The Cost of Biopharmaceutical R&D: Is Biotech Different?
The Cost of Biopharmaceutical R&D: Is Biotech Different?
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DOI：
10.1002/mde.1360
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发表时间：
2007-07-01
影响因子：
2.2
通讯作者：
Grabowski, Henry G.
中科院分区：
文献类型：
--
作者：
DiMasi, Joseph A.;Grabowski, Henry G.
一些研究报告估计了传统制药公司所追求的新药开发成本。然而，类似的分析还没有发表在开发生物技术公司所关注的分子类型的成本上。这项研究代表了第一次尝试，以了解与发现和开发新的治疗性生物药物相关的研发成本的大小（特别是重组蛋白和单克隆抗体[mAbs]）。我们利用药物特定的数据，包括现金支出，开发时间，并成功获得监管营销批准，以估计平均税前R& D生物制药的资源成本，直至美国首次上市批准（2005年美元）。我们发现，临床前阶段、临床阶段和总的平均自付（现金支出）成本估计分别为1.98亿美元、3.61亿美元和5.59亿美元。包括与生物制药研发相关的时间成本在内，我们发现每个获批生物制药的平均资本化成本估计分别为6.15亿美元、6.26亿美元和1.241亿美元，分别用于临床前阶段、临床阶段和总计。通过使用制药公司成本的过去增长率来调整先前公布的传统制药公司的研发成本估计，以对应我们的生物制药数据所适用的最近时期，我们发现，每个批准的生物制药的总自付成本略低于制药公司的数据（5.59亿美元对6.72亿美元）。然而，生物制药的每个获批新分子的估计总资本化成本与调整后的制药公司数据几乎相同（12.41亿美元对13.18亿美元）。鉴于有限数量的生物制药分子的现金支出数据，生物制药和制药公司药物的不同治疗类别分布，以及制药公司成本最近的增长率是否与过去的增长率不同的不确定性，目前应谨慎看待这些结果。版权所有（C）2007约翰威利父子有限公司
The costs of developing the types of new drugs that have been pursued by traditional pharmaceutical firms have been estimated in a number of studies. However, similar analyses have not been published on the costs of developing the types of molecules on which biotech firms have focused. This study represents a first attempt to get a sense for the magnitude of the R&D costs associated with the discovery and development of new therapeutic biopharmaceuticals (specifically, recombinant proteins and monoclonal antibodies [mAbs]).We utilize drug-specific data on cash outlays, development times, and success in obtaining regulatory marketing approval to estimate the average pre-tax R&D resource cost for biopharmaceuticals up to the point of initial US marketing approval (in year 2005 dollars). We found average out-of-pocket (cash outlay) cost estimates per approved biopharmaceutical of $198 million, $361 million, and $559 million for the preclinical period, the clinical period, and in total, respectively. Including the time costs associated with biopharmaceutical R&D, we found average capitalized cost estimates per approved biopharmaceutical of $615 million, $ 626 million, and $1241 million for the preclinical period, the clinical period, and in total, respectively. Adjusting previously published estimates of R&D costs for traditional pharmaceutical firms by using past growth rates for pharmaceutical company costs to correspond to the more recent period to which our biopharmaceutical data apply, we found that total out-of-pocket cost per approved biopharmaceutical was somewhat lower than for the pharmaceutical company data ($559 million vs $672 million). However, estimated total capitalized cost per approved new molecule was nearly the same for biopharmaceuticals as for the adjusted pharmaceutical company data ($1241 million versus $1318 million). The results should be viewed with some caution for now given a limited number of biopharmaceutical molecules with data on cash outlays, different therapeutic class distributions for biopharmaceuticals and for pharmaceutical company drugs, and uncertainty about whether recent growth rates in pharmaceutical company costs are different from immediate past growth rates. Copyright (C) 2007 John Wiley & Sons, Ltd.