The global sleep apnea oral appliances market is projected to reach USD 0.9 Billion by 2028 from USD 0.4 Billion in 2023, at a CAGR of 15.2% during the forecast period. The growth of this market is majorly driven by the increasing number of customized or personalised oral appliance, and collaboration between dentists and sleep specialists. However, the risks associated with sleep apnea oral appliances for obstructive sleep apnea treatment may restrain the market growth.
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Sleep Apnea Oral Appliances Market by Product (Mandibular Advancement Devices (MAD), Tongue-Retaining Devices (TRD)), Purchase Type (Physician-prescribed), Gender (Male, Female), Age Group, Distribution Channel (Online, Retail) – Global Forecast to 2028
Based on product, the sleep apnea oral appliances market is divided into three main categories—mandibular advancement devices (MADs), tongue-retaining devices (TRDs), and Daytime Nighttime Appliance (DNA). In 2022, the mandibular advancement devices segment accounted for the largest share of the sleep apnea oral appliances market. The large share of this segment can be attributed to technological advancements have improved the design, comfort, and effectiveness of MADs.
Base on purchase type, the sleep apnea oral appliances market is segmented into – physician-prescribed/ customized oral appliances and online OTC oral appliances. The physician-prescribed/customized oral appliances segment accounted for the largest share of the sleep apnea oral appliances market in 2022. Factors supporting the growth of this segment include rising demand for effective alternatives for managing sleep apnea under the guidance and recommendation of healthcare professionals.
On the basis of gender, the sleep apnea oral appliances market is segmented into male and female. In 2022, the male segment dominated this market. The large share of this segment can be attributed to the anatomical differences in upper airway, throat and neck structure between men and women
On the basis of region, the global sleep apnea oral appliances market is categorized into the North America, Europe, Asia-Pacific, and the RoW segments. North America holds the largest market share in 2022 due to the ongoing research and development initiatives by companies in North America for sleep apnea oral appliances innovation and rising aging population. Other factors boosting the demand for this market include advancement in telemedicine and remote monitoring to make sleep apnea treatment more accessible for patients.
Major Companies:
SomnoMed (Australia), ResMed (US), Whole You, Inc. (US), ProSomnus Sleep Technologies (US), Vivos Therapeutics, Inc. (US), Open Airway Dental Solutions Ltd. (Canada), Panthera Dental (Canada), Airway Management (US), Apnea Sciences (US), DynaFlex (US), OravanOSA (US), Myerson LLC (US), MPowrx Health & Wellness (Canada), The Snore Reliever Company, LLC (US), The Pure Sleep Company (US), Tomed GmbH (Germany), The Aurum Group (Canada), Erkodent Erich Kopp GmbH (Germany), OSCIMED SA (Switzerland), SICAT GmbH & Co. Kg. (Germany), Glidewell (US), ApnoMed (US), ZYPPAH (US), Dream Systems Dental Sleep Laboratory (US), and Alive Med (UAE)
Recent Developments of Sleep Apnea Oral Appliances Industry
In 2023, Vivos Therapeutics, Inc. (US) DNA appliance was granted 510(k) clearance from the U.S. Food & Drug Administration (or FDA) as a Class II medical device in December 2022 for the treatment of snoring and mild to moderate OSA in adults.
In 2022, ResMed (US) acquired the German-based clinical, financial, and operational solutions provider MEDIFOX DAN (Germany) to drive leadership in out-of-hospital software solutions.
In 2021, SomoMed (Australia) conducted SomSUMMIT ’21, which aimed to enhance research, education, and awareness of oral appliance therapy as a primary solution to successful OSA treatment.
The global market for Sleep Apnea Oral Appliances is experiencing rapid growth. In 2023, this market was valued at $0.4 billion. However, it is projected to reach $0.9 billion by 2028, expanding at an impressive compound annual growth rate (CAGR) of 15.2% during the forecast period of 2023 to 2028.
A key driver fueling this market’s expansion is the large pool of undiagnosed sleep apnea patients worldwide. Sleep apnea, a common sleep disorder affecting people across all age groups, is estimated to impact between 10% and 30% of adults in the United States alone, according to the American Sleep Apnea Association. With changing lifestyles contributing to rising obesity rates globally, the number of potential sleep apnea patients is likely to surge, presenting significant growth opportunities for oral appliance manufacturers.
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While continuous positive airway pressure (CPAP) therapy remains an effective treatment for obstructive sleep apnea (OSA), poor patient compliance poses a challenge. Many patients struggle to adhere to the recommended usage of CPAP machines, often using them for fewer than four hours per night. This lack of adherence compromises the long-term health benefits of CPAP therapy, creating an opportunity for oral appliances as an alternative treatment option.
However, the sleep apnea oral appliances market also faces some hurdles. One major challenge is the high cost associated with customizing these devices to fit each patient’s unique oral anatomy. This customization process is time-intensive and limits the potential for mass production, making customized oral appliances less accessible than standard CPAP treatment for some patients.
The market is dominated by prominent players such as SomnoMed (Australia), ResMed (US), Whole You, Inc. (US), ProSomnus Sleep Technologies (US), and Vivos Therapeutic, Inc. (US). These companies are well-established, financially stable manufacturers with diversified product portfolios, state-of-the-art technologies, and strong global sales and marketing networks.
In terms of product segments, mandibular advancement devices are expected to dominate the market in 2022 due to their enhanced effectiveness and patient comfort. Additionally, physician-prescribed or customized oral appliances are anticipated to lead the market based on purchase type, as they offer a more patient-centric approach with individualized treatment plans.
Geographically, North America is poised to dominate the sleep apnea oral appliances market during the forecast period, driven by rising obesity rates, ongoing technological advancements in sleep apnea devices, and favorable regulatory and reimbursement scenarios.
With increasing awareness and diagnosis of sleep apnea, as well as the availability and accessibility of oral appliances, the sleep apnea oral appliances market is positioned for remarkable growth in the coming years.
According to a new report by MarketsandMarkets – Sleep Apnea Oral Appliances Market in terms of revenue was estimated to be worth $0.4 billion in 2023 and is poised to reach $0.9 billion by 2028, growing at a CAGR of 15.2% from 2023 to 2028. The growth of this market is majorly driven by the high risk of growing awarrness and diagnosis of sleep apnea among patients and healthcare professionals. Furthermore, the poor compliance associated with CPAP is expected to drive the growth of the sleep apnea oral appliances market.
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Mandibular advancement devices force the lower jaw forward and downwards slightly, which keeps the airway open. The device helps treat OSA by offering maximum anterior tongue space along with the retention of teeth movement. This segment is expected to dominate the global sleep apnea oral appliances market during the forecast period, driven by a rising patient preference for non-CPAP solutions due comfort and ease of use.
By end user, the global sleep apnea oral appliances market is broadly segmented into home care settings/individuals, hospitals, and dental clinics. The large share of this segment can be attributed to factors such as the increasing number of sleep centers globally, the rise of number of sleep care devices for homecare settings offered by leading players.
Based on the region, the sleep apnea oral appliances market is segmented into North America, Europe, Asia Pacific, and the Rest of the World. The North American market is driven by high prevalence and diagnosis of sleep apnea in the region. Europe is the second-largest market for the sleep apnea oral appliances market due to the growing aging population in the region. Asia Pacific will observe high growth during the forecast period with its growing healthcare expenditure with improving accessibility to sleep clinics and treatment for sleep apnea in the region’s countries.
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Sleep Apnea Oral Appliances Market Dynamics:
Drivers:
- Large pool of undiagnosed sleep apnea patients
Restraints:
- Associated risks of oral appliances for obstructive sleep apnea treatment
Opportunities:
- Poor compliance associated with CPAP
Challenge:
- Expenses associated with customization of oral appliances
Key Market Players of Sleep Apnea Oral Appliances Industry:
Major players in the sleep apnea oral appliances market include SonmoMed (Australia), resMed (US), Whole You, Inc. (US), ProSomnus Sleep Technologies (US), and Vivos Therapeutics, Inc. (US).
Breakdown of supply-side primary interviews, by company type, designation, and region:
- By Company Type: Tier 1 (40%), Tier 2 (50%), and Tier 3 (10%)
- By Designation: C-level (48%), Director-level (37%), and Others (15%)
- By Region: North America (56%), Europe (20%), Asia- Pacific (17%), and Rest of the World (7%)
Sleep Apnea Oral Appliances Market Recent Developments:
- In 2023, Vivos Therapeutics, Inc. (US) DNA appliance was granted 510(k) clearance from the U.S. Food & Drug Administration (or FDA) as a Class II medical device in December 2022 for the treatment of snoring and mild to moderate OSA in adults.
- In 2022, ResMed (US) acquired the German-based clinical, financial, and operational solutions provider MEDIFOX DAN (Germany) to drive leadership in out-of-hospital software solutions.
- In 2021, SomoMed (Australia) conducted SomSUMMIT ’21, which aimed to enhance research, education, and awareness of oral appliance therapy as a primary solution to successful OSA treatment.