行业深度研究 | 医疗器械 心血管行业空间广阔，集采助力国产替代 心血管疾病相关医疗器械行业报告 心率不齐相关医疗器械市场规模大。根据弗若斯特沙利文研究报告，心 血管疾病中，心律不齐患病率相对较高，中国和全球范围的心脏电生理手术、 心律管理器械及心脏起搏器的市场规模不断增加。2021 年中国心脏电生理 器械市场规模达到65.80亿元，2025年预计将增至157.26亿元，预计到2032 年，中国心脏电生理器械市场规模进一步达到 419.73 亿元，全球范围达到 324.50 亿美元。 根据弗若斯特沙利文数据，全球心律管理器械市场的规模自 2016 年的 97 亿美元增加至 2021 年的 106 亿美元，复合年增长率为 1.8%，并预期于 2030 年将增加至 128 亿美元。根据弗若斯特沙利文数据，全球心脏起搏器市场预 期将由 2021 年的 3,597.4 百万美元增加至 2030 年的 4,224.9 百万美元，复 合年增长率为 1.8%。 冠状动脉和主动脉相关医疗器械市场规模较大。根据弗若斯特沙利文数据， 中国冠状动脉疾病患病人数不断增加，预计在 2026-2030 年的复合年均增长 率约 2.0%， ...

（编辑 袁冠琳） 证券日报网讯 蓝帆医疗9月19日发布公告，在公司回答调研者提问时表示，公司心脑血管事业部营业收 入国外占比约60%，国内占比约40%，预计未来国内占比有望进一步提升。2025年上半年公司心脑血管 事业部营业收入近7亿元，其中冠脉业务营业收入6.5亿元左右，心脏瓣膜营业收入0.5亿元左右。 ...

Core Insights - Bluefan Medical (002382) reported a revenue of 2.781 billion yuan for the first half of 2025, representing a year-on-year decline of 7.49% [2] - The company experienced a net profit attributable to shareholders of -135 million yuan, which is a year-on-year increase of 15.88% [2] Business Overview - Bluefan Medical's primary business segments include: - Cardiovascular business focusing on interventional devices such as stents, balloons, and heart valves [2] - Health protection business centered around disposable gloves, covering various applications in medical, industrial, and catering sectors, with a full range of gloves including PVC, nitrile, latex, TPE/CPE, and polyurethane [2] - Emergency rescue business that includes emergency kits and services [2]

Core Viewpoint - HeartTech Medical (02291) reported strong mid-term performance with a revenue of 330 million RMB, representing a year-on-year growth of 32.4%, and a net profit attributable to shareholders of 182 million RMB, up 29.8% [1] Company Performance - The company’s basic earnings per share reached 0.5249 RMB [1] - As of the announcement date, HeartTech Medical has a total of 30 products in the market, including occluders, heart valves, and accessories, with 4 products under registration review and 28 products in various stages of research and development [1] Product Pipeline and Market Position - According to CITIC Securities, HeartTech Medical has a comprehensive layout in the structural heart disease sector, covering products for congenital heart disease occluders, cardioembolic stroke, valves, and heart failure [1] - The company has a rich pipeline in the valve sector, with TAVR products already approved for market [1] - In the aortic and peripheral occluder fields, the company is developing biodegradable aortic occluders [1] Growth Drivers and Future Potential - The company has maintained rapid growth in recent years, primarily driven by the market expansion of new products such as biodegradable occluders [1] - HeartTech Medical's biodegradable occluder technology is at a leading level globally, with independent intellectual property rights [1] - There is potential for strong overseas license-out opportunities for this product series, considering the high costs of overseas clinical research and the company's technological advantages [1]

Core Insights - Brazil's medical device exports reached $572.6 million in the first half of 2025, marking a 7.5% year-on-year increase, indicating international recognition of Brazilian medical manufacturing [1] Group 1: Export Performance - The main exported products include surgical sutures, heart valves, medical plastic bags, and medical dressings [1] - The United States is the largest export destination for Brazilian medical devices, accounting for over $150 million, which is more than a quarter of total exports [1] - Other significant markets include Argentina, Colombia, Mexico, and Chile [1] Group 2: Industry Outlook - The Brazilian medical device industry is facing increased concerns regarding export prospects due to tariffs imposed by the U.S. [1]

Core Viewpoint - The article discusses the implications of the EU's recent ban on Chinese medical device participation in its procurement processes, highlighting the rapid growth of China's medical device industry and the potential for retaliatory measures from China [3][4]. Summary by Sections EU-China Medical Trade Dynamics - In 2024, the trade scale of medical devices between China and the EU is projected to be $37.04 billion, with China importing $28.04 billion (a 6.09% decrease year-on-year) and exporting $9 billion (a 12% increase) [5]. Product Composition and Market Trends - China's exports of high-end medical equipment to the EU have seen significant growth, with endoscopes increasing by 294% over four years. Advanced models like 7.0T MRI and 640-slice CT are gaining market share in Germany and France due to competitive pricing [6]. - Despite the EU being China's largest source of medical device imports, the market share of foreign brands is declining as domestic brands gain traction [6]. Rise of Domestic Brands - The domestic market for MRI machines has reached a localization rate of 35.1% in 2024, with CT machines seeing significant increases in installation rates in tertiary hospitals. Domestic brands have reduced PET-CT examination costs by approximately 25% [8]. - By early 2025, about 70% of medical linear accelerators approved by the National Medical Products Administration are domestically produced, showcasing the rapid advancement of local manufacturing capabilities [8]. Factors Supporting Domestic Growth - The rise of domestic brands is attributed to favorable policies like "Made in China 2025," which mandates the application of domestic medical devices in public hospitals. Regulatory support for emerging technologies has also accelerated domestic innovation [11]. - Domestic medical devices are iterating faster than imports, with significant advancements in technology and design tailored to local needs [12]. Innovations and Future Prospects - China is leading in brain-computer interface technology and surgical robotics, with unique innovations such as five-arm robots and non-inflated surgery techniques [13]. - The article emphasizes the potential for Chinese medical devices to become a global benchmark, driven by a large domestic market and rapid technological advancements [14].

Core Viewpoint - The article discusses the current state of the medical device industry in China, particularly focusing on the impact of centralized procurement on the supply and development of innovative medical devices, especially vascular stents and surgical sutures. It highlights the challenges faced by domestic manufacturers in replacing imported products and the ongoing efforts to develop competitive alternatives. Group 1: Medical Device Procurement and Supply - In the first half of the year, China approved 45 innovative medical device products, and the centralized procurement of peripheral vascular stents has been implemented in several provinces [1][3] - The procurement results show that the average price of stents has dropped by over 80%, with some prices falling to around 2,000 yuan, significantly impacting the supply of imported products [3][4] - The exit of major players like Gore from the market has led to supply shortages, particularly for small vascular stents, creating a gap that domestic manufacturers are trying to fill [3][4] Group 2: Challenges in Domestic Manufacturing - Domestic manufacturers are facing significant challenges in developing competitive products, particularly in the small vascular stent segment, where the technology and materials used in imported products are still superior [4][5] - The reliance on imported materials for manufacturing high-quality medical devices remains a bottleneck for domestic companies, despite some progress in clinical trials for alternative products [5][8] - The overall innovation ecosystem in China is still developing, with a need for better policy support and risk management to foster growth in the medical device sector [5][6] Group 3: Specific Medical Device Segments - The heart surgery segment has seen some domestic alternatives, but critical areas such as non-absorbable sutures still lack suitable local replacements, posing risks in surgical outcomes [7][8] - Pediatric cardiac devices are particularly underserved, with most options still being imported due to the small market size and lack of incentive for domestic manufacturers to develop specialized products [8][9] - The mechanical heart valve market remains a significant gap for domestic manufacturers, with only a few international companies providing these products, highlighting the challenges in entering mature markets [9][10]

Core Insights - The reliance on imported high-value medical consumables in China is decreasing as domestic brands emerge in critical areas such as intracranial aneurysm embolization devices, cardiac sutures, heart valves, artificial blood vessels, and ECMO consumables [1][4] - In the first half of this year, China approved 45 innovative medical device products, and the results of centralized procurement for peripheral vascular stents have been implemented in multiple provinces [1][2] Group 1: Market Dynamics - The fifth batch of centralized procurement results shows that 18 companies, including both multinational and domestic firms, have been selected, with prices for stents dropping by over 80% [2][3] - The exit of Gore from the procurement process has led to supply shortages for its self-expanding covered peripheral vascular stent, VIABHAN, which was previously the only option for small vessels [2][3] - The demand for peripheral vascular implants is significant, with 200,000 to 300,000 patients treated annually, yet domestic products currently hold less than 10% of the procurement share [3] Group 2: Challenges in Domestic Production - Domestic manufacturers are developing products to compete with Gore's stent, but face challenges in material quality and production processes [4][5] - The production of small vascular covered stents is particularly challenging due to stringent requirements for flexibility, support, and leakage prevention [3][4] - The heart suture market remains dominated by imports, with no domestic alternatives currently available for critical applications [6][7] Group 3: Clinical Implications - The shortage of small vascular covered stents has forced clinicians to seek temporary procurement solutions, which can take one to two weeks [3] - In pediatric cardiac care, the lack of suitable domestic devices leads to reliance on adult products, creating operational delays [7][8] - The mechanical valve market in China is largely unaddressed by domestic manufacturers, with only a few multinational companies providing these products [7][8] Group 4: Future Outlook - The potential for supply shortages in specific medical device areas exists if domestic solutions are not developed in time [9] - The market for interventional valves is attractive due to shorter development cycles and higher profit margins, which may incentivize domestic companies to invest [8]

Group 1 - The U.S. Court of Appeals has suspended a ruling that blocked Trump's global tariffs, with considerations for further extensions ongoing [2] - The U.S. Department of Commerce stated that communication between China and the U.S. regarding trade concerns has been maintained at multiple levels since the Geneva trade talks [2][3] - The Chinese Ministry of Foreign Affairs condemned the U.S. decision to revoke student visas for Chinese students, asserting it harms their legitimate rights [2] Group 2 - The Central Committee of the Communist Party of China and the State Council issued opinions to improve the market-oriented allocation system for resource and environmental factors by 2027 [3] - The Chinese Ministry of Commerce emphasized the need to address structural contradictions in certain sectors despite ongoing financial policy measures [3] - The Ministry of Commerce held a meeting to promote the construction of intelligent supply chains, focusing on digital economy and AI opportunities [3] Group 3 - Shanghai Customs reported that the city's foreign trade import and export value reached 1.4 trillion yuan in the first four months of the year, a 1% year-on-year increase [4] - The China Light Industry Federation indicated that revenue for large-scale light industry enterprises reached 7.35 trillion yuan, with a 4.9% year-on-year growth [4] Group 4 - A-shares experienced a strong performance with over 4,400 stocks rising, particularly in sectors like autonomous driving and AI hardware [5] - The Hang Seng Index closed up 1.35%, with significant gains in stablecoin and pharmaceutical stocks [5] Group 5 - Li Auto reported Q1 revenue of 25.9 billion yuan, a 1.1% year-on-year increase, but a 20.5% decline in adjusted net profit [6] - Shanghai Linqingxuan Biotechnology submitted a prospectus for an IPO, potentially becoming the first high-end skincare stock in Hong Kong [6] Group 6 - The U.S. government has effectively cut off certain semiconductor technology exports to China, impacting companies like Synopsys and Cadence [8] - China's fusion device has achieved new records in plasma current and ion temperature, marking significant progress in fusion research [8] Group 7 - The U.S. initial jobless claims rose by 14,000 to 240,000, the highest level since November 2021, indicating labor market challenges [13] - The U.S. first-quarter GDP was revised to a 0.2% contraction, with consumer spending growth significantly downgraded [13] Group 8 - The U.S. Federal Reserve's statement indicated that future monetary policy will depend on upcoming economic data [13] - The U.S. housing market showed signs of weakness, with a 6.3% drop in the pending home sales index, the largest decline since September 2022 [14]

Group 1 - The trend of Chinese medical device companies "going global" is long-term positive, especially in the upstream supply chain which has formed a certain scale [1] - In Q1 2025, China's medical device export trade total is projected to reach 69.26 billion yuan, a year-on-year increase of 5.03%, with high-end medical devices seeing significant growth [1] - The export value of China's medical device industry is expected to reach 48.75 billion USD in 2024, reflecting a year-on-year growth of 7.3% [1] Group 2 - Over 100 listed medical device companies have already initiated "going global" operations in 2024, covering various product areas such as medical consumables and diagnostic equipment [2] - Companies are advised to consider business, supply chain, and localization strategies for global expansion [2][3] - Localized production and supply chain management are essential for adapting to market demands in different regions [3] Group 3 - Companies like Haier Bio emphasize the importance of localizing product design and marketing to enhance user experience in overseas markets [4] - The trend of "going global" is common among mature, growth, and startup medical device companies, focusing on high-value and high-end products [6] - High-value medical devices, such as deep brain stimulators, require careful economic calculations and long-term service planning before entering foreign markets [6] Group 4 - Companies are encouraged to leverage digitalization and smart technologies to enhance their global strategies, as seen with Mindray Medical's remote monitoring capabilities [7] - Brand building is crucial for domestic medical device companies, with strategies including sponsorship of international sports events to enhance global influence [7] - The medical device market in Europe and the US accounts for over 65% of the global market share, making it a primary target for Chinese companies [8] Group 5 - Key conditions for Chinese medical device companies to "go global" include having sufficient capital, production capacity, and independent R&D capabilities [8] - Collaboration with local hospitals and doctors for joint R&D and clinical trials can facilitate product entry into new markets [8]