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市場調查報告書
商品編碼
1800811
腎臟去神經支配系統市場報告(按產品類型、產品(Symplicity、Vessix、EnligHTN、Paradise、Iberis 等)、技術、應用、最終用戶和地區)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,全球腎臟去神經支配系統市場規模達5.891億美元。展望未來, IMARC Group預計到2033年,市場規模將達到75.334億美元,2025-2033年期間的複合年成長率(CAGR)為31.1%。高血壓盛行率的上升、治療方法的技術進步以及大量臨床試驗證實其療效,共同推動市場的發展。醫院和診斷中心正在廣泛採用這些系統,再加上策略合作和監管部門的批准,這些因素將進一步推動市場成長。
臨床試驗的興起
臨床試驗的增加對腎臟去神經支配市場至關重要,因為它們提供了關於該手術長期益處和安全性的重要資料。這些試驗有助於確定腎臟去神經支配在高血壓管理中的有效性,從而贏得醫護人員和患者的信任。成功的試驗結果有助於獲得監管部門的批准,從而進一步推動產品的普及。此外,臨床試驗透過發現有待改進的領域和驗證新技術來促進創新,最終支持市場的成長和擴張。例如,2023年11月,美國食品藥物管理局(FDA)批准了一種超音波腎臟去神經支配裝置-Paradise系統,用於治療對生活方式改變和藥物治療無效的成人高血壓。 ReCor Medical的這款裝置利用超音波能量去除腎動脈周圍的交感神經,從而減少高血壓相關的過度活動。臨床研究表明,血壓顯著降低,因此FDA批准了該裝置。這為難以控制血壓的患者帶來了新的希望。
高血壓盛行率上升
高血壓,尤其是難治性高血壓的盛行率不斷上升,大大推動了對腎臟去神經系統的需求。隨著全球高血壓病例的增加,許多患者對傳統藥物的反應並不充分。根據世界衛生組織 (WHO) 發布的報告,全球約有 12.8 億 30-79 歲的成年人患有高血壓,其中三分之二生活在中低收入國家。約 46% 的高血壓成年人不知道自己患有高血壓,只有 42% 得到診斷和治療。約 21% 的成年人的高血壓得到控制。高血壓是全球過早死亡的主要原因。這迫切需要腎臟去神經等替代療法,它透過靶向腎臟神經來降低血壓,提供了一個有希望的解決方案。隨著全球高血壓負擔的增加,採用腎去神經等有效創新治療方法的緊迫性不斷增強,從而推動了腎去神經系統市場的成長。
技術進步
腎臟去神經支配技術的進步正在透過提高療效和安全性來徹底改變治療方案。導管技術的創新正在提高精準度並降低手術風險,使更廣泛的患者群體更容易接受腎臟去神經支配術。非侵入性技術也日益受到關注,具有縮短恢復時間和最大程度減輕患者不適等潛在優勢。隨著醫療保健提供者尋求可靠有效的高血壓和難治性高血壓管理解決方案,這些進步對於吸引更廣泛的臨床應用至關重要,從而推動腎臟去神經支配市場的成長。例如,2024年6月,韓國醫療科技公司DeepQure啟動了一項早期可行性研究,以評估其腎臟去神經支配裝置HyperQure在治療難治性高血壓方面的作用。該研究涉及美國各醫院的15名患者,先前已獲得FDA的臨床試驗豁免批准。該裝置能夠在不損傷血管內皮的情況下消融腎交感神經,使其在市場上脫穎而出。該公司計劃在這一監管里程碑之後推進全球臨床試驗。
導管佔據大部分市場佔有率
導管在腎臟去神經支配系統市場中佔據主導地位,這主要歸功於其在直接向腎神經輸送治療干預措施方面發揮的重要作用。這些裝置能夠實現針對交感神經的微創手術,而交感神經對調節血壓至關重要。先進的導管技術,包括射頻和超音波系統,能夠在干擾神經活動方面提供精確的控制和有效性,同時確保患者安全。基於導管的腎臟去神經支配術的日益普及反映了其在治療難治性高血壓和改善患者預後方面的有效性。例如,2024年3月,美國食品藥物管理局(FDA)批准了兩種新的基於導管的微創腎臟去神經支配裝置,用於幫助持續性高血壓患者。這些裝置可針對交感神經以降低血壓,從而可能減少對某些抗高血壓藥物的需求。隨著創新不斷改進導管設計和操作技術,預計它們將在不斷發展的高血壓管理領域中保持其突出地位。
Symplicity 佔據業界最大佔有率
Symplicity 公司在腎臟去神經系統產業中佔據最大佔有率,這主要得益於其在開發基於導管的高血壓治療技術方面的先鋒地位。 Symplicity 系統以其利用射頻能量干擾腎神經活動的功效而聞名,並憑藉其有效性的臨床證據建立了強大的市場地位。 2023 年 11 月,FDA 批准美敦力公司的 Symplicity 腎臟去神經系統用於治療高血壓。該系統採用基於導管的方法,利用射頻能量去除腎動脈的神經支配。臨床試驗表明,接受該設備的患者動態收縮壓顯著降低。此次批准為高血壓治療提供了一種結合藥物治療和生活方式改變的有前景的替代方案。持續的研發工作旨在增強設備功能和擴大適應症,進一步鞏固了這一領導地位,鞏固了 Symplicity 在不斷發展的腎臟去神經治療領域的主導地位。
射頻消融術代表著領先的細分市場
射頻消融確實是腎臟去神經支配系統市場的領先領域。這項技術利用射頻能量消融或失活腎神經,有助於降低高血壓。由於其有效性和與外科手術相比相對非侵入性,它已獲得廣泛關注。射頻消融系統通常使用配有電極的導管向腎臟神經輸送受控熱能,干擾其功能。根據休士頓衛理公會醫院發表的一篇文章,一項突破性的腎臟去神經支配手術為慢性或難治性高血壓帶來了新的希望。這種微創手術利用射頻消融干擾血壓升高訊號,可望實現長期緩解。導管技術的進步、越來越多的臨床證據支持其療效,以及在治療難治性高血壓方面為改善手術結果和病人安全而不斷進行的創新,共同推動了這一領域的成長。
腎臟去神經系統主要用於治療高血壓,尤其是傳統藥物無效的頑固性高血壓。透過靶向並破壞導致血壓升高的腎臟神經,該系統提供了一種創新的降血壓方案。該應用因其有望提供非藥物治療方案、改善患者預後並降低與未控制的高血壓相關的心血管事件風險而備受關注。
在心臟疾病領域,腎臟去神經支配系統透過降低交感神經系統活動來幫助控制心臟衰竭和心房顫動等疾病。這種降低可以減輕心臟壓力,改善心臟功能,並可能預防心律不整。腎臟去神經支配在心臟疾病的應用是一個新興領域,它透過解決神經系統對這些疾病的影響並增強整體心血管健康,帶來了巨大的益處。
腎臟去神經支配系統也因其在糖尿病管理中的潛在益處而被探索。透過調節交感神經系統,這些系統可以改善胰島素敏感性和葡萄糖代謝。這項應用可以幫助那些即使服用藥物仍難以控制血糖的糖尿病患者,為管理糖尿病相關併發症和增強整體代謝健康提供一種創新方法。
對於腎衰竭患者,腎臟去神經支配系統旨在透過減少可能加劇腎臟損害的腎神經過度活動來改善腎功能。該應用專注於減慢性腎病變的進展並改善腎臟預後。透過靶向導致腎功能障礙的潛在神經機制,該系統為腎衰竭的治療提供了一種新的途徑,並有望改善患者的生活品質。
診斷中心和醫院佔據市場主導地位
診斷中心和醫院憑藉其先進的醫療基礎設施以及在高血壓及相關疾病管理方面的專業知識,在腎臟去神經系統市場佔據主導地位。這些機構配備了必要的技術和熟練的專業人員,能夠安全有效地實施腎臟去神經手術。此外,醫院和診斷中心提供的全面患者護理確保了全面的術前評估和術後監測,從而改善了患者的預後。它們在醫療保健服務中的核心作用使其成為部署腎臟去神經技術、推動市場成長和這些創新療法普及的主要場所。
歐洲引領市場,佔據腎臟去神經支配系統最大的市場佔有率
該報告還對所有主要區域市場進行了全面分析,包括北美(美國和加拿大);歐洲(德國、法國、英國、義大利、西班牙、俄羅斯等);亞太地區(中國、日本、印度、韓國、澳洲、印尼等);拉丁美洲(巴西、墨西哥等);以及中東和非洲。報告指出,歐洲是腎臟去神經支配系統最大的區域市場。
歐洲引領市場,憑藉先進的醫療基礎設施、廣泛的臨床研究和良好的監管環境,佔據腎臟去神經系統最大的市場。該地區對創新醫療技術的重視和高血壓的高盛行率推動了腎臟去神經手術的採用。德國、法國和英國等歐洲國家擁有強大的醫療保健系統,有助於實施先進的治療方法。根據國際能源總署發布的報告,德國醫療保健市場至關重要,其醫療技術市場每年價值約 420 億美元。醫療保健產業在德國經濟中發揮關鍵作用,佔德國 GDP 的 12%。德國醫療設備市場預計複合年成長率為 5.1%(以歐元計算)和 6.8%(以美元計算),蘊藏成長機會。美國供應商有潛力參與醫療保健基礎設施和創新項目。此外,政府措施的大力支持和對醫療保健研究的增加投入,使歐洲在腎臟去神經市場佔據主導地位。
(請注意,這只是關鍵參與者的部分列表,完整列表在報告中提供。)
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.)