2025年头豹词条报告系列：AI医疗器械爆发前夜：医学影像与诊断设备引领千亿级市场变革

Investment Rating - The report indicates a positive outlook for the AI medical device industry, highlighting its potential for significant growth and transformation in the market [1]. Core Insights - The AI medical device industry is on the brink of explosive growth, driven by advancements in artificial intelligence technology, regulatory support, and increasing market penetration in medical institutions and third-party imaging centers [1]. - The market size of AI medical devices has expanded from 1.25 billion RMB in 2019 to 43.70 billion RMB in 2023, with a compound annual growth rate (CAGR) of 143.33% [30]. - The industry is expected to continue its growth trajectory, with projections indicating a market size increase to 524.85 billion RMB by 2028, reflecting a CAGR of 68.58% [30]. Industry Definition - AI medical devices are defined as medical devices that utilize artificial intelligence technology based on medical device data to achieve their intended medical purposes [2]. Industry Classification - AI medical devices can be classified into two main categories: decision-support devices and non-decision-support devices [4][6]. Industry Characteristics - The AI medical device industry is characterized by its wide application across various medical fields, a diverse range of participating companies, and a stable increase in the number of approved Class III medical device registrations [8]. - The number of approved Class III medical devices has shown consistent growth, with 81 AI medical devices approved by the end of 2023, marking a significant increase from previous years [11][18]. Development History - The AI medical device industry has evolved through three major stages, with significant milestones including the first AI medical device approval in 2018 and the subsequent commercialization of deep learning-based products starting in 2020 [12][15]. Industry Chain Analysis - The industry chain consists of upstream hardware suppliers, midstream AI medical device manufacturers, and downstream application terminals [16]. - The regulatory framework has driven the standardization of clinical trial institutions, enhancing the quality of clinical trials and supporting industry growth [17][20]. Market Size and Growth Drivers - The AI medical device market is projected to grow significantly due to the increasing adoption of AI technologies in healthcare, with applications in cancer detection, preoperative planning, and disease management [33]. - The report emphasizes the role of government policies in promoting innovation and development within the AI medical sector, which has been a key driver of market expansion [32]. Competitive Landscape - The competitive landscape of the AI medical device industry is structured into tiers, with leading companies such as Shukun Technology in the first tier, followed by companies like United Imaging Healthcare and Infervision in the second tier [38][39]. - The report notes that regulatory clarity has facilitated the entry of multiple players into the market, fostering a competitive environment [39]. Company Overview - United Imaging Healthcare has established itself as a leader in the AI medical device sector, providing a range of high-performance diagnostic and therapeutic equipment [44].