billion in 2010, and looks likely to continue this slide through to 2012 as more firms look to cut their research budgets.
Phil Miller, product director at Thomson Reuters, said: “High failure rates continue to be of great concern to the industry and this is compounded by the decrease in NMEs.”
He added that the strategy of big pharma to in-license more drugs for development “does not appear to be paying off at present”.
“An earlier focus on clearing out weak drug candidates will be instrumental to successfully progressing drugs to market,” he concluded.
On the positive side, total drugs sales reached an all time high of $856 billion last year, but this will start to falter over the coming years as the world’s biggest blockbusters lose their patent protection, wiping tens of billions of dollars from global sales.
In addition, there is little in pharma’s pipeline to fully replace this revenue, and many firms have been gambling on strategic mergers to help offset these looming losses.
Austerity measures in Europe and healthcare reforms in the US are also piling on yet more pressure on the industry, meaning it will continue to face tough years ahead.
Ben Adams
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