医药制造企业数字化转型的数字营商环境驱动组态研究

A Configurational Study on the Driving Forces of Digital Business Environment for the Digital Transformation of Pharmaceutical Manufacturing Enterprises

摘要: 数字营商环境是医药制造企业数字化转型的重要制度保障，然而，其影响医药制造企业数字化转型的组态路径仍待深入研究。本文采用NCA和fsQCA混合研究方法，分析数字营商环境驱动医药制造企业数字化转型的组态路径。通过对186家A股医药制造业上市企业数据的实证研究发现：(1) 医药制造企业实现高数字化转型存在数字基建主导、创新–监管双轮驱动、市场–安全协同驱动三类组态路径，呈现“合规先行、制度赋能”的鲜明特征，满足合规性是企业转型的普遍前提；(2) 数字基础设施在不同转型路径中具有情境依赖性，可在核心驱动、协同赋能与可补偿角色间切换，其功能实现高度依赖外部制度与市场环境的协同配置；(3) 政府监管服务与数据安全环境对医药制造企业数字化转型具有互补替代机制，这一发现深化了对数字营商环境要素间复杂互动关系的认识，为企业根据自身条件灵活选择转型策略提供了理论依据。研究结果为理解医药制造企业的数字化转型提供了新的分析视角与实践启示。

Abstract: The digital business environment serves as an important institutional guarantee for the digital transformation of pharmaceutical manufacturing enterprises. However, the configurational paths through which it influences this transformation remain underexplored. This study adopts a mixed-methods approach combining Necessary Condition Analysis (NCA) and fuzzy-set Qualitative Comparative Analysis (fsQCA) to analyze the configurational paths driving the digital transformation of pharmaceutical manufacturing enterprises. Based on empirical data from 186 A-share listed pharmaceutical manufacturing companies in China, the findings reveal that: (1) High-level digital transformation in pharmaceutical manufacturing can be achieved through three types of configurational paths: digital infrastructure-led, innovation-regulation dual-driven, and market-security synergy-driven. These paths exhibit a distinct characteristic of “compliance first, institution enabled”, where meeting compliance requirements is a universal prerequisite for transformation; (2) The role of digital infrastructure is context-dependent across different transformation paths. It can switch between acting as a core driver, a synergistic enabler, or a compensable factor, with its functionality highly reliant on synergistic alignment with external institutional and market environments; (3) A complementary and substitutable mechanism exists between government regulatory services and the data security environment concerning the digital transformation of pharmaceutical manufacturing enterprises. This finding deepens the understanding of the complex interactions among elements of the digital business environment and provides a theoretical basis for enterprises to flexibly select transformation strategies according to their specific conditions. The research results offer a new analytical perspective and practical insights for understanding the digital transformation of pharmaceutical manufacturing enterprises.