2012
DOI: 10.1038/nrd3681
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Diagnosing the decline in pharmaceutical R&D efficiency

Abstract: The past 60 years have seen huge advances in many of the scientific, technological and managerial factors that should tend to raise the efficiency of commercial drug research and development (RD). Yet the number of new drugs approved per billion US dollars spent on RD has halved roughly every 9 years since 1950, falling around 80-fold in inflation-adjusted terms. There have been many proposed solutions to the problem of declining RD efficiency. However, their apparent lack of impact so far and the contrast bet… Show more

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Cited by 1,660 publications
(1,168 citation statements)
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References 70 publications
(87 reference statements)
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“…For the last decade, pharmaceutical research and development productivity, measured by the relationship between investment input to develop new innovative drugs and the output/ outcome (e.g., medical and financial benefits resulting from the drug), dramatically deceased and, at the time of writing, remains low [1][2][3]. A number of factors contribute to the productivity issues in drug development, including increasing development costs, generic competition due to the patent expiry of several blockbuster drugs, increasingly conservative regulatory policies, and insufficient breakthrough innovations.…”
Section: Introductionmentioning
confidence: 99%
“…For the last decade, pharmaceutical research and development productivity, measured by the relationship between investment input to develop new innovative drugs and the output/ outcome (e.g., medical and financial benefits resulting from the drug), dramatically deceased and, at the time of writing, remains low [1][2][3]. A number of factors contribute to the productivity issues in drug development, including increasing development costs, generic competition due to the patent expiry of several blockbuster drugs, increasingly conservative regulatory policies, and insufficient breakthrough innovations.…”
Section: Introductionmentioning
confidence: 99%
“…First, the pharmaceutical sector in which regulation to a large extent dictates the speed and direction of innovation (Munos 2009;Scannell et al 2012). We focus on regulatory pathways that protect the development of pharmaceutical products for diseases with high unmet medical needs, i.e.…”
Section: Methodsmentioning
confidence: 99%
“…Regrettably, this increased productivity in ligands screening did not translate in a corresponding surge in the rate of approved drugs. [1] It is becoming increasingly clear that the observed decline in the R&D productivity in the pharmaceutical industry in the last decades, the so-called Eroom Law, [2] is largely due to the high cost of failures at some stage along the drug development sequence. Paradoxically, the screening capabilities in High throughput screening or computer-based de novo techniques, by letting many candidates to proceed further in the drug discovery pipeline, unavoidably produces a sharp increase in the cost of failure.…”
Section: Introductionmentioning
confidence: 99%