2025年中国植入式人工心脏行业进入壁垒、市场政策、产业链图谱、市场规模、竞争格局及发展趋势研判：行业技术壁垒极高[图]

Overview - The global number of end-stage heart failure patients is large, and heart transplantation is limited by donor scarcity. The success rate of patients receiving transplant surgery is very low. Implantable artificial hearts serve as an important alternative to heart transplantation, providing transitional treatment for patients awaiting transplant and long-term treatment for those unsuitable for transplantation. In 2024, the global implantation volume of implantable artificial hearts is expected to reach 7,538 units, a year-on-year increase of 33.84%, with a market size of $1.2 billion, also up by 33.33% [1][8]. Industry Barriers to Entry - The research and development of artificial hearts involve a multidisciplinary approach, requiring expertise in mechatronics, mechanical design, fluid mechanics, biomechanics, materials science, and clinical medicine. Currently, only a few medical device companies globally have the capability to engage in this industry, making it difficult for new entrants to gain a competitive advantage in the short term. The production of these devices requires high-quality control and complex manufacturing processes, necessitating long-term practical experience and technological breakthroughs [2][4]. Relevant Policies - The medical device industry, including implantable artificial hearts, is a strategic emerging industry in China, receiving significant attention from the government. Various policies have been issued to regulate the market, ensure product quality, and safeguard patient safety, creating a favorable environment for the development of the implantable artificial heart industry [4][5]. Industry Chain - The upstream of the implantable artificial heart industry includes suppliers of metals like titanium and stainless steel, polymer materials like polyurethane and polyethylene, core components like magnetic suspension motors and precision bearings, as well as external controllers and batteries. The midstream involves the research and production of implantable artificial hearts, while the downstream consists of healthcare institutions and heart failure patients, with the core consumer group being end-stage heart failure patients [5][6]. Current Development - The number of heart failure patients is increasing globally, driven by aging populations and the prevalence of chronic diseases. In 2024, the global number of heart failure patients is projected to reach 63 million, with end-stage heart failure patients numbering 6.1 million. In China, the number of heart failure patients is expected to reach 15.4 million, with 1.6 million in the end-stage category. This rising patient population is driving demand for implantable artificial hearts [7][8]. Competitive Landscape - The implantable artificial heart market has high technical barriers, with overseas companies having a head start. Abbott's HeartMate3 holds a significant market share globally. In China, five models of implantable artificial hearts have been launched, with Shenzhen Core Medical Technology Co., Ltd.'s Corheart®6 showing notable technological advantages. As of early 2025, Core Medical's Corheart6 accounted for 52.86% of the market share in terms of implantation volume [9][10]. Representative Domestic Companies - Shenzhen Core Medical Technology Co., Ltd. focuses on innovative artificial heart products and has developed five implantable and six interventional heart products. In 2024, the revenue from its left ventricular assist system reached approximately 93.69 million yuan, a year-on-year increase of 466.08% [10][11]. - Suzhou Tongxin Medical Technology Co., Ltd. has developed the first fully magnetic suspension left ventricular assist device in China, which has received regulatory approval. This product features several innovative technologies, marking a significant advancement in the domestic artificial heart field [11][12]. Future Development Trends - The industry is expected to see continued optimization of magnetic suspension technology, leading to improved stability and longevity of devices. There will be a trend towards smaller and lighter products to reduce surgical trauma and enhance post-operative convenience. Additionally, the integration of artificial intelligence and IoT technologies is anticipated to improve remote monitoring and management of patients post-surgery. The application of advanced materials may also reduce infection and rejection risks, expanding the use of implantable artificial hearts beyond adult end-stage heart failure patients to more specific scenarios [12].