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市場調査レポート
商品コード
1800811
腎除神経システム市場レポート:製品タイプ、製品、技術、用途、エンドユーザー、地域別、2025~2033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 |
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腎除神経システム市場レポート:製品タイプ、製品、技術、用途、エンドユーザー、地域別、2025~2033年 |
出版日: 2025年08月01日
発行: IMARC
ページ情報: 英文 121 Pages
納期: 2~3営業日
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腎除神経システムの世界市場規模は2024年に5億8,910万米ドルに達しました。今後、IMARC Groupは、市場は2033年までに75億3,340万米ドルに達し、2025年から2033年にかけて31.1%の成長率(CAGR)を示すと予測しています。市場を牽引しているのは、高血圧の有病率の上昇、治療法の技術的進歩、有効性を実証する広範な臨床試験です。病院や診断センターはこれらのシステムを広く採用しており、戦略的提携や規制当局の承認とともに、市場の成長をさらに後押ししています。
臨床試験の増加
臨床試験の増加は、腎除神経術の長期的な効果と安全性に関する重要なデータを提供するため、腎除神経術市場にとって極めて重要です。これらの臨床試験は、高血圧管理における腎除神経の有効性を立証するのに役立ち、それによって医療従事者や患者の信頼を得ることになります。臨床試験の成功は規制当局の承認につながり、製品採用をさらに促進します。さらに、臨床試験は改善すべき点を明らかにし、新技術を検証することで技術革新を促進し、最終的に市場の成長と拡大をサポートします。例えば、FDAは2023年11月、生活習慣の改善や薬物療法に反応しない成人の制御不能な高血圧を治療するための超音波腎除神経装置Paradiseシステムを承認しました。ReCor Medical社のこの装置は、超音波エネルギーを用いて腎動脈周囲の交感神経を脱神経し、高血圧に関連する過活動を抑制します。臨床研究では、血圧の有意な低下が実証され、FDAの承認につながりました。これは、血圧のコントロールに苦労している患者に新たな希望を与えるものです。
高血圧の有病率の上昇
高血圧、特に薬剤耐性高血圧の有病率の上昇が、腎除神経システムの需要を大きく牽引しています。世界中で高血圧症例が増加する中、多くの患者が従来の薬物療法に十分な反応を示さないです。世界保健機関(WHO)が発表した報告書によると、世界で30~79歳の成人は推定12億8,000万人が高血圧症であり、その3分の2は低・中所得国に居住しています。高血圧の成人の約46%は自分の症状に気づいておらず、診断を受けて治療を受けているのは42%に過ぎないです。高血圧をコントロールできている成人は約21%です。高血圧は、世界的に早死にの主な原因となっています。このため、腎神経を標的として血圧を下げることで有望な解決策を提供する腎除神経のような代替治療が急務となっています。高血圧の世界の負担が増大するにつれて、腎除神経のような効果的で革新的な治療を採用する緊急性は高まり続け、腎除神経システム市場の成長を後押ししています。
技術的進歩
腎除神経の技術的進歩は、有効性と安全性の両プロファイルを強化することで、治療選択肢に革命をもたらしています。カテーテルを用いた手技の革新は、精度の向上と手技リスクの低減をもたらし、腎除神経をより幅広い患者層にとって利用しやすいものにしています。非侵襲的な技術もまた、回復時間の短縮や患者の不快感の最小化といった潜在的な利点を提供し、支持を集めつつあります。これらの進歩は、医療提供者が高血圧や薬剤耐性高血圧を管理するための信頼性が高く効率的なソリューションを求める中で、より大きな臨床的採用を呼び込む上で極めて重要であり、腎除神経市場の成長を牽引しています。例えば、2024年6月、韓国の医療技術企業であるDeepQure社は、抵抗性高血圧の治療のための腎除神経デバイスであるHyperQureを評価するための早期実現可能性試験を開始しました。米国の病院全体で15人の患者が参加するこの研究は、FDAの治験機器免除の承認を受けて実施されます。この装置は、血管内皮を損傷することなく腎交感神経を切除することができるため、市場で差別化されます。同社は、この規制上のマイルストーンに続いて、世界の臨床試験を進めることを目指しています。
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.)