Renal denervation is a minimal invasive procedure used for the treatment of drug resistant or treatment resistant hypertension. This procedure reduces blood pressure by ablation of renal nerves. With rising incidences of uncontrolled and treatment resistant hypertension, demand for RDN devices is expected to grow in future. Benefits of the RDN procedure such as shorter treatment time and permanent effects over drug treatment, which indirectly reduces the cost of treatment, will also accelerate the market growth. Furthermore, increasing awareness of the RDN process and expected approvals from regulatory bodies such as FDA will boost the demand for RDN devices globally.
WHO estimates indicate that in 2012 more than 1.2 billion people were suffering from hypertension. Clinical data collected from various regions shows the global prevalence of hypertension to be about 38% to 45%. Moreover, new data released by National Health and Nutrition Examination Survey (NHANES) indicates the occurrence of hypertension in the US to be around 30%. After studying data from various clinical studies it is observed that more than 25% to 45% of hypertensive people suffer from uncontrolled hypertension and 15% of these people are observed to have treatment resistant hypertension. This represents a positive outlook for RDN procedure as it considerably reduces the blood pressure in patients with treatment resistant hypertension, thus providing a huge basis for growth of the market.
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Europe is the largest as well as fastest growing regional market for RDN devices followed by Asia-Pacific. Europe is expected to maintain its dominating position with a strong double digit growth through 2021. The RDN devices market in North America is expected to accelerate due to FDA approvals in the next 4-5 years coupled with the high incidence of lifestyle-related cardiovascular diseases in the region. Aging population along with a high incidence of diabetes will boost the demand for RDN devices in Asia-Pacific, which is estimated to have a large percentage of population that has not even been diagnosed. Large numbers of hypertensive people have not yet been diagnosed with uncontrolled hypertension globally and are still trying many alternate therapies and medications and struggling to control hypertension.
Due to insufficient clinical data, market players are currently struggling to get approvals from regulatory bodies. However, some leading players have received certification by adding innovation to their products coupled with strong research and development activities. Currently, only five devices have received approval for CE mark certification which includes Medtronic’s Symplicity, Boston Scientific’s (Vessix Vascular) V2, St. Jude’s EnligHTN, Covidien’s OneShot and ReCor Medical’s Paradise with not a single RDN therapy receiving approval from the US FDA. Medtronic is the leading player in the RDN devices market and contributes for more than 85% of the global market share. ReCor Medical Paradise is the only ultrasound denervation system that has CE certification. However, in the coming years, a high threat of new entrants is expected with innovative technologies which will reduce procedure time and have greater efficacy. Yet with all the challenges, the renal denervation procedure is considered a boon to treatment of uncontrolled hypertension and thus, the market growth in coming years is expected to be very strong.
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