The global renal denervation devices market size was valued at USD 31 million in 2021. It is estimated to reach an expected value of USD 385 million by 2030, growing at a CAGR of 37% during the forecast period (2022–2030). Blood pressure that persists over target values after taking anti-hypertensive drugs is referred to as resistant hypertension. A little more than 12 to 15% of people receiving treatment for high blood pressure have resistant hypertension. A minimally invasive treatment called renal denervation is used to treat resistant hypertension. The number of persons with hypertension and resistant hypertension is increasing along with the geriatric population, fueling the expansion of the global renal denervation market.
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Rising Prevalence of Hypertension
The burden of hypertension-induced diseases and chronic disorders is constantly growing worldwide. Hypertension, also called high blood pressure, is a severe medical condition that dramatically increases the chances of heart, kidney, brain, and other disorders. In the United States, the Centers for Disease Control (CDC) 2018 stated that high blood pressure was a primary cause of death for more than 494,873 persons, with over 100 million suffering from the illness. An increase in occurrences of hypertension is predicted to boost demand for renal denervation devices during the forecast period.
According to the 2019 United Nations Department of Economics and Social Affairs study, 16% of the global population will be over 65 years old by 2050, up from 9% in 2019. In 2018, people aged 65 and over outnumbered children under five globally for the first time in history. The number of people aged 80 and over is projected to double from 143 million in 2019 to around 426 million in 2050. According to the same report, the percentage of the population aged 65 years or over doubled from 6% in 1990 to 11% in 2019 in Eastern and South-Eastern Asia and from 5% in 1990 to 9% in 2019 in Latin America and the Caribbean. It is estimated that the percentage of the older population is projected to double in four regions, i.e., Central and Southern Asia, Northern Africa and Western Asia, Eastern and South-Eastern Asia, and Latin America and the Caribbean.
With the rising aging population worldwide, there is expected to be an increase in people suffering from hypertension issues. As people age, arterial stiffness, hemodynamic changes, neurohormonal and autonomic dysregulation, and declining renal function lead to hypertension. Therefore, all the factors mentioned above indicate that increase in cases of hypertension is expected to lead to a demand for renal denervation devices market during the forecast period., which may promote the growth of the market studied in the future.
Long Lasting Effect of the Procedure
Renal denervation usually has long-term positive impacts on blood pressure control in patients who have undergone the procedure, particularly those who have suffered from hemorrhagic stroke. In an August 2019 study in the SAGE Publication, researchers found that renal denervation can improve patients' outcomes in the acute phase of hemorrhagic stroke when the stroke was associated with malignant hypertension. The researchers also did a follow-up demonstrating the long-term sustained efficacy of renal denervation. The researchers also postulated that renal denervation-induced normalization of blood pressure might contribute to better outcomes in situations such as intracranial bleeding. Thus, this procedure is expected to increase in popularity as it can be used to treat a variety of issues.
In a March 2019 article in the European Heart Journal, researchers studied the effects of renal denervation on kidney function and long-term outcomes over three years. The study showed that systolic blood pressure (SBP) reduction in patients undergoing the procedure was sustained for over 3-years. This decrease included reductions in both offices (−16.5 mmHg) and 24-h ambulatory SBP (−8.0 mmHg) in patients. The renal denervation procedure thus showed a favorable short- and long-term efficacy and safety profile. The study also showed that there were no long-term safety concerns that were observed after the denervation procedure in patients. The above factors indicate that renal denervation procedures have long-lasting effects on patients' lives in treating disorders. Thus, these factors are expected to affect market growth during the forecast period positively.
One of the significant drawbacks of renal denervation procedures is the onset of pain during and immediately after the operation. The process is usually done under local anesthetic and sedation to alleviate the pain. The system is also a bit complex and long-drawn. After injecting a local anesthetic into the skin of the groin over the femoral artery, a tube is fed into the artery. A catheter (fine tube) is advanced into the renal artery under X‐ray control. A dye is injected through the catheter to confirm the position inside the artery. A special wire is then fed through the catheter, and high-frequency energy is delivered to heat the artery's wall from the inside. This is the time when the onset of pain can begin.
Each artery takes about 15 minutes to treat, while the whole procedure takes around an hour. During this time, the constant energy bursts from the wires can be a significant source of discomfort for some patients. The energy bursts into the nerves can lead to some patients feeling extreme pain and discomfort in the back or loin area. Due to the repeated occurrence of pain during and after procedures where renal denervation devices are used, many patients seek other methods to treat their conditions. Therefore, due to the nature of the procedure, which can lead to pain, and its relative complexity, the factors mentioned above are expected to act as significant restraints to the market growth of renal denervation devices.
New market opportunities are also rising due to groundbreaking research in hypertension. In February 2020, Ablative Solutions Inc. announced positive data from research where the safety and efficacy of the company's CE-marked Peregrine System Infusion Catheterwas studied. The study found that the renal denervation procedure using the Peregrine Catheter and alcohol as a neurolytic agent is safe and effective and can be used for lowering blood pressure in patients with poorly controlled hypertension on medication.
A rising number of companies are shaping the future of Renal Denervation Devices. As the healthcare industry's demand pushes for minimally invasive surgeries, there is rising interest in developing products for treating hypertension. The market is expected to grow in the future. The above factors will likely provide significant growth opportunities for the overall denervation devices market.
The global renal denervation devices market is segmented by technology and region.
By technology, the global renal denervation devices market is segmented into Radiofrequency-based, Ultrasound-based, and Micro-infusion-based.
Radiofrequency-based accounts for the largest market share and is estimated to grow at a CAGR of 37.1% during the forecast period. Radiofrequency renal denervation is one of the most-effective treatment options for hypertension. Many research studies have proved it to be more efficient. In March 2020, Medtronic announced positive clinical trial results for its Symplicity Spyral Radiofrequency Renal Denervation System, which effectively reduces blood pressure in patients with uncontrolled hypertension not treated with medication, from its three-month results from the SPYRAL HTN-OFF MED pivotal trial. As per the November 2020 research study published in Clinical Research in Cardiology, Sham-controlled trials were performed on 12 hypertensive Ossabaw pigs with catheter-based radiofrequency renal denervation. Their results showed that radiofrequency renal denervation is effective in hypertensive patients with and without concomitant antihypertensive medication. These factors are expected to drive this segment.
Ultrasound-based renal denervation devices are a minimally invasive procedure that uses ultrasound to ablate nerves in the wall of 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. The 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 trials is expected to increase the importance of these devices and revive them. Such factors propel the market demand.
Europe Reigns Supremacy Over Others
By region, the global renal denervation devices market is segmented by North America, Europe, Asia-Pacific, and SAMEA.
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Europe accounts for the largest market share and is estimated to grow at a CAGR of 37.5% during the forecast period. The growth is attributable to the rising geriatric population. The spiking cases of therapy-resistant hypertension are also a key factor driving the market. Hypertension is one of the most common diseases in Europe. Changes in lifestyle, such as excessive alcohol consumption, lack of physical activity, smoking, and consumption of fast food, increase the risk of hypertension. The increased blood pressure subsequently gives rise to various diseases, such as stroke, heart attacks, and pulmonary arterial hypertension. According to the "Our World in Data" statistics, Germany has a clustered burden of smoking. In 2017, almost 18.6% of women and 26.4% of men in Germany were smokers. Therefore, the increasing prevalence of smoking is becoming a healthcare burden in the country, causing hypertension and increasing the demand for renal denervation devices market.
Asia-Pacific is estimated to account for USD 90 million by 2030, registering a CAGR of 37.6%. The growth is attributable to the increasing incidence of hypertension and growing awareness of the advantages of the treatment in the country. The renal denervation can selectively ablate renal sympathetic nerve fibers and block the transmission of nerve impulses between the central sympathetic nerve and kidney to control blood pressure as a novel promising non-drug treatment option for resistant hypertension. The growing research on the efficacy of the treatment is the primary factor for the expected market growth. Therefore, the increasing burden of hypertension and cardiovascular diseases increases the demand for effective treatment, thus increasing the need for devices in the country.
North America is the third-largest region. The rising prevalence of hypertension, changing lifestyles, growing geriatric population, and the long-lasting effect of the procedure may result in the steep growth of demand. According to the Centers for Disease Control and Prevention, in 2018, approximately one out of two adults in the United States had hypertension, which accounts for 108 million US population. Various strategies, such as R&D, merger and acquisition, and product launch, are being adopted by domestic companies to strengthen their market position. For instance, in 2020, the US-based firm, ReCor Medical Inc., announced it received Breakthrough Device Designation from the FDA for its Paradise Ultrasound Renal Denervation System. The Paradise system uses ultrasound energy to ablate the renal nerve. Therefore, the increasing incidence of hypertension, continuous developments, and advancements being adopted by the market players in the country are likely to enhance the growth of the market studied.
List of key renal denervation devices market companies profiled