The global Sleep Apnea Devices Market, valued at US$0.4 billion in 2024, is forecasted to grow at a robust CAGR of 9.8%, reaching US$0.5 billion in 2025 and an impressive US$0.8 billion by 2030. The growth of the sleep apnea oral appliances market is primarily driven by an increasing number of patients with undiagnosed sleep apnea and a better understanding of the consequences of untreated sleep apnea. Additionally, rising awareness of sleep apnea products introduced by major players in the market is expected to impact market growth significantly.
DRIVER: Large pool of undiagnosed sleep apnea patients globally
A significant portion of the population remains undiagnosed for sleep apnea and does not receive medical attention. Due to worsening lifestyles, increasing obesity rates, and related diseases such as diabetes, the prevalence of sleep apnea has risen. Lifestyle changes are a key factor in this trend. Many individuals and healthcare providers fail to recognize sleep apnea because of a lack of public awareness, inadequate screening practices, and limited access to healthcare. More than a billion people over the age of 30 suffer from obstructive sleep apnea, ranging from mild to severe cases. However, the number of diagnosed cases is considerably lower, underscoring the extent of undiagnosed sleep apnea and the lack of recognition of this condition. The prevalence of sleep apnea also varies by race; for instance, African Americans have a significantly higher likelihood of developing sleep apnea compared to White Americans. Additionally, sleep apnea is linked to other chronic conditions, such as hypertension and ischemic heart disease, which can only be effectively managed with timely and accurate diagnosis and appropriate treatment.
RESTRAINT: Risks associated with oral appliance therapy for obstructive sleep apnea
Proper fitting of oral appliances is essential for comfortable and effective sleep apnea therapy, and it plays a crucial role in encouraging more patients to adopt this treatment option. Incorrectly fitted appliances can lead to serious complications. Patients may experience discomfort, such as misalignment of the teeth or pain in the lower jaw, particularly if the appliance is worn for an extended period.
Poorly fitted oral appliances can exacerbate the sleep apnea condition, causing significant disturbances during sleep and worsening symptoms, which may lead to persistent daytime drowsiness and other declining health issues. Furthermore, long-term use of oral appliances that are not correctly fitted and maintained can alter the oral microbiome, increasing the risk of oral infections. These infections can be avoided with custom-fitted and well-maintained appliances. Regular follow-ups can help manage the condition effectively.
OPPORTUNITY: Poor compliance associated with CPAP to drive adoption of oral appliances
More than 30% of patients are not compatible with CPAP (Continuous Positive Airway Pressure) therapy for the treatment of sleep apnea. Although CPAP devices are highly effective, they are often expensive and bulkier than oral appliances. This can lead to discomfort for many patients while using a CPAP machine during sleep. Common issues include skin rashes and irritation, difficulty fitting the mask to the nose, and feelings of claustrophobia. Additionally, the noise generated by the CPAP machine can disturb both the user and anyone sharing the sleeping space. Due to these drawbacks, many people avoid using CPAP machines and instead prefer oral appliances. Oral appliances are cost-effective, easy to use, and less intrusive. These points highlight the importance of customizing treatment plans to align with individual needs, lifestyle, and comfort preferences.
CHALLENGES: Complex referral pathways and long waiting periods
There is often a delay in diagnosing and treating sleep apnea due to the lengthy referral process from primary physicians to sleep specialists and then to durable medical equipment (DME) providers. This complex process can lead to frustration for patients, resulting in many individuals not completing the diagnostic procedures. Consequently, this delay in diagnosis can postpone treatment, which increases the risks associated with obstructive sleep apnea. Streamlining the patient pathway is crucial to improving outcomes and ensuring timely access to care and treatment. Another significant challenge is the lack of trained sleep specialists in the dental field and the limited number of well-equipped centers. This situation can result in repeated clinic visits, which increases the overall cost of treatment for patients. It highlights the urgent need for education, resources, and better coordination to reduce barriers for individuals seeking treatment.
By product, the mandibular advancement devices segment accounted for the largest market share in 2024.
The market is segmented by products: mandibular advancement devices, tongue-retaining devices, and daytime-nighttime appliances. In 2024, the mandibular advancement devices (MADs) segment held the largest market share, primarily due to their benefits in terms of compatibility and comfort. These devices are commonly used to treat obstructive sleep apnea, as they help reposition the lower jaw, which opens the airway and reduces the likelihood of the upper airway collapsing during sleep. Custom-made and designed for nighttime use, MADs improve airflow, decrease snoring, and enhance overall comfort and effectiveness for users. Recent technological advancements have further improved the customization of these appliances, ensuring a better fit to the teeth and making MADs a more reliable and effective treatment option.
By gender, the male patients segment accounted for the largest market share in 2024.
By gender, the sleep apnea oral appliances market is segmented into male and female patients. Male patients hold the majority of the market share as the number of males suffering from obstructive sleep apnea has increased. Due to the anatomical nature of male demographics, the tendency to store fat near the neck area is likely greater, leading to obstructive sleep apnea. Also, men are more likely to suffer from lifestyle diseases like obesity, diabetes, and hypertension, which can lead to sleep apnea. As the number of male patients suffering from sleep apnea increases, especially in middle age and old age, oral appliances are the preferred choice of treatment as they allow personalization. Men are usually covered under group insurance, which covers the cost of these appliances, which is generally not covered by other insurance companies.
By purchase type, the physician-prescribed/customized oral appliances segment accounted for the largest share of the market in 2024.
The market is segmented by purchase type into physician-prescribed/customized oral appliances and online OTC appliances. The physician-prescribed segment dominates the market as these devices are designed for specific needs, are mainly used by dentists and sleep specialists, and customize options to provide confidence and comfort to the patient. Additionally, these devices are covered under insurance or reimbursement policies, making them a more reliable and accessible option for the patient, along with personalized modification and ensuring patient compliance. Also, the ability of these devices to be adjustable over time allows ongoing therapy for a more extended period without changing the device.
By distribution channel, the retail pharmacies segment accounted for the largest share of the market in 2024.
The market is segmented by distribution channel into online pharmacies, retail pharmacies, and hospital pharmacies & dental clinics. The retail pharmacies segment accounted for the largest market share in 2024 due to the high patient volume and easy accessibility to products. Retail pharmacies provide enhanced patient access, and the products are delivered immediately without waiting times. Moreover, retail pharmacies usually provide the devices over the counter, and there is no special need for a prescription from any specialists for the simple use devices. This trend is particularly available in some regions like Asia Pacific, where there is increasing awareness among people and a significant number of retail pharmacies.
By end user, the home care settings/individuals segment accounted for the largest market share in 2024. By end user, the sleep apnea oral appliances market is segmented into home care settings, hospitals, and dental clinics. Home care settings/individuals accounted for the largest market share in 2024. The key factor contributing to market growth of this segment is that the management of sleep apnea at home is more convenient for individuals than visiting a hospital. Home healthcare is a more economical and affordable solution for patients. Advancements in technology and the availability of various products for sleep apnea management have reduced the need for invasive procedures, making it easier for patients to continue their treatment at home. These devices are user-friendly, portable, and self-adjustable, enhancing home-use accessibility.
