Obstructive Sleep Apnea (OSA) - Market Insight, Epidemiology And Market Forecast - 2032

Obstructive Sleep Apnea (OSA) - Market Insight, Epidemiology And Market Forecast - 2032

Key Highlights

Most Obstructive Sleep Apnea (OSA) patients either remain undiagnosed or get misdiagnosed, leading to the progression of the disease to severe conditions.

In 2022, the market size of OSA was highest in the US among the 7MM, accounting for approximately USD 290 million, which is further expected to increase by 2032.

The available treatment is focused on treating EDS in OSA, such as SUNOSI, making up the total market of around USD 62 million in 2022 in the US.

Despite the high prevalence, with total diagnosed cases of around 24 million in 2022 in the 7MM, the treatment market of OSA lacks approved therapy specific to OSA treatment.

As per the guidelines, CPAP is considered the standard OSA treatment. Apnimed’ AD109 is expected to launch by 2026 in the US and is expected to be competitive in the first line of treatment.

SUNOSI was approved in 2019 and 2020 in the US and EU to improve wakefulness in adults living with EDS because OSA is expected to lose patent protection in 2026–2037.

Emerging therapies have the potential to create a significant positive shift in the OSA market size.

DelveInsight’s “Obstructive Sleep Apnea (OSA) – Market Insights, Epidemiology and Market Forecast – 2032” report delivers an in-depth understanding of the OSA, historical and forecasted epidemiology as well as the OSA market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

The OSA market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM OSA market size from 2019 to 2032. The report also covers current OSA treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s underlying potential.

Geography Covered

The United States

EU4 (Germany, France, Italy, and Spain) and the United Kingdom

Japan

Study period: 2019–2032

Obstructive Sleep Apnea (OSA) Disease Understanding and Treatment Algorithm

Obstructive Sleep Apnea (OSA) Overview

Obstructive sleep apnea (OSA) is a common, chronic, sleep-related breathing disorder characterized by periodic narrowing and obstruction of the pharyngeal airway during sleep, leading to either complete or partial airway obstruction, resulting in apneas, hypopneas, or both. This disorder causes daytime somnolence, neurocognitive defects, and depression.

Obstructive Sleep Apnea (OSA) Diagnosis

The diagnosis of Obstructive Sleep Apnea (OSA) syndrome is determined when the patient exhibits recurrent episodes of partial or total collapse of the upper airway during sleep, resulting in apneas or hypopneas, respectively. Criteria defining an apnea or a hypopnea vary. The ideal diagnostic procedure is in-lab polysomnography (PSG). Unattended home sleep apnea testing (HSAT) with a Type 3 device is a feasible choice for patients in whom uncomplicated OSA is suspected, and the pretest likelihood is anticipated to be moderate to severe.

The journey begins when the patient starts experiencing the OSA cycle while sleeping, where frequent obstruction in breathing occurs, leading to the partial awakening of the patient. The patient may or may not get aware of this partial awakening; as a result, many patients remain undiagnosed. A well-aware patient goes to the physician, and after a physical examination and knowing the patient’s history, the doctor suggests other diagnostic techniques, such as PSG and sleep tests.

Although the current approach to the diagnosis of these patients is quite similar as most of the developing countries establish the diagnosis journey of a patient using the American Academy of Sleep Medicine Clinical Practice Guideline, however when it comes to analyzing the real-world scenario in varying geographies, there are some differences in diagnostic criteria, and risk stratification.

Further details related to country-based variations are provided in the report.

Obstructive Sleep Apnea (OSA) Treatment

Despite the high prevalence, the treatment rate for OSA is less due to unawareness of the condition. The current treatment market for OSA lacks approved drugs that target OSA; in turn, symptomatic treatment exists.

CPAP therapy is regarded as the gold standard treatment option for OSA; however, patient adherence to the therapy is low due to various side effects. Oral appliances (OA) may also improve upper airway patency during sleep by enlarging the upper airway and/or decreasing upper airway collapsibility (e.g., improving upper airway muscle tone).

Several pharmacological therapies are also currently being used to address the symptoms of OSA. These include SUNOSI (solriamfetol), OZAWADE (in Europe), and others for treating excessive daytime sleepiness due to OSA.

Obstructive Sleep Apnea (OSA) Epidemiology

As the market is derived using the patient-based model, the Obstructive Sleep Apnea (OSA) epidemiology chapter in the report provides historical and forecasted epidemiology segmented by total diagnosed prevalent cases of OSA, gender-specific diagnosed prevalent cases of OSA, age-specific diagnosed prevalent cases of OSA, and severity-specific diagnosed prevalent cases of OSA in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2019 to 2032. The total prevalent cases of Obstructive Sleep Apnea in the 7MM comprised approximately 24 million cases in 2022 and are projected to increase during the forecasted period

The total diagnosed prevalent cases of OSA in the United States were around 13 million cases in 2022.

The United States contributed to the largest diagnosed prevalent population of OSA, acquiring ~53% of the 7MM in 2022. Whereas EU4 and the UK, and Japan accounted for around 27% and 20% of the total population share, respectively, in 2022. These cases are attributed to the rise of the increasing population associated with OSA risk factors such as obesity, age, etc.

Among the EU4 countries, France accounted for the largest OSA cases, followed by Germany, whereas Spain accounted for the lowest number of cases in 2022.

In the 7MM, approximately 61% of the patient share is attributed to males, whereas only 39% of females suffer from OSA.

A higher number of diagnosed cases were estimated in the 65+ age group, suggesting that the prevalence of OSA increases with age.

According to DelveInsight estimates, based on severity, there were around 5 million cases of severe OSA cases, while mild and moderate cases of OSA were estimated to be around 4 million and 3 million, respectively, in the United States in 2022.

Obstructive Sleep Apnea (OSA) Drug Chapters

The drug chapter segment of the OSA report encloses a detailed analysis of OSA-marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also helps understand the OSA clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.

Marketed Drugs

SUNOSI (Solriamfetol): Axsome Therapeutics/Jazz Pharmaceuticals

SUNOSI is a dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) and is indicated to improve wakefulness in adults living with EDS due to narcolepsy or OSA. In 2014, Jazz Pharmaceuticals acquired a license to develop and commercialize SUNOSI from Aerial Biopharma.

The company holds several patents in the US, which are expected to expire during 2026–2037. This might lead to the availability of generics of the drug. Also, as there is no specific drug for OSA; therefore, an emerging drug, namely AD109, may give tough competition after approval.

Note: Detailed current therapies assessment will be provided in the full report of Obstructive Sleep Apnea (OSA).

Emerging Drugs

AD109: Apnimed

AD109 is a first-in-class, oral pharmaceutical combination dosed once daily at bedtime, designed to treat OSA patients across a broad spectrum of disease severity. As it treats the underlying cause of OSA, airway obstruction at night, and improves daytime consequences of OSA, such as fatigue, it strengthens its potential. Also, as the current market does not have treatment for OSA, if approved, AD109 could change the treatment paradigm of OSA.

Note: Detailed emerging therapies assessment will be provided in the final report.

Drug Class Insights

The existing Obstructive Sleep Apnea (OSA) treatment mainly includes different drug classes targeting the symptoms of OSA. These classes include dopamine-norepinephrine reuptake inhibitors, wakefulness-promoting agents, and H3 blockers.

Moreover, the upcoming treatment landscape is poised to see further expansion after the emergence of new classes such as AD109, which is a combination of norepinephrine reuptake inhibitor (NRI), atomoxetine, with a novel NCE selective antimuscarinic, aroxybutynin, which is effective in reducing the obstruction of the upper airway while sleeping. Such novel mechanism drugs are expected to change the dynamics of the current treatment regime.

Obstructive Sleep Apnea (OSA) Market Outlook

OSA’s evaluation and management goal is to ensure airflow is not obstructed during sleep. OSA is usually treated by weight management and exercise, CPAP therapy (first line of treatment for OSA), bilevel positive airway pressure (BPAP) machines (if CPAP therapy is not effective), and surgery. The most commonly associated indication of EDS can be treated by PROVIGIL/MODIODAL (modafinil), NUVIGIL (armodafinil), SUNOSI (solriamfetol), Pitolisant, and some other off-labeled drugs. The generics of modafinil and armodafinil is available in the US market.

The major challenge and unmet need in OSA treatment are that no drug is approved for the direct treatment of OSA. The key competitive factors that may affect the success of these products, and any other product candidates that are yet to reach the market, if approved, are likely to be efficacy, safety, convenience, cost, the availability of generic competition, and the reimbursement from government and/or other third-party payers.

Few new agents are being developed and tested as potential treatments for OSA; the emerging drugs include AD109, pitolisant (in Japan), and others.

The total market size of OSA in the 7MM is approximately USD 408 million in 2022 and is projected to increase during the forecast period (2022–2032).

The market size in the 7MM will increase at a constant CAGR due to increasing awareness of the disease, better diagnosis, and the launch of the emerging target therapy for OSA.

Among EU4 countries, France, with about USD 24 million, accounts for the maximum market size in 2022, while Spain and the UK occupy the bottom of the ladder with around USD 13 million in 2022.

Japan’s treatment market lacks approved targeted treatment for OSA, but with the expected approval of Aculys Pharma Pitolisant by 2025, the market is expected to experience positive growth.

Obstructive Sleep Apnea (OSA) Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to get launched in the market during the study period 2019–2032. For example, for AD109, we expect the drug uptake to be slow–medium with a probability-adjusted peak share of around 2%, and years to the peak is expected to be 6 years from the year of launch.

Further detailed analysis of emerging therapies and drug uptake is in the report.

Obstructive Sleep Apnea (OSA) Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I stage. It also analyzes key players involved in developing targeted therapeutics.

Pipeline development activities

The report covers detailed information on collaborations, acquisitions and mergers, licensing, and patent details for Obstructive Sleep Apnea (OSA) emerging therapies.

KOL Views

To keep up with current market trends, we take KOLs and SMEs’ opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts contacted for insights on OSA evolving treatment landscape, patient reliance on conventional therapies, patient’s therapy switching acceptability, and drug uptake along with challenges related to accessibility, include medical/scientific writers, medical oncologists, and professors, director of Henry Mayo Newhall Memorial Hospital, researchers from respiratory dept. Hospital Universitario y Politécnico La Fe, and others.

Delveinsight’s analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers such as the University of Palermo and CNR Institute of Biomedicine and Molecular Immunology (IBIM), Division of Behavioral Sleep Medicine, Iwate Medical University School of Medicine, etc., were contacted. Their opinion helps understand and validate current and emerging therapies and treatment patterns or Obstructive Sleep Apnea (OSA) market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform qualitative and market intelligence analysis using various approaches, such as SWOT 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, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

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

Reimbursement is a crucial point for any drug after its approval. Many drugs or therapies are not properly recognized by the reimbursement body and may fail to get reimbursed, or their reimbursement process gets delayed. CPAP, the first-line therapy for OSA, is currently included in the list of products and services qualifying for reimbursements and funded under the indications established due to the clinical symptoms reported (with the exclusion of any other sleep disorder) and an AHI score that must be =15.

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 governments' prescription drug programs, etc.

Scope of the Report

The report covers a segment of key events, an executive summary, and a descriptive overview of Obstructive Sleep Apnea (OSA), explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.

Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines.

Additionally, an all-inclusive account of the current and emerging therapies, along with the elaborative profiles of late-stage and prominent therapies, will impact the current treatment landscape.

A detailed review of the OSA market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.

The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM OSA market.

Obstructive Sleep Apnea (OSA) Report Insights

Patient population

Therapeutic approaches

OSA pipeline analysis

OSA market size and trends

Existing and future market opportunities

Obstructive Sleep Apnea (OSA) Reports Key Strengths

Ten years forecast

The 7MM coverage

OSA epidemiology segmentation

Key cross competition

Attribute analysis

Drugs uptake and key market forecast assumptions

Obstructive Sleep Apnea (OSA) Report Assessment

Current treatment practices

Unmet needs

Pipeline product profiles

Market attractiveness

Qualitative analysis (SWOT and conjoint analysis)

Key Questions

Market Insights

What were the Obstructive Sleep Apnea (OSA) total market size, the market size by therapies, and market share (%) distribution in 2019, and how would it all look in 2032? What are the contributing factors for this growth?

What unmet needs are associated with the current treatment market of OSA?

What will be the impact of SUNOSI’s expected patent expiry in 2028?

How is AD109 going to compete with the first line of therapy for OSA after approval?

Which drug is going to be the largest contributor in 2032?

What are the pricing variations among different geographies for approved and off-label therapies?

How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights

What are the disease risk, burden, and unmet needs of Obstructive Sleep Apnea (OSA)? What will be the growth opportunities across the 7MM concerning the patient population of OSA?

What is the historical and forecasted OSA patient pool in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?

Why do only limited patients appear for diagnosis? Why is the current year diagnosis rate not high?

Which severity stage is more prevalent and why?

What factors are affecting the diagnosis of the indication?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies

What are the current options for the treatment of Obstructive Sleep Apnea? What are the current treatment guidelines for the treatment of Obstructive Sleep Apnea in the US and Europe?

How many companies are developing therapies for the treatment of Obstructive Sleep Apnea?

How many emerging therapies are in the mid-stage and late stage of development for the treatment of Obstructive Sleep Apnea?

What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?

What key designations have been granted for the emerging therapies for Obstructive Sleep Apnea?

What will be the impact of SUNOSI’s and OZAWADE’s expected patent expiry?

What is the cost burden of approved therapies on the patient?

Patient acceptability in terms of preferred treatment options as per real-world scenarios?

What are the country-specific accessibility issues of expensive, recently approved therapies? Focus on reimbursement policies.

What are the 7MM historical and forecasted market of Obstructive Sleep Apnea?

Reasons to Buy

The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Obstructive Sleep Apnea Market

Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years

To understand the existing market opportunity in varying geographies and the growth potential over the coming years.

Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.

Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.

Detailed analysis and ranking of class-wise potential current and emerging therapies under the Conjoint analysis section to provide visibility around leading classes

Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of off-label expensive therapies, and patient assistance programs

To understand the perspective of Key Opinion Leaders’ around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in future

Detailed insights on the unmet need of the existing market so that the upcoming players can strengthen their development and launch strategy