The Policy-Driven Evolution of Non-Public Hemodialysis Centers in China: A Retrospective Analysis from 2009 to 2025

Abstract

Background: The number of patients with end-stage renal disease (ESRD) in China continues to rise, while hemodialysis services have long been concentrated in large public hospitals, creating a significant service gap in rural and grassroots areas. Non-public hemodialysis centers, as a crucial supplement to the national healthcare system, have seen their developmental trajectory profoundly shaped by phased adjustments in health policy. Methods: This study employs a qualitative policy analysis combined with a historical case study approach to examine the evolution of non-public hemodialysis centers in China from 2009 to 2025. We conducted a systematic review of publicly available primary sources, including official policy documents issued by the National Health Commission (NHC), the National Healthcare Security Administration (NHSA), and provincial-level health and medical insurance authorities. Complementary data were drawn from authoritative industry reports, peer-reviewed academic literature, and publicly disclosed corporate information from leading non-public dialysis providers. The analytical framework is structured around a three-phase historical periodization: (1) the Pilot Exploration Phase (2009–2015), (2) the Regulated Expansion Phase (2016–2020), and (3) the Quality-Driven Deepening Phase (2021–2025). Within each phase, we analyzed the interplay between key policy interventions and the strategic responses of the non-public dialysis sector, focusing on how these dynamics shaped operational models and market structures. The authors confirm that large language models (LLMs) or other artificial intelligence (AI)-based tools were used during the preparation of this manuscript solely for language polishing, grammatical refinement, and translation assistance. Specifically, AI tools (including Deepseek) were employed to improve the clarity and fluency of certain English-language passages in the Introduction, Methods, and Discussion sections. All intellectual content, conceptualization, data interpretation, analytical framework, and final editorial decisions were made exclusively by the human authors. No AI tool was used to generate original scientific content, analyze data, or draft core arguments. In accordance with journal policy, no AI system is listed as an author, nor did it fulfill any authorship role. Results: The industry’s evolution exhibits three distinct phases: Pilot Exploration Phase (2009–2015): Policy shifted from strict control to cautious deregulation, primarily through local pilots, fostering the initial forms of industry-driven and service-driven models. Regulated Expansion Phase (2016–2020): The policy system, centered on the “Basic Standards and Management Regulations for Hemodialysis Centers (for Trial Implementation)” (National Health Commission Document No. [2016] 67), was established, leading to explosive industry growth. The three dominant operational models—industry-driven, service-driven, and capital-driven—were formally established and rapidly expanded. Quality Deepening Phase (2021–2025): Policy focus shifted towards resource decentralization, quality homogenization, and value-based payment, driving the industry from scale-based competition to quality-based competition. The three operational models are now exhibiting trends of deep convergence and upgrading. Conclusion: The development of non-public hemodialysis centers in China exemplifies a typical path of “state-guided market creation.” Through staged interventions characterized by “pilot breakthroughs—regulatory guidance—quality and efficiency enhancement,” policy has effectively mobilized social capital to fill public service gaps. This “policy-driven evolution” framework offers a systematic reference for other emerging economies facing similar shortages in specialized medical services. In the future, the industry will continue to evolve towards greater quality, digitalization, and value orientation, becoming deeply integrated into the national chronic kidney disease prevention and treatment system.