Excessive Daytime Sleepiness (EDS) Market: Insights into Epidemiology, Treatment Landscape, and Key Players | Bioprojet Pharma, Harmony Biosciences, Jazz Pharmaceuticals, Avadel Pharmaceuticals, Axsom

The total Excessive Daytime Sleepiness market size in the 7MM was approximately USD 6,227 million in 2023 and is projected to increase during the forecast period (2024-2034).

Emerging therapies for Excessive Daytime Sleepiness (EDS), including WAKIX (pitolisant), XYREM (sodium oxybate), XYWAV (a combination of calcium, magnesium, potassium, and sodium oxybates), among others, are anticipated to drive significant growth in the EDS market in the coming years.

DelveInsight has released a new report titled "Excessive Daytime Sleepiness - Market Insights, Epidemiology, and Market Forecast-2034", offering a comprehensive analysis of the condition, covering historical and projected epidemiology, as well as market dynamics across the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.

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Some of the key facts of the Excessive daytime sleepiness Market Report:

DelveInsight estimates that in 2023, there were about 3.9 million diagnosed cases of Excessive Daytime Sleepiness (EDS) in the United States, a figure projected to rise by 2034 due to increased disease awareness, better differentiation from fatigue, and recognition of contributing lifestyle and mental health factors such as stress and depression.

In EU4 and the UK, nearly 2 million diagnosed prevalent cases were reported in 2023, with Germany accounting for the largest share, followed by France. Although EDS is widespread across Europe and significantly impacts quality of life, challenges remain due to limited diagnostic data and high misdiagnosis rates, particularly with conditions like obstructive sleep apnea (OSA) and bipolar disorder.

The 7MM EDS market was valued at approximately USD 6.2 billion in 2023, with expectations of continued growth through 2034. In the US alone, the market reached USD 4.7 billion in 2023. Key therapies included SUNOSI, WAKIX, XYREM, and XYWAV, with XYREM and WAKIX generating USD 1.16 billion and USD 565 million, respectively, across the 7MM. XYWAV, approved in 2020 as a lower-sodium alternative to XYREM for narcolepsy-related EDS, achieved USD 1.01 billion in 2023. In Japan, the market was valued at USD 382.8 million in 2023, also showing growth potential toward 2034.

Pipeline advancements are expected to reshape the treatment landscape. AXS-12 (reboxetine) is anticipated to enter the US market in 2025 for narcolepsy-related EDS, with moderate uptake projected to peak by its seventh year, benefiting from the expiration of patents for existing drugs.

Recent FDA approvals have further strengthened the market:

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June 2024: Harmony Biosciences' Wakix (pitolisant) approved for children greater than or equal to 6 years with narcolepsy, making it the first non-scheduled treatment for pediatric EDS.

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October 2024: Avadel Pharmaceuticals' Lumryz, an extended-release sodium oxybate for children greater than or equal to 7 years with narcolepsy, received approval. Its once-nightly dosing offers an advantage over twice-nightly options, potentially enhancing adherence.

Several leading companies, including Bioprojet Pharma, Harmony Biosciences, Jazz Pharmaceuticals, Avadel Pharmaceuticals, Axsome Therapeutics, Theranexus, Suven Life Sciences, NLS Pharma Ltd, XWPharma, and Takeda Pharmaceuticals, continue to advance innovative therapies. Among the most promising treatments are WAKIX (pitolisant), XYREM (sodium oxybate), XYWAV (multi-cation oxybates), and others, expected to fuel sustained market expansion.

Excessive daytime sleepiness Overview

Excessive Daytime Sleepiness (EDS) is characterized by an overwhelming urge to sleep or difficulty staying awake during typical waking hours. Unlike general fatigue or tiredness, EDS often persists despite adequate nighttime rest and can significantly interfere with daily activities, work, academic performance, and quality of life.

EDS can result from a range of underlying conditions, including sleep disorders (narcolepsy, obstructive sleep apnea, restless legs syndrome), neurological or psychiatric disorders (depression, bipolar disorder), chronic medical illnesses, and lifestyle factors such as poor sleep hygiene, irregular schedules, or high stress.

EDS diagnosis often requires careful differentiation from fatigue. Tools like the Epworth Sleepiness Scale (ESS), sleep diaries, polysomnography, and multiple sleep latency tests (MSLT) are commonly used to evaluate severity and underlying causes. Misdiagnosis is frequent, particularly with disorders like obstructive sleep apnea or psychiatric conditions.

Excessive daytime sleepiness Market Outlook

The assessment and treatment of excessive daytime sleepiness (EDS) aim to identify and address underlying causes such as narcolepsy, Parkinson's disease, obstructive sleep apnea (OSA), idiopathic hypersomnia (IH), and bipolar disorder. Management generally combines supportive care with approved pharmacological therapies to reduce symptoms. Supportive options include wake-promoting and stimulant drugs such as armodafinil (the R-enantiomer of modafinil), amphetamines, methamphetamine, dextroamphetamine, and methylphenidate.

EDS is most often managed with central nervous system (CNS) stimulants, including amphetamine-like medications such as methylphenidate, methamphetamine, and D-amphetamine, as well as non-amphetamine agents like modafinil and armodafinil. The American Academy of Sleep Medicine (AASM) has also recommended sodium oxybate, a short-acting sedative with an unclear mechanism of action, as a first-line therapy for both EDS and cataplexy. Amphetamine-based drugs remain widely used, though they are controlled substances (e.g., methylphenidate, methamphetamine, and D-amphetamine are Schedule II, while mazindol is Schedule IV), with usage guided by AASM practice standards.

Provigil (modafinil), introduced by Cephalon in 1999, is approved to treat EDS related to narcolepsy, OSA, and shift work disorder (SWD). It is available in over 30 countries, including the US, France, the UK, Italy, Ireland, and Germany. In Japan, the PMDA approved modafinil in 2007 for narcolepsy-related EDS, followed by approvals for OSA-related sleepiness with CPAP therapy in 2011 and idiopathic hypersomnia in 2020. Nuvigil (armodafinil), the R-isomer of modafinil, was launched in 2009 and is indicated for EDS associated with narcolepsy, OSA, and SWD.

In 2019, the FDA approved Sunosi (solriamfetol) for EDS linked to narcolepsy or OSA. Sunosi is the first dual-acting dopamine and norepinephrine reuptake inhibitor cleared by the FDA to improve wakefulness in adults with EDS due to these conditions. In 2020, it received EU marketing authorization for the same indications and is currently under evaluation for pediatric use. Notably, Sunosi is the only approved therapy in Europe for EDS in adults with OSA.

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Marketed Excessive daytime sleepiness Drugs

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WAKIX/ OZAWADE (pitolisant): Bioprojet Pharma/Harmony Biosciences

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SUNOSI (Solriamfetol): Jazz Pharmaceuticals

Excessive daytime sleepiness Emerging Drugs

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AXS-12 (Reboxetine): Axsome Therapeutic

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Samelisant (SUVN-G3031): Suven Life Sciences

Scope of the Excessive daytime sleepiness Market Report

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Study Period: 2020-2034

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Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]

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Key Excessive daytime sleepiness Companies: Bioprojet Pharma, Harmony Biosciences, Jazz Pharmaceuticals, Avadel Pharmaceutical, Axsome Therapeutic, Theranexus, Suven Life Sciences, NLS Pharma Ltd, XWPharma, Takeda Pharmaceutical, and others

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Key Excessive daytime sleepiness Therapies: WAKIX (pitolisant), XYREM (sodium oxybate), XYWAV (calcium, magnesium, potassium, and sodium oxybates), and others

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Excessive daytime sleepiness Therapeutic Assessment: Excessive daytime sleepiness current marketed and Excessive daytime sleepiness emerging therapies

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Excessive daytime sleepiness Market Dynamics: Excessive daytime sleepiness market drivers and Excessive daytime sleepiness market barriers

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Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies

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Excessive daytime sleepiness Unmet Needs, KOL's views, Analyst's views, Excessive daytime sleepiness Market Access and Reimbursement

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Key benefits of the Excessive daytime sleepiness Market Report:

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Excessive daytime sleepiness market report covers a descriptive overview and comprehensive insight of the Excessive daytime sleepiness Epidemiology and Excessive daytime sleepiness market in the 7MM (the United States, EU5 (Germany, Spain, France, Italy, UK) & Japan).

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The Excessive daytime sleepiness market report provides insights into the current and emerging therapies.

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The Excessive daytime sleepiness market report provides a global historical and forecasted market covering drug outreach in 7MM.

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The Excessive daytime sleepiness market report offers an edge that will help in developing business strategies by understanding trends shaping and driving the Excessive daytime sleepiness market.

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Table of Contents

1. Report Introduction

2. Executive Summary

3. SWOT analysis

4. Excessive daytime sleepiness Patient Share (%) Overview at a Glance

5. Excessive daytime sleepiness Market Overview at a Glance

6. Excessive daytime sleepiness Disease Background and Overview

7. Excessive daytime sleepiness Epidemiology and Patient Population

8. Country-Specific Patient Population of Excessive daytime sleepiness

9. Excessive daytime sleepiness Current Treatment and Medical Practices

10. Unmet Needs

11. Excessive daytime sleepiness Emerging Therapies

12. Excessive daytime sleepiness Market Outlook

13. Country-Wise Excessive daytime sleepiness Market Analysis (2020-2034)

14. Market Access and Reimbursement of Therapies

15. Market drivers

16. Market barriers

17. Appendix

18. Excessive daytime sleepiness Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

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Related Reports:

Excessive daytime sleepiness Pipeline Insights, DelveInsight

"Excessive daytime sleepiness Pipeline Insight, 2024" report by DelveInsight outlines comprehensive insights of present clinical development scenarios and growth prospects across the Excessive daytime sleepiness market. A detailed picture of the Excessive daytime sleepiness pipeline landscape is provided, which includes the disease overview and Excessive daytime sleepiness treatment guidelines.

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.

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