■了解药物开发的成本可以帮助制定降低成本的政策,鼓励创新,改善患者获得药物的机会。
■估算按治疗类别划分的药物开发成本以及药物研发(R&D)强度随时间变化的趋势。
■在这项经济评估研究中,使用公共和专有来源构建的药物开发分析模型,共同涵盖2000年至2018年的数据,用于估计将药物推向市场的成本,整体和特定的治疗类别。该研究的分析于2020年10月完成。
■估计了从非临床到上市后阶段的三种开发成本指标:平均自付成本或现金支出,平均预期成本,和预期资本化成本。医药研发强度,定义为研发支出与总销售额的比率,从2008年到2019年,根据可用数据的时间框架,也进行了分析。
■开发新药的估计平均成本约为1.727亿美元(2018年美元)(范围,泌尿生殖系统费用为7250万美元,疼痛和麻醉费用为2.972亿美元),包括上市后研究。当包括故障成本时,成本增加到5.158亿美元。当包括失败和资本的成本时,药物开发的平均预期资本化成本增加至8.793亿美元(范围,抗感染药3.787亿美元,疼痛和麻醉药1.7562亿美元);结果因治疗类别而异。制药行业整体经历了15.6%的销售额下降,但从2008年到2019年,研发强度从11.9%提高到17.7%。相比之下,大型制药企业的研发强度从16.6%提高到19.3%,而销售额在2008年至2019年同期增长了10.0%(从380.0亿美元增长到4180亿美元),尽管药物开发成本保持相对稳定或甚至可能有所下降。
■在对新药开发成本的经济评估中,尽管药物开发的成本似乎保持稳定,大型制药公司的研发强度保持相对不变,尽管在此期间收入大幅增长。这些发现可以为药物相关政策的设计及其对创新和竞争的潜在影响提供信息。
UNASSIGNED: Understanding the cost of drug development can help inform the development of policies to reduce costs, encourage innovation, and improve patient access to drugs.
UNASSIGNED: To estimate the cost of drug development by therapeutic class and trends in pharmaceutical research and development (R&D) intensity over time.
UNASSIGNED: In this economic evaluation study, an analytical model of drug development constructed using public and proprietary sources that collectively cover data from 2000 to 2018 was used to estimate the cost of bringing a drug to market, overall and for specific therapeutic classes. The analysis for the study was completed in October 2020.
UNASSIGNED: Three measures of development cost from nonclinical through postmarketing stages were estimated: mean out-of-pocket cost or cash outlay, mean expected cost, and mean expected capitalized cost. Pharmaceutical R&D intensity, defined as the ratio of R&D spending to total sales, from 2008 to 2019, based on the time frame for available data, was also analyzed.
UNASSIGNED: The estimated mean cost of developing a new drug was approximately $172.7 million (2018 dollars) (range, $72.5 million for genitourinary to $297.2 million for pain and anesthesia), inclusive of postmarketing studies. The cost increased to $515.8 million when cost of failures was included. When the costs of failures and capital were included, the mean expected capitalized cost of drug development increased to $879.3 million (range, $378.7 million for anti-infectives to $1756.2 million for pain and anesthesia); results varied widely by therapeutic class. The pharmaceutical industry as a whole experienced a decline of 15.6% in sales but increased R&D intensity from 11.9% to 17.7% from 2008 to 2019. By contrast, R&D intensity of large pharmaceutical companies increased from 16.6% to 19.3%, whereas sales increased by 10.0% (from $380.0 to $418.0 billion) over the same 2008 to 2019 period, even though the cost of drug development remained relatively stable or may have even decreased.
UNASSIGNED: In this economic evaluation of new drug development costs, even though the cost of drug development appears to have remained stable, R&D intensity of large pharmaceutical companies remained relatively unchanged, despite substantial growth in revenues during this period. These findings can inform the design of drug-related policies and their potential impacts on innovation and competition.