动态血糖监测仪(CGM)
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国产CGM出海竞速:从产品输出到生态共建,“抢滩”全球动态血糖监测市场
Cai Jing Wang· 2025-12-17 14:53
Core Insights - The current dynamic continuous glucose monitoring (CGM) market is experiencing a "price war," prompting Chinese manufacturers to target overseas markets to capture a share of the global multi-billion dollar market [1][2] - Chinese CGM companies such as Weitai Medical, Sanofi Biologics, and others are expanding into regions like India, Southeast Asia, and Europe, previously dominated by international giants [1][2][3] Market Expansion - Chinese CGM manufacturers are focusing on emerging markets like Indonesia and Algeria, where there is a growing demand for medical devices and relatively flexible market entry requirements [2][3] - Weitai Medical has recently received approval for its LinX CGM system in India, which has a significant diabetic population of nearly 90 million [1][2] - Sanofi Biologics has reported explosive growth in Indonesia, attributing this to a local team and tailored products [2][3] Regulatory Landscape - The European market is seen as a "test stone" for CGM companies due to its high regulatory standards and established healthcare systems [3] - Several Chinese CGM products have obtained EU CE certification, facilitating easier entry into other markets [3] Technological Advancements - Chinese CGM manufacturers are shifting from a "Made in China" image to a "Smart Manufacturing" approach, focusing on improving product accuracy and user experience [4][5] - The average absolute relative difference (MARD) value, a key performance indicator for CGM accuracy, has improved significantly, with leading brands now achieving values below 10% [5] Future Directions - The competition in the CGM market is expected to evolve beyond hardware specifications to include comprehensive diabetes management solutions [6][7] - The integration of advanced technologies, such as iCGM systems and artificial pancreas concepts, represents the future direction of diabetes management [7] Challenges and Considerations - Intellectual property issues pose significant challenges for Chinese CGM companies entering the global market, with patent litigation being a common concern in the US and Europe [8] - The global blood glucose monitoring market is valued at over $30 billion, and Chinese companies must enhance their technological capabilities and brand recognition to compete effectively [8] Strategic Outlook - The year 2026 is projected to be a critical juncture for Chinese CGM companies, influenced by FDA registration progress, EU healthcare access, and local production initiatives in emerging markets [8]