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 DISCLAIMER... 3 CHAPTER TWO: EXECUTIVE SUMMARY... 4 EXECUTIVE SUMMARY... 4 SMMARY TABLE TOTAL MARKET FOR DEPRESSIVE AND ANXIETY DISORDERS, THROUGH 2014 ($ MILLIONS)... 5 SUMMARY FIGURE TOTAL MARKET FOR DEPRESSIVE AND ANXIETY DISORDERS, 2007-2014 ($ MILLIONS)... 5 CHAPTER THREE: INDUSTRY OVERVIEW... 6 HISTORICAL PERSPECTIVE OF THE MENTAL HEALTH INDUSTRY... 6 HISTORICAL PERSPECTIVE OF THE (CONTINUED)... 7 HISTORICAL PERSPECTIVE OF THE (CONTINUED)... 8 HISTORICAL PERSPECTIVE OF THE (CONTINUED)... 9 HISTORICAL PERSPECTIVE OF THE (CONTINUED)... 10 HISTORICAL PERSPECTIVE OF THE (CONTINUED)... 11 HISTORICAL PERSPECTIVE OF THE (CONTINUED)... 12 HISTORICAL PERSPECTIVE OF THE (CONTINUED)... 13 INTRODUCTION TO THE NERVOUS SYSTEM AND BRAIN... 14 INTRODUCTION TO THE (CONTINUED)... 15 BLOOD-BRAIN BARRIER... 16 DEMOGRAPHICS... 16 TABLE 1 WORLD POPULATION BY SELECTED GEOGRAPHICAL REGION, 2008 2050 (MILLIONS)... 17 FIGURE 1 WORLD POPULATION BY SELECTED GEOGRAPHICAL REGION, 2008 2050 (MILLIONS)... 18 TABLE 2 ESTIMATED WORLD POPULATION BY AGE AND GEOGRAPHICAL REGION, 2008 (MILLIONS)... 18 FIGURE 2 ESTIMATED WORLD POPULATION BY AGE AND GEOGRAPHICAL REGION, 2008 (MILLIONS)... 19 TABLE 3 POPULATION OVER 65 BY YEAR AND REGION, 2008-2050 (%)... 20 FIGURE 3 POPULATION OVER 65 BY YEAR AND REGION, 2008-2050... 20 PREVALENCE OF MENTAL DISORDERS... 20 TABLE 4 BEST ESTIMATE 1-YEAR PREVALENCE RATES BASED ON ECA AND NCS, AGES 18-54 (%)... 21 TABLE 4 (CONTINUED)... 22
TABLE 5 PERCENTAGE OF INDIVIDUALS 12 YEARS AND OLDER WITH DEPRESSION BY DEMOGRAPHIC CHARACTERISTIC AGE, SEX, AND RACE, U.S. 2006 (%)... 23 TABLE 6 PERCENTAGE OF INDIVIDUALS WITH DEPRESSION BY AGE AND POVERTY STATUS, UNITED STATES 2006 (%)... 23 TABLE 7 INDIVIDUALS 12 YEAR OF AGE AND OLDER REPORTING DIFFICULTY WITH THEIR WORK, HOME, AND SOCIAL ACTIVITIES BY SEX AND DEPRESSION SEVERITY, UNITED STATES, 2006 (%)... 24 TABLE 8 INDIVIDUALS 12 YEARS OF AGE AND OLDER CONTACTING A MENTAL HEALTH PROFESSIONAL IN THE PAST 12 MONTHS, BY DEPRESSION SEVERITY, UNITED STATES 2006 (%)... 24 CHILDREN AND ADOLESCENTS... 25 OLDER ADULTS... 25 COSTS OF MENTAL ILLNESS... 26 TABLE 9 BEST ESTIMATE PREVALENCE RATES BASED ON EPIDEMIOLOGICAL CATCHMENT AREA, AGE 55+ (%)... 26 DEPRESSIVE DISORDERS... 27 MAJOR DEPRESSION... 27 Etiology and Neurobiology... 28 TABLE 10 RISK FACTORS FOR MAJOR DEPRESSIVE AND BIPOLAR DISORDERS... 28 TABLE 11 PREFRONTAL CORTEX AND SEROTONIN INTERCONNECTIONS: IMPLICATIONS IN DEPRESSION... 29 TABLE 11 (CONTINUED)... 30 Clinical Manifestations... 31 BIPOLAR DISORDER... 32 Etiology and Neurobiology... 33 Clinical Manifestations... 34 Bipolar I Disorder... 34 Bipolar II Disorder... 35 Bipolar II Disorder (Continued)... 36 SEASONAL AFFECTIVE DISORDER... 37 Clinical Manifestations... 37 ANXIETY DISORDERS... 38 Panic Disorder... 38 Etiology and Neurobiology... 39 Etiology and Neurobiology (Continued)... 40 Clinical Manifestations... 41 Generalized Anxiety Disorder... 41 Etiology and Neurobiology... 41 Etiology and Neurobiology (Continued)... 42 Clinical Manifestations... 43 Obsessive-Compulsive Disorder... 43 Etiology and Neurobiology... 44
Clinical Manifestations... 45 Specific and Social Phobias... 45 TABLE 12 CLINICAL NAMES FOR COMMON PHOBIAS... 46 Post-Traumatic Stress Disorder... 47 GENERIC INFLUENCE... 47 ELDERLY IMPACT... 48 DEPRESSION... 48 ANXIETY... 49 CHILDREN AND ADOLESCENT IMPACT... 49 DEPRESSION... 49 Symptoms of Depression in Children... 50 Symptoms of Depression in Children (Continued)... 51 ANXIETY... 52 ALTERNATIVE AND COMPLEMENTARY THERAPIES... 53 ST. JOHN S WORT (HYPERFORIN AND HYPERICIN)... 53 VALERIAN ROOT... 53 5-HTP... 54 RHODIOLA ROSEA... 54 SAM-E... 54 BACOPA... 54 GINSENG... 55 B VITAMINS - B1, B3, B5, B6, B9, AND B12... 55 ZINC... 55 MAGNESIUM... 56 KAVA KAVA... 56 OVERUSE OF ANTIDEPRESSANTS ANOTHER VIEW... 56 LEGISLATIVE ISSUES... 57 COMPLIANCE ISSUES... 58 COMPLIANCE ISSUES (CONTINUED)... 59 PRESCRIBING TRENDS... 60 DEPRESSION RISK DUE TO BRAIN THINNING... 60 DEPRESSION RISK DUE TO (CONTINUED)... 61 SUICIDAL BEHAVIOR AND ANTIDEPRESSANTS... 62 NOVEL APPROACH IN TEEN SUICIDE... 63 COMBINATION THERAPY... 64 REMOTE SUPPORT FOR DEPRESSION... 65 TREATMENTS AND PRODUCTS FOR DEPRESSIVE DISORDERS... 66 TREATMENTS AND PRODUCTS FOR (CONTINUED)... 67 PRESCRIPTION PRODUCTS... 68 Selective Serotonin Reuptake Inhibitors... 68 Side Effects... 68 Pharmacologics... 69 Serotonin-Norepinephrine Reuptake Inhibitors... 69 Tricyclic Antidepressants... 69
Chemical Aspects... 69 Mechanism of Action... 70 Actions and Side Effects... 70 Pharmacologics... 71 Monoamine Inhibitors... 72 Chemical Aspects... 73 Pharmacologics... 73 Side Effects... 74 Others... 74 Marketed Antidepressants... 75 Marketed Antidepressants (Continued)... 76 Marketed Antidepressants (Continued)... 77 Marketed Antidepressants (Continued)... 78 TABLE 13 SELECTED MARKETED ANTIDEPRESSANT DRUGS ($ MILLIONS)... 79 ALTERNATIVE TREATMENTS... 80 Light Therapy... 80 Electroconvulsive Therapy... 80 Acupressure... 81 Acupuncture... 81 Biofeedback... 81 Nutrition... 81 Reflexology... 82 Self-Help Groups... 82 Animal-Assisted Therapies... 83 Expressive Therapies... 83 Art Therapy... 83 Dance/Movement Therapy... 83 Music/Sound Therapy... 83 Guided Imagery or Visualization... 84 Massage Therapy... 84 Technology-Based Applications... 84 Telemedicine... 84 Telephone Counseling... 84 Electronic Communications... 85 Radio Psychiatry... 85 Vagus Nerve Stimulation (VNS)... 85 Transcranial Magnetic Stimulation (TMS)... 85 Deep Brain Stimulation... 85 TREATMENTS AND PRODUCTS FOR ANXIETY DISORDERS... 86 PRESCRIPTION PRODUCTS... 86 Barbiturates... 86 Benzodiazepines... 86 Tricyclic Antidepressants... 87
Selective Serotonin Reuptake Inhibitors... 87 Serotonin-Norepinephrine Reuptake Inhibitors... 88 Effexor... 88 Cymbalta... 89 Antihistamines... 89 Anticonvulsants/Bipolar... 89 Lamictal... 89 Lithium... 89 Beta-Blockers... 90 Antipsychotics... 90 Abilify... 90 BuSpar... 91 Geodon... 91 Risperdal... 91 Seroquel... 91 Zyprexa... 91 TABLE 14 SELECTED MARKETEDANTIANXIETY DRUGS... 92 TABLE 14 (CONTINUED)... 93 CHAPTER FOUR: MARKET SIZE AND GROWTH... 94 TOTAL MARKET... 94 Total Antidepressant and Antianxiety Drug Market by Product Classification... 94 TABLE 15 TOTAL MARKET FOR DEPRESSIVE AND ANXIETY DISORDERS, THROUGH 2014 ($ MILLIONS)... 94 FIGURE 4 TOTAL MARKET FOR DEPRESSIVE AND ANXIETY DISORDERS, 2007-2014 ($ MILLIONS)... 95 TABLE 16 TOTAL MARKET SHARE BY CATEGORY, 2009 AND 2014 (%)... 95 FIGURE 5 TOTAL MARKET SHARE BY CATEGORY, 2009 AND 2014 (%)... 96 TOTAL ANTIDEPRESSANT AND ANTIANXIETY DRUG MARKET BY GEOGRAPHIC SEGMENTS... 96 FIGURE 6 GLOBAL MARKET SIZE OF THERAPIES FOR DEPRESSIVE AND ANXIETY DISORDERS BY REGION, 2007-2014 ($ MILLIONS)... 97 TABLE 18 TOTAL MARKET SHARE BY REGION, 2009 AND 2014 (%)... 98 FIGURE 7 TOTAL MARKET SHARE BY REGION, 2009 AND 2014 (%)... 98 DEPRESSION MARKET... 99 ANTIDEPRESSANT DRUG MARKET BY PRODUCT CLASSIFICATION... 99 TABLE 19 GLOBAL MARKET FOR ANTIDEPRESSANTS BY PRODUCT, THROUGH 2014 ($ MILLIONS)... 100 FIGURE 8 GLOBAL MARKET FOR ANTIDEPRESSANTS BY PRODUCT, 2007-2014 ($ MILLIONS)... 100
TABLE 20 GLOBAL MARKET SHARE OF ANTIDEPRESSANTS BY PRODUCT, THROUGH 2014 (%)... 101 FIGURE 9 GLOBAL MARKET SHARE OF ANTIDEPRESSANTS BY PRODUCT, 2007-2014 (%)... 101 ANTIDEPRESSANT DRUG MARKET BY GEOGRAPHIC SEGMENTS... 101 United States... 102 European Union... 102 Japan... 102 Rest of World... 103 TABLE 21 GLOBAL MARKET FOR ANTIDEPRESSANTS BY REGION, 2007-2014 ($ MILLIONS)... 103 FIGURE 10 GLOBAL MARKET FOR ANTIDEPRESSANTS BY REGION, 2007-2014 ($ MILLIONS)... 104 TABLE 22 GLOBAL MARKET SHARE OF GLOBAL ANTIDEPRESSANTS BY REGION, 2007-2014 (%)... 104 FIGURE 11 GLOBAL MARKET SHARE OF GLOBAL ANTIDEPRESSANTS BY REGION, 2007-2014 (%)... 105 ANTIANXIETY MARKET... 105 ANTIANXIETY DRUG MARKET BY PRODUCT CLASSIFICATION... 105 TABLE 23 GLOBAL MARKET FOR ANTIANXIETY DRUGS BY PRODUCT TYPE, THROUGH 2014 ($ MILLIONS)... 106 TABLE 24 GLOBAL MARKET SHARE OF ANTIANXIETY DRUGS BY PRODUCT TYPE, 2007-2014 (%)... 107 FIGURE 12 GLOBAL MARKET FOR ANTIANXIETY DRUGS BY PRODUCT TYPE, 2007-2014 ($ MILLIONS)... 107 FIGURE 13 GLOBAL MARKET SHARE OF ANTIANXIETY DRUGS BY PRODUCT TYPE, 2007-2014 (%)... 108 ANTIANXIETY DRUG MARKET BY GEOGRAPHIC SEGMENTS... 108 United States... 108 European Union... 109 Japan... 109 Rest of World... 109 TABLE 25 GLOBAL MARKET SIZE OF ANTIANXIETY DRUGS BY REGION, THROUGH 2014 ($ MILLIONS)... 110 FIGURE 14 GLOBAL MARKET SIZE OF ANTIANXIETY DRUGS BY REGION, 2007-2014 ($ MILLIONS)... 110 TABLE 26 GLOBAL MARKET SHARE OF GLOBAL ANTIANXIETY DRUGS BY REGION, 2007-2014 (%)... 111 FIGURE 15 GLOBAL MARKET SHARE OF GLOBAL ANTIANXIETY DRUGS BY REGION, 2007-2014 (%)... 111 CHAPTER FIVE: RESEARCH AND DEVELOPMENT... 112
GEODON... 112 GEPIRONE ER... 112 RISPERDAL CONSTA... 112 SAPHRIS... 113 SEROQUEL XR... 113 TRAZODONE ONCE DAILY... 113 AGI0178... 113 CORLUX... 114 INVEGA... 114 LU AA21004... 114 LYRICA... 114 NUVIGIL... 115 SAREDUTANT... 115 VILAZODONE... 115 TABLE 27 THERAPIES IN DEVELOPMENT FOR DEPRESSION AND ANXIETY, 2009... 116 TABLE 27 (CONTINUED)... 117 NOVEL PRODUCTS IN DEVELOPMENT... 118 NOVEL PRODUCTS IN DEVELOPMENT (CONTINUED)... 119 CHAPTER SIX: COMPETITIVE ANALYSIS... 120 TOTAL COMPETITIVE ANALYSIS... 120 TABLE 28 TOTAL COMPETITIVE ANALYSIS OF THERAPIES FOR DEPRESSION AND ANXIETY DISORDERS BY DRUG MANUFACTURER MARKET SHARE, 2008 ($ MILLIONS/%)... 120 FIGURE 16 TOTAL COMPETITIVE ANALYSIS OF THERAPIES FOR DEPRESSION AND ANXIETY DISORDERS BY DRUG MANUFACTURER MARKET SHARE, 2008 (%)... 121 DEPRESSION COMPETITIVE ANALYSIS... 121 TABLE 29 COMPETITIVE ANALYSIS OF THERAPIES FOR DEPRESSION DISORDERS BY DRUG MANUFACTURER MARKET SHARE, 2008 ($ MILLIONS/%)... 122 FIGURE 17 COMPETITIVE ANALYSIS OF THERAPIES FOR DEPRESSION DISORDERS BY DRUG MANUFACTURER MARKET SHARE, 2008 (%)... 123 TABLE 30 COMPETITIVE ANALYSIS OF THERAPIES FOR DEPRESSION DISORDERS BY THE TOP FOUR DRUG MANUFACTURERS MARKET SHARE, 2008 ($ MILLIONS/%)... 123 FIGURE 18 COMPETITIVE ANALYSIS OF THERAPIES FOR DEPRESSION DISORDERS BY THE TOP FOUR DRUG MANUFACTURERS MARKET SHARE, 2008 (%)... 124 ANTIANXIETY COMPETITIVE ANALYSIS... 124
TABLE 31 COMPETITIVE ANALYSIS OF THERAPIES FOR ANXIETY DISORDERS BY DRUG MANUFACTURER MARKET SHARE, 2008 ($ MILLIONS/%)... 125 TABLE 32 COMPETITIVE ANALYSIS OF THERAPIES FOR ANXIETY DISORDERS BY THE TOP FOUR DRUG MANUFACTURER MARKET SHARE, 2008 ($ MILLIONS/%)... 126 FIGURE 19 COMPETITIVE ANALYSIS OF THERAPIES FOR ANXIETY DISORDERS BY DRUG MANUFACTURER MARKET SHARE, 2008 (%)... 126 FIGURE 20 COMPETITIVE ANALYSIS OF THERAPIES FOR ANXIETY DISORDERS BY THE TOP FOUR DRUG MANUFACTURER MARKET SHARE, 2008 (%)... 127 CHAPTER SEVEN: PATENT ANALYSIS... 128 TABLE 33 SELECTED MANUFACTURER PATENTS FOR TREATMENT OF DEPRESSION AND ANXIETY... 128 CHAPTER EIGHT: COMPANY PROFILES... 129 ASTRAZENECA... 129 BRIEF HISTORY... 129 PRODUCTS... 129 COMPANY REVENUE HISTORY... 129 TABLE 34 COMPANY REVENUES, 2007 AND 2008 ($ MILLIONS)... 130 RESEARCH AND DEVELOPMENT... 130 BRISTOL-MYERS SQUIBB COMPANY... 130 BRIEF HISTORY... 130 PRODUCTS... 131 COMPANY REVENUE HISTORY... 131 TABLE 35 COMPANY REVENUES, 2007 AND 2008 ($ MILLIONS)... 131 RESEARCH AND DEVELOPMENT... 132 DOV PHARMACEUTICAL, INC.... 132 BRIEF HISTORY... 132 PRODUCTS... 132 RESEARCH AND DEVELOPMENT... 132 ELI LILLY & COMPANY... 132 BRIEF HISTORY... 133 PRODUCTS... 133 COMPANY REVENUE HISTORY... 133 TABLE 36 COMPANY REVENUES, 2007 AND 2008 ($ MILLIONS)... 134 RESEARCH AND DEVELOPMENT... 134 FABRE-KRAMER PHARMACEUTICALS, INC.... 134 BRIEF HISTORY... 134 PRODUCTS... 134 RESEARCH AND DEVELOPMENT... 135 FOREST PHARMACEUTICALS, INC.... 135
BRIEF HISTORY... 135 PRODUCTS... 135 COMPANY REVENUE HISTORY... 136 TABLE 37 COMPANY REVENUES, 2007 AND 2008 ($ BILLIONS)... 136 RESEARCH AND DEVELOPMENT... 136 GLAXOSMITHKLINE... 136 BRIEF HISTORY... 136 PRODUCTS... 137 COMPANY REVENUE HISTORY... 137 TABLE 38 COMPANY REVENUES, 2007 AND 2008 ($ MILLIONS)... 138 RESEARCH AND DEVELOPMENT... 138 JAZZ PHARMACEUTICALS, INC.... 138 BRIEF HISTORY... 138 PRODUCTS... 139 COMPANY REVENUE HISTORY... 139 TABLE 39 COMPANY REVENUES, 2007 AND 2008 ($ MILLIONS)... 139 RESEARCH AND DEVELOPMENT... 139 JOHNSON & JOHNSON... 139 BRIEF HISTORY... 140 PRODUCTS... 140 COMPANY REVENUE HISTORY... 140 TABLE 40 COMPANY REVENUES, 2007 AND 2008 ($ MILLIONS)... 140 RESEARCH AND DEVELOPMENT... 140 H. LUNDBECK A/S... 141 BRIEF HISTORY... 141 PRODUCTS... 141 COMPANY REVENUE HISTORY... 142 TABLE 41 COMPANY REVENUES 2007 AND 2008 ($ MILLIONS)... 142 RESEARCH AND DEVELOPMENT... 142 MERCK & COMPANY, INC.... 142 BRIEF HISTORY... 142 PRODUCTS... 143 COMPANY REVENUE HISTORY... 143 TABLE 42 COMPANY REVENUES, 2007 AND 2008 ($ MILLIONS)... 143 RESEARCH AND DEVELOPMENT... 143 PFIZER, INC.... 144 BRIEF HISTORY... 144 PRODUCTS... 144 COMPANY REVENUE HISTORY... 144 TABLE 43 COMPANY REVENUES, 2007 AND 2008 ($ MILLIONS)... 145 RESEARCH AND DEVELOPMENT... 145 ROCHE, INC.... 145 BRIEF HISTORY... 145 PRODUCTS... 146
COMPANY REVENUE HISTORY... 146 TABLE 44 COMPANY REVENUES, 2007 AND 2008 ($ MILLIONS)... 146 RESEARCH AND DEVELOPMENT... 146 SANOFI-AVENTIS... 147 BRIEF HISTORY... 147 PRODUCTS... 147 COMPANY REVENUE HISTORY... 147 TABLE 45 COMPANY REVENUES, 2007 AND 2008 ($ MILLIONS)... 148 RESEARCH AND DEVELOPMENT... 148 SEPRACOR, INC.... 148 BRIEF HISTORY... 148 PRODUCTS... 149 COMPANY REVENUE HISTORY... 149 TABLE 46 COMPANY REVENUES, 2007 AND 2008 ($ MILLIONS)... 149 RESEARCH AND DEVELOPMENT... 149 SCHERING-PLOUGH CORP... 150 BRIEF HISTORY... 150 PRODUCTS... 150 COMPANY REVENUE HISTORY... 150 TABLE 47 COMPANY REVENUES, 2007 AND 2008 ($ MILLIONS)... 151 RESEARCH AND DEVELOPMENT... 151 WYETH... 151 BRIEF HISTORY... 151 PRODUCTS... 151 COMPANY REVENUE HISTORY... 152 TABLE 48 COMPANY REVENUES, 2007 AND 2008 ($ MILLIONS)... 152 RESEARCH AND DEVELOPMENT... 152 APPENDIX A... 153 ALTERNATIVE APPROACHES TO MENTAL HEALTH ORGANIZATIONS... 153 ALTERNATIVE APPROACHES TO (CONTINUED)... 154 APPENDIX B... 155 COMPANY LISTINGS... 155 TABLE 49 COMPANY LISTINGS... 155 TABLE 49 (CONTINUED)... 156 TABLE 49 (CONTINUED)... 157 TABLE 49 (CONTINUED)... 158 TABLE 49 (CONTINUED)... 159 TABLE 49 (CONTINUED)... 160 TABLE 49 (CONTINUED)... 161