Center for Research Innovation in Biotechnology, 4240 Duncan Ave, Suite 110, Washington University in St Louis, St Louis, MO 63110, USA.
Center for Research Innovation in Biotechnology, 4240 Duncan Ave, Suite 110, Washington University in St Louis, St Louis, MO 63110, USA.
Drug Discov Today. 2021 Jan;26(1):240-247. doi: 10.1016/j.drudis.2020.10.026. Epub 2020 Nov 2.
The biopharmaceutical industry has undergone remarkable changes over the past half century, driven largely by a need to offset the ever-rising costs of developing new medicines. In this report, we aggregated information about the creation and fate of all clinical-stage biopharmaceutical companies, assessing trends over time. These results reveal that the rate of new company formation has been declining at the same time that industry consolidation has been accelerating at an unprecedented rate. Consequently, the number of companies involved in biopharmaceutical research and development has declined by one-third over the past decade, while those able to achieve at least one FDA approval has dropped by more than half. These findings raise important questions about the sustainability of an industry that is vital for both public and economic health.
在过去的半个世纪里,生物制药行业发生了巨大的变化,主要是因为需要抵消开发新药的成本不断上升。在本报告中,我们汇总了所有临床阶段生物制药公司的创建和命运信息,评估了随时间推移的趋势。这些结果表明,新公司的形成率一直在下降,而行业整合的速度却以前所未有的速度加速。因此,在过去的十年中,参与生物制药研发的公司数量减少了三分之一,而能够获得至少一次 FDA 批准的公司数量则下降了一半以上。这些发现引发了人们对这个对公共和经济健康都至关重要的行业可持续性的重要问题。