东北证券发布研报称，国内市场历经多年的高速放量，在医保资金压力凸显、医保支付改革全面落地的 大背景下，逐步回归稳健成长;设备与耗材的全面集采倒逼企业寻找新利润增长点，"出海"已是国产先 进厂商的战略必然。中国医疗器械行业已具备全球竞争的硬实力，高端装备、高值耗材的产品输出与全 球供应链建设快速落地;随着国内医疗市场支付端逐步成熟，海外收入占比将逐渐成为衡量医疗器械公 司成长性与估值的核心指标。 东北证券主要观点如下： 医疗设备：高端装备率先突围，迈向全球第一梯队 高端突破：国产医疗设备已经摆脱中低端替代的刻板印象，以联影医疗、迈瑞医疗（300760）、微创机 器人为代表的国产尖端设备公司凭借5TMR、长轴MI、超高端彩超、腔镜手术机器人等创新产品，进军 欧美顶尖医疗体系。 本地化运营：全球化的营销网络和供应链体系是医疗设备国际业务做大做强的必经之路。通过在海外建 立营销网络(如鱼跃医疗（002223）泰国子公司已经形成"从产品输出到生态共建"的本土化路径模板)、 仓储基地、生产基地及研发中心(如联影医疗在美国建立休斯顿、西雅图双研发中心和休斯顿生产基地; 海泰新光、美好医疗（301363）海外产能持续扩张)， ...

Core Insights - The report emphasizes that the Chinese medical device industry is transitioning from rapid domestic growth to a more stable development phase, driven by increasing pressure from medical insurance funding and comprehensive payment reforms. As a result, "going global" has become a strategic necessity for advanced domestic manufacturers [2][3] - The report highlights that the Chinese medical device sector has developed the hard power necessary for global competition, with high-end equipment and high-value consumables rapidly establishing their presence in global supply chains. The increasing share of overseas revenue will become a core indicator of growth and valuation for medical device companies [2][3] Group 1: Market Growth and Strategic Shifts - The medical device market is expected to reach CNY 941.7 billion by 2024 and CNY 1,813.4 billion by 2035, with a CAGR of 6.14% from 2024 to 2035. The global market is projected to grow from USD 623 billion in 2024 to USD 1,157.6 billion by 2035, with a CAGR of 5.80% [17] - Domestic companies are accelerating their international expansion due to internal pressures, including the impact of centralized procurement policies that have significantly reduced prices in the domestic market [21][22] Group 2: International Expansion and Challenges - The report notes that many domestic high-value consumables are gaining FDA and CE certifications, indicating a growing international recognition of Chinese manufacturing capabilities. This trend is particularly evident in Southeast Asia and South America, where companies are gaining experience before tackling more stringent markets like the EU and the US [3][4] - The report discusses various patent disputes faced by Chinese companies during their international expansion, highlighting the challenges of overcoming established international competitors' patent barriers. This includes cases involving major companies like Mindray and Times Angel [27][28] Group 3: Product Categories and Market Dynamics - High-end medical devices, such as imaging equipment and surgical robots, are leading the charge in international markets, with companies like United Imaging and Mindray making significant strides in Europe and the US [3][4] - The report indicates that the demand for high-value consumables is increasing, with companies focusing on innovation and clinical effectiveness to enhance their competitive edge in global markets [4][5] Group 4: Supply Chain and Localization Strategies - The establishment of global marketing networks and supply chain systems is essential for the international success of medical device companies. This includes setting up local subsidiaries, warehouses, and production bases in key markets [3][4] - The report emphasizes the importance of academic promotion and clinical trials in gaining market acceptance, particularly in high-end markets where local healthcare systems may require extensive clinical data for reimbursement [32][33]