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Market Overview

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The global narcolepsy therapeutics market is expected to reach $4,912 million by 2032, growing at a CAGR of 15.93% during the forecast period of 2022-2032. This growth is driven by several factors, including low satisfaction with available therapies, a robust pipeline of products, increasing awareness programs for narcolepsy, and improved diagnosis rates.

Narcolepsy is a rare and chronic neurological disorder that affects approximately 1 in 2000 individuals worldwide, with around 0.05% of patients in the U.S. in 2021. While the disorder is rare, the current management of narcolepsy highlights the need for further research and development of drugs. Existing therapies mainly focus on managing symptoms but do not provide a cure. Diagnosis of the disorder is often delayed, especially in adolescents, and about 50% of cases experience onset before the age of 25. This limited effectiveness of available therapies and the lack of significant improvement in the quality of life for people with narcolepsy have led to the development of innovative treatment options in recent years.

The global narcolepsy therapeutics market is in a rapidly evolving and dynamic stage, presenting ample opportunities for companies in the life sciences sector. Companies involved in the development of narcolepsy therapies are striving to bring advanced treatment options to the market and improve the quality of life for patients. Major players such as Jazz Pharmaceuticals PLC, Takeda Pharmaceuticals Co. Ltd, and Bioproject Pharma are heavily investing in research and development for their therapeutic products, with a focus on disease-specific and personalized treatment approaches.

Despite being an orphan disorder that affects only around 3 million people globally, narcolepsy presents a significant area for drug research and development. The existing therapies primarily target symptoms rather than providing a cure. The disorder also imposes a considerable psychosocial burden on affected individuals, leading to high treatment costs and reduced work productivity. To address these challenges, companies are expanding their product portfolios by introducing novel therapeutics that aim to address the limitations of current therapies and improve the overall management of narcolepsy. This expansion strategy is expected to enhance the global presence of these companies.

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Market Segmentation

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The market is segmented based on various factors, including indication, product, therapeutic type, and region.

Segmentation by Indication
Type 1 Narcolepsy
Type 2 Narcolepsy
Secondary Narcolepsy

Segmentation by Product
Commercialized Products
Pipeline Products

Segmentation by Therapeutic Type
Central Nervous System Stimulant
Norepinephrine Reuptake Inhibitor
Histamine-3 (H3) Receptor Antagonist/Inverse Agonist

Segmentation by Region
U.S.
Germany
Italy
France
U.K.
Spain
Japan

Recent advancements in research and development have led to the emergence of significant therapies with novel mechanisms of action, reduced dosing, and improved efficacy for type 1 narcolepsy. As a result, the type 1 narcolepsy segment dominates the market, holding a share of 69.60% in 2021. This dominance can be attributed to the high prevalence of type 1 narcolepsy cases and increased research activities aimed at understanding the condition’s pathogenesis over the past decade. These improved treatment options aim to enhance the quality of life for patients with narcolepsy during the forecast period of 2022-2032.

Type 1 narcolepsy, formerly known as narcolepsy with cataplexy, is the most common and observed indication in patients. It is characterized by a momentary loss of muscle control, caused by impaired hypocretin or orexin neurons in the lateral hypothalamus, resulting in reduced levels of hypocretin-1 in the cerebrospinal fluid. Cataplexy, experienced by approximately 70% of patients with narcolepsy, is triggered by sudden emotions, leading to physical weakness or even loss of consciousness.

The global narcolepsy therapeutics market, specifically in terms of therapeutics, is currently dominated by central nervous system stimulants, with a value of $535 million in 2021. Central nervous system stimulants are the primary therapy used to promote wakefulness during the day. First-line treatments for narcolepsy include Xyrem, modafinil (Provigil), and armodafinil (Nuvigil), while second-line treatment options include Xywav and others. Jazz Pharmaceuticals PLC’s Xyrem, commercialized in 2002, has become the mainstay treatment for narcolepsy and reported net product sales of $1,742 million in 2020. However, with generic launches expected in 2023, the company has introduced new product lines to maintain its dominance in the global narcolepsy therapeutics market.

In 2021, the United States accounted for 93.48% of the global narcolepsy therapeutics market and is projected to reach $4,328 million in 2032, growing at a CAGR of 15.24% during the forecast period of 2022-2032. The U.S. is expected to remain the dominant market due to its high adoption rate of existing and emerging products. The early launch of pipeline products, supported by several key companies in the market, will further drive market growth. The country is expected to experience the highest compound annual growth rate (CAGR) of 15.24% during the forecast period, followed by the United Kingdom and EU-4 countries (Germany, France, Spain, and Italy). Japan is also anticipated to witness significant growth in the later years, attributed to the introduction of pipeline products within the country.

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Competitive Landscape

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The selection of the profiled companies was based on inputs collected from primary experts, as well as the analysis of their company coverage, product portfolio, and market penetration.

Key companies profiled in this report include 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.

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Recent Industry Developments

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On March 28, 2022, Jazz Pharmaceuticals PLC executed the divestiture of Sunosi. In line with this, Axsome Therapeutics, Inc. will enhance its presence in the field of neuroscience through the acquisition of Sunosi (solriamfetol) from Jazz Pharmaceuticals PLC.

Health Canada granted approval for Jazz Pharmaceutical’s Sunosi (solriamfetol) on August 31, 2021, specifically for the treatment of excessive daytime sleepiness associated with narcolepsy.

Harmony Biosciences LLC’s successful track record with Wakix caught the attention of Blackstone, leading to a strategic financing collaboration. Under the agreement, Blackstone agreed to invest up to $330.0 million in financing and growth capital to support Harmony Biosciences LLC.

On September 16, 2021, Axsome Therapeutics, Inc. announced the enrollment of the first patient in their new phase 3 clinical trial, SYMPHONY. This trial aims to evaluate AXS-12, a mechanistic approach to treating narcolepsy, in patients diagnosed with the condition.

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Key Questions Answered

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What are the primary market drivers, challenges, and opportunities in the global narcolepsy therapeutics market?

What are the major players implementing as key development strategies to sustain their position in the competitive market?

Among the leading and emerging players, which therapeutic type dominates the field of narcolepsy treatment?

Which class of drugs have the leading players in the global narcolepsy therapeutics market considered as key options?

What are the most promising emerging and investigational therapies for narcolepsy?

How is each segment of the market expected to grow between 2022 and 2032 according to the forecast period?

Which companies are expected to disrupt the market significantly in the future, and what are the reasons behind this anticipation?

What is the reimbursement scenario and the regulatory landscape for narcolepsy treatment in the seven major markets?

What are the treatment guidelines for narcolepsy in the seven major markets?