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Schizophrenia - 5EU Drug Forecast and Market Analysis to 2025

Schizophrenia - 5EU Drug Forecast and Market Analysis to 2025

Summary

Schizophrenia is a heterogeneous behavioral and cognitive syndrome involving chronic or recurrent psychosis. The disorder is characterized by several symptom domains including positive symptoms (such as hallucinations or delusions and disorganized speech), negative symptoms (such as a flat affect and poverty of speech), and cognitive deficits (including attention, memory, and executive functions). A multitude of antipsychotic products are currently available for the pharmacological management of schizophrenia, many of which are already available as inexpensive generics. Further patent and exclusivity losses in key franchises throughout the forecast period will act as a barrier to growth in the 7MM, making the schizophrenia market more competitive and crowded. Growth in the schizophrenia market is expected to be driven by the potential introduction of six promising late-stage pipeline products into the market during the forecast period, all of which are directed towards significant unmet needs.

GlobalData estimates that drug sales for schizophrenia in the 5EU reached $806.5m in 2015. As with the US market, a number of brands available in the 5EU are expected to face generic erosion following patent expiry during the forecast period. The patents protecting Janssen’s Invega, Invega Sustenna (known as Xeplion within the 5EU), and Risperdal Consta; AstraZeneca’s Seroquel; Eli Lilly’s Zyprexa (known as Zypadhera); and Allergan’s Vraylar (marketed by Gedeon Richter in the 5EU) are all due to expire throughout the forecast period, leaving the 5EU to become widely genericized and limiting sales growth in these markets.

Scope

  • Overview of Schizophrenia including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
  • Detailed information on the key drugs in the 5EU including product description, safety and efficacy profiles as well as a SWOT analysis.
  • Sales forecast for the top drugs in the 5EU from 2015-2025.
  • Analysis of the impact of key events as well the drivers and restraints affecting the 5EU Schizophrenia market.
Reasons to buy
  • Understand and capitalize by identifying products that are most likely to ensure a robust return
  • Stay ahead of the competition by understanding the changing competitive landscape for Schizophrenia.
  • Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential
  • Make more informed business decisions from insightful and in-depth analysis of drug performance
  • Obtain sales forecast for drugs from 2015-2025 in the 5EU.


1 Table of Contents
1.1 List of Tables
1.2 List of Figures
2 Introduction
2.1 Catalyst
2.2 Related Reports
3 Disease Overview
3.1 Etiology and Pathophysiology
3.1.1 Etiology
3.1.2 Pathophysiology
3.2 Classification
3.3 Symptoms
3.4 Course
3.5 Prognosis
4 Disease Management
4.1 Diagnosis Overview
4.1.1 Clinical Evaluation
4.2 Treatment Overview
4.2.1 Treatment Initiation
4.2.2 Maintenance Treatment
4.2.3 Treatment of Breakthrough Episodes
4.2.4 Long-Acting Injectables
4.2.5 Treatment-Resistance
4.2.6 Acute Agitation
4.2.7 Adjunctive Psychotherapy
4.3 Treatment Guidelines and Leading Prescribed Drugs
4.4 5EU
5 Competitive Assessment
5.1 Overview
5.2 Product Profiles - Atypical Antipsychotics
5.2.1 Abilify (aripiprazole)
5.2.2 Aristada (aripiprazole lauroxil)
5.2.3 Clozapine (widely genericized)
5.2.4 Fanapt (iloperidone)
5.2.5 Geodon (ziprasidone)
5.2.6 Invega (paliperidone)
5.2.7 Latuda (lurasidone)
5.2.8 Lonasen (blonanserin)
5.2.9 Rexulti (brexpiprazole)
5.2.10 Risperdal (risperidone)
5.2.11 Saphris (asenapine)
5.2.12 Seroquel (quetiapine)
5.2.13 Vraylar (cariprazine)
5.2.14 Zyprexa (olanzapine)
5.3 Product Profiles - Typical Antipsychotics
15.3.1 Typical Antipsychotics
5.3.2 Adasuve (Staccato loxapine)
5.4 Other Therapeutic Classes
6 Unmet Needs and Opportunities
6.1 Overview
6.2 Development of Cognitive-Enhancing Drugs
6.2.1 Unmet Need
6.2.2 Gap Analysis
6.2.3 Opportunity
6.3 Development of Drugs to Treat Negative Symptoms
6.3.1 Unmet Need
6.3.2 Gap Analysis
6.3.3 Opportunity
6.4 Improved Treatment Options for Treatment-Resistant Patients
6.4.1 Unmet Need
6.4.2 Gap Analysis
6.4.3 Opportunity
6.5 Development of Drugs with Enhanced Safety Profiles
6.5.1 Unmet Need
6.5.2 Gap Analysis
6.5.3 Opportunity
6.6 Development of Drugs to Increase Compliance
6.6.1 Unmet Need
6.6.2 Gap Analysis
6.6.3 Opportunity
7 Pipeline Assessment
7.1 Overview
7.1.1 Clinical Trials by Class of Therapy
7.2 Promising Drugs in Clinical Development
7.2.1 ALKS-3831
7.2.2 ITI-007
7.2.3 Lu AF35700
7.2.4 MIN-101
7.2.5 Risperidone implant
7.2.6 Risperidone ISM
7.2.7 RBP-7000
7.2.8 AVN-211
7.2.9 NaBen
7.3 Other Drugs in Development
8 Market Outlook
8.1 5EU
8.1.1 Forecast
8.1.2 Key Events
8.1.3 Drivers and Barriers
9 Appendix
9.1 Bibliography
9.2 Abbreviations
9.3 Methodology
9.4 Forecasting Methodology
9.4.1 Diagnosed Schizophrenia Patients
9.4.2 Percent Drug-Treated Patients
9.4.3 Launch and Patent Expiry Dates
9.4.4 General Pricing Assumptions
9.4.5 Individual Drug Assumptions
9.4.6 Generic Erosion
9.4.7 Pricing of Pipeline Agents
9.5 Primary Research - KOLs Interviewed for this Report
9.6 Primary Research - Prescriber Survey
9.7 About the Authors
9.7.1 Analyst
9.7.2 Therapy Area Director
9.7.3 Epidemiologist
9.7.4 Managing Epidemiologist
9.7.5 Global Director of Therapy Analysis and Epidemiology
9.8 About GlobalData
9.9 Disclaimer
1.1 List of Tables
Table 1: DSM-V Schizophrenia Specifiers
Table 2: Classification of Schizophrenia According to DSM-IV and ICD-10
Table 3: Other Schizophrenia Spectrum Disorders, 2015
Table 4: Symptoms of Schizophrenia
Table 5: Treatment Guidelines for Schizophrenia
Table 6: Most Prescribed Drugs for Schizophrenia in the 7MM, 2015
Table 7: Country Profile - 5EU
Table 8: Leading Treatments for Schizophrenia, 2015
Table 9: Product Profile - Abilify
Table 10: Efficacy Results for Abilify in Schizophrenia Trials
Table 11: Efficacy Results for Abilify in Schizophrenia Trials
Table 12: AEs at ≥2% Incidence in Schizophrenia and Bipolar I Disorder Trials of Abilify
Table 13: AEs at ≥2% Incidence in a Schizophrenia Trial of Abilify Maintena
Table 14: Abilify SWOT Analysis, 2016
Table 15: Product Profile - Aristada
Table 16: Efficacy Results for Aristada in Schizophrenia Trial
Table 17: AEs at ≥2% Incidence in a Schizophrenia Trial of Aristada
Table 18: Aristada SWOT Analysis, 2016
Table 19: Product Profile - Clozapine
Table 20: Efficacy Results for Clozapine in Treatment-Resistant Schizophrenia Patients
Table 21: AEs at ≥5% Incidence in a Short-Term Trial of Clozapine
Table 22: AEs at ≥2% Incidence in All Clinical Trials of Clozapine (Excluding InterSePT)
Table 23: AEs at ≥10% Incidence During the InterSePT Trial of Clozapine
Table 24: Clozapine SWOT Analysis, 2016
Table 25: Product Profile - Fanapt
Table 26: AEs at ≥2% Incidence in Short-Term Trials of Fanapt
Table 27: Fanapt SWOT Analysis, 2016
Table 28: Product Profile - Geodon
Table 29: AEs at ≥2% Incidence in Schizophrenia Trials of Geodon
Table 30: Geodon SWOT Analysis, 2016
Table 31: Product Profile - Invega
Table 32: Efficacy of Invega Sustenna in Adult Schizophrenia Short-Term Trials
Table 33: AEs at ≥2% Incidence in Adult Schizophrenia Trials of Invega
Table 34: AEs at ≥2% Incidence in an Adolescent Schizophrenia Trial of Invega
Table 35: AEs at ≥2% Incidence in Schizophrenia Trials of Invega Sustenna
Table 36: AEs at ≥2% Incidence in a Long-Term Maintenance Trial of Invega Trinza in Schizophrenic Patients
Table 37: Invega SWOT Analysis, 2016
Table 38: Product Profile - Latuda
Table 39: Efficacy Results for Latuda in Schizophrenia Trials
Table 40: AEs at ≥2% Incidence in Schizophrenia Trials of Latuda
Table 41: Latuda SWOT Analysis, 2016
Table 42: Product Profile - Lonasen
Table 43: Efficacy Results for Lonasen in Haloperidol-Controlled Clinical Trial
Table 44: Efficacy Results for Lonasen in Risperidone-Controlled Clinical Trial
Table 45: AEs at ≥5% Incidence in a Short-Term Trial of Lonasen
Table 46: Lonasen SWOT Analysis, 2016
Table 47: Product Profile - Rexulti
Table 48: Efficacy Results for Rexulti in Short-Term Schizophrenia Trials
Table 49: AEs at ≥2% Incidence in Schizophrenia Trials of Rexulti
Table 50: Rexulti SWOT Analysis, 2016
Table 51: Product Profile - Risperdal
Table 52: Efficacy Results for Risperdal Consta in a 12-Week Schizophrenia Study
Table 53: AEs at ≥2% Incidence in Adult Schizophrenia Trials of Risperdal
Table 54: AEs at ≥5% Incidence in a Pediatric Schizophrenia Trial of Risperdal
Table 55: AEs at ≥5% Incidence in an Adult Schizophrenia Trial of Risperdal Consta
Table 56: Risperdal SWOT Analysis, 2016
Table 57: Product Profile - Saphris
Table 58: Efficacy Results for Saphris in Short-Term Schizophrenia Trials
Table 59: AEs at ≥2% Incidence in Schizophrenia Trials of Saphris
Table 60: Saphris SWOT Analysis, 2016
Table 61: Product Profile - Seroquel
Table 62: Efficacy Results for Seroquel in a Six-Week Schizophrenia Study
Table 63: Efficacy Results for Seroquel in Short-Term Schizophrenia Studies
Table 64: Efficacy Results for Seroquel XR in Schizophrenia Trials
Table 65: AEs at ≥2% Incidence in Adult Schizophrenia and Bipolar Mania Trials of Seroquel
Table 66: AEs at ≥2% Incidence in a Short-Term Trial of Seroquel in Schizophrenic Adolescents
Table 67: AEs at ≥2% Incidence in Six-Week Trials of Seroquel XR in Schizophrenic Adults
Table 68: Seroquel SWOT Analysis, 2016
Table 69: Product Profile - Vraylar
Table 70: Efficacy Results for Vraylar in a Six-Week Schizophrenia Study
Table 71: Efficacy Results for Vraylar in Short-Term Schizophrenia Studies
Table 72: AEs at ≥2% Incidence in Short-Term Schizophrenia Trials of Vraylar
Table 73: Vraylar SWOT Analysis, 2016
Table 74: Product Profile - Zyprexa
Table 75: AEs at ≥5% Incidence in Adult Schizophrenia Trials of Zyprexa
Table 76: AEs at ≥2% Incidence in Short-Term Trials of Zyprexa
Table 77: AEs at ≥1% Incidence in Adult Schizophrenia Trials of Zyprexa IntraMusular
Table 78: AEs at ≥5% Incidence in Adolescent Schizophrenia Trials of Zyprexa
Table 79: AEs Reported at ≥2% Incidence in a Schizophrenia Trial of Zyprexa Relprevv
Table 80: Zyprexa SWOT Analysis, 2016
Table 81: Typical antipsychotics SWOT Analysis, 2016
Table 82: Product Profile - Adasuve
Table 83: Efficacy Results for Adasuve in Agitation Trial of Schizophrenia Patients
Table 84: Decrease in FEV1 in Pulmonary Safety Trials of Adasuve
Table 85: Adasuve SWOT Analysis, 2016
Table 86: Summary of Minor Therapeutic Classes, 2015
Table 87: Unmet Need and Opportunity in Schizophrenia
Table 88: Product Profile - ALKS-3831
Table 89: ALKS-3831 SWOT Analysis, 2016
Table 90: Product Profile - ITI-007
Table 91: Efficacy Results for ITI-007 in a Phase II Schizophrenia Trial
Table 92: Key Safety Data From a Phase II in a Schizophrenia Trial of ITI-007
Table 93: ITI-007 SWOT Analysis, 2016
Table 94: Product Profile - Lu AF35700
Table 95: Lu AF35700 SWOT Analysis, 2016
Table 96: Product Profile - MIN-101
Table 97: Efficacy Results for MIN-101 in a 12-Week Phase IIb Schizophrenia Study
Table 98: Safety Evaluation of MIN-101 Phase IIa Clinical Trial in Schizophrenia
Table 99: AEs at ≥5% Incidence in a Phase IIb Schizophrenia Trial of MIN-101
Table 100: Safety Evaluation of MIN-101 Phase IIb Clinical Trial in Schizophrenia
Table 101: MIN-101 SWOT Analysis, 2016
Table 102: Product Profile - Risperidone Implant
Table 103: Risperidone Implant SWOT Analysis, 2016
Table 104: Product Profile - Risperidone ISM
Table 105: Risperidone ISM SWOT Analysis, 2016
Table 106: Product Profile - RBP-7000
Table 107: Efficacy Results for RBP-7000 in a Phase III Schizophrenia Trial
Table 108: AEs reported in a Phase III Schizophrenia Trial of RBP-7000A
Table 109: RBP-7000 SWOT Analysis, 2016
Table 110: Product Profile - AVN-211
Table 111: Attention tests and measures evaluated in a Phase IIa Schizophrenia Trial of AVN-211
Table 112: Psychometric Results in a Phase IIa Schizophrenia Trial of AVN-211
Table 113: Results of the Attention Measures that Showed Significant Changes in a Phase IIa Schizophrenia Trial of AVN-211
Table 114: AVN-211 SWOT Analysis, 2016
Table 115: Product Profile - NaBen
Table 116: PANSS Clinical Measures During the Phase II Trial of Sodium Benzoate Adjunctive Therapy in Schizophrenia
Table 117: Other Clinical Measures During the Phase II Trial of Sodium Benzoate Adjunctive Therapy in Schizophrenia
Table 118: Cognitive Measures During the Phase II Trial of Sodium Benzoate Adjunctive Therapy in Schizophrenia
Table 119: NaBen SWOT Analysis, 2016
Table 120: Drugs in Development for Schizophrenia, 2015
Table 121: Key Events Impacting Sales for Schizophrenia in the 5EU, 2015-2025
Table 122: Schizophrenia Market in the 5EU - Drivers and Barriers, 2015-2025
Table 123: Key Launch Dates
Table 124: Key Patent/Exclusivity Expiries
Table 125: High-Prescribing Psychiatrists (Non-KOLs) Surveyed, By Country
1.2 List of Figures
Figure 1: Longitudinal Course of Schizophrenia
Figure 2: Schizophrenia Therapeutics - Class of Therapy, 2016
Figure 3: Schizophrenia - Promising Late-Stage Phase IIb-III Pipeline Drugs, 2016
Figure 4: Competitive Assessment of Promising Late-Stage Pipeline Agents in Schizophrenia, 2015-2025
Figure 5: Clinical and Commercial Positioning of ALKS-3831
Figure 6: Clinical and Commercial Positioning of ITI-007
Figure 7: Clinical and Commercial Positioning of Lu AF35700
Figure 8: Clinical and Commercial Positioning of MIN-101
Figure 9: Clinical and Commercial Positioning of the Risperidone Implant
Figure 10: Clinical and Commercial Positioning of Risperidone ISM
Figure 11: Clinical and Commercial Positioning of RBP-7000
Figure 12: Clinical and Commercial Positioning of AVN-211
Figure 13: Clinical and Commercial Positioning of NaBen
Figure 14: Sales for Schizophrenia in the 5EU by Drug Class, 2015-2025

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