1312The RAND Corporation, Arlington, VA, USA.
1312The RAND Corporation, Santa Monica, CA, USA.
Inquiry. 2021 Jan-Dec;58:469580211059731. doi: 10.1177/00469580211059731.
Research and development (R&D) costs factor into considerations of the tradeoffs between prices, intellectual property protection, and incentivizing innovation, all of which can have implications for policy development. Yet, there is little consensus on the actual cost of R&D for new drugs. We review and synthesize papers estimating drug R&D costs incurred by industry. We find a substantial range of per-drug costs, from $113 million to just over $6 billion in 2018 dollars. This range includes estimates covering all new drugs, new molecular entities, and drugs in specific therapeutic classes. The range is narrower-$318 million to $2.8 billion-for estimates of the per-drug cost for new molecular entities. We discuss the data sources, methods, and assumptions used in each study to provide context for the wide range in existing estimates. Differences in definitions, methods, and assumptions lead to large divergences in the main estimates, and the combination of fragmented data sources and different assumptions across studies means that the resulting estimates that can rarely be directly compared. We suggest areas for future research and data collection that would result in more comparable and robust estimates to inform ongoing policy discussion.
研发（R&D）成本是权衡价格、知识产权保护和激励创新之间关系的因素，这些因素都可能对政策制定产生影响。然而，对于新药研发的实际成本，人们并没有达成共识。我们回顾并综合了评估行业药品研发成本的文献。我们发现，每款药品的成本差异很大，从 2018 年的 1.13 亿美元到超过 60 亿美元不等。这一范围包括涵盖所有新药、新分子实体和特定治疗类别的药品的估计。对于新分子实体的每款药品成本估计，范围较窄，为 3.18 亿美元至 28 亿美元。我们讨论了每项研究中使用的数据来源、方法和假设，为现有估计值的广泛差异提供了背景信息。定义、方法和假设的差异导致主要估计值存在较大差异，而且研究之间的数据来源碎片化和假设不同，意味着由此产生的估计值很少能够直接比较。我们建议未来进行研究和数据收集，以获得更可比和稳健的估计值，为正在进行的政策讨论提供信息。
