The global sleep apnea devices market was valued at USD 4.5 billion in the year 2019 and is estimated to reach USD 4.98 billion by the year 2020.
It is expected to grow at the CAGR of 10.7% within the time horizon of 2020-2025. Its market value will reach USD 8.28 billion by the end of the year 2025.
- Definition / Scope
- Market Overview
- Market Risks
- Top Market Opportunities
- Market Trends
- Industry Challenges
- Technology Trends
- Pricing Trends
- Regulatory Trends
- Market Size and Forecast
- Market Outlook
- Technology Roadmap
- Distribution Chain Analysis
- Competitive Factors
- Key Market Players
- Strategic Conclusion
- References
- Appendix
Definition / Scope
Sleep apnea is an acute sleep disorder in which the breathing of the individual is interrupted due to the repeated blockage of the upper airways during the sleeping condition. It can be obstructive sleep apnea, central sleep apnea, and complex sleep apnea syndrome.
It is one of the serious sleep disorders that are largely undiagnosed and untreated, which can cause chronic health disorders if left untreated. Sleep apnea devices are used for the diagnosis and treatment of sleep apnea which can be positive airway pressure devices, masks, oral appliances, adaptive servo-ventilators, accessories, oxygen devices, polysomnography devices, home sleep testing devices, oximeters, and actigraphy system.
These devices are applied in hospitals, sleep laboratories, and home care settings. The global sleep apnea devices market is concerned with the manufacture, distribution, and sale of the sleep apnea devices. Based on the product type and end-users, the global sleep apnea devices market is categorized into the following:

Market Overview
The total market size of the global sleep apnea devices market is valued at USD 4.5 billion in the year 2019 and is expected to reach USD 4.98 billion in the year 2020. Its market value is expected to grow at a CAGR of 10.7 % within the forecasted time horizon of 2020-2025.
Its market value is expected to reach USD 8.28 billion by the end of the year 2025. Based on geography, the North American region is leading the global market with a market share of almost 56% of the total global sleep apnea devices market. The market size of this region is valued at USD 2.52 billion in the year 2019.
Based on the type of product, the therapeutic segment is leading the market with a market share of almost 64.1% of the total global sleep apnea device market. The market size of this segment is valued at USD2.88 billion in the year 2019.
Based on the end-users, the home care segment is leading the market with a market share of almost 55% of the total global sleep apnea devices market. The market size of this segment is valued at USD 2.47 billion in the year 2019.
The large pool of undiagnosed sleep apneas patients, increasing focus on telehealth and mHealth solutions for its management, increasing prevalence of sleep disorders, and replacement of the ventilators with sleep apnea devices are the factors responsible for the growth and development of the global sleep apnea devices market.
However, side effects associated with sleep apnea devices and non-compliance of patients with sleep apnea devices might restrain the growth and development of this market.
The key market players engaged in the operation of its market are ResMed, Koninklijke Philips, Fisher & Paykel healthcare, SomnoMed, Oventus Medical, Compumedics, Lowenstein Medical, BMC Medical, and Braebon Medical.
Market Risks
- Side effects associated with sleep apnea devices
Sometimes, the use of sleep apnea devices can cause side effects on the health of sleep apnea patients. For instance, the common side effects of oral appliances are drooling, temporomandibular disturbances, tooth pain, etc.
A study conducted by Fritsch K M. and its colleagues among the 22 obstructive sleep apnea patients using the oral appliances has revealed that almost 86% of the study participants have experienced mucosal dryness followed by tooth discomfort (59%), and hypersalivation (55%).
The side effects associated with the use of continuous positive airway pressure machine are aerophagia, discomfort, claustrophobia, mask leak, dry, stuffy nose or nosebleeds, skin irritation, dry mouth, infections, lung discomfort, dizziness, and shortness of breath. Although these side effects aren’t life-threatening, the side effects associated with its use can be problematic.
These side effects associated with its use might restrain the growth and development of the global sleep apnea devices market.
Top Market Opportunities
- Large pool of undiagnosed sleep apneas patient
Sleep apnea is the most common sleep disorders all around the world. Almost 936 million people are affected by sleep apnea globally, increased by about 10 times. According to the American Sleep Apnea Association, almost 22 million people are suffered from obstructive sleep apnea in which almost 80% of the moderate and severe obstructive sleep apnea are undiagnosed in the context of the United States.
Almost 1.5 million adults are affected by obstructive sleep apnea in which almost 85% of the cases are undiagnosed. Along with this, the diagnosed rate of obstructive sleep apnea in the context of India, China is less than 1%.
Along with this, the prevalence of obesity is also in increasing trend and it has been estimated that almost 40% of obese people have obstructive sleep apnea. The large pool of undiagnosed sleep apnea patients and the necessity to diagnose this problem will create a significant opportunity for the growth and development of the global sleep apnea devices market.
- Increasing focus on telehealth and mHealth solutions for its management
Obstructive sleep apnea is a highly prevalent chronic condition and continuous follow up is required for its management. The follow-up management can be done with self-management platforms, continuous supply of the positive airway-pressure data, and mobile-based application for the patient feedback and queries.
mHealth solutions provide the short and more frequent assessment of the patients, can alert the physicians about the patient conditions, and can assist in the follow-up of the patients through the simple mobile-based questionnaire and applications.
The global mHealth market is expected to grow at a CAGR of 29.2% within the forecasted time horizon of 2020-2025. The market size of this market is valued at USD 40.7 billion in the year 2019 and will reach USD 111.1 billion by the end of the year 2025. Along with this, the healthcare institutions are developing telehealth programs to provide complete health care at home.
For instance, Oventus has launched the Telehealth and homecare model to provide the care to the patients affected with the obstructive sleep apnea. The increasing use of mHealth solutions and telemedicine in the sector of sleep apnea management is creating a significant opportunity for the growth and development of the global sleep apnea market.
Market Trends
The factors driving the growth and development of the global sleep apnea devices market are growing awareness about ill-effects of untreated sleep apnea, increasing prevalence of sleep disorders, replacement of ventilators with sleep apnea devices, technological advancement in sleep apnea devices, growing demand for home healthcare, rising healthcare expenditure, increase in disposable income, increasing medical coverage for sleep apnea devices, and rising geriatric population.
Some of the major driving factors of this market are discussed as follows:
- Increasing prevalence of sleep disorders
Globally, the prevalence of sleep disorders is in increasing trend. In the year 2019, more than 936 million people are expected to suffer from sleep apnea globally, which is almost 836% higher in comparison to the suffering in the year 2007.
The prevalence of obstructive sleep apnea in Europe is about 175 million. In the context of the United States, it has been estimated that almost 26% of the adult populations are suffered from the sleep apnea problem.
It has been estimated that almost 37% of the adults of North, Central, and South America might be affected by obstructive sleep apnea. It affects almost 13-32% of the population above 65 years of age and the condition of OBS will increase as the World Health Organization has expected the global population with age more than 60 years will reach 2 billion by the year 2050.
Increasing sleep disorders is driving the growth and development of the global sleep apnea devices market.
- Replacement of the ventilators with sleep apnea devices
The existing pandemic outbreak of the COVID-19 disease has created a situation of scarcity of the ventilators to treat the patient suffered from the novel coronavirus. To deal with this, the health care associations are seeking alternative solutions for the ventilators.
The Food and Drug Administration of the United States has recommended the use of continuous positive airway pressure and other positive airway pressure devices in the replacement of the ventilators.
Because of this, the UC Berkeley Department of Mechanical Engineering has initiated the project entitled Ventilator SOS to donate the unwanted sleep apnea machines for the COVID-19 patients.
The increasing burden of the existing pandemic outbreak of the novel coronavirus and replacement of the ventilators with the sleep apnea devices is driving the growth and development of the global sleep apnea devices market.
- Non-compliance of patients with sleep apnea devices
The compliance of the patients who suffered from sleep apnea towards the use of the CPAP and PAP devices is quite low. It has been estimated that almost 29% to 83% of the patients are non-adherent, which means that the meaningful use of the CPAP devices is less than four hours per night.
A retrospective telephonic interview conducted among the patients suffered from moderate and severe obstructive sleep apnea syndrome in Kerala, India has found that the net compliance rate of the CPAP devices is about 14.7%.
The major causes of non-compliance with the CPAP and PAP devices are side effects associated with its use and high cost of these devices. The non-compliance with the CPAP and PAP devices might restrain the growth and development of the global sleep apnea devices market.
Industry Challenges
- Highly concentrated market
The global market for global sleep apnea devices is highly concentrated. The top three key market players account for the Majority of the market value of the global sleep apnea devices market. The major top three market players are ResMed, Koninklijke Philips, and Fisher & Paykel Healthcare, which accounts for almost 94.4% of the total global sleep apnea devices market.
The other market players engaged in this global sleep apnea market accounts for almost 5.6% of the total global sleep apnea devices market. So, it is quite challenging for the market players other than the top three key market players to establish their market value.
Technology Trends
The adoption of new and advanced technologies is creating a favorable environment for the growth and development of the global sleep apnea devices market. Some of the key technological trends in this market are discussed as follows:
- Hypoglossal Nerve Stimulator: This medical device is used to stimulate the hypoglossal nerve electrically to reduces the occurrence of obstructive sleep apnea. It is implanted beneath the skin and controlled with a remote.
- Polysomnogram: This device is used for the sleep study to diagnose the type of sleep disorders by recording the brain waves, the blood oxygen level, heart rate, eye & leg movements, and breathing status.
- Nasal cradle cushion: This type of cushion covers less of our face and eases to sleep in any position. It has its self-adjusting SpringFit frame that adapts to create a stable situation.
- Bluetooth technology: It is equipped in the sleep apnea diagnostic system to send data to the smart devices for quality control, continuous monitoring, and another testing. It provides the services of the wireless transmission of the recording modules to the main body unit worn by the patient at the chest.
Pricing Trends
The price of sleep apnea devices depends upon the type of product, technology type, application, and brand name. For instance, the price of the ResMed Airsense 10 Autoset CPAP machine is about USD 680.25 per unit while the price of the ResMed AirMini CPAP Machine is about USD 734.67 per unit.
The price of the BMC Auto GII CPAP machine is about USD 258.49 per piece. The average price of the CPAP machine ranges from USD 500 to USD 3000 per unit. The average cost of the sleep apnea mouth guard ranges from USD 1800 to USD 2000 per unit.
Regulatory Trends
Some of the regulations directly or indirectly related to the global sleep apnea devices market are discussed as follows:
FDA Premarket Regulation of Devices for sleep Disordered Breathing: It has classified the sleep apnea devices into three cases based on risk. According to it, premarket approval is required for the class III medical devices to evaluate the safety and effectiveness of these devices.
All-State Dental Practice Acts: According to it, a lab can’t proceed in manufacturing a dental device without prescribed by the dentist or oral surgeon.
Intraoral devices for OSA- Class II Special Controls Guidance Document: According to this, the firm submitting a 510k premarket notification for the intraoral devices for OSA must show that its devices address the issue of safety and effectiveness.
Market Size and Forecast
The total market size of the global sleep apnea devices market is valued at USD 4.5 billion in the year 2019 and is expected to reach USD 4.98 billion in the year 2020.
Its market value is expected to grow at a CAGR of 10.7 % within the forecasted time horizon of 2020-2025. Its market value is expected to reach USD 8.28 billion by the end of the year 2025.
Based on geography
- The North American region is leading the global market with a market share of almost 56% of the total global sleep apnea devices market. The market size of this region is valued at USD 2.52 billion in the year 2019.
- The European region accounts for a market share of almost 20% of the total global sleep apnea devices market. The market size of this segment is valued at USD 0.9 billion in the year 2019.
- The APAC region accounts for a market share of almost 17% of the total global sleep apnea devices market. The market size of this segment is valued at USD 0.76 billion in the year 2019.
- ROW stands for the rest of the world, which includes Middle East Africa and South America. This segment accounts for a market share of almost 7% of the total global sleep apnea devices market. The market size of this segment is valued at USD 0.31 billion in the year 2019.


Based on the type of product
- The therapeutic segment is leading the market with a market share of almost 64.1% of the total global sleep apnea device market. The market size of this segment is valued at USD2.88 billion in the year 2019.
- The diagnostic segment accounts for a market share of almost 35.9% of the total global sleep apnea devices market. The market size of this segment is valued at USD 1.61 billion in the year 2019.

Based on the end-users
- The home care segment is leading the market with a market share of almost 55% of the total global sleep apnea devices market. The market size of this segment is valued at USD 2.47 billion in the year 2019.
- The hospitals & sleeping laboratories account for a market share of almost 45% of the total global sleep apnea devices market. The market size of this segment is valued at USD 2.02 billion in the year 2019.

Market Outlook
The global sleep apnea devices market is expected to grow at the CAGR of 10.7% within the forecasted time horizon of 2020-2025 because of the large pool of undiagnosed sleep apneas patient, increasing focus on telehealth and mHealth solutions for its management, increasing prevalence of sleep disorders, and replacement of the ventilators with sleep apnea devices. Its market value will reach USD 8.28 billion by the end of the year 2025.

Technology Roadmap
The advanced technological solutions and communication technologies are embedded in the sleep apnea diagnostic and therapeutic devices. For instance, the sleep apnea diagnostic system consists of Bluetooth technology to ease the wireless transmission of information about the patient’s condition.
The technologically advanced sleep apnea devices are hypoglossal nerve stimulator, polysomnogram, nasal cradle cushion, etc. These technological changes are driving the growth and development of the global sleep apnea devices market.
Distribution Chain Analysis
The key stakeholders involved in the operation of this global sleep apnea devices market are sleep apnea devices manufacturers, distributors, online & retail sales, software vendors, approving governmental authorities, and end-users.
At first, the companies manufacture the sleep apnea devices and submits it to the governmental authorities for approval. Once approved, they are available for end-users through and retail and online sales.

Competitive Factors
The key market players engaged in this market are competing for the new product invention, high investment in research and development activities, mergers & acquisitions, geographical expansion, and collaborations.
For instance, Royal Philips has launched the Dream Series range to improve the sleep therapy experience for people with obstructive sleep apnea. ResMed has launched AirFit N30i and newly designed nasal cradle cushion in the year 2019.
Key Market Players
The key market players engaged in the global sleep apnea devices market are ResMed, Koninklijke Philips, Fisher & Paykel healthcare, SomnoMed, Oventus Medical, Compumedics, Lowenstein Medical, BMC Medical, and Braebon Medical. Short profile of the key market players engaged in this market are discussed as follows:
ResMed: It is the US-based medical equipment company engaged in the provision of the cloud-connected medical devices for the treatment of sleep apnea and other respiratory conditions. The revenue of this company is valued at USD 3 billion in the year 2020.
Koninklijke Philips: It is the Netherlands-based multinational company engaged in the sector of the development of the audio system, electronics, lighting, and medical equipment.
Fisher & Paykel healthcare: It is the New Zealand-based company engaged in the manufacture, design and marketing of the products for the treatment of obstructive sleep apnea, and other respiratory care.
SomnoMed: It is the US-based company engaged in the provision of dental sleep products and services for the treatment of obstructive sleep apnea.
Oventus Medical: It is the Australia-based medical device company engaged in the development of oral appliances for the treatment of sleep apnea and snoring.
Compumedics: It is the -based company engaged in the development, manufacture, and commercialization of the diagnostic technology for the sleep, brain, and ultrasonic blood-flow monitoring application.
Strategic Conclusion
The global sleep apnea devices market is growing at a rate of 10.7% within the forecasted time horizon of 2020-2025 because of the large pool of undiagnosed sleep apneas patient, increasing focus on telehealth and mHealth solutions for its management, increasing prevalence of sleep disorders, and replacement of the ventilators with sleep apnea devices.
However, side effects associated with sleep apnea devices and non-compliance of patients with sleep apnea devices might restrain the growth and development of this market.
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Appendix
- CPAP= Continuous positive airway pressure
- PAP= Positive airway pressure
- OSA= Obstructive sleep apnea
- USD= United States Dollar
- CAGR= Compound Annual Growth Rate