Japan Hypersomnia Therapeutics Market Analysis

Japan Hypersomnia Therapeutics Market Executive Summary

The Japan Hypersomnia Therapeutics Market is at around $63.25 Mn in 2023 and is projected to reach $80.47 Mn in 2030, exhibiting a CAGR of 3.5% during the forecast period.

Hypersomnia is a group of neurological disorders characterized by excessive daytime sleepiness, despite getting enough sleep at night. This can significantly impair daily functioning and reduce quality of life. While the exact causes are still being researched, hypersomnia can be linked to underlying medical conditions, neurological disorders, or disruptions in sleep regulation mechanisms. People with hypersomnia often experience symptoms such as not feeling refreshed upon waking, feeling groggy and slow for extended periods after waking, and an excessive need for sleep despite sleeping for long periods. Chronic headaches, loss of appetite, excessive sweating, and depression have also been reported. Treatment for hypersomnia focuses on managing daytime sleepiness. This can involve adopting healthy lifestyle practices like eating well and exercising regularly. Medications like stimulants can also be prescribed to promote wakefulness. In some cases, cognitive behavioral therapy for insomnia (CBT-I) can help address underlying sleep habits that contribute to hypersomnia.

The prevalence of excessive daytime sleepiness, a key symptom of hypersomnia, is 2.5% (2.8% in males and 2.2% in females) in Japan. The market therefore is driven by significant factors like the increasing awareness about hypersomnia disorders, rising aging demographic, and advances in sleep disorder research. However, potential side effects, limited accessibility to specialized healthcare services, and strict regulatory approval impede market growth.

Since there is no cure for hypersomnia, treatment currently focuses on managing symptoms, particularly excessive daytime sleepiness. The leading pharmaceutical companies include Aculys Pharma is developing the drug pitolisant (brand name Wakix) for the treatment of hypersomnia disorders in Japan. Takeda Pharmaceuticals, Eisai, and Merck are also significant contributors to the hypersomnia therapeutics landscape, with continuous research and development activities.

Market Dynamics

Market Growth Drivers

Increasing Awareness about Hypersomnia Disorders: Increased public awareness campaigns and healthcare professional education are leading to more accurate diagnoses, raising the potential patient pool for these medications. The Japanese government has acknowledged the importance of sleep health. Initiatives like the "Good Sleep Challenge" and sleep guideline publications highlight the need for healthy sleep habits.

Expanding Geriatric Population: Increased prevalence of hypersomnia in older adults can be attributed to alterations in sleep patterns and existing health issues. The increasing number of older adults, making up 30% of the population, is projected to lead to a rise in hypersomnia disorders, thereby increasing the need for specialized treatment options for this demographic.

Advances in Sleep Disorder Research: Advances in sleep disorder research and the development of new treatments, such as the launch of Eisai's insomnia drug Dayvigo in Japan, are contributing to the growth of the hypersomnia drug market.

Market Restraints

Strict Regulatory Approval Process: Japan has a lengthy and challenging regulatory process for approving new drugs. This slows down the entry of potentially more effective medications into the market, limiting treatment options for patients and hindering market expansion.

Limited Accessibility to Specialized Healthcare Services: In Japan, while healthcare is generally accessible, diagnosing and treating hypersomnia is challenging, particularly in rural regions. Sleep clinics, neurologists, and sleep medicine specialists with expertise in sleep disorders are mainly found in urban areas. People with hypersomnia in rural areas often have to wait for diagnoses, treatments, and ongoing care.

Potential Side Effects:  Hypersomnia medications, while beneficial for managing excessive sleepiness, often come with a range of side effects. Unfortunately, the presence of these side effects can dissuade some individuals from seeking treatment altogether, or prompt them to discontinue medication prematurely. Consequently, not only does this impact the quality of life for those affected by hypersomnia, but it also poses a challenge to market growth within the pharmaceutical industry.

Regulatory Landscape and Reimbursement Scenario

The Pharmaceuticals and Medical Devices Agency (PMDA) and the Ministry of Health, Labour and Welfare (MHLW) is responsible for drug approval in Japan. The regulatory process for approving drugs in Japan follows a set of rigorous standards to ensure safety, efficacy, and quality.

Pharmaceutical companies submit a New Drug Application (NDA) to the PMDA. The NDA includes comprehensive data from preclinical and clinical studies, as well as information on the drug's formulation, manufacturing process, and proposed labeling. The PMDA conducts a thorough review of the NDA. Once approved, hypersomnia drugs may be eligible for reimbursement under Japan's national health insurance system. The MHLW evaluates the clinical and cost-effectiveness of new drugs to determine their inclusion in the national formulary and reimbursement pricing.

Japan has a universal health insurance system, where all citizens are enrolled in at least one of the public health insurance schemes. This ensures that everyone has access to medical care for a relatively low co-payment. The government provides subsidies to support the health insurance system, particularly for community-based insurers.

Competitive Landscape

Key Players

Here are some of the major key players in the Japan Hypersomnia Therapeutics Market:

• Aculys Pharma, Inc.
• Otsuka Pharmaceutical
• Zenyaku Kogyo
• Teva
• Takeda Pharmaceuticals
• Merck
• Eisai
• Mylan N.V.
• Fisher and Paykel Healthcare
• GlaxoSmithKline
• Theranexus