|Fastest Growing Market:||North America|
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The renal denervation devices market is expected to register a CAGR of 36.89% during the forecast period.
The COVID-19 outbreak impacted the renal denervation devices market as hospital and healthcare services significantly reduced due to social distancing measures taken by governments globally. Moreover, the COVID-19 pandemic affected the global economy and impacted general hospital care for non-COVID-19 patients worldwide. During the COVID-19 outbreak, many medical device manufacturers either delayed or postponed the launch of their devices due to resource and fund crunch, negatively impacting the renal denervation devices market. For example, in March 2020, Medtronic announced the delay of its PMA application for the Symplicity Spyral renal denervation system.
The major factors responsible for the growth of the renal denervation devices market include the rising prevalence of hypertension and the long-lasting effect of the procedure. High blood pressure is called hypertension. The prevalence of hypertension has been observing a significant rise over the past few years. Generally, blood pressure rises and falls throughout the day, but it can damage one’s heart and result in health problems if hypertension stays high for a long time. According to the World Health Organization, 2021, around 1.28 billion people aged between 30 and 79 years are affected by hypertension globally. An increase in the number of cases of hypertension is expected to create demand for renal denervation devices during the forecast period. Some of the major reasons for an increase in the prevalence of hypertension are the increasing geriatric population, high sodium and low potassium intake, rising cases of obesity, increasing alcohol consumption in low- and middle-income countries, physical inactivity, and the lack of a balanced diet. The rising number of geriatrics in the world is one of the major reasons leading to an increase in the risk of hypertension. The high prevalence is not just limited to the United States, as the European and South Asian countries also have a high rate of hypertension, making this a global problem.
Though only a few renal denervation devices have been approved in Europe, many major players have been gaining approval for clinical trials from the FDA in the United States. The process required for a new commercial device to gain approval for marketing by the FDA can be costly and time-consuming, sometimes taking many years, depending on how complicated the test is. Several ideas for tests never make it to the clinical trial stage, where the safety and efficacy are evaluated on patient volunteers. If commercial tests become available, the laboratory tests must meet stringent standards during the manufacturing process and in the clinical laboratory.
Scope of the Report
As per the scope of the report, renal denervation devices are one of several innovative device-based interventional therapies that help control blood pressure. It is safe, minimally invasive, and does not leave any implants behind. The renal denervation devices market is segmented by technology (radiofrequency-based, ultrasound-based, and micro-infusion-based) and geography (North America, Europe, Asia-Pacific, and Rest of the World). The market report also covers the estimated market sizes and trends for 17 countries across major regions globally. The report offers the value (in USD million) for the above segments.
|Rest of the World|
Key Market Trends
The Ultrasound-based Segment is Expected to be the Fastest-growing Segment
The ultrasound-based renal denervation devices are a minimally invasive procedure that uses ultrasound to ablate nerves in the wall of the renal arteries. It disrupts the transmission of nerve impulses to and from the kidney and lowers blood pressure.
According to the 2020 European Society of Cardiology’s comparative study of trials, Radiance-HTN Solo (ultrasound-based device - Paradise) showed more efficacy than the radiofrequency-based SPYRAL HTN-OFF MED trial device. Paradise ultrasound-based renal denervation device reduced -6.3 mmHg in daytime ambulatory BP and -6.5 mmHg in office systolic BP compared to the sham group. The high efficacy of ultrasound-based devices proven in the trials is expected to increase the importance of these devices and revive them. The increasing geriatric population is a risk factor for hypertension, boosting the segment’s growth.
The COVID-19 outbreak has negatively impacted the number of procedures and the production of devices worldwide. Due to the fear of transmission of the virus, many hospitals have canceled the procedures, and the manufacturing and supply chain was disturbed due to the lockdowns worldwide. Many trials and product approvals have been pending for the year, impacting the market’s growth.
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Europe is Expected to Dominate the Market
Europe held a major share of the renal denervation devices market, and it is expected to show a similar trend over the forecast period, without significant fluctuations. According to the data published by Public Health England, high blood pressure affects more than one in four adults in England. NHS Digital data collected through the 2019 Health Survey for England showed that the proportion of men with hypertension increased from 28% to 30% from 2017 to 2018, and rates for women rose by 25% to 26%. Two-thirds of men aged 75 and more have some form of hypertension Changes in lifestyles, such as excessive alcohol consumption, lack of physical activity, smoking, and consumption of fast food, increase the risk of hypertension. Increased blood pressure subsequently gives rise to various diseases, such as stroke, heart attacks, and pulmonary arterial hypertension.
Europe has a large number of renal denervation devices that received CE approval. The major factor driving the market's growth is growing R&D activities to develop efficient devices. The launch of products in the region will also contribute to the market’s growth. For instance, in October 2021, ReCor Medical Inc. launched the ultrasound renal denervation system in Europe, which will be used to treat uncontrolled hypertension in Germany. Rising cases of drug-resistant hypertension may boost the overall growth of the market over the forecast period.
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The market is consolidated due to the presence of some major market players. Some of the market players are Abbott, Ablative Solutions, Boston Scientific Corporation, CardioSonic, Kona Medical, Medtronic PLC, Mercator MedSystems, ReCor Medical, and Symple Surgical.
- In December 2020, ReCor Medical announced positive results in the RADIANCE-HTN TRIO Study and Breakthrough Device Designation for Paradise Ultrasound Renal Denervation System.
- In March 2020, Medtronic PLC announced the first-ever clinical data from the SPYRAL HTN-OFF MED Pivotal Trial. The landmark SPYRAL HTN-OFF MED Pivotal Trial shows superiority for renal denervation in patients with high blood pressure compared to the sham procedure.
Table of Contents
1.1 Study Deliverables
1.2 Study Assumptions
1.3 Scope of the Study
2. RESEARCH METHODOLOGY
3. EXECUTIVE SUMMARY
4. MARKET DYNAMICS
4.1 Market Overview
4.2 Market Drivers
4.2.1 Rising Prevalence of Hypertension
4.2.2 Long Lasting Effect of the Procedure
4.3 Market Restraints
4.3.1 Painful Procedure
4.3.2 Stringent Approval Process for Renal Denervation Devices and Reimbursement Systems
4.4 Porter's Five Forces Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5. MARKET SEGMENTATION (Market Size by Value - USD million)
5.1 By Technology
5.2 By Geography
5.2.1 North America
220.127.116.11 United States
18.104.22.168 United Kingdom
22.214.171.124 Rest of Europe
126.96.36.199 South Korea
188.8.131.52 Rest of Asia-Pacific
5.2.4 Rest of the World
6. COMPETITIVE LANDSCAPE
*List Not Exhaustive
6.1 Company Profiles
6.1.1 Medtronic PLC
6.1.2 Abbott Laboratories (St. Jude Medical Inc.)
6.1.3 Otsuka Holdings Co. Ltd (ReCor Medical Inc.)
6.1.4 Ablative Solutions Inc.
6.1.5 Mercator MedSystems
6.1.6 Terumo Corporation
6.1.7 Symple Surgical
6.1.8 Boston Scientific Corporation (Vessix Vascular Inc.)
6.1.10 Recor Medical Inc.
7. MARKET OPPORTUNITIES AND FUTURE TRENDS
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Frequently Asked Questions
What is the study period of this market?
The Global Renal Denervation Devices Market market is studied from 2019 - 2027.
What is the growth rate of Global Renal Denervation Devices Market?
The Global Renal Denervation Devices Market is growing at a CAGR of 36.89% over the next 5 years.
Which region has highest growth rate in Global Renal Denervation Devices Market?
North America is growing at the highest CAGR over 2021- 2026.
Which region has largest share in Global Renal Denervation Devices Market?
Europe holds highest share in 2021.
Who are the key players in Global Renal Denervation Devices Market?
Boston Scientific Corporation, CardioSonic, Medtronic PLC, ReCor Medical, Symple Surgical are the major companies operating in Global Renal Denervation Devices Market.