수면장애 치료 시장 : 점유율 분석, 업계 동향과 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the sleep disorder treatment market size was valued at USD 23.34 billion in 2025 and estimated to grow from USD 24.98 billion in 2026 to reach USD 35.10 billion by 2031, at a CAGR of 7.03% during the forecast period (2026-2031).

This report is Segmented by Drug Class (Benzodiazepines, Non-Benzodiazepines, Dual Orexin Receptor Antagonists, and More), Disorder Type (Insomnia, Sleep Apnea, and More), Distribution Channel (Hospital Pharmacies, Retail Pharmacies, and More), and Geography (North America, Europe, Asia-Pacific, The Middle East and Africa, and South America). The Market Forecasts are Provided in Terms of Value (USD).

Global Sleep Disorders Treatment Market Trends and Insights

Rising Global Burden of Insomnia & Sleep Apnea Driven by Ageing, Obesity and Mental-Health Stressors

An estimated 30 million to 90 million Americans live with OSA, yet only 6 million have been formally diagnosed, illustrating a deep pool of untreated need that sustains the sleep disorder treatment market. The obesity epidemic intensifies OSA incidence, and December 2024 FDA clearance of tirzepatide created the first pharmacologic pathway for obese OSA patients, linking metabolic control to respiratory improvement. Pandemic-era anxiety and depression elevated chronic insomnia across every major region, with DORAs showing 87.5% response rates in psychiatric populations and reinforcing clinician confidence in newer mechanisms. ResMed now monitors 28 million cloud-connected devices and captures 20 billion nights of sleep data that feed proprietary AI engines, scaling personalised therapy adjustments in real time. Among older adults, preference is shifting to non-invasive, digitally delivered programs such as SleepioRx-cleared by FDA in August 2024-which reduce pill burden while maintaining durable efficacy.

Enhanced Screening and Public-Awareness Programs Accelerating Diagnosis Rates

System-wide screening protocols are raising detection in primary care and consumer settings. Samsung's collaboration with Stanford Medicine embeds algorithmic sleep-apnea screening in smartphones, signalling a move from laboratory polysomnography to home-based triage. In February 2024 the FDA cleared EnsoData's pulse-oximetry AI platform, enabling lower-cost identification of OSA risk in resource-limited environments. Japan's first insomnia drug approval in a decade-QUVIVIQ in September 2024-followed national media campaigns that highlighted untreated sleep disorders affecting 20% of adults and spurred physician education. Start-ups such as Sleep Cycle launched clinical studies in June 2025 to validate smartphone-based apnea screening, potentially reaching rural communities lacking specialty clinics. FDA clearance of ResMed's NightOwl home test adds medical-grade support to direct-to-consumer pathways, shortening time-to-therapy and expanding the sleep disorder treatment market.

Safety Concerns and Dependency Risks Associated with Long-Term Hypnotic Pharmacotherapy

Regulators are tightening oversight of traditional hypnotics, curbing label expansions and encouraging safer alternatives. In March 2024 the FDA issued a complete-response letter to Vanda's HETLIOZ jet-lag supplement, signalling unwillingness to tolerate vague benefit-risk profiles in sleep medicine. Benzodiazepines and Z-drugs continue showing higher incidences of complex behaviours such as sleep-driving, prompting guideline revisions that prioritise non-pharmacologic or DORA-based approaches. American Academy of Sleep Medicine 2024 guidance on restless-legs syndrome substitutes calcium-channel ligands for dopamine agonists to cut impulse-control disorders and augmentation risks. Real-world data confirm daridorexant's lower serious adverse-event frequency; regulators across North America, Europe and APAC cite these findings when green-lighting wider indications. In parallel, auricular vagus-nerve stimulation has produced clinically meaningful sleep-quality gains without pharmacology, offering a drug-free refuge for risk-averse patients and reinforcing diversification within the sleep disorder treatment market.

Other drivers and restraints analyzed in the detailed report include:

1. Launch of Novel Pharmacological Classes Expanding Therapeutic Options
2. Continuous Innovation in Device-Based and Digital Therapeutics Improving Outcomes & Adherence
3. High Cost of Branded Drugs and Advanced Devices Limiting Access in Low- and Middle-Income Regions

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Non-benzodiazepines held 32.06% of the sleep disorder treatment market in 2025 as clinicians balanced familiarity with improved safety over benzodiazepines. Despite that anchor, DORAs are growing at 9.52% CAGR and are forecast to erode historical share as guidelines elevate orexin-based therapy to first-line status for chronic insomnia. Real-world pharmacovigilance confirms fewer residual cognitive effects and lower dependency signals, a combination that encourages payers to include DORAs on preferred tiers, thereby reinforcing volume growth within the sleep disorder treatment market.

Second-line classes remain relevant. Benzodiazepines are preserved for acute, severe insomnia when rapid onset is critical, though physicians now cap prescription lengths to mitigate dependence. Off-label antidepressants satisfy complex insomnia with comorbid mood disturbance, while melatonin receptor agonists dominate paediatric niches where neurodevelopmental safety outweighs speed. Pipeline momentum stays concentrated in orexin biology: Takeda's oveporexton and Alkermes' alixorexton promise once-daily oral dosing that could simplify current multi-dose oxybate regimens. These forces together keep the sleep disorder treatment market size for pharmacologic segments on a durable expansion path through 2031.

Complete Report Scope:

• By Drug Class
  • Benzodiazepines
  • Non-benzodiazepines
  • Dual Orexin Receptor Antagonists
  • Antidepressants
  • Melatonin Receptor Agonists
  • Other Drug Class
• By Disorder Type
  • Insomnia
  • Sleep Apnea
  • Narcolepsy
  • Circadian Rhythm Disorders
  • Other Disorder Types
• By Distribution Channel
  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies
  • Sleep Clinics
• Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East & Africa
    • GCC
    • South Africa
    • Rest of Middle East & Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America commanded 42.35% of the sleep disorder treatment market in 2025, supported by sophisticated payer systems that fast-track breakthrough therapies and by high public awareness of sleep's impact on cardiometabolic health. FDA approvals for tirzepatide and multiple DORAs exemplify the regulator's openness to novel mechanisms. Employer-driven wellness benefits, including subsidised Sleepio licences and CPAP subscription models, are normalising proactive sleep management. ResMed's Q3 FY2025 revenue climbed 8% to USD 1.3 billion, reflecting robust demand for cloud-connected devices that integrate with electronic health-record workflows, thereby reinforcing adherence and reducing downstream hospitalisations.

Asia-Pacific is the fastest rising territory at 8.22% CAGR through 2031. China alone hosts 172.5 million insomnia sufferers, catalysing product localisation and broad-based formulary negotiations following DAYVIGO's approval in May 2025. Japan's September 2024 endorsement of QUVIVIQ broke a decade-long drought in novel insomnia therapies, sparking renewed clinician education campaigns and boosting prescription volume. South Korea's Phase 3 daridorexant trial underscores regional regulatory momentum, while universities accelerate fundamental research, such as light-sensitive somnogen molecules under development at University of Tsukuba. Rising middle-class income and government initiatives to modernise sleep labs underpin sustained premium adoption, making Asia-Pacific the engine for volume and revenue expansion of the sleep disorder treatment market.

Europe maintains steady growth on the back of universal coverage and coordinated regulatory processes through the European Medicines Agency. Idorsia's first-mover role with QUVIVIQ exploited EU-wide mutual recognition to build share before Merck's Belsomra and Eisai's Dayvigo entered, and public procurement emphasises price-volume agreements that favour drugs with proven safety and health-economic benefits. The UK National Health Service's system-wide rollout of Sleepio free of charge exemplifies how digital therapeutics can penetrate large public systems and drive cost offsets, potentially unlocking similar models continent-wide. Multidisciplinary clinics such as Switzerland's Sleep House Bern pilot fast triage pathways that could set new standards for European sleep-care delivery. Collectively, these trends keep Europe's contribution to the sleep disorder treatment market resilient despite mature baseline adoption.

1. Dr Reddy's Laboratories
2. Merck
3. Viatris (Mylan)
4. Pfizer
5. Sanofi
6. Takeda Pharmaceutical Co.
7. Teva Pharmaceutical Industries
8. Transcept Pharmaceuticals
9. Vanda Pharmaceuticals
10. Zydus Lifesciences
11. Eisai
12. Jazz Pharmaceuticals
13. Resmed
14. Koninklijke Philips
15. Fisher & Paykel Healthcare
16. Sommetrics Inc.
17. Minerva Neurosciences
18. Neurocrine Biosciences
19. Avadel Pharmaceuticals
20. Currax Pharmaceuticals
21. Arena Pharmaceuticals
22. SomnoMed Limited

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Rising Global Burden of Insomnia & Sleep Apnea Driven by Ageing, Obesity and Mental-Health Stressors
  • 4.2.2 Enhanced Screening and Public-Awareness Programs Accelerating Diagnosis Rates
  • 4.2.3 Launch Of Novel Pharmacological Classes (Dual-Orexin Antagonists, Next-Gen GABA Modulators) Expanding Therapeutic Options
  • 4.2.4 Continuous Innovation in Device-Based and Digital Therapeutics Improving Outcomes & Adherence
  • 4.2.5 AI-Powered Sleep-Data Analytics Enabling Earlier, Personalised Interventions
  • 4.2.6 Employer And Insurer-Led Sleep-Wellness Initiatives Widening Reimbursement Coverage
• 4.3 Market Restraints
  • 4.3.1 Safety Concerns and Dependency Risks Associated with Long-Term Hypnotic Pharmacotherapy
  • 4.3.2 High Cost of Branded Drugs and Advanced Devices Limiting Access in Low- And Middle-Income Regions
  • 4.3.3 Poor Patient Adherence to CPAP Therapy and Behavioural Regimens Undermining Efficacy
  • 4.3.4 Boom In Unregulated OTC/Nutraceutical Sleep Aids Diverting Patients from Evidence-Based Care
• 4.4 Regulatory Landscape
• 4.5 Porter's Five Forces Analysis
  • 4.5.1 Threat of New Entrants
  • 4.5.2 Bargaining Power of Buyers/Consumers
  • 4.5.3 Bargaining Power of Suppliers
  • 4.5.4 Threat of Substitute Products
  • 4.5.5 Intensity of Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Drug Class
  • 5.1.1 Benzodiazepines
  • 5.1.2 Non-benzodiazepines
  • 5.1.3 Dual Orexin Receptor Antagonists
  • 5.1.4 Antidepressants
  • 5.1.5 Melatonin Receptor Agonists
  • 5.1.6 Other Drug Class
• 5.2 By Disorder Type
  • 5.2.1 Insomnia
  • 5.2.2 Sleep Apnea
  • 5.2.3 Narcolepsy
  • 5.2.4 Circadian Rhythm Disorders
  • 5.2.5 Other Disorder Types
• 5.3 By Distribution Channel
  • 5.3.1 Hospital Pharmacies
  • 5.3.2 Retail Pharmacies
  • 5.3.3 Online Pharmacies
  • 5.3.4 Sleep Clinics
• 5.4 Geography
  • 5.4.1 North America
    • 5.4.1.1 United States
    • 5.4.1.2 Canada
    • 5.4.1.3 Mexico
  • 5.4.2 Europe
    • 5.4.2.1 Germany
    • 5.4.2.2 United Kingdom
    • 5.4.2.3 France
    • 5.4.2.4 Italy
    • 5.4.2.5 Spain
    • 5.4.2.6 Rest of Europe
  • 5.4.3 Asia-Pacific
    • 5.4.3.1 China
    • 5.4.3.2 Japan
    • 5.4.3.3 India
    • 5.4.3.4 Australia
    • 5.4.3.5 South Korea
    • 5.4.3.6 Rest of Asia-Pacific
  • 5.4.4 Middle East & Africa
    • 5.4.4.1 GCC
    • 5.4.4.2 South Africa
    • 5.4.4.3 Rest of Middle East & Africa
  • 5.4.5 South America
    • 5.4.5.1 Brazil
    • 5.4.5.2 Argentina
    • 5.4.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global-level Overview, Market-level Overview, Core Segments, Financials, Strategic Information, Market Rank/Share, Products & Services, Recent Developments)
  • 6.3.1 Dr Reddy's Laboratories
  • 6.3.2 Merck & Co.
  • 6.3.3 Viatris (Mylan)
  • 6.3.4 Pfizer Inc.
  • 6.3.5 Sanofi SA
  • 6.3.6 Takeda Pharmaceutical Co.
  • 6.3.7 Teva Pharmaceutical Industries
  • 6.3.8 Transcept Pharmaceuticals
  • 6.3.9 Vanda Pharmaceuticals
  • 6.3.10 Zydus Lifesciences
  • 6.3.11 Eisai Co., Ltd.
  • 6.3.12 Jazz Pharmaceuticals
  • 6.3.13 ResMed Inc.
  • 6.3.14 Koninklijke Philips N.V.
  • 6.3.15 Fisher & Paykel Healthcare
  • 6.3.16 Sommetrics Inc.
  • 6.3.17 Minerva Neurosciences
  • 6.3.18 Neurocrine Biosciences
  • 6.3.19 Avadel Pharmaceuticals
  • 6.3.20 Currax Pharmaceuticals
  • 6.3.21 Arena Pharmaceuticals
  • 6.3.22 SomnoMed Limited

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-Need Assessment