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• For decades, the U.S. market and R&D ecosystem have been central to leading pharma strategies. • The established pharma model is under pressure from recent U.S. policy shifts toward nationalism, re-shoring, and supply chain control. • Pharma companies must rethink assumptions and better understand shifting forces in R&D. • Future R&D strategies should be dynamic, open, and aligned with today’s complex reality. 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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Kwisda et al. (2025) studied this question.
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