Estimated Research and Development Investment Needed to Bring a New Medicine to Market, 2009-2018.

ABSTRACT:

Importance

The mean cost of developing a new drug has been the subject of debate, with recent estimates ranging from $314 million to $2.8 billion.

Objective

To estimate the research and development investment required to bring a new therapeutic agent to market, using publicly available data.

Design and setting

Data were analyzed on new therapeutic agents approved by the US Food and Drug Administration (FDA) between 2009 and 2018 to estimate the research and development expenditure required to bring a new medicine to market. Data were accessed from the US Securities and Exchange Commission, Drugs@FDA database, and ClinicalTrials.gov, alongside published data on clinical trial success rates.

Exposures

Conduct of preclinical and clinical studies of new therapeutic

SUBMITTER: Wouters OJ 

PROVIDER: S-EPMC7054832 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature