Stakeholder Insight: Bipolar Disorders - Zyprexa Sets the Mood for Revenue Growth

Table of Contents

CHAPTER 1 EXECUTIVE SUMMARY

Scope of the analysis

Datamonitor insight into the bipolar market

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

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

Lilly�fs 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

Key metrics

CHAPTER 2 INTRODUCTION AND SCOPE

Coverage of the Stakeholder Insight survey – bipolar disorders

CHAPTER 3 COUNTRY TREATMENT TREES

US

Japan

France

Germany

Italy

Spain

UK

CHAPTER 4 EPIDEMIOLOGY AND PATIENT SEGMENTATION OF BIPOLAR DISORDER

Bipolar disorder: definitions and classification

Types of BD

Etiology of bipolar disorders

Causes of bipolar disorders

Epidemiology of bipolar disorder

Prevalence of BD

Segmentation of BD

Prevalence of BD types

Average age of onset of BD

Gender differences in BD

Episodes of BD

Prevalence of different mania types in BD

Prevalence of different depressive types in BD

Comorbidities of BD

Living with BD

Economic burden of BD

CHAPTER 5 DIAGNOSIS AND TREATMENT OPTIONS

Introduction

Diagnostic tools in clinical trials

DSM-IV

ICD-10

Core Diagnostic Module

Complications with diagnostic criteria

Mania and hypomania

Mixed episodes

BDII and major depressive disorder

Differential diagnosis: ADHD

Diagnosis rate of BD

Diagnostic unmet needs

Improvement of diagnostic algorithms

Introduction of novel diagnostic strategies

Time to diagnosis

Education

Treatment guidelines

Primary aims for the treatment of mania

Primary aims for the treatment of depression

Treatment options

Mania episodes: mood stabilizer monotherapy

Mania episodes: antipsychotic monotherapy

Mania episodes: combination therapy

Depressive episodes: mood stabilizer monotherapy

Depressive episodes: antidepressant monotherapy

Depressive episodes: combination therapy

Drug overview

Mood stabilizers

Anticonvulsants used (and referred to) as mood stabilizers

Antidepressants

Antipsychotics

Other drug classes used

Non-pharmacological treatment

CHAPTER 6 CLINICAL TRIAL DESIGN

Introduction

Clinical trial assessment tools

Young mania rating scale

Hamilton Rating Scale for Depression

PANSS

Clinical trial features

Levels of drug approval

Problems of BD clinical trial design

BD clinical trial design

Double-blind, placebo-controlled

Study length

Randomization, number of subjects, diversity and drop-out rate

Comparator usage

Clinical trial design

CHAPTER 7 PRESCRIBING TRENDS AND INFLUENCING FACTORS

Treatment of mania episodes

First-line treatment strategy for mania episodes

Second-line treatment strategy for mania episodes

Mania treatment: drugs of choice

Treatment of depressive episodes

First-line treatment of depressive episodes

Second-line treatment of depressive episodes

Depression: drugs of choice

Treatment of RCBD

First-line treatment of RCBD

Second-line treatment of RCBD

Treatment of psychotic depression

First-line treatment of psychotic depression

Second-line treatment of psychotic depression

Psychotic depression: drugs of choice

Treatment of mixed episodes

Second-line treatment of mixed episodes

Mixed episode: drugs of choice

Factors influencing prescribing trends

Type of episode of BD/recognized and approved treatment algorithms

Clinical trial data supporting specific pharmacological treatment, combinations, efficacy and side-effect profiles

Patient drug history

Patient�fs influence on treatment type

Patient lethality

Brand versus generic

Approved versus off-label prescribing

CHAPTER 8 IMPROVING TREATMENT OUTCOMES

Unmet needs

Product development

Antidepressants

Mood stabilizers and anticonvulsants

Antipsychotics

List of Tables

Table 1: Potential prevalence of BD across the seven major markets (000s), 2003–11

Table 2: Prevalence of BD between countries, 2003

Table 3: Potential prevalence of BD across the seven major markets (000s), 2003–11

Table 4: Percentage of BD patients suffering from each type of BD, 2003

Table 5: Mean age of onset of BD (years), 2003

Table 6: Prevalence of different types of mania in BD, 2003

Table 7: Prevalence of different types of depression in BD, 2003

Table 8: Lifetime prevalence rates of substance abuse among patients with affective disorders

Table 9: Adult population correctly diagnosed with BD (000s), 2003–11

Table 10: Switch rates in controlled trials in acute bipolar depression.

Table 11: Mood stabilizers identified for the treatment of BD, according to Datamonitor physician research, 2003

Table 12: Selected versions of valproate available on the seven major markets, 2003

Table 13: Antidepressants identified for the treatment of BD, according to Datamonitor physician research, 2003

Table 14: Antipsychotics identified for the treatment of BD according to Datamonitor physician research, 2003

Table 15: Young mania rating scale

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

Table 17: Preferential comparator drug, 2003

Table 18: First-line treatment strategies for mania episodes, 2003

Table 19: Second-line treatment strategies for mania episodes, 2003

Table 20: First-line treatment strategies for depressive episode, 2003

Table 21: Second-line treatment strategies for depressive episodes, 2003

Table 22: First-line treatment strategies for RCBD, 2003

Table 23: Second-line treatment strategies for RCBD, 2003

Table 24: First-line treatment strategies for psychotic depression, 2003

Table 25: Second-line treatment strategies for psychotic depression, 2003

Table 26: First-line treatment strategies for mixed episodes, 2003

Table 27: Second-line treatment strategies for mixed episodes, 2003

Table 28: Drugs currently approved for the treatment of BD, 2003

Table 29: Reasons for patient non-compliance, 2003

Table 30: Antipsychotics identified for the treatment of BD according to Datamonitor physician research, 2003

Table 31: Novel therapeutic research in BD

Table 32: US physician sample breakdown, 2003

Table 33: Japan physician sample breakdown, 2003

Table 34: France physician sample breakdown, 2003

Table 35: Germany physician sample breakdown, 2003

Table 36: Spain physician sample breakdown, 200

Table 37: Italy physician sample breakdown, 2003

Table 38: UK physician sample breakdown, 2003

List of Figures

Figure 1: Total BD drug-treated population in seven major markets, based on diagnosis rates and drug treatment rates, 2003

Figure 2: Prevalence of different types of bipolar disorder in the US, 2003

Figure 3: First- and second-line therapeutic strategies for different episodes of BD in the US, 2003

Figure 4: Prevalence of different types of bipolar disorder in Japan, 2003

Figure 5: First- and second-line therapeutic strategies for different episodes of BD in Japan, 2003

Figure 6: Prevalence of different types of bipolar disorder in France, 2003

Figure 7: First- and second-line therapeutic strategies for different episodes of BD in France, 2003

Figure 8: Prevalence of different types of bipolar disorder in Germany, 2003

Figure 9: First- and second-line therapeutic strategies for different episodes of BD in Germany, 2003

Figure 10: Prevalence of different types of bipolar disorder in Italy, 2003

Figure 11: First- and second-line therapeutic strategies for different episodes of BD in Italy, 2003

Figure 12: Prevalence of different types of bipolar disorder in Spain, 2003

Figure 13: First- and second-line therapeutic strategies for different episodes of BD in Spain, 2003

Figure 14: Prevalence of different types of bipolar disorder in the UK, 2003

Figure 15: First- and second-line therapeutic strategies for different episodes of BD in the UK, 2003

Figure 16: Cycles of bipolar episodes over time

Figure 17: Potential prevalence of BD across the seven major markets, 2003

Figure 18: Percentage of BD patients suffering from each type of BD, 2003

Figure 19: Mean age of onset of BD, 2003

Figure 20: Gender differences in BD, 2003

Figure 21: Mean number of episodes per year in BDI, 2003

Figure 22: Mean number of episodes per year in BDII, 2003

Figure 23: Mean number of episodes per year in RCBD, 2003

Figure 24: Relationship between cycle length and episode number

Figure 25: Prevalence of different types of mania in BDI, BDII, cyclothymia and RCBD, 2003

Figure 26: Prevalence of different types of depression in BDI, BDII, Cyclothymia and RCBD, 2003

Figure 27: DSM-IV diagnostic algorithm

Figure 28: Population correctly diagnosed with BD, 2003

Figure 29: Average number of drugs received by 258 bipolar outpatients followed up prospectively for one year, 2003

Figure 30: Treatment guidelines for acute mania

Figure 31: Treatment guidelines for acute depression

Figure 32: Sample page from a BD mood diary, 2003

Figure 33: Efficacy of psychosocial therapy plus medication in improving recovery.

Figure 34: BD clinical trial features, 2003

Figure 35: Mean number of weeks for a drug to demonstrate efficacy in treatment and prevention of BD across the seven major markets, 2003

Figure 36: Mean number of weeks for a drug to demonstrate efficacy in treatment and prevention of BD, 2003

Figure 37: Clinical trial design, 2003

Figure 38: First-line monotherapies for treatment of mania, 2003

Figure 39: First-line combination therapies for treatment of mania, 2003

Figure 40: Second-line combination therapies for treatment of mania, 2003

Figure 41: Prescription rate of drugs used in first- and second-line treatment of mania, 2003

Figure 42: First-line monotherapies for treatment of depression, 2003

Figure 43: First-line combination therapies for treatment of depression, 2003

Figure 44: Second-line combination therapies for treatment of depression, 2003

Figure 45: Prescription rate of drugs used in first- and second-line treatment of depression, 2003

Figure 46: First-line monotherapies for treatment of RCBD, 2003

Figure 47: First-line combination therapies for treatment of RCBD, 2003

Figure 48: Second-line combination therapies for treatment of RCBD, 2003

Figure 49: Prescription rate of drugs used in first- and second-line treatment of RCBD, 2003

Figure 50: First-line monotherapies for treatment of psychotic depression, 2003

Figure 51: First-line combination therapies for treatment of psychotic depression, 2003

Figure 52: Second-line combination therapies for treatment of psychotic depression, 2003

Figure 53: Prescription rate of drugs used in first- and second-line treatment of psychotic depression, 2003

Figure 54: First-line monotherapies for treatment of mixed episodes, 2003

Figure 55: First-line combination therapies for treatment of mixed episodes, 2003

Figure 56: Second-line combination therapies for treatment of mixed episodes, 2003

Figure 57: Prescription rate of drugs used in first- and second-line treatment of psychotic depression, 2003

Figure 58: Unmet needs of BD, 2003