Does pharma R&D need a strategic reset? Adapting to a changing US landscape

IF 7.5 2区医学 Q1 PHARMACOLOGY & PHARMACY

Drug Discovery Today Pub Date : 2025-07-28 DOI:10.1016/j.drudis.2025.104442

Sebastian Kwisda , Malte Kremer , Niels Sievertsen , Oliver Gassmann , Dominik Hartl , Alexander Schuhmacher

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引用次数: 0

Abstract

R&D productivity has long challenged research-based pharmaceutical companies, raising concerns about the sustainability of their research-driven business models. These firms have traditionally relied on the U.S. as a stable hub for biomedical innovation, skilled talent, and high-price markets—supporting the biotech-leveraged pharma company (BIPCO) model However, recent geopolitical shifts—especially under the new Trump administration, including FDA budget cuts, reduced U.S. research funding, and pharmaceutical tariffs—are destabilizing this foundation. The once-reliable “safe harbor” is no longer secure. As a result, pharma R&D now faces strategic risks beyond its prior scope. With the weakening of the U.S.-centered innovation model, companies must rethink R&D pipelines, secure key technologies, maintain global clinical networks, and adjust supply chain and tax strategies. The viability of the current R&D model—rooted in U.S. leadership and premium markets—is now uncertain, requiring urgent strategic realignment.

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制药研发需要战略重置吗？适应不断变化的美国环境。

长期以来，研发生产力一直是研究型制药公司面临的挑战，这引发了人们对其研究驱动型商业模式的可持续性的担忧。传统上，这些公司一直依赖美国作为生物医学创新、技术人才和高价市场的稳定中心，支持生物技术杠杆制药公司（BIPCO）模式。然而，最近的地缘政治变化——尤其是在特朗普新政府的领导下，包括FDA预算削减、美国研究经费减少和药品关税——正在破坏这一基础。曾经可靠的“安全港”不再安全。因此，制药研发面临的战略风险超出了之前的范围。随着以美国为中心的创新模式的弱化，企业必须重新思考研发管道，确保关键技术，维持全球临床网络，调整供应链和税收战略。当前的研发模式——植根于美国的领导地位和高端市场——的可行性现在是不确定的，需要紧急的战略调整。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Drug Discovery Today 医学-药学

CiteScore

14.80

自引率

2.70%

发文量

293

审稿时长

6 months

期刊介绍： Drug Discovery Today delivers informed and highly current reviews for the discovery community. The magazine addresses not only the rapid scientific developments in drug discovery associated technologies but also the management, commercial and regulatory issues that increasingly play a part in how R&D is planned, structured and executed. Features include comment by international experts, news and analysis of important developments, reviews of key scientific and strategic issues, overviews of recent progress in specific therapeutic areas and conference reports.