中国家用医疗器械出海之路：因势而动，扬帆出海

Industry Investment Rating - The report maintains a "Recommended" rating for the medical and biological industry, specifically focusing on the home medical equipment (HME) sector [1] Core Viewpoints - The home medical equipment market is experiencing significant growth, driven by manufacturing advantages, product quality, and channel strategies, with Chinese companies well-positioned to expand globally [1] - North America dominates the global HME market, accounting for 42% of total revenue in 2021, while the Asia-Pacific region is expected to grow at a CAGR of over 8% from 2023 to 2032 [1] - Key barriers for Chinese companies entering the global market include stricter FDA approvals, patent risks, and challenges in accessing DME channels and insurance coverage [1] Market Overview - The global HME market is vast, with North America leading in revenue and the Asia-Pacific region showing the fastest growth potential [7][8] - Treatment-oriented devices dominate the HME market, holding 43% of the global market share in 2021, while diagnostic devices are emerging as a high-potential segment [6] - The U.S. DME market is supported by robust insurance coverage, with health insurance accounting for 56.6% of DME expenditures in 2022, up from 24.2% in 1980 [9][11] Market Access and Sales - U.S. FDA certification is challenging, with stricter effectiveness standards compared to CE certification, particularly for Class II and III devices [18] - European CE certification is becoming more stringent under the new MDR regulations, which require enhanced clinical evidence and post-market surveillance [19][20] - In the U.S., DME distribution channels are fragmented, with DME suppliers and pharmacies being the primary sales channels, while Europe relies on a mix of direct sales and distributors [26][28] Pricing Advantages - Chinese HME manufacturers benefit from significant cost advantages, with overseas prices averaging 70% higher than domestic prices, offering substantial profit margins [31][32] - For example, the domestic price of the Sannuo iCan i3 glucose monitor ranges from 119-251 RMB, while its overseas price is approximately 455 RMB, 1.8-3.8 times higher [31] Globalization Trends - The HME market is increasingly globalized, with companies like Abbott, Omron, and Dexcom seeing significant growth in overseas revenue, which now accounts for over 50% of their total revenue [33][34] - Chinese companies are exploring various globalization strategies, including OEM/ODM, self-built teams, and acquisitions of overseas brands, to establish a global presence [35][36] Key Companies - Yuwell Medical (鱼跃医疗): Focused on respiratory therapy and home electronic testing products, with significant revenue from Southeast Asia, South America, and Africa [39] - Sannuo Biosciences (三诺生物): A leader in glucose monitoring, with a strong presence in North America and Southeast Asia, achieving 42.16% of its revenue from overseas markets in 2023 [39] - iHealth (九安医疗): Primarily operates in the U.S. market through its iHealth brand, with overseas revenue accounting for 92.28% of total revenue in 2023 [39] - BMC Medical (怡和嘉业): A leading domestic respiratory equipment manufacturer, with 65.31% of its revenue coming from overseas markets in 2023, primarily through its partnership with React Health in the U.S. [39] Blood Glucose Monitoring (BGM) and Continuous Glucose Monitoring (CGM) - The global blood glucose monitoring market is expected to grow from $26.8 billion in 2020 to $73.8 billion by 2030, driven by the rising prevalence of diabetes and advancements in CGM technology [41][42] - CGM devices, which offer continuous glucose monitoring without frequent finger pricks, are gaining traction, with their market share expected to increase from 21.4% in 2020 to 49.4% by 2030 [46] - Chinese companies are accelerating their entry into the CGM market, with firms like Sannuo Biosciences and Yuwell Medical focusing on product registration and channel development in Europe and the U.S. [41][46] Non-Invasive Ventilators - The global non-invasive ventilator market is projected to grow from $2.66 billion in 2022 to $4.85 billion by 2032, driven by the increasing prevalence of COPD and OSA [1] - Chinese companies like BMC Medical are benefiting from the reshuffling of the global competitive landscape, with BMC's market share in home non-invasive ventilators rising from 4.5% in 2020 to 17.7% in 2022 [1]