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시장보고서
상품코드
2082883
과도한 주간 졸림증(EDS) : 시장 인사이트, 역학 및 시장 예측(2036년)Excessive Daytime Sleepiness (EDS) - Market Insight, Epidemiology, and Market Forecast - 2036 |
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DelveInsight
본 EDS 시장 보고서에서는 표준 치료, 임상 실무, 진화하는 치료 알고리즘 등 현재의 치료 현황에 대한 종합적인 분석을 제공합니다. 또한, EDS 환자의 부담 추이, 수익 및 시장 점유율 추이, 피크 시기의 환자 점유율 및 치료 도입 현황에 대한 분석을 평가하는 한편, 세계 각 지역의 시장 규모에 대한 상세한 평가 및 성장률 예측(과거 데이터 및 2022-2036년 예측)을 제시하고 있습니다. 본 보고서에서는 EDS 분야의 주요 미충족 요구 사항을 부각시키고, 경쟁 환경 및 임상 상황을 분석하여 고부가가치의 성장 기회를 도출함으로써, 향후 시장 성장 가능성에 대한 명확한 전망을 제시하고 있습니다.
표적 중심의 새로운 치료법의 발전 : 각성 촉진제 및 오렉신 수용체를 표적으로 한 치료법의 개발은 EDS 치료 방식을 혁신하고 있으며, 효능을 향상시키고 기초가 되는 수면·각성 조절 메커니즘을 보다 적절하게 관리할 수 있게 하고 있습니다.
조기 및 정확한 진단의 보급 : 수면 장애에 대한 인식이 높아진 데 더해, 수면 다원 검사나 다중 수면 잠복기 검사(MSLT) 등의 진단 도구가 발전함에 따라 주간의 과도한 졸음을 조기에 발견할 수 있게 되었으며, 그 결과 치료 대상이 되는 환자층이 확대되고 있습니다.
탄탄한 파이프라인과 지원적인 규제 환경 : 신약 개발 파이프라인이 견실할 뿐만 아니라, 규제상의 인센티브와 수면 장애에 관한 임상 연구의 증가가 혁신을 가속화하고 시장 성장에 기여하고 있습니다.
과도한 주간 졸림증(EDS) 개요 및 진단
EDS는 낮 동안 깨어 있는 상태나 주의력을 유지하지 못해, 종종 의도하지 않은 졸음을 유발하는 것이 특징인 임상적 상태입니다. 일반적으로, 기면증, 폐쇄성 수면무호흡증후군, 생체리듬 장애 등 기초가 되는 수면 장애나 신경학적·정신과적 질환과 관련이 있습니다. 환자들에게는 일반적으로 지속적인 졸음, 집중력 저하, 일상생활 기능 장애가 나타납니다. 진단에는 종합적인 임상 평가, 수면 이력 평가, 그리고 수면 다원 검사나 다중 수면 잠복기 검사(MSLT)와 같은 객관적 검사가 포함됩니다. 수면 진단 기술의 발전으로 근본적인 원인을 보다 정확하게 파악할 수 있게 되어, 목표가 명확한 관리 전략을 수립할 수 있게 되었습니다.
현재 일본과 중국에서의 과다수면증(EDS) 치료 현황
EDS 치료의 현황은 각성 상태의 개선과 근본적인 원인에 대한 대처에 중점을 두고 있습니다. 약물 요법에는 모다피닐이나 암페타민 계열 약물 등의 각성 촉진제 및 자극제 외에도, 수면·각성 경로를 표적으로 하는 새로운 약물이 포함됩니다. 행동 요법이나 원발성 수면 장애 관리(예 : 수면 무호흡 증후군에 대한 CPAP 요법)를 포함한 비약물적 치료도 치료의 중요한 요소입니다. 이러한 치료법은 증상 완화를 가져오지만, 환자별 반응에 차이가 있고 내약성 문제도 여전히 남아 있기 때문에 보다 효과적이고 표적화된 치료법의 필요성이 부각되고 있습니다.
과도한 주간 졸림증(EDS)의 역학적 분석 및 예측에 관한 주요 조사 결과
현재 EDS의 치료 현황은 개별 환자의 필요에 맞춘 폭넓은 접근 방식으로 구성되어 있습니다. 여기에는 각성을 촉진하는 모다피닐이나 알모다피닐 등의 처방약 외에도 암페타민류 등의 흥분제가 포함됩니다. 카타플렉시가 동반된 나르코레프시에는 옥시바트나트륨이 처방되는 경우가 있으며, SSRI나 SNRI 등의 항우울제는 기분 장애와 관련된 EDS를 치료하는 데 도움이 될 수 있습니다. 생활 습관의 개선, CBT-I(인지행동치료) 등의 행동 치료, 그리고 전략적인 낮잠 자는 방법도 중요한 역할을 합니다. 수면무호흡증 환자에게는 CPAP 요법이 효과적이며, 과체중인 분에게는 체중 관리가 도움이 될 수 있습니다. 최적의 치료 방침을 결정하기 위해서는 의료 전문가와 상담하는 것이 필수적입니다.
일반적으로 환자에게는 저용량부터 투여를 시작하여, 만족스러운 결과가 나올 때까지 서서히 용량을 늘려갑니다. 모다피닐이나 알모다피닐 등, 유효성이나 효능이 비교적 낮은 온화한 자극제가 보통 먼저 시도됩니다. 필요에 따라, 더 효과적인 암페타민계 자극제(메틸페니데이트, D-암페타민, 메탄페타민)가 사용됩니다. 기면증 환자의 경우, 자극제는 일반적으로 내약성이 양호합니다.
G7 국가에서는 PROVIGIL/MODIODAL(모다피닐), NUVIGIL(알모다피닐), SUNOSI(솔리암페톨), WAKIX(피트리산), XYWAV(옥시바트 칼슘, 마그네슘, 칼륨, 나트륨), 그리고 XYREM(옥시바트 나트륨) 등 몇 가지 약물이 승인되어 있습니다. PROVIGIL/MODIODAL(모다피닐), NUVIGIL(알모다피닐) 및 XYREM(옥시바토나트륨)의 제네릭 의약품은 미국 시장에서 구입할 수 있습니다.
최근, 나르코레프시와 관련이 있는 것으로 여겨지는 오렉신 신호 전달의 조절 이상을 표적으로 하는 오렉신 수용체 길항제 등, EDS에 대한 새로운 치료법에 대한 관심이 높아지고 있습니다.
각성 촉진 요법 및 자극제 요법 : 현재의 약물 요법은 주로 각성 상태를 높이고, 낮 동안의 수면 발작을 완화하는 것을 목적으로 합니다. 모다피닐, 알모다피닐, 암페타민계 자극제 등의 약물은 1차 선택 약물로 널리 사용되고 있으며, 중추신경계 경로를 통해 작용하여 각성도와 인지 기능을 개선합니다. 이러한 치료법은 효과적이긴 하지만, 반응에 차이가 있고 잠재적인 부작용도 수반하기 때문에 환자 개개인에 맞춘 치료 접근이 필요합니다.
표적화된 새로운 치료법 : 최근의 진전으로는 오렉신 수용체 조절제나 히스타민계 약물 등, 수면 조절에 관여하는 특정 경로를 표적으로 하는 치료법이 있습니다. 이러한 접근법은 특히 나르코레프시와 같은 질환에서 EDS의 근본적인 병리생리학적 기전을 해결하는 것을 목적으로 하며, 효능을 향상시키고 지속적인 각성을 유도할 가능성을 지니고 있습니다. 현재 진행 중인 연구에서는 안전성, 내약성 및 장기적인 치료 성과가 개선된 차세대 약물의 개발에 초점을 맞추고 있습니다.
DelveInsight's Excessive Daytime Sleepiness (EDS) - Market Insights, Epidemiology and Market Forecast - 2036' report delivers an in-depth understanding of the EDS, historical and forecasted epidemiology, as well as the EDS market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.
The EDS market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates EDS patient burden trends, revenue & market share dynamics, peak patient share & therapy uptake analysis, and provides an in-depth market size assessment, and growth rate projections (Historical & Forecast 2022-2036) across global regions. The report highlights key unmet medical needs in EDS and maps the competitive and clinical landscape to uncover high-value opportunities, providing a clear outlook on future market growth potential.
Key Factors Driving the Excessive Daytime Sleepiness (EDS) Market
Advancements in targeted and novel therapies: The development of wake-promoting agents and orexin receptor-targeted therapies is transforming the treatment landscape of EDS, offering improved efficacy and better management of underlying sleep-wake regulation mechanisms.
Increasing adoption of early and accurate diagnosis: Growing awareness of sleep disorders, along with advancements in diagnostic tools such as polysomnography and multiple sleep latency tests (MSLT), is enabling earlier identification of excessive daytime sleepiness, thereby expanding the treatable patient population.
Strong pipeline and supportive regulatory environment: A robust pipeline of novel therapeutics, coupled with regulatory incentives and increasing clinical research in sleep disorders, is accelerating innovation and contributing to market growth.
Excessive Daytime Sleepiness (EDS) Overview and Diagnosis
EDS is a clinical condition characterized by an inability to maintain wakefulness and alertness during the day, often resulting in unintended lapses into sleep. It is commonly associated with underlying sleep disorders such as narcolepsy, obstructive sleep apnea, and circadian rhythm disturbances, as well as neurological or psychiatric conditions. Patients typically present with persistent drowsiness, reduced concentration, and impaired daily functioning. Diagnosis involves a comprehensive clinical evaluation, sleep history assessment, and objective testing such as polysomnography and the multiple sleep latency test (MSLT). Advances in sleep diagnostics are enabling more accurate identification of underlying causes, supporting targeted management strategies.
Current Excessive Daytime Sleepiness (EDS) Treatment Landscape
The treatment landscape for EDS focuses on improving wakefulness and addressing the underlying cause. Pharmacological management includes wake-promoting agents and stimulants, such as modafinil and amphetamine-based therapies, along with newer agents targeting sleep-wake pathways. Non-pharmacological approaches, including behavioral interventions and management of primary sleep disorders (e.g., CPAP therapy for sleep apnea), are also critical components of care. While these therapies provide symptomatic relief, variability in patient response and tolerability issues persist, highlighting the need for more effective and targeted options.
Excessive Daytime Sleepiness (EDS) Unmet Needs
The section "unmet needs of Excessive Daytime Sleepiness (EDS)" outlines the critical gaps between the current state of patient care, diagnosis, and the ideal & effective management of the disease. It highlights the obstacles experienced by patients, clinicians, and researchers and identifies potential solutions for future progress.
Key Findings from Excessive Daytime Sleepiness (EDS) Epidemiological Analysis and Forecast
Excessive Daytime Sleepiness (EDS) Drug Chapters & Competitive Analysis
The EDS drug chapter provides a detailed, market-focused review of approved therapies and the emerging pipeline across Phase I-III clinical trials. It covers the mechanism of action, clinical trial data, regulatory approvals, patents, collaborations, and strategic partnerships for each therapy, along with their advantages, limitations, and recent developments. This section offers critical insights into the EDS treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the EDS market.
Approved Therapies for Excessive Daytime Sleepiness (EDS)
Pitolisant (WAKIX/OZAWADE): Bioprojet Pharma/Harmony Biosciences
WAKIX is a selective histamine 3 (H3) receptor antagonist/inverse agonist. The mechanism of action of WAKIX is unclear; however, its efficacy could be mediated through its activity at H3 receptors, thereby increasing the synthesis and release of histamine, a wake-promoting neurotransmitter. WAKIX was designed and developed by Bioprojet (France). Harmony has an exclusive license from Bioprojet to develop, manufacture, and commercialize WAKIX in the US. It was granted orphan drug designation (ODD) for the treatment of narcolepsy in 2010 and breakthrough therapy designation for the treatment of cataplexy in 2018.
In February 2026, Harmony Biosciences announced that the US Food and Drug Administration (FDA) had approved its supplemental new drug application (sNDA) for WAKIX tablets for the treatment of cataplexy in pediatric patients 6 years of age and older with narcolepsy. WAKIX is now the first and only FDA-approved non-scheduled treatment for pediatric and adult narcolepsy patients with or without cataplexy.
Solriamfetol (SUNOSI): Jazz Pharmaceuticals
SUNOSI is a dual-acting dopamine and norepinephrine reuptake inhibitor that is indicated to improve wakefulness in adults living with EDS 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 ODD for narcolepsy in the US.
Excessive Daytime Sleepiness (EDS) Pipeline Analysis
AXS-12 (Reboxetine): Axsome Therapeutics
Reboxetine is a highly selective and potent norepinephrine reuptake inhibitor being developed for the treatment of narcolepsy. It is thought to modulate 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's approved for the treatment of depression. In narcolepsy, Reboxetine is supported by positive pre-clinical and Phase II clinical results. Reboxetine has been granted FDA ODD for the treatment of narcolepsy. The product is in Phase III of development.
In December 2025, Axsome Therapeutics announced that it had received formal pre-New Drug Application (NDA) meeting minutes from the US FDA supporting an NDA submission for Reboxetine in narcolepsy. Reboxetine is a highly selective and potent norepinephrine reuptake inhibitor and cortical dopamine modulator. The purpose of the meeting was to reach an agreement with the FDA on the proposed content and format of the Company's planned NDA submission, including the clinical and nonclinical requirements.
Samelisant (SUVN-G3031): Suven Life Sciences
Samelisant is an oral, potent, selective, and well-differentiated histamine H3 receptor inverse agonist. Its efficacy has been established in nonclinical sleep models. The drug has shown excellent ADME properties with no drug-drug interaction liability. It enhanced the in vivo release of several neurotransmitters in the cortex and showed robust wake-promoting effects in various animal models. Samelisant has an excellent safety profile in preclinical models with no propensity to induce abuse liability. The drug candidate was evaluated in two Phase I studies in the US in 72 healthy adult and elderly male/female populations with no serious adverse events.
The company recently announced the results of a Phase II proof-of-concept study, assessing the safety and efficacy of Samelisant for the treatment of excessive daytime sleepiness in adult narcolepsy patients with and without cataplexy. The study met the primary endpoint, with Samelisant demonstrating a statistically significant and clinically meaningful reduction in Excessive Daytime Sleepiness measured by the Epworth Sleepiness Scale total score compared to the placebo at Day 14.
Excessive Daytime Sleepiness (EDS) Key Players, Market Leaders, and Emerging Companies
Excessive Daytime Sleepiness (EDS) Drug Updates
The current treatment landscape for EDS encompasses a range of approaches tailored to individual needs. This includes prescription medications like modafinil and armodafinil, which promote wakefulness, along with stimulants such as amphetamines. Sodium oxybate may be prescribed for narcolepsy with cataplexy, while antidepressants like SSRIs or SNRIs can address EDS linked to mood disorders. Lifestyle modifications, behavioral therapies like CBT-I, and strategic napping strategies also play significant roles. For those with sleep apnea, CPAP therapy is effective, while weight management can be beneficial for overweight individuals. Consulting a healthcare professional is essential to determine the best course of action.
Typically, a patient is started on a low dose, which is then increased progressively to obtain satisfactory results. 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. Stimulant compounds are generally well tolerated in patients with narcolepsy.
There are a few drugs approved in the 7MM for the treatment of EDS, 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), and XYREM (sodium oxybate) are available in the US market.
In recent years, there has been growing interest in novel treatment approaches for EDS, including orexin receptor antagonists, which target the dysregulation of orexin signaling implicated in narcolepsy.
Drug Class/Insights into Leading Emerging and Marketed Therapies in Excessive Daytime Sleepiness (EDS) (2022-2036 Forecast)
The treatment landscape of EDS remains largely focused on symptomatic management and improving daytime alertness; however, emerging therapies are increasingly targeting the underlying neurobiological mechanisms of sleep-wake regulation.
Wake-promoting and stimulant therapies: Current pharmacological options primarily aim to enhance wakefulness and reduce daytime sleep episodes. Agents such as modafinil, armodafinil, and amphetamine-based stimulants are widely used as first-line treatments, acting on central nervous system pathways to improve alertness and cognitive function. While effective, these therapies are associated with variability in response and potential side effects, necessitating individualized treatment approaches.
Targeted and novel therapies: Recent advancements include therapies targeting specific pathways involved in sleep regulation, such as orexin receptor modulators and histamine-based agents. These approaches aim to address the underlying pathophysiology of EDS, particularly in conditions like narcolepsy, and offer the potential for improved efficacy and sustained wakefulness. Ongoing research is focused on developing next-generation agents that provide better safety, tolerability, and long-term outcomes.
Excessive Daytime Sleepiness (EDS) Drug Uptake
This section focuses on the uptake rate of potential drugs expected to be launched in the market during the forecast period (2026-2036). The analysis covers the EDS market's uptake by drugs, patient uptake by therapy, and sales of each drug.
Among the therapies, XYWAV is expected to capture the largest market share. XYWAV is expected to witness strong uptake in the Excessive Daytime Sleepiness (EDS) market, primarily driven by its differentiated clinical and safety profile. One of the key advantages of XYWAV over XYREM is its significantly lower sodium content, which reduces long-term cardiovascular risk-an important consideration for patients requiring chronic therapy. This improved safety profile is likely to encourage both physicians and patients to prefer XYWAV, particularly in populations with comorbid cardiovascular concerns.
Detailed insights into emerging therapies' drug uptake are included in the report...
Market Access and Reimbursement of Approved Therapies in Excessive Daytime Sleepiness (EDS)
Reimbursement is a crucial factor that affects the drug's access to the market. Often, the decision to reimburse comes down to the price of the drug relative to the benefit it produces in treated patients. To reduce the healthcare burden of these high-cost therapies, many payment models are being considered by payers and other industry insiders.
HealthPartners' Medicaid List of Covered Drugs includes SUNOSI within a quantity limit of one tablet a day. To avail of the reimbursement, the patient must get prior authorization before filling a prescription for this drug. HealthPartners is an integrated, nonprofit health care provider and health insurance company located in Bloomington, Minnesota, offering care, coverage, research, and education to its members, patients, and the community.
In July 2020, Haute Autorite de Sante (HAS) posted a favorable opinion for reimbursement of Sunosi to improve wakefulness and reduce EDS:
NOTE: Further Details are provided in the final report....
Excessive Daytime Sleepiness (EDS) Therapies Price Scenario & Trends
Pricing and analogue assessment of EDS therapies highlights evolving price dynamics structures. This section summarizes the cost of approved treatments, the closest and most appropriate analogue selection for emerging therapies, and the understanding of how pricing influences market access, adherence, and long-term uptake.
XYWAV is approved for managing cataplexy or EDS in narcolepsy patients aged 7 years and older. The initial recommended oral dose is 4.5 g nightly, split into two 2.25 g doses: one at bedtime and the second 2.5-4 hours later. Its annual cost is approximately USD 165,000.
Industry Experts and Physician Views for Excessive Daytime Sleepiness (EDS)
To keep up with EDS market trends, we take Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts were contacted for insights on the EDS emerging therapies, evolving treatment landscape, patient adherence to conventional therapies, therapy switching trends, drug adoption and uptake, accessibility challenges, and epidemiology and real-world prescription patterns in EDS, including MD, PhD, Instructor, Postdoctoral Researcher, Professor, Researcher, and others.
DelveInsight's analysts connected with 10+ KOLs to gather insights at the country level. Centers such as the EDS Research Foundation (MMRF), University of Texas MD Anderson Cancer Center, and Iwate Medical University, etc. were contacted. Their opinion helps understand and validate current and emerging EDS therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in EDS.
Qualitative Analysis: SWOT and Conjoint Analysis
We perform qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and conjoint analysis.
In the SWOT analysis of EDS, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.
Conjoint analysis analyzes emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.
The team of analysts analyzes promising emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. In efficacy, the trial's primary and secondary outcome measures are evaluated, whereas the therapies' safety is evaluated, wherein the acceptability, tolerability, and adverse events are mainly observed. In addition, the scoring is also based on the route of administration, order of entry, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.
Market Insights