PharmaPoint: Schizophrenia – Global Drug Forecast and Market Analysis to 2025

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.

Scope

Overview of schizophrenia, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.

Annualized schizophrenia market revenue, annual cost of therapy and treatment usage pattern data from 2015 and forecast for ten years to 2025.

Key topics covered include market characterization, unmet needs, R&D and clinical trials assessment, late stage clinical trial analysis and implications for the schizophrenia therapeutics market.

Pipeline analysis: focus on nine late-stage pipeline schizophrenia drugs, discussing emerging trends as well as an overview of earlier phase drugs.

Analysis of the current and future market competition in the global schizophrenia therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Key Highlights

The schizophrenia market is widely genericized and many of the unexpired patents are due to expire during the forecast period. In light of this, what are the current clinical and environmental unmet needs? Will there be opportunities in this market for drug developers throughout the forecast period?

There are five substantial unmet needs that exist in the schizophrenia market. Will pipeline drugs fulfil any of the unmet needs for schizophrenia? Which unmet needs will continue to provide opportunity for drug developers during the forecast period?

Out of the nine late-stage pipeline products, six of these are expected to launch during the forecast period to 2025. What impact will these drugs have on the market? How will they affect the treatment algorithm for schizophrenia?

Companies mentioned

Alexza Pharmaceuticals

Alkermes

Allergan

Almirall Prodesfarma

Astellas

AstraZeneca

Avanir Pharmaceuticals

Avineuro Pharmaceuticals

Braeburn Pharmaceuticals

Bristol-Myers Squibb

Dainippon Sumitomo/Sunovion

Eli Lilly

Epomedics

Ferrer

Gedeon Richter

HLS ...

Alexza Pharmaceuticals

Alkermes

Allergan

Almirall Prodesfarma

Astellas

AstraZeneca

Avanir Pharmaceuticals

Avineuro Pharmaceuticals

Braeburn Pharmaceuticals

Bristol-Myers Squibb

Dainippon Sumitomo/Sunovion

Eli Lilly

Epomedics

Ferrer

Gedeon Richter

HLS Therapeutics

Indivior

Intra-Cellular Therapies

Janssen

Laboratorios Farmaceuticos Rovi

Lundbeck

Meiji Seika

Merck & Co.

Minerva Neurosciences

Mitsubishi Tanabe Pharma

Neurocrine Biosciences

Nitto Denko Corporation

Novartis

Otsuka

Pfizer

Sandoz

Sanofi

SyneuRx

Takeda

Teva Pharmaceutical

Titan Pharmaceutical

Vanda Pharmaceuticals

Yoshitomi Yakuhin Corporation

Table of Contents

1Table of Contents

1.1List of Tables

1.2List of Figures

2Introduction

2.1Catalyst

2.2Related Reports

3Disease Overview

3.1Etiology and Pathophysiology

3.1.1Etiology

3.1.2Pathophysiology

3.2Classification

3.3Symptoms

3.4Course

3.5Prognosis

4Epidemiology ...

1Table of Contents

1.1List of Tables

1.2List of Figures

2Introduction

2.1Catalyst

2.2Related Reports

3Disease Overview

3.1Etiology and Pathophysiology

3.1.1Etiology

3.1.2Pathophysiology

3.2Classification

3.3Symptoms

3.4Course

3.5Prognosis

4Epidemiology

4.1Disease Background

4.2Risk Factors and Comorbidities

4.3Global Trends

4.3.1US

4.3.25EU

4.3.3Japan

4.4Forecast Methodology

4.4.1Sources Used

4.4.2Forecast Assumptions and Methods

4.4.3Sources Not Used

4.5Epidemiological Forecast for Schizophrenia (2015–2025)

4.5.112-Month Diagnosed Prevalent Cases of Schizophrenia

4.5.2Age-Specific 12-Month Diagnosed Prevalent Cases of Schizophrenia

4.5.3Sex-Specific 12-Month Diagnosed Prevalent Cases of Schizophrenia

4.5.4Age-Standardized 12-Month Diagnosed Prevalence of Schizophrenia

4.6Discussion

4.6.1Epidemiological Forecast Insight

4.6.2Limitations of the Analysis

4.6.3Strengths of the Analysis

5Disease Management

5.1Diagnosis Overview

5.1.1Clinical Evaluation

5.2Treatment Overview

5.2.1Treatment Initiation

5.2.2Maintenance Treatment

5.2.3Treatment of Breakthrough Episodes

5.2.4Long-Acting Injectables

5.2.5Treatment-Resistance

5.2.6Acute Agitation

5.2.7Adjunctive Psychotherapy

5.3Treatment Guidelines and Leading Prescribed Drugs

5.4US

5.55EU

5.6Japan

6Competitive Assessment

6.1Overview

6.2Product Profiles – Atypical Antipsychotics

6.2.1Abilify (aripiprazole)

6.2.2Aristada (aripiprazole lauroxil)

6.2.3Clozapine (widely genericized)

6.2.4Fanapt (iloperidone)

6.2.5Geodon (ziprasidone)

6.2.6Invega (paliperidone)

6.2.7Latuda (lurasidone)

6.2.8Lonasen (blonanserin)

6.2.9Rexulti (brexpiprazole)

6.2.10Risperdal (risperidone)

6.2.11Saphris (asenapine)

6.2.12Seroquel (quetiapine)

6.2.13Vraylar (cariprazine)

6.2.14Zyprexa (olanzapine)

6.3Product Profiles – Typical Antipsychotics

6.3.1Typical Antipsychotics

6.3.2Adasuve (Staccato loxapine)

6.4Other Therapeutic Classes

7Unmet Needs and Opportunities

7.1Overview

7.2Development of Cognitive-Enhancing Drugs

7.2.1Unmet Need

7.2.2Gap Analysis

7.2.3Opportunity

7.3Development of Drugs to Treat Negative Symptoms

7.3.1Unmet Need

7.3.2Gap Analysis

7.3.3Opportunity

7.4Improved Treatment Options for Treatment-Resistant Patients

7.4.1Unmet Need

7.4.2Gap Analysis

7.4.3Opportunity

7.5Development of Drugs with Enhanced Safety Profiles

7.5.1Unmet Need

7.5.2Gap Analysis

7.5.3Opportunity

7.6Development of Drugs to Increase Compliance

7.6.1Unmet Need

7.6.2Gap Analysis

7.6.3Opportunity

8Pipeline Assessment

8.1Overview

8.1.1Clinical Trials by Class of Therapy

8.2Promising Drugs in Clinical Development

8.2.1ALKS-3831

8.2.2ITI-007

8.2.3Lu AF35700

8.2.4MIN-101

8.2.5Risperidone implant

8.2.6Risperidone ISM

8.2.7RBP-7000

8.2.8AVN-211

8.2.9NaBen

8.3Other Drugs in Development

9Current and Future Players

9.1Overview

9.2Trends in Corporate Strategy

9.3Company Profiles

9.3.1Alkermes

9.3.2Dainippon Sumitomo

9.3.3Eli Lilly

9.3.4Intra-Cellular Therapies

9.3.5Janssen

9.3.6Lundbeck

9.3.7Minerva Neurosciences

9.3.8Otsuka

10Market Outlook

10.1Global Markets

10.1.1Forecast

10.1.2Drivers and Barriers – Global Issues

10.2US

10.2.1Forecast

10.2.2Key Events

10.2.3Drivers and Barriers

10.35EU

10.3.1Forecast

10.3.2Key Events

10.3.3Drivers and Barriers

10.4Japan

10.4.1Forecast

10.4.2Key Events

10.4.3Drivers and Barriers

11Appendix

11.1Bibliography

11.2Abbreviations

11.3Methodology

11.4Forecasting Methodology

11.4.1Diagnosed Schizophrenia Patients

11.4.2Percent Drug-Treated Patients

11.4.3Launch and Patent Expiry Dates

11.4.4General Pricing Assumptions

11.4.5Individual Drug Assumptions

11.4.6Generic Erosion

11.4.7Pricing of Pipeline Agents

11.5Primary Research – KOLs Interviewed for this Report

11.6Primary Research – Prescriber Survey

11.7About the Authors

11.7.1Analyst

11.7.2Therapy Area Director

11.7.3Epidemiologist

11.7.4Managing Epidemiologist

11.7.5Global Director of Therapy Analysis and Epidemiology

11.8About GlobalData

11.9Contact Us

11.10Disclaimer

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 ...

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: Risk Factors and Comorbidities for Schizophrenia

Table 6: 7MM, Sources of 12-Month Diagnosed Prevalence Data

Table 7: 7MM, 12-Month Diagnosed Prevalent Cases of Schizophrenia, Ages =13 Years, Both Sexes, N, Select Years, 2015–2025

Table 8: 7MM, Age-Specific 12-Month Diagnosed Prevalent Cases of Schizophrenia, Ages =13 Years, Both Sexes, N (Row %), 2015

Table 9: 7MM, Sex-Specific 12-Month Diagnosed Prevalent Cases of Schizophrenia, Ages =13 Years, N (Row %), 2015

Table 10: Treatment Guidelines for Schizophrenia

Table 11: Most Prescribed Drugs for Schizophrenia in the 7MM, 2015

Table 12: Country Profile – US

Table 13: Country Profile – 5EU

Table 14: Country Profile – Japan

Table 15: Leading Treatments for Schizophrenia, 2015

Table 16: Product Profile – Abilify

Table 17: Efficacy Results for Abilify in Schizophrenia Trials

Table 18: Efficacy Results for Abilify in Schizophrenia Trials

Table 19: AEs at =2% Incidence in Schizophrenia and Bipolar I Disorder Trials of Abilify

Table 20: AEs at =2% Incidence in a Schizophrenia Trial of Abilify Maintena

Table 21: Abilify SWOT Analysis, 2016

Table 22: Product Profile – Aristada

Table 23: Efficacy Results for Aristada in Schizophrenia Trial

Table 24: AEs at =2% Incidence in a Schizophrenia Trial of Aristada

Table 25: Aristada SWOT Analysis, 2016

Table 26: Product Profile – Clozapine

Table 27: Efficacy Results for Clozapine in Treatment-Resistant Schizophrenia Patients

Table 28: AEs at =5% Incidence in a Short-Term Trial of Clozapine

Table 29: AEs at =2% Incidence in All Clinical Trials of Clozapine (Excluding InterSePT)

Table 30: AEs at =10% Incidence During the InterSePT Trial of Clozapine

Table 31: Clozapine SWOT Analysis, 2016

Table 32: Product Profile – Fanapt

Table 33: AEs at =2% Incidence in Short-Term Trials of Fanapt

Table 34: Fanapt SWOT Analysis, 2016

Table 35: Product Profile – Geodon

Table 36: AEs at =2% Incidence in Schizophrenia Trials of Geodon

Table 37: Geodon SWOT Analysis, 2016

Table 38: Product Profile – Invega

Table 39: Efficacy of Invega Sustenna in Adult Schizophrenia Short-Term Trials

Table 40: AEs at =2% Incidence in Adult Schizophrenia Trials of Invega

Table 41: AEs at =2% Incidence in an Adolescent Schizophrenia Trial of Invega

Table 42: AEs at =2% Incidence in Schizophrenia Trials of Invega Sustenna

Table 43: AEs at =2% Incidence in a Long-Term Maintenance Trial of Invega Trinza in Schizophrenic Patients

Table 44: Invega SWOT Analysis, 2016

Table 45: Product Profile – Latuda

Table 46: Efficacy Results for Latuda in Schizophrenia Trials

Table 47: AEs at =2% Incidence in Schizophrenia Trials of Latuda

Table 48: Latuda SWOT Analysis, 2016

Table 49: Product Profile – Lonasen

Table 50: Efficacy Results for Lonasen in Haloperidol-Controlled Clinical Trial

Table 51: Efficacy Results for Lonasen in Risperidone-Controlled Clinical Trial

Table 52: AEs at =5% Incidence in a Short-Term Trial of Lonasen

Table 53: Lonasen SWOT Analysis, 2016

Table 54: Product Profile – Rexulti

Table 55: Efficacy Results for Rexulti in Short-Term Schizophrenia Trials

Table 56: AEs at =2% Incidence in Schizophrenia Trials of Rexulti

Table 57: Rexulti SWOT Analysis, 2016

Table 58: Product Profile – Risperdal

Table 59: Efficacy Results for Risperdal Consta in a 12-Week Schizophrenia Study

Table 60: AEs at =2% Incidence in Adult Schizophrenia Trials of Risperdal

Table 61: AEs at =5% Incidence in a Pediatric Schizophrenia Trial of Risperdal

Table 62: AEs at =5% Incidence in an Adult Schizophrenia Trial of Risperdal Consta

Table 63: Risperdal SWOT Analysis, 2016

Table 64: Product Profile – Saphris

Table 65: Efficacy Results for Saphris in Short-Term Schizophrenia Trials

Table 66: AEs at =2% Incidence in Schizophrenia Trials of Saphris

Table 67: Saphris SWOT Analysis, 2016

Table 68: Product Profile – Seroquel

Table 69: Efficacy Results for Seroquel in a Six-Week Schizophrenia Study

Table 70: Efficacy Results for Seroquel in Short-Term Schizophrenia Studies

Table 71: Efficacy Results for Seroquel XR in Schizophrenia Trials

Table 72: AEs at =2% Incidence in Adult Schizophrenia and Bipolar Mania Trials of Seroquel

Table 73: AEs at =2% Incidence in a Short-Term Trial of Seroquel in Schizophrenic Adolescents

Table 74: AEs at =2% Incidence in Six-Week Trials of Seroquel XR in Schizophrenic Adults

Table 75: Seroquel SWOT Analysis, 2016

Table 76: Product Profile – Vraylar

Table 77: Efficacy Results for Vraylar in a Six-Week Schizophrenia Study

Table 78: Efficacy Results for Vraylar in Short-Term Schizophrenia Studies

Table 79: AEs at =2% Incidence in Short-Term Schizophrenia Trials of Vraylar

Table 80: Vraylar SWOT Analysis, 2016

Table 81: Product Profile – Zyprexa

Table 82: AEs at =5% Incidence in Adult Schizophrenia Trials of Zyprexa

Table 83: AEs at =2% Incidence in Short-Term Trials of Zyprexa

Table 84: AEs at =1% Incidence in Adult Schizophrenia Trials of Zyprexa IntraMusular

Table 85: AEs at =5% Incidence in Adolescent Schizophrenia Trials of Zyprexa

Table 86: AEs Reported at =2% Incidence in a Schizophrenia Trial of Zyprexa Relprevv

Table 87: Zyprexa SWOT Analysis, 2016

Table 88: Typical antipsychotics SWOT Analysis, 2016

Table 89: Product Profile – Adasuve

Table 90: Efficacy Results for Adasuve in Agitation Trial of Schizophrenia Patients

Table 91: Decrease in FEV1 in Pulmonary Safety Trials of Adasuve

Table 92: Adasuve SWOT Analysis, 2016

Table 93: Summary of Minor Therapeutic Classes, 2015

Table 94: Unmet Need and Opportunity in Schizophrenia

Table 95: Product Profile – ALKS-3831

Table 96: ALKS-3831 SWOT Analysis, 2016

Table 97: Product Profile – ITI-007

Table 98: Efficacy Results for ITI-007 in a Phase II Schizophrenia Trial

Table 99: Key Safety Data From a Phase II in a Schizophrenia Trial of ITI-007

Table 100: ITI-007 SWOT Analysis, 2016

Table 101: Product Profile – Lu AF35700

Table 102: Lu AF35700 SWOT Analysis, 2016

Table 103: Product Profile – MIN-101

Table 104: Efficacy Results for MIN-101 in a 12-Week Phase IIb Schizophrenia Study

Table 105: Safety Evaluation of MIN-101 Phase IIa Clinical Trial in Schizophrenia

Table 106: AEs at =5% Incidence in a Phase IIb Schizophrenia Trial of MIN-101

Table 107: Safety Evaluation of MIN-101 Phase IIb Clinical Trial in Schizophrenia

Table 108: MIN-101 SWOT Analysis, 2016

Table 109: Product Profile – Risperidone Implant

Table 110: Risperidone Implant SWOT Analysis, 2016

Table 111: Product Profile – Risperidone ISM

Table 112: Risperidone ISM SWOT Analysis, 2016

Table 113: Product Profile – RBP-7000

Table 114: Efficacy Results for RBP-7000 in a Phase III Schizophrenia Trial

Table 115: AEs reported in a Phase III Schizophrenia Trial of RBP-7000A

Table 116: RBP-7000 SWOT Analysis, 2016

Table 117: Product Profile – AVN-211

Table 118: Attention tests and measures evaluated in a Phase IIa Schizophrenia Trial of AVN-211

Table 119: Psychometric Results in a Phase IIa Schizophrenia Trial of AVN-211

Table 120: Results of the Attention Measures that Showed Significant Changes in a Phase IIa Schizophrenia Trial of AVN-211

Table 121: AVN-211 SWOT Analysis, 2016

Table 122: Product Profile – NaBen

Table 123: PANSS Clinical Measures During the Phase II Trial of Sodium Benzoate Adjunctive Therapy in Schizophrenia

Table 124: Other Clinical Measures During the Phase II Trial of Sodium Benzoate Adjunctive Therapy in Schizophrenia

Table 125: Cognitive Measures During the Phase II Trial of Sodium Benzoate Adjunctive Therapy in Schizophrenia

Table 126: NaBen SWOT Analysis, 2016

Table 127: Drugs in Development for Schizophrenia, 2015

Table 128: Key Companies in the Schizophrenia Market in the 7MM, 2015

Table 129: Alkermes’ Schizophrenia Portfolio Assessment, 2015

Table 130: Alkermes SWOT Analysis in Schizophrenia, 2015–2025

Table 131: Dainippon Sumitomo’s Schizophrenia Portfolio Assessment, 2015

Table 132: Dainippon Sumitomo SWOT Analysis in Schizophrenia, 2015–2025

Table 133: Eli Lilly’s Schizophrenia Portfolio Assessment, 2015

Table 134: Eli Lilly SWOT Analysis in Schizophrenia, 2015–2025

Table 135: Intra-Cellular Therapies’ Schizophrenia Portfolio Assessment, 2015

Table 136: Intra-Cellular Therapies SWOT Analysis in Schizophrenia, 2015–2025

Table 137: Janssen’s Schizophrenia Portfolio Assessment, 2015

Table 138: Janssen SWOT Analysis in Schizophrenia, 2015–2025

Table 139: Lundbeck’s Schizophrenia Portfolio Assessment, 2015

Table 140: Lundbeck SWOT Analysis in Schizophrenia, 2015–2025

Table 141: Minerva Neurosciences’ Schizophrenia Portfolio Assessment, 2015

Table 142: Minerva Neurosciences SWOT Analysis in Schizophrenia, 2015–2025

Table 143: Otsuka’s Schizophrenia Portfolio Assessment, 2015

Table 144: Otsuka SWOT Analysis in Schizophrenia, 2015–2025

Table 145: Schizophrenia Market – Drivers and Barriers, 2015–2025

Table 146: Key Events Impacting Sales for Schizophrenia in the US, 2015–2025

Table 147: Schizophrenia Market in the US – Drivers and Barriers, 2015–2025

Table 148: Key Events Impacting Sales for Schizophrenia in the 5EU, 2015–2025

Table 149: Schizophrenia Market in the 5EU – Drivers and Barriers, 2015–2025

Table 150: Key Events Impacting Sales for Schizophrenia in Japan, 2015–2025

Table 151: Schizophrenia Market in Japan – Drivers and Barriers, 2015–2025

Table 152: Key Launch Dates

Table 153: Key Patent/Exclusivity Expiries

Table 154: High-Prescribing Psychiatrists (Non-KOLs) Surveyed, By Country

List of Figures

Figure 1: Longitudinal Course of Schizophrenia

Figure 2: 7MM, 12-Month Diagnosed Prevalent Cases of Schizophrenia, Ages =13 Years, Both Sexes, N, Select Years, 2015–2025

Figure ...

Figure 1: Longitudinal Course of Schizophrenia

Figure 2: 7MM, 12-Month Diagnosed Prevalent Cases of Schizophrenia, Ages =13 Years, Both Sexes, N, Select Years, 2015–2025

Figure 3: 7MM, Age-Specific 12-Month Diagnosed Prevalent Cases of Schizophrenia, Ages =13 Years, Both Sexes, N, 2015

Figure 4: 7MM, Sex-Specific 12-Month Diagnosed Prevalent Cases of Schizophrenia, Ages =13 Years, N, 2015

Figure 5: 7MM, Age-Standardized 12-Month Diagnosed Prevalence of Schizophrenia (Cases per 100,000 Population), Ages =13 Years, Both Sexes, 2015

Figure 6: Schizophrenia Therapeutics – Class of Therapy, 2016

Figure 7: Schizophrenia – Promising Late-Stage Phase IIb–III Pipeline Drugs, 2016

Figure 8: Competitive Assessment of Promising Late-Stage Pipeline Agents in Schizophrenia, 2015–2025

Figure 9: Clinical and Commercial Positioning of ALKS-3831

Figure 10: Clinical and Commercial Positioning of ITI-007

Figure 11: Clinical and Commercial Positioning of Lu AF35700

Figure 12: Clinical and Commercial Positioning of MIN-101

Figure 13: Clinical and Commercial Positioning of the Risperidone Implant

Figure 14: Clinical and Commercial Positioning of Risperidone ISM

Figure 15: Clinical and Commercial Positioning of RBP-7000

Figure 16: Clinical and Commercial Positioning of AVN-211

Figure 17: Clinical and Commercial Positioning of NaBen

Figure 18: Global Sales of Products for Schizophrenia by Company, 2015–2025

Figure 19: Company Portfolio Gap Analysis in Schizophrenia, 2015–2025

Figure 20: Global Sales for Schizophrenia by Region, 2015–2025

Figure 21: Global Sales for Schizophrenia by Drug Class, 2015–2025

Figure 22: Sales for Schizophrenia in the US by Drug Class, 2015–2025

Figure 23: Sales for Schizophrenia in the 5EU by Drug Class, 2015–2025

Figure 24: Sales for Schizophrenia in Japan by Drug Class, 2015–2025

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