Excessive Daytime Sleepiness Eds Market

DelveInsight’s ‘Excessive Daytime Sleepiness-Market Insights, Epidemiology, and Market Forecast–2032’ report deliver an in-depth understanding of the Excessive Daytime Sleepiness, historical and forecasted epidemiology as well as the Excessive Daytime Sleepiness market trends in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.

 

The Excessive Daytime Sleepiness market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM Excessive Daytime Sleepiness market size from 2019 to 2032. The Report also covers current Excessive Daytime Sleepiness treatment practice, market drivers, market barriers, SWOT analysis, reimbursement and market access, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Geography Covered

  • The United States
  • EU5 (Germany, France, Italy, Spain, and the United Kingdom)
  • Japan

Study Period: 2019–2032

Excessive Daytime Sleepiness Disease Understanding and Treatment Algorithm

Excessive Daytime Sleepiness Overview

Excessive Daytime Sleepiness is characterized by a difficulty to stay awake and alert during the major waking episodes of the day, with sleep occurring unintentionally or at inappropriate times of the wake period. Excessive Daytime Sleepiness is often associated with a wide range of illnesses, including metabolic, cardiovascular, neurological, and psychiatric diseases with voluntary behaviors reflecting poor sleep and sleep debt, leading to disability and increased risk of mortality. Excessive Daytime Sleepiness is also commonly associated with social and economic consequences, thus constituting a significant public health problem.

 

Sleep plays a vital role in consolidating memory, restoring the immune system, and other vital processes. As a result, a lack of quality sleep may result in a host of symptoms that may not immediately connect to sleep.

Continued in the report…..

 

Excessive Daytime Sleepiness Diagnosis

If an individual constantly feels drowsy during the day and tends to fall asleep at an awkward time and places that affect the productivity of the individual, then that individual needs to consult with a treating physician and discuss the situation. The physician will inquire about the sleeping habits of the patient. The physician will also inquire about any history of alcohol or drug use or abuse currently or in the past. The individual may also be referred to a psychologist for a counseling session if the individual has some stress or emotional problem in life, which could be interfering with sleep. The physician may also order tests to know about the exact cause of Excessive Daytime Sleepiness.

 

Sleep studies, such as the polysomnogram (PSG), the multiple sleep latency tests (MSLT), and the maintenance of wakefulness test (MWT), must be performed in a sleep laboratory, and although more labor-intensive, may also help evaluate diminished alertness and excessive sleepiness

Continued in the report…..

 

Excessive Daytime Sleepiness Treatment

The treatment of Excessive Daytime Sleepiness includes nonpharmacological and pharmacological treatment options. The management of Excessive Daytime Sleepiness depends on the underlying condition. Addressing the underlying cause is the mainstay of treatment of excessive daytime sleepiness. The first step in treating Excessive Daytime Sleepiness is always the optimization and maintenance of good sleep hygiene. In OSA—the most dangerous and physiologically disruptive cause of excessive daytime sleepiness—treatment with positive pressure devices (e.g., CPAP) during sleep improves symptoms of daytime sleepiness for most patients.

 

Typically, a patient is started on a low dose, which is then increased progressively to obtain satisfactory results. Studies have shown that daytime sleepiness can be greatly improved subjectively, but sleep variables are never completely normalized by stimulant treatments. Milder stimulants with low efficacy and potency, such as modafinil or armodafinil, are usually tried first. More effective amphetamine-like stimulants (methylphenidate, D-amphetamine, and methamphetamine) are then used if needed.

 

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) is available in the US market.

Continued in the report…..

Excessive Daytime Sleepiness Epidemiology 

The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by total diagnosed prevalent cases of Excessive Daytime Sleepiness, and diagnosed prevalent cases of Excessive Daytime Sleepiness in different disorders in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2019 to 2032.

 

Key Findings

  • In the Epidemiology model of DelveInsight, we have considered five major indications for the estimation of total Excessive Daytime Sleepiness patients population i.e. Parkinson’s disease (PD), Narcolepsy, Idiopathic Hypersomnia (IH), Obstructive Sleep Apnea (OSA), and Bipolar Disorder.
  • In the 7MM, the total diagnosed prevalent population of Excessive Daytime Sleepiness in 7MM was observed to be 6,857,997 cases in 2021.
  • In 2021, the highest cases of Excessive Daytime Sleepiness was estimated from OSA, followed Bipolar Disorder in the United States.
  • Assessments as per DelveInsight analysis showed that the US accounted for majority of cases in the 7MM with approximately 3,736,749 diagnosed prevalent cases in 2021.
  • In 2021, there were approximately 2,047,802 diagnosed prevalent cases of Excessive Daytime Sleepiness in EU5. Germany accounted highest number of cases.
  • In 2021, Japan accounted for approximately 1,073,447 cases of Excessive Daytime Sleepiness. Majority of Excessive Daytime Sleepiness cases were repoted in OSA.

Country-Wise Excessive Daytime Sleepiness Epidemiology

The epidemiology segment also provides the Excessive Daytime Sleepiness epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.

Excessive Daytime Sleepiness Drug Chapters

The drug chapter segment of the Excessive Daytime Sleepiness report encloses the detailed analysis of Excessive Daytime Sleepiness marketed drugs, mid-phase, and late-stage pipeline drugs. It also helps to understand the Excessive Daytime Sleepiness clinical trial details, expressive pharmacological action, agreements and collaborations, approval, and patent details of each included drug and the latest news and press releases.

 

Excessive Daytime Sleepiness Marketed Drugs

 

Wakix/ Ozawade (Pitolisant): Bioprojet Pharma/ Harmony Biosciences

Pitolisant, a histamine H3 receptor (H3R) antagonist, was developed for its awakening effect in the treatment of narcolepsy with or without cataplexy. Approval from the European marketing authorization was obtained for this indication in March 2016 (under the brand name Wakix). A pediatric investigation plan is underway, and studies are being carried out in narcoleptic children.

Products detail in the report…

 

Sunosi (Solriamfetol): Jazz Pharmaceuticals.

Sunosi is dual-acting dopamine, and norepinephrine reuptake inhibitor (DNRI) is indicated to improve wakefulness in adults living with Excessive Daytime Sleepiness due to narcolepsy or OSA. In 2014, Jazz Pharmaceuticals acquired a license to develop and commercialize Sunosi from Aerial Biopharma. Jazz Pharmaceuticals has worldwide development, manufacturing, and commercialization rights to Sunosi, excluding certain jurisdictions in Asia. SK Biopharmaceuticals, the discoverer of the compound, maintains rights in 12 Asian markets, including Korea, China, and Japan. Sunosi has received Orphan Drug designation for narcolepsy in the United States

Products detail in the report…

 

Excessive Daytime Sleepiness Emerging Drugs

 

FT218 (Sodium Oxybate): Avadel Pharmaceutical

Avadel’s FT218 is an investigational, once-nightly formulation of sodium oxybate using a proprietary micropump technology for extended-release oral suspension in treating Excessive Daytime Sleepiness and cataplexy in patients suffering from narcolepsy. Sodium oxybate is indicated for the treatment of Excessive Daytime Sleepiness and cataplexy in patients with narcolepsy. The currently marketed product, an immediate release (IR) sodium oxybate is required to be taken twice nightly: at bedtime and 2.5–4 h later, thus requiring patients to awaken in the middle of the night. Avadel is currently evaluating the long-term safety and tolerability of FT218 in the open-label RESTORE clinical study, and the NDA is under FDA reviewing procedure.

Products detail in the report…

 

AXS-12 (Reboxetine): Axsome Therapeutic

AXS-12 (reboxetine) is a highly selective and potent norepinephrine reuptake inhibitor under development for the treatment of narcolepsy. It modulates noradrenergic activity to promote wakefulness, maintain muscle tone, and enhance cognition. Reboxetine has an extensive safety record in Europe and in over 40 countries, including the US, where it is approved for the treatment of depression. AXS-12 in narcolepsy is supported by positive preclinical and preliminary clinical results. It significantly reduced narcoleptic episodes in the hypocretin (orexin)-deficient mice and improved daytime sleepiness with reduced cataplexy in patients with narcolepsy in an open-label pilot trial. The drug is presently being evaluated in the Phase III clinical trials for the treatment of narcolepsy.

Products detail in the report…

List to be continued in the report…

Excessive Daytime Sleepiness Market Outlook

The evaluation and management of Excessive Daytime Sleepiness are based on the identification and treatment of underlying conditions (particularly Narcolepsy, Parkinson's disease, Obstructive sleep apnea (OSA), Idiopathic hypersomnia (IH), and Bipolar Disorder, etc.). For all the indications, the mainstay of treatment is supportive care and approved therapies to alleviate the symptoms. Supportive therapies include armodafinil (R-enantiomer of modafinil), amphetamine, methamphetamine, dextroamphetamine, and methylphenidate, etc.

 

Sleepiness is usually treated using amphetamine-like CNS stimulants (i.e., methylphenidate or modafinil and its R-enantiomer, armodafinil), which are wake-promoting compounds unrelated to amphetamines. More recently, the American Academy of Sleep Medicine (AASM) recommended the use of sodium oxybate, a short-lasting sedative of unknown mechanisms, as the first-line treatment of Excessive Daytime Sleepiness and cataplexy. The most commonly used amphetamine-like compounds are methylphenidate, methamphetamine, D-amphetamine (all schedule II compounds), and mazindol (a schedule IV compound). The clinical use of stimulants in narcolepsy often has been the subject of standards of practice published by AASM.

 

According to DelveInsight, market of Excessive Daytime Sleepiness in 7MM is expected to change in the study period 2019–2032.

 

Key Findings

  • The therapeutic market of Excessive Daytime Sleepiness in the 7MM was USD 4,946 million in 2021.
  • The therapeutic market of Excessive Daytime Sleepiness in the United States was USD 3,399 million in the year 2021.
  • The current market of Excessive Daytime Sleepiness is mainly covered by Sunosi, Wakix, Xyrem, Xywav, and others. The market size of Xyrem and Wakix was USD 1,594 million and USD 432 million, respectively in 2021, in the 7MM.
  • The market size in the 7MM might increase at a CAGR of 6.77%. An increase in the prevalence of Excessive Daytime Sleepiness, expansion in label of current therapies, and expected launch of emerging treatment, are the primary factors driving the growth of the Excessive Daytime Sleepiness market.
  • With the expected launch of upcoming therapies, FT218 (Sodium Oxybate), AXS-12 (Reboxetine), and Xywav (in EU) for Excessive Daytime Sleepiness in Narcolepsy; THN102 for Excessive Daytime Sleepiness in PD, Xywav for Excessive Daytime Sleepiness in IH; Ozawade for Excessive Daytime Sleepiness in OSA, the total market of Excessive Daytime Sleepiness is expected to show a decent change in upcoming years specially for PD, and IH.
  • The therapeutic market of Excessive Daytime Sleepiness in Japan was observed to be USD 361 million in the year 2021.

 

The United States Market Outlook

This section provides the total Excessive Daytime Sleepiness market size and; market size by therapies in the United States.

 

EU-5 Market Outlook

The total Excessive Daytime Sleepiness market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.

 

Japan Market Outlook

The total Excessive Daytime Sleepiness market size and market size by therapies in Japan are provided.

Excessive Daytime Sleepiness Drugs Uptake

This section focusses on the rate of uptake of the potential drugs recently launched in the Excessive Daytime Sleepiness market or expected to get launched in the market during the study period 2019–2032. The analysis covers Excessive Daytime Sleepiness market uptake by drugs; patient uptake by therapies; and sales of each drug. 

 

This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs and allows the comparison of the drugs based on market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

Excessive Daytime Sleepiness Development Activities

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

 

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition, and merger, licensing, and patent details for Excessive Daytime Sleepiness emerging therapies.

Reimbursement Scenario in Excessive Daytime Sleepiness

Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In the report, we consider reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.

Competitive Intelligence Analysis

We perform competitive and market Intelligence analysis of the Excessive Daytime Sleepiness market by using various competitive intelligence tools that include–SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the Report

  • The report covers the descriptive overview of Excessive Daytime Sleepiness, explaining its signs and symptoms, causes, classification and currently available therapies.
  • Comprehensive insight has been provided into the Excessive Daytime Sleepiness epidemiology and treatment.
  • Additionally, an all-inclusive account of both the current and emerging therapies for Excessive Daytime Sleepiness is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
  • A detailed review of the Excessive Daytime Sleepiness market; historical and forecasted is included in the report, covering the 7MM drug outreach.
  • The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM Excessive Daytime Sleepiness market.

Report Highlights

  • The robust pipeline with novel MOA and oral ROA and increasing prevalence will positively drive the Excessive Daytime Sleepiness market.
  • The companies and academics are working to assess challenges and seek opportunities that could influence Excessive Daytime Sleepiness R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition and underlying cause.
  • Major players are involved in developing therapies for Excessive Daytime Sleepiness. Launch of emerging therapies will significantly impact the Excessive Daytime Sleepiness market.
  • Our in-depth analysis of the pipeline assets across different stages of development (phase III and phase II), different emerging trends and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.

Excessive Daytime Sleepiness Report Insights

  • Patient Population
  • Therapeutic Approaches
  • Excessive Daytime Sleepiness Pipeline Analysis
  • Excessive Daytime Sleepiness Market Size and Trends
  • Market Opportunities
  • Impact of upcoming Therapies

Excessive Daytime Sleepiness Report Key Strengths

  • 11-Years Forecast
  • 7MM Coverage
  • Excessive Daytime Sleepiness Epidemiology Segmentation
  • Key Cross Competition
  • Highly Analyzed Market
  • Drugs Uptake

Excessive Daytime Sleepiness Report Assessment

  • Current Treatment Practices
  • Unmet Needs
  • Pipeline Product Profiles
  • Market Attractiveness
  • Market Drivers and Barriers
  • SWOT analysis

Key Questions

Market Insights:

  • What was the Excessive Daytime Sleepiness’s market share (%) distribution in 2019 and how it would look like in 2032?
  • What would be the Excessive Daytime Sleepiness’s total market size as well as market size by therapies across the 7MM during the forecast period (2022–2032)?
  • What are the key findings pertaining to the market across the 7MM and which country will have the largest Excessive Daytime Sleepiness market size during the forecast period (2022–2032)?
  • At what CAGR, the Excessive Daytime Sleepiness market is expected to grow at the 7MM level during the forecast period (2022–2032)?
  • What would be the Excessive Daytime Sleepiness market outlook across the 7MM during the forecast period (2022–2032)?
  • What would be the Excessive Daytime Sleepiness market growth till 2032 and what will be the resultant market size in the year 2032?
  • How would the market drivers, barriers and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

 

Epidemiology Insights:

  • What is the disease risk, burden and unmet needs of Excessive Daytime Sleepiness?
  • What is the historical Excessive Daytime Sleepiness patient population in the United States, EU5 (Germany, France, Italy, Spain, and the UK) and Japan?
  • What would be the forecasted patient population of Excessive Daytime Sleepiness at the 7MM level?
  • What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Excessive Daytime Sleepiness?
  • Out of the above-mentioned countries, which country would have the highest prevalent population of Excessive Daytime Sleepiness during the forecast period (2022–2032)?
  • At what CAGR the population is expected to grow across the 7MM during the forecast period (2022–2032)?

 

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:

  • What are the current options for the treatment of Excessive Daytime Sleepiness along with the approved therapy?
  • What are the current treatment guidelines for the treatment of Excessive Daytime Sleepiness in the US and Europe?
  • What are the Excessive Daytime Sleepiness marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, and efficacy, etc.?
  • How many companies are developing therapies for the treatment of Excessive Daytime Sleepiness?
  • How many emerging therapies are in the mid-stage and late stages of development for the treatment of Excessive Daytime Sleepiness?
  • What are the key collaborations (Industry–Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Excessive Daytime Sleepiness therapies?
  • What are the recent therapies, targets, mechanisms of action and technologies developed to overcome the limitation of existing therapies?
  • What are the clinical studies going on for Excessive Daytime Sleepiness and their status?
  • What are the key designations that have been granted for the emerging therapies for Excessive Daytime Sleepiness?
  • What are the 7MM historical and forecasted market of Excessive Daytime Sleepiness?

Reasons to buy

  • The report will help in developing business strategies by understanding trends shaping and driving the Excessive Daytime Sleepiness.
  • To understand the future market competition in the Excessive Daytime Sleepiness market and Insightful review of the key market drivers and barriers.
  • Organize sales and marketing efforts by identifying the best opportunities for Excessive Daytime Sleepiness in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom) and Japan.
  • Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
  • Organize sales and marketing efforts by identifying the best opportunities for the Excessive Daytime Sleepiness market.
  • To understand the future market competition in the Excessive Daytime Sleepiness market.

1. Key Insights

2. Report Introduction

3. Excessive Daytime Sleepiness Market Overview at a Glance

3.1. Market Share (%) Distribution of Excessive Daytime Sleepiness in 2019

3.2. Market Share (%) Distribution of Excessive Daytime Sleepiness in 2032

4. Excessive Daytime Sleepiness Market: Future Perspective

5. Executive Summary of Excessive Daytime Sleepiness

6. Key Events

7. Excessive Daytime Sleepiness: Disease Background and Overview

7.1. Introduction

7.2. Causes of Excessive Daytime Sleepiness

7.3. Symptoms of Excessive Daytime Sleepiness

7.4. Classification

7.5. Diagnosis

7.5.1. Diagnostic Algorithm

7.5.2. Diagnosis Guidelines

7.6. Treatment and Management of Excessive Daytime Sleepiness

7.6.1. Treatment Algorithm

7.6.2. American Academy of Sleep Medicine Clinical Practice Guideline

8. Epidemiology and Patient Population

8.1. Key Findings

8.2. Epidemiology Methodology

8.3. Assumptions and Rationale: 7MM

8.3.1. The United States

8.3.2. Five Major European Countries (Germany, France, Italy, Spain, and the United Kingdom)

8.3.2.1. Germany

8.3.2.2. France

8.3.2.3. Italy

8.3.2.4. Spain

8.3.2.5. The United Kingdom

8.3.3. Japan

8.4. Total Diagnosed Prevalent Population of Excessive Daytime Sleepiness in the 7MM

8.5. The United States

8.5.1. Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in the US

8.5.2. Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in Different Disorders in the US

8.6. Five Major European Countries (Germany, France, Italy, Spain, and the United Kingdom)

8.6.1. Germany

8.6.1.1. Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in Germany

8.6.1.2. Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in Different Disorders in Germany

8.6.2. France

8.6.2.1. Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in France

8.6.2.2. Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in Different Disorders in France

8.6.3. Italy

8.6.3.1. Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in Italy

8.6.3.2. Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in Different Disorders in Italy

8.6.4. Spain

8.6.4.1. Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in Spain

8.6.4.2. Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in Different Disorders in Spain

8.6.5. The United Kingdom

8.6.5.1. Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in the UK

8.6.5.2. Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in Different Disorders in the UK

8.7. Japan

8.7.1. Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in Japan

8.7.2. Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in Different Disorders in Japan

9. Patient Journey

10. Marketed drugs:

10.1. Key Competitors

10.2. Wakix/ Ozawade (Pitolisant): Bioprojet Pharma/ Harmony Biosciences

10.2.1. Drug Description

10.2.2. Regulatory Milestones

10.2.3. Other Development Activities

10.2.4. Clinical Development

10.2.5. Clinical Trials Information

10.2.6. Safety and Efficacy

10.2.7. Product Profile

10.3. Sunosi (Solriamfetol): Jazz Pharmaceuticals

10.3.1. Drug Description

10.3.2. Regulatory Milestones

10.3.3. Other Development Activities

10.3.4. Clinical Development

10.3.5. Clinical Trials Information

10.3.6. Safety and Efficacy

10.3.7. Product Profile

10.4. Xyrem (Sodium oxybate): Jazz Pharmaceuticals

10.4.1. Drug Description

10.4.2. Regulatory Milestones

10.4.3. Other Development Activities

10.4.4. Clinical Development

10.4.5. Clinical Trials Information

10.4.6. Safety and Efficacy

10.4.7. Product Profile

10.5. Xywav (calcium, magnesium, potassium, and sodium oxybates): Jazz Pharmaceuticals

10.5.1. Drug Description

10.5.2. Regulatory Milestones

10.5.3. Other Development Activities

10.5.4. Clinical Development

10.5.5. Clinical Trials Information

10.5.6. Safety and Efficacy

10.5.7. Product Profile

11. Emerging Drugs

11.1. Key Cross Competition

11.2. FT218 (Sodium Oxybate): Avadel Pharmaceutical

11.2.1. Product Description

11.2.2. Other Development Activities

11.2.3. Clinical Development

11.2.4. Clinical Trials Information

11.2.5. Safety and Efficacy

11.2.6. Product Profile

11.2.7. Analysts’ Views

11.3. AXS-12 (Reboxetine): Axsome Therapeutic

11.3.1. Product Description

11.3.2. Other Development Activities

11.3.3. Clinical Development

11.3.4. Clinical Trials Information

11.3.5. Safety and Efficacy

11.3.6. Product Profile

11.3.7. Analysts’ Views

11.4. THN102 (Flecainide and Modafinil): Theranexus

11.4.1. Product Description

11.4.2. Other Developmental Activities

11.4.3. Clinical Development

11.4.4. Clinical Trials Information

11.4.5. Safety and Efficacy

11.4.6. Product Profile

11.4.7. Analysts’ Views

11.5. Samelisant (SUVN-G3031): Suven Life Sciences

11.5.1. Product Description

11.5.2. Other Developmental Activities

11.5.3. Clinical Development

11.5.4. Clinical Trials Information

11.5.5. Safety and Efficacy

11.5.6. Product Profile

11.6. Quilience (Mazindol Extended-release/NLS-2): NLS Pharma Ltd

11.6.1. Product Description

11.6.2. Other Developmental Activities

11.6.3. Clinical Development

11.6.4. Clinical Trials Information

11.6.5. Product Profile

11.6.6. Analysts’ Views

11.7. XW10172: XWPharma

11.7.1. Product Description

11.7.2. Clinical Development

11.7.3. Clinical Trials Information

11.7.4. Safety and Efficacy

11.7.5. Product Profile

11.7.6. Analysts’ Views

11.8. TAK-994: Takeda Pharmaceutical

11.8.1. Product Description

11.8.2. Other Developmental Activities

11.8.3. Clinical Development

11.8.4. Clinical Trials Information

11.8.5. Product Profile

11.8.6. Analysts’ Views

12. Excessive Daytime Sleepiness: Seven Major Market Analysis

12.1. Key Findings

12.2. Market Methodology

12.3. Market Size of Excessive Daytime Sleepiness in the 7MM

12.4. Market Size of Excessive Daytime Sleepiness by Therapies in the 7MM

12.5. Potential of Current and Emerging Therapies

12.6. Key Market Forecast Assumptions

12.7. Attribute Analysis

12.8. Market Outlook

12.9. Market Size of Excessive Daytime Sleepiness in the United States

12.9.1. Total Market Size of Excessive Daytime Sleepiness

12.9.2. Market Size of Excessive Daytime Sleepiness by Therapies

12.10. Market Size of Excessive Daytime Sleepiness in the EU-5

12.10.1. Germany

12.10.1.1. Total Market Size of Excessive Daytime Sleepiness

12.10.1.2. Market Size of Excessive Daytime Sleepiness by Therapies

12.10.2. France

12.10.2.1. Total Market Size of Excessive Daytime Sleepiness

12.10.2.2. Market Size of Excessive Daytime Sleepiness by Therapies

12.10.3. Italy

12.10.3.1. Total Market Size of Excessive Daytime Sleepiness

12.10.3.2. Market Size of Excessive Daytime Sleepiness by Therapies

12.10.4. Spain

12.10.4.1. Total Market Size of Excessive Daytime Sleepiness

12.10.4.2. Market Size of Excessive Daytime Sleepiness by Therapies

12.10.5. The United Kingdom

12.10.5.1. Total Market Size of Excessive Daytime Sleepiness

12.10.5.2. Market Size of Excessive Daytime Sleepiness by Therapies

12.11. Market Size of Excessive Daytime Sleepiness in Japan

12.11.1. Total Market Size of Excessive Daytime Sleepiness

12.11.2. Market Size of Excessive Daytime Sleepiness by Therapies

13. Key Opinion Leaders’ Views

14. Market Drivers

15. Market Barriers

16. SWOT Analysis

17. Unmet Needs

18. Reimbursement and Market Access

19. Appendix

19.1. Bibliography

19.2. Report Methodology

20. DelveInsight Capabilities

21. Disclaimer

22. About DelveInsight

List of Table

Table 1: Summary of Excessive Daytime Sleepiness Market and Epidemiology (2019–2032)

Table 2: Key Events

Table 3: Common Causes or Contributors to Excessive Daytime Sleepiness

Table 4: ESS Scores

Table 5: Diagnostic Criteria for Narcolepsy Types 1 and 2 (Adapted from ICSD-3)

Table 6: Diagnostic Criteria for Idiopathic Hypersomnia (adapted from ICSD-3)

Table 7: Current Pharmacologic Treatment of Excessive Daytime Sleepiness Associated with Narcolepsy

Table 8: American Academy of Sleep Medicine Clinical Practice Guideline for the Treatment of Central Disorders of Hypersomnolence (1/3)

Table 9: American Academy of Sleep Medicine Clinical Practice Guideline for the Treatment of Central Disorders of Hypersomnolence (2/3)

Table 10: American Academy of Sleep Medicine Clinical Practice Guideline for the Treatment of Central Disorders of Hypersomnolence (3/3)

Table 11: Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in the 7MM (2019–2032)

Table 12: Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in the US (2019–2032)

Table 13: Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in Different Disorders in the US (2019–2032)

Table 14: Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in EU-5 (2019–2032)

Table 15: Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in Different Disorders in EU-5 (2019–2032)

Table 16: Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in Germany (2019–2032)

Table 17: Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in Different Disorders in Germany (2019–2032)

Table 18: Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in France (2019–2032)

Table 19: Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in Different Disorders in France (2019–2032)

Table 20: Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in Italy (2019–2032)

Table 21: Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in Different Disorders in Italy (2019–2032)

Table 22: Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in Spain (2019–2032)

Table 23: Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in Different Disorders in Spain (2019–2032)

Table 24: Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in the UK (2019–2032)

Table 25: Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in Different Disorders in the UK (2019–2032)

Table 26: Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in Japan (2019–2032)

Table 27: Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in Different Disorders in the Japan (2019–2032)

Table 28: Comparison of Marketed Drugs Under Development

Table 29: Wakix (Pitolisant), Clinical Trial Description, 2022 (1/3)

Table 30: Wakix (Pitolisant), Clinical Trial Description, 2022 (2/3)

Table 31: Wakix (Pitolisant), Clinical Trial Description, 2022 (3/3)

Table 32: Highlights of Clinical trials

Table 33: Sunosi, Clinical Trial Description, 2022 (1/2)

Table 34: Sunosi, Clinical Trial Description, 2022 (2/2)

Table 35: Efficacy Results for Maintenance of Wakefulness Test (minutes) in Patients With Narcolepsy (Study 1) and OSA (Study 2)

Table 36: Efficacy Results for Epworth Sleepiness Scale in Patients With Narcolepsy (Study 1) and OSA (Study 2)

Table 37: Efficacy Results from Randomized Withdrawal Studies in Patients With Narcolepsy and OSA in Studies 3 and 4

Table 38: Xyrem, Clinical Trial Description, 2022

Table 39: Median Number of Cataplexy Attacks in Trials N1 and N2

Table 40: Change from Baseline in Daytime Sleepiness Score (Epworth Sleepiness Scale) at Week 8 in Trial N3 (Range 0–24)

Table 41: The Proportion of Patients with a Very Much or Much Improved Clinical Global Impression of Change in Daytime and Nighttime Symptoms in Trial N3

Table 42: Change in Baseline in the Maintenance of Wakefulness Test Score (in minutes) at Week 8 in Trial N4

Table 43: Number of Weekly Cataplexy Attacks and Epworth Sleepiness Scale (Child and Adolescent) Score (Trial N5)

Table 44: Clinical Global Impression of Change (CGIc) for Cataplexy Severity and Narcolepsy Overall (Trial N5)

Table 45: Xywav, Clinical Trial Description, 2022

Table 46: Mean and Median Number of Weekly Cataplexy Attacks and Epworth Sleepiness Scale (ESS)

Table 47: Number of Weekly Cataplexy Attacks and Epworth Sleepiness Scale (Child and Adolescent) Score

Table 48: Clinical Global Impression of Change (CGIc) for Cataplexy Severity and Narcolepsy Overall

Table 49: Comparison of Emerging Drugs Under Development (1/3)

Table 50: Comparison of Emerging Drugs Under Development (2/3)

Table 51: Comparison of Emerging Drugs Under Development (3/3)

Table 52: FT218, Clinical Trial Description, 2022

Table 53: AXS-12, Clinical Trial Description, 2022

Table 54: THN102, Clinical Trial Description, 2022

Table 55: Samelisant, Clinical Trial Description, 2022

Table 56: Quilience, Clinical Trial Description, 2022

Table 57: XW10172, Clinical Trial Description, 2022

Table 58: TAK-994, Clinical Trial Description, 2022

Table 59: Market Size of Excessive Daytime Sleepiness in the 7MM, in USD Million (2019–2032)

Table 60: Market Size of Excessive Daytime Sleepiness by Therapies in the 7MM, in USD Million (2019–2032)

Table 61: Key Market Forecast Assumptions for FT218 (for EDS in Narcolepsy)

Table 62: Key Market Forecast Assumptions for Xywav (for EDS in Narcolepsy)

Table 63: Key Market Forecast Assumptions for AXS-12 (for EDS in Narcolepsy)

Table 64: Key Market Forecast Assumptions for Ozawade (for EDS in obstructive sleep apneoa)

Table 65: Key Market Forecast Assumptions for Xywav (for EDS in Idiopathic Hypersomnia)

Table 66: Key Market Forecast Assumptions for THN102 (for EDS in Parkinson’s disease)

Table 67: The United States Market Size of Excessive Daytime Sleepiness in USD Million (2019–2032)

Table 68: Market Size of Excessive Daytime Sleepiness by Therapies in the US, in USD Million (2019–2032)

Table 69: EU-5 Market Size of Excessive Daytime Sleepiness in USD Million (2019–2032)

Table 70: EU-5 Market Size of Excessive Daytime Sleepiness by Therapies, in USD Million (2019–2032)

Table 71: Germany Market Size of Excessive Daytime Sleepiness in USD Million (2019–2032)

Table 72: Market Size of Excessive Daytime Sleepiness by Therapies in Germany, in USD Million (2019–2032)

Table 73: France Market Size of Excessive Daytime Sleepiness in USD Million (2019–2032)

Table 74: Market Size of Excessive Daytime Sleepiness by Therapies in France, in USD Million (2019–2032)

Table 75: Italy Market Size of Excessive Daytime Sleepiness in USD Million (2019–2032)

Table 76: Market Size of Excessive Daytime Sleepiness by Therapies in Italy, in USD Million (2019–2032)

Table 77: Spain Market Size of Excessive Daytime Sleepiness in USD Million (2019–2032)

Table 78: Market Size of Excessive Daytime Sleepiness by Therapies in Spain, in USD Million (2019–2032)

Table 79: The United Kingdom Market Size of Excessive Daytime Sleepiness in USD Million (2019–2032)

Table 80: Market Size of Excessive Daytime Sleepiness by Therapies in the UK, in USD Million (2019–2032)

Table 81: Market Size of Excessive Daytime Sleepiness in Japan, in USD Million (2019–2032)

List of Figures

Figure 1: How EDS is Different from Fatigue?

Figure 2: Causes of Excessive Daytime Sleepiness

Figure 3: Symptoms of Excessive Daytime Sleepiness

Figure 4: Suggested Clinical Algorithm for the Diagnosis of Suspected OSA, Narcolepsy, or Other Sleep Disorders Based on Symptoms of Excessive Daytime Sleepiness

Figure 5: Clinical Approach in the Diagnosis of Excessive Daytime Sleepiness

Figure 6: Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in the 7MM (2019–2032)

Figure 7: Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in the US (2019–2032)

Figure 8: Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in Different Disorders in the US (2019–2032)

Figure 9: Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in EU-5 (2019–2032)

Figure 10: Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in Different Disorders in EU-5 (2019–2032)

Figure 11: Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in Germany (2019–2032)

Figure 12: Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in Different Disorders in Germany (2019–2032)

Figure 13: Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in France (2019–2032)

Figure 14: Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in Different Disorders in France (2019–2032)

Figure 15: Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in Italy (2019–2032)

Figure 16: Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in Different Disorders in Italy (2019–2032)

Figure 17: Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in Spain (2019–2032)

Figure 18: Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in Different Disorders in Spain (2019–2032)

Figure 19: Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in the UK (2019–2032)

Figure 20: Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in Different Disorders in the UK (2019–2032)

Figure 21: Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in Japan (2019–2032)

Figure 22: Total Diagnosed Prevalent Cases of Excessive Daytime Sleepiness in Different Disorders in the Japan (2019–2032)

Figure 23: Diagnostic and Treatment Approach for Excessive Daytime Sleepiness

Figure 24: Market Size of Excessive Daytime Sleepiness in the 7MM, in USD Million (2019–2032)

Figure 25: Market Size of Excessive Daytime Sleepiness by Therapies in the 7MM, in USD Million (2019–2032)

Figure 26: Key Market Forecast Assumptions for FT218 (for EDS in Narcolepsy)

Figure 27: Key Market Forecast Assumptions for Xywav (for EDS in Narcolepsy)

Figure 28: Key Market Forecast Assumptions for AXS-12 (for EDS in Narcolepsy)

Figure 29: Key Market Forecast Assumptions for Ozawade (for EDS in obstructive sleep apneoa)

Figure 30: Key Market Forecast Assumptions for Xywav (for EDS in Idiopathic Hypersomnia)

Figure 31: Key Market Forecast Assumptions for THN102 (for EDS in Parkinson’s disease)

Figure 32: The United States Market Size of Excessive Daytime Sleepiness in USD Million (2019–2032)

Figure 33: Market Size of Excessive Daytime Sleepiness by Therapies in the US, in USD Million (2019–2032)

Figure 34: EU-5 Market Size of Excessive Daytime Sleepiness in USD Million (2019–2032)

Figure 35: EU-5 Market Size of Excessive Daytime Sleepiness by Therapies, in USD Million (2019–2032)

Figure 36: Germany Market Size of Excessive Daytime Sleepiness in USD Million (2019–2032)

Figure 37: Market Size of Excessive Daytime Sleepiness by Therapies in Germany, in USD Million (2019–2032)

Figure 38: France Market Size of Excessive Daytime Sleepiness in USD Million (2019–2032)

Figure 39: Market Size of Excessive Daytime Sleepiness by Therapies in France, in USD Million (2019–2032)

Figure 40: Italy Market Size of Excessive Daytime Sleepiness in USD Million (2019–2032)

Figure 41: Market Size of Excessive Daytime Sleepiness by Therapies in Italy, in USD Million (2019–2032)

Figure 42: Spain Market Size of Excessive Daytime Sleepiness in USD Million (2019–2032)

Figure 43: Market Size of Excessive Daytime Sleepiness by Therapies in Spain, in USD Million (2019–2032)

Figure 44: The United Kingdom Market Size of Excessive Daytime Sleepiness in USD Million (2019–2032)

Figure 45: Market Size of Excessive Daytime Sleepiness by Therapies in the UK, in USD Million (2019–2032)

Figure 46: Market Size of Excessive Daytime Sleepiness in Japan, in USD Million (2019–2032)

Figure 47: Market Size of Excessive Daytime Sleepiness by Therapies in Japan, in USD Million (2019–2032)

Figure 48: Market Drivers

Figure 49: Market Barriers

Figure 50: SWOT Analysis

Figure 51: Unmet Needs

Bioprojet Pharma
Harmony Biosciences
Jazz Pharmaceuticals
Avadel Pharmaceutical
Axsome Therapeutic
Theranexus
Suven Life Sciences
NLS Pharma Ltd
XWPharma
Takeda Pharmaceutical

 

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