Vrije Universiteit Amsterdam, Athena Institute, De Boelelaan 1085, 1081 HV Amsterdam, the Netherlands.
Vrije Universiteit Amsterdam, Athena Institute, De Boelelaan 1085, 1081 HV Amsterdam, the Netherlands.
Drug Discov Today. 2024 Nov;29(11):104160. doi: 10.1016/j.drudis.2024.104160. Epub 2024 Sep 5.
Rising research and development costs, currently exceeding $3.5 billion per novel drug, reflect a five-decade decline in pharmaceutical R&D efficiency. While recent reports suggest a potential turnaround, this review offers a systems-level analysis to explore whether this marks a structural shift or transient reversal. We analyzed financial data from the 200 largest pharmaceutical firms, novel drug approvals, and more than 80 000 clinical trials between 2012 and 2023. Our analysis revealed that despite recent stabilization, the pharmaceutical industry continues to face challenges, particularly due to elevated late-stage clinical attrition, suggesting that a sustained turnaround in R&D efficiency remains elusive.
研发成本不断上升,目前新型药物的研发成本超过 35 亿美元,反映出半个世纪以来制药行业研发效率的下降。尽管最近有报告显示情况可能出现好转,但本综述提供了一个系统层面的分析,以探讨这是否标志着结构性转变或暂时逆转。我们分析了 2012 年至 2023 年间 200 家最大制药公司的财务数据、新型药物批准情况以及 8 万多项临床试验。我们的分析表明,尽管最近趋于稳定,但制药行业仍面临挑战,特别是由于晚期临床淘汰率居高不下,这表明研发效率持续好转仍难以实现。