Sleep Apnea - Market Insight, Epidemiology And Market Forecast - 2034
Description
Key Highlights
Sleep apnea is a serious condition in which breathing repeatedly stops during sleep, leading to disrupted rest and imbalanced oxygen and carbon dioxide levels. It can result from upper airway blockage (as in obstructive sleep apnea) or from abnormal brain signals affecting breathing (as in complex sleep apnea).
OSA, the more common form, occurs due to partial or complete blockage of the upper airway during sleep. In contrast, CSA arises from a failure of the brain’s respiratory control center—particularly the pre-Bötzinger complex—to signal breathing, leading to missed breaths during sleep. Complex Sleep Apnea is a mixed form involving features of both OSA and CSA.
In 2024, the total prevalent cases of sleep apnea were approximately 220,000,000 in the 7MM.
In 2024, the US accounted for approximately 50% of diagnosed prevalent cases of sleep apnea among the 7MM, while EU4 and the UK represented about 37%, and Japan contributed nearly 13% cases.
Treatment focuses on both risk factors and the sleep apnea itself. For mild cases, weight loss, smoking cessation, and limiting alcohol use are typically recommended. Continuous Positive Airway Pressure (CPAP) is the primary treatment for individuals with OSA, especially those experiencing excessive daytime sleepiness (EDS).
Some individuals using CPAP may still experience EDS and may benefit from stimulants like modafinil, solriamfeto and others. In CSA, treatment focuses on managing the underlying condition, such as using medications to improve heart failure.
In December 2024, a major milestone was achieved with the approval of ZEPBOUND (US)/ MOUNJARO (EU) as the first and only approved pharmacological therapy for OSA in both the US and Europe.
In 2024, the United States dominated the sleep apnea market among the 7MM, capturing approximately 76% of the total 7MM market share.
In 2024, the total market size for sleep apnea in EU4 and the UK was approximately USD 120 million, accounting for almost 20% of market in 7MM.
In May 2025, Apnimed announced positive Phase III SynAIRgy trial results for AD109, an oral drug for OSA. The trial met its primary endpoint, showing a significant reduction in apnea-hypopnea index (AHI) at 26 weeks vs placebo. Efficacy was seen across all OSA severities and weight classes. AD109 was well-tolerated, with no serious drug-related adverse events. These results position AD109 as a potential first-in-class oral therapy for OSA.
The sleep apnea treatment pipeline is rapidly evolving, with a primary focus on OSA. Key developments include Eli Lilly’s retatrutide and orforglipron, Incannex’s IHL-42X (acetazolamide + dronabinol), and Apnimed’s AD109 (aroxybutynin + atomoxetine). Notably, SASS-001 by Shionogi Apnimed Sleep Science is the only known candidate targeting CSA.
Report Summary
The report offers extensive knowledge regarding the epidemiology segments and predictions, presenting a deep understanding of the potential future growth in diagnosis rates, disease progression, and treatment guidelines. It provides comprehensive insights into these aspects, enabling a thorough assessment of the subject matter.
Additionally, an all-inclusive account of the current management techniques and emerging therapies and the elaborative profiles of late-stage (Phase III and Phase II) and prominent therapies that would impact the current treatment landscape and result in an overall market shift has been provided in the report.
The report also encompasses a comprehensive analysis of the sleep apnea market, providing an in-depth examination of its historical and projected market size (2020–2034). It also includes the market share of therapies, detailed assumptions, and the underlying rationale for our methodology. The report also includes drug outreach coverage in the 7MM region.
The report includes qualitative insights that provide an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, including experts from various hospitals and prominent universities, patient journey, and treatment preferences that help shape and drive the 7MM sleep apnea market.
Sleep Apnea Drug Chapters
The section dedicated to drugs in the sleep apnea report provides an in-depth evaluation of late-stage pipeline drugs (Phase III and Phase II) related to sleep apnea. The drug chapters section provides valuable information on various aspects related to clinical trials of sleep apnea, such as the pharmacological mechanisms of the drugs involved, designations, approval status, patent information, and a comprehensive analysis of the pros and cons associated with each drug. Furthermore, it presents the most recent news updates and press releases on drugs targeting sleep apnea.
Marketed Therapies
ZEPBOUND/ MOUNJARO (tirzepatide): Eli Lilly and Company
ZEPBOUND/MOUNJARO is a Glucose-dependent Insulinotropic Polypeptide (GIP) receptor and Glucagon-like Peptide-1 (GLP-1) receptor agonist indicated in combination with a reduced-calorie diet and increased physical activity to treat moderate- to- severe OSA in adults with obesity.
In December 2024, ZEPBOUND (tirzepatide) was approved in the US and Europe for treating moderate-to-severe OSA in adults with obesity, alongside a reduced-calorie diet and increased physical activity.
SUNOSI (solriamfetol): Axsome Therapeutics/Jazz Pharmaceuticals
SUNOSI is a Dopamine and Norepinephrine Reuptake Inhibitor (DNRI) indicated to improve wakefulness in adult patients with EDS associated with narcolepsy or OSA. It is thought to improve wakefulness by increasing the activity of two wakefulness neurotransmitters in the brain: dopamine and norepinephrine. It is the first and only approved medication for EDS due to OSA that works this way to help keep you awake during the day.
In March 2019, Jazz Pharmaceuticals announced that the US FDA has approved SUNOSI (solriamfetol) for the treatment of EDS associated with narcolepsy or OSA.
In January 2020, Jazz Pharmaceuticals received EU marketing authorization for SUNOSI (solriamfetol) for the treatment of EDS in adults with narcolepsy or OSA.
OZAWADE (Pitolisant): Bioprojet
OZAWADE contains pitolisant as its active ingredient, which acted as a histamine H3 receptor antagonist/inverse agonist, promoting wakefulness by increasing histamine levels in the brain. This mechanism made it a non-stimulant alternative to traditional therapies such as modafinil. OZAWADE is approved only in Europe for the treatment of EDS associated with OSA in adults. It represented an important treatment option for patients with OSA who continued to experience daytime sleepiness despite optimal management of their airway obstruction.
In September 2021, the European Medicines Agency issued a marketing authorization for OZAWADE, which was indicated for the treatment of EDS associated with OSA in adults.
Emerging Therapies
AD109 (Aroxybutynin + Atomoxetine): Apnimed
AD109 (Aroxybutynin + atomoxetine) is an investigational first-in-class combination of aroxybutynin, a novel antimuscarinic, and atomoxetine, a NRI. AD109 is designed to target the neurobiology of the hypoglossal motor nucleus (HMN) to increase signals to the upper airway during sleep to limit or prevent upper airway collapse in people living with OSA.
AD109 is also currently being studied in two large, pivotal Phase III randomized clinical trials, LunAIRo and SynAIRgy, for mild, moderate, and severe OSA.
In June 2022, Apnimed announced that the FDA granted Fast Track designation (FTD) to AD109, its oral treatment for OSA.
Retatrutide: Eli Lilly and Company
Retatrutide is a novel GLP-1/GIP/GLP-2 receptor agonist developed by Eli Lilly. The TRIUMPH Phase III development program is evaluating the safety and efficacy of retatrutide for OSA, and others in people with obesity and overweight. The core registration studies include:
TRIUMPH-1: randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety in participants without type 2 diabetes who are obese or overweight, including participants with OSA and osteoarthritis.
TRIUMPH-2: randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety in participants with type 2 diabetes who have obesity or overweight including participants with OSA.
Orforglipron: Eli Lilly and Company
Orforglipron, Eli Lilly’s investigational oral GLP-1 receptor agonist, is being evaluated for its potential to treat OSA in individuals with obesity or overweight. The ongoing ATTAIN-OSA Phase III trial is assessing orforglipron’s impact on the AHI over 52 weeks, aiming to determine whether its significant weight loss effects can translate into meaningful improvements in OSA severity.
As a once-daily oral therapy, orforglipron could offer a convenient alternative to injectable GLP-1s and CPAP for patients who are non-adherent or intolerant.
Sleep Apnea Market Outlook
During the forecast period (2025–2034), pipeline candidates such as Eli Lilly’s retatrutide and orforglipron, Incannex’s IHL-42X (acetazolamide + dronabinol), and Apnimed’s AD109 (aroxybutynin + atomoxetine). and others are expected to drive the rise in sleep apnea market size.
In 2024, the total market size of sleep apnea in 7MM was approximately USD 600 million.
In 2024, in the EU4 and the UK, Germany has the highest market size of approximately USD 50 million.
In 2024, the total market size for sleep apnea in Japan was approximately 20 USD million.
In a nutshell, therapies are being investigated to manage sleep apnea. Even though it is too soon to comment on the above-mentioned promising candidate to enter the market during the forecast period (2024–2034), it is safe to assume that the future of this market is bright. Eventually, these drugs will create a significant difference in the landscape of sleep apnea in the coming years. The treatment space is expected to experience a significant positive shift in the coming years owing to the improvement in healthcare spending worldwide.
Further details are provided in the report…
Sleep Apnea Understanding and Treatment
Sleep Apnea Overview
Sleep apnea is a common condition where breathing repeatedly stops and starts during sleep, reducing the body's oxygen supply. Individuals may snore loudly or gasp for air—signs that warrant medical attention. These breathing interruptions, often lasting 10 to 20s, can occur 5 to over 100 times per hour. Though people may not fully wake up, each pause disrupts deep, restorative sleep, leading to poor sleep quality and persistent fatigue upon waking.
OSA occurs when throat muscles relax during sleep, narrowing or blocking the airway, causing reduced oxygen levels and repeated brief awakenings to resume breathing. In contrast, CSA stems from the brain’s inability to properly regulate breathing during sleep, often due to impaired detection of carbon dioxide levels, resulting in shallow or paused breathing and disrupted sleep patterns.
Sleep apnea symptoms reflect both disrupted breathing during sleep and the consequences of poor sleep quality during the day. Common signs of OSA include loud snoring, gasping or choking during sleep, EDS, morning headaches, dry mouth upon waking, restless sleep, frequent nighttime urination, irritability, and difficulty concentrating. CSA symptoms overlap but are more neurologically driven, including irregular breathing patterns, nighttime awakenings, and sudden shortness of breath or chest pain, difficulty focusing, morning headaches, and persistent daytime sleepiness.
Further details are provided in the report…
Sleep Apnea Diagnosis
Diagnosis is based on clinical symptoms and may be supported by screening questionnaires that assess excessive daytime sleepiness and related risk factors. A confirmed diagnosis, however, requires an overnight sleep study (polysomnography) conducted in a sleep lab.
Health history and physical exam: The assessment for sleep apnea usually begins with a review of the individual's symptoms, medical history, and a physical examination. This process helps identify potential signs of sleep apnea and uncover any risk factors that may be contributing to the condition.
Polysomnogram: A polysomnogram is a sleep study that uses sensors to monitor breathing, heart rate, and brain activity during sleep. It is essential for diagnosing sleep apnea and can be conducted either in a sleep lab or at home.
Home sleep apnea tests: A home sleep apnea test (HSAT) may be recommended for individuals likely to have moderate to severe OSA based on their symptoms and medical history. Unlike in-lab studies, HSATs use fewer sensors and do not measure brain activity or sleep stages.
Further details related to country-based variations are provided in the report…
Sleep Apnea Treatment
The management of OSA involves a tailored approach combining lifestyle changes, such as weight loss and avoiding alcohol or sedatives, with therapeutic options like positional therapy, CPAP, oral appliances (e.g., mandibular advancement devices), and surgical treatments including Uvulopalatopharyngoplasty (UPPP), Maxillomandibular Advancement (MMA), and Hypoglossal Nerve Stimulation (HNS). While CPAP remains the gold standard, adherence issues are common, and alternatives are often explored. In severe, refractory cases, tracheostomy may be necessary.
The primary goal in managing CSA is to stabilize breathing patterns and address underlying conditions through a personalized approach. Key treatment options include positive airway pressure (PAP) therapies—CPAP, BiPAP, and adaptive servo-ventilation (ASV)—with CPAP often being first-line. Other interventions include supplemental oxygen, phrenic nerve stimulation, and experimental pharmacological agents like acetazolamide, theophylline, and certain hypnotics or serotonergic drugs. Oxygen therapy and nerve stimulation have shown benefits in improving sleep quality, reducing apnea events, and enhancing quality of life. Treatment choice depends on the type and cause of CSA, comorbidities, and patient response.
Further details related to treatment and management are provided in the report…
Sleep Apnea Epidemiology
The sleep apnea epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total prevalent cases, total diagnosed prevalent cases, type-specific cases, age-specific cases, gender-specific cases, and severity-specific cases in the United States, EU4 countries (Germany, France, Italy, Spain) and the United Kingdom, and Japan from 2020 to 2034.
In 2024, the total diagnosed prevalent cases of sleep apnea was approximately 29,000,000 in the 7MM.
In 2024, the severity-specific cases of sleep apnea were approximately 15,800,000 and 13,000,000 cases for mild and moderate to severe, respectively, in the 7MM.
In 2024, OSA accounted for approximately 92% of the prevalent cases of sleep apnea.
In 2024, the age-specific cases of sleep apnea were approximately 420,000, 10,270,000, and 3,800,000 cases for =18years, 18–69years, and =69years, respectively, in the US.
KOL Views
To stay abreast of the latest trends in the market, we conduct primary research by seeking the opinions of Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) who work in the relevant field. This helps us fill any gaps in data and validate our secondary research.
We have reached out to industry experts to gather insights on various aspects of sleep apnea, including the evolving treatment landscape, patients’ reliance on conventional therapies, their acceptance of therapy switching, drug uptake, and challenges related to accessibility. The experts we contacted included medical/scientific writers, professors, and researchers from prestigious universities in the US, Europe, the UK, and Japan.
Our team of analysts at Delveinsight connected with more than 10 KOLs across the 7MM. We contacted institutions such as the University of Munich, the University of Tokyo, Stanford Health Care Sleep Medicine Center, and University of Minnesota, etc., among others. By obtaining the opinions of these experts, we gained a better understanding of the current and emerging treatment patterns in the sleep apnea market, which will assist our clients in analyzing the overall epidemiology and market scenario.
Qualitative Analysis
We perform Qualitative and Market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.
Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, designation, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.
In efficacy, the trial’s primary and secondary outcome measures are evaluated; for instance, in trials for sleep apnea, one of the most important primary endpoints was achieving changes in AHI, oxygen desaturation index, CPAP adherence, and validated patient-reported outcomes like the Epworth Sleepiness Scale, etc. Based on these, the overall efficacy is evaluated.
Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.
Market Access and Reimbursement
Because newly authorized drugs are often expensive, some patients escape receiving proper treatment or use off-label, less expensive prescriptions. Reimbursement plays a critical role in how innovative treatments can enter the market. The cost of the medicine, compared to the benefit it provides to patients who are being treated, sometimes determines whether or not it will be reimbursed. Regulatory status, target population size, the setting of treatment, unmet needs, the number of incremental benefit claims, and prices can all affect market access and reimbursement possibilities.
Eli Lilly offers the ZEPBOUND Savings Card to help reduce prescription costs, regardless of insurance status. Eligible patients with commercial insurance and coverage for ZEPBOUND may pay as little as USD 25 for a 1-month or 3-month supply of the ZEPBOUND pen. For those who are commercially insured but do not have coverage for ZEPBOUND, the out-of-pocket cost may be as low as USD 650 for a 1-month prescription. Eligibility requirements apply.
The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.
Sleep Apnea Report Insights
Patient Population
Therapeutic Approaches
Sleep Apnea Market Size and Trends
Existing Market Opportunity
Sleep Apnea Report Key Strengths
Ten-year Forecast
The 7MM Coverage
Sleep Apnea Epidemiology Segmentation
Key Cross Competition
Sleep Apnea Report Assessment
Current Treatment Practices
Reimbursements
Market Attractiveness
Qualitative Analysis (SWOT, Conjoint Analysis, Unmet needs)
Key Questions
Would there be any changes observed in the current treatment approach?
Will there be any improvements in sleep apnea management recommendations?
Would research and development advances pave the way for future tests and therapies for Sleep Apnea?
Would the diagnostic testing space experience a significant impact and lead to a positive shift in the treatment landscape of sleep apnea?
What kind of uptake will the new therapies witness in the coming years in sleep apnea patients?
Sleep apnea is a serious condition in which breathing repeatedly stops during sleep, leading to disrupted rest and imbalanced oxygen and carbon dioxide levels. It can result from upper airway blockage (as in obstructive sleep apnea) or from abnormal brain signals affecting breathing (as in complex sleep apnea).
OSA, the more common form, occurs due to partial or complete blockage of the upper airway during sleep. In contrast, CSA arises from a failure of the brain’s respiratory control center—particularly the pre-Bötzinger complex—to signal breathing, leading to missed breaths during sleep. Complex Sleep Apnea is a mixed form involving features of both OSA and CSA.
In 2024, the total prevalent cases of sleep apnea were approximately 220,000,000 in the 7MM.
In 2024, the US accounted for approximately 50% of diagnosed prevalent cases of sleep apnea among the 7MM, while EU4 and the UK represented about 37%, and Japan contributed nearly 13% cases.
Treatment focuses on both risk factors and the sleep apnea itself. For mild cases, weight loss, smoking cessation, and limiting alcohol use are typically recommended. Continuous Positive Airway Pressure (CPAP) is the primary treatment for individuals with OSA, especially those experiencing excessive daytime sleepiness (EDS).
Some individuals using CPAP may still experience EDS and may benefit from stimulants like modafinil, solriamfeto and others. In CSA, treatment focuses on managing the underlying condition, such as using medications to improve heart failure.
In December 2024, a major milestone was achieved with the approval of ZEPBOUND (US)/ MOUNJARO (EU) as the first and only approved pharmacological therapy for OSA in both the US and Europe.
In 2024, the United States dominated the sleep apnea market among the 7MM, capturing approximately 76% of the total 7MM market share.
In 2024, the total market size for sleep apnea in EU4 and the UK was approximately USD 120 million, accounting for almost 20% of market in 7MM.
In May 2025, Apnimed announced positive Phase III SynAIRgy trial results for AD109, an oral drug for OSA. The trial met its primary endpoint, showing a significant reduction in apnea-hypopnea index (AHI) at 26 weeks vs placebo. Efficacy was seen across all OSA severities and weight classes. AD109 was well-tolerated, with no serious drug-related adverse events. These results position AD109 as a potential first-in-class oral therapy for OSA.
The sleep apnea treatment pipeline is rapidly evolving, with a primary focus on OSA. Key developments include Eli Lilly’s retatrutide and orforglipron, Incannex’s IHL-42X (acetazolamide + dronabinol), and Apnimed’s AD109 (aroxybutynin + atomoxetine). Notably, SASS-001 by Shionogi Apnimed Sleep Science is the only known candidate targeting CSA.
Report Summary
The report offers extensive knowledge regarding the epidemiology segments and predictions, presenting a deep understanding of the potential future growth in diagnosis rates, disease progression, and treatment guidelines. It provides comprehensive insights into these aspects, enabling a thorough assessment of the subject matter.
Additionally, an all-inclusive account of the current management techniques and emerging therapies and the elaborative profiles of late-stage (Phase III and Phase II) and prominent therapies that would impact the current treatment landscape and result in an overall market shift has been provided in the report.
The report also encompasses a comprehensive analysis of the sleep apnea market, providing an in-depth examination of its historical and projected market size (2020–2034). It also includes the market share of therapies, detailed assumptions, and the underlying rationale for our methodology. The report also includes drug outreach coverage in the 7MM region.
The report includes qualitative insights that provide an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, including experts from various hospitals and prominent universities, patient journey, and treatment preferences that help shape and drive the 7MM sleep apnea market.
Sleep Apnea Drug Chapters
The section dedicated to drugs in the sleep apnea report provides an in-depth evaluation of late-stage pipeline drugs (Phase III and Phase II) related to sleep apnea. The drug chapters section provides valuable information on various aspects related to clinical trials of sleep apnea, such as the pharmacological mechanisms of the drugs involved, designations, approval status, patent information, and a comprehensive analysis of the pros and cons associated with each drug. Furthermore, it presents the most recent news updates and press releases on drugs targeting sleep apnea.
Marketed Therapies
ZEPBOUND/ MOUNJARO (tirzepatide): Eli Lilly and Company
ZEPBOUND/MOUNJARO is a Glucose-dependent Insulinotropic Polypeptide (GIP) receptor and Glucagon-like Peptide-1 (GLP-1) receptor agonist indicated in combination with a reduced-calorie diet and increased physical activity to treat moderate- to- severe OSA in adults with obesity.
In December 2024, ZEPBOUND (tirzepatide) was approved in the US and Europe for treating moderate-to-severe OSA in adults with obesity, alongside a reduced-calorie diet and increased physical activity.
SUNOSI (solriamfetol): Axsome Therapeutics/Jazz Pharmaceuticals
SUNOSI is a Dopamine and Norepinephrine Reuptake Inhibitor (DNRI) indicated to improve wakefulness in adult patients with EDS associated with narcolepsy or OSA. It is thought to improve wakefulness by increasing the activity of two wakefulness neurotransmitters in the brain: dopamine and norepinephrine. It is the first and only approved medication for EDS due to OSA that works this way to help keep you awake during the day.
In March 2019, Jazz Pharmaceuticals announced that the US FDA has approved SUNOSI (solriamfetol) for the treatment of EDS associated with narcolepsy or OSA.
In January 2020, Jazz Pharmaceuticals received EU marketing authorization for SUNOSI (solriamfetol) for the treatment of EDS in adults with narcolepsy or OSA.
OZAWADE (Pitolisant): Bioprojet
OZAWADE contains pitolisant as its active ingredient, which acted as a histamine H3 receptor antagonist/inverse agonist, promoting wakefulness by increasing histamine levels in the brain. This mechanism made it a non-stimulant alternative to traditional therapies such as modafinil. OZAWADE is approved only in Europe for the treatment of EDS associated with OSA in adults. It represented an important treatment option for patients with OSA who continued to experience daytime sleepiness despite optimal management of their airway obstruction.
In September 2021, the European Medicines Agency issued a marketing authorization for OZAWADE, which was indicated for the treatment of EDS associated with OSA in adults.
Emerging Therapies
AD109 (Aroxybutynin + Atomoxetine): Apnimed
AD109 (Aroxybutynin + atomoxetine) is an investigational first-in-class combination of aroxybutynin, a novel antimuscarinic, and atomoxetine, a NRI. AD109 is designed to target the neurobiology of the hypoglossal motor nucleus (HMN) to increase signals to the upper airway during sleep to limit or prevent upper airway collapse in people living with OSA.
AD109 is also currently being studied in two large, pivotal Phase III randomized clinical trials, LunAIRo and SynAIRgy, for mild, moderate, and severe OSA.
In June 2022, Apnimed announced that the FDA granted Fast Track designation (FTD) to AD109, its oral treatment for OSA.
Retatrutide: Eli Lilly and Company
Retatrutide is a novel GLP-1/GIP/GLP-2 receptor agonist developed by Eli Lilly. The TRIUMPH Phase III development program is evaluating the safety and efficacy of retatrutide for OSA, and others in people with obesity and overweight. The core registration studies include:
TRIUMPH-1: randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety in participants without type 2 diabetes who are obese or overweight, including participants with OSA and osteoarthritis.
TRIUMPH-2: randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety in participants with type 2 diabetes who have obesity or overweight including participants with OSA.
Orforglipron: Eli Lilly and Company
Orforglipron, Eli Lilly’s investigational oral GLP-1 receptor agonist, is being evaluated for its potential to treat OSA in individuals with obesity or overweight. The ongoing ATTAIN-OSA Phase III trial is assessing orforglipron’s impact on the AHI over 52 weeks, aiming to determine whether its significant weight loss effects can translate into meaningful improvements in OSA severity.
As a once-daily oral therapy, orforglipron could offer a convenient alternative to injectable GLP-1s and CPAP for patients who are non-adherent or intolerant.
Sleep Apnea Market Outlook
During the forecast period (2025–2034), pipeline candidates such as Eli Lilly’s retatrutide and orforglipron, Incannex’s IHL-42X (acetazolamide + dronabinol), and Apnimed’s AD109 (aroxybutynin + atomoxetine). and others are expected to drive the rise in sleep apnea market size.
In 2024, the total market size of sleep apnea in 7MM was approximately USD 600 million.
In 2024, in the EU4 and the UK, Germany has the highest market size of approximately USD 50 million.
In 2024, the total market size for sleep apnea in Japan was approximately 20 USD million.
In a nutshell, therapies are being investigated to manage sleep apnea. Even though it is too soon to comment on the above-mentioned promising candidate to enter the market during the forecast period (2024–2034), it is safe to assume that the future of this market is bright. Eventually, these drugs will create a significant difference in the landscape of sleep apnea in the coming years. The treatment space is expected to experience a significant positive shift in the coming years owing to the improvement in healthcare spending worldwide.
Further details are provided in the report…
Sleep Apnea Understanding and Treatment
Sleep Apnea Overview
Sleep apnea is a common condition where breathing repeatedly stops and starts during sleep, reducing the body's oxygen supply. Individuals may snore loudly or gasp for air—signs that warrant medical attention. These breathing interruptions, often lasting 10 to 20s, can occur 5 to over 100 times per hour. Though people may not fully wake up, each pause disrupts deep, restorative sleep, leading to poor sleep quality and persistent fatigue upon waking.
OSA occurs when throat muscles relax during sleep, narrowing or blocking the airway, causing reduced oxygen levels and repeated brief awakenings to resume breathing. In contrast, CSA stems from the brain’s inability to properly regulate breathing during sleep, often due to impaired detection of carbon dioxide levels, resulting in shallow or paused breathing and disrupted sleep patterns.
Sleep apnea symptoms reflect both disrupted breathing during sleep and the consequences of poor sleep quality during the day. Common signs of OSA include loud snoring, gasping or choking during sleep, EDS, morning headaches, dry mouth upon waking, restless sleep, frequent nighttime urination, irritability, and difficulty concentrating. CSA symptoms overlap but are more neurologically driven, including irregular breathing patterns, nighttime awakenings, and sudden shortness of breath or chest pain, difficulty focusing, morning headaches, and persistent daytime sleepiness.
Further details are provided in the report…
Sleep Apnea Diagnosis
Diagnosis is based on clinical symptoms and may be supported by screening questionnaires that assess excessive daytime sleepiness and related risk factors. A confirmed diagnosis, however, requires an overnight sleep study (polysomnography) conducted in a sleep lab.
Health history and physical exam: The assessment for sleep apnea usually begins with a review of the individual's symptoms, medical history, and a physical examination. This process helps identify potential signs of sleep apnea and uncover any risk factors that may be contributing to the condition.
Polysomnogram: A polysomnogram is a sleep study that uses sensors to monitor breathing, heart rate, and brain activity during sleep. It is essential for diagnosing sleep apnea and can be conducted either in a sleep lab or at home.
Home sleep apnea tests: A home sleep apnea test (HSAT) may be recommended for individuals likely to have moderate to severe OSA based on their symptoms and medical history. Unlike in-lab studies, HSATs use fewer sensors and do not measure brain activity or sleep stages.
Further details related to country-based variations are provided in the report…
Sleep Apnea Treatment
The management of OSA involves a tailored approach combining lifestyle changes, such as weight loss and avoiding alcohol or sedatives, with therapeutic options like positional therapy, CPAP, oral appliances (e.g., mandibular advancement devices), and surgical treatments including Uvulopalatopharyngoplasty (UPPP), Maxillomandibular Advancement (MMA), and Hypoglossal Nerve Stimulation (HNS). While CPAP remains the gold standard, adherence issues are common, and alternatives are often explored. In severe, refractory cases, tracheostomy may be necessary.
The primary goal in managing CSA is to stabilize breathing patterns and address underlying conditions through a personalized approach. Key treatment options include positive airway pressure (PAP) therapies—CPAP, BiPAP, and adaptive servo-ventilation (ASV)—with CPAP often being first-line. Other interventions include supplemental oxygen, phrenic nerve stimulation, and experimental pharmacological agents like acetazolamide, theophylline, and certain hypnotics or serotonergic drugs. Oxygen therapy and nerve stimulation have shown benefits in improving sleep quality, reducing apnea events, and enhancing quality of life. Treatment choice depends on the type and cause of CSA, comorbidities, and patient response.
Further details related to treatment and management are provided in the report…
Sleep Apnea Epidemiology
The sleep apnea epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total prevalent cases, total diagnosed prevalent cases, type-specific cases, age-specific cases, gender-specific cases, and severity-specific cases in the United States, EU4 countries (Germany, France, Italy, Spain) and the United Kingdom, and Japan from 2020 to 2034.
In 2024, the total diagnosed prevalent cases of sleep apnea was approximately 29,000,000 in the 7MM.
In 2024, the severity-specific cases of sleep apnea were approximately 15,800,000 and 13,000,000 cases for mild and moderate to severe, respectively, in the 7MM.
In 2024, OSA accounted for approximately 92% of the prevalent cases of sleep apnea.
In 2024, the age-specific cases of sleep apnea were approximately 420,000, 10,270,000, and 3,800,000 cases for =18years, 18–69years, and =69years, respectively, in the US.
KOL Views
To stay abreast of the latest trends in the market, we conduct primary research by seeking the opinions of Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) who work in the relevant field. This helps us fill any gaps in data and validate our secondary research.
We have reached out to industry experts to gather insights on various aspects of sleep apnea, including the evolving treatment landscape, patients’ reliance on conventional therapies, their acceptance of therapy switching, drug uptake, and challenges related to accessibility. The experts we contacted included medical/scientific writers, professors, and researchers from prestigious universities in the US, Europe, the UK, and Japan.
Our team of analysts at Delveinsight connected with more than 10 KOLs across the 7MM. We contacted institutions such as the University of Munich, the University of Tokyo, Stanford Health Care Sleep Medicine Center, and University of Minnesota, etc., among others. By obtaining the opinions of these experts, we gained a better understanding of the current and emerging treatment patterns in the sleep apnea market, which will assist our clients in analyzing the overall epidemiology and market scenario.
Qualitative Analysis
We perform Qualitative and Market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.
Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, designation, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.
In efficacy, the trial’s primary and secondary outcome measures are evaluated; for instance, in trials for sleep apnea, one of the most important primary endpoints was achieving changes in AHI, oxygen desaturation index, CPAP adherence, and validated patient-reported outcomes like the Epworth Sleepiness Scale, etc. Based on these, the overall efficacy is evaluated.
Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.
Market Access and Reimbursement
Because newly authorized drugs are often expensive, some patients escape receiving proper treatment or use off-label, less expensive prescriptions. Reimbursement plays a critical role in how innovative treatments can enter the market. The cost of the medicine, compared to the benefit it provides to patients who are being treated, sometimes determines whether or not it will be reimbursed. Regulatory status, target population size, the setting of treatment, unmet needs, the number of incremental benefit claims, and prices can all affect market access and reimbursement possibilities.
Eli Lilly offers the ZEPBOUND Savings Card to help reduce prescription costs, regardless of insurance status. Eligible patients with commercial insurance and coverage for ZEPBOUND may pay as little as USD 25 for a 1-month or 3-month supply of the ZEPBOUND pen. For those who are commercially insured but do not have coverage for ZEPBOUND, the out-of-pocket cost may be as low as USD 650 for a 1-month prescription. Eligibility requirements apply.
The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.
Sleep Apnea Report Insights
Patient Population
Therapeutic Approaches
Sleep Apnea Market Size and Trends
Existing Market Opportunity
Sleep Apnea Report Key Strengths
Ten-year Forecast
The 7MM Coverage
Sleep Apnea Epidemiology Segmentation
Key Cross Competition
Sleep Apnea Report Assessment
Current Treatment Practices
Reimbursements
Market Attractiveness
Qualitative Analysis (SWOT, Conjoint Analysis, Unmet needs)
Key Questions
Would there be any changes observed in the current treatment approach?
Will there be any improvements in sleep apnea management recommendations?
Would research and development advances pave the way for future tests and therapies for Sleep Apnea?
Would the diagnostic testing space experience a significant impact and lead to a positive shift in the treatment landscape of sleep apnea?
What kind of uptake will the new therapies witness in the coming years in sleep apnea patients?
Table of Contents
186 Pages
- 1. Key Insights
- 2. Report Introduction
- 3. Sleep Apnea Market Overview at a Glance
- 3.1. Market Share (%) Distribution of Sleep Apnea by Country in 2024 in the 7MM
- 3.2. Market Share (%) Distribution of Sleep Apnea by Country in 2034 in the 7MM
- 4. Methodology
- 5. Executive Summary of Sleep Apnea
- 6. Key Events
- 7. Disease Background and Overview
- 7.1. Introduction
- 7.2. Classification of Sleep Apnea
- 7.3. Signs and Symptoms of Sleep Apnea
- 7.3.1. Symptoms of OSA
- 7.3.2. Symptoms of CSA
- 7.4. Risk Factors and Causes
- 7.4.1. Risk Factors of OSA
- 7.4.2. Risk Factors of CSA
- 7.5. Pathophysiology of Sleep Apnea
- 7.5.1. Pathophysiology of Sleep Apnea
- 7.6. Complications of Sleep Apnea
- 7.7. Diagnosis of Sleep Apnea
- 7.7.1. Diagnostic Guidelines for Sleep Apnea
- 7.7.2. Differential Diagnosis
- 8. Treatment and Management of Sleep Apnea
- 8.1. Treatment/Management of OSA
- 8.2. Treatment/Management of CSA
- 8.3. Treatment Guidelines for Sleep Apnea
- 8.3.1. Treatment of Adult OSA with Positive Airway Pressure: An American Academy of Sleep Medicine Clinical Practice Guideline
- 8.3.2. NICE Guideline for OSA/Hypopnea Syndrome
- 8.3.3. Sleep Apnea Syndrome (SAS) Clinical Practice Guidelines 2020
- 8.3.4. European Respiratory Society Guideline on Non-CPAP Therapies for OSA
- 8.3.5. Japan Circulation Society (JCS) 2023 Guideline
- 8.4. Diagnostic and Treatment Algorithm for Sleep Apnea
- 9. Epidemiology and Patient Population
- 9.1. Key Findings
- 9.2. Assumptions and Rationale
- 9.3. Total Diagnosed Prevalent Cases of Sleep Apnea in the 7MM
- 9.4. The United States
- 9.4.1. Total Prevalent Cases of Sleep Apnea in the United States
- 9.4.2. Total Diagnosed Prevalent Cases of Sleep Apnea in the United States
- 9.4.3. Type-specific Cases of Sleep Apnea in the United States
- 9.4.4. Age-specific Cases of Sleep Apnea in the United States
- 9.4.5. Gender-specific Cases of Sleep Apnea in the United States
- 9.4.6. Severity-specific Cases of Sleep Apnea in the United States
- 9.5. EU4 and the UK
- 9.5.1. Total Prevalent Cases of Sleep Apnea in EU4 and the UK
- 9.5.2. Total Diagnosed Prevalent Cases of Sleep Apnea in EU4 and the UK
- 9.5.3. Type-specific Cases of Sleep Apnea in EU4 and the UK
- 9.5.4. Age-specific Cases of Sleep Apnea in EU4 and the UK
- 9.5.5. Gender-specific Cases of Sleep Apnea in EU4 and the UK
- 9.5.6. Severity-specific Cases of Sleep Apnea in EU4 and the UK
- 9.6. Japan
- 9.6.1. Total Prevalent Cases of Sleep Apnea in Japan
- 9.6.2. Total Diagnosed Prevalent Cases of Sleep Apnea in Japan
- 9.6.3. Type-specific Cases of Sleep Apnea in Japan
- 9.6.4. Age-specific Cases of Sleep Apnea in Japan
- 9.6.5. Gender-specific Cases of Sleep Apnea in Japan
- 9.6.6. Severity-specific Cases of Sleep Apnea in Japan
- 10. Patient Journey
- 11. Marketed Therapies
- 11.1. Key Cross Competition
- 11.2. ZEPBOUND/MOUNJARO (tirzepatide): Eli Lilly and Company
- 11.2.1. Product Description
- 11.2.2. Regulatory Milestones
- 11.2.3. Other Developmental Activities
- 11.2.4. Safety and efficacy
- 11.3. SUNOSI (solriamfetol): Axsome Therapeutics/Jazz Pharmaceuticals
- 11.3.1. Product Description
- 11.3.2. Regulatory Milestones
- 11.3.3. Other Developmental Activities
- 11.3.4. Safety and Efficacy
- 11.4. OZAWADE (Pitolisant): Bioprojet
- 11.4.1. Product Description
- 11.4.2. Regulatory Milestones
- 11.4.3. Other Developmental Activities
- 11.4.4. Safety and Efficacy
- 12. Emerging Therapies
- 12.1. Key Cross Competition
- 12.2. Aroxybutynin + Atomoxetine (AD109): Apnimed
- 12.2.1. Product Description
- 12.2.2. Other Developmental Activities
- 12.2.3. Clinical Development
- 12.2.4. Safety and Efficacy
- 12.2.5. Analyst View
- 12.3. Retatrutide: Eli Lilly and Company
- 12.3.1. Product Description
- 12.3.2. Clinical Development
- 12.3.3. Analyst View
- 12.4. Orforglipron: Eli Lilly and Company
- 12.4.1. Product Description
- 12.4.2. Clinical Development
- 12.4.3. Analyst View
- 12.5. Acetazolamide + Dronabinol (IHL-42X): Incannex Healthcare
- 12.5.1. Product Description
- 12.5.2. Other Developmental Activities
- 12.5.3. Clinical Development
- 12.5.4. Safety and Efficacy
- 12.5.5. Analyst View
- 13. Sleep Apnea- Seven Major Market Analysis
- 13.1. Key Findings
- 13.2. Market Outlook
- 13.3. Conjoint Analysis
- 13.4. Key Market Forecast Assumptions
- 13.5. Market Size in the 7MM
- 13.5.1. Total Market Size of Sleep Apnea in the 7MM
- 13.5.2. Market Size of Sleep Apnea by Therapies in the 7MM
- 13.6. Market Size in the United States
- 13.6.1. Total Market Size of Sleep Apnea in the United States
- 13.6.2. Market Size of Sleep Apnea by Therapies in the United States
- 13.7. Market Size in EU4 and the UK
- 13.7.1. Total Market size of Sleep Apnea in EU4 and the UK
- 13.7.2. Market Size of Sleep Apnea by Therapies in EU4 and the UK
- 13.8. Market Size in Japan
- 13.8.1. Total Market Size of Sleep Apnea in Japan
- 13.8.2. Market size of Sleep Apnea by Therapies in Japan
- 14. KOL Views
- 15. SWOT Analysis
- 16. Unmet Needs
- 17. Market Access and Reimbursement
- 17.1. United States
- 17.1.1. Centre for Medicare and Medicaid Services (CMS)
- 17.2. EU4 and the UK
- 17.2.1. Germany
- 17.2.2. France
- 17.2.3. Italy
- 17.2.4. Spain
- 17.2.5. United Kingdom
- 17.3. Japan
- 17.3.1. MHLW
- 17.4. Reimbursement Senario in Sleep Apnea
- 17.4.1. United States
- 17.4.2. EU4 and the UK
- 17.4.3. Japan
- 18. Appendix
- 18.1. Bibliography
- 18.2. Report Methodology
- 19. DelveInsight Capa bilities
- 20. Disclaimer
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