Sleep Apnea Implants Market - By Product (Hypoglossal Neurostimulation Devices, Palatal Implants, Bone Screw System, Phrenic Nerve Stimulator), By Indication (Central Sleep Apnea, Obstructive Sleep Apnea), By End-use & Forecast, 2022-2030

Sleep Apnea Implants Market Size

Sleep Apnea Implants Market size exceeded USD 311 million in 2021 and is estimated to register around 16% CAGR through 2030. The rising incidence of sleep apnea disorder is the key factor propelling the global market growth.
 

The economic burden of sleep apnea disorder & undiagnosed cases inflicts significant toll on the healthcare ecosystem. For instance, according to a published report in 2021, the socio-economic burden of obstructive sleep apnea inflicts both direct and indirect health-related costs accounting for around USD 67 to USD 165 billion annually in the U.S. Thus, the heightened healthcare costs along with the surging adoption of sleep apnea implants are predicted to fuel the sleep apnea implants industry outlook.
 

Sleep apnea implants refers to discreet devices implanted in the patient’s body to stimulate the natural breathing mechanism, open the airway, and enable the oxygen flow. Sleep apnea implants aid in reducing the impact of sleep apnea & the devices are majorly used in managing moderate to severe sleep apnea.
 

However, high costs associated with sleep apnea implants, stringent government regulations, and peri-operative complications may negatively impact the business growth. The high cost of sleep apnea implants, specifically the hypoglossal neurostimulation devices & phrenic nerve stimulator may affect the adoption rate of these devices, thereby affecting the market growth.
 

For instance, as of 2019, the Inspire Medical System’s hypoglossal nerve stimulation implant was priced at USD 23,800 in the U.S. & USD 23,400 in Europe. Such incremental costs would affect the adoption of these sleep apnea implants. Furthermore, the U.S. FDA overviews the R&D activities, approval, and post-approval surveillance associated with medical devices, including sleep apnea implants. Certain sleep apnea implants, including the Inspire UAS system is classified as class III medical device. These devices are required to adhere to stringent regulatory approval processes & compliances including the premarket approval (PMA). Thus, the strict regulatory framework & high cost may limit the adoption of sleep apnea implants, further hindering the industry growth.
 

The COVID-19 pandemic arose as an unparalleled health pandemic and impacted the industrial sectors by hampering the supply chain. The pandemic slowed down the sleep apnea implants market growth, during the initial phase of the pandemic, in the first half of 2020. To contain the spread of the SARS-CoV-2 virus, national emergencies and lockdowns were enforced in several economies.
 

The shutdown and movement restrictions impacted the medical practices. The coronavirus pandemic affected the medical device industry by limiting the product adoption & associated procedures. It affected the business operations of market players by substantially decreasing and delaying the number of implantation procedures performed and patients screened for the eligibility of sleep apnea implants therapy.
 

Additionally, the industry players also faced certain challenges in recruiting patients for clinical trials owing to the pandemic. However, the collaborative efforts of certain regulatory agencies and market players aided in mitigating the impact of pandemic.
 

or instance, as per the Inspire Medical Systems, all Inspire therapy procedures scheduled in March 2020 were either cancelled or postponed. Although by October 2020, majority of the surgical centers were performing these implantation procedures. Further in 2021, elective surgical procedures achieved the pre-pandemic surgical volume. Thus, the COVID-19 pandemic had slightly slowed down the industry growth; although, the restoring surgical volume would facilitate the market growth in near future.
 

Surging prevalence of obstructive sleep apnea is expected to fuel the business landscape

Substantial surge in the number of patients affected with sleep apnea is amongst the major factors propelling the demand for sleep apnea implants. Obstructive sleep apnea (OSA) is a chronic ailment that is notably underdiagnosed and results in frequent breathing interruptions during sleep.
 

This condition occurs as the throat and tongue muscles along with soft tissues relax & collapse, thereby limiting the amount of air that reaches the lungs. OSA promotes significant health consequences and co-morbidities, including cardiovascular conditions, atherosclerosis, heart failure, hypertension, stroke, diabetes, and depression among others that also results in substantial mortality.
 

As per the Lancet Respiratory Medicine journal, published in 2019, OSA is the most profound sleep disorder, affecting approximately 936 million people globally. Around 425 million individuals suffer with moderate-to-severe OSA that require treatment. Similarly, in Germany, around 14.3 million people suffer from this condition as of 2019.
 

As a result, with the surging patient population, the market is anticipated to foresee significant growth pertaining to the rising adoption & awareness regarding sleep apnea implants. Thus, as these implants offer an effective solution to patients for managing obstructive sleep apnea, the market is projected to witness unprecedented growth in the foreseeable future.
 

Sleep Apnea Implants Market Analysis

Based on product, the market is segregated as hypoglossal neurostimulation devices, palatal implants, bone screw system, and phrenic nerve stimulators. The hypoglossal neurostimulation devices accounted for majority market share in 2021 and is expected to register over 16.8% CAGR during the estimation timeframe. This majority market share is pertaining to rapid adoption of hypoglossal neurostimulation devices and higher efficacy in managing obstructive sleep apnea.
 

Hypoglossal nerve stimulation arose as an effective mechanism for muscle stimulation. The hypoglossal nerve regulates the movement of tongue and airway muscles. By stimulating this nerve, hypoglossal neurostimulation assists in maintaining an open airway during sleep. Over the last decade, novel technologies concentrating on the stimulation of hypoglossal nerve have emerged as a therapeutic alternative for individuals suffering with moderate-to-severe OSA patients that are non-compliant with conventional CPAP therapy. Further, the ongoing clinical studies & R&D efforts to assess and promote efficacy is set to proliferate the sleep apnea implants market share.
 

The obstructive sleep apnea segment was valued at around USD 286 million in 2021 and is anticipated to grow at 16.6% CAGR from 2022-2030. This dominant market growth is majorly attributed to the high prevalence of obstructive sleep apnea. According to an article published by the National Centers for Biotechnology Information, in 2019, obstructive sleep apnea is a condition characterized by recurrent upper airway obstruction during sleep.
 

This disorder affects approximately 6% to 7% population and is concerned with surged recurrence of cardiovascular disease, stroke, daytime sleepiness, and reduced quality of life. These symptoms are majorly observed in patients suffering with moderate-to-severe OSA, referred to as apneahypopnea index (AHI) greater than 15 events per hour. Thus, the significant prevalence of OSA is expected to expedite the industry expansion.
 

The ambulatory surgical centers segment accounted for significant market share of more than 41% in 2021 and is expected to register a significant CAGR during the analysis period. This dominant market share is owing to the surged adoption of these implants and implantation procedures in these healthcare settings.
 

Ambulatory surgical centers provide novel surgical technology, advanced implants, and these treatments are being offered by certified surgeons & healthcare professionals that secures the overall market expansion and drives the preference for these facilities. Moreover, availability and surging demand for surgical procedures at these healthcare settings for better patient management and care further accelerates the sleep apnea implants market growth in the coming years.
 

U.S. sleep apnea implants market is projected to reach more than USD 967 million by 2030. This dominant market share is owing to several factors such as the rising prevalence & incidence of OSA, high OSA associated disease burden, product launches, and presence of major players across the country. According to the Lancet Respiratory journal statistics in 2019, approximately 23.6 million people were suffering from OSA in the U.S. The considerable OSA population base has led to incremental surge in the OSA associated economic burden.
 

Further, the low awareness regarding OSA and underdiagnosed cases represent significant market development opportunity for the key players. According to Nyxoah’s 2021 annual report, OSA remains notably underdiagnosed with the diagnosis rate in the U.S. averaged at 18%. Also, the presence of major players in the country launching novel products is expected to benefit the market in the U.S.
 

Sleep Apnea Implants Market Share

Some of the major players operating in the sleep apnea implants industry are

• Inspire Medical Systems
• Medtronic
• Nyxoah
• Siesta Medical
• LivaNova
• Respicardia, Inc. (Asahi Kasei Company)

These prominent players focus on strategic partnerships, new product launch & commercialization for business expansion. Furthermore, these players are heavily investing in research that allows them to introduce innovative products and garner maximum revenue.
 

Recent industry developments:

• In April 2021, Siesta Medical announced the publication a clinical study highlighting the clinical efficacy and effectivity of AIRLIFT procedure for the treatment of obstructive sleep apnea. This development helped the company to highlight its product capabilities and thereby gain competitive advantage over its competitors.
   
• In May 2019, Siesta Medical announced the U.S. FDA clearance for its Encore System for extended indications. The Encore System is employed in AIRLIFT hyoid suspension that is used to treat airway obstructions and obstructive sleep apnea severity. This development helped the company to drive its revenue generation.
   

Sleep apnea implants market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD and Units from 2017 to 2030, for the following segments:

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By Product

• Hypoglossal Neurostimulation Devices
• Palatal Implants
• Bone Screw System
• Phrenic Nerve Stimulator

By Indication

• Central Sleep Apnea
• Obstructive Sleep Apnea (OSA)

By End-use

• Hospitals
• Ambulatory surgical centers
• Others

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

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • The Netherlands
  • Switzerland

• RoW