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Obstructive Sleep Apnea Market Set for Significant Growth Through 2034, Driven by Recent FDA Approvals and Innovative Therapeutic Developments | DelveInsight

10-28-2025 05:11 PM CET | Health & Medicine

Press release from: DelveInsight Business Research

Obstructive Sleep Apnea Market Insights

Obstructive Sleep Apnea Market Insights

The obstructive sleep apnea treatment market is experiencing remarkable expansion, driven by increasing disease awareness, rising prevalence, and breakthrough therapies from key pharmaceutical players, including Eli Lilly and Company, Apnimed, Incannex Healthcare, Bioprojet Pharma, Aculys Pharma, Axsome Therapeutics, Jazz Pharmaceuticals, Pharmanovia, Nyxoah Inc., ICUREsearch, Eisai Inc., Purdue Pharma LP, Desitin Arzneimittel GmbH, Berendo Scientific LLC, Sumitomo Pharma America Inc., and Apnex Medical Inc., among others.

DelveInsight's "Obstructive Sleep Apnea Market Insight, Epidemiology And Market Forecast - 2034" report delivers an in-depth understanding of the obstructive sleep apnea treatment market, historical and forecasted epidemiology, as well as market trends across the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan. The report comprehensively evaluates the current treatment landscape, emerging therapies, market share of individual treatments, and obstructive sleep apnea market forecasts through 2034, providing crucial insights for stakeholders in the obstructive sleep apnea therapeutic area.

According to DelveInsight's analysis, the obstructive sleep apnea market size was valued at approximately USD 360 million in 2023 across the 7MM and is anticipated to grow significantly with a significant CAGR of approximately 17% during the forecast period (2025-2034). This growth is driven by enhanced understanding of disease mechanisms and the introduction of novel therapeutic approaches.

Furthermore, the US held the largest market share for obstructive sleep apnea treatments among the 7MM in 2023, valued at around USD 247 million, with a projected CAGR of 17.3% by 2034.

Download the Obstructive Sleep Apnea Market report to understand which factors drive the Obstructive Sleep Apnea therapeutic market @ https://www.delveinsight.com/sample-request/obstructive-sleep-apnea-osa-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=xpr

In 2023, the total obstructive sleep apnea diagnosed prevalence was more than 25 million cases in the 7MM, which is expected to increase further by 2034. The United States accounted for the highest proportion of diagnosed cases among the 7MM, with approximately 14 million cases (54% of total cases) in 2023.

DelveInsight's epidemiology model reveals that Japan accounted for approximately 20% of obstructive sleep apnea diagnosed prevalent cases in the 7MM, with approximately 3.200 million cases for males and 1.8 million cases for females. These figures reflect notable gender distribution in diagnosed cases due to differences in risk factors, lifestyle habits, and biological variations between males and females.

In the 7MM, the analysis reveals that the highest obstructive sleep apnea prevalence is observed in the 65 years and above age bracket, with approximately 9 million cases, while the lowest is in the 19-24 years group, with approximately 180 thousand cases. This distribution highlights a significant increase in prevalence with age, underscoring the growing impact of OSA in older populations.

Discover evolving trends in the Obstructive Sleep Apnea patient pool forecasts @ https://www.delveinsight.com/sample-request/obstructive-sleep-apnea-osa-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=xpr

The DelveInsight report also analyses the current and emerging obstructive sleep apnea treatment landscape. The current OSA treatment market includes a few marketed therapies and other off-label therapies that only provide nonspecific relief that may be temporary. Continuous positive airway pressure (CPAP) therapy remains the gold standard treatment, but patient adherence issues present significant challenges.

The obstructive sleep apnea treatment pipeline is promising, with several novel treatments in late-stage development:

Apnimed's AD109, a first-in-class oral medication combining aroxybutynin and atomoxetine, is advancing through Phase III trials for obstructive sleep apnea. In May 2025, AD109 met the primary endpoint in its first Phase III trial, reducing sleep apnea severity by 55.6% from baseline.

In May 2025, Incannex Healthcare Inc. received FDA protocol clearance to advance the Phase 3 component of its RePOSA clinical trial for IHL-42X, an oral combination therapy targeting obstructive sleep apnea.

Eli Lilly is also advancing retatrutide, a triagonist targeting GIP, GLP-1, and glucagon receptors, in Phase III trials for obstructive sleep apnea. The TRIUMPH phase III development program is evaluating the safety and efficacy of retatrutide for chronic weight management, obstructive sleep apnea, and knee osteoarthritis in people with obesity and overweight.

In January 2025, the FDA approved an IND for a Phase 2 clinical trial of lorundrostat to treat OSA and hypertension. The trial, set to begin in Q1 2025, will evaluate the drug's potential to reduce upper airway obstruction and nocturnal hypertension in patients with moderate-to-severe OSA.

Despite advancements, obstructive sleep apnea unmet needs persist for effective, non-invasive solutions that enhance patient compliance and long-term management, highlighting ongoing market opportunities. The condition often remains undiagnosed because of limited screening methods and symptom similarities with other disorders.

The obstructive sleep apnea therapeutic market is rapidly evolving. Recently, in September 2025, Airway Management received FDA clearance for Nylon flexTAP, the first digitally printed single-point midline oral appliance for treating mild to moderate obstructive sleep apnea, featuring patented Vertex Technology for enhanced comfort and effectiveness.

In December 2024, Eli Lilly and Company announced that the FDA approved ZEPBOUND (tirzepatide), a once-weekly injectable GIP and GLP-1 receptor agonist, as the first and only prescription medication for the treatment of moderate to severe obstructive sleep apnea in adults with obesity.

Furthermore, in February 2025, Huxley Medical received FDA clearance for its SANSA home sleep apnea test, which now allows cellular data upload, eliminating the need for Bluetooth or smartphone apps and simplifying the diagnostic process.

Emerging research is also exploring the link between gut microbiota and OSA. A research published in April 2025 suggested that modulation of gut health could open new therapeutic avenues for managing sleep apnea.

Recently, in August 20205, the FDA approved Nyxoah's Genio hypoglossal nerve stimulation system for moderate to severe OSA patients. In July 2025, Apnimed announced positive topline results from LunAIRo, its second pivotal Phase 3 trial of AD109 (aroxybutynin/atomoxetine), the first potential oral pill for OSA.

Discover more recent advancements in the Obstructive Sleep Apnea treatment landscape @ https://www.delveinsight.com/sample-request/obstructive-sleep-apnea-osa-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=xpr

The obstructive sleep apnea therapies face strong market drivers, including rising prevalence and increased awareness. However, barriers such as high treatment costs and limited patient adherence affect market growth. The high cost of therapies is another major factor restraining the growth of the obstructive sleep apnea drugs market, increasing the economic burden and leading patients to exit proper treatment.

Looking ahead, DelveInsight's analysis underscores that despite therapeutic advances, substantial opportunities remain for developing more effective, convenient, and affordable treatment options that can improve quality of life for obstructive sleep apnea patients worldwide. As research continues and awareness grows, the obstructive sleep apnea market is poised for remarkable expansion and therapeutic innovation through 2034.

Related Reports:
Obstructive Sleep Apnea Pipeline Insight [https://www.delveinsight.com/sample-request/obstructive-sleep-apnea-osa-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=xpr]

Obstructive Sleep Apnea Pipeline Insight provides comprehensive insights about the Obstructive Sleep Apnea pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the Obstructive Sleep Apnea companies, including Apnimed, Incannex Healthcare Ltd, Mineralys Therapeutics Inc., Eli Lilly and Company, Desitin Arzneimittel GmbH, and Shionogi Apnimed Sleep Science, among others.

Company Name: DelveInsight Business Research LLP
Contact Person: Arpit Anand
Email: info@delveinsight.com
Phone: +14699457679
Address: 304 S. Jones Blvd #2432
City: Las Vegas
State: Nevada
Country: United States
Website: https://www.delveinsight.com/

About DelveInsight
DelveInsight is a leading market research and consulting firm specializing in disease-specific insights and therapeutic market analysis. Their reports integrate real-world data, clinical trial findings, and expert interviews to deliver comprehensive industry intelligence.

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