The company’s latest report* states that across the 10 major markets (the US, France, Germany, Italy, Spain, UK, Japan, Brazil, China and India), only the European Union has approved the use of renal denervation. GlobalData predicts that the intervention will be given approval in all of the countries studied by the end of the forecast period.
This, along with a number of other anticipated events, is expected to drive the global procedure volume from approximately 3,000 procedures in 2012 to nearly 40,000 by 2019.
Joseph Gregory, GlobalData’s Analyst covering Surgical Devices, says: “While there has been much enthusiasm for renal denervation since its introduction to the market in 2010, the intervention has been met with considerable barriers to its adoption. As a result of this, the number of global procedure volumes has been coasting in the low thousands, which is expected to continue through 2014.”
Another reason for the low numbers is the utilization of renal denervation in resistant hypertension only. However, this is expected to change in 2015, when the anticipated CE Mark for the heart failure indication is obtained in Europe. Additionally, the uncontrolled hypertension indication is expected to be approved in the US in 2016, with a subsequent CE Mark in 2018.
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Still, major market restraints will impede further adoption of renal denervation, including reimbursement and ambulatory blood pressure readings.
Gregory says: “Health insurance agencies want to see long-term clinical trial data from sophisticated studies, but the longest follow-up to date is three years in a nonrandomized study. Additionally, the purported efficacy results from the majority of company-sponsored clinical trials have recently come into question, given the use of office-based blood pressure measurements rather than ambulatory measurements.”
Compounded with several other market barriers, such as game-changing technologies developed by competitors, renal denervation will have to bear a decade of significant scrutiny before it takes off and sees optimal adoption, according to GlobalData.
This report provides renal denervation diagnosis rates, patient segmentation, treatment rates, procedure volumes, average selling prices, and market values over a 10-year period (2010–2019)
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