Idiopathic Hypersomnia Treatment Market Size, Share, Industry, Forecast and outlook (2024-2031)

Global idiopathic hypersomnia treatment market is segmented By Treatment Type(Non-Stimulant Wake-Promoting Medications (Modafinil, Armodafinil, Solriamfetol, Pitolisant and Others), CNS Depressants(Xyrem , Xywav), Psychostimulants(Amphetamines, Methylphenidate, Others) and Others), By Distribution Channel(Hospital Pharmacies, Retail Pharmacies, Online Pharmacies), and By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2023-2030  

Market Overview

Global idiopathic hypersomnia treatment market reached US$ YY million in 2022 and is expected to reach US$ YY million by 2030, growing at a CAGR of YY% during the forecast period 2023-2030.

Idiopathic hypersomnia (IH) is a chronic neurologic disorder characterized by an insatiable need to sleep that is not eased by a full night’s slumber. People with idiopathic hypersomnia sleep normally or for long amounts of time each night but still feel excessively sleepy during the day. 

Moreover, there is no cure for the idiopathic hypersomnia. Because the cause of idiopathic hypersomnia is not known, the treatment is aimed at easing symptoms. Stimulant medication, such as modafinil (Provigil, Alertec), might be prescribed to help you stay awake during the day. In 2021, the FDA approved the Xywav (calcium, magnesium, potassium, and sodium oxybates),  the first and only FDA-approved treatment for idiopathic hypersomnia. 

Market Scope

Market Dynamics: Drivers

Increasing demand for novel therapeutics 

The increasing demand for novel therapeutics is expected to drive the market over the forecast period. The idiopathic hypersomnia has no cure but the novel therapeutics aim to address the unmet needs associated with the management of the condition and associated severity by providing alternative or complementary treatment options for better disease management. 

For instance, on November 18, 2022, KemPharm, Inc., a biotechnology company focused on the discovery, development and commercialization of novel treatments for the rare central nervous system (CNS) and neurodegenerative diseases released that the U.S. Food and Drug Administration (FDA) has granted the Orphan Drug Designation to serdexmethylphenidate for the treatment of idiopathic hypersomnia (IH).

Moreover, many clinical trials are going on for the development of novel therapeutics that show better results in treatment. For instance, on June 03, 2023, Zevra Therapeutics, Inc., a rare disease therapeutics company, released an oral presentation featuring the Phase 2 clinical trial design evaluating KP1077 as a treatment for idiopathic hypersomnia (IH).

In addition, the regulatory approvals increase the trust in patients about the development of novel therapeutics. For instance, on December 1, 2021, Harmony Biosciences Holdings, Inc., a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, cleared that the U.S. Food and Drug Administration (FDA) accepted an Investigational New Drug (IND) application for pitolisant for the treatment of idiopathic hypersomnia (IH).

Further, the increasing prevalence of idiopathic hypersomnia, rising FDA approvals, increasing clinical trials, increasing awareness and advancements in the development of novel drugs and therapies are the factors expected to drive the market over the forecast period.

Restraints

Factors such as complications associated with the high doses of drugs, the high cost of the treatment and the lack of better treatment for the idiopathic hypersomnia treatment are expected to hamper the market. 

Segment Analysis

The global idiopathic hypersomnia treatment market is segmented based on treatment type, distribution channel and region.

The CNS depressants segment accounted for approximately 38.5% of the idiopathic hypersomnia treatment market share

The CNS depressants such as Xywav and Xyrem are expected to hold the largest market share over the forecast period. As the disease has no cure, and the Xywav is the first FDA-approved treatment for idiopathic hypersomnia. Xywav is effective at reducing excessive daytime sleepiness, which is a hallmark symptom of idiopathic hypersomnia. It can help individuals stay awake and alert during the day, improving their overall quality of life.

For instance, on August 12, 2021, Jazz Pharmaceuticals plc cleared the U.S. Food and Drug Administration (FDA) approval for Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for the treatment of idiopathic hypersomnia in adults. Xywav, also known as JZP258, is a lower-sodium oxybate approved by the U.S. Food and Drug Administration (FDA) for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy and for the treatment of idiopathic hypersomnia in adults. 

Moreover, the Xywav can improve the quality of nighttime sleep by reducing the number of nighttime awakenings and sleep disruptions. This results in more restorative sleep, which is essential for individuals with idiopathic hypersomnia.

Further, the effects of Xywav often last throughout the night, providing continuous relief from daytime sleepiness and improved sleep quality. This contrasts with some other medications that may have a shorter duration of action.

Geographical Analysis

North America accounted for approximately 38.6% of the market share 

North America region is expected to hold the largest market share over the forecast period owing to the strong presence of major players and increasing research activities. North America especially the United States is known for its strong presence of major players such as pharmaceutical companies and medical device companies which actively develop novel therapeutics for the treatment of idiopathic hypersomnia. The presence of major players actively performing in clinical trials, leads to the launch of novel therapeutics and alternative treatment options.

For instance, on April 27, 2022, Harmony Biosciences began the Phase III INTUNE clinical trial of its Wakix tablets to treat adult patients with idiopathic hypersomnia (IH). The placebo-controlled, randomized, double-blind withdrawal trial will enroll nearly 200 IH patients at 60 to 80 trial sites in the US. Assessing the efficacy and safety of Wakix versus placebo to treat EDS in adult IH patients is the primary objective of the trial. 

Furthermore, increasing research activities also help to develop more advanced therapeutics for the better management of the symptoms in the early stages. As the research activities increase, the therapeutics are developed more precisely by reducing the adverse effects and complications associated with the therapeutics, which results in better patient outcomes.

Competitive Landscape

The major global players in the idiopathic hypersomnia treatment market include Jazz Pharmaceuticals plc, Harmony Biosciences Holdings, Inc., AVADEL PHARMACEUTICALS PLC, Zevra Therapeutics, Inc., Teva Pharmaceuticals USA, Inc., Mylan N.V., Hoffmann-La Roche Limited, BIOPROJET, Theranexus, Shionogi Inc. and among others. 

Key Developments

• On June 05, 2023, Avadel Pharmaceuticals plc, a biopharmaceutical company focused on transforming medicines to transform lives, released that LUMRYZ is now commercially available. LUMRYZ is an extended-release formulation of sodium oxybate indicated to be taken once at bedtime for the treatment of cataplexy or excessive daytime sleepiness (EDS) and IH in adults.
• On March 28, 2022, NLS Pharmaceutics Ltd., cleared that it has entered into an agreement with Caligor Coghlan Pharma Services (CCPS) to administer a Named Patient Program enabling European patients with Idiopathic Hypersomnia (IH) to have pre-approval access to treatment with the Company's novel Mazindol ER formulation. CCPS will provide Mazindol ER under this program, in which physicians can prescribe Mazindol ER to patients who are not receiving adequate relief from currently approved IH treatments.

COVID-19 Impact Analysis

The COVID-19 pandemic significantly impacted the global idiopathic hypersomnia treatment market. Clinical trials for new medications or treatments for idiopathic hypersomnia are temporarily halted due to the pandemic, which could affect the timeline for the development and approval of new treatments due to the redirected focus on the COVID-19 pandemic and its related restrictions. The pandemic also disrupted the supply chain of these treatment drugs globally.

Why Purchase the Report?

• To visualize the global idiopathic hypersomnia treatment market segmentation based on treatment type, distribution channel and region as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development
• Excel data sheet with numerous data points of idiopathic hypersomnia treatment market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as excel consisting of key products of all the major players

The global idiopathic hypersomnia treatment market report would provide approximately 55 tables, 48 figures, and 187 Pages.

Target Audience 2023

• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies

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