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September 16, 2022

Malfunctions in leading TMVR device could end Abbott’s market primacy

With the recent warning from the FDA about MitraClip malfunctions, physicians may search elsewhere for their transcatheter mitral valve repair (TMVR) solutions.

By GlobalData Healthcare

Transcatheter mitral valve repair (TMVR) is one of the fastest growing fields in the realm of heart surgery and repair at the moment. GlobalData expects the market to triple in size from 2021 to 2030. In 2021 GlobalData estimated the total market size to be just over $1 billion. In 2030 GlobalData expects the TMVR market to reach a market cap of $3.4 billion. The CEO of Abbott, Robert Ford, has echoed this sentiment, stating that the “[Mitral valve repair] market still remains pretty underpenetrated and there’s a lot of opportunity for growth there.” At this moment in time, Abbott, as a large multinational and early entrant to the space, sits comfortably at the lead of the pack with an estimated 99% market share. However, with the recent warning from the FDA about MitraClip malfunctions, physicians may search elsewhere for their TMVR solutions.

The FDA has reported that malfunctions occur in about 1.3% of all MitraClip procedures; GlobalData estimates this is about 600 people worldwide. This can result in relapse of the conditions as the implant fails to fulfill its purpose. In the worst-case scenarios, this can result in the patient needing to undergo surgery to both remove the implant and correct the surgical pathology. This recent spate of malfunctions is a new development resulting from a change in material in one of the components of the device. Abbott is reportedly looking into ways to fix this problem but is not issuing a recall for the current products, instead opting for informing physicians of the issue and how to work around it.

This new increase in malfunctions, coupled with Abbott’s lackadaisical approach to fixing structural issues with an incredibly expensive device, may shake the faith of physicians and cause them to look elsewhere. Currently in the market there are several competitors such as Cardiac Dimensions, NeoChord, and most significantly, Edwards Lifesciences Corp with its Pascal device. If the other companies can capitalize on this to showcase the relative efficacy and safety of their products, they may win market share in a niche that is set to explode in growth in the coming years.

It is important to note that even if the market shares of competitors stay constant in coming years, GlobalData expects that all market entrants will still enjoy high natural growth due to changing patient populations and treatment patterns. TMVR patients are largely much older, with the youngest patients being 75 years old currently. As the world’s population ages, the number of people in this age range is set to explode. Additionally, as treatment opportunities and knowledge grow, the percentage of eligible patients who are successfully diagnosed and treated will also increase. This will result in the explosive growth GlobalData is expecting.

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