Sleep Apnea Oral Appliances Market

Sleep Apnea Oral Appliances Market Overview

The global Sleep Apnea Oral Appliances Market size was valued at USD 728.03 million in 2024 and is predicted to reach USD 1855.08 million by 2030 with a CAGR of 16.9% from 2025-2030. 

Multiple factors propel Sleep Apnea Oral Appliances market growth including Increasing Prevalence of OSA Drive the Market Growth, Increasing Technological Advancements in Oral Appliances and Ongoing Research and Development Supporting Efficacy. However, regulatory approvals and compliance standards limits market growth. On the contrary, integration of telehealth services represents a promising growth opportunity in the market enhancing patient access to care and supporting more modified treatment approaches.

Moreover, key firms such as Achaemenid LLC, ResMed Inc., SomnoMed, Glidewell, and others are actively contributing to market growth through innovative products and technological progressions.

Rising Prevalence of OSA Drive the Market Growth

The rising awareness regarding sleep apnea disorders, especially obstructive sleep apnea (OSA), is augmenting the increased adoption of sleep apnea oral appliances in the healthcare industry. OSA and its associations are wide-ranging, as of October 2024, the National Council on Aging estimates that almost 39 million adults in the U.S. suffers from OSA and an estimated 936 million adults worldwide faces mild to severe OSA. 

The growing prevalence of sleep apnea stands as one of the prominent factors fueling growth in the sleep apnea oral appliances market as both healthcare professionals and patients look toward effective, non-invasive methods of treatment.

Increasing Technological Advancements in Oral Appliances Drive the Market Growth

Increasing technology in oral appliances are enhancing their efficacy and comfort during sleep and are aiding in triggering oral appliances market alluring sleep apnea market. They make use of modern technology to provide a wide array of patient-specific devices and technology for improved treatments. 

As an example, in May 2024 Glidewell, a major dental technology provider, introduced the Digital Silent Nite, a 3D-printed sleep appliance to manage obstructive sleep apnea. The appliance is a custom-fitted oral device that shifts the lower jaw forward while you sleep that helps keep the airway open and reduce sleep apnea symptoms.

Ongoing Research and Development Supporting Efficacy Fuels the Market Growth

The growing evidence demonstrating the effectiveness of oral appliances for the management of sleep apnea further enhances professional and consumer confidence in their application. With increasing evidence of long-term benefits and safety of these devices, the confidence in using the Appliances continues to increase. 

For instance, the FDA in November 2023 approved Vivos Therapeutics’ line of Complete Airway Repositioning and Expansion (CARE) oral appliances to treat severe obstructive sleep apnea (OSA) in adults. This was the first time the FDA has cleared an oral appliance for the treatment of moderate and severe OSA.

Regulatory Approvals and Compliance Standards Hinders Market Growth

The rise of sleep apnea oral appliances market growth is impeded by regional variability in regulatory approvals and compliance standards with requirements such as the FDA 510(k) clearance in the U.S., CE marking under the European Medical Device Regulation and Health Canada's licensing creating challenges for the global market entry.  

Incorporation of Telehealth Services Creates Opportunity Growth

Integration of telehealth services, including e-consultation and remote patient monitoring (RPM) for sleep apnea oral appliances enable providers to ease the consultation and follow-up process. This integration of telehealth services represents a promising growth opportunity in the market enhancing patient access to care and supporting more personalized treatment approaches.

In February 2024, for example, ProSomnus Inc. created the RPMO2 OSA a device for remote patient monitoring, that integrates an oximeter into an oral appliance to continuously monitor blood oxygen saturation levels in patients with obstructive sleep apnea. This enables the continuous remote monitoring of treatment statuses and cardiovascular risks and associated predictive metrics by healthcare providers.

Market Segmentation and Scope of the Study

The sleep apnea oral appliance market report is segmented on the basis of product, purchase type, distribution channel, end-user, and region. On the basis of product, the market is divided into mandibular advancement devices, tongue-retaining devices, and rapid maxillary expansion. On the basis of purchase type, the market is divided into physician-prescribed and online OTC oral appliances. On the basis of distribution channels, the market is categorized into online pharmacies, retail pharmacies, hospital pharmacies, and dental clinics. On the basis of end-user, the market is classified into hospital, home care settings/individual, pharmacies, and others. Geographic breakdown and analysis of each of the aforesaid segments include regions comprising North America, Europe, Asia-Pacific, and RoW.

Geographical Analysis

North America dominates the sleep apnea oral appliances market share and is estimated to sustain their domination throughout the forecast period. The sleeping apnea one of the key sleeping disorders that affect a person, and the sleeping apnea witnessed increasing popularity as people in the U.S., Canada and other countries are increasingly becoming aware of the sleeping apnea. 

As per the American Medical Association in 2022, approximately 30 million Americans have sleep apnea and only 6 million Americans are diagnosed with the condition. The firmer statistics highlight the importance of queuing for sleep apnea oral appliances in the area.

Also, the presence of key market players in the market such as ProSomnus Holdings Inc., Whole You, Inc., and others are establishing several market strategies in the region to maximize market expansion including collaboration and launching of the products. 

As an example, in May 2022, ProSomnus Holdings Inc. acquired Lakeshore Acquisition through the definitive business combination agreement that resulted in ProSomnus, Inc. This transaction is anticipated to drive ProSomnus' oral appliance therapy device advancement and commercialization. 

On the other hand, the Asia-Pacific region is experiencing a steady growth in the sleep apnea oral appliances market expansion due to the healthcare sector and development in Sleep Apnea Devices such as CPAP in countries like India and China. 

The Press Information Bureau (PIB) reported that the IIT Ropar has developed a power-free CPAP device named 'Jivan Vayu' as a replacement for regular CPAP machines. The device can deliver high flow of oxygen (20-60 LPM) while creating a continuous positive pressure of 20 cm H2O and is compatible with portable oxygen cylinders as well as hospital pipes.

In addition, increasing healthcare initiatives and awareness towards diagnosis of sleep apnea and other sleep disorders in the prevailing population is propelling market growth in this region. About 104 million working-age Indians (15-64 years) are impacted with obstructive sleep apnoea (OSA), according to a study conducted in October 2023 by researchers from the All-India Institute of Medical Sciences (AIIMS). Therefore, it is essential to address these issues for OSA diagnosis and treatment to enhance public health outcomes and relieve the healthcare systems burden.

Competitive Landscape

The sleep apnea oral appliances industry comprises various key market players including SomnoMed, ResMed, Whole You, Inc., ProSomnus Holding Inc., Oventus Medical Limited, Panthera Dental, Airway Management, DynaFlex, Dentsply Sirona, Myerson LLC., and others. These market players are adopting various strategies such as acquisitions, and collaboration to maintain their dominance in the market. 

Recently, Panthera Dental announced in October 2024 that the company had extended its distribution agreement with MK1 Dental-Attachment GmbH, allowing both companies to broaden their distribution of oral sleep apnea as well as dental products throughout the U.S. and Canada. 

In addition, in February 2023 SomnoMed released the world's first technology-enabled oral appliances for the treatment of sleep apnea, helping to deliver real-time data objectively about treatment outcomes and patient compliance and focusing on empowering the patient and informing clinical care.

Key Benefits

• The report provides quantitative analysis and estimations of the sleep apnea oral appliances industry from 2025 to 2030, which assists in identifying the prevailing market opportunities.

• The study comprises a deep dive analysis of the current and future sleep apnea oral appliances market trends to depict prevalent investment pockets in the market.

• Information related to key drivers, restraints, and opportunities and their impact on the sleep apnea oral appliances industry is provided in the report. 

• Competitive analysis of the players, along with their market share is provided in the report.

• SWOT analysis and Porters Five Forces model is elaborated on the study.

• Value chain analysis in the market study provides a clear picture of roles of stakeholders.

Sleep Apnea Oral Appliances Market Key Segments

By Product

• Mandibular Advancement Devices 

• Tongue-retaining Devices

• Rapid Maxillary Expansion 

By Purchase Type

• Physician-prescribed 

• Online OTC Oral Appliances

By Distribution Channel

• Online Pharmacies

• Retail Pharmacies

• Hospital Pharmacies and dental clinic

By End User

• Hospital

• Home Care Settings/Individual

• Pharmacies

• Others

By Region

• North America

  • The U.S.

  • Canada

  • Mexico

• Europe

  • The UK

  • Germany

  • France        

  • Italy        

  • Spain        

  • Denmark        

  • Netherlands        

  • Finland        

  • Sweden        

  • Norway        

  • Russia        

  • Rest of Europe    

• Asia-Pacific

  • China

  • Japan

  • India

  • South Korea

  • Australia

  • Indonesia

  • Singapore

  • Taiwan

  • Thailand

  • Rest of Asia Pacific

• Rest of the World

  • Latin America

  • Middle East

  • Africa

Key Players

• SomnoMed 

• ResMed

• Whole You, Inc.

• ProSomnus Holding Inc.

• Oventus Medical Limited

• Panthera Dental

• Airway Management

• DynaFlex

• Dentsply Sirona

• Myerson LLC

• OmniSleep Solutions

• MayoClinic Inc.

• Tonguetie Inc.

• Vivos Corp.

• SLIIIP Inc.

REPORT SCOPE AND SEGMENTATION:

Parameters	Details
Market Size in 2024	USD 728.03 Million
Revenue Forecast in 2030	USD 1855.08 Million
Growth Rate	CAGR of 16.9% from 2025 to 2030
Analysis Period	2024–2030
Base Year Considered	2024
Forecast Period	2025–2030
Market Size Estimation	Million (USD)
Growth Factors	The heightened awareness of sleep apnea disorders propels the market growth. Rising technological advancements in oral appliances drives the growth of market. Increasing research and clinical studies towards oral appliances in treating sleep apnea boost the market expansion.
Countries Covered	28
Companies Profiled	15
Market Share	Available for 10 companies
Customization Scope	Free customization (equivalent up to 80 working hours of analysts) after purchase. Addition or alteration to country, regional, and segment scope.
Pricing and Purchase Options	Avail customized purchase options to meet your exact research needs.