Department of Health Policy and Management, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Health Econ. 2010 Aug;19(8):1002-5. doi: 10.1002/hec.1538.
In a widely cited article, DiMasi, Hansen, and Grabowski (2003) estimate the average pre-tax cost of bringing a new molecular entity to market. Their base case estimate, excluding post-marketing studies, was $802 million (in $US 2000). Strikingly, almost half of this cost (or $399 million) is the cost of capital (COC) used to fund clinical development expenses to the point of FDA marketing approval. The authors used an 11% real COC computed using the capital asset pricing model (CAPM). But the CAPM is a single factor risk model, and multi-factor risk models are the current state of the art in finance. Using the Fama-French three factor model we find that the cost of drug development to be higher than the earlier estimate.
在一篇广为引用的文章中，DiMasi、Hansen 和 Grabowski（2003 年）估计了将一种新的分子实体推向市场的平均税前成本。他们的基本案例估计，不包括上市后研究，为 8.02 亿美元（2000 年美元）。引人注目的是，这一成本的近一半（3.99 亿美元）是用于为临床开发费用提供资金以获得 FDA 营销批准的资本成本（COC）。作者使用了使用资本资产定价模型（CAPM）计算的 11%的实际 COC。但是，CAPM 是一个单一因素风险模型，而多因素风险模型是金融领域的最新技术。使用 Fama-French 三因素模型，我们发现药物开发成本高于早期估计。
