一致性评价对医药CRO公司的影响

The Impact of Consistency Evaluation on Pharmaceutical CRO Companies

摘要

目的：分析仿制药一致性评价政策对中国医药合同研究组织（CRO）行业的影响机制与演化路径，为理解政策驱动型行业的转型规律提供实证依据。方法：基于产业生命周期理论，采用政策文本分析与行业案例研究相结合的方法。结果：一致性评价政策使CRO行业经历了“需求爆发-产能扩张-价格内卷-行业出清-被迫转型”的完整产业周期。结论：一致性评价政策对CRO行业的影响本质上是创造性破坏过程。建议CRO企业降低政策红利依赖、建立差异化技术壁垒。

Abstract

Objective: To analyze the impact mechanism and evolutionary path of the generic drug consistency evaluation policy on China’s pharmaceutical Contract Research Organization (CRO) industry, thereby providing empirical evidence for understanding the transformation patterns of policy-driven industries. Methods: Based on the industrial life cycle theory, this study combines policy text analysis with case studies of the CRO industry. Results: The consistency evaluation policy has driven the CRO industry through a complete industrial cycle characterized by “demand explosion - capacity expansion - price competition - industry consolidation - forced transformation”. Conclusion: The impact of the consistency evaluation policy on the CRO industry is essentially a process of creative destruction. Recommendations - CRO enterprises should reduce their reliance on policy dividends and establish differentiated technological barriers.

关键词

一致性评价 / 医药CRO / 产业周期

Key words

consistency evaluation / pharmaceutical CROs / Industry Cycle

参考文献

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