ITIF-_通胀削减法案_正在谈判美国退出药物创新(英)-2025.2_22页_813kb
报告摘要
The Inflation Reduction Act (IRA) distinguishes between small-molecule and large-molecule drugs by allowing price negotiations after 9 and 13 years, respectively, impacting innovation incentives.
Small molecule drugs are cheaper, easier to produce, orally administered, and widely used (86% of prescriptions). They treat common conditions and some complex ones like certain cancers.
Large molecule (biologics) drugs are more complex, expensive to produce, require injection, and target immune-related diseases.
The 9 vs. 13-year distinction reduces revenue anticipation for small molecules, discouraging R&D investment and leading to a projected 70% decline in small molecule funding from 2021 onward.
Venture capital and pharmaceutical companies are shifting focus away from small molecules, halting current projects and delaying pipeline expansion.
Post-market R&D, crucial for expanding drug applications, is stifled due to shortened revenue windows.
Small firms, vital for first-in-class drugs, face reduced funding, harming innovation.
Legislative proposals like the EPIC Act aim to extend market exclusivity for small molecules, but the current divergence risks narrowing treatment options and increasing healthcare costs.
The IRA's policy could disproportionately affect underserved and elderly populations who rely on affordable small molecule therapies.
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