Obstructive sleep apnea (OSA) is a chronic sleep disorder characterized by periodic narrowing and obstruction of the pharyngeal airways during sleep. There is considerable morbidity involved in the disease due to resulting complications, which includes cardiovascular and metabolic disorder, sometimes in addition to cognitive impairment and depression due to severely affected sleep cycle in the patients.

The epidemiology assessment by the analysts at DelveInsight in the report Obstructive Sleep Apnea Market Insight, Epidemiology And Market Forecast – 2032 estimates that there were 25 million cases of OSA in the 7MM (the US, EU4 countries (Germany, France, Italy, Spain) and the UK, and Japan). Around 13.7 million assessed cases have been diagnosed in the US only in 2022. The gold standard of treatment in the disease is CPAP (continuous positive airway pressure), in which a machine delivers pressurized air through tubing into a mask worn during sleep to avoid shifting the uvula and soft palate into airways, causing obstruction. Other oral devices are also recommended for the treatment. Various wakefulness-promoting therapeutic agents are approved that specifically target symptomatic relief by treating Excessive Daytime Sleepiness (EDS). For example, an oral therapy, SUNOSI, was approved in 2019 by the FDA and treats EDS in such patients. Additionally, Ozawade was granted market authorization by EMA for treating EDS in OSA in 2021. These therapies primarily treat the symptoms and not cure the disease.

To evolve the existing treatment modalities for OSA, considerable research is underway in the domain. On a similar note, an oral drug, AD109 (aroxybutynin/atomoxetine), considered to have the potential to treat the underlying cause of OSA by resolving concerns of airway obstruction at night and improving daytime manifestation of the disease, is currently in the pipeline. The novel therapy is being developed and investigated by Apnimed – a completed Phase II trial. It targets the overall OSA patient pool instead of relieving severe symptomatic patients. The MOA of the drug is based on selective antimuscarinic and norepinephrine reuptake inhibitory activity.

At the European Respiratory Society International Conference 2023, Apnimed will be presenting the post hoc analysis of its MARIPOSA Phase IIb trial for the drug AD109, elucidating the estimation of OSA endotypes from oxyhemoglobin saturation signal in patients dosed with AD109 under the poster presentation title, “Basic and Clinical Science in Sleep Breathing Disorders: A Bidirectional Relationship.”

The US-based trial was a randomized, double-blind, placebo-controlled, dose-finding study that included 294 patients with OSA of different severity (AHI 10-45). For the study, the trial enrollment included treatment-naïve participants and OSA patients unwilling or unable to tolerate the current standard of care therapy, CPAP. The results were published by the Apnimed detailing the drug meeting the primary endpoint of AHI, showing a statistically significant reduction in the parameter for all severity types. The study encourages the company to advance into Phase III.

Based on the market forecast model of DelveInsight, the OSA market size in the US is currently USD 291 million and is expected to expand considerably with the approval of AD109 by 2026. Upon approval of the therapy, it is expected to erode the market share of EDS-based approved drugs in the region. By 2032, the total OSA market is anticipated to attain a size of more than USD 1 billion in the US only.

Significant market opportunity is available for the key players in the OSA domain, which can be utilized to capture a fair share of patients who are either untreated or do not tolerate the current treatment therapies.