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市场调查报告书
商品编码
1800811
肾臟去神经支配系统市场报告(按产品类型、产品(Symplicity、Vessix、EnligHTN、Paradise、Iberis 等)、技术、应用、最终用户和地区)2025 年至 2033 年Renal Denervation Systems Market Report by Product Type, Product (Symplicity, Vessix, EnligHTN, Paradise, Iberis, and Others), Technology, Application, End User, and Region 2025-2033 |
2024年,全球肾臟去神经支配系统市场规模达5.891亿美元。展望未来, IMARC Group预计到2033年,市场规模将达到75.334亿美元,2025-2033年期间的复合年增长率(CAGR)为31.1%。高血压盛行率的上升、治疗方法的技术进步以及大量临床试验证实其疗效,共同推动市场的发展。医院和诊断中心正在广泛采用这些系统,再加上策略合作和监管部门的批准,这些因素将进一步推动市场成长。
临床试验的兴起
临床试验的增加对肾臟去神经支配市场至关重要,因为它们提供了关于该手术长期益处和安全性的重要资料。这些试验有助于确定肾臟去神经支配在高血压管理中的有效性,从而赢得医护人员和患者的信任。成功的试验结果有助于获得监管部门的批准,从而进一步推动产品的普及。此外,临床试验透过发现有待改进的领域和验证新技术来促进创新,最终支持市场的成长和扩张。例如,2023年11月,美国食品药物管理局(FDA)批准了一种超音波肾臟去神经支配装置-Paradise系统,用于治疗对生活方式改变和药物治疗无效的成人高血压。 ReCor Medical的这款装置利用超音波能量去除肾动脉周围的交感神经,从而减少高血压相关的过度活动。临床研究表明,血压显着降低,因此FDA批准了该装置。这为难以控制血压的患者带来了新的希望。
高血压盛行率上升
高血压,尤其是难治性高血压的盛行率不断上升,大大推动了对肾臟去神经系统的需求。随着全球高血压病例的增加,许多患者对传统药物的反应并不充分。根据世界卫生组织 (WHO) 发布的报告,全球约有 12.8 亿 30-79 岁的成年人患有高血压,其中三分之二生活在中低收入国家。约 46% 的高血压成年人不知道自己患有高血压,只有 42% 得到诊断和治疗。约 21% 的成年人的高血压得到控制。高血压是全球过早死亡的主要原因。这迫切需要肾臟去神经等替代疗法,它透过靶向肾臟神经来降低血压,提供了一个有希望的解决方案。随着全球高血压负担的增加,采用肾去神经等有效创新治疗方法的紧迫性不断增强,从而推动了肾去神经系统市场的成长。
技术进步
肾臟去神经支配技术的进步正在透过提高疗效和安全性来彻底改变治疗方案。导管技术的创新正在提高精准度并降低手术风险,使更广泛的患者群体更容易接受肾臟去神经支配术。非侵入性技术也日益受到关注,具有缩短恢復时间和最大程度减轻患者不适等潜在优势。随着医疗保健提供者寻求可靠有效的高血压和难治性高血压管理解决方案,这些进步对于吸引更广泛的临床应用至关重要,从而推动肾臟去神经支配市场的成长。例如,2024年6月,韩国医疗科技公司DeepQure启动了一项早期可行性研究,以评估其肾臟去神经支配装置HyperQure在治疗难治性高血压方面的作用。该研究涉及美国各医院的15名患者,先前已获得FDA的临床试验豁免批准。该装置能够在不损伤血管内皮的情况下消融肾交感神经,使其在市场上脱颖而出。该公司计划在这一监管里程碑之后推进全球临床试验。
导管占据大部分市场份额
导管在肾臟去神经支配系统市场中占据主导地位,这主要归功于其在直接向肾神经输送治疗干预措施方面发挥的重要作用。这些装置能够实现针对交感神经的微创手术,而交感神经对调节血压至关重要。先进的导管技术,包括射频和超音波系统,能够在干扰神经活动方面提供精确的控制和有效性,同时确保患者安全。基于导管的肾臟去神经支配术的日益普及反映了其在治疗难治性高血压和改善患者预后方面的有效性。例如,2024年3月,美国食品药物管理局(FDA)批准了两种新的基于导管的微创肾臟去神经支配装置,用于帮助持续性高血压患者。这些装置可针对交感神经以降低血压,从而可能减少对某些抗高血压药物的需求。随着创新不断改进导管设计和操作技术,预计它们将在不断发展的高血压管理领域中保持其突出地位。
Symplicity 占据业界最大份额
Symplicity 公司在肾臟去神经系统产业中占据最大份额,这主要得益于其在开发基于导管的高血压治疗技术方面的先锋地位。 Symplicity 系统以其利用射频能量干扰肾神经活动的功效而闻名,并凭藉其有效性的临床证据建立了强大的市场地位。 2023 年 11 月,FDA 批准美敦力公司的 Symplicity 肾臟去神经系统用于治疗高血压。该系统采用基于导管的方法,利用射频能量去除肾动脉的神经支配。临床试验表明,接受该设备的患者动态收缩压显着降低。此次批准为高血压治疗提供了一种结合药物治疗和生活方式改变的有前景的替代方案。持续的研发工作旨在增强设备功能和扩大适应症,进一步巩固了这一领导地位,巩固了 Symplicity 在不断发展的肾臟去神经治疗领域的主导地位。
射频消融术代表着领先的细分市场
射频消融确实是肾臟去神经支配系统市场的领先领域。这项技术利用射频能量消融或失活肾神经,有助于降低高血压。由于其有效性和与外科手术相比相对非侵入性,它已获得广泛关注。射频消融系统通常使用配有电极的导管向肾臟神经输送受控热能,干扰其功能。根据休士顿卫理公会医院发表的一篇文章,一项突破性的肾臟去神经支配手术为慢性或难治性高血压带来了新的希望。这种微创手术利用射频消融干扰血压升高讯号,可望实现长期缓解。导管技术的进步、越来越多的临床证据支持其疗效,以及在治疗难治性高血压方面为改善手术结果和病人安全而不断进行的创新,共同推动了这一领域的成长。
肾臟去神经系统主要用于治疗高血压,尤其是传统药物无效的顽固性高血压。透过靶向并破坏导致血压升高的肾臟神经,该系统提供了一种创新的降血压方案。该应用因其有望提供非药物治疗方案、改善患者预后并降低与未控制的高血压相关的心血管事件风险而备受关注。
在心臟疾病领域,肾臟去神经支配系统透过降低交感神经系统活动来帮助控制心臟衰竭和心房颤动等疾病。这种降低可以减轻心臟压力,改善心臟功能,并可能预防心律不整。肾臟去神经支配在心臟疾病的应用是一个新兴领域,它透过解决神经系统对这些疾病的影响并增强整体心血管健康,带来了巨大的益处。
肾臟去神经支配系统也因其在糖尿病管理中的潜在益处而被探索。透过调节交感神经系统,这些系统可以改善胰岛素敏感性和葡萄糖代谢。这项应用可以帮助那些即使服用药物仍难以控制血糖的糖尿病患者,为管理糖尿病相关併发症和增强整体代谢健康提供一种创新方法。
对于肾衰竭患者,肾臟去神经支配系统旨在透过减少可能加剧肾臟损害的肾神经过度活动来改善肾功能。该应用专注于减慢性肾病变的进展并改善肾臟预后。透过靶向导致肾功能障碍的潜在神经机制,该系统为肾衰竭的治疗提供了一种新的途径,并有望改善患者的生活品质。
诊断中心和医院占据市场主导地位
诊断中心和医院凭藉其先进的医疗基础设施以及在高血压及相关疾病管理方面的专业知识,在肾臟去神经系统市场占据主导地位。这些机构配备了必要的技术和熟练的专业人员,能够安全有效地实施肾臟去神经手术。此外,医院和诊断中心提供的全面患者护理确保了全面的术前评估和术后监测,从而改善了患者的预后。它们在医疗保健服务中的核心作用使其成为部署肾臟去神经技术、推动市场成长和这些创新疗法普及的主要场所。
欧洲引领市场,占据肾臟去神经支配系统最大的市场份额
该报告还对所有主要区域市场进行了全面分析,包括北美(美国和加拿大);欧洲(德国、法国、英国、义大利、西班牙、俄罗斯等);亚太地区(中国、日本、印度、韩国、澳洲、印尼等);拉丁美洲(巴西、墨西哥等);以及中东和非洲。报告指出,欧洲是肾臟去神经支配系统最大的区域市场。
欧洲引领市场,凭藉先进的医疗基础设施、广泛的临床研究和良好的监管环境,占据肾臟去神经系统最大的市场。该地区对创新医疗技术的重视和高血压的高盛行率推动了肾臟去神经手术的采用。德国、法国和英国等欧洲国家拥有强大的医疗保健系统,有助于实施先进的治疗方法。根据国际能源总署发布的报告,德国医疗保健市场至关重要,其医疗技术市场每年价值约 420 亿美元。医疗保健产业在德国经济中发挥关键作用,占德国 GDP 的 12%。德国医疗设备市场预计复合年增长率为 5.1%(以欧元计算)和 6.8%(以美元计算),蕴藏成长机会。美国供应商有潜力参与医疗保健基础设施和创新项目。此外,政府措施的大力支持和对医疗保健研究的增加投入,使欧洲在肾臟去神经市场占据主导地位。
(请注意,这只是关键参与者的部分列表,完整列表在报告中提供。)
The global renal denervation systems market size reached USD 589.1 Million in 2024. Looking forward, IMARC Group expects the market to reach USD 7,533.4 Million by 2033, exhibiting a growth rate (CAGR) of 31.1% during 2025-2033. The market is driven by the rising prevalence of hypertension, technological advancements in treatment methods, and extensive clinical trials demonstrating efficacy. Hospitals and diagnostic centers are widely adopting these systems, which, along with strategic collaborations and regulatory approvals are further fuelingl market growth.
Rising Clinical Trials
Increasing clinical trials are pivotal for the renal denervation market as they provide essential data on the long-term benefits and safety of the procedure. These trials help establish the efficacy of renal denervation in managing hypertension, thereby gaining confidence among healthcare providers and patients. Successful trial outcomes lead to regulatory approvals, thereby further driving the product adoption. Additionally, clinical trials foster innovation by highlighting areas for improvement and validating new technologies, ultimately supporting market growth and expansion. For instance, in November 2023, FDA approved an ultrasound renal denervation device, the Paradise system, for treating uncontrolled hypertension in adults not responding to lifestyle changes and medications. The device by ReCor Medical uses ultrasound energy to denervate sympathetic nerves surrounding the renal arteries reducing hypertension-related overactivity. Clinical studies demonstrated a significant reduction in blood pressure leading to the FDA's approval. This offers new hope for patients struggling to control their blood pressure.
Rising Prevalence of Hypertension
The rising prevalence of hypertension, particularly drug-resistant hypertension, is significantly driving the demand for renal denervation systems. With increasing cases of hypertension worldwide, many patients do not respond adequately to traditional medications. According to the report published by the World Health Organization (WHO), an estimated 1.28 billion adults aged 30-79 years worldwide have hypertension with two-thirds living in low- and middle-income countries. Approximately 46% of adults with hypertension are unaware of their condition and only 42% are diagnosed and treated. Around 21% of adults have their hypertension under control. Hypertension is a major cause of premature death globally. This creates a pressing need for alternative treatments like renal denervation, which offers a promising solution by targeting the renal nerves to lower blood pressure. As the global burden of hypertension grows, the urgency to adopt effective, innovative treatments such as renal denervation continues to intensify, boosting renal denervation systems market growth.
Technological Advancements
Technological advancements in renal denervation are revolutionizing treatment options by enhancing both efficacy and safety profiles. Innovations in catheter-based techniques are improving precision and reducing procedural risks, making renal denervation more accessible to a broader patient base. Non-invasive technologies are also gaining traction, offering potential benefits such as reduced recovery times and minimal patient discomfort. These advancements are crucial in attracting greater clinical adoption as healthcare providers seek reliable and efficient solutions for managing hypertension and drug-resistant hypertension, thereby driving growth in the renal denervation market. For instance, in June 2024, South Korean medtech firm DeepQure initiated an Early Feasibility Study to assess its renal denervation device, HyperQure, for treating resistant hypertension. The study, involving 15 patients across US hospitals, follows FDA approval for investigational device exemption. The device's ability to ablate renal sympathetic nerves without damaging the vascular endothelium distinguishes it in the market. The company aims to advance global clinical trials following this regulatory milestone.
Catheters accounts for the majority of the market share
Catheters dominate the renal denervation systems market share, primarily due to their essential role in delivering therapeutic interventions directly to renal nerves. These devices enable minimally invasive procedures that target sympathetic nerves, crucial for regulating blood pressure. Advanced catheter technologies, including radiofrequency and ultrasound-based systems, offer precise control and efficacy in disrupting nerve activity while ensuring patient safety. The increasing adoption of catheter-based renal denervation reflects their effectiveness in treating drug-resistant hypertension and improving patient outcomes. For instance, in March 2024, two new minimally invasive catheter-based renal denervation devices have been approved by the FDA to help people with persistent hypertension. These devices target sympathetic nerves to lower blood pressure, potentially reducing the need for some antihypertensive medications. As innovations continue to enhance catheter designs and procedural techniques, they are expected to maintain their prominent position in the evolving landscape of hypertension management.
Symplicity holds the largest share of the industry
Symplicity holds the largest share of the renal denervation systems industry primarily due to its pioneering role in developing catheter-based technologies for treating hypertension. The Symplicity system, known for its efficacy in disrupting renal nerve activity using radiofrequency energy, has established a strong market presence based on clinical evidence supporting its effectiveness. In November 2023, FDA approves Medtronic's Symplicity Renal Denervation System to treat hypertension. The system uses a catheter-based approach to denervate the renal arteries with radiofrequency energy. Clinical trials showed a significant reduction in ambulatory systolic blood pressure in patients who received the device. The approval offers a promising alternative for hypertension treatment in combination with medication and lifestyle changes. This leadership position is further bolstered by ongoing research and development efforts aimed at enhancing device capabilities and expanding indications, reinforcing Symplicity's dominance in the evolving landscape of renal denervation therapies.
Radiofrequency Ablation represents the leading market segment
Radiofrequency ablation is indeed a leading segment in the renal denervation systems market. This technology involves using radiofrequency energy to ablate or deactivate renal nerves, which helps in reducing hypertension. It has gained prominence due to its effectiveness and relative non-invasiveness compared to surgical approaches. Radiofrequency ablation systems typically use catheters equipped with electrodes to deliver controlled thermal energy to the renal nerves, thereby disrupting their function. According to an article published by Houston Methodist, a groundbreaking renal denervation procedure offers new hope for chronic or treatment-resistant hypertension. The minimally invasive procedure disrupts blood pressure-elevating signals using radiofrequency ablation, providing potential long-term relief. This segment's growth is driven by advancements in catheter technology, increasing clinical evidence supporting its efficacy, and ongoing innovations to improve procedural outcomes and patient safety in treating drug-resistant hypertension.
Renal denervation systems are primarily used to treat hypertension, especially resistant hypertension where traditional medications are ineffective. By targeting and disrupting renal nerves that contribute to elevated blood pressure, these systems provide an innovative solution for lowering blood pressure. This application has gained significant attention due to its potential to offer a non-pharmacological treatment option, improving patient outcomes and reducing the risk of cardiovascular events associated with uncontrolled hypertension.
In the context of cardiac disorders, renal denervation systems help manage conditions like heart failure and atrial fibrillation by reducing sympathetic nervous system activity. This reduction can alleviate stress on the heart, improve cardiac function, and potentially prevent arrhythmias. The use of renal denervation in cardiac disorders is an emerging field, offering promising benefits by addressing the neural contributions to these conditions and enhancing overall cardiovascular health.
Renal denervation systems are also being explored for their potential benefits in managing diabetes. By modulating the sympathetic nervous system, these systems may improve insulin sensitivity and glucose metabolism. This application could help diabetic patients who struggle with blood sugar control despite medication, offering an innovative approach to managing diabetes-related complications and enhancing overall metabolic health.
For patients with renal failure, renal denervation systems aim to improve kidney function by reducing the overactivity of renal nerves that can exacerbate kidney damage. This application focuses on slowing the progression of chronic kidney disease and improving renal outcomes. By targeting the underlying neural mechanisms contributing to renal dysfunction, these systems offer a novel therapeutic avenue for managing renal failure and potentially improving quality of life for affected patients.
Diagnostic Centers and Hospitals dominate the market
Diagnostic centers and hospitals dominate the renal denervation systems market due to their advanced medical infrastructure and expertise in managing hypertension and related conditions. These institutions are equipped with the necessary technology and skilled professionals to perform renal denervation procedures safely and effectively. Additionally, the comprehensive patient care provided by hospitals and diagnostic centers ensures thorough pre-procedure assessments and post-procedure monitoring, enhancing patient outcomes. Their central role in healthcare delivery makes them the primary settings for deploying renal denervation technologies, driving market growth and adoption of these innovative treatments.
Europe leads the market, accounting for the largest renal denervation systems market share
The report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, Europe represents the largest regional market for renal denervation systems.
Europe leads the market, holding the largest renal denervation systems market share due to advanced healthcare infrastructure, extensive clinical research, and favorable regulatory environments. The region's emphasis on innovative medical technologies and high prevalence of hypertension drives the adoption of renal denervation procedures. European countries like Germany, France, and the UK have robust healthcare systems that facilitate the implementation of advanced treatments. According to the report published by IEA, the German healthcare market is crucial, with a medical technology market valued at approximately $42 billion annually. The healthcare sector plays a pivotal role in the country's economy, representing 12% of Germany's GDP. With an expected CAGR of 5.1% in Euro-terms and 6.8% in USD-terms, the German medical equipment market presents opportunities for growth. U.S. suppliers have potential to engage in healthcare infrastructure and innovation projects. Moreover, strong support from government initiatives and increased investment in healthcare research contribute to Europe's dominant position in the renal denervation market.
(Please note that this is only a partial list of the key players, and the complete list is provided in the report.)