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PharmaPoint: Schizophrenia - Global Drug Forecast and Market Analysis to 2022
Publication Date Feb 2014
Publisher GlobalData
Product Type Report
Pages 250
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Schizophrenia is a persistent long-term brain disorder that causes severe, debilitating psychotic episodes. Its core symptoms, auditory or visual hallucinations, are often accompanied by fixed, false, and often paranoid beliefs, called delusions. These two features are often combined with learning and cognitive deficits. WHO experts have estimated that roughly 24 million people are affected by schizophrenia worldwide. While the arrival of atypical antipsychotics has greatly expanded pharmacologic treatment options over the past two decades, the current drug market does not treat the negative and cognitive symptoms that are associated with the disease. GlobalData expects that the growing popularity of long-acting injectable (LAI) antipsychotics, along with the arrival of novel treatments that achieve higher efficacy in negative- and cognitive-predominant patients, will serve to stimulate growth in the marketplace over the forecast period. Country-specific treatment recommendations and policy implementation will be an essential metric for determining future mental health services in the 7MM.

Scope
Overview of schizophrenia, including etiology, general symptoms, and country-specific treatment recommendations and compliance data.
Annualized schizophrenia market revenue, annual cost of vaccination and treatment usage pattern data from 2012 and forecast for ten years to 2022.
Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the schizophrenia market.
Pipeline analysis: comprehensive data split across different phases and emerging trends, specifically as Otsuka/Lundbeck’s Abilify Maintena and Alkermes’ Aripiprazole lauroxil.
Analysis of the current and future market competition in the global schizophrenia drug market. Insightful review of the key industry and governmental drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.
Market Model Features
An interactive excel forecast model based on primary research interviews and surveys with KOLs and high-prescribing physicians is included in this report*. This patient based model provides diagnosis rates, patient segmentation, treatment rates, annual costs of therapy , and indication-specific drug sales for the 10 year forecast period. The forecast model is robust, fully transparent, and easy to navigate. Moreover, our models support data presented in the reports and the complete methodology is outlined in the report and the model.

Key Findings
Country-specific mental health policy heavily influences antipsychotics prescribing patterns and sales in the marketplace.
The impact of negative and cognitive symptom therapies in the marketplace will be challenging without the use of biomarkers and laboratory measurements that can demonstrate a patient’s response to treatment.
Patient and prescriber endorsements of new and existing LAIs, in particular, atypical LAI antipsychotics, are anticipated to dramatically influence market growth.
Major players will leverage their R&D, manufacturing, and distribution networks to maintain their stakes in the market.

Key Benefits
Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
Develop business strategies by understanding the trends shaping and driving the schizophrenia market.
Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global schizophrenia market in the future.
Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
Track drug sales in the global schizophrenia market from 2012-2022.
Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Key Questions Answered in this Report
What are the preferred antipsychotic therapies for each country?
The developmental pipeline consists of LAI antipsychotics that address medication compliance concerns. Which of these LAIs will attain high sales revenues during 2012-2022 and in which markets?
Will LAI antipsychotics face adoption challenges in the market? What is the projected uptake of new LAIs, such as Otsuka/Lundbeck’s Abilify Maintena and Alkermes’ Aripiprazole lauroxil, over the forecast period?
How large an impact will bitopertin and EVP-6124 have on the schizophrenia market? What do key opinion leaders think of these treatment approaches?
What governmental and industry developments are likely to affect healthcare access and treatment rates in the markets researched? Which is the largest growth market globally?

Companies Mentioned
Otsuka
Lundbeck
Bristol-Myers Squibb
Merck
Forest
Vanda
Novartis
Sunovion
Eli Lilly
Johnson & Johnson
AstraZeneca
Alkermes
Pfizer
Roche
EnVivo

Table of Contents
1    Table of Contents    9

1.1    List of Tables    15

1.2    List of Figures    21

2    Introduction    22

2.1    Catalyst    22

2.2    Related Reports    22

2.3    Upcoming Reports    22

3    Disease Overview    23

3.1    Etiology and Pathophysiology    23

3.1.1    Etiology    23

3.1.2    Pathophysiology    24

3.2    Symptoms    25

4    Epidemiology    26

4.1    Disease Background    26

4.2    Risk Factors and Comorbidities    27

4.2.1    Psychiatric illness in first-degree relatives is a strong predictor of schizophrenia    28

4.2.2    Advancing paternal age increases the risk of schizophrenia in offspring    29

4.2.3    Psychiatric comorbidities are common in patients with schizophrenia    31

4.2.4    People with schizophrenia suffer from several medical comorbidities    31

4.3    Global Trends    34

4.3.1    US    36

4.3.2    5EU    37

4.3.3    Japan    40

4.4    Forecast Methodology    41

4.4.1    Sources Used    41

4.4.2    Sources Not Used    44

4.4.3    Forecast Assumptions and Methods, Prevalent Cases    44

4.5    Epidemiological Forecast of Schizophrenia (2012–2022)    46

4.5.1    Diagnosed Prevalent Cases of Schizophrenia    46

4.5.2    Age-Specific Prevalent Cases of Schizophrenia    48

4.5.3    Sex-Specific Prevalent Cases of Schizophrenia    49

4.5.4    Age-Standardized Diagnosed Prevalence of Schizophrenia    51

4.6    Discussion    52

4.6.1    Epidemiological Forecast Insight    52

4.6.2    Limitations of the Analysis    53

4.6.3    Strengths of the Analysis    54

5    Disease Management    55

5.1    Diagnosis    55

5.1.1    Subjective Assessments    56

5.1.2    Disease Subtypes    57

5.2    Treatment Overview    59

5.2.1    Treatment of Acute Agitation Associated with Schizophrenia    62

5.2.2    Maintenance Treatment of Schizophrenia    62

5.3    US    63

5.3.1    Diagnosis    63

5.3.2    Clinical Practice    64

5.4    France    65

5.4.1    Diagnosis    65

5.4.2    Clinical Practice    65

5.5    Germany    67

5.5.1    Diagnosis    67

5.5.2    Clinical Practice    67

5.6    Italy    68

5.6.1    Diagnosis    68

5.6.2    Clinical Practice    69

5.7    Spain    70

5.7.1    Diagnosis    70

5.7.2    Clinical Practice    70

5.8    UK    71

5.8.1    Diagnosis    71

5.8.2    Clinical Practice    71

5.9    Japan    72

5.9.1    Diagnosis    72

5.9.2    Clinical Practice    73

6    Competitive Assessment    75

6.1    Overview    75

6.2    Strategic Competitor Assessment    76

6.3    Product Profiles by Generation    77

6.3.1    Conventional Antipsychotics    77

6.3.2    Atypical Antipsychotics    81

7    Opportunity and Unmet Need    116

7.1    Unmet Needs Overview    116

7.1.1    Public Awareness    117

7.1.2    Early Diagnosis and Treatment    118

7.1.3    Long-Acting and Advanced Drug Delivery Systems    120

7.1.4    Effective Management of Negative and Cognitive Symptom Domains    121

7.2    Gap Analysis    121

7.2.1    Long-Acting Drug Delivery    122

7.2.2    Treatment of Negative and Cognitive Symptoms    122

8    Pipeline Assessment    124

8.1    Overview    124

8.2    Clinical Trial Mapping    124

8.2.1    Clinical Trials by Country    124

8.2.2    Clinical Trials by Phase and Trial Status    125

8.3    Early-Stage Pipeline Assessment    126

8.4    Novel Therapeutic Approaches    127

8.4.1    Negative Symptoms    128

8.4.2    Cognitive Symptoms    128

8.5    Long-Acting Drug Delivery    128

8.6    Technology Trends Analysis    129

8.7    Key Drugs in Clinical Development    129

8.7.1    Aripiprazole Lauroxil    132

8.7.2    Cariprazine    137

8.7.3    Brexpiprazole    141

8.7.4    Zicronapine    145

8.7.5    Bitopertin    148

8.7.6    EVP-6124    152

9    Current and Future Players    156

9.1    Overview    156

9.2    Trends in Corporate Strategy    157

9.3    Company Profiles    157

9.3.1    Janssen Pharmaceuticals    157

9.3.2    Eli Lilly and Company    160

9.3.3    Roche    162

9.3.4    Alkermes    164

9.3.5    EnVivo Pharmaceuticals    165

10    Market Outlook    168

10.1    Global Markets    168

10.1.1    Forecast    168

10.1.2    Global Drivers and Barriers    172

10.2    US    173

10.2.1    Forecast    173

10.2.2    Key Events    177

10.2.3    Drivers and Barriers    177

10.3    France    180

10.3.1    Forecast    180

10.3.2    Key Events    184

10.3.3    Drivers and Barriers    184

10.4    Germany    186

10.4.1    Forecast    186

10.4.2    Key Events    190

10.4.3    Drivers and Barriers    190

10.5    Italy    192

10.5.1    Forecast    192

10.5.2    Key Events    195

10.5.3    Drivers and Barriers    196

10.6    Spain    198

10.6.1    Forecast    198

10.6.2    Key Events    202

10.6.3    Drivers and Barriers    202

10.7    UK    203

10.7.1    Forecast    203

10.7.2    Key Events    207

10.7.3    Drivers and Barriers    207

10.8    Japan    209

10.8.1    Forecast    209

10.8.2    Key Events    213

10.8.3    Drivers and Barriers    213

11    Appendix    216

11.1    Bibliography    216

11.2    Abbreviations    228

11.3    Methodology    234

11.4    Forecasting Methodology    234

11.4.1    Diagnosis and Treatment Rates    234

11.4.2    Adherence Rates    235

11.4.3    Drugs Included in Each Therapeutic Class    235

11.4.4    Launch and Patent Expiry Dates    236

11.4.5    General Pricing Assumptions    237

11.4.6    Drug Assumptions    238

11.4.7    Generic Erosion    245

11.4.8    Pricing of Pipeline Agents    245

11.5    Key Opinion Leaders    247

11.6    About the Authors    248

11.6.1    Author    248

11.6.2    Epidemiology    248

11.6.3    Reviewers    249

11.6.4    Global Head of Healthcare    249

11.7    About GlobalData    249

11.8    Disclaimer    250


List Of Tables


Table 1: Symptom Clusters of Schizophrenia    25

Table 2: ICD-9 Codes and Classification of Schizophrenia    26

Table 3: Risk Factors and Comorbidities for Schizophrenia    28

Table 4: Prevalence of Most Frequent Comorbidities in People with Schizophrenia and People without Schizophrenia, Both Sexes, Ages =18 Years, 2007    32

Table 5: Prevalence of Most Frequent Comorbidities in People with Schizophrenia and People without Schizophrenia, 1996–2001    33

Table 6: Distribution of Estimates of Schizophrenia from Three Meta-Analysis Studies of Incidence, Prevalence, and Mortality, by Sex    35

Table 7: Trends in the Annual Incidence of Schizophrenia (per 100,000 Population), Portogruaro, Italy, 1982–1989    37

Table 8: Trends in the Prevalence of Schizophrenia (per 1,000 Population), Portogruaro, Italy, 1982–1989    38

Table 9: Trends in the Prevalence of Schizophrenia (per 1,000 Population), Japan, 1984–2008    40

Table 10: Sources of Schizophrenia Prevalence Data    41

Table 11: 7MM, Diagnosed Prevalent Cases of Schizophrenia, Both Sexes, Ages =15 Years, N, 2012–2022    46

Table 12: 7MM, Age-Specific Diagnosed Prevalent Cases of Schizophrenia, Both Sexes, N (Row %), 2012    48

Table 13: 7MM, Sex-Specific Diagnosed Prevalent Cases of Schizophrenia, Ages =15 Years, N (Row %), 2012    49

Table 14: Common Subjective Rating Scales Employed in Schizophrenia Diagnosis    57

Table 15: Development-Based Classification of Antipsychotic Drugs    60

Table 16: Receptor Binding Profiles of Atypical Antipsychotics    61

Table 17: Guidelines for the Treatment of Schizophrenia    61

Table 18: Leading Branded Treatments for Schizophrenia, 2013    76

Table 19: Chemical Classifications of FGAs    78

Table 20: Receptor Affinity Profiles for FGAs    79

Table 21: First-Generation Antipsychotics SWOT Analysis, 2013    80

Table 22: Global Sales Forecast ($m) for First-Generation Antipsychotics, 2012–2022    81

Table 23: Product Profile – Abilify    83

Table 24: Abilify SWOT Analysis, 2014    87

Table 25: Global Sales Forecast ($m) for Abilify, 2012–2022    87

Table 26: Product Profile – Saphris    88

Table 27: Saphris SWOT Analysis, 2013    90

Table 28: Global Sales Forecast ($m) for Saphris, 2012–2022    91

Table 29: Product Profile – Clozaril    92

Table 30: Clozaril SWOT Analysis, 2014    93

Table 31: Global Sales Forecast ($m) for Clozaril, 2012–2022    93

Table 32: Product Profile – Fanapt    94

Table 33: Fanapt SWOT Analysis, 2014    96

Table 34: Global Sales Forecast ($m) for Fanapt, 2012–2022    96

Table 35: Product Profile – Latuda    97

Table 36: Latuda SWOT Analysis, 2014    98

Table 37: Global Sales Forecasts ($m) for Latuda, 2012–2022    99

Table 38: Product Profile – Zyprexa    100

Table 39: Zyprexa SWOT Analysis, 2014    103

Table 40: Global Sales Forecast ($m) for Zyprexa, 2012–2022    103

Table 41: Product Profile – Invega    104

Table 42: Invega SWOT Analysis, 2013    106

Table 43: Global Sales Forecast ($m) for Invega, 2012–2022    106

Table 44: Product Profile – Seroquel    107

Table 45: Seroquel SWOT Analysis, 2013    108

Table 46: Global Sales Forecast ($m) for Seroquel, 2012–2022    109

Table 47: Product Profile – Risperdal    110

Table 48: Risperdal SWOT Analysis, 2013    111

Table 49: Global Sales Forecast ($m) for Risperdal, 2012–2022    112

Table 50: Product Profile – Geodon    113

Table 51: Geodon SWOT Analysis, 2013    114

Table 52: Global Sales Forecasts ($m) for Geodon, 2012–2022    114

Table 53: Unmet Needs – Current Level of Attainment    116

Table 54: Clinical Unmet Needs – Gap Analysis, 2013    122

Table 55: Schizophrenia – Clinical Trials by Phase and Status, 2013    125

Table 56: Technological Trends Analytic Framework in the Schizophrenia Pipeline, 2014    129

Table 57: Pipeline Candidates in Development for Schizophrenia, 2014    130

Table 58: Comparison of Novel Therapeutic Classes in Development for Schizophrenia, 2013    131

Table 59: Product Profile – Aripiprazole Lauroxil    132

Table 60: Aripiprazole Lauroxil SWOT Analysis, 2014    136

Table 61: Global Sales Forecast ($m) for Aripiprazole Lauroxil, 2012–2022    136

Table 62: Product Profile – Cariprazine    137

Table 63: Cariprazine SWOT Analysis, 2014    140

Table 64: Global Sales Forecast ($m) for Cariprazine, 2012–2022    141

Table 65: Product Profile – Brexpiprazole    142

Table 66: Brexpiprazole SWOT Analysis, 2014    143

Table 67: Global Sales Forecasts ($m) for Brexpiprazole, 2012–2022    144

Table 68: Product Profile – Zicronapine    145

Table 69: Zicronapine SWOT Analysis, 2014    147

Table 70: Global Sales Forecast ($m) for Zicronapine, 2012–2022    148

Table 71: Product Profile – Bitopertin    148

Table 72: Bitopertin SWOT Analysis, 2014    151

Table 73: Global Sales Forecast ($m) for Bitopertin, 2012–2022    151

Table 74: Product Profile – EVP-6124    152

Table 75: EVP-6124 SWOT Analysis, 2014    154

Table 76: Global Sales Forecast ($m) for EVP-6124, 2012–2022    154

Table 77: Janssen Schizophrenia Portfolio Assessment, 2014    159

Table 78: Janssen SWOT Analysis, 2014    159

Table 79: Eli Lilly Schizophrenia Portfolio Assessment, 2014    161

Table 80: Eli Lilly SWOT Analysis, 2014    162

Table 81: Roche Schizophrenia Portfolio Assessment, 2014    163

Table 82: Roche SWOT Analysis, 2014    163

Table 83: Alkermes Schizophrenia Portfolio Assessment, 2014    165

Table 84: Alkermes SWOT Analysis, 2014    165

Table 85: EnVivo Schizophrenia Portfolio Assessment, 2014    166

Table 86: EnVivo Pharmaceuticals SWOT Analysis, 2014    166

Table 87: Global Sales Forecast ($m) for Schizophrenia, 2012–2022    169

Table 88: Global Schizophrenia Market, Drivers and Barriers, 2012–2022    172

Table 89: Sales Forecast ($m) for Schizophrenia in the US, 2012–2022    174

Table 90: Key Events Impacting Sales for Schizophrenia in the US, 2012–2022    177

Table 91: Schizophrenia Market in the US – Drivers and Barriers, 2012–2022    177

Table 92: Sales Forecast ($m) for Schizophrenia in France, 2012–2022    181

Table 93: Key Events Impacting Sales for Schizophrenia in France, 2012–2022    184

Table 94: Schizophrenia Market in France – Drivers and Barriers, 2012–2022    184

Table 95: Sales Forecast ($m) for Schizophrenia in Germany, 2012–2022    187

Table 96: Key Events Impacting Sales for Schizophrenia in Germany, 2012–2022    191

Table 97: Schizophrenia Market in Germany – Drivers and Barriers, 2012–2022    191

Table 98: Sales Forecast ($m) for Schizophrenia in Italy, 2012–2022    194

Table 99: Key Events Impacting Sales for Schizophrenia in Italy, 2012–2022    197

Table 100: Schizophrenia Market in Italy – Drivers and Barriers, 2012–2022    197

Table 101: Sales Forecast ($m) for Schizophrenia in Spain, 2012–2022    200

Table 102: Key Events Impacting Sales for Schizophrenia in Spain, 2012–2022    203

Table 103: Schizophrenia Market in Spain – Drivers and Barriers, 2012–2022    203

Table 104: Sales Forecast ($m) for Schizophrenia in the UK, 2012–2022    205

Table 105: Key Events Impacting Sales for Schizophrenia in the UK, 2012–2022    208

Table 106: Schizophrenia Market in the UK – Drivers and Barriers, 2012–2022    208

Table 107: Sales Forecast ($m) for Schizophrenia in Japan, 2012–2022    210

Table 108: Key Events Impacting Sales for Schizophrenia in Japan, 2012–2022    214

Table 109: Schizophrenia Market in Japan – Drivers and Barriers, 2012–2022    214

Table 110: Key Launch Dates    237

Table 111: Key Patent Expirations    237

List Of Figures

Figure 1: 7MM, Diagnosed Prevalent Cases of Schizophrenia, Both Sexes, Ages =15 Years, N, 2012–2022    47

Figure 2: 7MM, Age-Specific Diagnosed Prevalent Cases of Schizophrenia, Both Sexes, N, 2012    49

Figure 3: 7MM, Sex-Specific Diagnosed Prevalent Cases of Schizophrenia, Ages =15 Years, N, 2012    50

Figure 4: 6MM, Age-Standardized Diagnosed Prevalence (%) of Schizophrenia, Ages =15 Years, by Sex, 2012    52

Figure 5: Strategic Competitor Assessment of the Marketed Products in Schizophrenia, 2014    77

Figure 6: Active Schizophrenia Clinical Trials by Location, 2014    125

Figure 7: Schizophrenia – Pipeline Drugs by Target, 2014    127

Figure 8: Competitive Assessment of Late-Stage Pipeline Agents in Schizophrenia, 2012–2022    131

Figure 9: Schizophrenia Therapeutics – Pipeline by Company, 2014    156

Figure 10: Global Schizophrenia Drug Sales by Region, 2012–2022    171

Figure 11: Sales for Schizophrenia in the US by Drug Class, 2012–2022    176

Figure 12: Sales for Schizophrenia in France by Drug Class, 2012–2022    183

Figure 13: Sales for Schizophrenia in Germany by Drug Class, 2012–2022    190

Figure 14: Sales for Schizophrenia in Italy by Drug Class, 2012–2022    196

Figure 15: Sales for Schizophrenia in Spain by Drug Class, 2012–2022    202

Figure 16: Sales for Schizophrenia in the UK by Drug Class, 2012–2022    207

Figure 17: Sales for Schizophrenia in Japan by Drug Class, 2012–2022    213

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