GlobalData estimates that the global market value for TAVR devices in 2019 will be just under $3.5bn, and predicts a compound annual growth rate (CAGR) of just under 20 percent for TAVR devices in the US in the foreseeable future.
Ashley Young, Ph.D., Medical Device Analyst at GlobalData, commented: “The global TAVR market is currently dominated by Edwards LifeSciences’ Sapien line of TAVR valves and Medtronic’s CoreValve Evolut brand. These devices are far ahead of any potential competition because they have been Food and Drug Administration (FDA) approved for use in severe aortic stenosis patients at high, intermediate and low risk as a surgical alternative to aortic valve replacement.
“Most other devices in the market are only approved for the high-risk patient pool. However, a major drawback to these and other devices on the market is the lack of available long-term clinical trial data. As a result, it is not known how long these TAVR valves will last in the body, and therefore the procedure is generally not recommended for young patients (ages 65 years and younger) whose lifespans may surpass that of the device.”
However, Admedus’ device may be the solution to this problem. Devices made with its ADAPT-treated tissue have been shown to last nine years without calcification or degradation, and Admedus states that a product lifespan without calcification will allow for device usage across a broader age span.
Young concluded: “The TAVR market is already large and growing quickly. If Admedus can successfully prove that its TAVR device lasts longer than other devices on the market, it may become the device of choice for a younger patient population, allowing the company to gain significant market share.”