This "2025 China Medical Device Overseas Status and Trends Blue Book" is released by Frost & Sullivan, with support from UL Solutions and Jingtian & Gongcheng Law Firm. It provides a comprehensive analysis of the current situation, challenges, strategies, and trends of Chinese medical devices going overseas. The specific content is as follows:
-Current Status of Going Overseas: Chinese medical devices are experiencing simultaneous growth in both quantity and quality. In 2023, exports exceeded 100 billion USD, with product structures upgrading towards high-end. Breakthroughs have been made in categories such as medical equipment, medical consumables, and in vitro diagnostics. Companies like Mindray Medical and United Imaging have emerged in the global market, with the proportion of overseas revenue gradually increasing.
-Driving Factors
-Internal Factors: Domestic enterprises have large production capacity but low per-unit output, and centralized procurement policies compress profits, forcing companies to go overseas. R&D and innovation capabilities have improved, overseas channels and brand awareness increased during the pandemic, policies support the overseas expansion of innovative devices, and leading companies have accumulated international experience.
-External Factors: The global medical device market is huge, Chinese products have price advantages, international influence is increasing, and overseas markets have strong demand for high cost-performance products.
-Overseas Strategies
-Basic Strategies: Including distribution models, overseas capacity building, OEM/ODM, mergers and acquisitions, cross-border e-commerce, etc. For example, Mindray Medical acquires overseas companies to obtain technology and channels, while Andon Health expands its market through cross-border e-commerce.
-Paths and Cases: Strategies differ for companies of different scales, product types, and target markets. Large enterprises such as Mindray Medical adopt a combination of direct sales and distribution, as well as globalized production strategies; high-value consumables companies such as Lepu Medical focus on clinical cooperation and overseas certification; home medical device companies such as Yuwell Medical explore markets through cross-border e-commerce and cost advantages.
-Segment Track Analysis
-Medical Equipment: Imaging and life support equipment have made progress overseas, but face challenges such as reliance on imported core components and patent barriers.
-High-value Consumables: Technological upgrades in fields such as vascular intervention and orthopedic materials, some companies have obtained overseas approvals, but market entry barriers are high and clinical data requirements are strict.
-In Vitro Diagnostics: Exports of reagents and instruments are growing, with continuous breakthroughs in Europe, America, and emerging markets, but facing competition from international brands and regulatory requirements.
-Key Regional Analysis
-Developed Countries: Markets such as the US, EU, and Japan have strong demand but strict regulations and long certification cycles, such as high requirements for US FDA and EU CE certifications.
-“Belt and Road” and Related Countries: Southeast Asia, Middle East, and Latin America have great market potential and rapid growth in medical expenditure, but weak infrastructure and reliance on imports. Chinese companies expand markets through cost-performance advantages and policy support.
-Pain Points and Trends
-Pain Points: Unclear overseas paths, inaccurate regional assessments, complex market access processes, and international localization just beginning.
-Trends: Increase R&D investment and promote product innovation; align with international standards and obtain foreign certifications; enhance cross-cultural communication skills and become familiar with local regulations; improve brand image through diversified strategies.
-Service Provider Introduction: UL Solutions provides regulatory compliance, testing, and certification services, while Jingtian & Gongcheng Law Firm provides legal support to help enterprises go overseas.
