수면무호흡증용 구강내 장치 시장 : 제품 유형별, 연령대별, 성별, 구매 유형별, 최종사용자별, 지역별, 기회 및 예측(2017-2031년)

Global sleep apnea oral appliances market is projected to witness a CAGR of 14.68% during the forecast period 2024-2031, growing from USD 451.1 million in 2023 to USD 1349.03 million in 2031. The market has experienced significant growth in recent years and is expected to maintain a strong pace of expansion in the coming years. Sleep apnea oral devices are used to diagnose, treat, and manage the disorder of sleep apnea in people which causes interruptions in breathing during sleep. Sleep apnea oral appliances facilitate continuous and smooth breathing in people during their sleep. These devices improve quality of sleep, reduce chances of any severe risks and overall improve someone's life who is battling with sleep apnea.

The sleep apnea oral appliances market is being driven due to many factors such as increasing prevalence of sleep apnea, rising geriatric population, improvements in technology and rising awareness about this condition and treatment options. Companies that manufacture these devices in this market are coming forward with different solutions to combat and treat the disease. The availability of portable devices that have battery backups or a digital system that keeps a patient record available all the time for consultation is gaining traction and people are opting for them. Companies in the market are collaborating together through strategic partnerships and mergers and acquisitions. Significant investments are being made to manufacture high-end medical devices that monitor sleep apnea. For instance, in May 2022, Panthera Dental, in collaboration with Medit Corp., announced the development of a digital workflow to provide world-class custom-made snoring and obstructive sleep apnea management through an integrated digital workflow.

Rising Prevalence of Sleep Apnea

Increasing prevalence of sleep apnea is acting as a significant driver for global sleep apnea oral appliances market. The disease is characterized by discontinued or interrupted breathing patterns that can be fatal to severe extent. Awareness about sleep apnea is increasing at a global scale which is leading to increasing demand for sleep apnea oral devices. In 2022, a report published by the journal of the American Thoracic Society, stated that obstructive sleep apnea has a global prevalence of more than 22.6%.

Additionally, the rising geriatric population is fueling the demand for oral sleep apnea devices because elderly people are more prone to sleep apnea. In June 2022, a study was published by the National Library of Medicine stating that 1 billion people globally suffered from obstructive sleep apnea accounting for 425 million adults aged between 40-60 years with a moderate level of sleep apnea. The study found that as people turn 50 years old, the prevalence of sleep apnea rises. WHO predicts that by 2030, one out of every six people will be 60 years of age or older. Sleep health organization stated that obesity has a direct correlation with obesity. A higher body fat percentage or BMI (body mass index) increases the chances of developing sleep apnea in the future.

Technological Advancements

Technological advancements in the sleep apnea oral devices market are the key foundation of growth and expansion, promoting innovation, and adoption of novel technologies. Advancements have steered into a new era of efficacy, safety and development, contributing prominently to expanding the market.

One of the key drivers in the market is the growing popularity of devices such as flexTAP, O2vent, and MADs developed by different brands that feature advanced pressure relief technology. These devices stimulate the pressure of air to match the patient's breathing pattern, providing them ultimate comfort and ease while not making them feel that they are fighting the air pressure. Nowadays modern devices come with digital data monitoring capabilities that enable the patient and doctors to access detailed information and data related to the therapy they are taking.

Wireless connectivity allows remote access to data thus enabling telemedicine consultations. Companies are coming up with smaller sizes of oral devices that are travel friendly. Machines that make less noise are being developed by companies which provide a peaceful environment for the patient while they are sleeping. Additionally, devices are coming with the ability to adjust the temperature and humidity to avoid any discomfort while sleeping. Battery backups are a value addition, especially in case of traveling or during any power outages.

Vivos Therapeutics announced the clearance of its oral device for sleep apnea in November 2023. It is the first oral device for severe obstructive sleep apnea which has a respiratory ventilation or exercise program for the muscles around the face, tongue, and mouth to treat and moderate OSA in adults.

Mandibular Advancement Devices Dominate Market Share

Mandibular advancement devices (MADs) devices provide a non-invasive alternative to PAP devices and effectively treat moderate to mild sleep apnea. PAP devices often make people feel uneasy when used to treat mild to moderate level of sleep apnea. However, MAD are designed in such a way that they can be customized to offer the utmost level of flexibility to tackle the problem. Many research papers and journals have reported the effectiveness of MADs. For instance, Journal of Craniomandibular and Sleep Practice focused on the efficacy of MADs for management of mild to severe sleep apnea. They published the report in July 2022, highlighting the positive results of using MAD to combat the problem of sleep apnea and related symptoms such as snoring or excessive exhaustion during the day. Glidwell launched its mandibular advancement device in July 2022, and is called the Silent Nite Sleep Appliance. The device is an extension of Silent Nite brand, which is famous among dentists for treating sleep apnea and snoring.

North America to Dominate Market

North America is dominating the market with a significant market share over the forecast period with a significant market share. Due to the rising incidence of sleep apnea among the population of North America, devices used to combat this condition are needed more, thus increasing the demand of oral appliances in North America. Increasing population is accompanied by rising geriatric population in the region which is prone to sleep apnea. Strategic partnerships and developments taking place between medical device companies present an opportunity for growth in the region.

For instance, ProSomnus Holdings Inc. in May 2022, along with Lakeshore merged under the definitive business combination agreement to become ProSomnus, Inc. The deal is expected to accelerate the development and commercialization of ProSomnus's oral appliance therapy devices. Panthera Dental signed an exclusive distribution agreement with MK1 dental-attachment GmbH to expand the oral sleep apnea and dental product offerings in the United States and Canada.

Future Market Scenario (2024 - 2031F)

The market growth of sleep apnea oral appliances is steadily increasing due to several factors. The market is expected to grow quickly in the forecast period for reasons such as the increasing geriatric population and technological advancements. As awareness of sleep apnea and its associated health risks, such as cardiovascular disease and metabolic disorders increases, more people are seeking diagnosis and treatment. Technological advancements in sleep apnea devices, such as the integration of smart features and digital sensors to enhance therapy management, are making the devices more comfortable and effective for patients. Market players are collaborating to enhance the quality of its products further and expand the market. For instance, ResMed (US) acquired German-based clinical, financial, and operational solutions provider MEDIFOX DAN based in Germany to drive out-of-hospital based software solutions.

Key Players Landscape and Outlook

Several companies are expanding their businesses by planning and adopting new strategies. They are forming with new strategic initiatives regarding various sleep apnea oral appliances, to help people combat with the condition and to increase their presence in the market. New product launches, agreements based on contracts, acquisitions and mergers, investments and partnerships are a few strategies through which they are trying increase their revenues and market presence on a global scale.

Apnimed was granted fast-track designation by the USFDA in June 2022 for its oral drug AD109, which treats OSA. The fast-track designation will allow Apnimed to accelerate the drug's regulatory approval and make it available as a therapy option to OSA patients.

In February 2022, Panthera Dental rebranded its oral sleep apnea appliance SomNyx as D-SADMoyo within the range of Panthera's digital sleep appliance. The device is focused on pediatric treatment of OSA with a combination of physiological mandibular advancement and myofunctional therapy.

Table of Contents

1.Research Methodology

2.Project Scope & Definitions

3.Executive Summary

4.Global Sleep Apnea Oral Appliances Market Outlook, 2017-2031F

• 4.1.Market Size & Forecast
  • 4.1.1.By Value
  • 4.1.2.By Volume
• 4.2.By Product Type
  • 4.2.1.Mandibular Advancement Devices
  • 4.2.2.Tongue-Retaining Devices
  • 4.2.3.Rapid Maxillary Expansion Devices
• 4.3.By Age-Group
  • 4.3.1.Below 40-Years
  • 4.3.2.40-60 Years
  • 4.3.3.Above 60-Years
• 4.4.By Gender Type
  • 4.4.1.Male
  • 4.4.2.Female
• 4.5.By Purchase Type
  • 4.5.1.Physician-Prescribed Oral Appliances
  • 4.5.2.Online/OTC Oral Appliances
• 4.6.By End-user
  • 4.6.1.Hospitals
  • 4.6.2.Dental Clinics
  • 4.6.3.Home-Care Settings
  • 4.6.4.Others
• 4.7.By Region
  • 4.7.1.North America
  • 4.7.2.Europe
  • 4.7.3.Asia-Pacific
  • 4.7.4.South End-user America
  • 4.7.5.Middle East and Africa
• 4.8.By Company Market Share (%), 2023

5.Global Sleep Apnea Oral Appliances Market Outlook, By Region, 2017-2031F

• 5.1.North America*
  • 5.1.1.Market Size & Forecast
    • 5.1.1.1.By Value
    • 5.1.1.2.By Volume
  • 5.1.2.By Product Type
    • 5.1.2.1.Mandibular Advancement Devices
    • 5.1.2.2.Tongue-Retaining Devices
    • 5.1.2.3.Rapid Maxillary Expansion Devices
  • 5.1.3.By Age-Group
    • 5.1.3.1.Below 40-Years
    • 5.1.3.2.40-60 Years
    • 5.1.3.3.Above 60-Years
  • 5.1.4.By Gender Type
    • 5.1.4.1.Male
    • 5.1.4.2.Female
  • 5.1.5.By Purchase Type
    • 5.1.5.1.Physician-Prescribed Oral Appliances
    • 5.1.5.2.Online/OTC Oral Appliances
  • 5.1.6.By End-user
    • 5.1.6.1.Hospitals
    • 5.1.6.2.Dental Clinics
    • 5.1.6.3.Home-Care Settings
    • 5.1.6.4.Others
  • 5.1.7.United States*
    • 5.1.7.1.Market Size & Forecast
      • 5.1.7.1.1.By Value
      • 5.1.7.1.2.By Volume
    • 5.1.7.2.By Product Type
      • 5.1.7.2.1.Mandibular Advancement Devices
      • 5.1.7.2.2.Tongue-Retaining Devices
      • 5.1.7.2.3.Rapid Maxillary Expansion Devices
    • 5.1.7.3.By Age-Group
      • 5.1.7.3.1.Below 40-Years
      • 5.1.7.3.2.40-60 Years
      • 5.1.7.3.3.Above 60-Years
    • 5.1.7.4.By Gender Type
      • 5.1.7.4.1.Male
      • 5.1.7.4.2.Female
    • 5.1.7.5.By Purchase Type
      • 5.1.7.5.1.Physician-Prescribed Oral Appliances
      • 5.1.7.5.2.Online/OTC Oral Appliances
    • 5.1.7.6.By End-user
      • 5.1.7.6.1.Hospitals
      • 5.1.7.6.2.Dental Clinics
      • 5.1.7.6.3.Home-Care Settings
      • 5.1.7.6.4.Others
  • 5.1.8.Canada
  • 5.1.9.Mexico

All segments will be provided for all regions and countries covered

• 5.2.Europe
  • 5.2.1.Germany
  • 5.2.2.France
  • 5.2.3.Italy
  • 5.2.4.United Kingdom
  • 5.2.5.Russia
  • 5.2.6.Netherlands
  • 5.2.7.Spain
  • 5.2.8.Turkey
  • 5.2.9.Poland
• 5.3.Asia-Pacific
  • 5.3.1.India
  • 5.3.2.China
  • 5.3.3.Japan
  • 5.3.4.Australia
  • 5.3.5.Vietnam
  • 5.3.6.South Korea
  • 5.3.7.Indonesia
  • 5.3.8.Philippines
• 5.4.South America
  • 5.4.1.Brazil
  • 5.4.2.Argentina
• 5.5.Middle East & Africa
  • 5.5.1.Saudi Arabia
  • 5.5.2.UAE
  • 5.5.3.South Africa

6.Market Mapping, 2023

• 6.1.By Product Type
• 6.2.By Age-Group
• 6.3.By Gender Type
• 6.4.By Purchase Type
• 6.5.By End-user
• 6.6.By Region

7.Macro Environment and Industry Structure

• 7.1.Demand Supply Analysis
• 7.2.Import Export Analysis
• 7.3.Value Chain Analysis
• 7.4.PESTEL Analysis
  • 7.4.1.Political Factors
  • 7.4.2.Economic System
  • 7.4.3.Social Implications
  • 7.4.4.Technological Advancements
  • 7.4.5.Environmental Impacts
  • 7.4.6.Legal Compliances and Regulatory Policies (Statutory Bodies Included)
• 7.5.Porter's Five Forces Analysis
  • 7.5.1.Supplier Power
  • 7.5.2.Buyer Power
  • 7.5.3.Substitution Threat
  • 7.5.4.Threat from New Entrant
  • 7.5.5.Competitive Rivalry

8.Market Dynamics

• 8.1.Growth Drivers
• 8.2.Growth Inhibitors (Challenges and Restraints)

9.Regulatory Framework and Innovation

• 9.1.Clinical Trials
• 9.2.Patent Landscape
• 9.3.Regulatory Approvals
• 9.4.Innovations/Emerging Technologies

10.Key Players Landscape

• 10.1.Competition Matrix of Top Five Market Leaders
• 10.2.Market Revenue Analysis of Top Five Market Leaders (in %, 2023)
• 10.3.Mergers and Acquisitions/Joint Ventures (If Applicable)
• 10.4.SWOT Analysis (For Five Market Players)
• 10.5.Pricing Analysis

11.Case Studies

12.Key Players Outlook

• 12.1.SomnoMed Ltd.
  • 12.1.1.Company Details
  • 12.1.2.Key Management Personnel
  • 12.1.3.Products & Services
  • 12.1.4.Financials (As reported)
  • 12.1.5.Key Market Focus & Geographical Presence
  • 12.1.6.Recent Developments
• 12.2.ResMed, Inc.
• 12.3.ProSomnus Sleep Technologies, Inc.
• 12.4.Whole You, Inc.
• 12.5.Vivos Therapeutics, Inc.
• 12.6.Open Airway Dental Solutions Ltd.
• 12.7.Panthera Dental Inc.
• 12.8.Airway Management, Inc.
• 12.9.Dynaflex Private Limited
• 12.10.OravanOSA

Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.

13.Strategic Recommendations

14.About Us & Disclaimer