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Narcolepsy Therapeutics Market Analysis and Forecast, 2022-2032

The global narcolepsy therapeutics market is projected to reach $4,912.3 million by 2032 from $915.2 million in 2021 at a CAGR of 15.93% during the forecast period 2022-2032.

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Narcolepsy Therapeutics Market Analysis and Forecast, 2022-2032

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  1. Narcolepsy Therapeutics Market - A Global and Country Level Analysis Table of Content GLOBAL NARCOLEPSY THERAPEUTICS MARKET Focus on Therapeutics, Indication, Product, and Country Analysis and Forecast: 2022-2032 July 2022 All rights reserved at BIS Research Inc. 1

  2. BIS Research is a leading market intelligence and technology research company. BIS Research publishes in- depth market intelligence reports focusing on the market estimations, technology analysis, emerging high- growth applications, deeply segmented granular country-level market data and other important market parameters useful in the strategic decision making for senior management. BIS Research provides multi-client reports, company profiles, databases, and custom research services. GLOBAL NARCOLEPSY THERAPEUTICS MARKET Copyright © 2022 BIS Research Inc. All Rights Reserved. This document contains highly confidential information and is the sole property of BIS Research. Disclosing, copying, circulating, quoting, or otherwise reproducing any or all contents of this document is strictly prohibited. Access to this information is provided exclusively for the benefit of the people or organization concerned. It may not be accessed by or offered, whether for sale or otherwise, to any third party. All rights reserved at BIS Research Inc. 2

  3. Table of Content Executive Summary .......................................................................... 15 1.Market ....................................................................................... 20 1.1 Product Definition ............................................................................................ 21 Inclusion and Exclusion .................................................................................. 21 2.Market Scope ............................................................................ 22 1.2 2.1 Key Questions Answered in the Report......................................................... 23 3.Research Methodology .............................................................. 24 3.1 Data Sources .................................................................................................... 25 3.1.1Primary Data Source ................................................................................... 25 3.1.2Secondary Data Sources ............................................................................ 26 3.2 Market Estimation Model ................................................................................. 26 3.3 Criteria for Company Profiling ........................................................................ 28 4.Market Overview ........................................................................ 29 4.1 Introduction ...................................................................................................... 29 4.2 Epidemiology of Narcolepsy ........................................................................... 30 4.2.1U.S. ............................................................................................................... 31 4.2.2EU4 and U.K. ................................................................................................ 32 4.2.3Japan ............................................................................................................ 32 4.3 Key Therapeutic Classes for Narcolepsy ...................................................... 33 GLOBAL NARCOLEPSY THERAPEUTICS MARKET 4.3.1Central Nervous System Stimulants .......................................................... 33 4.3.2Histamine-3 (H3) Receptor Antagonist/Inverse Agonist .......................... 33 4.3.3Dopamine and Norepinephrine Reuptake Inhibitor (DNRI) ...................... 33 4.4 Currently Approved and Investigational Treatments for Narcolepsy ......... 34 4.5 Current Market Size and Growth Potential, $Million, 2021-2031 .................. 36 5.Industry Insights ........................................................................ 38 5.1 Overview ........................................................................................................... 38 5.2 Treatment Guideline for Narcolepsy Therapeutics ....................................... 38 5.3 Legal Requirements and Frameworks ........................................................... 40 All rights reserved at BIS Research Inc. 3

  4. 5.3.1Legal Requirement and Framework in the U.S. ........................................ 40 5.3.1.1 Clinical Trial Authorization ................................................................................. 40 5.3.1.2 Marketing Authorization ..................................................................................... 41 5.3.1.3 USFDA Guidelines for NDA Submission ........................................................... 42 5.3.1.4 Post Authorization Regulations .......................................................................... 43 5.3.2Legal Requirement and Framework in Europe ......................................... 43 5.3.2.1 EMA Drug Licence Application Process ............................................................ 44 5.3.2.2 Centralized Procedure ....................................................................................... 45 5.3.2.3 Decentralized Procedure ................................................................................... 45 5.3.2.4 Mutual-Recognition Procedure .......................................................................... 45 5.3.2.5 National Procedure ............................................................................................ 45 5.3.3Legal Requirements and Frameworks in Japan ....................................... 45 Reimbursement Scenario ................................................................................ 47 6.Market Dynamics ....................................................................... 48 5.4 6.1 Overview ........................................................................................................... 48 6.2 Impact Analysis ............................................................................................... 48 6.3 Market Drivers .................................................................................................. 49 6.3.1Large Population of Undiagnosed and Untreated Narcolepsy Patients ........................................................................................................ 49 6.3.2Increasing Research Funding for Neuroscience ...................................... 50 6.3.3Approval of Advanced Therapies with Novel Mechanism of Action (MoA) ............................................................................................................ 51 GLOBAL NARCOLEPSY THERAPEUTICS MARKET 6.3.4Existing Unmet Needs of Patients and Healthcare Professionals (HCPs) .......................................................................................................... 52 6.4 Market Restraints ............................................................................................. 53 6.4.1Delayed Diagnosis ....................................................................................... 53 6.4.2Lack of Awareness ...................................................................................... 54 6.5 Market Opportunities ....................................................................................... 55 6.5.1Growing Opportunities in Asian Countries ............................................... 55 6.5.2Opportunity for Narcolepsy Therapies with Novel Composition and Route of Administration .............................................................................. 55 All rights reserved at BIS Research Inc. 4

  5. 7.Competitive Insights .................................................................. 57 7.1 Corporate Strategies ....................................................................................... 57 7.1.1Synergistic Activities .................................................................................. 57 7.1.2Mergers and Acquisitions ........................................................................... 58 7.1.3Funding and Business Expansion Activities ............................................ 58 7.2 Business Strategies ........................................................................................ 59 7.2.1Regulatory and Legal Developments ......................................................... 59 7.2.2Clinical Developments ................................................................................ 60 8.Global Narcolepsy Therapeutics Market, by Product, $Million, 2021-2032 .................................................................................. 61 8.1 Overview ........................................................................................................... 62 8.2 Commercialized Products ............................................................................... 63 8.2.1Xywav ........................................................................................................... 64 8.2.2Sunosi .......................................................................................................... 67 8.2.3Wakix ............................................................................................................ 69 8.3 Pipeline Products ............................................................................................ 72 8.3.1Phase 1 ......................................................................................................... 72 8.3.2Phase 2 ......................................................................................................... 73 8.3.2.1 SUVN-G3031 ..................................................................................................... 73 8.3.2.2 Quilience ............................................................................................................ 74 8.3.3Phase 3 ......................................................................................................... 76 GLOBAL NARCOLEPSY THERAPEUTICS MARKET 8.3.3.1 AXS-12 .............................................................................................................. 76 8.3.3.2 FT218 ................................................................................................................ 77 9.Global Narcolepsy Therapeutics Market, by Indication, $Million, 2021-2032 .................................................................... 79 9.1 Overview ........................................................................................................... 80 9.2 Type 1 Narcolepsy ........................................................................................... 81 9.3 Type 2 Narcolepsy ........................................................................................... 82 9.4 Secondary Narcolepsy .................................................................................... 83 10.Global Narcolepsy Therapeutics Market, by Therapeutics, $Million, 2021-2032 .................................................................... 85 All rights reserved at BIS Research Inc. 5

  6. 10.1Overview ........................................................................................................... 86 10.2Central Nervous System Stimulant ................................................................ 87 10.3Norepinephrine Reuptake Inhibitor ................................................................ 88 10.4Histamine-3 (H3) Receptor Antagonist/Inverse Agonist ............................... 89 11.Global Narcolepsy Therapeutics Market, by Country, $Million, 2021-2032 .................................................................................. 91 11.1Overview ........................................................................................................... 92 11.2U.S. .................................................................................................................... 93 11.3U.K. ................................................................................................................... 95 11.4Germany ........................................................................................................... 97 11.5France ............................................................................................................... 99 11.6Italy ................................................................................................................. 101 11.7Spain ............................................................................................................... 103 11.8Japan .............................................................................................................. 105 12.Market - Competitive Benchmarking & Company Profiles ......... 107 12.1Overview ......................................................................................................... 108 12.2Jazz Pharmaceuticals PLC ............................................................................ 109 12.2.1Company Overview ................................................................................... 109 12.2.2Role of Jazz Pharmaceuticals PLC in the Global Narcolepsy Therapeutics Market .................................................................................. 109 12.2.3Key Competitors ........................................................................................ 110 GLOBAL NARCOLEPSY THERAPEUTICS MARKET 12.2.4Key Distributors......................................................................................... 111 12.2.5Financials ................................................................................................... 111 12.2.6Corporate Strategies ................................................................................. 113 12.2.7Analyst’s Perspective ............................................................................... 114 12.3Harmony Bioscience, LLC ............................................................................ 115 12.3.1Company Overview ................................................................................... 115 12.3.2Role of Harmony Biosciences, LLC in the Global Narcolepsy Therapeutics Market .................................................................................. 115 12.3.3Key Competitors ........................................................................................ 116 12.3.4Key Distributors......................................................................................... 116 All rights reserved at BIS Research Inc. 6

  7. 12.3.5Financials ................................................................................................... 116 12.3.6Corporate Strategies ................................................................................. 117 12.3.7Analyst’s Perspective ............................................................................... 118 12.4Axsome Therapeutics, Inc. ........................................................................... 119 12.4.1Company Overview ................................................................................... 119 12.4.2Role of Axsome Therapeutics, Inc. in the Global Narcolepsy Therapeutics Market .................................................................................. 119 12.4.3Key Competitors ........................................................................................ 120 12.4.4Financials ................................................................................................... 120 12.4.5Corporate Strategies ................................................................................. 121 12.4.6Analyst’s Perspective ............................................................................... 122 12.5Avadel Pharmaceuticals PLC ....................................................................... 123 12.5.1Company Overview ................................................................................... 123 12.5.2Role of in Avadel Pharmaceuticals PLC in the Global Narcolepsy Therapeutics Market .................................................................................. 123 12.5.3Key Competitors ........................................................................................ 124 12.5.4Key Distributors......................................................................................... 124 12.5.5Financials ................................................................................................... 125 12.5.6Corporate Strategies ................................................................................. 126 12.5.7Analyst’s Perspective ............................................................................... 127 12.6Takeda Pharmaceutical Co Ltd ..................................................................... 128 GLOBAL NARCOLEPSY THERAPEUTICS MARKET 12.6.1Company Overview ................................................................................... 128 12.6.2Role of Takeda Pharmaceutical Co Ltd in the Global Narcolepsy Therapeutics Market .................................................................................. 128 12.6.3Key Competitors ........................................................................................ 129 12.6.4Key Distributors......................................................................................... 129 12.6.5Financials ................................................................................................... 129 12.6.6Corporate Strategies ................................................................................. 132 12.6.7Analyst’s Perspective ............................................................................... 132 12.7Sumitomo Pharma Co Ltd ............................................................................. 133 12.7.1Company Overview ................................................................................... 133 All rights reserved at BIS Research Inc. 7

  8. 12.7.2Role of Sumitomo Pharma Co Ltd in the Global Narcolepsy Therapeutics Market .................................................................................. 133 12.7.3Key Competitors ........................................................................................ 134 12.7.4Key Distributors......................................................................................... 134 12.7.5Financials ................................................................................................... 134 12.7.6Corporate Strategies ................................................................................. 136 12.7.7Analyst Perspectives ................................................................................ 137 12.8Suven Life Sciences Limited ........................................................................ 138 12.8.1Company Overview ................................................................................... 138 12.8.2Role of Suven Life Sciences Limited in the Global Narcolepsy Therapeutics Market .................................................................................. 138 12.8.3Key Competitors ........................................................................................ 139 12.8.4Financials ................................................................................................... 139 12.8.5Corporate Strategies ................................................................................. 140 12.8.6Analyst Perspectives ................................................................................ 141 12.9NLS Pharmaceutics AG ................................................................................. 142 12.9.1Company Overview ................................................................................... 142 12.9.2Role of NLS Pharmaceutics AG in the Global Narcolepsy Therapeutics Market .................................................................................. 142 12.9.3Key Competitors ........................................................................................ 143 12.9.4Financials ................................................................................................... 143 GLOBAL NARCOLEPSY THERAPEUTICS MARKET 12.9.5Corporate Strategies ................................................................................. 144 12.9.6Analyst’s Perspective ............................................................................... 145 12.10Balance Therapeutics .................................................................................... 146 12.10.1 Company Overview ............................................................................. 146 12.10.2 Role of Balance Therapeutics in the Global Narcolepsy Therapeutics Market .................................................................................. 146 12.10.3 Key Competitors ................................................................................. 147 12.10.4 Corporate Strategies ........................................................................... 147 12.10.5 Analyst’s Perspective ......................................................................... 147 All rights reserved at BIS Research Inc. 8

  9. List of Figures Figure 1: Global Narcolepsy Therapeutics Market Dynamics Figure 2: Global Narcolepsy Therapeutics Market (by Indication), $Million, 2021 and 2032 Figure 3: Global Narcolepsy Therapeutics Market (by Therapeutics), $Million, 2021 and 2032 Figure 4: Global Narcolepsy Therapeutics Market (by Country), $Million, 2021-2032 Figure 5: Global Narcolepsy Therapeutics Market Segmentation Figure 6: Global Narcolepsy Therapeutics Market Research Methodology Figure 7: Primary Research Methodology Figure 8: Epidemiology-Based Market Sizing and Forecasting Methodology Figure 9: Symptoms of Narcolepsy Figure 10: Impact of Narcolepsy on Day-to-Day Activities Figure 11: Prevalence, Diagnosed Population, and Diagnosed and Treated Population of Narcolepsy in the U.S., 2021-2032 Figure 12: Estimated Population of Narcolepsy in EU-4 and U.K., 2021 Figure 13: Existing Treatment Options for Managing Excessive Daytime Sleepiness (EDS) and Cataplexy in Type 1 Narcolepsy Figure 14: Global Narcolepsy Therapeutics Market, $Million, 2021-2032 Figure 15: U.S. Narcolepsy Treatment Guideline Figure 16: European Narcolepsy Treatment Guideline Figure 17: Clinical Trial Authorization for Narcolepsy Therapeutics in the U.S. Figure 18: Steps for Obtaining Marketing Authorization Figure 19: U.S. FDA Review Timeline GLOBAL NARCOLEPSY THERAPEUTICS MARKET Figure 20: EMA Review Timeline Figure 21: Market Dynamics Figure 22: Impact Analysis Figure 23: Narcolepsy Patients: Undiagnosed, Diagnosed and Treated, Diagnosed and Untreated Figure 24: Neuroscience Research Funding (2013-2022) Figure 25: Recently Approved Narcolepsy Products Figure 26: Narcolepsy Therapeutics Unmet Needs: Patients and HCPs' Perspective Figure 27: Market Restraints: Delayed Diagnosis Figure 28: Advanced Narcolepsy Therapies Figure 29: Share of Key Developments and Strategies, January 2019-May 2022 All rights reserved at BIS Research Inc. 9

  10. Figure 30: Synergistic Activities Share (by Company), January 2019-May 2022 Figure 31: Funding and Business Expansion Activities (by Company), January 2019-May 2022 Figure 32: Regulatory and Legal Developments (by Company), January 2019-May 2022 Figure 33: Regulatory and Legal Developments (by Company), January 2019-May 2022 Figure 34: Current Narcolepsy Treatment Figure 35: Share of Global Narcolepsy Therapeutics Market (by Product), $Million, 2021 and 2032 Figure 36: Global Narcolepsy Therapeutics Market (by Commercialized Product) Figure 37: Xywav Concept to Launch Figure 38: Xywav U.S. Prescribing Information Figure 39: Xywav Adoption and Awareness in the U.S. Figure 40: Global Narcolepsy Therapeutics Market (Xywav), $Million, 2021-2032 Figure 41: Xywav Recent Development Key Takeaways Figure 42: Sunosi Development and Launch Timeline in the U.S. Figure 43: Sunosi’s Strong Market Access Position Figure 44: Global Narcolepsy Therapeutics Market (Sunosi), $Million, 2021-2032 Figure 45: Wakix Development Timeline Figure 46: Wakix Favorable Benefit Profile Key Features Figure 47: Healthcare Professional and Patient Research Key Findings, 2021 Figure 48: Global Narcolepsy Therapeutics Market (Wakix), $Million, 2021-2032 Figure 49: Global Narcolepsy Therapeutics Market (by Pipeline Product) Figure 50: Recent Developments and Key Milestones in TAK-925 and TAK-861 Phase 1 Trial Figure 51: Global Narcolepsy Therapeutics Market (SUVN-G3031), $Million, 2021-2032 GLOBAL NARCOLEPSY THERAPEUTICS MARKET Figure 52: Quilience’s Distinctive Competitive Advantages Figure 53: Global Narcolepsy Therapeutics Market (SUVN-G3031), $Million, 2021-2032 Figure 54: Global Narcolepsy Therapeutics Market (AXS-12), $Million, 2021-2032 Figure 55: FT218 Regulatory Timeline in U.S. Figure 56: Global Narcolepsy Therapeutics Market (FT218), $Million, 2021-2032 Figure 57: Global Narcolepsy Therapeutics Market (by Indication) Figure 58: Share of Global Narcolepsy Therapeutics Market (by Indication), $Million, 2021 and 2032 Figure 59: Global Narcolepsy Therapeutics Market (Type 1 Narcolepsy), $Million, 2021-2032 Figure 60: Global Narcolepsy Therapeutics Market (Type 2 Narcolepsy), $Million, 2021-2032 Figure 61: Global Narcolepsy Therapeutics Market (Secondary Narcolepsy), $Million, 2021-2032 Figure 62: Global Narcolepsy Therapeutics Market (by Therapeutics), $Million, 2021 and 2032 All rights reserved at BIS Research Inc. 10

  11. Figure 63: Global Narcolepsy Therapeutics Market (Central Nervous System Stimulant), $Million, 2021- 2032 Figure 64: Global Narcolepsy Therapeutics Market (Norepinephrine Reuptake Inhibitor), $Million, 2021- 2032 Figure 65: Global Narcolepsy Therapeutics Market (Histamine-3 (H3) Receptor Antagonist/Inverse Agonist), $Million, 2021-2032 Figure 66: Global Narcolepsy Therapeutics Market (by Country), $Million, 2021-2032 Figure 67: Market Dynamics of U.S. Narcolepsy Therapeutics Market Figure 68: U.S. Narcolepsy Therapeutics Market, $Million, 2021-2032 Figure 69: Market Dynamics of U.K. Narcolepsy Therapeutics Market Figure 70: U.K. Narcolepsy Therapeutics Market, $Million, 2021-2032 Figure 71: Market Dynamics of Germany Narcolepsy Therapeutics Market Figure 72: Germany Narcolepsy Therapeutics Market, $Million, 2021-2032 Figure 73: Market Dynamics of France Narcolepsy Therapeutics Market Figure 74: France Narcolepsy Therapeutics Market, $Million, 2021-2032 Figure 75: Market Dynamics of Italy Narcolepsy Therapeutics Market Figure 76: Italy Narcolepsy Therapeutics Market, $Million, 2021-2032 Figure 77: Market Dynamics of Spain Narcolepsy Therapeutics Market Figure 78: Spain Narcolepsy Therapeutics Market, $Million, 2021-2032 Figure 79: Market Dynamics of Japan Narcolepsy Therapeutics Market Figure 80: Japan Narcolepsy Therapeutics Market, $Million, 2021-2032 Figure 81: Total Number of Companies Profiled Figure 82: Jazz Pharmaceutical PLC: Product Portfolio GLOBAL NARCOLEPSY THERAPEUTICS MARKET Figure 83: Jazz Pharmaceuticals PLC: Overall Financials, 2019-2021 Figure 84: Jazz Pharmaceuticals PLC: Revenue (by Business Segment), 2019-2021 Figure 85: Jazz Pharmaceuticals PLC: Revenue (by Region), 2019-2021 Figure 86: Jazz Pharmaceutical PLC: R&D Expenditure, 2019-2021 Figure 87: Harmony Biosciences, LLC.: Product Portfolio Figure 88: Harmony Biosciences, LLC: Overall Financials, 2019-2021 Figure 89: Harmony Biosciences, LLC: R&D Expenditure, 2019-2021 Figure 90: Axsome Therapeutics, Inc.: Pipeline Product Figure 91: Axsome Therapeutics, Inc.: R&D Expenditure, 2019-2021 Figure 92: Axsome Therapeutics, Inc.: R&D Expenditure (AXS-12), 2019-2021 All rights reserved at BIS Research Inc. 11

  12. Figure 93: Regulatory Timeline of FT218 Figure 94: Avadel Pharmaceuticals PLC: Product Portfolio Figure 95: Avadel Pharmaceuticals PLC: Overall Financials, 2019-2021 Figure 96: Avadel Pharmaceuticals PLC: R&D Expenditure, 2019-2021 Figure 97: Takeda Pharmaceutical Co Ltd: Product Portfolio Figure 98: Takeda Pharmaceutical Co Ltd: Overall Financials, 2019-2021 Figure 99: Takeda Pharmaceutical Co Ltd: Revenue (by Business Segment), 2019-2021 Figure 100: Takeda Pharmaceutical Co Ltd: Revenue (by Region), 2019-2021 Figure 101: Takeda Pharmaceutical Co Ltd: R&D Expenditure, 2019-2021 Figure 102: Sumitomo Pharma Co Ltd: Product Portfolio Figure 103: Sumitomo Pharma Co Ltd: Overall Financials, 2019-2021 Figure 104: Sumitomo Pharma Co Ltd: Revenue (by Business Segment), 2019-2021 Figure 105: Sumitomo Pharma Co Ltd: Revenue (by Region), 2019-2021 Figure 106: Sumitomo Pharma Co Ltd: R&D Expenditure, 2019-2021 Figure 107: Suven Life Sciences Limited: Product Portfolio Figure 108: Suven Life Sciences Limited: Overall Financials, 2019-2021 Figure 109: Suven Life Sciences Limited: R&D Expenditure, 2019-2021 Figure 110: NLS Pharmaceutics AG: Product Portfolio Figure 111: NLS Pharmaceutics AG: R&D Expenditure, 2019-2021 Figure 112: Balance Therapeutics: Product Portfolio GLOBAL NARCOLEPSY THERAPEUTICS MARKET All rights reserved at BIS Research Inc. 12

  13. List of Tables Table 1: Recently Marketed and Pipeline Therapies for the Treatment of Narcolepsy Table 2: Market Status of Commercialized and Pipeline Therapies Table 3: Current Therapies Available for the Treatment of Narcolepsy Table 4: Investigational Therapies for the Treatment of Narcolepsy Table 5: Narcolepsy Therapeutics Coverage Table 6: Narcolepsy Treatment Recommendation by American Academy of Sleep Medicine clinical Table 7: Most Common Symptoms in Narcolepsy Table 8: Key Marketed and Pipeline Central Nervous System Stimulants Table 9: Key Marketed and Pipeline Norepinephrine Reuptake Inhibitors Table 10: Key Marketed and Pipeline Histamine-3 (H3) Receptor Antagonist/Inverse Agonist Table 11: Key Marketed and Pipeline Products in the U.S. Table 12: Key Marketed and Pipeline Products in the U.K. Table 13: Key Marketed and Pipeline Products in Germany Table 14: Key Marketed and Pipeline Products in France Table 15: Key Marketed and Pipeline Products in Italy Table 16: Key Marketed and Pipeline Products in Spain Table 17: Jazz Pharmaceutical PLC: Key Competitors Table 18: Harmony Biosciences, LLC: Key Competitors Table 19: Axsome Therapeutics, Inc.: Key Competitors Table 20: Avadel Pharmaceuticals PLC: Key Competitors GLOBAL NARCOLEPSY THERAPEUTICS MARKET Table 21: Takeda Pharmaceutical Co Ltd: Key Competitors Table 22: Sumitomo Pharma Co Ltd: Key Competitors Table 23: Suven Life Sciences Limited: Key Competitors Table 24: NLS Pharmaceutics AG: Key Competitors Table 25: Balance Therapeutics: Key Competitors All rights reserved at BIS Research Inc. 13

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