R&D costs and returns by therapeutic category
R&D costs and returns by therapeutic category
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DOI：
10.1177/009286150403800301
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发表时间：
2004-01-01
影响因子：
--
通讯作者：
Vernon, J
中科院分区：
文献类型：
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作者：
DiMasi, JA;Grabowski, HG;Vernon, J
目的：本研究探讨治疗类占药物开发成本的可变性的程度。它还审查了销售水平如何在已进入市场的药物的相关治疗类别之间变化。数据和方法：从10家制药公司的管道中选择了1983年至1994年在世界任何地方首次进入临床试验的68种研究药物的分层随机样本。获得了这些化合物的临床阶段成本数据。样本包括测试失败的药物和获得上市批准的药物。我们按治疗类别对药物进行了分类。获得了镇痛/麻醉剂、抗感染、心血管和中枢神经系统（CNS）治疗类别的每种获批新药的临床周期成本（包括失败）。根据IMS Health销售数据计算了1990年至1994年在美国批准的新药在20年产品生命周期内的全球销售概况。所有成本和销售额均以2000年美元表示。结果如下：心血管（2.77亿美元）和CNS（2.73亿美元）药物的每种获批药物的自付临床期成本（包括失败）接近总体平均水平（2.82亿美元）。然而，抗感染药物的成本远高于平均水平（3.62亿美元），镇痛/麻醉药物的成本略低于平均水平（2.52亿美元）。当使用开发时间表来确定资本化（自付加上时间）成本时，结果在质量上相似。与4.66亿美元的总体平均数相比，中枢神经系统药物（4.64亿美元）和心血管药物（4.6亿美元）的每种获批药物的资本化成本略低。镇痛/麻醉药物的资本化成本为3.75亿美元，抗感染药物为4.92亿美元。20世纪90年代前半期批准的新药的生命周期销售额的平均净现值分别为24.34亿美元、10.80亿美元、21.99亿美元、36.68亿美元和41.77亿美元，分别为所有药物、镇痛/麻醉药物、抗感染药物、心血管药物和CNS药物。结论：开发成本因药物而异。药物的治疗类别可以解释这种变异性。按广泛治疗类别划分的新药销售与平均开发成本没有很好的相关性。然而，鉴于制药市场的动态性质和研究与开发（R & D）支出份额随时间的变化，结果仍然是一致的企业行为模型，假定R & D的努力将一般转向高净回报，远离低净回报，治疗领域。
Objectives: This study examines the degree to which therapeutic class accounts for variability in drug development costs. It also scrutinizes how sales levels vary across the associated therapeutic classes for those drugs that have reached the marketplace. Data and Methods: A stratified random sample of 68 investigational drugs that first entered clinical testing anywhere in the world from 1983 to 1994 was selected from the pipelines of 10 pharmaceutical firms. Clinical period cost data were obtained for these compounds by phase. The sample consisted both of drugs that failed in testing and drugs that obtained marketing approval. We grouped the drugs by therapeutic category. Clinical period costs per approved new drug (inclusive of failures) were obtained for the analgesic/anesthetic, antiinfective, cardiovascular, and central nervous system (CNS) therapeutic classes. Worldwide sales profiles for new drugs approved in the United States from 1990 to 1994 over a 20-year product life cycle were computed based on IMS Health sales data. All costs and sales were expressed in year 2000 dollars. Results: Out-of-pocket clinical period cost per approved drug (inclusive of failures) for cardiovascular ($277 million) and CNS ($273 million) drugs was close to the overall average ($282 million). However, antiinfective drug costs were considerably above average ($362 million) and analgesic/anesthetic drug costs were modestly below average ($252 million). The results were qualitatively similar when the development timelines were used to determine capitalized (out-of-pocket plus time) costs. In comparison to the overall average of $466 million, the capitalized cost per approved drug was slightly lower for CNS ($464 million) and for cardiovascular ($460 million) drugs. The capitalized costs were $375 million for analgesic/anesthetic drugs and $492 million for antiinfective drugs. The mean net present values of life cycle sales for new drugs approved in the first half of the 1990s were $2434 million, $1080 million, $2199 million, $3668 million, and $4177 million for all drugs, analgesic/anesthetic drugs, antiinfective drugs, cardiovascular drugs, and CNS drugs, respectively. Conclusions: Development costs vary substantially from drug to drug. A drug's therapeutic class can explain some of that variability. The sales of new drugs by broad therapeutic category did not correlate well with average development costs. However, given the dynamic nature of pharmaceutical markets and changes over time in research and development (R&D) expenditure shares, the results are still consistent with a model of firm behavior that posits that R&D efforts will generally shift toward high net return, and away from low net return, therapeutic areas.