Stakeholder Insight: Bipolar Disorders - Zyprexa Sets the Mood for Revenue Growth
Introduction
The bipolar disorder market is experiencing a renewed expansion in product life-cycle management. Presently, mood stabilizers are the basis of treatment, although the antipsychotics led by Zyprexa, are evolving as a new therapeutic strategy. Companies will have to differentiate their products in the increasingly crowded market if they wish to protect their market share.
Scope
- Analysis is based on a survey of 164 treating physicians in the seven major markets as well as in-depth interviews with Bipolar key opinion leaders
- Detailed treatment trees showing the prevalence, diagnosis and treatment rates of bipolar across the seven major markets
- Assessment of the use of mono- and combination-therapy in specific bipolar affective episodes
- Identification of therapeutic and diagnostic unmet needs, highlights areas where stakeholder investment is vital to drive patient identification
Highlights
Datamonitor primary research has identified variances in class and brand prescribing preferences among physicians, according to BD type and geography; although prescribing trends generally follow recognized national and international guidelines. However, there is concern over the use of tricyclic antidepressants in bipolar depression.
Only 48% of the BD population are accurately diagnosed. Datamonitor has highlighted a number of serious diagnostic issues, which infers that many of the patients currently diagnosed may receive incorrect BD categorization.
Lilly's Zyprexa is currently leading the bipolar market in terms of revenue and life cycle management, with recent approval for maintenance therapy and reformulation in a combination pill with Prozac as Symbyax. Other atypical antipsychotics appear to be following suit, and could threaten anticonvulsant dominance of mood stabilization.
Why you should buy this report
- Understand differential treatment unmet needs in key patient populations identified by sex, co-morbidities and bipolar disorder type
- Gain expert insight into current diagnostic unmet needs and key growth areas in the public and healthcare sectors
- Target physicians more effectively, through an understanding of prescribing behavior
Table of Contents
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope of the analysis - page 3
- Datamonitor insight into the bipolar market - page 4
- Only 48% of the BD population are accurately diagnosed. As such, Datamonitor has highlighted a number of serious diagnostic issues, which infers that many of the patients currently diagnosed may receive incorrect BD categorization. Consequently, Datamonitor has identified a number of key areas, which, if exploited, have the propensity for increasing diagnosis and prescription rates - page 5
- As the licensed bipolar market becomes increasingly crowded, efficacy in managing both bipolar symptoms and comorbidities will become a differentiating factor. With the high prevalence of migraine and anxiety, companies will have the opportunity to capitalize on the use of anticonvulsants and SSRIs, in the face of increasing antipsychotic usage - page 7
- Lilly's Zyprexa (olanzapine) is currently leading the bipolar market in terms of revenue and lifecycle management. With recent EMEA and FDA approval for maintenance therapy and reformulation in a combination pill with Prozac as Symbyax. As such, Lilly appears to be making all the right moves for bipolar market dominance - page 8
- Key metrics - page 9
- TABLE OF CONTENTS - page 11
- CHAPTER 2 INTRODUCTION AND SCOPE - page 21
- Coverage of the Stakeholder Insight survey - bipolar disorders - page 21
- CHAPTER 3 COUNTRY TREATMENT TREES - page 23
- US - page 23
- Japan - page 28
- France - page 31
- Germany - page 34
- Italy - page 37
- Spain - page 40
- UK - page 43
- CHAPTER 4 EPIDEMIOLOGY AND PATIENT SEGMENTATION OF BIPOLAR DISORDER - page 47
- Bipolar disorder: definitions and classification - page 48
- Types of BD - page 48
- Etiology of bipolar disorders - page 51
- Causes of bipolar disorders - page 51
- Epidemiology of bipolar disorder - page 54
- Prevalence of BD - page 54
- Segmentation of BD - page 58
- Prevalence of BD types - page 58
- Average age of onset of BD - page 60
- Gender differences in BD - page 62
- Episodes of BD - page 64
- Prevalence of different mania types in BD - page 67
- Prevalence of different depressive types in BD - page 70
- Comorbidities of BD - page 73
- Living with BD - page 77
- Economic burden of BD - page 78
- Bipolar disorder: definitions and classification - page 48
- CHAPTER 5 DIAGNOSIS AND TREATMENT OPTIONS - page 81
- Introduction - page 82
- Diagnostic tools in clinical trials - page 82
- DSM-IV - page 82
- ICD-10 - page 82
- Core Diagnostic Module - page 84
- Complications with diagnostic criteria - page 84
- Mania and hypomania - page 84
- Mixed episodes - page 84
- BDII and major depressive disorder - page 85
- Differential diagnosis: ADHD - page 86
- Diagnosis rate of BD - page 87
- Diagnostic unmet needs - page 88
- Improvement of diagnostic algorithms - page 88
- Introduction of novel diagnostic strategies - page 89
- Time to diagnosis - page 90
- Education - page 92
- Treatment guidelines - page 94
- Primary aims for the treatment of mania - page 95
- Primary aims for the treatment of depression - page 98
- Treatment options - page 102
- Mania episodes: mood stabilizer monotherapy - page 102
- Mania episodes: antipsychotic monotherapy - page 102
- Mania episodes: combination therapy - page 104
- Depressive episodes: mood stabilizer monotherapy - page 104
- Depressive episodes: antidepressant monotherapy - page 105
- Depressive episodes: combination therapy - page 106
- Drug overview - page 108
- Mood stabilizers - page 108
- Anticonvulsants used (and referred to) as mood stabilizers - page 111
- Antidepressants - page 116
- Antipsychotics - page 123
- Other drug classes used - page 132
- Non-pharmacological treatment - page 132
- CHAPTER 6 CLINICAL TRIAL DESIGN - page 137
- Introduction - page 138
- Clinical trial assessment tools - page 138
- Young mania rating scale - page 138
- Hamilton Rating Scale for Depression - page 139
- PANSS - page 139
- Clinical trial features - page 139
- Levels of drug approval - page 139
- Problems of BD clinical trial design - page 140
- BD clinical trial design - page 141
- Double-blind, placebo-controlled - page 142
- Study length - page 144
- Randomization, number of subjects, diversity and drop-out rate - page 148
- Comparator usage - page 150
- Clinical trial design - page 153
- CHAPTER 7 PRESCRIBING TRENDS AND INFLUENCING FACTORS - page 154
- Treatment of mania episodes - page 155
- First-line treatment strategy for mania episodes - page 155
- Second-line treatment strategy for mania episodes - page 158
- Mania treatment: drugs of choice - page 160
- Treatment of depressive episodes - page 162
- First-line treatment of depressive episodes - page 162
- Second-line treatment of depressive episodes - page 165
- Depression: drugs of choice - page 168
- Treatment of RCBD - page 169
- First-line treatment of RCBD - page 169
- Second-line treatment of RCBD - page 172
- Treatment of psychotic depression - page 175
- First-line treatment of psychotic depression - page 175
- Second-line treatment of psychotic depression - page 179
- Psychotic depression: drugs of choice - page 181
- Treatment of mixed episodes - page 182
- Second-line treatment of mixed episodes - page 186
- Mixed episode: drugs of choice - page 188
- Factors influencing prescribing trends - page 189
- Type of episode of BD/recognized and approved treatment algorithms - page 189
- Clinical trial data supporting specific pharmacological treatment, combinations, efficacy and side-effect profiles - page 190
- Patient drug history - page 190
- Patient's influence on treatment type - page 190
- Patient lethality - page 191
- Brand versus generic - page 191
- Approved versus off-label prescribing - page 191
- Treatment of mania episodes - page 155
- CHAPTER 8 IMPROVING TREATMENT OUTCOMES - page 193
- Unmet needs - page 194
- Product development - page 198
- Antidepressants - page 199
- Mood stabilizers and anticonvulsants - page 200
- Antipsychotics - page 201
- List of Tables
- Table 1: Potential prevalence of BD across the seven major markets (000s), 2003-11 - page 9
- Table 2: Prevalence of BD between countries, 2003 - page 56
- Table 3: Potential prevalence of BD across the seven major markets (000s), 2003-11 - page 58
- Table 4: Percentage of BD patients suffering from each type of BD, 2003 - page 59
- Table 5: Mean age of onset of BD (years), 2003 - page 60
- Table 6: Prevalence of different types of mania in BD, 2003 - page 69
- Table 7: Prevalence of different types of depression in BD, 2003 - page 71
- Table 8: Lifetime prevalence rates of substance abuse among patients with affective disorders - page 75
- Table 9: Adult population correctly diagnosed with BD (000s), 2003-11 - page 88
- Table 10: Switch rates in controlled trials in acute bipolar depression. - page 106
- Table 11: Mood stabilizers identified for the treatment of BD, according to Datamonitor physician research, 2003 - page 109
- Table 12: Selected versions of valproate available on the seven major markets, 2003 - page 112
- Table 13: Antidepressants identified for the treatment of BD, according to Datamonitor physician research, 2003 - page 117
- Table 14: Antipsychotics identified for the treatment of BD according to Datamonitor physician research, 2003 - page 124
- Table 15: Young mania rating scale - page 138
- Table 16: Mean number of weeks for a drug to demonstrate efficacy in treatment and prevention of BD in the US, Japan and EU, 2003 - page 146
- Table 17: Preferential comparator drug, 2003 - page 151
- Table 18: First-line treatment strategies for mania episodes, 2003 - page 157
- Table 19: Second-line treatment strategies for mania episodes, 2003 - page 159
- Table 20: First-line treatment strategies for depressive episode, 2003 - page 164
- Table 21: Second-line treatment strategies for depressive episodes, 2003 - page 167
- Table 22: First-line treatment strategies for RCBD, 2003 - page 171
- Table 23: Second-line treatment strategies for RCBD, 2003 - page 174
- Table 24: First-line treatment strategies for psychotic depression, 2003 - page 177
- Table 25: Second-line treatment strategies for psychotic depression, 2003 - page 180
- Table 26: First-line treatment strategies for mixed episodes, 2003 - page 184
- Table 27: Second-line treatment strategies for mixed episodes, 2003 - page 187
- Table 28: Drugs currently approved for the treatment of BD, 2003 - page 192
- Table 29: Reasons for patient non-compliance, 2003 - page 197
- Table 30: Antipsychotics identified for the treatment of BD according to Datamonitor physician research, 2003 - page 201
- Table 31: Novel therapeutic research in BD - page 205
- Table 32: US physician sample breakdown, 2003 - page 225
- Table 33: Japan physician sample breakdown, 2003 - page 226
- Table 34: France physician sample breakdown, 2003 - page 226
- Table 35: Germany physician sample breakdown, 2003 - page 227
- Table 36: Spain physician sample breakdown, 200 - page 227
- Table 37: Italy physician sample breakdown, 2003 - page 228
- Table 38: UK physician sample breakdown, 2003 - page 228
- List of Figures
- Figure 1: Total BD drug-treated population in seven major markets, based on diagnosis rates and drug treatment rates, 2003 - page 10
- Figure 2: Prevalence of different types of bipolar disorder in the US, 2003 - page 26
- Figure 3: First- and second-line therapeutic strategies for different episodes of BD in the US, 2003 - page 27
- Figure 4: Prevalence of different types of bipolar disorder in Japan, 2003 - page 29
- Figure 5: First- and second-line therapeutic strategies for different episodes of BD in Japan, 2003 - page 30
- Figure 6: Prevalence of different types of bipolar disorder in France, 2003 - page 32
- Figure 7: First- and second-line therapeutic strategies for different episodes of BD in France, 2003 - page 33
- Figure 8: Prevalence of different types of bipolar disorder in Germany, 2003 - page 35
- Figure 9: First- and second-line therapeutic strategies for different episodes of BD in Germany, 2003 - page 36
- Figure 10: Prevalence of different types of bipolar disorder in Italy, 2003 - page 38
- Figure 11: First- and second-line therapeutic strategies for different episodes of BD in Italy, 2003 - page 39
- Figure 12: Prevalence of different types of bipolar disorder in Spain, 2003 - page 41
- Figure 13: First- and second-line therapeutic strategies for different episodes of BD in Spain, 2003 - page 42
- Figure 14: Prevalence of different types of bipolar disorder in the UK, 2003 - page 44
- Figure 15: First- and second-line therapeutic strategies for different episodes of BD in the UK, 2003 - page 45
- Figure 16: Cycles of bipolar episodes over time - page 51
- Figure 17: Potential prevalence of BD across the seven major markets, 2003 - page 55
- Figure 18: Percentage of BD patients suffering from each type of BD, 2003 - page 59
- Figure 19: Mean age of onset of BD, 2003 - page 61
- Figure 20: Gender differences in BD, 2003 - page 63
- Figure 21: Mean number of episodes per year in BDI, 2003 - page 64
- Figure 22: Mean number of episodes per year in BDII, 2003 - page 65
- Figure 23: Mean number of episodes per year in RCBD, 2003 - page 66
- Figure 24: Relationship between cycle length and episode number - page 67
- Figure 25: Prevalence of different types of mania in BDI, BDII, cyclothymia and RCBD, 2003 - page 70
- Figure 26: Prevalence of different types of depression in BDI, BDII, Cyclothymia and RCBD, 2003 - page 72
- Figure 27: DSM-IV diagnostic algorithm - page 83
- Figure 28: Population correctly diagnosed with BD, 2003 - page 87
- Figure 29: Average number of drugs received by 258 bipolar outpatients followed up prospectively for one year, 2003 - page 95
- Figure 30: Treatment guidelines for acute mania - page 96
- Figure 31: Treatment guidelines for acute depression - page 100
- Figure 32: Sample page from a BD mood diary, 2003 - page 133
- Figure 33: Efficacy of psychosocial therapy plus medication in improving recovery. - page 135
- Figure 34: BD clinical trial features, 2003 - page 141
- Figure 35: Mean number of weeks for a drug to demonstrate efficacy in treatment and prevention of BD across the seven major markets, 2003 - page 145
- Figure 36: Mean number of weeks for a drug to demonstrate efficacy in treatment and prevention of BD, 2003 - page 146
- Figure 37: Clinical trial design, 2003 - page 153
- Figure 38: First-line monotherapies for treatment of mania, 2003 - page 157
- Figure 39: First-line combination therapies for treatment of mania, 2003 - page 158
- Figure 40: Second-line combination therapies for treatment of mania, 2003 - page 160
- Figure 41: Prescription rate of drugs used in first- and second-line treatment of mania, 2003 - page 161
- Figure 42: First-line monotherapies for treatment of depression, 2003 - page 164
- Figure 43: First-line combination therapies for treatment of depression, 2003 - page 165
- Figure 44: Second-line combination therapies for treatment of depression, 2003 - page 167
- Figure 45: Prescription rate of drugs used in first- and second-line treatment of depression, 2003 - page 168
- Figure 46: First-line monotherapies for treatment of RCBD, 2003 - page 171
- Figure 47: First-line combination therapies for treatment of RCBD, 2003 - page 172
- Figure 48: Second-line combination therapies for treatment of RCBD, 2003 - page 174
- Figure 49: Prescription rate of drugs used in first- and second-line treatment of RCBD, 2003 - page 175
- Figure 50: First-line monotherapies for treatment of psychotic depression, 2003 - page 178
- Figure 51: First-line combination therapies for treatment of psychotic depression, 2003 - page 178
- Figure 52: Second-line combination therapies for treatment of psychotic depression, 2003 - page 181
- Figure 53: Prescription rate of drugs used in first- and second-line treatment of psychotic depression, 2003 - page 182
- Figure 54: First-line monotherapies for treatment of mixed episodes, 2003 - page 185
- Figure 55: First-line combination therapies for treatment of mixed episodes, 2003 - page 185
- Figure 56: Second-line combination therapies for treatment of mixed episodes, 2003 - page 188
- Figure 57: Prescription rate of drugs used in first- and second-line treatment of psychotic depression, 2003 - page 189
- Figure 58: Unmet needs of BD, 2003 - page 194
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