classification of positive airway pressure (PAP) delivery systems.
The surge in the prevalence of hypertension, cardiovascular diseases, obesity, and chronic obstructive pulmonary disease is driving the sleep apnea devices market growth. As per sleepapnea.org, approximately 22 million Americans suffer from sleep apnea, with 80% of the moderate to severe obstructive sleep cases undiagnosed. In addition, as per FAIR Health, Inc., the number of sleep apnea cases was highest in five states—Maryland, Idaho, Utah, Iowa, and Arkansas. The number of cases is expected to significantly increase in the forthcoming years owing to the rising incidence of lifestyle diseases, such as obesity, hypertension, & stress. Approximately 70% of sleep apnea patients are obese or overweight.
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The first-line treatment for obstructive sleep apnea (OSA) is continuous positive airway pressure (CPAP) therapy. However, poor adherence to CPAP reduces its effectiveness, thereby limiting its beneficial outcomes. OSA is a widely prevalent condition that remains largely undiagnosed. Low awareness among existing patients regarding the effects of sleep apnea is a key factor responsible for the high prevalence of OSA. It has been estimated that 1 out of every 5 individuals suffers from sleep-related disorders; however, awareness about the condition among patients is significantly low.
Untreated sleep apnea can lead to the occurrence of chronic diseases such as hypertension, heart failure, stroke, and other cardiovascular ailments. Increasing demand for high-end medical devices, such as travel-friendly & portable sleep apnea devices is expected to create new growth avenues for the industry. For instance, AirMini, a portable CPAP machine provided by ResMed, is regarded as the world’s lightest and smallest CPAP machine. Furthermore, the availability of reimbursement for sleep apnea treatment is opportunistic for the product demand.
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Key Technology Trends:
Increasing awareness about sleep disorders and the rising availability of technologically advanced sleep apnea devices are expected to provide lucrative opportunities for device manufacturers. Key advancements include the introduction of wireless communication between actigraph & actigraphy providers and under-mattress bed sensors. Technological advancements have resulted in the development of state-of-the-art actigraphs, which can be used for applications such as environmental data collection, basic sleep estimation, comprehensive sleep scoring, and high-resolution analog data collection.
The FDA has issued a new rule for classification of positive airway pressure (PAP) delivery systems. It reclassified the PAP delivery system from Class III medical devices to Class II medical devices. These devices are continued to be used only by prescription. CPAP manufacturers are now innovating their products to achieve better compliance rates on their new CPAP designs. PAP device manufacturers are focusing on producing a more comfortable mask with more stable straps, and smaller breathing masks made of soft material. Also, they are working on improving noise reduction features. This is expected to improve the efficiency of CPAP machines and increase patient compliance.
Key companies are acquiring other relevant companies to strengthen their portfolio and expand their reach. For instance, in July 2023, ResMed announced that it had acquired Somnoware. The acquisition aimed to introduce an interoperable platform for enhancing patient experience and health outcomes.
The Sleep Apnea Devices Industry at a Glimpse:
According to a study by Grand View Research , the global market size for sleep apnea devices was valued at USD 4.5 billion in 2023 and is projected to expand at a CAGR of 6.2% from 2024 to 2030. Some of the key market leaders include ResMed, Phillips Respironics, Fisher & Paykel Healthcare Limited, and Invacare Corporation among others. Fierce competition between market participants to expand their geographic footprints and strengthen their customer pool through several product launches & new product developments are major factors anticipated to drive sleep apnea devices industry growth.
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