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Therapeutic Class Is a Critical Determinant of Drug Development Cost, Time

BOSTON – April 29, 2004 – The cost and time required to develop a new drug and bring it to market is directly tied to the therapeutic category of that drug, according to a study recently completed by the Tufts Center for the Study of Drug Development.

Summary findings of the study, which were released today, show that analgesic/anesthetic drugs were the least costly to develop, requiring an average of $375 million for total out-of-pocket and time costs. This compares to an average of $466 million for all drugs, when phase attrition rates and clinical approval success rates are factored in.

The most expensive category of drugs to develop includes medicines that treat diseases of the central nervous system — known as CNS drugs — which cost an average of $527 million.

These figures exclude non-clinical research and development costs.

The Tufts CSDD study examined four categories of drugs: analgesic/anesthetic, antiinfective, cardiovascular, and CNS.

Total time required for clinical and approval phases for the four categories of drugs also varied widely by therapeutic class. Analgesic/anesthetic drugs required an average of 61.8 months, according to Tufts CSDD, while CNS drugs required an average of 114.6 months. Average clinical and approval phase time for all drugs was 90.3 months.

The analysis also found that average worldwide sales for new drugs showed considerable variability by therapeutic class — from 56% below the average for analgesic/anesthetic drugs to 72% above the average for CNS drugs

“Given the dynamic nature of pharmaceutical markets and changes over time in R&D strategy, our findings are consistent with a model that suggests R&D efforts have generally shifted toward high net return, and away from low net return, therapeutic areas,” said Tufts CSDD Director Kenneth I Kaitin.

He added, “The challenge for drug developers is to reduce development times and terminate unpromising compounds earlier in development. Because these actions help improve success rates, they can have a substantial impact on R&D costs.”

About the Tufts Center for the Study of Drug Development
The Tufts Center for the Study of Drug Development ( at Tufts University provides strategic information to help drug developers, regulators, and policy makers improve the quality and efficiency of pharmaceutical development, review, and utilization. Based in Boston, the Tufts Center conducts a wide range of in-depth analyses on pharmaceutical issues and hosts symposia, workshops, and public forums on related topics.

Source: The Tufts Center for the Study of Drug Development

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