我国生物制造正快速上升为国家战略前沿和生物经济核心引擎，是实现“换道超车”的重要支点，并在政策推动、技术突破和产业扩张的共同作用下步入高速增长阶段。然而，我国生物制造业仍面临多重结构性瓶颈，包括监管体系碎片化、制度供给滞后、底层核心技术薄弱、创新链与产业链协同不足、关键原料依赖进口以及人才供给不足等问题，这些因素共同制约了产业高质量发展和国际竞争力提升。为破解上述挑战，文章提出相关对策建议。研究旨在为我国生物制造业实现规模化、体系化和高质量跃升提供战略思考与政策建议。

China’s bio-manufacturing industry is rapidly emerging as a national strategic frontier and a core driver of the bioeconomy, serving as a critical leverage point for achieving leapfrog development. Supported by policy momentum, technological breakthroughs, and accelerating industrial expansion, the industry is entering a phase of high-speed growth. However, it continues to face a range of structural bottlenecks, including fragmented regulatory frameworks, lagging institutional supply, weaknesses in foundational and enabling technologies, insufficient synergy across innovation and industrial chains, reliance on imported key raw materials, and shortages in talent supply. These challenges collectively constrain the sector’s high-quality development and global competitiveness. To address these issues, the study proposes corresponding policy recommendations. The research aims to provide strategic insights and policy guidance to advance China’s bio-manufacturing industry toward scaled, systematic, and high-quality growth.