Narcolepsy Therapeutics Market

Market Overview

The global narcolepsy therapeutics market size was valued at USD 3.9 billion in 2022 and is projected to reach a value of USD 7.9 billion by 2031, registering a CAGR of 8.2% during the forecast period (2023-2031). The rising prevalence of narcolepsy is a factor in the narcolepsy therapeutics market growth.

Narcolepsy is a chronic neurological disorder in which the brain's ability to regulate sleep-wake cycles is impaired. It can cause people to fall asleep during the day without warning. Narcolepsy therapeutics are medications and other interventions used to treat the symptoms of narcolepsy, a chronic neurological disorder characterized by excessive daytime sleepiness, sudden loss of muscle tone (Cataplexy), hallucinations, sleep paralysis, and disrupted nighttime sleep. The primary goal of narcolepsy treatment is to improve daytime wakefulness and manage other symptoms to improve the overall quality of life for people who have the condition.

Increased research and development activities on narcolepsy treatments are likely to boost the narcolepsy therapeutics market share. Pharmaceutical companies and academic organizations are working hard to create new treatments for narcolepsy. R&D activities have picked up steam in recent years, resulting in the launch of novel treatment alternatives in the coming years. With ongoing research, technological advancements, and a focus on improving patient outcomes, the global market is expected to continue evolving. The future landscape of narcolepsy treatment is likely to be shaped by the development of novel therapies, increased awareness, and efforts to address diagnostic challenges.

Highlights

• Narcolepsy with Cataplexy holds a significant market share by treatment.
• Sodium Oxybate generates the most revenue by product.
• North America dominates the global market.

Market Dynamics

Global Narcolepsy Therapeutics Market Drivers

Increasing Prevalence of Narcolepsy

The global prevalence of narcolepsy is increasing, contributing to an expanding patient population in need of effective therapeutic interventions. The increased diagnosis of narcolepsy is influenced by factors such as genetic predisposition, autoimmune mechanisms, and environmental triggers. Narcolepsy affects approximately one in every 2,000 people in the United States, according to the Narcolepsy Network. This equates to about 200,000 Americans and nearly 3 million people worldwide. However, it is estimated that only 25% of people with narcolepsy have been diagnosed and are receiving treatment.

Narcolepsy's rising prevalence has severe implications for the pharmaceutical industry and healthcare providers. It increases the demand for narcolepsy therapeutics, such as medications for excessive daytime sleepiness, Cataplexy, and other associated symptoms. The increasing prevalence is directly proportional to the increased market size for narcolepsy therapeutics. Pharmaceutical companies are encouraged to invest in R&D to meet the growing demand for effective treatments. The ever-increasing market opens up new avenues for drug development, clinical trials, and the commercialization of new medications. As a result, the Narcolepsy Therapeutics Market trend emphasizes the significance of ongoing research, public awareness campaigns, and collaboration among healthcare professionals, patient advocacy groups, and pharmaceutical companies.

Global Narcolepsy Therapeutics Market Restraints

Limited Awareness and Underdiagnosis

Despite medical advances, there is a persistent lack of awareness about narcolepsy, resulting in significant underdiagnosis. Both healthcare professionals and the general public may lack a comprehensive understanding of narcolepsy, which contributes to diagnostic and treatment delays. Narcolepsy is thought to be underdiagnosed, with approximately half of patients going undiagnosed. The average time between diagnosis and treatment is 8-10 years. Narcolepsy is frequently misdiagnosed as other conditions like psychiatric disorders or emotional issues. In one study, more than half of the patients with narcolepsy had previously been diagnosed with depression. Underdiagnosis and lack of awareness have real-world consequences, such as delayed access to appropriate treatment and management strategies. Undiagnosed narcolepsy patients may experience symptoms for an extended period, affecting their quality of life and overall well-being. In the United States and Western Europe, one in every 2,000 people suffers from narcolepsy. However, the disorder is probably underdiagnosed, especially in people who have mild symptoms. 

As a result, the impact on the global market is substantial. The market potential is not fully realized because there are fewer diagnosed patients. Pharmaceutical companies face challenges in reaching the entire target market, and narcolepsy underdiagnosis remains a barrier to broader narcolepsy therapeutic adoption.

Global Narcolepsy Therapeutics Market Opportunity

Growing Research and Development

The increased emphasis on research and development in the field of narcolepsy therapeutics opens the door to the introduction of novel medications and treatment modalities. Ongoing research into the underlying mechanisms of narcolepsy and potential drug targets helps to develop more effective and targeted therapies. The introduction of novel narcolepsy therapeutics with improved efficacy, safety profiles, and modes of administration has the potential to reshape the treatment landscape, giving healthcare providers and patients more options for treating the disorder. Lumryz (sodium oxybate) was approved by the FDA in May 2023 as the first and only once-at-bedtime oxybate for Cataplexy or excessive daytime sleepiness in adults with narcolepsy. This opportunity has a significant impact.

Additionally, breakthroughs in research may lead to the development of more effective and well-tolerated narcolepsy medications that target specific symptoms more precisely. The introduction of such therapeutics has the potential to influence treatment paradigms and increase market potential significantly. Ongoing research efforts are likely to shape the future of narcolepsy therapeutics. Pharmaceutical companies are expected to introduce new and innovative treatment options as scientific understanding grows, further expanding the market and providing patients with advanced solutions for managing narcolepsy.

Regional Analysis

The global narcolepsy therapeutics market analysis is conducted in North America, Europe, Asia-Pacific, the Middle East and Africa, and Latin America.

North America Dominates the Global Market

North America is the most significant global narcolepsy therapeutics market shareholder and is estimated to grow at a CAGR of 8.4% over the forecast period.The segment is growing due to increased R&D activities and result-oriented collaborations in research, academic, and corporate sectors. The market is expected to be driven by the availability of many products, increased R&D activities, and government-friendly initiatives; for example, according to a study published in September 2021 by Stanford Medicine, the extended-release of sodium oxybate reduced muscle weakness attacks in patients. Narcolepsy affects between 135,000 and 200,000 people in the United States, according to a fact sheet updated in November 2021 by the National Institute of Neurological Disorders and Stroke. However, the number could be much higher because this condition is frequently misdiagnosed. Given the high prevalence of narcolepsy in developed countries such as the United States, increased adoption of narcolepsy therapeutics will drive market growth in this region.

Furthermore, Stanford researchers demonstrated that once-nightly narcolepsy treatment is safe and effective in a phase 3 study, showing that an extended-release sodium oxybate reduces daytime sleepiness and attacks muscle weakness in narcolepsy patients. The increasing efficacy of narcolepsy treatments in the United States will result in increased adoption of these therapies, driving the growth of this market in this region. Furthermore, Wake Up Narcolepsy, a charity group, received USD 1 million in donations for neurological research illnesses such as narcolepsy in December 2021. The increase in donations for the development of narcolepsy treatments in the United States is expected to fuel the future growth of this market in this region.

Asia-Pacific is anticipated to exhibit a CAGR of 8.1% over the forecast period, with the region's rapid economic development, rising awareness among people, high disposable income, growing investments in pharmaceutical and biotechnology sectors, and supportive government initiatives. Furthermore, the thriving generics industry and improving healthcare facilities will drive further market growth in the coming years. The country's generative efforts to raise public awareness about sleep disorders, including narcolepsy, have made it a lucrative segment for the growth of the narcolepsy treatment market, given the emergence of local pharmaceutical players in China.

In addition, the annual incidence of narcolepsy in China is 0.79 per 100 people. Most patients visit multiple hospitals before diagnosis, with adults spending an average of 2.98 years and children and adolescents spending 0.7 years. However, a 2022 psychiatrist believes that the prevalence of narcolepsy in India may be lower than in the Western world. However, there are only a few published case reports of narcolepsy from the Indian subcontinent. As a result of the low prevalence of narcolepsy, the region's growth will be slower.

Europe holds a significant market share. According to Narcolepsy Therapeutics Market insights, Germany's market value share in the European narcolepsy treatment market increased by nearly 25%. The expansion is linked to the framework associated with new guidelines framed by the combined efforts of the European Sleep Research Society (ESRS), European Academy of Neurology (EAN), and European Narcolepsy Network (EU-NN) for the treatment of narcolepsy and associated sleep disorders in adults and children in the region.

Previously, the prevalence of narcolepsy in Europe was estimated to be 47 patients per 100,000 people, with a yearly incidence of 0.64-1.37 per 100,000. However, according to the European Narcolepsy Network (EU-NN) database, narcolepsy with Cataplexy is a rare disease, with a 0.02% prevalence in European populations. As a result, the need for treatment is also reduced.Furthermore, favorable reimbursement policies for therapeutic products, a robust clinical pipeline, and rising stress levels are expected to drive revenue growth.

Segmental Analysis

The global narcolepsy therapeutics market is segmented based on treatment, product, and region.

The market is further segmented by treatment into Narcolepsy with Cataplexy, Narcolepsy without Cataplexy, and Secondary Narcolepsy.

Narcolepsy with Cataplexy

Narcolepsy with Cataplexy holds a significant market share.

Narcolepsy with Cataplexy was identified as the largest revenue segment in 2022, with a market share of 55%. Narcolepsy with Cataplexy is a type of narcolepsy that is characterized by sudden episodes of muscle weakness or paralysis caused by strong emotions such as laughter or excitement. The treatment for this subtype frequently focuses on managing both excessive daytime sleepiness and cataplexy symptoms. Harmony Biosciences Holdings, Inc. received FDA approval for its WAKIX (pitolisant) in October 2020 to treat adult cataplexy associated with narcolepsy.

Furthermore, in some cases, Cataplexy is the confirming symptom for a conclusive diagnosis. Although Cataplexy is rarely the first symptom of narcolepsy, it affects approximately 75% of narcoleptic patients.

Narcolepsy Without Cataplexy

Excessive daytime sleepiness without Cataplexy is characterized by narcolepsy without Cataplexy. The primary goal of treatment for this subtype is to improve wakefulness and daily functioning by managing daytime sleepiness. The high prevalence of the disease and the increase in public awareness through awareness campaigns conducted by various networks, such as the U.S. Narcolepsy Network and the Europe Narcolepsy Network, are the key factors responsible for the growth of this segment.

The market can be further bifurcated by-products into CNS Stimulants, Sodium Oxybate, SSRI, and Tricyclic Antidepressants.

Sodium Oxybate

Sodium Oxybate generates the most revenue in the market.

With a revenue share of 50% in 2022, sodium oxybate dominated the global market and is expected to grow at the fastest CAGR during the forecast period. Sodium oxybate is a medication used to treat narcolepsy, specifically to manage Cataplexy and improve nighttime sleep. It is a CNS depressant that works on the brain to promote deep and restorative sleep. Sodium oxybate, when taken orally at bedtime and throughout the night, aids in regulating sleep patterns and reducing cataplexy episodes. It is an important therapeutic option for treating narcolepsy's excessive daytime sleepiness and cataplexy symptoms.

CNS Stimulants

CNS stimulants are medications that act on the brain and spinal cord to increase alertness and arousal. CNS stimulants such as modafinil and armodafinil are commonly prescribed in narcolepsy treatment to alleviate excessive daytime sleepiness. These medications improve wakefulness by influencing neurotransmitters in the brain, improving focus, and decreasing sleepiness in people with narcolepsy.

Recent Developments

• December 2023- Bristol-Myers Squibb announced the acquisition of Karuna Therapeutics to expand its neuroscience portfolio. Bristol-Myers Squibb has agreed to buy Karuna for a total equity value of USD 14.0 billion, or USD 12.7 billion, after deducting the projected cash obtained.
• October 2023- West Virginia University (WVU) joined the BRAIN Center to advance neurological disorder technology. WVU will be the primary clinical testing site for a consortium of top universities and industries working to develop technologies to improve the care and rehabilitation of people with neurological disorders.
• October 2023- Jazz Pharmaceuticals plc announced that the company and its partners will present 14 abstracts from its sleep medicine portfolio, including two oral presentations, at the 17th annual World Sleep 2023 Congress, which will be held in Rio de Janeiro, Brazil, from October 20-25.