Sleep Apnea Devices Market Size By Product (Therapeutics {Airway Clearance System, Adaptive Servo-ventilation {ASV}, Positive Airway Pressure {PAP} Device, Oral Appliances, Oxygen Devices}, Diagnostics {Actigraphy Systems, Polysomnography {PSG} Device, Respiratory Polygraph, Sleep Screening Devices}), By End-use (Home Care Settings & Individuals, Sleep Laboratories & Hospitals), COVID19 Impact Analysis, Regional Outlook, Application Potential, Price Trends, Competitive Market Share & Forecast, 2021 – 2027

Published Date: May 2021  |  Report ID: GMI489  |  Authors: Sumant Ugalmugle, Rupali Swain

Report Format: PDF   |   Pages: 200   |   Base Year: 2020

Summary Table of Contents Industry Coverage Methodology

Industry Trends

Sleep Apnea Devices Market size was valued at around USD 6 billion in 2020 and is estimated to grow at a CAGR of over 9% between 2021 and 2027. Increasing incidence of sleep apnea and associated co-morbidities is propelling the market growth. Rising awareness regarding sleep apnea, other sleep disorders and their treatment would impel the adoption of these devices. The use of sleep apnea devices reduces the further amplification of several health ailments such as hypertension, cardiac diseases, diabetes, metabolic symptoms among others that are associated with untreated sleep apnea. Furthermore, technological advancements are further fostering the demand for sleep apnea devices.

Sleep Apnea Devices Market Overview

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Sleep apnea devices are the equipment used for managing sleeping apnea and they facilitate breathing in patients suffering from sleep disorders. Sleep apnea is a serious sleep disorder wherein, breathing repeatedly starts and stops. People suffering from sleep apnea exhibit abnormal breathing pattern during sleep that is mainly due to lack of oxygen supply to the brain and other body parts. Sleep apnea devices promote steady oxygen flow and support the airways, thereby promoting normal breathing.

However, the sleep apnea devices are classified as class II medical devices and are subject to stringent regulatory requirements and compliances. As a result, these devices are strictly regulated by the U.S. FDA. Class II medical devices feature moderate to high risk to the patient. Moreover, majority of class II medical devices require a premarket notification, or 510(k) process prior to their commercial distribution. Additionally, Class II devices are required to follow guidelines issued as per the Special Controls and General Controls. These additional controls include mandates such as post-market surveillance, special labeling requirements and meeting the pre-set performance standards.

The European Union Commission has revised medical device regulation to ensure high standards related to efficacy and safety for all CE-marked medical products and accessories. As per the new regulation, sleep apnea devices are classified as class 3 devices that exhibit potentially high-risk and these devices are subject to strictest compliances and regulatory process. In addition to this, the clinical consequences of these devices and lack of adherence to sleep apnea treatment will restrict the industry growth.

The emergence of COVID-19 pandemic at a global level is an unprecedented health concern and has significantly impacted the sleep apnea devices market. As coronavirus pandemic has spread across the world with high magnitude, priority is given to essential procedures and elective procedures are either delayed or cancelled. Coronavirus is being shed as aerosols and can be present in the equipment at sleep clinics, increasing the risk of infection. The American Sleep Association agreed with postponing elective and in-person sleep laboratory appointments, thereby negatively affecting the sleep laboratories and hospitals.

However, COVID-19 pandemic has fueled the demand for sleep apnea devices in home care settings. Advancements in the technology has led to advent of these devices that incorporates telemedicine and remote assessment with the help smartphone. Moreover, in patients diagnosed with COVID-19 infection, Obstructive Sleep Apnea was related to high risk of hospitalization and approximately doubled the risk of respiratory failure. Owing to increased risk of Obstructive Sleep Apnea, the demand for these devices is expected to positively impact the sleep apnea market in the future. Thus, the disruption of manufacturing & distribution of products during COVID-19 will have negative affect on the market. Although, the growing demand for home care sleep apnea equipment will foster the market expansion in the coming years.

Growing prevalence of sleep apnea and related co-morbidities in North America is poised to spur the market revenue

Rising prevalence of sleep apnea coupled with associated co-morbidities will promote the sleep apnea devices market progression. Several studies across the region have showcased high prevalence of sleep apnea and other sleep disorders such as obstructive sleep apnea (OSA). High number of patients suffering from obstructive sleep apnea is due to obesity, diabetes, metabolic syndrome, cardiovascular diseases, hyperlipidemia, and others health ailments. In the U.S., the estimated incidence of obesity in adult populace was over 30% and that of extreme obesity was reported around 6.7% in women and 2.8% in men. Furthermore, as per the American Sleep Association estimates, around 50-70 million adults in the U.S. were diagnosed with a sleep disorder in 2018. Among them, about 38% were diagnosed with unintentional falling asleep during the day and over 48% reported suffering from having snoring disorders, among others. Around 25 million adult population in the U.S. is suffering from obstructive sleep apnea and insomnia.

The huge population base suffering from sleep apnea and related sleep disorders increase the risk of co-morbidities and chronic health conditions such as cardiac arrest, stroke, asthma, and coronary heart disease among others. The Centers for Disease Control and Prevention (CDC) has revealed that the risk of chronic health conditions in adults suffering from sleep disorders or short sleeper adults is significantly higher than normal adults. Growing geriatric population in the region is further predicted to augment the acceptance rate of these devices, as the elderly population is highly susceptible to sleep disorders. In addition to this, the incidence of sleep apnea is growing in the elderly population, as related comorbidities with sleep apnea are also high in this age group.

Technological advancements in sleep apnea devices will stimulate the industry expansion

Therapeutics segment in the sleep apnea devices market accounted for USD 3.72 billion in 2020 led by the wide range of therapeutic options and constant technological advancements in the equipment. Technological developments are reducing the drawbacks related to conventional systems, making them more convenient, quieter, and easy to use without causing side effects. The emergence of alternative therapies to conventional continuous positive airway pressure (CPAP) treatment such as minimally invasive neurostimulators and oral appliances has provided broad range of options to the patients. The use of sleep apnea oral appliances in treatment is growing with its rising popularity and awareness amongst the population. Oral appliances offer over 100 different oral equipment that are approved by the U.S. FDA for treating obstructive sleep apnea and snoring. Integration of computer-assisted development and manufacturing, advancements in plastics, and higher acceptance of digital scanning technology will offer more innovations that will enhance comfort as well as compliance.

Increasing adoption of home care sleep apnea devices will influence the market value

Sleep Apnea Devices Market Size

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Sleep apnea devices market for home care settings & individuals segment exceeded USD 3.71 billion in 2020 on account of the growing usage of homecare sleep apnea devices, easy accessibility, and rising awareness regarding treatment availability in home care settings. As per a published research, in 2018, around one-third of obstructive sleep apnea testing was carried out at the patients’ homes and this number has significantly increased from around 15% in 2013. Market players are emphasizing on commercialization sleep apnea devices for home care settings.

Rise in incidence of obstructive sleep apnea in North America will drive the regional growth

Global Sleep Apnea Devices Market

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U.S. dominated the North America sleep apnea devices market and held largest revenue share of over 91% in 2020 owing to the shorter sleep duration, high healthcare expenditure and increasing prevalence of obstructive sleep apnea in the country. Obstructive sleep apnea is closely associated with obesity and increasing age. The geriatric population in the U.S. along with high number of obese adults is one of the factors responsible for the rising prevalence of sleep disorders in the country. Additionally, around 35% of all adults in the U.S. have reported sleeping less than seven hours on average. Furthermore, inadequate sleep has an economic burden of over USD 411 billion every year in the U.S.

Germany held the largest revenue share in the Europe market in 2020 and accounted for USD 396 million in 2020 due to high prevalence of chronic conditions such as chronic obstructive pulmonary disease (COPD), asthma & sleep apnea, availability of sleep laboratories & clinics and growing demand for advanced sleep apnea devices in the region. According to the National Institute of Health Research, in Germany, the prevalence of chronic obstructive pulmonary disease (COPD) was approximately 2.7 million in 2019. Chronic ailments such as asthma, chronic obstructive pulmonary disease and other respiratory disorders increase the risk of sleep apnea. The availability of hospitals for treating sleep apnea and product accessibility in the country will augment the industry value.

Business growth strategies implemented by major industry players will amplify the market demand

Some of the major companies operating in the sleep apnea devices market are BMC Medical, CareFusion Corporation, Cadwell Laboratories, Braebon Medical, Compumedics, Curative Medical, Fisher & Paykel Healthcare, GE Healthcare, ImThera Medical, Invacare Corporation, Natus Medical, Itamar Medical, Philips Healthcare, ResMed, Nihon Kohden, Somnetics International, SOMNOmedics, Weinmann Medical Devices and Teleflex among others. Several strategic initiatives such as novel product launches, mergers, acquisitions, strategic collaborations and geographic expansion to gain a competitive advantage are being undertaken. These prominent market participants also emphasize on research and development activities that allow in garnering maximum revenue.

Recent industry developments:

  • In April 2020, Cadwell Laboratories launched ApneaTrak home sleep apnea testing device. This device features three models to meet the clinical requirements to aid in diagnosis of sleep apnea and to validate the efficacy of treatments. This launch helped the company to reinstate its position in home care sleep apnea devices segment.
  • In September 2019, Royal Phillips announced commercial launch of Philips NightBalance, a prescription-based therapeutic device developed for patients with obstructive sleep apnea (OSA). This product features wireless connectivity along with a smartphone app that regulates the product use and offers insights to patients and physicians. This launch assisted the company in expanding and strengthening their product portfolio.

Sleep apnea devices market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD from 2016 to 2027, for the following segments:

Market, By Product, 2016 - 2027 (USD Million)

  • Therapeutics
    • Airway Clearance Systems
    • Adaptive Servo-ventilation (ASV)
    • Positive Airway Pressure (PAP) Device
    • Oral Appliances
    • Oxygen Devices
    • Others
  • Diagnostics
    • Actigraphy Systems
    • Polysomnography (PSG) Device
    • Respiratory Polygraph
    • Sleep Screening Devices

Market, By End-use, 2016 - 2027 (USD Million)

  • Home Care Settings & Individuals
  • Sleep Laboratories & Hospitals

The above information is provided for the following regions and countries:

  • North America
    • U.S.
    • Canada
  • Europe
    • Germany
    • UK
    • France
    • Spain
    • Italy
  • Asia Pacific
    • Japan
    • China
    • India
    • Australia
    • South Korea
  • Latin America
    • Brazil
    • Mexico
    • Argentina
  • Middle East & Africa
    • South Africa
    • Saudi Arabia
    • UAE

Frequently Asked Questions (FAQ) :

The sleep apnea devices industry size had reached nearly USD 6 billion in 2020 and will register a 9% CAGR up to 2027.
Revenue share from therapeutics products surpassed USD 3.72 billion in 2020 and will grow with constant technological advancements in the equipment and presence of extensive range of options.
The home care settings & individuals end-user segment was responsible for over USD 3.71 billion in 2020 and will witness expansion owing to the higher adoption of homecare sleep apnea devices, and the increasing awareness regarding the treatment availability.
U.S. sleep apnea devices market accounted for the largest revenue share of more than 91% in 2020 due to the increasing healthcare expenditure and higher cases of obstructive sleep apnea across the country.

Premium Report Details

  • Published Date: May 2021
  • Pages: 200
  • Tables: 231
  • Charts / Figures: 14
  • Companies covered: 19
  • Countries covered: 18

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