The renal denervation devices market is valued at USD 31.01 million in 2020, and it is expected to reach USD 193.43 million in 2026, registering a CAGR of 36.89% during the forecast period.
The outbreak of COVID-19 showed an impact on the renal denervation devices market because hospital and healthcare services were significantly reduced due to social distancing measures taken by governments across the globe. Moreover, the COVID-19 pandemic not only affected the global economy but also showed a huge impact on the functioning of general hospital care for non-COVID-19 patients in hospitals across the globe. The COVID-19 outbreak has also caused many medical device manufacturers to either delay or postpone the launch of their devices due to resource and funds crunch. This is having negative effects on the renal denervation devices market. For example, in March 2020, Medtronic announced that it was delaying the completion 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. In the United States, the Centers for Disease Control (CDC) in 2018 stated that high blood pressure was a primary or contributing cause of death for more than 494,873 people in the country with over 100 million people suffering from the disorder. An increase in cases of hypertension is expected to create demand for renal denervation devices during the forecast period. Some of the major reasons why there is an increase in hypertension are because of an increase in 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. In fact, the rising number of geriatric 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, owing to the fact that the European and South Asian countries also have a high rate of hypertension, which makes this a global problem.
On the other hand, only a few renal denervation devices have only been approved in Europe, while the major players have ben gaining approval for the 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 a costly and time-consuming process, 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 do become available, the laboratory tests must meet stringent standards both during the manufacturing process and when they are used in the clinical laboratory.
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, and 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. The 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 an increasing risk factor for hypertension and increases the growth of the segment.
Furthermore, COVID-19 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 lockdown worldwide. Additionally, many trials and product approvals have been pending for the year, which is impacting the market growth.
Europe is Expected to Dominate the Market
Europe has been found to hold 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 upwards have some form of hypertension Also 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.
There is a large number of renal denervation devices, which have received CE approval, in Europe. The major factor driving the growth of the market studied is rising R&D activities for the development of efficient devices. As per clinicaltrials.gov, one of the market players, Abbott Medical Devices, completed the observational study of the EnligHTN renal denervation system, in Europe, in February 2019. Additionally, rising cases of drug-resistant hypertension may boost the overall growth of the market, over the forecast period.
The market studied is a consolidated market, owing 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.
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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
- 5.1 By Technology
- 5.1.1 Radiofrequency-based
- 5.1.2 Ultrasound-based
- 5.1.3 Micro-infusion-based
- 5.2 Geography
- 5.2.1 North America
- 126.96.36.199 United States
- 188.8.131.52 Canada
- 184.108.40.206 Mexico
- 5.2.2 Europe
- 220.127.116.11 Germany
- 18.104.22.168 United Kingdom
- 22.214.171.124 France
- 126.96.36.199 Italy
- 188.8.131.52 Spain
- 184.108.40.206 Rest of Europe
- 5.2.3 Asia-Pacific
- 220.127.116.11 China
- 18.104.22.168 Japan
- 22.214.171.124 India
- 126.96.36.199 Australia
- 188.8.131.52 South Korea
- 184.108.40.206 Rest of Asia-Pacific
- 5.2.4 Rest of the World
6 COMPETITIVE LANDSCAPE
- 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.)
- 6.1.9 SoniVie
7 MARKET OPPORTUNITIES AND FUTURE TRENDS