Description
Global Narcolepsy Therapeutics Market: Industry Overview
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. This The market is driven by certain factors, such as low satisfaction with available therapies, robust pipeline products, rising uptake of narcolepsy awareness programs, and improving diagnosis.
Market Lifecycle Stage
The global narcolepsy therapeutics market is in the rapidly evolving and dynamic stage, which opens ample opportunities for life science companies. Also, companies that are already in the development phase for narcolepsy therapies are trying to bring advanced treatment options to the market to improve the quality of life of people with narcolepsy.
The companies operating in the global narcolepsy therapeutics market are now focusing more on disease-specific and personalized treatment options. Also, major players such as Jazz Pharmaceuticals PLC, Takeda Pharmaceuticals Co. Ltd, and Bioproject Pharma are investing heavily in research and development for their respective therapeutic products.
Impact
Albeit narcolepsy is an orphan disorder with only about 3 million people globally, the existing management of narcolepsy propounds the area as investigational for drug research and development. Currently, all available therapies are symptom-centric and do not cure the condition. In about 50% of people, disorder onset often occurs prior to age 25 with a delayed diagnosis, especially in adolescents.
Insubstantial abilities of existing therapies to cover a complete range of symptoms and insignificant improvement in the quality of life of people with narcolepsy have led to the emergence of several innovative therapies in recent years. The market witnessed approximately 39 regulatory and legal developments during the time period between January 2019 and May 2022.
In addition, the disorder profoundly increases the psychosocial burden on people with narcolepsy. Associated high treatment costs and dwindled work productivity with reduced income levels are some of the key factors adding to the psychosocial burden for people living with narcolepsy.
Most companies are focusing on expanding their product portfolio with the launch of best-in-class distinctive novel therapeutics and trying to address the limitations and challenges with available therapies in an effort to increase their global footprint alongside.
Market Segmentation
Segmentation 1: by Indication
• Type 1 Narcolepsy
• Type 2 Narcolepsy
• Secondary Narcolepsy
Due to recent research and development in type 1 narcolepsy, significant therapies with novel mechanisms of action, reduced dosing, and better efficacy are emerging. Therefore, the segment is dominated by type 1 narcolepsy, which held a share of 69.60% in 2021.
Segmentation 2: by Product
• Commercialized Products
• Pipeline Products
In 2021, the global narcolepsy therapeutics market (by product) is dominated by commercialized products with 100% market share.
Segmentation 3: by Therapeutic Type
• Central Nervous System Stimulant
• Norepinephrine Reuptake Inhibitor
• Histamine-3 (H3) Receptor Antagonist/Inverse Agonist
The global narcolepsy therapeutics market (by therapeutics) is presently dominated by central nervous system stimulant, with a value of $535.3 million, as of 2021.
Segmentation 4: by Country
• U.S.
• Germany
• Italy
• France
• U.K.
• Spain
• Japan
In 2021, the U.S. accounted for a share of 93.48% of the global narcolepsy therapeutics market. The segment is expected to reach $4,327.7 million in 2032 from $855.5 million in 2021 at a CAGR of 15.24% during the forecast period 2022-2032.
Recent Developments in the Global Narcolepsy Therapeutics Market
• On March 28, 2022, Jazz Pharmaceuticals PLC divested Sunosi. Axsome Therapeutics, Inc. will expand its presence in neuroscience by acquiring Sunosi (solriamfetol) from Jazz Pharmaceuticals PLC.
• On August 31, 2021, Health Canada approved Jazz Pharmaceutical’s Sunosi (solriamfetol) for excessive daytime sleepiness associated with narcolepsy.
• On August 10, 2021, Harmony Biosciences LLC’s successful track record of Wakix motivated Blackstone to enter a strategic financing collaboration, where the company agreed to invest up to $330.0 million of financing and growth capital in Harmony Biosciences LLC.
• On September 16, 2021, Axsome Therapeutics, Inc. announced the enrolment of the first patient in the new phase 3 clinical trial SYMPHONY (a study evaluating a mechanistic approach to treating narcolepsy) of AXS-12 in narcoleptic patients.
Demand – Drivers and Limitations
Following are the demand drivers for the global narcolepsy therapeutics market:
• Large Population of Undiagnosed and Untreated Narcolepsy Population
• Increasing Research Funding for Neuroscience
• Approval of Advanced Therapies with Novel Mechanism of Action (MoA)
• Existing Unmet Needs of Patients and Healthcare Professionals (HCPs)
The market is expected to face some limitations due to the following challenges:
• Delayed Diagnosis
• Lack of Awareness
How Can This Report Add Value to an Organization?
Innovation Strategy: The therapeutic segment helps the reader understand the different drug classes being targeted to develop novel and advanced therapies for narcolepsy in the market.
Growth/Marketing Strategy: The global narcolepsy therapeutics market has seen major development by key players operating in the market, such as regulatory and legal developments, clinical developments, synergistic activities, product approvals, product launches and updates, mergers and acquisitions, business expansion and funding, and other developments.
The favored strategy for the companies has been regulatory and legal activities along with product approvals to strengthen their position in the market.
Competitive Strategy: Key players in the global narcolepsy therapeutics market have been analyzed and profiled in the study. Moreover, a detailed competitive benchmarking of players operating in the global narcolepsy therapeutics market has been done to help the reader understand how players stack against each other, presenting a clear market landscape.
Additionally, comprehensive competitive strategies such as partnerships, agreements, and collaborations will aid the reader in understanding the untapped revenue pockets in the market.
Key Market Players and Competition Synopsis
The companies that are profiled have been selected based on inputs gathered from primary experts and analyzing company coverage, product portfolio, and market penetration.
Some of the prominent names established in this market are:
• Jazz Pharmaceuticals PLC
• Harmony Bioscience, LLC
• Axsome Therapeutics, Inc.
• Avadel Pharmaceuticals PLC
• Takeda Pharmaceutical Co Ltd
• Sumitomo Pharma Co Ltd
• Suven Life Sciences Limited
• NLS Pharmaceutics AG
• Balance Therapeutics
Table of Contents
1 Market
1.1 Product Definition
1.2 Inclusion and Exclusion
2 Market Scope
2.1 Key Questions Answered in the Report
3 Research Methodology
3.1 Data Sources
3.1.1 Primary Data Source
3.1.2 Secondary Data Sources
3.2 Market Estimation Model
3.3 Criteria for Company Profiling
4 Market Overview
4.1 Introduction
4.2 Epidemiology of Narcolepsy
4.2.1 U.S.
4.2.2 EU4 and U.K.
4.2.3 Japan
4.3 Key Therapeutic Classes for Narcolepsy
4.3.1 Central Nervous System Stimulants
4.3.2 Histamine-3 (H3) Receptor Antagonist/Inverse Agonist
4.3.3 Dopamine and Norepinephrine Reuptake Inhibitor (DNRI)
4.4 Currently Approved and Investigational Treatments for Narcolepsy
4.5 Current Market Size and Growth Potential, $Million, 2021-2031
5 Industry Insights
5.1 Overview
5.2 Treatment Guideline for Narcolepsy Therapeutics
5.3 Legal Requirements and Frameworks
5.3.1 Legal Requirement and Framework in the U.S.
5.3.1.1 Clinical Trial Authorization
5.3.1.2 Marketing Authorization
5.3.1.3 USFDA Guidelines for NDA Submission
5.3.1.4 Post Authorization Regulations
5.3.2 Legal Requirement and Framework in Europe
5.3.2.1 EMA Drug Licence Application Process
5.3.2.2 Centralized Procedure
5.3.2.3 Decentralized Procedure
5.3.2.4 Mutual-Recognition Procedure
5.3.2.5 National Procedure
5.3.3 Legal Requirements and Frameworks in Japan
5.4 Reimbursement Scenario
6 Market Dynamics
6.1 Overview
6.2 Impact Analysis
6.3 Market Drivers
6.3.1 Large Population of Undiagnosed and Untreated Narcolepsy Patients
6.3.2 Increasing Research Funding for Neuroscience
6.3.3 Approval of Advanced Therapies with Novel Mechanism of Action (MoA)
6.3.4 Existing Unmet Needs of Patients and Healthcare Professionals (HCPs)
6.4 Market Restraints
6.4.1 Delayed Diagnosis
6.4.2 Lack of Awareness
6.5 Market Opportunities
6.5.1 Growing Opportunities in Asian Countries
6.5.2 Opportunity for Narcolepsy Therapies with Novel Composition and Route of Administration
7 Competitive Insights
7.1 Corporate Strategies
7.1.1 Synergistic Activities
7.1.2 Mergers and Acquisitions
7.1.3 Funding and Business Expansion Activities
7.2 Business Strategies
7.2.1 Regulatory and Legal Developments
7.2.2 Clinical Developments
8 Global Narcolepsy Therapeutics Market, by Product, $Million, 2021-2032
8.1 Overview
8.2 Commercialized Products
8.2.1 Xywav
8.2.2 Sunosi
8.2.3 Wakix
8.3 Pipeline Products
8.3.1 Phase 1
8.3.2 Phase 2
8.3.2.1 SUVN-G3031
8.3.2.2 Quilience
8.3.3 Phase 3
8.3.3.1 AXS-12
8.3.3.2 FT218
9 Global Narcolepsy Therapeutics Market, by Indication, $Million, 2021-2032
9.1 Overview
9.2 Type 1 Narcolepsy
9.3 Type 2 Narcolepsy
9.4 Secondary Narcolepsy
10 Global Narcolepsy Therapeutics Market, by Therapeutics, $Million, 2021-2032
10.1 Overview
10.2 Central Nervous System Stimulant
10.3 Norepinephrine Reuptake Inhibitor
10.4 Histamine-3 (H3) Receptor Antagonist/Inverse Agonist
11 Global Narcolepsy Therapeutics Market, by Country, $Million, 2021-2032
11.1 Overview
11.2 U.S.
11.3 U.K.
11.4 Germany
11.5 France
11.6 Italy
11.7 Spain
11.8 Japan
12 Market – Competitive Benchmarking & Company Profiles
12.1 Overview
12.2 Jazz Pharmaceuticals PLC
12.2.1 Company Overview
12.2.2 Role of Jazz Pharmaceuticals PLC in the Global Narcolepsy Therapeutics Market
12.2.3 Key Competitors
12.2.4 Key Distributors
12.2.5 Financials
12.2.6 Corporate Strategies
12.2.7 Analyst’s Perspective
12.3 Harmony Bioscience, LLC
12.3.1 Company Overview
12.3.2 Role of Harmony Biosciences, LLC in the Global Narcolepsy Therapeutics Market
12.3.3 Key Competitors
12.3.4 Key Distributors
12.3.5 Financials
12.3.6 Corporate Strategies
12.3.7 Analyst’s Perspective
12.4 Axsome Therapeutics, Inc.
12.4.1 Company Overview
12.4.2 Role of Axsome Therapeutics, Inc. in the Global Narcolepsy Therapeutics Market
12.4.3 Key Competitors
12.4.4 Financials
12.4.5 Corporate Strategies
12.4.6 Analyst’s Perspective
12.5 Avadel Pharmaceuticals PLC
12.5.1 Company Overview
12.5.2 Role of in Avadel Pharmaceuticals PLC in the Global Narcolepsy Therapeutics Market
12.5.3 Key Competitors
12.5.4 Key Distributors
12.5.5 Financials
12.5.6 Corporate Strategies
12.5.7 Analyst’s Perspective
12.6 Takeda Pharmaceutical Co Ltd
12.6.1 Company Overview
12.6.2 Role of Takeda Pharmaceutical Co Ltd in the Global Narcolepsy Therapeutics Market
12.6.3 Key Competitors
12.6.4 Key Distributors
12.6.5 Financials
12.6.6 Corporate Strategies
12.6.7 Analyst’s Perspective
12.7 Sumitomo Pharma Co Ltd
12.7.1 Company Overview
12.7.2 Role of Sumitomo Pharma Co Ltd in the Global Narcolepsy Therapeutics Market
12.7.3 Key Competitors
12.7.4 Key Distributors
12.7.5 Financials
12.7.6 Corporate Strategies
12.7.7 Analyst Perspectives
12.8 Suven Life Sciences Limited
12.8.1 Company Overview
12.8.2 Role of Suven Life Sciences Limited in the Global Narcolepsy Therapeutics Market
12.8.3 Key Competitors
12.8.4 Financials
12.8.5 Corporate Strategies
12.8.6 Analyst Perspectives
12.9 NLS Pharmaceutics AG
12.9.1 Company Overview
12.9.2 Role of NLS Pharmaceutics AG in the Global Narcolepsy Therapeutics Market
12.9.3 Key Competitors
12.9.4 Financials
12.9.5 Corporate Strategies
12.9.6 Analyst’s Perspective
12.1 Balance Therapeutics
12.10.1 Company Overview
12.10.2 Role of Balance Therapeutics in the Global Narcolepsy Therapeutics Market
12.10.3 Key Competitors
12.10.4 Corporate Strategies
12.10.5 Analyst’s Perspective
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
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
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
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
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
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
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
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
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
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