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Sleep Apnea Devices Global Market - Forecast to 2026

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1 EXECUTIVE SUMMARY 25

    2 INTRODUCTION 30

    • 2.1 KEY TAKEAWAYS 30
    • 2.2 SCOPE OF THE REPORT 30
    • 2.3 REPORT DESCRIPTION 31
    • 2.4 MARKETS COVERED 34
    • 2.5 STAKEHOLDERS 36
    • 2.6 RESEARCH METHODOLOGY 36
      • 2.6.1 MARKET SIZE ESTIMATION 37
      • 2.6.2 MARKET BREAKDOWN AND DATA TRIANGULATION 40
      • 2.6.3 SECONDARY SOURCES 41
      • 2.6.4 PRIMARY SOURCES 41
      • 2.6.5 KEY DATA POINTS FROM SECONDARY SOURCES 42
      • 2.6.6 KEY DATA POINTS FROM PRIMARY SOURCES 43
      • 2.6.7 ASSUMPTIONS 43

    3 MARKET ANALYSIS 45

    • 3.1 INTRODUCTION 45
    • 3.2 MARKET SEGMENTATION 46
    • 3.3 FACTORS INFLUENCING MARKET 48
      • 3.3.1 DRIVERS AND OPPORTUNITIES 48
        • 3.3.1.1 The increasing rate of sleep apnea population 48
        • 3.3.1.2 Increasing lifestyle changes that causing poor sleep patterns elevated rates of stress, obesity and cardiovascular disease 49
        • 3.3.1.3 Favorable reimbursement policies 50
        • 3.3.1.4 Technological advancements 51
      • 3.3.2 RESTRAINTS AND THREATS 52
        • 3.3.2.1 Alternative therapies of sleep apnea 52
        • 3.3.2.2 Non-compliances of patients with pap devices 53
        • 3.3.2.3 Lack of awareness about sleep apnea disorder 54
        • 3.3.2.4 Stringent regulatory requirements for new products 54
    • 3.4 REGULATORY AFFAIRS 56
      • 3.4.1 INTERNATIONAL ORGANIZATION FOR STANDARDIZATION 56
        • 3.4.1.1 ISO 9001: 2015 Quality Management System 57
        • 3.4.1.2 ISO 13485 Medical Devices 57
      • 3.4.2 THE U.S. 57
      • 3.4.3 CANADA 58
      • 3.4.4 EUROPE 59
      • 3.4.5 INDIA 60
      • 3.4.6 CHINA 61
      • 3.4.7 JAPAN 62
    • 3.5 TECHNOLOGICAL ADVANCEMENTS 63
      • 3.5.1 INTRODUCTION 63
      • 3.5.2 ARTIFICIAL INTELLIGENCE IN SLEEP APNEA DIAGNOSIS

    AND TREATMENT 63

    • 3.5.3 MAGNAP TREATMENT FOR SLEEP APNEA 64
    • 3.5.4 SMART PAP DEVICES 64
    • 3.5.5 3D IMAGING THE NEW TREATMENT TECHNIQUES FOR

    OBSTRUCTIVE SLEEP APNEA 65

    • 3.5.6 WEARABLE PATCH DEVICES TO DETECT SLEEP APNEA 65
    • 3.5.7 SLEEP TELEMEDICINE IN DIAGNOSIS AND TREATMENT OF SLEEP APNEA 66
    • 3.5.8 REMOTE MONITORING IN SLEEP APNEA MANAGEMENT AND

    PAP ADHERENCE 66

    • 3.6 PORTER’S FIVE FORCE ANALYSIS 67
      • 3.6.1 THREAT OF NEW ENTRANTS 68
      • 3.6.2 THREAT OF SUBSTITUTES 68
      • 3.6.3 COMPETITIVE RIVALRY 69
      • 3.6.4 BARGAINING POWER OF SUPPLIERS 69
      • 3.6.5 BARGAINING POWER OF BUYERS 70
    • 3.7 SUPPLY CHAIN ANALYSIS 70
    • 3.8 MARKET SHARE ANALYSIS BY MAJOR PLAYERS 73
      • 3.8.1 SLEEP APNEA DEVICES MARKET SHARE ANALYSIS 73
      • 3.8.2 POLYSOMNOGRAPHY MARKET SHARE ANALYSIS 76
      • 3.8.3 CPAP DEVICES MARKET SHARE ANALYSIS 78
      • 3.8.4 APAP DEVICES MARKET SHARE ANALYSIS 80
      • 3.8.5 BPAP MARKET SHARE ANALYSIS 81
    • 3.9 CLINICAL TRIALS 82
    • 3.10 SLEEP APNEA PRODUCT APPROVALS AND NEW PRODUCT LAUNCH 85
    • 3.11 SLEEP APNEA DEVICES-DEALS 87
    • 3.12 FUNDING SCENARIO 88
    • 3.13 REIMBURSEMENT SCENARIO 91
    • 3.14 SLEEP APNEA DEVICES UNITS SOLD, INSTALLED BASE AND MARKET PENETRATION 95

    4 SLEEP APNEA DEVICES GLOBAL MARKET, BY PRODUCT 98

    • 4.1 INTRODUCTION 98
    • 4.2 SLEEP APNEA DIAGNOSTIC DEVICES 100
      • 4.2.1 IN-LAB SLEEP TEST 102
        • 4.2.1.1 Attended polysomnography 104
        • 4.2.1.2 Respiratory polygraph 106
        • 4.2.1.3 Pulse oximeter 108
      • 4.2.2 HOME SLEEP TEST 109
        • 4.2.2.1 Unattended polysomnography 112
        • 4.2.2.2 Actigraphy 114
        • 4.2.2.3 Others 115
    • 4.3 SLEEP APNEA TREATMENT DEVICES 117
      • 4.3.1 POSITIVE AIRWAY PRESSURE DEVICES (PAP) AND ACCESSORIES 119
        • 4.3.1.1 Continuous PAP Devices (CPAP) 123
        • 4.3.1.2 Automatic Pap (APAP) Devices 125
        • 4.3.1.3 Bi-Level Pap (BPAP) Devices 127
        • 4.3.1.4 Adaptive Servo-Ventilator (ASV) 128
        • 4.3.1.5 Accessories 129
        • 4.3.1.5.1 Full face mask 132
        • 4.3.1.5.2 Nasal masks 134
        • 4.3.1.5.3 Nasal pillow masks 135
        • 4.3.1.5.4 Other masks 136
        • 4.3.2 ORAL APPLIANCES 138
        • 4.3.3 MANDIBULAR REPOSITIONING DEVICE 140
        • 4.3.4 TONGUE RETAINING DEVICES 141
        • 4.3.5 PHRENIC NERVE STIMULATION (PNS) 142
        • 4.3.6 HYPOGLOSSAL NERVE STIMULATION (HGNS) 144
        • 4.3.7 OTHER SLEEP THERAPEUTIC DEVICES 146

      5 SLEEP APNEA DEVICES GLOBAL MARKET, BY APPLICATION 148

      • 5.1 INTRODUCTION 148
      • 5.2 OBSTRUCTIVE SLEEP APNEA (OSA) 151
      • 5.3 CENTRAL SLEEP APNEA (CSA) 154
      • 5.4 COMPLEX SLEEP APNEA 156

      6 SLEEP APNEA DEVICES GLOBAL MARKET, BY END-USERS 158

      • 6.1 INTRODUCTION 158
      • 6.2 HOSPITALS 161
      • 6.3 SLEEP CENTERS 163
      • 6.4 HOME HEALTHCARE 164
      • 6.5 OTHERS 166

      7 SLEEP APNEA DEVICES MARKET BY REGION 168

      • 7.1 INTRODUCTION 168
      • 7.2 NORTH AMERICA 172
        • 7.2.1 U.S. 195
        • 7.2.2 REST OF NORTH AMERICA 201
      • 7.3 EUROPE 210
        • 7.3.1 GERMANY 237
        • 7.3.2 U.K. 243
        • 7.3.3 FRANCE 250
        • 7.3.4 REST OF EUROPE 256
      • 7.4 APAC 262
        • 7.4.1 JAPAN 288
        • 7.4.2 CHINA 294
        • 7.4.3 INDIA 300
        • 7.4.4 REST OF APAC 306
      • 7.5 ROW 312
        • 7.5.1 BRAZIL 339
        • 7.5.2 REST OF LATAM 345
        • 7.5.3 MIDDLE EAST AND OTHERS 351

      8 COMPETITIVE LANDSCAPE 358

      • 8.1 INTRODUCTION 358
      • 8.2 NEW PRODUCT LAUNCH 359
      • 8.3 APPROVALS 361
      • 8.4 AGREEMENTS 362
      • 8.5 ACQUISITION 363
      • 8.6 OTHERS 363

      9 MAJOR COMPANIES 365

      • 9.1 APEX MEDICAL CORPORATION 365
        • 9.1.1 OVERVIEW 365
        • 9.1.2 FINANCIALS 366
        • 9.1.3 PRODUCT PORTFOLIO 367
        • 9.1.4 KEY DEVELOPMENTS 367
        • 9.1.5 BUSINESS STRATEGY 368
        • 9.1.6 SWOT ANALYSIS 368
      • 9.2 DRIVE MEDICAL (DRIVE DEVILBISS HEALTHCARE). 369
        • 9.2.1 OVERVIEW 369
        • 9.2.2 FINANCIALS 369
        • 9.2.3 PRODUCT PORTFOLIO 370
        • 9.2.4 KEY DEVELOPMENTS 370
        • 9.2.5 BUSINESS STRATEGY 370
        • 9.2.6 SWOT ANALYSIS 371
      • 9.3 FISHER AND PAYKEL HEALTHCARE CORPORATION LIMITED 372
        • 9.3.1 OVERVIEW 372
        • 9.3.2 FINANCIALS 373
        • 9.3.3 PRODUCT PORTFOLIO 376
        • 9.3.4 KEY DEVELOPMENTS 377
        • 9.3.5 BUSINESS STRATEGY 377
        • 9.3.6 SWOT ANALYSIS 379
      • 9.4 INSPIRE MEDICAL SYSTEMS INC. 380
        • 9.4.1 OVERVIEW 380
        • 9.4.2 FINANCIALS 381
        • 9.4.3 PRODUCT PORTFOLIO 382
        • 9.4.4 KEY DEVELOPMENTS 382
        • 9.4.5 BUSINESS STRATEGY 383
        • 9.4.6 SWOT ANALYSIS 384
      • 9.5 KONINKLIJKE PHILIPS N.V. 385
        • 9.5.1 OVERVIEW 385
        • 9.5.2 FINANCIALS 386
        • 9.5.3 PRODUCT PORTFOLIO 388
        • 9.5.4 KEY DEVELOPMENTS 389
        • 9.5.5 BUSINESS STRATEGY 389
        • 9.5.6 SWOT ANALYSIS 390
      • 9.6 NATUS MEDICAL INCORPORATED. 391
        • 9.6.1 OVERVIEW 391
        • 9.6.2 FINANCIALS 392
        • 9.6.3 PRODUCT PORTFOLIO 395
        • 9.6.4 KEY DEVELOPMENTS 396
        • 9.6.5 BUSINESS STRATEGY 396
        • 9.6.6 SWOT ANALYSIS 397
      • 9.7 NIHON KOHDEN CORPORATION. 398
        • 9.7.1 OVERVIEW 398
        • 9.7.2 FINANCIALS 399
        • 9.7.3 PRODUCT PORTFOLIO 401
        • 9.7.4 KEY DEVELOPMENTS 401
        • 9.7.5 BUSINESS STRATEGY 401
        • 9.7.6 SWOT ANALYSIS 402
      • 9.8 RESMED INC. 403
        • 9.8.1 OVERVIEW 403
        • 9.8.2 FINANCIALS 404
        • 9.8.3 PRODUCT PORTFOLIO 407
        • 9.8.4 KEY DEVELOPMENTS 409
        • 9.8.5 BUSINESS STRATEGY 411
        • 9.8.6 SWOT ANALYSIS 412
      • 9.9 SOMNOMED 413
        • 9.9.1 OVERVIEW 413
        • 9.9.2 FINANCIALS 414
        • 9.9.3 PRODUCT PORTFOLIO 414
        • 9.9.4 KEY DEVELOPMENTS 415
        • 9.9.5 BUSINESS STRATEGY 415
        • 9.9.6 SWOT ANALYSIS 416
      • 9.10 VYAIRE MEDICAL, INC 417
        • 9.10.1 OVERVIEW 417
        • 9.10.2 FINANCIALS 417
        • 9.10.3 PRODUCT PORTFOLIO 417
        • 9.10.4 KEY DEVELOPMENTS 418
        • 9.10.5 BUSINESS STRATEGY 418

    Sleep apnea is a serious disorder that occurs when breathing is interrupted during sleep, this happens, when the upper airway becomes repeatedly blocked and preventing the brain and lungs from getting enough oxygen, resulting in heavy snoring and choking. Patients are affected by different types of sleep apnea, such as obstructive sleep apnea (OSA) caused by the blockage of the airway, when the muscle in the back of the throat collapses during sleep, central sleep apnea (CSA), caused when the brain fails to send the signal to the muscle to breathe, due to instability in the respiratory control center and complex sleep apnea syndrome a mixture of OSA and CSA, that central sleep apnea may emerge during titration of CPAP in patients with obstructive sleep apnea. Sleep apnea may cause due to physical structure or certain medical conditions such as obesity, large tonsils, endocrine disorders, neuromuscular disorders, certain genetic syndrome and premature birth.
    The Sleep apnea devices global market is expected to grow at high single digit CAGR from 2019 to 2026 to reach $8,173.8 million by 2026. The increase in the rate of sleep apnea population, increasing lifestyle changes that causing poor sleep patterns elevated rates of stress, obesity and cardiovascular disease and increasing funding and investment in patient monitoring are driving the market growth. However, the alternative therapies of sleep apnea, stringent regulatory requirements for product approvals and non-compliances of patients with PAP devices are restraining the market growth.
    The Sleep apnea devices market segmented based on products, application, end-users and geography. The product market is segmented into diagnostic devices and treatment devices. According to IQ4I research, treatment devices accounted for the largest revenue in 2019 and expected to grow at high single digit CAGR from 2019 to 2026. The diagnostic devices segment is expected to grow at a mid-single digit CAGR from 2019 to 2026 due to increasing diagnosis rate of sleep apnea and increasing connectivity of rural areas.
    The sleep apnea diagnostic devices market is further classified into in-lab sleep test and home sleep test. Among these, the in-lab sleep test accounted for the largest revenue in 2019 and the market is expected to grow at a mid-single digit CAGR from 2019 to 2026. Based on products, in – lab sleep test is further segmented into attended polysomnography (PSG), Respiratory polygraph and pulse oximeter. Among them, attended polysomnography segment held the largest revenue in 2019 of the market and the market is expected to grow at a high single digit CAGR from 2019 to 2026. Increasing incidence of obstructive sleep apnea, increasing demand for gold standard polysomnography devices are the factors driving the market growth. The home sleep test is further segmented into unattended polysomnography, Actigraphy and others, among these; unattended polysomnography segment accounted for the largest revenue in 2019 and the market is expected to grow at mid-single digit CAGR of from 2019 to 2026.
    The sleep apnea treatment devices market is segmented into PAP devices, oral appliances, phrenic nerve stimulators, hypoglossal nerve stimulator and others. Among them, the PAP devices segment commanded the largest revenue in 2019 and the market is expected to grow at high single digit CAGR from 2019 to 2026. Increasing the incidence of sleep apnea disorder and increasing the use of PAP devices are the factors driving the market. The hypoglossal nerve stimulator is expected to grow at high teen CAGR from 2019 to 2026. PAP devices are further segmented into CPAP, APAP, BiPAP, ASV and accessories, among these, Accessories accounted for the largest revenue in 2019 and expected to grow at mid-single digit CAGR from 2019 to 2026, APAP devices segment is expected to grow at double digit CAGR from 2019 to 2026. An oral appliance segment is further segmented into Mandibular repositioning devices (MRD) and Tongue retaining devices (TRD), among these, MRD accounted for the largest revenue in 2019 and the market is expected to grow at mid-single digit CAGR from 2019 to 2026, due to increased use wearable devices. Accessories are further segmented into full face masks, nasal masks, nasal pillow masks and others, among these, the full face masks segmented is accounted for the largest revenue in 2019 and the market is expected to grow at double digit CAGR from 2019 to 2026.
    The sleep apnea application market is segmented into obstructive sleep apnea (OSA), central sleep apnea (CSA) and complex sleep apnea syndrome (ComSAS). Among these, OSA accounted for the largest revenue in 2019 and the market is expected to grow at high single digit CAGR from 2019 to 2026.
    The Sleep apnea devices global market based on end-user is segmented into hospitals, sleep centers, home healthcare and others. Among these, the sleep centers segment accounted for the largest revenue in 2019 and the market is expected to grow at high single digit from 2019 to 2026. The homecare market is expected to be the fastest-growing segment with high single digit CAGR from 2019 to 2026 due to the improvement and acceptance of home care devices has increased.
    The Sleep apnea devices global market based on geography is segmented into North America, Europe, Asia – Pacific and Rest of the World, among these, North America accounted for the largest revenue of $2,365.1 million in 2019 and the market is expected to grow at a CAGR of high single digit from 2019 to 2026. Increasing awareness about the diseases complications in developed countries, high investments in healthcare infrastructures and demand for quality services are propelling the market growth. Asia – Pacific is expected to grow at a double digit CAGR from 2019 to 2026 due to increasing awareness about the health in emerging countries.
    Major players in Sleep apnea devices global market are ResMed Inc. (U.S.), Koninklijke Philips N.V. (Netherlands), Fisher and Paykel Healthcare Corporation Ltd., (New Zealand), Apex Medical Corporation (Taiwan), Nihon Kohden Corporation (Japan) Natus Medical Inc.. (U.S.), Inspire Medical Inc. (U.S.), Drive Medical (Drive DeVilbiss Healthcare) (U.S.), and SomnoMed (U.S.).
    The report provides an in-depth market analysis of the above-mentioned segments across the following regions:
    • North America
    o U.S.
    o Rest of North America
    • Europe
    o Germany
    o U.K.
    o France
    o Rest of Europe
    • Asia-Pacific
    o Japan
    o China
    o India
    o Rest of APAC
    • Rest of the World (RoW)
    o Brazil
    o Rest of Latin America
    o Middle East and Others
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