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Drug Dropout in Clinical Trials Is at Unsustainable Levels, According to Thomson Reuters, CMR International

PHILADELPHIA and LONDON, June 26, 2011 /PRNewswire/ -- The pharmaceutical industry spent less on drug R&D last year than at any time in the last three years, according to data released today from the 2011 Pharmaceutical R&D Factbook complied by CMR International, a Thomson Reuters business.

Key highlights from the 2011 R&D Factbook include:

  • 21 new molecular entities (NMEs) were launched on the global market in 2010, a decrease from 26 in the previous year.
  • 2010 saw the lowest number of NMEs launched by Major Pharma in the past 10 years
  • The number of drugs entering Phase I and Phase II trials fell 47% and 53% respectively
  • Self-originated molecules have a 20% greater chance of reaching the market from Phase III and Submission versus in-licensed or acquired compounds
  • Patient recruitment for clinical trials has shifted towards SE Asia
  • The proportion of total sales from drugs reached an all time high of $856 billion*

The 2011 edition of the Pharmaceutical R&D Factbook shows that R&D expenditure continued to drop in 2010 to an estimated three year low of $68 billion, which is in stark contrast to the growth rate leading up to 2008. The report also highlights that drug success rates continue to show the declining trends of the past decade. There were 55 phase III 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 55 percent in 2010.

Faced with more than 110 drugs losing patent exclusivity in the US, including 14 "blockbusters", the world's leading pharmaceutical companies face considerable risk to their revenue streams in next three years. The strategy of in-licensing or acquiring compounds is also facing difficulty, as self-originated drugs currently have a 20% higher chance of making it to market.

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. 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."

In addition, despite the overall decrease in the number of new drugs entering each stage of clinical trials, Anti-Cancer is one of only two therapeutic areas to see positive growth in the number of drugs being developed for launch.

The information published in the Factbook is based on primary sources covering major pharmaceutical companies which account for approximately 80 percent of the industry's global R&D expenditure.

CMR International, a Thomson Reuters business, is the world leader in global pharmaceutical R&D performance measurement. For almost 15 years, CMR International has worked with the leading global pharmaceutical companies to assess R&D productivity and provide insights into industry trends in order to strengthen planning and effectiveness of R&D. Since 2003, CMR International has published the pharmaceutical R&D Factbook, an annual report for the pharmaceutical R&D sector providing a reliable source of key reference metrics.

*Source IMS Health

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Thomson Reuters

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