Emerging therapies for narcolepsy, including AXS-12 (reboxetine) and others, are anticipated to drive significant growth in the narcolepsy market over the coming years.
DelveInsight has published a new report titled “Narcolepsy – Market Insights, Epidemiology, and Market Forecast–2034”, offering a comprehensive analysis of the disorder, covering historical and projected epidemiology along with market trends 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 Narcolepsy Market Report:
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According to DelveInsight, the narcolepsy market is expected to witness steady growth from 2023 to 2032, fueled by the launch of novel therapies and the increasing prevalence of the disorder. On October 16, 2024, the U.S. FDA approved Lumryz (sodium oxybate) for treating cataplexy and excessive daytime sleepiness in pediatric patients aged 7 years and older with narcolepsy. This once-nightly extended-release formulation reduces the need for middle-of-the-night dosing and was initially approved for adults in May 2023. The pediatric approval grants Orphan Drug Exclusivity until October 2031, though Lumryz carries a boxed warning regarding its CNS depressant properties and risk of abuse and misuse. Distribution is restricted under a Risk Evaluation and Mitigation Strategy (REMS) program.
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On November 26, 2024, Axsome Therapeutics announced positive results from its Phase 3 ENCORE trial, where its investigational therapy AXS-12 (reboxetine) significantly reduced cataplexy episode frequency compared with placebo, meeting the primary endpoint.
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Leading companies shaping the narcolepsy treatment landscape include Alkermes, Avadel Pharmaceuticals, Axsome Therapeutics, Centessa Pharmaceuticals, Cephalon Inc., ConSynance Therapeutics, Harmony Biosciences, Jazz Pharmaceuticals, KemPharm, NLS Pharmaceutics, Ono Pharma, Otsuka Pharmaceutical, Reset Therapeutics, Sunovion Pharmaceuticals, Suven Life Sciences, Takeda, Vallon Pharmaceuticals, and XWPharma, among others. Promising pipeline therapies, such as AXS-12 (reboxetine), are expected to further expand treatment options and drive market growth in the coming years.
Narcolepsy Overview
Narcolepsy is a chronic neurological disorder that impairs the brain’s ability to properly regulate sleep–wake cycles. People affected often experience excessive daytime sleepiness (EDS), leading to sudden and uncontrollable episodes of falling asleep during routine activities. A hallmark symptom of the condition is cataplexy—an abrupt loss of muscle control brought on by strong emotions. Additional features may include sleep paralysis, vivid dream-like hallucinations, and disrupted nighttime sleep.
Narcolepsy Market Outlook
The narcolepsy market is experiencing steady growth, driven by a rising prevalence of the condition, increased disease awareness, and the introduction of novel therapies. Narcolepsy is a chronic neurological disorder marked by excessive daytime sleepiness (EDS), cataplexy, hallucinations, and disrupted nighttime sleep, all of which create a significant unmet need for effective treatments.
Currently approved therapies include sodium oxybate formulations (XYREM, XYWAV, Lumryz), wake-promoting agents (modafinil, armodafinil, solriamfetol/Sunosi, pitolisant/Wakix), and stimulants like amphetamines and methylphenidate. Recent regulatory approvals, such as Lumryz for pediatric narcolepsy (2024) and expanding use of Wakix and Sunosi, highlight the growing treatment landscape.
The market is further supported by an active pipeline. AXS-12 (reboxetine) from Axsome Therapeutics has shown positive Phase 3 results in reducing cataplexy episodes, while other investigational therapies aim to offer safer, longer-lasting, and more convenient treatment options.
Key players in the narcolepsy market include Jazz Pharmaceuticals, Harmony Biosciences, Avadel Pharmaceuticals, Axsome Therapeutics, Takeda, Otsuka, Sunovion, and Bioprojet, among others. With multiple late-stage candidates and recent FDA approvals, the narcolepsy market across the US, EU5, and Japan is projected to grow significantly through 2034.
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Narcolepsy Emerging Drugs
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Dazukibart (PF-06823859): Pfizer
Scope of the Narcolepsy 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 Narcolepsy Companies: Alkermes, Avadel Pharmaceuticals, Axsome Therapeutics, Inc., Centessa Pharmaceuticals, Cephalon Inc., ConSynance Therapeutics, Harmony Biosciences, Jazz Pharmaceuticals, KemPharm, NLS Pharmaceutics, Ono Pharma, Otsuka Pharmaceutical, Reset Therapeutics, Sunovion Pharmaceuticals, Suven Life Sciences, Takeda, Vallon Pharmaceuticals, XWPharma, and others
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Key Narcolepsy Therapies: AXS-12 (reboxetine), and others
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Narcolepsy Therapeutic Assessment: Narcolepsy current marketed and Narcolepsy emerging therapies
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Narcolepsy Market Dynamics: Narcolepsy market drivers and Narcolepsy 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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Narcolepsy Unmet Needs, KOL’s views, Analyst’s views, Narcolepsy Market Access and Reimbursement
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Key benefits of the Narcolepsy Market Report:
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Narcolepsy market report covers a descriptive overview and comprehensive insight of the Narcolepsy Epidemiology and Narcolepsy market in the 7MM (the United States, EU5 (Germany, Spain, France, Italy, UK) & Japan).
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The Narcolepsy market report provides insights into the current and emerging therapies.
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The Narcolepsy market report provides a global historical and forecasted market covering drug outreach in 7MM.
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The Narcolepsy market report offers an edge that will help in developing business strategies by understanding trends shaping and driving the Narcolepsy market.
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Table of Contents
1. Report Introduction
2. Executive Summary
3. SWOT analysis
4. Narcolepsy Patient Share (%) Overview at a Glance
5. Narcolepsy Market Overview at a Glance
6. Narcolepsy Disease Background and Overview
7. Narcolepsy Epidemiology and Patient Population
8. Country-Specific Patient Population of Narcolepsy
9. Narcolepsy Current Treatment and Medical Practices
10. Unmet Needs
11. Narcolepsy Emerging Therapies
12. Narcolepsy Market Outlook
13. Country-Wise Narcolepsy Market Analysis (2020–2034)
14. Market Access and Reimbursement of Therapies
15. Market drivers
16. Market barriers
17. Appendix
18. Narcolepsy Report Methodology
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight
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Related Reports:
Narcolepsy Pipeline Insights, DelveInsight
“Narcolepsy Pipeline Insight, 2024” report by DelveInsight outlines comprehensive insights of present clinical development scenarios and growth prospects across the Narcolepsy market. A detailed picture of the Narcolepsy pipeline landscape is provided, which includes the disease overview and Narcolepsy 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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