In January, Abbott Laboratories became the first company to receive Conformitè Europëenne (CE) approval for a transcatheter mitral valve implantation (TMVI) device. The company is expected to receive US Food and Drug Administration (FDA) approval in 2021, according to GlobalData’s Pipeline Devices database. GlobalData expects that Abbott will capture the majority of market share due to being the first to enter the market and believes that Abbott’s future position can be estimated by analysing the established transcatheter aortic valve implantation (TAVI) device market.
Transcatheter valve implantation and repair devices is a rapidly growing field. They provide therapeutic options to patients with valve regurgitation or stenosis who are not good candidates for surgery. Often, the first company to gain approval and launch their product gain a lasting competitive advantage in that market. In the TAVI space, Edwards Lifesciences received FDA approval for Sapien in 2011 while its main competitor Medtronic only received FDA approval for CoreValve in 2014. Edwards Lifesciences has been well-positioned as the market leader since it launched Sapien and is estimated to have 75% of the US market share.
Compared to the TAVI market, the TMVI market is in its early infancy. Abbott’s Tendyne will not only lay claim to early European market share by receiving CE approval but will also gain the patient numbers required to file for approval in other countries, especially the US. Additionally, Abbott was recently awarded Best Medical Technology for 2020 by Prix Galien USA for its first-in-class transcatheter mitral valve repair (TMVR) device, MitraClip. Abbott is expected to launch its first-in-class TMVI device in the US in 2021 and will likely be met with competition from Edwards Lifesciences, Medtronic, and Neovasc in 2023 if their products receive FDA approvals. However, due to the propensity Abbott has displayed for transcatheter valve devices and being first to launch, it is likely to retain the majority of market share through 2030 similar to the position Edwards Lifesciences has held for the past ten years.
Abbott will attempt to leverage its promising positions in the TMVI and TMVR markets to help increase its market share in TAVI, where it is a new entrant. However, for the next two-three years, Abbott will have an exclusive presence in two spaces and will be cementing its market share with its first-in-class devices.