Excessive Daytime Sleepiness Eds Market
DelveInsight’s ‘Excessive Daytime Sleepiness (EDS)-Market Insights, Epidemiology, and Market Forecast–2030’ report deliver an in-depth understanding of the EDS, historical and forecasted epidemiology as well as the EDS market trends in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.
The EDS market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM EDS market size from 2017 to 2030. The Report also covers current EDS treatment practices, market drivers, market barriers, unmet medical needs, SWOT analysis to curate the best of the opportunities, and assesses the underlying potential of the market.
- The United States
- EU5 (Germany, France, Italy, Spain, and the United Kingdom)
Study Period: 2017–2030
Excessive Daytime Sleepiness (EDS) Disease Understanding and Treatment Algorithm
Excessive Daytime Sleepiness (EDS) Overview
Excessive daytime sleepiness (EDS) 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. EDS is often associated with a wide range of illnesses including metabolic, cardiovascular, neurological, psychiatric diseases but also with voluntary behaviors reflecting poor sleep and sleep debt, leading to disability and increased risk of mortality. EDS is also commonly associated with social and economic consequences thus constituting a significant public health problem.
Excessive Daytime Sleepiness (EDS) Diagnosis
The diagnosis of EDS includes questionnaires, identification of underlying medical condition, and diagnosis testing [i.e., Epworth Sleepiness Scale (ESS), Multiple Sleep Latency Test (MSLT), and Maintenance of Wakefulness Test (MWT)].
As EDS is usually considered as a symptom of other medical conditions, the diagnosis is often delayed. The patient pool suffering from EDS is mostly misdiagnosed of their condition; when the symptoms are highlighted further, they are often non-specific.
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Excessive Daytime Sleepiness (EDS) Treatment
The treatment of EDS usually starts with the maintenance of good sleep hygiene. EDS management begins with behavioral and nonpharmacological approaches, with pharmacotherapy used as an adjunct, based on the common nature of the problems.
Therapy for insomnia and other causes of insufficient sleep often begins with behavioral and nonpharmacologic approaches, with pharmacotherapy used as an adjunct, based on the common nature of the problems (e.g., behavioral and habitual). The first step in treating EDS is always the optimization and maintenance of good sleep hygiene. Specific treatment options for patients with OSA include adenotonsillectomy, weight reduction, and continuous positive airway pressure.
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. 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 EDS 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. 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.
Excessive Daytime Sleepiness (EDS) Epidemiology
The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Total Diagnosed Prevalent Cases of EDS and Total Diagnosed Prevalent Cases of EDS in Different Disorder scenario of EDS in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2017 to 2030.
- In the epidemiology report, we have considered major indications in which EDS occurs, such as Parkinson’s disease (PD), Narcolepsy, Idiopathic Hypersomnia (IH), Obstructive Sleep Apnea (OSA), and Bipolar Disorder.
- The total diagnosed prevalent population of EDS in these five disorders in the 7MM was estimated to be 6,295,782 in 2017.
- The total diagnosed prevalent cases of EDS in the US were 2,960,518 in 2017.
- In the US, the majority of the cases of EDS are found in OSA and Bipolar disorder, followed by Parkinson's Disease, Narcolepsy, and Idiopathic Hypersomnia.
- Among the European countries, Germany had the highest diagnosed prevalent population of EDS with 590,827 cases, followed by France which had a diagnosed prevalent population of 487,146 in 2017. On the other hand, Italy had the lowest diagnosed prevalent cases.
- The total diagnosed prevalent cases of EDS in Japan were estimated to be 1,410,155 in 2017. The highest cases were estimated in OSA, followed by Bipolar Disorder. There were about 1,177,957 EDS cases diagnosed in OSA, followed by 149,322 EDS cases in Bipolar Disorder. The diagnosed EDS cases in other disorders were 47,419 in Narcolepsy, 1,600 in IH, and 33,857 in PD.
Excessive Daytime Sleepiness (EDS) Epidemiology
The epidemiology segment also provides the EDS epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.
Excessive Daytime Sleepiness (EDS) Drug Chapters
The drug chapter segment of the EDS report encloses the detailed analysis of EDS current therapies, mid-phase, and late-stage pipeline drugs. It also helps to understand the EDS 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 (EDS) Marketed Drugs
Wakix (Pitolisant): Bioprojet Pharma/Harmony Biosciences
Pitolisant, histamine H3 receptor (H3R) antagonist, was developed for its awakening effect in the treatment of narcolepsy with or without cataplexy. European marketing authorization was obtained for this indication in March 2016 (Wakix). A pediatric investigation plan is underway, and studies are being carried out in narcoleptic children. In October 2020, the US FDA also approved Wakix (pitolisant) for the treatment of cataplexy in adult patients with narcolepsy.
Pitolisant has also been developed for treating excessive daytime sleepiness (EDS) related to obstructive sleep apnea (OSA) and Parkinson’s disease. It is the subject of several international multicenter phase III studies. The phase III clinical trial of evaluating pitolisant for the treatment of EDS in OSA shows that treatment with pitolisant, as compared with placebo, reduced EDS and improved several other outcomes among patients with obstructive sleep apnea who refuse Continuous positive airway pressure (CPAP).
It was designed and developed by Bioprojet Societe Civile de Recherche (Bioprojet), which has marketed the product in Europe since its approval by the European Medicines Agency in 2016. Harmony has an exclusive license from Bioprojet to develop, manufacture, and commercialize pitolisant in the United States. It is in Phase I study for Prader–Willi syndrome and has completed the pre-IND phase for myotonic dystrophy.
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 obstructive sleep apnea (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 received orphan drug designation for narcolepsy in the United States.
Products detail in the report…
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Excessive Daytime Sleepiness (EDS) Emerging Drugs
AXS-12 (reboxetine): Axsome Therapeutics
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 where it is approved for the treatment of depression. AXS-12 in narcolepsy is supported by positive preclinical and preliminary clinical results where it significantly reduced narcoleptic episodes in the hypocretin (orexin)-deficient mice as well as improving daytime sleepiness with reduced cataplexy in patients with narcolepsy in an open-label pilot trial. It is approved for depression in over 40 countries outside of the US.
Axsome Therapeutics is currently evaluating AXS-12 in Phase II clinical trial in patients with EDS and cataplexy in narcolepsy and has planned to start the Phase III clinical trial in the first quarter of 2021 for the treatment of narcolepsy. In August 2020, the company presented Phase II clinical data that showed AXS-12 to rapidly and significantly reduce EDS.
Products detail in the report…
BEN-2001 (Bavisant): BenevolentAI Bio
BEN-2001 (bavisant, JNJ-31001074) is a highly selective, orally active antagonist of the human H3 receptor with a novel mechanism of action, involving wakefulness and cognition. Bavisant has been used in trials studying the basic science and treatment of alcoholism, attention deficit hyperactivity disorder, and attention deficit disorders with hyperactivity.
BenevolentAI Bio evaluated BEN-2001 in Phase II clinical trial in subjects with EDS with Parkinson’s disease. In November 2020, the results of this clinical trial were updated. BenevolentAI, using its AI platform, identified bavisant as a potential treatment for Parkinson’s disease patients who suffer from excessive daytime sleepiness.
Products detail in the report…
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Excessive Daytime Sleepiness (EDS) Market Outlook
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.
For Parkinson’s disease, Idiopathic hypersomnia (IH), and Bipolar Disorder, the mainstay treatment is supportive care which includes modafinil or armodafinil, etc. The patent of both these drugs was expired and generics are already available in the market. There are no approved therapies for EDS with Parkinson’s disease, Idiopathic hypersomnia, and Bipolar disorder in the United States.
The drugs approved in the 7MM for the treatment of EDS are 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.
Provigil (modafinil), which was launched by Cephalon in 1999, is indicated for the treatment of EDS with narcolepsy, obstructive sleep apnea (OSA), and shift work disorder (SWD). Outside the US, Provigil is approved, under various trade-names, in more than 30 countries, including France, the United Kingdom, Ireland, Italy, and Germany, for the treatment of EDS associated with narcolepsy. In Jan 2007, modafinil was approved by PMDA for treatment of EDS associated with narcolepsy. It was later approved in Japan for the treatment of EDS in OSA who receive treatment of airway obstruction with continuous positive airway pressure (2011) and EDS in idiopathic hypersomnia (2020).
Nuvigil (armodafinil), the R-isomer of modafinil, is indicated for the treatment of EDS associated with narcolepsy, OSA, and SWD. In March 2019, the US FDA approved Sunosi (solriamfetol) for EDS associated with narcolepsy or OSA. In January 2020, the company also received EU Marketing Authorisation for Sunosi (solriamfetol) for EDS in adults with narcolepsy or OSA. It is also being evaluated for the treatment of EDS in pediatric patients. Sunosi is the only licensed therapy in Europe for the treatment of EDS in adults living with OSA. In August 2019, the US FDA approved Wakix (pitolisant) for the treatment of EDS in adult patients with narcolepsy. It was also approved by the European Commission in 2016 for the treatment of narcolepsy with or without cataplexy. It is also evaluated for EDS in OSA.
Xyrem (sodium oxybate) was first approved in 2002 in the US for the treatment of cataplexy in patients with narcolepsy. Later in 2005, it got the US FDA approval for the treatment of EDS in narcolepsy. In October 2018, the US FDA approved its supplemental new drug application (sNDA) to include an indication to treat cataplexy or EDS patients with narcolepsy ages seven and older. Xyrem is also approved in the EU for the treatment of cataplexy in adult patients with narcolepsy (2005) and narcolepsy with cataplexy in adult patients (2007). The generics of Xyrem are expected to reach the market by 2023. The extended-release formulation of the sodium oxybate, FT218, is in the queue for approval.
The most recent approval in the EDS market is Xywav (calcium, magnesium, potassium, and sodium oxybates), which was approved in July 2020 in the US for cataplexy or EDS in patients with 7 years of age and older with associated narcolepsy. It is also in evaluation for the treatment of EDS in idiopathic hypersomnia.
Overall, the EDS therapeutics market is further expected to grow in the forecast period (2020–2030).
- The market size of EDS in seven major markets (7MM) was USD 2,587.4 million in 2017.
- The United States accounts for the highest market size of EDS, in comparison to the other major markets i.e., EU5 countries (the United Kingdom, Germany, Italy, France, and Spain), and Japan.
- Among the EU5 countries, Germany had the highest market size with USD 227.4 million in 2017, while Italy had the lowest market size of EDS with USD 65.9 million in 2017.
- With the expected launch of upcoming therapies, BEN-2001, THN102 for EDS with Parkinson’s disease, FT218 (Sodium Oxybate) Extended-Release Oral Suspension, AXS-12 (Reboxetine) for EDS in Narcolepsy, Xywav (JZP-258) for EDS in Idiopathic hypersomnia (IH), and Wakix (Pitolisant) for EDS with Obstructive Sleep Apnea (OSA), the total market of EDS might show a decent change in upcoming years especially for Parkinson’s disease, and Idiopathic Hypersomnia (IH). Only Sunosi is expected to be launch in Japan in the year 2022.
- BEN-2001 and THN102 are the only drugs that are being investigated for the treatment of EDS with PD, so it is expected to cover a major market share as it has no competition.
- Xywav (JZP-258) is the only drug that is being investigated for the treatment of EDS with IH, so it is expected to cover a major market share as it has no competition.
- The market size for EDS in Japan was estimated to be USD 382.7 Million in 2017, which accounts for 14.79% of the total 7MM market.
The United States Market Outlook
This section provides the total EDS market size and market size by therapies in the United States.
EU-5 Market Outlook
The total EDS 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 EDS market size and market size by therapies in Japan are provided.
Excessive Daytime Sleepiness (EDS) Drugs Uptake
This section focuses on the rate of uptake of the drugs expected to get launched in the market during the study period 2017–2030. The analysis covers the EDS 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 (EDS) 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 EDS emerging therapies.
Reimbursement Scenario in Excessive Daytime Sleepiness (EDS)
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 EDS 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 EDS, explaining its causes, diagnosis, and currently available therapies.
- Comprehensive insight has been provided into the EDS epidemiology and treatment.
- Additionally, an all-inclusive account of both the current and emerging therapies for EDS is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
- A detailed review of the EDS 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 EDS market.
- The increasing prevalence of the disease along with promising emerging pipeline therapies will positively drive the EDS market.
- The companies and academics are working to assess challenges and seek opportunities that could influence EDS R&D.
- Major players are involved in developing therapies for EDS. The launch of emerging therapies will significantly impact the EDS 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 (EDS) Report Insights
- Patient Population
- Therapeutic Approaches
- EDS Pipeline Analysis
- EDS Market Size and Trends
- Market Opportunities
- Impact of Upcoming Therapies
Excessive Daytime Sleepiness (EDS) Report Key Strengths
- Eleven Years Forecast
- 7MM Coverage
- EDS Epidemiology Segmentation
- Key Cross Competition
- Highly Analyzed Market
- Drugs Uptake
Excessive Daytime Sleepiness (EDS) Report Assessment
- Current Treatment Practices
- Unmet Needs
- Pipeline Product Profiles
- Market Attractiveness
- Market Drivers and Barriers
- SWOT Analysis
- Market Access and Reimbursement
- What was the EDS market share (%) distribution in 2017 and how it would look like in 2030?
- What would be the EDS total market size as well as market size by therapies across the 7MM during the forecast period (2020–2030)?
- What are the key findings pertaining to the market across the 7MM and which country will have the largest EDS market size during the forecast period (2020–2030)?
- At what CAGR, the EDS market is expected to grow at the 7MM level during the forecast period (2020–2030)?
- What would be the EDS market outlook across the 7MM during the forecast period (2020–2030)?
- What would be the EDS market growth till 2030 and what will be the resultant market size in the year 2030?
- How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
- What are the disease risk, burdens, and unmet needs of EDS?
- What is the historical EDS patient pool in the United States, EU5 (Germany, France, Italy, Spain, and the UK), and Japan?
- What would be the forecasted patient pool of EDS at the 7MM level?
- What will be the growth opportunities across the 7MM with respect to the patient population pertaining to EDS?
- Out of the above-mentioned countries, which country would have the highest prevalent population of EDS during the forecast period (2020–2030)?
- At what CAGR the population is expected to grow across the 7MM during the forecast period (2020–2030)?
Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:
- What are the current options for the treatment of EDS along with the approved therapy?
- What are the EDS emerging drugs and their MOA, product development activities, advantages, disadvantages, safety, and efficacy, etc.?
- How many companies are developing therapies for the treatment of EDS?
- How many emerging therapies are in the mid-stage and late stages of development for the treatment of EDS?
- What are the key collaborations (Industry–Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the EDS therapies?
- What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
- What are the clinical studies going on for EDS and their status?
- What are the key designations that have been granted for the emerging therapies for EDS?
- What are the 7MM historical and forecasted market of EDS?
Reasons to buy
- The report will help in developing business strategies by understanding trends shaping and driving the EDS.
- To understand the future market competition in the EDS market and Insightful review of the key market drivers and barriers.
- Organize sales and marketing efforts by identifying the best opportunities for EDS 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 EDS market.
- To understand the future market competition in the EDS market.