Bipolar Disorder Disease Coverage to 2024

  • ID: 3797408
  • Drug Pipelines
  • 349 pages
  • Datamonitor Healthcare
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Disease Overview

Bipolar disorder is a psychiatric disorder characterized by unusual shifts in mood, energy, activity levels, and the ability to carry out everyday tasks. Patients with the disorder may experience periods of mania (an overly joyful or overexcited state) followed by periods of depression (feelings of extreme sadness or hopelessness). Symptoms of bipolar disorder are severe and can result in damaged relationships, poor educational or occupational performance, and even suicide.

Market Snapshot
  • Temporary downturn in bipolar market value will be recouped by oral drug approvals/launches and sales momentum of LAIs.
  • The complexity of bipolar disorder is yet to be unlocked, contributing to a lack of episode-tailored treatment strategies.
  • Forecasted growth in the total prevalence of bipolar I disorder and bipolar II disorder will be driven by demographics.
  • New brand Vraylar is yet to distinguish itself, but its long patent life permits ample time to improve product positioning.
  • Otsuka initiates Phase III development of Rexulti for bipolar mania without proof-of-concept trial.
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FORECAST: BIPOLAR DISORDER (Published on 09 April 2018)
OVERVIEW
EXECUTIVE SUMMARY
MARKET OVERVIEW AND TRENDS
MARKET DEFINITION AND METHODOLOGY
ABILIFY (ARIPIPRAZOLE)
ABILIFY MAINTENA (ARIPIPRAZOLE)
GEODON (ZIPRASIDONE)
LAMICTAL/LAMICTAL XR (LAMOTRIGINE)
LATUDA (LURASIDONE)
LUMATEPERONE
RISPERDAL CONSTA (RISPERIDONE)
SAPHRIS (ASENAPINE)
SEROQUEL/SEROQUEL XR (QUETIAPINE)
VRAYLAR (CARIPRAZINE)
ZYPREXA (OLANZAPINE)
PRIMARY RESEARCH METHODOLOGY

TREATMENT: BIPOLAR DISORDER (Published on 21 August 2017)
OVERVIEW
EXECUTIVE SUMMARY
PRIMARY RESEARCH METHODOLOGY
DISEASE DEFINITION AND DIAGNOSIS
PATIENT SEGMENTATION
CURRENT TREATMENT OPTIONS
TREATMENT DYNAMICS
UNMET NEEDS IN BIPOLAR DISORDER

EPIDEMIOLOGY: BIPOLAR DISORDER IN THE US, JAPAN, AND 5EU (Published on 17 July 2017)
OVERVIEW
EXECUTIVE SUMMARY
DISEASE BACKGROUND
SOURCES AND METHODOLOGY
FORECAST: BIPOLAR I DISORDER
FORECAST: BIPOLAR II DISORDER
EPIDEMIOLOGIST INSIGHT
STRENGTHS AND LIMITATIONS
APPENDIX: ADDITIONAL SOURCES

MARKETED DRUGS: BIPOLAR DISORDER (Published on 09 April 2018)
OVERVIEW
EXECUTIVE SUMMARY
PRODUCT OVERVIEW
PRODUCT PROFILE: ABILIFY
PRODUCT PROFILE: ABILIFY MAINTENA
PRODUCT PROFILE: GEODON
PRODUCT PROFILE: LAMICTAL
PRODUCT PROFILE: LATUDA
PRODUCT PROFILE: RISPERDAL CONSTA
PRODUCT PROFILE: SAPHRIS
PRODUCT PROFILE: SEROQUEL/SEROQUEL XR
PRODUCT PROFILE: VRAYLAR
PRODUCT PROFILE: ZYPREXA

PIPELINE: BIPOLAR DISORDER (Published on 09 April 2018)
OVERVIEW
EXECUTIVE SUMMARY
CLINICAL PIPELINE OVERVIEW
PRODUCT PROFILE (LATE STAGE): ALKS 3831
PRODUCT PROFILE (LATE STAGE): REXULTI
PRODUCT PROFILE (LATE STAGE): LUMATEPERONE

List of Figures
Figure 1: Bipolar disorder market sales across the US, Japan, and five major EU markets, by country, 2017-26
Figure 2: Growth dynamics of the bipolar disorder market across the US, Japan, and five major EU markets, by country, 2017-26
Figure 3: Bipolar disorder market sales across the US, Japan, and five major EU markets, by disease phase, 2017-26
Figure 4: Bipolar disorder market sales across the US, Japan, and five major EU markets, by drug class, 2017-26
Figure 5: Sales of selected competing LAI brands across the US, Japan, and five major EU markets, 2017-26
Figure 6: Sales of selected competing bipolar depression brands across the US, Japan, and five major EU markets, 2017-26
Figure 7: Methodology flow for the author’s bipolar disorder patient-based forecast
Figure 8: Price sources and calculations, by country
Figure 9: Abilify sales for bipolar disorder across the US, Japan, and five major EU markets, by country, 2017-26
Figure 10: Abilify Maintena sales for bipolar disorder across the US, Japan, and five major EU markets, by country, 2017-26
Figure 11: Geodon/Zeldox sales for bipolar disorder across the US, Germany, Italy, and Spain, by country, 2017-26
Figure 12: Lamictal/Lamictal XR sales for bipolar disorder across the US, Japan, and five major EU markets, by country, 2017-26
Figure 13: Latuda sales for bipolar disorder across the US, Japan, Germany, Italy, Spain, and the UK, by country, 2017-26
Figure 14: Lumateperone sales for bipolar disorder in the US, 2017-26
Figure 15: Risperdal Consta sales for bipolar disorder across the US, Japan, and major EU markets, by country, 2017-26
Figure 16: Saphris/Sycrest sales for bipolar disorder across the US, Japan, and major EU markets, by country, 2017-26
Figure 17: Seroquel/Seroquel XR sales for bipolar disorder across the US, Japan, and five major EU markets, by country, 2017-26
Figure 18: Vraylar sales for bipolar disorder in the US and five major EU markets, by country, 2017-26
Figure 19: Zyprexa sales for bipolar disorder across the US, Japan, and five major EU markets, by country, 2017-26
Figure 20: DSM-V diagnostic criteria for mood episodes based on symptoms
Figure 21: DSM-V diagnostic criteria for bipolar disorder subtypes
Figure 22: Diagnosis rates for bipolar disorder in the US, Japan, and five major EU markets, by country
Figure 23: Segmentation of bipolar disorder patients by disease phase in the US, Japan, and five major EU markets, by country
Figure 24: Segmentation of bipolar disorder patients by line of therapy across the US, Japan, and five major EU markets
Figure 25: Drug treatment rate for bipolar disorder in the US, Japan, and five major EU markets, by country
Figure 26: Psychological interventions for bipolar disorder
Figure 27: Guidelines for bipolar disorder treatment
Figure 28: Drug classes recommended in bipolar disorder treatment guidelines, by disease phase and line of therapy
Figure 29: Guideline recommendations for acute mania by line of treatment
Figure 30: Guideline recommendations for acute depression by line of treatment
Figure 31: Guideline recommendations for maintenance therapy by line of treatment
Figure 32: Top five overall class regimens across the US, Japan, and five major EU markets, by bipolar disorder disease phase and line of therapy
Figure 33: Top five overall drug treatments across the US, Japan, and five major EU markets, by bipolar disorder disease phase and line of therapy
Figure 34: Top five first-line drug treatments for mania in the US, Japan, and five major EU markets, by country
Figure 35: Top five second-line and beyond drug treatments for mania in the US, Japan, and five major EU markets, by country
Figure 36: Top five first-line drug treatments for depression in the US, Japan, and five major EU markets, by country
Figure 37: Top five second-line and beyond drug treatments for bipolar depression in the US, Japan, and five major EU markets, by country
Figure 38: Top five first-line drug treatments for maintenance therapy in the US, Japan, and five major EU markets, by country
Figure 39: Top five second-line and beyond drug treatments for maintenance therapy in the US, Japan, and five major EU markets, by country
Figure 40: Compliance rates of bipolar disorder patients in the US, Japan, and five major EU markets, by country and disease phase
Figure 41: Key unmet needs for bipolar disorder, 2017
Figure 42: Trend in total prevalent cases of bipolar I disorder in the US, Japan, and five major EU markets, by country, 2016-36
Figure 43: Absolute change in total prevalent cases of bipolar I disorder in the US, Japan, and five major EU markets, by country, 2016-36
Figure 44: Trend in total prevalent cases of bipolar II disorder in the US, Japan, and five major EU markets, by country, 2016-36
Figure 45: Absolute change in total prevalent cases of bipolar II disorder in the US, Japan, and five major EU markets, by country, 2016-36
Figure 46: Abilify for bipolar disorder - SWOT analysis
Figure 47: Drug assessment summary for Abilify in bipolar disorder
Figure 48: Drug assessment summary for Abilify in bipolar disorder
Figure 49: Abilify Maintena for bipolar disorder - SWOT analysis
Figure 50: Drug assessment summary for Abilify Maintena in bipolar disorder
Figure 51: Drug assessment summary for Abilify Maintena in bipolar disorder
Figure 52: Geodon for bipolar disorder - SWOT analysis
Figure 53: Drug assessment summary for Geodon in bipolar disorder
Figure 54: Drug assessment summary for Geodon in bipolar disorder
Figure 55: Lamictal for bipolar disorder - SWOT analysis
Figure 56: Drug assessment summary for Lamictal in bipolar disorder
Figure 57: Drug assessment summary for Lamictal in bipolar disorder
Figure 58: Latuda for bipolar disorder - SWOT analysis
Figure 59: Drug assessment summary for Latuda in bipolar disorder
Figure 60: Drug assessment summary for Latuda in bipolar disorder
Figure 61: Risperdal Consta for bipolar disorder - SWOT analysis
Figure 62: Drug assessment summary for Risperdal Consta in bipolar disorder
Figure 63: Drug assessment summary for Risperdal Consta in bipolar disorder
Figure 64: Saphris for bipolar disorder - SWOT analysis
Figure 65: Drug assessment summary for Saphris in bipolar disorder
Figure 66: Drug assessment summary for Saphris in bipolar disorder
Figure 67: Seroquel/Seroquel XR for bipolar disorder - SWOT analysis
Figure 68: Drug assessment summary for Seroquel/Seroquel XR in bipolar disorder
Figure 69: Drug assessment summary for Seroquel/Seroquel XR in bipolar disorder
Figure 70: Vraylar for bipolar disorder - SWOT analysis
Figure 71: Drug assessment summary for Vraylar in bipolar disorder
Figure 72: Drug assessment summary for Vraylar in bipolar disorder
Figure 73: Zyprexa for bipolar disorder - SWOT analysis
Figure 74: Drug assessment summary for Zyprexa in bipolar disorder
Figure 75: Drug assessment summary for Zyprexa in bipolar disorder
Figure 76: ALKS 3831 for bipolar disorder - SWOT analysis
Figure 77: Rexulti for bipolar disorder - SWOT analysis
Figure 78: Lumateperone for bipolar disorder - SWOT analysis
Figure 79: Drug assessment summary for lumateperone in bipolar disorder
Figure 80: Drug assessment summary for lumateperone in bipolar disorder

List of Tables
Table 1: Bipolar disorder market sales across the US, Japan, and five major EU markets, by country ($m), 2017-26
Table 2: Bipolar disorder market sales across the US, Japan, and five major EU markets, by disease phase and line of therapy ($m), 2017-26
Table 3: Bipolar disorder market sales across the US, Japan, and five major EU markets, by drug class ($m), 2017-26
Table 4: Sales of selected competing LAI brands across the US, Japan, and five major EU markets ($m), 2017-26
Table 5: Sales of selected competing bipolar depression brands across the US, Japan, and five major EU markets ($m), 2017-26
Table 6: Summary of drug classes and molecules included in the author’s bipolar disorder patient-based forecast
Table 7: Exchange rates used for calculating prices
Table 8: Estimated patent expiry/loss of exclusivity dates for key marketed brands in bipolar disorder, by country, 2017-26
Table 9: Estimated launch and approval dates for key products in bipolar disorder, by country, 2017-26
Table 10: Abilify sales for bipolar disorder across the US, Japan, and five major EU markets, by country ($m), 2017-26
Table 11: Abilify Maintena sales for bipolar disorder across the US, Japan, and five major EU markets, by country ($m), 2017-26
Table 12: Geodon/Zeldox sales for bipolar disorder across the US, Germany, Italy, and Spain, by country ($m), 2017-26
Table 13: Lamictal/Lamictal XR sales for bipolar disorder across the US, Japan, and five major EU markets, by country ($m), 2017-26
Table 14: Latuda sales for bipolar disorder across the US, Japan, Germany, Italy, Spain, and the UK, by country ($m), 2017-26
Table 15: Lumateperone sales for bipolar disorder in the US ($m), 2017-26
Table 16: Risperdal Consta sales for bipolar disorder across the US, Japan, and major EU markets, by country ($m), 2017-26
Table 17: Saphris/Sycrest sales for bipolar disorder across the US, Japan, and major EU markets, by country ($m), 2017-26
Table 18: Seroquel/Seroquel XR sales for bipolar disorder across the US, Japan, and five major EU markets, by country ($m), 2017-26
Table 19: Vraylar sales for bipolar disorder in the US and five major EU markets, by country ($m), 2017-26
Table 20: Zyprexa sales for bipolar disorder across the US, Japan, and five major EU markets, by country ($m), 2017-26
Table 21: Physicians surveyed for the bipolar disorder primary research study, 2017
Table 22: Physicians surveyed for the bipolar disorder primary research study, 2017
Table 23: Diagnosis rates for bipolar disorder in the US, Japan, and five major EU markets (%), by country
Table 24: Segmentation of bipolar disorder patients by disease phase in the US, Japan, and five major EU markets (%), by country
Table 25: Segmentation of bipolar disorder patients by disease phase and line of therapy in the US, Japan, and five major EU markets (%), by country
Table 26: Drug treatment rate for bipolar disorder in the US, Japan, and five major EU markets (%), by country and disease phase
Table 27: Leading therapies for bipolar disorder
Table 28: Leading class regimens according to patient share across the US, Japan, and five major EU markets (%), by bipolar disorder disease phase and line of therapy
Table 29: Leading drug treatments according to patient share across the US, Japan, and five major EU markets (%), by bipolar disorder disease phase and line of therapy
Table 30: Monotherapy and combination therapy use of lithium across the US, Japan, and five major EU markets (%), by bipolar disorder disease phase and line of therapy
Table 31: First-line drug treatments for mania in the US, Japan, and five major EU markets (%), by country
Table 32: Second-line and beyond drug treatments for mania in the US, Japan, and five major EU markets (%), by country
Table 33: First-line drug treatments for depression in the US, Japan, and five major EU markets (%), by country
Table 34: Second-line and beyond drug treatments for bipolar depression in the US, Japan, and five major EU markets (%), by country
Table 35: First-line drug treatments for maintenance therapy in the US, Japan, and five major EU markets (%), by country
Table 36: Second-line and beyond drug treatments for maintenance therapy in the US, Japan, and five major EU markets (%), by country
Table 37: Compliance rates of bipolar disorder patients in the US, Japan, and five major EU markets (%), by country and disease phase
Table 38: DSM-IV definitions of bipolar disorder subtypes
Table 39: Sources used for the epidemiological analysis of bipolar disorder in the US, Japan, and five major EU markets, by country
Table 40: Sources not used for the epidemiological analysis of bipolar disorder in the US, Japan, and five major EU markets, by country
Table 41: Total prevalent cases of bipolar I disorder in the US, Japan, and five major EU markets, by country, 2016-36
Table 42: Age-specific total prevalent cases of bipolar I disorder in the US, Japan, and five major EU markets, by country, 2016
Table 43: Gender-specific total prevalent cases of bipolar I disorder in the US, Japan, and five major EU markets, by country, 2016
Table 44: Total prevalent cases of bipolar II disorder in the US, Japan, and five major EU markets, by country, 2016-36
Table 45: Age-specific total prevalent cases of bipolar II disorder in the US, Japan, and five major EU markets, by country, 2016
Table 46: Gender-specific total prevalent cases of bipolar II disorder in the US, Japan, and five major EU markets, by country, 2016
Table 47: Prevalence of psychiatric co-morbidities among patients with bipolar disorder, by type
Table 48: Total prevalent cases of bipolar I disorder with psychiatric co-morbidities in the US, Japan, and five major EU markets, by country and type, 2016
Table 49: Total prevalent cases of bipolar II disorder with psychiatric co-morbidities in the US, Japan, and five major EU markets, by country and type, 2016
Table 50: Prevalence of medical co-morbidities among patients with bipolar disorder, by co-morbidity
Table 51: Total prevalent cases of bipolar I disorder with medical co-morbidities in the US, Japan, and five major EU markets, by country and co-morbidity, 2016
Table 52: Total prevalent cases of bipolar II disorder with medical co-morbidities in the US, Japan, and five major EU markets, by country and co-morbidity, 2016
Table 53: Key marketed drugs for bipolar disorder
Table 54: Abilify bipolar disorder indication approvals
Table 55: Abilify drug profile
Table 56: Overview of key clinical trial data for Abilify in bipolar disorder
Table 57: Commonly observed adverse reactions in clinical trials of Abilify in bipolar mania
Table 58: Abilify Maintena bipolar disorder indication approvals
Table 59: Abilify Maintena drug profile
Table 60: Overview of key clinical trial data for Abilify Maintena in bipolar disorder
Table 61: Commonly observed adverse reactions in clinical trials of Abilify Maintena in bipolar I disorder
Table 62: Geodon bipolar disorder indication approvals
Table 63: Geodon drug profile
Table 64: Overview of key clinical trial data for Geodon in bipolar disorder
Table 65: Treatment-emergent adverse reactions in =5% of Geodon-treated adult patients with bipolar mania in doubleblind, placebo-controlled trials
Table 66: Geodon ongoing late-phase clinical trials as a therapy in children and adolescents with bipolar I disorder
Table 67: Overview of key clinical trial data for Geodon in bipolar depression
Table 68: Lamictal bipolar disorder indication approvals
Table 69: Lamictal drug profile
Table 70: Overview of clinical trial data for Lamictal in maintenance treatment of adults with bipolar I disorder
Table 71: Key side effects reported in clinical trials of Lamictal as a maintenance therapy in adults with bipolar I disorder
Table 72: Selected clinical trials of Lamictal in bipolar depression
Table 73: Latuda bipolar disorder indication approvals
Table 74: Latuda drug profile
Table 75: Overview of pivotal Phase III PREVAIL trials of Latuda in adults with bipolar depression
Table 76: Adverse reactions in =5% of Latuda-treated adult patients in bipolar depression studies
Table 77: Overview of the Phase III ILLUMINATE trial of Latuda in adolescents and children with bipolar depression
Table 78: Adverse reactions in =5% of Latuda-treated pediatric patients in bipolar depression studies
Table 79: Overview of key Japanese clinical trial data for Latuda in bipolar disorder
Table 80: Overview of clinical trial data for Latuda in maintenance treatment of bipolar I disorder
Table 81: Risperdal Consta bipolar disorder indication approvals
Table 82: Risperdal Consta drug profile
Table 83: Risperdal Consta pivotal trial data in bipolar disorder
Table 84: Adverse reactions in =5% of Risperdal Consta-treated adult patients with bipolar disorder
Table 85: Saphris bipolar disorder indication approvals
Table 86: Saphris drug profile
Table 87: Saphris pivotal trial data for the acute treatment of manic episodes in bipolar disorder
Table 88: Adverse events in =5% of Saphris-treated adult patients with bipolar mania in double-blind, placebo-controlled trials
Table 89: Adverse events in =5% of Saphris-treated adult patients with bipolar mania in a double-blind, placebo-controlled trial
Table 90: Trial data for Saphris as a maintenance therapy
Table 91: Overview of key pivotal trial data for Saphris in pediatric bipolar disorder patients
Table 92: Adverse reactions in =5% of Saphris-treated pediatric patients (10-17 years) with bipolar mania in a double-blind, placebo-controlled trial
Table 93: Seroquel/Seroquel XR bipolar disorder indication approvals
Table 94: Seroquel/Seroquel XR drug profile
Table 95: Overview of key pivotal trial data for Seroquel in adult bipolar disorder patients
Table 96: Adverse reactions in =5% of Seroquel-treated adult patients in Phase III trials for bipolar disorder
Table 97: Overview of key pivotal trial data for Seroquel in pediatric bipolar disorder patients
Table 98: Overview of key pivotal trial data for Seroquel XR in adult bipolar disorder
Table 99: Key side effects (=5%) reported in clinical trials of Seroquel XR in bipolar disorder
Table 100: Vraylar bipolar disorder indication approvals
Table 101: Vraylar drug profile
Table 102: Overview of key pivotal trial data for Vraylar in bipolar disorder
Table 103: Key side effects (=5%) reported in clinical trials of Vraylar monotherapy for bipolar mania
Table 104: Vraylar Phase III trials in bipolar depression
Table 105: Zyprexa bipolar disorder indication approvals
Table 106: Zyprexa drug profile
Table 107: Overview of key pivotal trial data for Zyprexa in bipolar disorder
Table 108: Adverse reactions reported in =5% of patients in six-week clinical trials of Zyprexa as an adjunct to lithium or valproate in adult bipolar disorder (manic/mixed episodes)
Table 109: Key side effects reported in clinical trials of Zyprexa in bipolar disorder
Table 110: Profiled pipeline products in development for bipolar disorder
Table 111: ALKS 3831 drug profile
Table 112: ALKS 3831 Phase III trials in bipolar disorder
Table 113: Rexulti drug profile
Table 114: Rexulti Phase III trials in bipolar mania
Table 115: Rexulti Phase IV trial in bipolar depression
Table 116: Lumateperone drug profile
Table 117: Lumateperone Phase III trials in bipolar disorder
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