ResMed’s Class I recall of its AirFit and AirTouch products 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 over 20 million continuous positive airflow pressure (CPAP) masks. ResMed is a major player in the PAP market, making up approximately 25.6% of the market. It also dominates the CPAP market, making up 72.8% of the sub-market.

Aidan Robertson, Medical Analyst at GlobalData, comments: “While it would be unlikely for ResMed to lose its dominating position in the CPAP market, if buyers start to lose confidence in some ResMed products moving forward, this setback could provide opportunities for other players to capitalize and expand their coverage of the market.”

The recall in this case is a correction compared to a full product removal. This correction involves updating labels, adding extra warnings, and providing further information. However, this news could still negatively impact ResMed’s standing. Additionally, although these devices only apply to CPAP masks, this sub-market makes up approximately 48% of the total PAP market so changes in performance can have significant revenue consequences for the overall market.

The issue itself is due to the magnets in the masks causing interference with medical implants such as pacemakers, neurostimulators, or diabetes devices. This can, in turn, cause the implants to move or shift, risking patient injury. While ResMed deals with their current predicament, smaller players in the CPAP market such as Teijin with their SLEEPMATE product or Phillips Respironics could look to make gains in this space.

Robertson concludes: “The demand for PAP devices continues to grow as an aging population has increased the incidence rate of chronic obstructive pulmonary disease (COPD). Additionally, there is an increasing prevalence of sleep apnea, which will drive growth.

“While this recall causing significant consequences for ResMed is improbable, that comes down to whether the patient population and hospitals determine that the added instructions and labels for their products are enough to warrant continued use.”