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Trends in development cycles

Nature Reviews Drug Discovery volume 1, pages 335–336 (2002)Cite this article

Underlying this productivity deficit is an expensive, lengthy and risky drug development process. Companies spend more than US $500 million and require approximately 12–15 years to bring a new compound to the market. Fewer than 5% of all compounds that are screened enter preclinical development, and only 2% of these candidates enter clinical testing. Of all drugs that enter Phase I trials, approximately 80% fail in development.

Shortening development times

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Figure 1: The US $350-m hurdle.
Figure 2: The drug development and approval chain.
Figure 3: Changing clinical development and approval times.

References

  1. Kaitin, K. I. & DiMasi, J. A. Measuring the pace of new drug development in the user fee era. Drug Inf. J. 34, 673–680 (2000).

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  1. Decision Resources, Inc., 260 Charles Street, Waltham, 02453, Massachusetts, USA

    Barbara M. Bolten & Tracy DeGregorio

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  1. Barbara M. Bolten
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  2. Tracy DeGregorio
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Correspondence to Barbara M. Bolten.

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Barbara M. Bolten is a Program Manager and Tracy DeGregorio is a Director

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Decision Resources, Inc.

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Tufts Center for the Study of Drug Development

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Bolten, B., DeGregorio, T. Trends in development cycles. Nat Rev Drug Discov 1, 335–336 (2002). https://doi.org/10.1038/nrd805

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