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市场调查报告书
商品编码
1732163
全球生物可吸收支架市场规模(依材料类型、应用、最终用户、地区、预测)- 2020 年Bioabsorbable Stent Market Size By Material Type (Polymer-Based, Metal-Based), By Application (Coronary Artery Disease, Peripheral Artery Disease), By End-user (Hospitals, Cardiac Centers), By Geographic Scope And Forecast |
2024 年全球生物可吸收支架市场规模为 4.4717 亿美元,预计到 2032 年将达到 9.9397 亿美元,2026 年至 2032 年的复合年增长率为 10.50%。
生物可吸收支架,也称为生物可吸收血管支架 (BVS),旨在为接受治疗的血管提供支撑后随着时间的推移被人体完全吸收。
这种创新设备的开发是为了克服永久性金属支架的局限性,包括晚期支架血栓症和长期双重抗血小板治疗的需要。
此外,该技术旨在恢復血管的自然功能,同时减少与永久性植入相关的长期併发症。
影响生物可吸收支架市场的关键市场动态是:
心血管疾病(CVD)盛行率上升:全球心血管疾病负担的增加是生物可吸收支架市场的主要驱动力。根据世界卫生组织(WHO)统计,心血管疾病每年导致约1,790万人死亡,占全球整体的32%。心臟疾病率的不断上升推动了对生物可吸收支架的需求。生物可吸收支架具有与永久性植入相关的併发症较少的优势,使其成为需要支架治疗的患者的首选。
支架技术的进步:支架设计和材料的技术进步正在加速生物可吸收支架在冠状动脉疾病治疗中的应用。生物可吸收支架由生物分解性的聚合物製成,一旦达到保持动脉畅通的目的,就会自然分解。根据美国食品药物管理局(FDA) 的研究,生物可吸收支架已显示出减少支架血栓症等晚期问题的巨大潜力,从而改善患者预后并支持更广泛的市场应用。
医疗保健支出的增加和可近性的提高:医疗保健基础设施投资的增加和创新疗法可近性的改善正在推动生物可吸收支架市场的发展。据世界银行称,全球医疗保健支出不断增加,许多国家加大对先进心血管护理的投资。医疗保健支出的增加,加上人们试图提供最尖端科技,推动了对生物可吸收支架作为冠状动脉疾病有效治疗方法的需求不断增长。
主要挑战
对临床表现的担忧:一些医疗保健提供者对生物可吸收支架的长期有效性和安全性提出了质疑。第一代支架曾出现过一些併发症,影响了市场信心。
监管障碍:新支架技术的核准必须遵守严格的监管要求。在任何新型支架上市前,监管机构都需要进行长期临床试验并提供安全资料。
製造成本高:事实证明,製造生物可吸收支架比传统金属支架更复杂、更昂贵。这些高昂的成本转嫁给了医疗保健提供者和患者,限制了价格敏感市场的采用。
主要趋势
个人化医疗方法:正在开发客製化支架设计以满足个别患者的需求。利用先进的成像和 3D 列印技术,可以创建针对特定患者的设备。
专注于新材料:正在研究具有改进的机械性能和更可控的降解率的新型生物可吸收材料。正在研究结合聚合物和金属优点的复合材料。
整合药物释放型功能:增强型药物传输系统整合到可生物吸收支架中。这些进展旨在改善癒合效果并降低血管再阻塞的风险。
北美:
根据 Verified Market Research 的调查,预计预测期内北美将主导生物可吸收支架市场。心血管疾病 (CVD) 仍然是北美最大的死亡原因,推动了对生物可吸收支架等先进治疗方案的需求。根据美国心臟协会 (AHA) 的数据,到 2021 年,大约有 1.215 亿美国成年人将患有某种形式的心血管疾病。这种高疾病负担导致生物可吸收支架的采用率增加。与传统金属支架相比,生物可吸收支架可降低晚期支架血栓症的风险,且无需长期双重抗血小板治疗,提供更好的长期疗效。
北美市场受益于鼓励采用创新医疗技术的法律规范。美国食品药物管理局(FDA)越来越多地核准治疗冠状动脉疾病的生物可吸收支架,以促进其在临床实践中的应用。近年来,FDA 透过其突破性设备计划加快了生物可吸收支架的核准,从而加快了此类产品进入市场的速度并支持了该地区的发展。
此外,北美人口老化也对生物可吸收支架的需求成长产生了重大影响。根据美国人口普查局的报告,到2032年,婴儿潮世代的年龄都将达到65岁或以上,这将导致与老龄化相关的心血管疾病的增加。由于老年人更有可能需要接受冠状动脉疾病的支架手术,预计未来几年对生物可吸收支架的需求将稳定成长,以减少长期併发症。
亚太地区:
预计亚太地区将在预测期内引领市场。在亚太地区,由于生活方式的改变和人口老化,心血管疾病(CVD)的盛行率不断上升,这是生物可吸收支架市场的主要驱动力。根据世界卫生组织(WHO)统计,心血管疾病是造成中低收入国家,尤其是东南亚等地区过早死亡的75%以上的原因。心血管疾病负担的持续加重推动了对先进疗法的需求,例如生物可吸收支架,它可以透过减少长期併发症来帮助改善患者的治疗效果。
亚太地区各国政府正在投资医疗保健基础设施和改革,以改善获得先进医疗技术的机会。例如,印度的国家卫生政策和中国的「健康中国2032」倡议都强调改善心血管护理,包括扩大尖端支架技术的可用性。这些政策鼓励采用生物可吸收支架,作为加强全部区域心血管护理的更广泛努力的一部分。
此外,由于提供高品质且价格合理的医疗服务,医疗旅游业在亚太地区蓬勃发展,尤其是在印度、泰国和马来西亚等国家。这一趋势还包括对生物可吸收支架等先进心血管治疗的需求不断增长。据医疗旅游协会称,亚太地区是寻求心血管手术的医疗游客的首选目的地。医疗旅游业的成长促进了该地区生物可吸收支架市场的扩张。
生物可吸收支架市场根据材料类型、应用、最终用户和地区进行细分。
根据材料类型,生物可吸收支架市场分为聚合物基和金属基。预计聚合物基支架将主导生物可吸收支架市场,因为它们具有优异的生物相容性和在体内缓慢的吸收性,从而减少了与永久性支架相关的长期併发症。聚合物支架具有灵活性和能够药物释放型以防止血管再阻塞等优点,使其成为治疗冠状动脉疾病的理想选择。聚合物材料的技术进步提高了机械强度并控制了降解,从而导致聚合物支架的采用率更高。
根据应用,生物可吸收支架市场分为冠状动脉疾病和周边动脉疾病。冠状动脉疾病 (CAD) 在世界范围内十分常见,是导致死亡的主要原因之一,因此,冠状动脉疾病领域预计将占据生物可吸收支架市场的主导地位。生物可吸收支架在治疗冠状动脉疾病方面具有巨大优势,它可为动脉提供临时支撑,同时限制血管再阻塞和血栓症等长期併发症。药物释放型设计等生物可吸收支架的技术进步进一步提高了其治疗 CAD 的有效性。周边动脉疾病的治疗也可以受益于生物可吸收支架,但由于患有 CAD 的患者群体庞大,因此该领域占据市场主导地位。
根据最终用户,生物可吸收支架市场分为医院、心臟中心和其他。由于医院进行的支架植入手术量大,医院部门预计将主导生物可吸收支架市场。该医院拥有先进的基础设施和广泛的专业服务,是需要冠状动脉介入治疗的患者的主要治疗中心。此外,医院可以使用更广泛的生物可吸收支架技术,并且更有可能采用尖端的医疗创新。
根据地区,生物可吸收支架市场分为北美、欧洲、亚太地区和世界其他地区。由于心血管疾病盛行率高、医疗基础设施先进以及早期采用创新医疗技术等多种因素,北美预计将在生物可吸收支架市场占据主导地位。该地区强而有力的法律规范在美国食品药物管理局(FDA)的支持下,正在加速生物可吸收支架的核准和临床使用。此外,北美受惠于对研发的大量投资,推动了生物可吸收支架技术的持续进步。虽然欧洲和亚太地区也是主要市场,但北美凭藉其强大的医疗保健体系和对微创手术的高需求在全球市场占据主导地位。
我们的市场分析还设有专门针对这些主要企业的部分,我们的分析师在其中提供所有主要企业的财务报表见解以及产品基准评效和 SWOT 分析。竞争格局部分还包括上述全球公司的关键发展策略、市场占有率和市场排名分析。
Bioabsorbable Stent Market size was valued at USD 447.17 Million in 2024 and is projected to reach USD 993.97 Million by 2032, growing at a CAGR of 10.50 % from 2026 to 2032.
Bioabsorbable stents, which are also referred to as bioresorbable vascular scaffolds (BVS), are designed to be fully absorbed by the body over time after supporting the treated blood vessel.
These innovative devices are developed to overcome the limitations of permanent metallic stents, such as late stent thrombosis and the need for long-term dual antiplatelet therapy.
Furthermore, the technology is aimed at restoring the natural function of the vessel while reducing long-term complications associated with permanent implants.
The key market dynamics that are shaping the bioabsorbable stent market include:
Rising Prevalence of Cardiovascular Diseases (CVDs): The growing global burden of cardiovascular illnesses is a key driver of the bioabsorbable stent market. According to the World Health Organization (WHO), CVDs kill around 17.9 million people each year, accounting for 32% of all global fatalities. The growing prevalence of cardiac disease is driving demand for bioabsorbable stents, which have the advantage of decreasing difficulties associated with permanent implants, making them the preferred choice for patients requiring stent-based treatments.
Advancements in Stent Technology: Technological advances in stent design and material have accelerated the use of bioabsorbable stents in the treatment of coronary artery disease. Bioabsorbable stents, created from biodegradable polymers, disintegrate naturally after serving their purpose of maintaining the artery. According to research from the United States Food and Drug Administration (FDA), bioabsorbable stents have shown substantial potential in lowering late-stage problems such as stent thrombosis, therefore improving patient outcomes and boosting wider market adoption.
Increasing Healthcare Expenditure and Accessibility: Growing investment in healthcare infrastructure and improved access to innovative medical treatments are propelling the bioabsorbable stent market. The World Bank said that worldwide healthcare spending has continuously increased, with many countries investing more in advanced cardiovascular treatment. This increase in healthcare spending, combined with attempts to provide access to cutting-edge technologies, is driving rising demand for bioabsorbable stents as an effective therapy for coronary artery disease.
Key Challenges
Clinical Performance Concerns: Questions about the long-term efficacy and safety of bioabsorbable stents are raised by some healthcare providers. Several first-generation devices have been associated with complications, which is affecting market confidence.
Regulatory Hurdles: Strict regulatory requirements are imposed for the approval of new stent technologies. Extended clinical trials and safety data are demanded by regulatory bodies before new devices are brought to market.
High Production Costs: The manufacturing of bioabsorbable stents is found to be more complex and expensive compared to traditional metallic stents. These higher costs are passed on to healthcare providers and patients, which is limiting adoption in price-sensitive markets.
Key Trends
Personalized Medicine Approach: Customized stent designs are developed to meet individual patient needs. Advanced imaging and 3D printing technologies are utilized to create patient-specific devices.
Focus on Novel Materials: Research is conducted on new bioabsorbable materials that offer improved mechanical properties and more controlled degradation rates. Composite materials that combine the benefits of both polymers and metals are explored.
Integration of Drug-Elution Capabilities: Enhanced drug-delivery systems are incorporated into bioabsorbable stents. These advancements are aimed at improving healing outcomes and reducing the risk of restenosis.
The regional analysis of the bioabsorbable stent market:
North America:
According to Verified Market Research, North America is estimated to dominate the bioabsorbable stent market over the forecast period. Cardiovascular diseases (CVDs) remain a leading cause of death in North America, driving the demand for advanced treatment options like bioabsorbable stents. According to the American Heart Association (AHA), nearly 121.5 million American adults had some form of cardiovascular disease by 2021. This high disease burden has resulted in increased adoption of bioabsorbable stents, which offer better long-term outcomes compared to traditional metal stents by reducing the risk of late-stent thrombosis and eliminating the need for prolonged dual antiplatelet therapy.
The North American market benefits from a supportive regulatory framework that accelerates the adoption of innovative medical technologies. The U.S. Food and Drug Administration (FDA) has been increasingly approving bioabsorbable stents for coronary artery disease treatment, promoting their use in clinical settings. In recent years, the FDA has fast-tracked approvals for bioabsorbable stents under its Breakthrough Devices Program, enabling quicker market access and supporting growth in the region.
Furthermore, the aging population in North America significantly contributes to the rising demand for bioabsorbable stents. The U.S. Census Bureau reports that by 2032, all baby boomers will be over the age of 65, leading to an increase in age-related cardiovascular conditions. As older adults are more likely to require stent procedures due to coronary artery disease, the need for bioabsorbable stents, which reduce long-term complications, is expected to grow steadily in the coming years.
Asia Pacific:
The Asia Pacific region is estimated to exhibit the market during the forecast period. The increasing prevalence of cardiovascular diseases (CVDs) in Asia-Pacific, due to lifestyle changes and aging populations, is a significant driver of the bioabsorbable stent market. According to the World Health Organization (WHO), CVDs account for over 75% of premature deaths in low- and middle-income countries, particularly in regions like Southeast Asia. This growing burden of CVDs is driving the demand for advanced treatments like bioabsorbable stents, which help improve patient outcomes by reducing long-term complications.
Governments in Asia-Pacific countries are investing in healthcare infrastructure and reforms to improve access to advanced medical technologies. For instance, India's National Health Policy and China's Healthy China 2032 initiative both emphasize improving cardiovascular care, including expanding the availability of cutting-edge stent technologies. These policies are encouraging the adoption of bioabsorbable stents as part of broader efforts to enhance cardiovascular treatment across the region.
Furthermore, the Asia-Pacific region, particularly countries like India, Thailand, and Malaysia, has seen rapid growth in medical tourism due to the availability of high-quality yet affordable healthcare. This trend includes a growing demand for advanced cardiovascular treatments such as bioabsorbable stents. According to the Medical Tourism Association, Asia-Pacific is one of the top destinations for medical tourists seeking cardiac procedures. This rise in medical tourism is contributing to the expansion of the bioabsorbable stent market in the region.
The Bioabsorbable Stent Market is segmented based on Material Type, Application, End-user, and Geography.
Based on material type, the bioabsorbable stent market is segmented into Polymer-Based and Metal-Based stents. The polymer-based segment is estimated to dominate the bioabsorbable stent market due to its superior biocompatibility and gradual absorption in the body, reducing long-term complications associated with permanent stents. Polymer-based stents offer advantages such as flexibility and the ability to elute drugs to prevent restenosis, making them ideal for coronary artery disease treatment. Technological advancements in polymer materials have led to improved mechanical strength and controlled degradation, further driving the adoption of polymer-based stents.
Based on application, the bioabsorbable stent market is segmented into Coronary Artery Disease and Peripheral Artery Disease. The coronary artery disease segment is estimated to dominate the bioabsorbable stent market due to the high prevalence of coronary artery disease (CAD) worldwide, which is one of the leading causes of death. Bioabsorbable stents offer significant advantages in the treatment of CAD by providing temporary support to arteries while reducing long-term complications such as restenosis and thrombosis. Technological advancements in bioabsorbable stents, such as drug-eluting designs, have further enhanced their effectiveness in treating CAD. While peripheral artery disease treatment also benefits from bioabsorbable stents, the large patient population suffering from CAD ensures this segment's dominance in the market.
Based on End-user, the bioabsorbable stent market is segmented into Hospitals, Cardiac Centers, and Others. The hospital segment is expected to dominate the bioabsorbable stent market due to the high volume of stent implantation procedures performed in these settings. Hospitals, equipped with advanced infrastructure and a broad range of specialized services, are the primary point of care for patients requiring coronary interventions. Additionally, hospitals have access to a wider range of bioabsorbable stent technologies and are more likely to adopt cutting-edge medical innovations.
Based on geography, the bioabsorbable stent market is segmented into North America, Europe, Asia Pacific, and the Rest of the World. The North American region is estimated to dominate the bioabsorbable stent market due to several factors, including the high prevalence of cardiovascular diseases, advanced healthcare infrastructure, and early adoption of innovative medical technologies. The region's strong regulatory framework, supported by the U.S. Food and Drug Administration (FDA), has accelerated the approval and clinical use of bioabsorbable stents. Additionally, North America benefits from significant investments in research and development, enabling continuous advancements in bioabsorbable stent technology. While Europe and Asia Pacific are also key markets, North America's robust healthcare system and high demand for minimally invasive procedures secure its leading position in the global market.
Our market analysis also entails a section solely dedicated to such major players wherein our analysts provide an insight into the financial statements of all the major players, along with product benchmarking and SWOT analysis. The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the above-mentioned players globally.