ResMed’s Class I recall of its AirFit and AirTouch continuous positive airflow pressure (CPAP) masks threatens the company’s position in the positive airway pressure (PAP) devices market, which was worth $2.44 billion in 2023 and is expected to reach $5.15 billion in 2033, according to GlobalData, a leading data and analytics company.

The recall impacts more than 20 million CPAP masks. So far, there have been six reported injuries and no deaths amongst users. The issue is of magnets in the masks causing interference with medical implants such as pacemakers, neurostimulators or diabetes devices. This interference can cause the implants to move or shift, risking patient injury.

This recall is a correction rather than a full product removal. The correction involves updating labels, adding extra warnings and providing further information. However, the news could still negatively impact ResMed’s standing.

ResMed is a major player in the PAP market, with a market share of approximately 25.6%. It specifically dominates the CPAP sub-market with a market share of 72.8%. The CPAP sub-market makes up approximately 48% of the total PAP market, meaning that changes in performance there can create significant revenue consequences for the overall market.

ResMed is unlikely to lose its dominant position in the CPAP market. However, if buyers start to lose confidence in some ResMed products, this setback could provide opportunities for other players to capitalise on, enabling them to expand their coverage of the market. While ResMed deals with its current predicament, smaller players in the CPAP market such as Teijin, with its SLEEPMATE product, or Phillips Respironics, could look to make gains in this space.

The demand for PAP devices continues to grow as population ageing drives the incidence rate of chronic obstructive pulmonary disease. There is also an increasing prevalence of sleep apnea. While it is improbable that this recall will cause significant consequences for ResMed, that will ultimately depend on whether the patient population and hospitals determine that the added instructions and labels for ResMed’s products still warrant their continued use.

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By GlobalData