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医疗器械出海深度(一)欧洲市场:高壁垒但可突破,未来中国企业销售有望提速
Changjiang Securities·2025-09-02 09:46

Investment Rating - The report maintains a "Positive" investment rating for the medical device industry [14]. Core Insights - The European market is a core market for global medical devices, with a market size of approximately €160 billion in 2023, growing by 2.4% year-on-year. The global medical device market reached $582.6 billion in 2023, with Europe accounting for about 26% of the total market share [4][9]. - The report emphasizes that European medical device companies should focus on direct sales strategies in key markets such as Germany, France, and the UK, while utilizing distributors in other regions to penetrate the market [10][11]. - Chinese medical device companies are expected to accelerate their sales in Europe, leveraging their cost advantages and localizing their teams to adapt to the market [12][11]. Summary by Sections European Market Overview - Europe is the second-largest medical device market globally, with a stable growth rate and a concentration of market share among the top five countries: Germany, France, Italy, the UK, and Spain, which together account for 66% of the market [9][34]. - The average healthcare expenditure in Europe is about 11% of GDP, with approximately 7.9% allocated to medical technology [9][27]. Regulatory Environment - The report highlights the increased difficulty in obtaining regulatory approval under the new EU Medical Device Regulation (MDR), with costs for certification reaching approximately €4.25 million for medical devices and €2.34 million for in vitro diagnostics (IVD) [10][58]. - The certification process is lengthy, with an average duration of 1.5 to 2 years for mature technologies [10][58]. Sales Strategies - The report suggests that companies should prioritize direct sales in the UK, France, and Germany, while using distributors in other regions due to language barriers and varying regulatory environments [10][65]. - Distributors are increasingly providing comprehensive solutions, integrating product supply, technical services, training, and customer relationship management [10][73]. Market Opportunities for Chinese Companies - Chinese medical device companies are making inroads into the European market, with strategies including establishing local teams and partnerships to enhance market penetration [11][96]. - The report identifies that the medical consumables segment is the primary focus for Chinese exports to Europe, accounting for 49% of the total export value [125][130].