Schizophrenia - US Drug Forecast and Market Analysis to 2025

  • ID: 4032624
  • Report
  • Region: United States
  • 350 pages
  • GlobalData
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Schizophrenia - US 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.

The author estimates that drug sales for schizophrenia in the US reached $4.9 billion during 2015, making the US the largest market within the 7MM in this space. Sales are expected to initially decline to 2020 due to patent expiries of a number of brands during the forecast period, such as Otsuka’s Abilify and Abilify Maintena; Vanda Pharmaceuticals’ Fanapt; Janssen’s Invega Sustenna, Invega Trinza, and Risperdal; Dainippon Sumitomo’s Latuda; AstraZeneca’s Seroquel XR; and Eli Lilly’s Zyprexa Relprevv.

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 US including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for the top drugs in the US from 2015-2025.
- Analysis of the impact of key events as well the drivers and restraints affecting the US 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 US.
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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 US

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

5.3.1 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 US

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 the Author

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 - US

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 US, 2015-2025

Table 122: Schizophrenia Market in the US - 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 US by Drug Class, 2015-2025
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