Overall, the global transcatheter mitral valve repair device market was valued at $763.6 million in 2020, which is a 2.2% increase from $747 million in 2019. This is expected to increase over the forecast period at a CAGR of 16.4% to reach $2.2 billion.
What do transcatheter mitral valve repair devices treat?
The human heart has four valves, the mitral valve, tricuspid valve, aortic valve, and pulmonary valve. Of the four valves, the mitral valve is the most susceptible to regurgitation. Regurgitation is a condition where blood is funneled back into the left atrium of the heart. Either a congenital defect or myxomatous degeneration can cause mitral regurgitation (MR). There are two types of MR: functional mitral regurgitation (FMR) and degenerative mitral regurgitation (DMR).
The treatment for MR is usually open-heart surgery. However, for those that are not candidates, transcatheter mitral valve repair procedures are an alternative. Transcatheter mitral valve repair (TMVr) involves the use of a clip to prevent MR. These clips work by securing the flaps of the mitral valve. Regarding the devices used, the MitraClip® procedure uses a steerable guide catheter inserted into the femoral vein at the groin and provides a conduit to access the mitral valve.
What are the current market drivers and limiters?
Trends suggest that the market will increase over the span of 6 years and into 2027. Similarly, TMVr procedures should increase in volume over into 2027, driven by this expanding indication over the forecast period.
Currently, the first and only TMVr device approved in the U.S. is the Mitraclip™. Recently, Abbott received FDA approval to expand the indication for the Mitraclip™ to patients with clinically significant secondary mitral regurgitation. With hopes to expand the cohort of patients that can benefit from the MitraClip™ and increase the market growth. In addition, the large patient population eligible for TMVr procedures with mitral valve disorders will positively influence the market. Lastly, the ineligibility for mitral valve patients who are high-risk and unable to receive surgery will drive TMVr device unit sales.
Limitations on the market surround the complexity of TMVr procedures and new market entrants. The TMVr procedure is complex, time-consuming, and requires extensive physician training. Because of the complexity of the procedure, it will continue to limit the market as untrained surgeons will not be able to perform the procedure. Additionally, the development of new transcatheter mitral valve repair technology, although exciting, will limit this market. Increased competition will saturate the market and push down average selling prices, exerting downward pressure on the market value.
Who are the top companies within the TMVr market?
Abbott, Edwards Lifesciences, and Cardiac Dimensions are the three global market leaders. Abbott’s TMVr device, MitraClip®, was the world’s first device. The company expects to retain its market-leading position over the forecast period despite increasing competition from new market entrants as physicians are already comfortable performing the MitraClip® procedure, and reimbursement for MitraClip® is more favorable than for alternative devices.
Edwards Lifesciences and Cardiac Dimensions are the second and third leading competitors, respectively, within the TMVr market. Both companies distribute their products throughout Europe and have received CE marking. Further, Edwards Lifesciences offers its Cardioband® Mitral Reconstruction System, and Cardiac Dimensions offers its CARILLION® Mitral Contour System™.
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