세계의 신장 제세동기 시장 보고서 : 제품 유형, 제품, 기술, 용도, 최종 사용자 및 지역별(2024-2032년)

The global renal denervation systems market size reached US$ 443.8 Million in 2023. Looking forward, IMARC Group expects the market to reach US$ 6,077.3 Million by 2032, exhibiting a growth rate (CAGR) of 32.7% during 2024-2032. 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.

Renal Denervation Systems Market Analysis:

Major Market Drivers: The market is mainly driven by the rising incidence of hypertension and drug resistant hypertension which drives the demand for effective treatments. Technological advancements in catheter based and non-invasive methods enhances the treatment efficiency and safety thereby fostering the adoption. Extensive clinical trials validating long term benefits further boost the market growth. The growing emphasis on improving patient outcomes and managing chronic conditions underscores the renal denervation systems market growth.

Key Market Trends: Key market trends include various technological innovations like advanced catheter-based systems and non-invasive systems which improves the overall efficacy and safety. Gradual increase in clinical trials is validating long term benefits further fostering the wider acceptance. Approvals are accelerating the market entry while strategic collaborations are enhancing the research and development efforts. The rising incidence of hypertension is also contributing positively to the renal denervation systems market growth.

Geographical Trends: Geographical trends in the market shows significant adoption and growth in Europe generally driven by their advanced healthcare infrastructure and favorable regulatory environments. North America is also expanding gradually mainly due to the rising prevalence of hypertension and various technological advancements. The Asia Pacific is witnessing a significant increase in market activity due to the growing healthcare investments and rising awareness among consumers. Latin America and Middle East are emerging markets with potential for growth as healthcare systems.

Competitive Landscape: Some of the major market players in the renal denervation systems industry include Boston Scientific Group, Kona Medical Inc., Medtronic Plc, Mercator MedSystems, ReCor Medical Inc. (Otsuka Holdings Co. Ltd.), Renal Dynamics, St. Jude Medical Inc. (Abbott) and Terumo Corporation, among many others.

Challenges and Opportunities: The market faces various challenges like high costs, regulatory hurdles and the need for extensive clinical trials. However, it also presents opportunities such as technological advancements, increasing demand due to the rise in drug-resistant hypertension, and expanding healthcare infrastructure in emerging markets. Strategic collaborations and favorable regulatory developments further enhance growth potential, while rising awareness about renal denervation benefits can drive the renal denervation systems market growth and penetration globally.

Renal Denervation Systems Market Trends:

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.

Renal Denervation Systems Market Segmentation:

IMARC Group provides an analysis of the key trends in each segment of the market, along with forecasts at the global, regional, and country levels for 2024-2032. Our report has categorized the market based on product type, product, technology, application and end user.

Breakup by Product Type:

Catheters

Single Electrode Catheter

Multi Electrode Catheter

RF Generator

Nerve Modifying Agents

Catheters accounts for the majority of the market share

The report has provided a detailed breakup and analysis of the market based on the product type. This includes catheters (single electrode catheter, multi electrode catheter), RF generator and nerve modifying agents. According to the report, catheters represented the largest segment.

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.

Breakup by Product:

Symplicity

Vessix (V2)

EnligHTN

Paradise

Iberis

Others

Symplicity holds the largest share of the industry

A detailed breakup and analysis of the market based on the product have also been provided in the report. This includes Symplicity, Vessix (V2), EnligHTN, Paradise, Iberis and others. According to the report, Symplicity accounted for the largest market share.

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.

Breakup by Technology:

Ultrasound Ablation

Radiofrequency Ablation

Microinfusion

Radiofrequency Ablation represents the leading market segment

The report has provided a detailed breakup and analysis of the market based on the technology. This includes ultrasound ablation, radiofrequency ablation and microinfusion. According to the report, radiofrequency ablation represented the largest 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.

Breakup by Application:

Hypertension

Cardiac Disorders

Diabetes

Renal Failure

Others

A detailed breakup and analysis of the market based on the application have also been provided in the report. This includes hypertension, cardiac disorders, diabetes, renal failure and others.

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.

Breakup by End User:

Diagnostic Centers and Hospitals

Ambulatory Care Centers

Others

Diagnostic Centers and Hospitals dominate the market

The report has provided a detailed breakup and analysis of the market based on the end user. This includes diagnostic centers and hospitals, ambulatory care centers and others. According to the report, diagnostic centers and hospitals represented the largest segment.

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.

Breakup by Region:

North America

United States

Canada

Asia Pacific

China

Japan

India

South Korea

Australia

Indonesia

Others

Europe

Germany

France

United Kingdom

Italy

Spain

Russia

Others

Latin America

Brazil

Mexico

Others

Middle East and Africa

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.

Competitive Landscape:

The market research report has also provided a comprehensive analysis of the competitive landscape in the market. Detailed profiles of all major companies have also been provided. Some of the major market players in the renal denervation systems industry include Boston Scientific Group, Kona Medical Inc., Medtronic Plc, Mercator MedSystems, ReCor Medical Inc. (Otsuka Holdings Co. Ltd.), Renal Dynamics, St. Jude Medical Inc. (Abbott) and Terumo Corporation.

(Please note that this is only a partial list of the key players, and the complete list is provided in the report.)

The Renal Denervation Systems market is highly competitive, with key players such as Medtronic, Boston Scientific, and ReCor Medical leading innovation and market share. These companies focus on technological advancements, extensive clinical trials, and strategic partnerships to enhance their product portfolios and market reach. For instance, in May 2024, Medtronic's Symplicity Spyral renal denervation (RDN) system was approved for commercial use in China by the National Medical Products Administration (NMPA). The system aims to address hypertension, a major health concern in China, with the potential for significant blood pressure reduction. This approval adds to the device's availability in over 70 countries globally, following recent FDA approval and launch in India and Canada. Emerging players are also entering the market with novel solutions and minimally invasive technologies, increasing competitive pressure. Continuous R&D efforts and regulatory approvals play crucial roles in maintaining a competitive edge in this rapidly evolving market.

Renal Denervation Systems Market News:

In June 2024, Boston Scientific announced the acquisition of Silk Road Medical, Inc. for approximately $1.16 billion. Silk Road Medical's innovative transcarotid artery revascularization (TCAR) platform helps prevent strokes in patients with carotid artery disease through a minimally invasive procedure. The acquisition enhances Boston Scientific's vascular portfolio and demonstrates the company's dedication to providing advanced solutions for peripheral vascular disease. The transaction is expected to be completed in the second half of 2024, subject to customary closing conditions.

In June 2024, NexJ Health and Kona Medical Consulting announced a strategic alliance to transform value-based care for physician groups. By combining NexJ's virtual health programs with Kona's managed service organization expertise, the alliance aims to enhance patient care, improve operational efficiency, and address regulatory requirements. This collaboration introduces a new era in value-based care, offering a holistic solution that integrates technology, expertise, and patient-centricity for physician groups nationwide.

Key Questions Answered in This Report:

• How has the global renal denervation systems market performed so far, and how will it perform in the coming years?
• What are the drivers, restraints, and opportunities in the global renal denervation systems market?
• What is the impact of each driver, restraint, and opportunity on the global renal denervation systems market?
• What are the key regional markets?
• Which countries represent the most attractive renal denervation systems market?
• What is the breakup of the market based on the product type?
• Which is the most attractive product type in the renal denervation systems market?
• What is the breakup of the market based on the product?
• Which is the most attractive product in the renal denervation systems market?
• What is the breakup of the market based on the technology?
• Which is the most attractive technology in the renal denervation systems market?
• What is the breakup of the market based on the application?
• Which is the most attractive application in the renal denervation systems market?
• What is the breakup of the market based on the end user?
• Which is the most attractive end user in the renal denervation systems market?
• What is the breakup of the market based on the region?
• Which is the most attractive region in the renal denervation systems market?
• What is the competitive structure of the market?
• Who are the key players/companies in the global renal denervation systems market?

Table of Contents

1 Preface

2 Scope and Methodology

• 2.1 Objectives of the Study
• 2.2 Stakeholders
• 2.3 Data Sources
  • 2.3.1 Primary Sources
  • 2.3.2 Secondary Sources
• 2.4 Market Estimation
  • 2.4.1 Bottom-Up Approach
  • 2.4.2 Top-Down Approach
• 2.5 Forecasting Methodology

3 Executive Summary

4 Introduction

• 4.1 Overview
• 4.2 Key Industry Trends

5 Global Renal Denervation Systems Market

• 5.1 Market Overview
• 5.2 Market Performance
• 5.3 Impact of COVID-19
• 5.4 Market Forecast

6 Market Breakup by Product Type

• 6.1 Catheters
  • 6.1.1 Market Trends
  • 6.1.2 Major Types
    • 6.1.2.1 Single Electrode Catheter
    • 6.1.2.2 Multi Electrode Catheter
  • 6.1.3 Market Forecast
• 6.2 RF Generator
  • 6.2.1 Market Trends
  • 6.2.2 Market Forecast
• 6.3 Nerve Modifying Agents
  • 6.3.1 Market Trends
  • 6.3.2 Market Forecast

7 Market Breakup by Product

• 7.1 Symplicity
  • 7.1.1 Market Trends
  • 7.1.2 Market Forecast
• 7.2 Vessix (V2)
  • 7.2.1 Market Trends
  • 7.2.2 Market Forecast
• 7.3 EnligHTN
  • 7.3.1 Market Trends
  • 7.3.2 Market Forecast
• 7.4 Paradise
  • 7.4.1 Market Trends
  • 7.4.2 Market Forecast
• 7.5 Iberis
  • 7.5.1 Market Trends
  • 7.5.2 Market Forecast
• 7.6 Others
  • 7.6.1 Market Trends
  • 7.6.2 Market Forecast

8 Market Breakup by Technology

• 8.1 Ultrasound Ablation
  • 8.1.1 Market Trends
  • 8.1.2 Market Forecast
• 8.2 Radiofrequency Ablation
  • 8.2.1 Market Trends
  • 8.2.2 Market Forecast
• 8.3 Microinfusion
  • 8.3.1 Market Trends
  • 8.3.2 Market Forecast

9 Market Breakup by Application

• 9.1 Hypertension
  • 9.1.1 Market Trends
  • 9.1.2 Market Forecast
• 9.2 Cardiac Disorders
  • 9.2.1 Market Trends
  • 9.2.2 Market Forecast
• 9.3 Diabetes
  • 9.3.1 Market Trends
  • 9.3.2 Market Forecast
• 9.4 Renal Failure
  • 9.4.1 Market Trends
  • 9.4.2 Market Forecast
• 9.5 Others
  • 9.5.1 Market Trends
  • 9.5.2 Market Forecast

10 Market Breakup by End User

• 10.1 Diagnostic Centers and Hospitals
  • 10.1.1 Market Trends
  • 10.1.2 Market Forecast
• 10.2 Ambulatory Care Centers
  • 10.2.1 Market Trends
  • 10.2.2 Market Forecast
• 10.3 Others
  • 10.3.1 Market Trends
  • 10.3.2 Market Forecast

11 Market Breakup by Region

• 11.1 North America
  • 11.1.1 United States
    • 11.1.1.1 Market Trends
    • 11.1.1.2 Market Forecast
  • 11.1.2 Canada
    • 11.1.2.1 Market Trends
    • 11.1.2.2 Market Forecast
• 11.2 Asia Pacific
  • 11.2.1 China
    • 11.2.1.1 Market Trends
    • 11.2.1.2 Market Forecast
  • 11.2.2 Japan
    • 11.2.2.1 Market Trends
    • 11.2.2.2 Market Forecast
  • 11.2.3 India
    • 11.2.3.1 Market Trends
    • 11.2.3.2 Market Forecast
  • 11.2.4 South Korea
    • 11.2.4.1 Market Trends
    • 11.2.4.2 Market Forecast
  • 11.2.5 Australia
    • 11.2.5.1 Market Trends
    • 11.2.5.2 Market Forecast
  • 11.2.6 Indonesia
    • 11.2.6.1 Market Trends
    • 11.2.6.2 Market Forecast
  • 11.2.7 Others
    • 11.2.7.1 Market Trends
    • 11.2.7.2 Market Forecast
• 11.3 Europe
  • 11.3.1 Germany
    • 11.3.1.1 Market Trends
    • 11.3.1.2 Market Forecast
  • 11.3.2 France
    • 11.3.2.1 Market Trends
    • 11.3.2.2 Market Forecast
  • 11.3.3 United Kingdom
    • 11.3.3.1 Market Trends
    • 11.3.3.2 Market Forecast
  • 11.3.4 Italy
    • 11.3.4.1 Market Trends
    • 11.3.4.2 Market Forecast
  • 11.3.5 Spain
    • 11.3.5.1 Market Trends
    • 11.3.5.2 Market Forecast
  • 11.3.6 Russia
    • 11.3.6.1 Market Trends
    • 11.3.6.2 Market Forecast
  • 11.3.7 Others
    • 11.3.7.1 Market Trends
    • 11.3.7.2 Market Forecast
• 11.4 Latin America
  • 11.4.1 Brazil
    • 11.4.1.1 Market Trends
    • 11.4.1.2 Market Forecast
  • 11.4.2 Mexico
    • 11.4.2.1 Market Trends
    • 11.4.2.2 Market Forecast
  • 11.4.3 Others
    • 11.4.3.1 Market Trends
    • 11.4.3.2 Market Forecast
• 11.5 Middle East and Africa
  • 11.5.1 Market Trends
  • 11.5.2 Market Breakup by Country
  • 11.5.3 Market Forecast

12 SWOT Analysis

• 12.1 Overview
• 12.2 Strengths
• 12.3 Weaknesses
• 12.4 Opportunities
• 12.5 Threats

13 Value Chain Analysis

14 Porters Five Forces Analysis

• 14.1 Overview
• 14.2 Bargaining Power of Buyers
• 14.3 Bargaining Power of Suppliers
• 14.4 Degree of Competition
• 14.5 Threat of New Entrants
• 14.6 Threat of Substitutes

15 Price Analysis

16 Competitive Landscape

• 16.1 Market Structure
• 16.2 Key Players
• 16.3 Profiles of Key Players
  • 16.3.1 Boston Scientific Group
    • 16.3.1.1 Company Overview
    • 16.3.1.2 Product Portfolio
    • 16.3.1.3 Financials
    • 16.3.1.4 SWOT Analysis
  • 16.3.2 Kona Medical Inc.
    • 16.3.2.1 Company Overview
    • 16.3.2.2 Product Portfolio
  • 16.3.3 Medtronic Plc
    • 16.3.3.1 Company Overview
    • 16.3.3.2 Product Portfolio
    • 16.3.3.3 Financials
    • 16.3.3.4 SWOT Analysis
  • 16.3.4 Mercator MedSystems
    • 16.3.4.1 Company Overview
    • 16.3.4.2 Product Portfolio
  • 16.3.5 ReCor Medical Inc. (Otsuka Holdings Co. Ltd.)
    • 16.3.5.1 Company Overview
    • 16.3.5.2 Product Portfolio
  • 16.3.6 Renal Dynamics
    • 16.3.6.1 Company Overview
    • 16.3.6.2 Product Portfolio
  • 16.3.7 St. Jude Medical Inc. (Abbott)
    • 16.3.7.1 Company Overview
    • 16.3.7.2 Product Portfolio
  • 16.3.8 Terumo Corporation
    • 16.3.8.1 Company Overview
    • 16.3.8.2 Product Portfolio
    • 16.3.8.3 Financials
    • 16.3.8.4 SWOT Analysis