DelveInsight’s “Excessive Daytime Sleepiness Market Insights, Epidemiology, and Market Forecast 2034” report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the Excessive Daytime Sleepiness market size, share, trends, and growth opportunities in the seven major markets (7MM) (i.e., the United States, EU4 (Germany, Spain, Italy, France), the United Kingdom and Japan).
Key highlights from the excessive daytime sleepiness market report:
In 2020, XYWAV (calcium, magnesium, potassium, and sodium oxybate), a lower sodium alternative to Xyrem, was approved for the treatment of Excessive Daytime Sleepiness in narcolepsy. It generated a revenue of USD 1,007 million in 2023.
In 2023, Japan with a Excessive Daytime Sleepiness revenue of approximately USD 382.8 million, which is expected to increase by 2034.
The global market for Excessive Daytime Sleepiness (EDS) across the 7MM was valued at approximately USD 6.23 billion in 2023 and is projected to grow throughout the forecast period (2024–2034). In the United States, the EDS therapeutic market was valued at USD 4.69 billion in 2023.
The current EDS market is primarily driven by drugs such as SUNOSI, WAKIX, XYREM, XYWAV, and others. In 2023, the market sizes for XYREM and WAKIX in the 7MM were USD 1.16 billion and USD 565 million, respectively. The rising prevalence of EDS in recent years can be attributed to improved disease diagnosis, heightened awareness, and lifestyle factors such as poor diet, lack of exercise, smoking, alcohol use, and stress, which increase the risk of developing EDS.
Despite advancements in diagnosis, challenges remain, including a lack of standardized guidelines, the nonspecific nature of symptoms, and variability in disease presentation, often leading to delays in diagnosis. There is also a need for a deeper understanding of the neurobiology of sleep and wakefulness.
The management of EDS typically begins with improving sleep hygiene, followed by behavioral and nonpharmacological interventions. Pharmacotherapy is introduced as an adjunct based on the specific nature of the condition. Approved treatments for EDS include PROVIGIL/MODIODAL (modafinil), NUVIGIL (armodafinil), SUNOSI (solriamfetol), WAKIX (pitolisant), XYWAV (calcium, magnesium, potassium, and sodium oxybates), and XYREM (sodium oxybate), though most of these are primarily indicated for EDS in narcolepsy.
The highest number of EDS cases in the 7MM are linked to obstructive sleep apnea (OSA), bipolar disorder, and Parkinson’s disease. However, much of the focus in drug development has been on narcolepsy-related EDS, with a strong clinical pipeline in that area, leaving a significant gap in treatment options for EDS associated with other conditions like OSA, bipolar disorder, and Parkinson’s disease.
There remains a clear unmet need for affordable treatments that cater to a broader patient population, as current therapies are mostly designed for narcolepsy, with limited options for EDS in OSA, bipolar disorder, and Parkinson’s disease.
In 2020, XYWAV, a lower-sodium alternative to XYREM, was approved for the treatment of EDS in narcolepsy. XYWAV generated USD 1.01 billion in revenue in 2023, and its sales are expected to continue growing, especially as XYREM’s patent expires in 2023, allowing XYWAV to capture a significant portion of the market previously dominated by XYREM.
For EDS associated with OSA, SUNOSI (solriamfetol) was approved by the U.S. FDA in 2019, and it generated USD 132 million in revenue in 2023, with growth expected in the coming years.
AXS-12 (reboxetine), anticipated to enter the U.S. market by 2025 for the treatment of EDS in narcolepsy, is poised to make an impact as a potential treatment following the patent expirations of existing therapies. AXS-12 is expected to experience medium uptake, with peak sales projected to occur in its seventh year on the market.
For EDS in Parkinson’s disease, treatment options remain largely off-label, with no approved therapies currently available. The pipeline for EDS treatments in Parkinson’s disease is limited, and development in this niche remains relatively slow.
The report covers emerging Excessive Daytime Sleepiness drugs, current treatment practices, market share of individual therapies, and current & forecasted market size from 2020 to 2034. It also evaluates the current Excessive Daytime Sleepiness treatment practice/algorithm, key drivers & barriers impacting the market growth, and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.
Excessive Daytime Sleepiness Overview
Excessive Daytime Sleepiness (EDS) is characterized by an overwhelming difficulty in staying awake and alert during the day, often leading to unintentional sleep episodes or sleep occurring at inappropriate times throughout the waking period.
EDS is commonly linked to a variety of underlying conditions, including metabolic, cardiovascular, neurological, and psychiatric disorders, as well as lifestyle factors like poor sleep habits and sleep deprivation. These factors can contribute to significant disability and increase the risk of mortality. In addition to its health-related impact, EDS can also lead to social and economic challenges, making it a major public health concern.
The International Classification of Sleep Disorders (ICSD-2) recognizes EDS as a core symptom in the diagnosis of several conditions, including narcolepsy, hypersomnia, and behaviorally induced insufficient sleep syndrome. However, EDS is also frequently associated with a broad spectrum of other conditions, including psychiatric and neurological disorders, as well as pulmonary and cardiovascular diseases.
Excessive Daytime Sleepiness Market Key Facts:
There are few drugs approved in the 7MM for the treatment of Excessive Daytime Sleepiness such as PROVIGIL/MODIODAL (modafinil), NUVIGIL (armodafinil), SUNOSI (solriamfetol), WAKIX (Pitolisant), XYWAV (calcium, magnesium, potassium, and sodium oxybates), AND XYREM (sodium oxybate). The generics of PROVIGIL/MODIODAL (modafinil) and NUVIGIL (armodafinil) are available in the US market.
According to DelveInsight estimates, the number of diagnosed prevalent cases of excessive daytime sleepiness (EDS) in the United States was approximately 3.9 million in 2023, with projections indicating a rise by 2034. This increase is expected to result from enhanced disease awareness, better differentiation of EDS from conditions like fatigue, and growing recognition of lifestyle and mental health factors such as stress and depression.
In the EU4 and the UK, around 2 million total diagnosed prevalent cases of EDS were reported in 2023. Germany had the highest number of diagnosed cases, followed by France. Despite EDS being a widespread issue in Europe, affecting a substantial portion of the population and potentially compromising daily functioning and quality of life, there is a notable lack of comprehensive data on disease diagnosis, as well as conditions associated with EDS, such as obstructive sleep apnea (OSA). Additionally, misdiagnosis rates are high, particularly in cases of bipolar disorder.
In the U.S., the highest number of EDS cases in 2023 were associated with OSA, which accounted for nearly 2 million diagnosed cases. This was followed by approximately 1 million cases of EDS linked to bipolar disorder and about 611,000 cases related to Parkinson’s disease.
Japan represented roughly 16% of the diagnosed EDS population across the 7MM in 2023. However, misdiagnosis remains a significant challenge due to the non-specific nature of EDS symptoms. The lack of clarity regarding the clinical course and relevance of EDS further complicates the accurate assessment of its prevalence in Japan and other regions.
Excessive Daytime Sleepiness Market
The evaluation and management of excessive daytime sleepiness (EDS) primarily involve identifying and addressing the underlying conditions, such as narcolepsy, Parkinson’s disease, obstructive sleep apnea (OSA), idiopathic hypersomnia (IH), and bipolar disorder. Treatment typically focuses on supportive care, including the use of approved therapies to alleviate symptoms. Common supportive treatments include central nervous system (CNS) stimulants like armodafinil (the R-enantiomer of modafinil), amphetamines (methamphetamine, dextroamphetamine), and methylphenidate.
CNS stimulants, particularly amphetamine-like compounds such as methylphenidate, modafinil, and its R-enantiomer armodafinil, are commonly used to treat sleepiness. These wake-promoting agents, while related to amphetamines, are not themselves classified as amphetamines. More recently, the American Academy of Sleep Medicine (AASM) has recommended sodium oxybate, a short-acting sedative of unclear mechanisms, as a first-line treatment for both excessive daytime sleepiness and cataplexy. Other amphetamine-like medications used in the treatment of narcolepsy include methylphenidate, methamphetamine, D-amphetamine, and mazindol.
PROVIGIL (modafinil), launched by Cephalon in 1999, is indicated for the treatment of excessive daytime sleepiness associated with narcolepsy, OSA, and shift work disorder (SWD). In addition to its U.S. approval, modafinil is marketed under various brand names in over 30 countries, including France, the UK, Ireland, Italy, and Germany, for the treatment of EDS related to narcolepsy. Modafinil was approved in Japan by PMDA in January 2007 for EDS associated with narcolepsy. It was later approved for use in OSA (2011) and idiopathic hypersomnia (2020).
NUVIGIL (armodafinil), the R-enantiomer of modafinil, was launched in June 2009 and is indicated for the treatment of excessive sleepiness related to narcolepsy, OSA, and SWD.
In March 2019, the U.S. FDA approved SUNOSI (solriamfetol) for the treatment of EDS associated with narcolepsy and OSA. Sunosi is the first and only dual-acting dopamine and norepinephrine reuptake inhibitor approved by the FDA to improve wakefulness in adults with EDS related to these conditions. In January 2020, the European Union also granted marketing authorization for Sunosi for use in adults with narcolepsy or OSA. The drug is also being evaluated for use in pediatric patients and is currently the only licensed therapy in Europe for EDS associated with OSA.
Several companies, including Axsome Therapeutics and Suven Life Sciences, are actively developing treatments for excessive daytime sleepiness. Their lead candidates are in various stages of clinical development, with the aim of offering new therapies for patients living with this condition.
Excessive Daytime Sleepiness Epidemiology Assessment
Total Diagnosed Prevalent Cases of EDS in the 7MM [2020–2034]
Total Diagnosed Prevalent Cases of EDS in Different Disorders in the 7MM [2020–2034]
Excessive Daytime Sleepiness Drugs Uptake and Pipeline Development Activities
The American Academy of Sleep Medicine (AASM) recommends sodium oxybate as the first-line treatment for excessive daytime sleepiness (EDS) and cataplexy. The most commonly used amphetamine-like compounds for EDS include methylphenidate, methamphetamine, D-amphetamine (all Schedule II controlled substances), and mazindol (a Schedule IV controlled substance). The clinical use of stimulants for conditions like narcolepsy is guided by established standards of practice, with treatment typically starting at a low dose that is gradually increased to achieve optimal results.
Modafinil is a unique compound developed in France for the treatment of EDS. The R-enantiomer of modafinil, known as armodafinil, has a longer half-life and is FDA-approved for EDS associated with narcolepsy, as well as for residual sleepiness in individuals using continuous positive airway pressure (CPAP) for obstructive sleep apnea (OSA) and for shift work sleep disorder. Armodafinil’s half-life of 10–15 hours is longer than modafinil’s S-enantiomer, which has a half-life of 3–4 hours. The pharmacokinetic properties of modafinil, especially when taken twice daily, contribute to its potency early in therapy during drug accumulation. On a milligram-to-milligram basis, armodafinil results in higher plasma concentrations later in the day than modafinil, which is why modafinil is generally taken twice daily at the start of treatment, while armodafinil is administered once daily.
Methylphenidate, a piperazine derivative of amphetamine, was introduced in 1959 for the treatment of narcolepsy and shares similar pharmacologic properties with amphetamines. Methylphenidate’s chemical structure, like that of amphetamines, resembles endogenous catecholamines. Methylphenidate is frequently used to treat EDS in narcolepsy, with a racemic mixture of both the D-enantiomer and L-enantiomer. However, the D-enantiomer is primarily responsible for the clinical effects, particularly after oral administration. Common side effects of methylphenidate include reduced appetite, nausea, headache, insomnia, and potential psychosis.
Sodium oxybate is widely used as the first-line treatment for cataplexy and to improve EDS, particularly when combined with modafinil. It is a GABA receptor agonist, but the exact mechanism by which it works in narcolepsy is not fully understood. Sodium oxybate is typically taken in two doses before bedtime and 2–4 hours later, with a total daily dose of 6–9 grams. Side effects may include sedation, nausea, weight loss, nocturnal enuresis, and sleepwalking. Because sodium oxybate is a respiratory depressant, it should never be combined with alcohol, hypnotics, or used in patients with untreated OSA, moderate to severe lung disease, or other causes of hypoventilation. It is a Schedule I controlled substance and requires special registration for prescribing, being dispensed through a single pharmacy in the U.S.
Pitolisant is an FDA-approved treatment for EDS in narcolepsy that also reduces the frequency of cataplexy. Unlike other treatments, pitolisant acts as a histamine H3 receptor antagonist/inverse agonist, which stimulates histaminergic neurons at the presynaptic level. This leads to the release of wakefulness-promoting neurotransmitters, including dopamine, noradrenaline, and acetylcholine, making it a unique treatment option in the management of narcolepsy and EDS.
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Excessive Daytime Sleepiness Companies Actively Working in the Therapeutics Market Include
Avadel Pharmaceutical
Axsome Therapeutics
Balance Therapeutics
Benevolent AI Bio
Bioprojet Pharma
Harmony Biosciences
Jazz Pharmaceuticals
NLS Pharma Ltd
Suven Life Sciences
Takeda Pharmaceuticals
Theranexus
XWPharma
And Many Others
Emerging and Marketed Excessive Daytime Sleepiness Therapies Covered in the Report Include:
Pentetrazol: Balance Therapeutics
TAK 925: Takeda Pharmaceuticals
FT218 (Sodium Oxybate): Avadel Pharmaceutical
AXS-12 (Reboxetine): Axsome Therapeutic
Wakix/ Ozawade (Pitolisant): Bioprojet Pharma/ Harmony Biosciences
Sunosi (Solriamfetol): Jazz Pharmaceuticals
And many more
Report Covers the In-depth Assessment of the Emerging Drugs & Key Companies. Download the Sample Report to Learn More @ https://www.delveinsight.com/sample-request/excessive-daytime-sleepiness-eds-market
Table of Contents
1. Key Insights
2. Executive Summary
3. Excessive Daytime Sleepiness Competitive Intelligence Analysis
4. Excessive Daytime Sleepiness Market Overview at a Glance
5. Excessive Daytime Sleepiness Disease Background and Overview
6. Excessive Daytime Sleepiness Patient Journey
7. Excessive Daytime Sleepiness Patient Population and Epidemiology Trends (In the US, EU5, and Japan)
8. Excessive Daytime Sleepiness Treatment Algorithm, Current Treatment, and Medical Practices
9. Excessive Daytime Sleepiness Unmet Needs
10. Key Endpoints of Excessive Daytime Sleepiness Treatment
11. Excessive Daytime Sleepiness Marketed Therapies
12. Excessive Daytime Sleepiness Emerging Drugs and Latest Therapeutic Advances
13. Excessive Daytime Sleepiness Seven Major Market Analysis
14. Attribute Analysis
15. Excessive Daytime Sleepiness Market Outlook (In US, EU5, and Japan)
16. Excessive Daytime Sleepiness Companies Active in the Market
17. Excessive Daytime Sleepiness Access and Reimbursement Overview
18. KOL Views on the Excessive Daytime Sleepiness Market
19. Excessive Daytime Sleepiness Market Drivers
20. Excessive Daytime Sleepiness Market Barriers
21. Appendix
22. DelveInsight Capabilities
23. Disclaimer
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