医疗检验标准化赋能分级诊疗：从制度到技术的IVD市场全链条解析

Core Viewpoint - The article emphasizes the importance of standardization and mutual recognition in medical testing as a key direction for China's hierarchical diagnosis and treatment reform, reshaping the development landscape of the medical testing industry and presenting new market opportunities and challenges for IVD manufacturers [2][3]. Group 1: Hierarchical Medical System - China's medical hierarchical system is structured into a "three-level, nine-grade" system, categorizing hospitals into three levels, each further divided into three grades, with tertiary hospitals having an additional special grade [5]. - Each level of hospital has distinct functional characteristics: - Primary hospitals focus on community health services, managing common diseases and public health [6]. - Secondary hospitals serve as regional medical centers, providing specialized services and handling referrals from primary hospitals [6]. - Tertiary hospitals offer comprehensive medical services, including advanced specialty care and research, and serve as training centers [6]. Group 2: Policy and Development Trends - The hierarchical diagnosis and treatment system is a core component of China's medical reform, with a target of establishing 3,099 tightly-knit county medical communities by November 2025, covering 9.24 billion people [7]. - Specific regional goals have been set, such as in Henan Province, aiming for 65% of medical services to be provided at the grassroots level by 2025 [7]. Group 3: Hospital Distribution and Trends - As of the end of 2024, there are 1,093,551 medical institutions in China, with 38,710 hospitals. The growth rate of hospitals has slowed to 0.93%, primarily due to a significant slowdown in the growth of private hospitals [8]. - Tertiary hospitals are experiencing rapid growth, with an increase of 256 hospitals in 2024, reflecting a trend of concentrating quality medical resources at higher levels [8]. Group 4: Testing Department Standards and Equipment Requirements - Different levels of hospitals have varying standards and requirements for their testing departments, directly impacting the demand structure for IVD products [9]. - The construction and equipment standards for testing departments vary significantly across hospital levels, with tertiary hospitals requiring the most advanced and comprehensive equipment [10]. Group 5: IVD Demand Decoding - Primary hospitals are moving towards integrated and simplified equipment needs, with a focus on upgrading outdated devices and ensuring compliance with new standards [12]. - Secondary hospitals require modular and mid-level automated equipment to meet both routine and specialized testing demands, with a growing emphasis on laboratory information management systems [15]. - Tertiary hospitals focus on high-throughput and cutting-edge platforms, emphasizing the need for comprehensive automation and integration to support clinical research and advanced diagnostics [18]. Group 6: Revenue Structure Analysis - In 2023, the examination and testing revenue for secondary public hospitals accounted for approximately 30% of their total revenue, while for tertiary hospitals, it constituted about 29.59% of their medical service revenue [22]. - The income structure varies significantly across hospital levels, with primary hospitals relying on basic testing projects, secondary hospitals benefiting from specialized projects, and tertiary hospitals driving revenue growth through high-value specialized projects [23][24]. Group 7: Market Transformation in Primary Care - The focus of enhancing primary healthcare institutions is shifting from mere equipment updates to deeper system standardization and centralized operations [26]. - Standardization in testing is driven by the need for result mutual recognition and cost control, making standardized reagents and quality control systems essential for primary healthcare institutions [28]. - The "medical community" model is changing procurement and supply methods, leading to a market shift towards centralized purchasing and integrated solution offerings [30][31].