Sleep Apnea Oral Appliances Market by Product (Mandibular Advancement Devices, Tongue-Retaining Devices), Purchase (Online OTC Oral Appliances, Physician-Prescribed/Customized Oral Appliances), Age, Distribution Channel, End User - Global Forecast 2024-20

Sleep Apnea Oral Appliances Market by Product (Mandibular Advancement Devices, Tongue-Retaining Devices), Purchase (Online OTC Oral Appliances, Physician-Prescribed/Customized Oral Appliances), Age, Distribution Channel, End User - Global Forecast 2024-2030


The Sleep Apnea Oral Appliances Market size was estimated at USD 589.42 million in 2023 and expected to reach USD 665.16 million in 2024, at a CAGR 13.28% to reach USD 1,411.74 million by 2030.

Sleep apnea devices are medical appliances used to treat a common sleep disorder known as obstructive sleep apnea (OSA). This condition is characterized by repetitive interruptions in breathing during sleep due to the partial or complete obstruction of the airway. The rising number of patients diagnosed with sleep apnea significantly contributes to the need for sleep apnea devices. Innovations in custom-fit and adjustable devices that improve comfort and effectiveness are driving growth. The preference for home-based care has surged, especially due to the impact of the COVID-19 pandemic, which has further incentivized patients to choose sleep apnea oral appliances over in-clinic options such as continuous positive airway pressure machines. However, some users may experience discomfort, including jaw pain or soreness, tooth pain, and changes to their bite, which has reduced their usage. Market players are investing in clinical research to validate the efficacy of new designs and encourage wider acceptance by healthcare providers. Improved insurance coverage for oral appliances has reduced out-of-pocket expenses for patients, making the devices more accessible and supporting market growth. Technological innovations have led to the production of more comfortable and effective oral appliances. Custom-fitted devices, created with the help of digital dentistry and 3D printing, have greatly improved patient adherence and expanded the market reach.

Regional Insights

In the Americas, the use of sleep apnea oral appliances is on the rise due to increasing awareness of sleep disorders and a preference for non-invasive treatment options. Manufacturing in the Americas, particularly in the U.S., is characterized by technologically advanced production facilities adhering to stringent FDA regulations. The Asia-Pacific (APAC) region is witnessing a similar trend, propelled by improvements in healthcare infrastructure and growing middle-class populations with access to healthcare services. The APAC region features a mix of local manufacturers and international companies setting up production units to cater to the growing demand, leveraging lower production costs. The Americas market is dominated by established players and start-ups innovating within the field of sleep apnea treatment. The APAC market is more fragmented, with both global and local players, and the region has become a hotbed for expansion due to its large population base. The Europe, Middle East, and Africa (EMEA) area shows varying usage rates, with high adoption in Western Europe, while emerging markets are still recognizing their benefits. Production in the EMEA region is primarily driven by well-established medical device manufacturers in Western Europe, with a focus on innovation and quality. The EMEA market sees a mix of global leaders and European companies, with strategic partnerships and mergers being a common path for expansion and distribution.

Market Insights

Market Dynamics

The market dynamics represent an ever-changing landscape of the Sleep Apnea Oral Appliances Market by providing actionable insights into factors, including supply and demand levels. Accounting for these factors helps design strategies, make investments, and formulate developments to capitalize on future opportunities. In addition, these factors assist in avoiding potential pitfalls related to political, geographical, technical, social, and economic conditions, highlighting consumer behaviors and influencing manufacturing costs and purchasing decisions.

Market Drivers
  • Growing incidence of sleep apnea disorder globally
  • Government awareness and screening programs regarding sleep apnea
  • Adoption of digital platforms for distribution of sleep apnea devices
Market Restraints
  • Adverse recalls of sleep apnea oral appliances
Market Opportunities
  • Advancements in customization and new technology integration in sleep apnea devices
  • Improved insurance and reimbursement coverage for oral appliances
Market Challenges
  • Limitations associated with discomfort and adjustments of sleep apnea oral appliances
Market Segmentation Analysis
  • Product: Potential of mandibular advancement devices to optimize treatment effectiveness and comfort
  • Age Group: Increased incidence of sleep apnea among above 60 years old individuals
  • Distribution Channel: Provision of products suitable for varying patient needs and anatomical considerations in hospital pharmacies and dental clinics
  • End User: Need for robust, easily sanitized, and adjustable sleep apnea oral devices in hospitals
Market Disruption Analysis
  • Porter’s Five Forces Analysis
  • Value Chain & Critical Path Analysis
  • Pricing Analysis
  • Technology Analysis
  • Patent Analysis
  • Trade Analysis
  • Regulatory Framework Analysis
FPNV Positioning Matrix

The FPNV positioning matrix is essential in evaluating the market positioning of the vendors in the Sleep Apnea Oral Appliances Market. This matrix offers a comprehensive assessment of vendors, examining critical metrics related to business strategy and product satisfaction. This in-depth assessment empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success, namely Forefront (F), Pathfinder (P), Niche (N), or Vital (V).

Market Share Analysis

The market share analysis is a comprehensive tool that provides an insightful and in-depth assessment of the current state of vendors in the Sleep Apnea Oral Appliances Market. By meticulously comparing and analyzing vendor contributions, companies are offered a greater understanding of their performance and the challenges they face when competing for market share. These contributions include overall revenue, customer base, and other vital metrics. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With these illustrative details, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.

Recent Developments

New Home Sleep Apnea Testing Device to Launch in US

UK-based medical device company, Acurable, is set to expand the reach of its innovative sleep apnea diagnostic tool, AcuPebble, to the US market this summer following recent clearance from the FDA. AcuPebble technology enables the user to self-administer the test using a sensor attached to their neck, improving the timeliness of diagnosis and treatment for obstructive sleep apnea.

Bresotec’s BresoDX1 for At-Home Sleep Apnea Testing Receives FDA 510(k) Clearance

Bresotec Medical has achieved a breakthrough with its BresoDX1 device, securing FDA 510(k) clearance for this innovative at-home diagnostic tool designed to identify moderate to severe sleep apnea in adults. The BresoDX1 simplifies the diagnosis process with an intuitive two-input system that monitors sleep-related physiological signals, enabling patients to self-administer the test without clinical supervision.

ProSomnus, Player in Patient-Preferred Sleep Apnea Therapy, to be Listed on Nasdaq Through Business Combination with Lakeshore Acquisition I Corp.

ProSomnus Holdings Inc., a foremost developer of medical devices for treating obstructive sleep apnea, and Lakeshore Acquisition I Corp., made public their confirmed merger agreement. This strategic alliance signifies a pivotal step for ProSomnus in extending its market presence and enhancing its commitment to providing superior patient-preferred treatment options.

Strategy Analysis & Recommendation

The strategic analysis is essential for organizations seeking a solid foothold in the global marketplace. Companies are better positioned to make informed decisions that align with their long-term aspirations by thoroughly evaluating their current standing in the Sleep Apnea Oral Appliances Market. This critical assessment involves a thorough analysis of the organization’s resources, capabilities, and overall performance to identify its core strengths and areas for improvement.

Key Company Profiles

The report delves into recent significant developments in the Sleep Apnea Oral Appliances Market, highlighting leading vendors and their innovative profiles. These include Accutech Orthodontic Lab, Inc., Apnea Sciences Corporation, James R. Glidewell Dental Ceramics, Inc., Michigan Sleep Network, P.C., MicroDental Laboratories, Inc., Myerson LLC, Omnisleep, OravanOSA, Oventus Medical Ltd., Panthera Dental, Prosomnus Sleep Technologies, Inc., ResMed Inc., SomnoMed, Tomed GmbH, Vivos Therapeutics, Inc., and Whole You, Inc..

Market Segmentation & Coverage

This research report categorizes the Sleep Apnea Oral Appliances Market to forecast the revenues and analyze trends in each of the following sub-markets:

Product
  • Mandibular Advancement Devices
  • Tongue-Retaining Devices
  • Purchase
  • Online OTC Oral Appliances
  • Physician-Prescribed/Customized Oral Appliances
  • Age
  • Above 60 Years
  • Age 40-60 Years
  • Below 40 Years
  • Distribution Channel
  • Hospital Pharmacies & Dental Clinics
  • Online Pharmacies
  • Retail Pharmacies
  • End User
  • Home Care Settings/ Individuals
  • Hospitals
  • Region
    • Americas
    • Argentina
    • Brazil
    • Canada
    • Mexico
    • United States
    • California
    • Florida
    • Illinois
    • New York
    • Ohio
    • Pennsylvania
    • Texas
    • Asia-Pacific
    • Australia
    • China
    • India
    • Indonesia
    • Japan
    • Malaysia
    • Philippines
    • Singapore
    • South Korea
    • Taiwan
    • Thailand
    • Vietnam
    • Europe, Middle East & Africa
    • Denmark
    • Egypt
    • Finland
    • France
    • Germany
    • Israel
    • Italy
    • Netherlands
    • Nigeria
    • Norway
    • Poland
    • Qatar
    • Russia
    • Saudi Arabia
    • South Africa
    • Spain
    • Sweden
    • Switzerland
    • Turkey
    • United Arab Emirates
    • United Kingdom


    Please Note: PDF & Excel + Online Access - 1 Year


    1. Preface
    1.1. Objectives of the Study
    1.2. Market Segmentation & Coverage
    1.3. Years Considered for the Study
    1.4. Currency & Pricing
    1.5. Language
    1.6. Stakeholders
    2. Research Methodology
    2.1. Define: Research Objective
    2.2. Determine: Research Design
    2.3. Prepare: Research Instrument
    2.4. Collect: Data Source
    2.5. Analyze: Data Interpretation
    2.6. Formulate: Data Verification
    2.7. Publish: Research Report
    2.8. Repeat: Report Update
    3. Executive Summary
    4. Market Overview
    5. Market Insights
    5.1. Market Dynamics
    5.1.1. Drivers
    5.1.1.1. Growing incidence of sleep apnea disorder globally
    5.1.1.2. Government awareness and screening programs regarding sleep apnea
    5.1.1.3. Adoption of digital platforms for distribution of sleep apnea devices
    5.1.2. Restraints
    5.1.2.1. Adverse recalls of sleep apnea oral appliances
    5.1.3. Opportunities
    5.1.3.1. Advancements in customization and new technology integration in sleep apnea devices
    5.1.3.2. Improved insurance and reimbursement coverage for oral appliances
    5.1.4. Challenges
    5.1.4.1. Limitations associated with discomfort and adjustments of sleep apnea oral appliances
    5.2. Market Segmentation Analysis
    5.2.1. Product: Potential of mandibular advancement devices to optimize treatment effectiveness and comfort
    5.2.2. Age Group: Increased incidence of sleep apnea among above 60 years old individuals
    5.2.3. Distribution Channel: Provision of products suitable for varying patient needs and anatomical considerations in hospital pharmacies and dental clinics
    5.2.4. End User: Need for robust, easily sanitized, and adjustable sleep apnea oral devices in hospitals
    5.3. Market Disruption Analysis
    5.4. Porter’s Five Forces Analysis
    5.4.1. Threat of New Entrants
    5.4.2. Threat of Substitutes
    5.4.3. Bargaining Power of Customers
    5.4.4. Bargaining Power of Suppliers
    5.4.5. Industry Rivalry
    5.5. Value Chain & Critical Path Analysis
    5.6. Pricing Analysis
    5.7. Technology Analysis
    5.8. Patent Analysis
    5.9. Trade Analysis
    5.10. Regulatory Framework Analysis
    6. Sleep Apnea Oral Appliances Market, by Product
    6.1. Introduction
    6.2. Mandibular Advancement Devices
    6.3. Tongue-Retaining Devices
    7. Sleep Apnea Oral Appliances Market, by Purchase
    7.1. Introduction
    7.2. Online OTC Oral Appliances
    7.3. Physician-Prescribed/Customized Oral Appliances
    8. Sleep Apnea Oral Appliances Market, by Age
    8.1. Introduction
    8.2. Above 60 Years
    8.3. Age 40-60 Years
    8.4. Below 40 Years
    9. Sleep Apnea Oral Appliances Market, by Distribution Channel
    9.1. Introduction
    9.2. Hospital Pharmacies & Dental Clinics
    9.3. Online Pharmacies
    9.4. Retail Pharmacies
    10. Sleep Apnea Oral Appliances Market, by End User
    10.1. Introduction
    10.2. Home Care Settings/ Individuals
    10.3. Hospitals
    11. Americas Sleep Apnea Oral Appliances Market
    11.1. Introduction
    11.2. Argentina
    11.3. Brazil
    11.4. Canada
    11.5. Mexico
    11.6. United States
    12. Asia-Pacific Sleep Apnea Oral Appliances Market
    12.1. Introduction
    12.2. Australia
    12.3. China
    12.4. India
    12.5. Indonesia
    12.6. Japan
    12.7. Malaysia
    12.8. Philippines
    12.9. Singapore
    12.10. South Korea
    12.11. Taiwan
    12.12. Thailand
    12.13. Vietnam
    13. Europe, Middle East & Africa Sleep Apnea Oral Appliances Market
    13.1. Introduction
    13.2. Denmark
    13.3. Egypt
    13.4. Finland
    13.5. France
    13.6. Germany
    13.7. Israel
    13.8. Italy
    13.9. Netherlands
    13.10. Nigeria
    13.11. Norway
    13.12. Poland
    13.13. Qatar
    13.14. Russia
    13.15. Saudi Arabia
    13.16. South Africa
    13.17. Spain
    13.18. Sweden
    13.19. Switzerland
    13.20. Turkey
    13.21. United Arab Emirates
    13.22. United Kingdom
    14. Competitive Landscape
    14.1. Market Share Analysis, 2023
    14.2. FPNV Positioning Matrix, 2023
    14.3. Competitive Scenario Analysis
    14.3.1. New Home Sleep Apnea Testing Device to Launch in US
    14.3.2. Bresotec’s BresoDX1 for At-Home Sleep Apnea Testing Receives FDA 510(k) Clearance
    14.3.3. ProSomnus, Player in Patient-Preferred Sleep Apnea Therapy, to be Listed on Nasdaq Through Business Combination with Lakeshore Acquisition I Corp.
    14.4. Strategy Analysis & Recommendation
    15. Competitive Portfolio
    15.1. Key Company Profiles
    15.2. Key Product Portfolio

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