拜登政府重塑原料药供应链:进展与前景

The Biden Administration's Reshaping of Active Pharmaceutical Ingredients Supply Chains:Progress and Prospects

美国在新药研发上长期占据领先优势,但在原料药生产能力方面较为薄弱,对外依赖性较强且集中度高,这被美国政府视为存在供应链风险。这种风险产生的原因有三:一是美国制药产业转移导致的客观风险,二是新冠疫情暴露了美国在大宗原料药上对中国的依赖,三是美国将原料药对华依赖定性为国家安全威胁。拜登政府执政后,通过评估和管理原料药供应链、投资生物技术和连续生产工艺等先进制造、以“友岸外包”和“近岸外包”推动原料药供应链多元化等举措,来增强美国本土生产能力,重塑原料药供应链,缓解药品短缺等问题。从前景看,拜登政府重塑原料药生产能力恐难达到预期,清晰掌握原料药供应链信息的难度较大。从中国竞争优势、大国技术竞争和市场格局变化来看,拜登政府的政策举措对中国大宗原料药生产的负面影响不大,对特色原料药和专利原料药的消极影响将逐渐增强。

While the United States has long held a leading position in new drug research and development,it is relatively weak in active pharmaceutical ingredients(API)production,with a high degree of dependency and concentration on foreign sources.The U.S.government views such weakness as a supply chain risk for three main reasons:first,the objective risks caused by the transfer of the U.S.pharmaceutical industry abroad;second,the COVID-19 pandemic has exposed America's dependence on China for bulk APIs;third,the U.S.has characterized its API dependence on China as a national security threat.Upon taking office,the Biden administration has sought to enhance domestic production capacity,reshape the API supply chain,and alleviate drug shortages through various measures,which include assessing and managing the API supply chain,investing in advanced manufacturing technologies such as biotechnology and continuous manufacturing,and promoting the diversification of API supply chain through“friend-shoring”and“near-shoring”.Looking ahead,the Biden administration's efforts to reshape API production capacity might fall short of expectations,while the administration faces challenges in securing a clear understanding of the API supply chain information.Given China's competitive advantages,the dynamics of technological competition among major powers,and changes in market structure,the Biden administrations policy measures are unlikely to significantly impact China's bulk API production,while there will be increasing negative effects on the production of specialty APIs and patented APIs.