CHAPTER ONE: INTRODUCTION... 1 STUDY GOALS AND OBJECTIVES... 1 REASONS FOR STUDY... 1 SCOPE OF STUDY... 1 METHODOLOGY AND INFORMATION SOURCES... 2 ANALYST CREDENTIALS... 2 RELATED BCC REPORTS... 2 BCC ONLINE SERVICES... 3 DISCLAIMER... 3 CHAPTER TWO: EXECUTIVE SUMMARY... 4 EXECUTIVE SUMMARY... 4 EXECUTIVE SUMMARY (CONTINUED)... 5 EXECUTIVE SUMMARY (CONTINUED)... 6 SUMMARY TABLE A TOTAL WORLDWIDE MARKET FOR SLEEP AIDS BY PRODUCT TYPE, THROUGH 2014 ($ MILLIONS)... 7 SUMMARY TABLE B WORLWIDE MARKET FOR SLEEP AIDS: TECHNOLOGIES AND MARKETS BY REGION, 2008-2014 (%)... 8 SUMMARY FIGURE PERCENT OF TOTAL WORLWIDE MARKET FOR SLEEP AIDS: TECHNOLOGIES AND MARKETS BY REGION, 2014 (%)... 8 CHAPTER THREE: INDUSTRY OVERVIEW... 9 PHYSIOLOGY OF SLEEP... 9 STAGES OF SLEEP... 9 NREM Sleep... 10 Stage 1... 10 Stage 2... 10 Stage 3... 10 Stage 4... 10 REM Sleep... 11 SLEEP CYCLE... 12 BIOLOGICAL CLOCK... 12 FACTORS AFFECTING SLEEP... 13 COMFORT LEVEL... 13 ANXIETY AND STRESS... 13 CULTURAL NORMS... 13 DRUGS/MEDICATIONS... 14 ENVIRONMENT... 14 HORMONES... 14 LIFESPAN CONSIDERATIONS... 14 Lifespan Considerations (Continued)... 15 LIFESTYLE... 16 NUTRITION/DIET... 16
ALTERATION IN SLEEP PATTERNS... 16 INSOMNIA... 17 Psychological Insomnia... 17 Idiopathic Insomnia... 17 Sleep-State Misinterpretation... 18 NARCOLEPSY/HYPERSOMNIA... 18 SLEEP APNEA AND SNORING... 18 PARASOMNIA... 19 SLEEP DEPRIVATION... 20 DEMOGRAPHICS... 20 TABLE 1 WORLD POPULATION BY SELECTED GEOGRAPHICAL REGION, 2008 2050 (MILLIONS)... 21 TABLE 2 ESTIMATED WORLD POPULATION BY AGE AND GEOGRAPHICAL REGION, 2008 (MILLIONS)... 21 TABLE 2 (CONTINUED)... 22 TABLE 3 PERCENTAGE OF WORLWIDE POPULATION OVER 65 BY YEAR AND REGION, 2008 2050 (%)... 22 FIGURE 1 PERCENTAGE OF WORLDWIDE POPULATION OVER 65 BY YEAR AND REGION, 2008 2050 (%)... 23 PREVALENCE OF SLEEP APNEA... 24 TABLE 4 PREVALENCE OF SLEEP APNEA WORLDWIDE BY REGION AND COUNTRY, 2006... 24 TABLE 4 (CONTINUED)... 25 TABLE4 (CONTINUED)... 26 TABLE 4 (CONTINUED)... 27 OTHER SLEEP DISORDER STATISTICS... 27 TABLE 5 U.S. OTHER SLEEP DISORDER STATISTICS 2008... 27 NARCOLEPSY... 28 RESTLESS LEG SYNDROME... 29 SUBSTANCE ABUSE AND SLEEP DISORDERS... 29 ALTERNATIVE SNORING AIDS... 30 ALTERNATIVE SNORING AIDS (CONTINUED)... 31 REIMBURSEMENT... 32 SLEEP AND THE ELDERLY... 33 DROWSY DRIVING... 33 HOME TESTING... 34 HOME TESTING (CONTINUED)... 35 OTHER SLEEP PRODUCTS... 36 OBESITY AND SLEEP PROBLEMS... 37 INNOVATIVE COST-SAVING PROGRAMS... 38 INNOVATIVE COST-SAVING PROGRAMS (CONTINUED)... 39 CHAPTER FOUR: MARKET SIZE AND GROWTH... 40 SLEEP MEDICATIONS MARKET... 40 PRESCRIPTION... 40
Benzodiazepines... 40 ProSom... 41 Dalmane... 41 Doral... 42 Restoril... 42 Halcion... 42 Nonbenzodiazepines... 43 Lunesta... 43 Ambien... 44 Sonata... 44 Melatonin Receptor Agonists... 45 Rozerem... 45 Narcolepsy Treatment... 46 Provigil... 46 Restless Leg Syndrome... 46 ReQuip... 46 Mirapex... 46 Neupro... 47 TABLE 6 GLOBAL SELECTED MARKETED PRESCRIPTION SLEEP AIDS, 2008 ($ MILLIONS)... 47 TABLE 6 (CONTINUED)... 48 OTC... 48 Medications... 48 Medications (Continued)... 49 TABLE 7 GLOBAL SELECTED MARKETED OTC SLEEP AIDS, 2008 ($ MILLIONS)... 50 Natural Remedies... 50 Herbs... 50 Melatonin... 51 Tryptophan, L-tryptophan... 51 New Over-the-Counter Sleep Aids... 51 New Over-the- (Continued)... 52 SLEEP MEDICATION MARKET SIZE AND FORECAST... 53 TABLE 8 GLOBAL MARKET FOR SLEEP AID MEDICATIONS AT MANUFACTURERS SALES LEVELS, THROUGH 2014 ($ MILLIONS)... 54 FIGURE 2 GLOBAL MARKET FOR SLEEP AID MEDICATIONS AT MANUFACTURERS SALES LEVELS, THROUGH 2014 ($ MILLIONS)... 54 TABLE 9 GLOBAL MARKET FOR PRESCRIPTION SLEEP AID MEDICATIONS BY TYPE AT MANUFACTURERS SALES LEVELS, THROUGH 2014 ($ MILLIONS)... 55
FIGURE 3 GLOBAL MARKET FOR PRESCRIPTION SLEEP AID MEDICATIONS BY TYPE AT MANUFACTURERS SALES LEVELS, THROUGH 2014 ($ MILLIONS)... 56 TABLE 10 GLOBAL MARKET FOR OTC SLEEP AID MEDICATIONS BY DRUG CLASS AT MANUFACTURERS SALES LEVELS, THROUGH 2014 ($ MILLIONS)... 57 FIGURE 4 GLOBAL MARKET FOR OTC SLEEP AID MEDICATIONS BY DRUG CLASS AT MANUFACTURERS SALES LEVELS, 2008-2014 ($ MILLIONS)... 57 United States... 58 European Union... 58 Japan... 58 Rest of World... 59 TABLE 11 GLOBAL MARKET FOR SLEEP AID MEDICATIONS BY REGION, THROUGH 2014 ($ MILLIONS)... 59 FIGURE 5 GLOBAL MARKET FOR SLEEP AID MEDICATIONS BY REGION, 2008-2014 ($ MILLIONS)... 60 TABLE 12 GLOBAL PERCENTAGE OF MARKET FOR SLEEP AID MEDICATIONS BY REGION, 2008-2014 (%)... 60 FIGURE 6 GLOBAL PERCENTAGE OF MARKET FOR SLEEP AID MEDICATIONS BY REGION, 2008-2014 (%)... 61 COMPETITIVE ANALYSIS OF THE PRESCRIPTION AND OTC SLEEP AID MEDICATIONS MARKET... 61 TABLE 13 GLOBAL COMPETITIVE ANALYSIS OF PRESCRIPTION AND OTC SLEEP AIDS BY DRUG MANUFACTURER REVENUES AND MARKET SHARE, 2009 ($ MILLIONS/%)... 62 FIGURE 7 GLOBAL COMPETITIVE ANALYSIS OF PRESCRIPTION AND OTC SLEEP AIDS BY DRUG MANUFACTURER REVENUES, 2009 ($ MILLIONS)... 63 SLEEP APNEA DEVICES MARKET... 63 SLEEP APNEA... 63 Obstructive Sleep Apnea... 64 Obstructive Sleep Apnea (Continued)... 65 Obstructive Sleep Apnea (Continued)... 66 Obstructive Sleep Apnea (Continued)... 67 Obstructive Sleep Apnea (Continued)... 68 Central Apnea... 69 Central Apnea (Continued)... 70 Mixed Apnea... 71 SLEEP APNEA THERAPEUTIC EQUIPMENT... 71 Flow Generators... 71 CPAP Devices... 72 Bi-Level PAP Devices... 72 APAP Devices... 72
Facial Interfaces... 72 SLEEP APNEA DEVICE MARKET SIZE AND FORECAST... 73 TABLE 14 GLOBAL MARKET FOR SLEEP APNEA DEVICES, THROUGH 2014 ($ MILLIONS)... 73 United States... 74 European Union... 74 Japan... 74 Rest of World... 74 TABLE 15 GLOBAL MARKET FOR SLEEP APNEA DEVICES BY REGION, THROUGH 2014 ($ MILLIONS)... 75 FIGURE 8 GLOBAL MARKET FOR SLEEP APNEA DEVICES BY REGION, 2008-2014 ($ MILLIONS)... 75 TABLE 16 GLOBAL MARKET FOR SLEEP APNEA DEVICES BY REGION, 2008-2014 (%)... 76 COMPETITIVE ANALYSIS OF THE SLEEP APNEA DEVICES MARKET... 76 TABLE 17 COMPETITIVE ANALYSIS OF SLEEP APNEA DEVICE MANUFACTURERS WITH GLOBAL MARKET SHARES AND REVENUES, 2009 ($ MILLIONS/%)... 77 FIGURE 9 COMPETITIVE ANALYSIS OF SLEEP APNEA DEVICE MANUFACTURERS WITH GLOBAL MARKET SHARES, 2009 (%)... 77 SLEEP LABORATORIES MARKET... 78 BACKGROUND OF SLEEP LABORATORIES... 78 SLEEP LAB PROTOCOLS... 78 Polysomnogram... 79 Split Night Study... 80 Multiple Sleep Latency Test... 80 CPAP Titration Study... 81 SLEEP LABORATORIES MARKET SIZE AND FORECAST... 81 TABLE 18 GLOBAL MARKET FOR SLEEP LABORATORIES BY REGION, THROUGH 2014 ($ MILLIONS)... 82 FIGURE 10 GLOBAL MARKET FOR SLEEP LABORATORIES BY REGION, 2008-2014 ($ MILLIONS)... 82 TABLE 19 GLOBAL MARKET FOR SLEEP LABORATORIES BY REGION, THROUGH 2014 (%)... 83 FIGURE 11 GLOBAL MARKET FOR SLEEP LABORATORIES BY REGION, 2014 (%)... 83 MATTRESS AND PILLOW MARKET... 84 MATTRESSES... 84 Innerspring... 84 Foam... 84 Air Beds... 84 Air Beds (Continued)... 85 PILLOWS... 86
Bed Pillows... 87 Orthopedic Pillows... 88 Decorative... 88 Decorative (Continued)... 89 MATTRESS AND PILLOW MARKET SIZE AND FORECAST... 90 TABLE 20 GLOBAL MARKET FOR MATTRESSES AND PILLOWS, THROUGH 2014 ($ MILLIONS)... 90 FIGURE 12 GLOBAL MARKET FOR MATTRESSES AND PILLOWS, 2008-2014 ($ MILLIONS)... 91 TABLE 21 GLOBAL MARKET FOR MATTRESSES AND PILLOWS BY REGION, THROUGH 2014 ($ MILLIONS)... 92 FIGURE 13 GLOBAL MARKET FOR MATTRESSES AND PILLOWS BY REGION, 2008-2014 ($ MILLIONS)... 92 TABLE 22 GLOBAL MARKET FOR MATTRESSES AND PILLOWS BY REGION, 2008-2014 (%)... 93 FIGURE 14 GLOBAL MARKET FOR MATTRESSES AND PILLOWS BY REGION, 2014 (%)... 93 COMPETITIVE ANALYSIS OF THE MATTRESS AND PILLOW MARKET... 94 Competitive Analysis of the Mattress (Continued)... 94 TABLE 23 GLOBAL COMPETITIVE ANALYSIS OF MATTRESS AND PILLOW MANUFACTURERS WITH MARKET SHARES AND REVENUES, 2009 ($ MILLIONS/%)... 95 FIGURE 15 GLOBAL COMPETITIVE ANALYSIS OF MATTRESS AND PILLOW MANUFACTURERS REVENUES, 2009 ($ MILLIONS)... 95 CHAPTER FIVE RESEARCH AND DEVELOPMENT... 96 RECENT APPROVALS... 96 EDLUAR... 96 ZOLPIMIST... 96 AWAITING APPROVAL... 97 CILTYRI... 97 INDIPLON... 97 INTERMEZZO... 97 SILENOR... 97 SOLZIRA... 98 PHASE III... 98 ALMOREXANT... 98 NUVIGIL... 99 VEC-162 (TASIMELTEON)... 99 TABLE 24 DRUGS IN DEVELOPMENT WORLDWIDE FOR SLEEP DISORDERS, 2009... 100 TABLE 24 (CONTINUED)... 101 NEW DEVELOPMENTS... 101 MARKET SUMMARY... 102
TOTAL MARKET... 102 TABLE 25 GLOBAL MARKET FOR SLEEP AIDS: TECHNOLOGIES AND MARKETS, THROUGH 2014 ($ MILLIONS)... 102 TOTAL MARKET BY PRODUCT TYPE... 102 TABLE 26 GLOBAL MARKET FOR SLEEP AIDS BY PRODUCT TYPE, THROUGH 2014 ($ MILLIONS)... 103 FIGURE 16 GLOBAL MARKET FOR SLEEP AIDS BY PRODUCT TYPE, 2008-2014 ($ MILLIONS)... 104 FIGURE 17 GLOBAL MARKET FOR SLEEP AIDS BY PRODUCT TYPE, 2009 (%)... 104 FIGURE 17 (CONTINUED)... 105 TOTAL MARKET BY GEOGRAPHIC REGION... 105 TABLE 27 GLOBAL MARKET FOR SLEEP AIDS: TECHNOLOGIES AND MARKETS BY REGION, THROUGH 2014 ($ MILLIONS)... 106 FIGURE 18 GLOBAL MARKET FOR SLEEP AIDS: TECHNOLOGIES AND MARKETS BY REGION, THROUGH 2014 ($ MILLIONS)... 106 TABLE 28 GLOBAL MARKET FOR SLEEP AIDS: TECHNOLOGIES AND MARKETS BY REGION, 2008-2014 (%)... 107 FIGURE 19 GLOBAL MARKET FOR SLEEP AIDS: TECHNOLOGIES AND MARKETS BY REGION, 2008-2014 (%)... 107 TOTAL COMPETITIVE ANALYSIS OF THE SLEEP AIDS MARKET... 108 TABLE 29 TOP COMPETITORS IN SLEEP AIDS: TECHNOLOGIES AND GLOBAL MARKETS, 2009 ($ MILLIONS/%)... 108 FIGURE 20 TOP COMPETITORS IN SLEEP AIDS: TECHNOLOGIES AND GLOBAL MARKETS, 2009 (%)... 108 INDUSTRY PARTICIPANTS BY PRODUCT TYPE... 109 TABLE 30 SELECTED SLEEP AID DISORDERS TREATMENT MANUFACTURERS BY TYPE, 2009... 109 TABLE 30 (CONTINUED)... 110 CHAPTER SIX: COMPANY PROFILES... 111 CADWELL LABORATORIES, INC.... 111 BRIEF HISTORY... 111 PRODUCTS... 111 COMPANY REVENUE HISTORY... 112 CAREFUSION CORP.... 112 BRIEF HISTORY... 112 PRODUCTS... 112 COMPANY REVENUE HISTORY... 112 TABLE 31 COMPANY REVENUES, 2008 AND 2009... 112 CEPHALON, INC.... 113 BRIEF HISTORY... 113 PRODUCTS... 113 COMPANY REVENUE HISTORY... 114
TABLE 32 COMPANY REVENUES, 2008 AND 2009 ($ MILLIONS)... 114 COMPUMEDICS, LTD. AUSTRALIA... 114 BRIEF HISTORY... 115 PRODUCTS... 115 COMPANY REVENUE HISTORY... 115 TABLE 33 COMPANY REVENUES, 2008 AND 2009 ($ MILLIONS)... 116 DEVILBISS HEALTHCARE... 116 BRIEF HISTORY... 116 PRODUCTS... 116 COMPANY REVENUE HISTORY... 116 EMBLA SYSTEMS... 117 BRIEF HISTORY... 117 PRODUCTS... 117 COMPANY REVENUE HISTORY... 118 FISHER & PAYKEL... 118 BRIEF HISTORY... 118 PRODUCTS... 118 COMPANY REVENUE HISTORY... 118 TABLE 34 COMPANY REVENUES, 2008 AND 2009 ($ MILLIONS)... 119 GLAXOSMITHKLINE... 119 BRIEF HISTORY... 119 PRODUCTS... 119 COMPANY REVENUE HISTORY... 120 TABLE 35 COMPANY REVENUES, 2008 AND 2009 ($ MILLIONS)... 120 JOHNSON & JOHNSON... 120 BRIEF HISTORY... 120 PRODUCTS... 121 COMPANY REVENUE HISTORY... 121 TABLE 36 COMPANY REVENUES, 2008 AND 2009 ($ BILLIONS)... 121 KING PHARMACEUTICALS, INC.... 121 BRIEF HISTORY... 121 PRODUCTS... 122 COMPANY REVENUE HISTORY... 122 TABLE 37 COMPANY REVENUES, 2008 AND 2009 ($ MILLIONS)... 122 MERCK & CO., INC.... 123 BRIEF HISTORY... 123 PRODUCTS... 123 COMPANY REVENUE HISTORY... 123 TABLE 38 COMPANY REVENUES 2007 AND 2008 ($ MILLIONS)... 123 NATUS MEDICAL, INC.... 124 BRIEF HISTORY... 124 PRODUCTS... 124 COMPANY REVENUE HISTORY... 124 TABLE 39 COMPANY REVENUES, 2008 AND 2009 ($ MILLIONS)... 124
NEUROCRINE BIOSCIENCES, INC.... 125 BRIEF HISTORY... 125 PRODUCTS... 125 COMPANY REVENUE HISTORY... 125 TABLE 40 COMPANY REVENUES, 2008 AND 2009 ($ MILLIONS)... 125 NOVADEL PHARMA, INC.... 126 BRIEF HISTORY... 126 PRODUCTS... 126 COMPANY REVENUE HISTORY... 126 TABLE 41 COMPANY REVENUES, 2008 AND 2009 ($ MILLIONS)... 126 PFIZER, INC.... 127 BRIEF HISTORY... 127 PRODUCTS... 127 COMPANY REVENUE HISTORY... 127 TABLE 42 COMPANY REVENUES, 2008 AND 2009 ($ MILLIONS)... 128 PHILIPS RESPIRONICS, INC.... 128 BRIEF HISTORY... 128 PRODUCTS... 129 COMPANY REVENUE HISTORY... 130 TABLE 43 COMPANY REVENUES, 2008 AND 2009 ($ MILLIONS)... 130 RESMED, INC.... 130 BRIEF HISTORY... 130 PRODUCTS... 131 COMPANY REVENUE HISTORY... 131 TABLE 44 COMPANY REVENUES, 2008 AND 2009 ($ MILLIONS)... 131 SANOFI-AVENTIS... 132 BRIEF HISTORY... 132 PRODUCTS... 132 COMPANY REVENUE HISTORY... 133 TABLE 45 COMPANY REVENUES, 2008 AND 2009 ($ MILLIONS)... 133 SEALY CORP.... 134 BRIEF HISTORY... 134 PRODUCTS... 134 COMPANY REVENUE HISTORY... 135 TABLE 46 COMPANY REVENUES, 2008 AND 2009 ($ MILLIONS)... 135 SELECT COMFORT CORP.... 135 BRIEF HISTORY... 135 PRODUCTS... 135 COMPANY REVENUE HISTORY... 136 TABLE 47 COMPANY REVENUES, 2008 AND 2009 ($ MILLIONS)... 136 SEPRACOR, INC.... 136 BRIEF HISTORY... 136 PRODUCTS... 137 COMPANY REVENUE HISTORY... 137
TABLE 48 COMPANY REVENUES, 2008 AND 2009 ($ MILLIONS)... 137 SLEEPMED, INC.... 138 BRIEF HISTORY... 138 PRODUCTS... 138 COMPANY REVENUE HISTORY... 138 SOMAXON PHARMACEUTICALS, INC.... 138 BRIEF HISTORY... 139 PRODUCTS... 139 COMPANY REVENUE HISTORY... 140 TABLE 49 COMPANY REVENUES, 2008 AND 2009 ($ MILLIONS)... 140 TEMPUR-PEDIC INTERNATIONAL, INC.... 140 BRIEF HISTORY... 140 PRODUCTS... 141 COMPANY REVENUE HISTORY... 141 TABLE 50 COMPANY REVENUES, 2008 AND 2009 ($ MILLIONS)... 142 UCB, INC.... 142 BRIEF HISTORY... 142 PRODUCTS... 143 COMPANY REVENUE HISTORY... 144 TABLE 51 COMPANY REVENUES, 2008 AND 2009 ($ MILLIONS)... 144 VANDA PHARMACEUTICALS, INC.... 144 BRIEF HISTORY... 144 PRODUCTS... 144 COMPANY REVENUE HISTORY... 145 TABLE 52 COMPANY REVENUES, 2008 AND 2009 ($ MILLIONS)... 145 XENOPORT, INC.... 145 BRIEF HISTORY... 145 PRODUCTS... 146 COMPANY REVENUE HISTORY... 146 TABLE 53 COMPANY REVENUES, 2008 AND 2009 ($ MILLIONS)... 146 APPENDIX A... 147 SLEEP ASSOCIATIONS... 147 AMERICAN ACADEMY OF SLEEP MEDICINE... 147 AMERICAN SLEEP APNEA ASSOC.... 147 AMERICAN SLEEP DISORDERS ASSOCIATIONS (ASDA)... 148 INTERNATIONAL SLEEP PRODUCTS ASSOC. (ISPA)... 148 NARCOLEPSY NETWORK, INC.... 148 NATIONAL CENTER ON SLEEP DISORDERS RESEARCH (NCSDR)... 148 NATIONAL FOUNDATION FOR SLEEP AND RELATED DISORDERS IN CHILDEN (NFSRDC)... 149 NATIONAL HEART, LUNG AND BLOOD INSTITUTE (NHLBI)... 149 NATIONAL SLEEP FOUNDATION... 149
SLEEP MEDICINE RESEARCH FOUNDATION, INC.... 149 APPENDIX B... 150 TABLE 54 LIST OF PARTICIPATING COMPANIES... 150 TABLE 54 (CONTINUED)... 151 TABLE 54 (CONTINUED)... 152 TABLE 54 (CONTINUED)... 153 TABLE 54 (CONTINUED)... 154 TABLE 54 (CONTINUED)... 155 TABLE 54 (CONTINUED)... 156 TABLE 54 (CONTINUED)... 157 TABLE 54 (CONTINUED)... 158 TABLE 54 (CONTINUED)... 159 TABLE 54 (CONTINUED)... 160 TABLE 54 (CONTINUED)... 161 TABLE 54 (CONTINUED)... 162 TABLE 54 (CONTINUED)... 163 TABLE 54 (CONTINUED)... 164 TABLE 54 (CONTINUED)... 165 TABLE 54 (CONTINUED)... 166