The CNS Market Outlook to 2013: Competitive landscape, pipeline analysis and growth opportunities

The CNS Market Outlook to 2013: Competitive landscape, pipeline analysis and growth opportunities

The CNS disorders market is one of the largest and fastest growing markets in the pharmaceutical industry. Reimbursement terms continue to be favorable within the area, despite the relatively high risks associated with product development. This is largely due to significant levels of unmet medical need and the clinical specificity of many CNS drugs. High levels of investment have contributued to a rich product pipeline, with an estimated 600 clinical candidates currently under development, and companies are widely engaged in licensing novel/clinically differentiated CNS products. The sector has struggled recently however, with previously dominant product classes coming under increasing pressure from generic competition and safety concerns. ‘The CNS Market Outlook to 2013’ is a new report published by Business Insights that provides comprehensive coverage of the major markets within the global CNS disorders market, incorporating a detailed epidemiological analysis of major indications and key factors impacting their prevalence. This report profiles the factors and underlying trends shaping the market landscape and identifies the most promising areas of potential growth. Current leading brands of treatment within each indication are assessed and ten of the market’s leading players are profiled. Sales forecasts for currently marketed and key pipeline products over the 2008-13 period are also provided. Discover the key trends and growth drivers of the CNS market, assess the competitive dynamics of leading companies and evaluate the future prospects of pipeline products with this new report.

Table of Contents
The CNS Market Outlook to 2013
Executive Summary 14
Overview and epidemiology of CNS disorders 14
Global market analysis 14
Pipeline analysis 15
Competitive landscape 16
Chapter 1 Scope and methodology 20
Scope 20
Methodology 21
Chapter 2 Overview and epidemiology of
CNS disorders 24
Summary 24
Introduction 25
Schizophrenia 28
Overview 28
Epidemiology 30
Forecast epidemiology 31
Major depressive disorder 32
Overview 32
Epidemiology 35
Forecast epidemiology 36
Epilepsy 37
Overview 37
Epidemiology 38
Forecast epidemiology 39
Alzheimer’s disease 40
Overview 40
Epidemiology 43
Forecast epidemiology 44
iv
Insomnia 46
Overview 46
Epidemiology 47
Epidemiology 47
Parkinson’s disease 47
Overview 47
Epidemiology 48
Forecast epidemiology 50
Migraine 51
Overview 51
Epidemiology 53
Forecast epidemiology 53
Attention-deficit hyperactivity disorder 54
Overview 54
Epidemiology 56
Chapter 3 Global market analysis 58
Summary 58
Introduction 59
Market analysis by country 59
Licensing trends 60
Market analysis by indication 61
Leading brand dynamics 63
Key events in the CNS disorder market 64
Launch of first transdermal patch formulation of Novartis’ Exelon
for the treatment of AD 64
Once-Daily and long acting stimulants remain the gold standard in
the treatment of ADHD 65
Disappointing clinical results from bapineuzumab 65
Recall of Neupro in the US due to manufacturing problems 65
Spheramine fails to demonstrate efficacy in Phase IIb Parkinson's
disease study 66
GLP-1 may treat Parkinson’s disease 66
Acetyl cholinesterase inhibitors to remain the mainstay treatment
option for AD 67
Newer therapies in epilepsy prove efficacious in multiple CNS
disorder indications 67
FDA orders warning labels for antipsychotic drugs 67
Newer agents continue to dominate antipsychotic market 67
Label expansions for SSRIs provides an opportunity for growth and
differentiation 68
Schizophrenia 68
Market analysis 68
Leading brands in the schizophrenia market 70
v
Atypical antipsychotics 71
Key brand analysis 71
Schizophrenia sales forecast to 2013 76
Major depressive disorder (MDD) 77
Market analysis 77
Leading brands in the antidepressants market 78
Selective Serotonin Reuptake inhibitors 79
Market Dynamics 80
Key brand analysis 80
Selective Norepinephrine Reuptake Inhibitors 82
Market Dynamics 82
Key brand analysis 83
Antidepressants sales forecast to 2013 85
Epilepsy 86
Market analysis 86
Leading brands in the anti-epileptic market 87
Second generation anti-epileptics 88
Key brand analysis 88
Anti-epilepsy sales forecast to 2013 92
Alzheimer’s disease 93
Market analysis 93
Leading brands in the anti-Alzheimer’s market 94
Cholinesterase inhibitors market analysis 95
Market analysis 95
Key brand analysis 96
NMDA receptor antagonists market analysis 98
Key brand analysis 98
Anti-Alzheimer’s sales forecast to 2013 100
Insomnia 101
Market analysis 101
Non-benzodiazepines 103
Key brand analysis 103
Anti-insomnia sales forecast to 2013 106
Parkinson’s disease (PD) 107
Market analysis 107
Leading brands in the anti-parkinson’s market 108
COMT inhibitors 109
Key brand analysis 109
Dopamine agonists 110
Key brand analysis 110
Mono-amino oxidase (MAO) inhibitors 111
Key brand analysis 111
Anti-parkinson’s sales forecast to 2013 112
Migraine 113
Market analysis 113
Leading brands in the anti-migraine market 114
Triptans 115
Key brand analysis 115
Anti-migraine sales forecast to 2013 118
vi
Attention-deficit hyperactivity disorder (ADHD) 119
Market analysis 119
Leading brands in the ADHD market 120
Stimulants 121
Key brand analysis 121
Non-stimulants 122
Key brand analysis 122
ADHD sales forecast to 2013 123
Total CNS disorders’ sales forecast 124
Chapter 4 Pipeline analysis 128
Summary 128
Introduction 129
Key trends in R & D 130
Disease modifying agents hold promise in AD 131
Novel drugs with differentiated profiles represent a sizeable market
opportunity 131
New drug delivery formulations confer a competitive advantage 132
Combination drugs demonstrate advantages over individual components 132
CNS disorders pipeline 133
Leading drugs in development 136
Profiles of key pipeline products 137
Recently marketed drugs 137
Invega 137
Pristiq 140
Treximet 142
Vyvanse 144
Drugs in registration 146
Asenapine 146
Inovelon 148
Paliperidone Palmitate 149
Vimpat 151
Drugs in phase III clinical studies 152
Almorexant (ACT-078573) 152
Amibegron (SR-58611) 154
Bapineuzumab (AAB-001) 156
Eplivanserin (SR-46349) 158
Saredutant (SR-48968) 160
Semagacestat (LY-450139) 161
Telcagepant (MK-0974) 163
Pipeline forecast 166
vii
Chapter 5 Competitive landscape 170
Summary 170
Introduction 171
Sales performance of leading players 171
Detailed analysis of leading CNS players 178
Johnson & Johnson (J&J) 178
Overview 178
Sales focus by drug class 179
Marketed product portfolio 180
R&D pipeline analysis 181
Strategic and growth analysis 182
Eli Lilly 183
Overview 183
Sales focus by drug class 184
Marketed product portfolio 185
Marketed product portfolio: Strattera 186
R&D pipeline analysis 186
Strategic and growth analysis 187
GlaxoSmithKline (GSK) 188
Overview 188
Sales focus by drug class 188
Marketed product portfolio 190
R&D pipeline analysis 191
Strategic and growth analysis 192
Pfizer 193
Overview 193
Sales focus by drug class 193
Marketed product portfolio 194
R&D pipeline analysis 195
Strategic and growth analysis 197
AstraZeneca 198
Overview 198
Sales focus by drug class 198
Marketed product portfolio 200
R&D pipeline analysis 201
Strategic and growth analysis 202
Novartis 203
Overview 203
Sales focus by drug class 203
Marketed product portfolio 204
R&D pipeline analysis 205
Strategic and growth analysis 206
Sanofi-Aventis 207
Overview 207
Sales focus by drug class 207
Marketed product portfolio 208
R&D pipeline analysis 209
Strategic and growth analysis 211
viii
Wyeth 211
Overview 211
Sales focus by drug class 211
Marketed product portfolio 213
R&D pipeline analysis 213
Strategic and growth analysis 214
Forest 215
Overview 215
Sales focus by drug class 216
Marketed product portfolio 217
R&D pipeline analysis 217
Strategic and growth analysis 219
Eisai 219
Overview 219
Sales focus by drug class 219
Marketed product portfolio 221
R&D pipeline analysis 221
Strategic and growth analysis 222
Chapter 6 Appendix 226
IMS Data 226
N2C - Anti-Migraine preparations 226
N3A – Anti-Epileptics 226
N4A – Anti-Parkinson drugs 226
N5A – Antipsychotics 226
N5B – Hypnotics/Sedatives 226
N6A – Antidepressants 226
N6B - Psychostimulants 226
N7D - Anti-Alzheimer’s products 226
N7X – Other CNS drugs 226
Glossary 227
AD Assessment Scale cognition; (ADAS-cog) 227
ADHD-RS 227
Clinical Dementia Rating (CDR) scale 227
HAM-D17 227
Mini Mental State Exam (MMSE) 227
Neuropsychological Test Battery (NTB) 227
Personal and Social Performance Scale (PSP) 228
Positive and Negative Syndrome Scale for schizophrenia (PANSS) 228
List of Figures
Figure 2.1: Schizophrenia: classification of symptoms 29
Figure 2.2: Typical treatment patterns in the treatment of schizophrenia 30
ix
Figure 2.3: Different forms of epilepsy 37
Figure 2.4: Different stages of Alzheimer’s disease 42
Figure 2.5: Typical treatment patterns in the treatment of Alzheimer’s disease 43
Figure 2.6: Typical treatment patterns in the treatment of migraine 52
Figure 3.7: Global CNS market share by geography, 2007 59
Figure 3.8: Sales of types of CNS disorder brands, 2006–2007 60
Figure 4.9: Key trends in the R&D of CNS disorders, 2008 130
Figure 4.10: Leading recently launched products and late-stage R&D compounds indicated for the
treatment of CNS disorders, 2008 136
Figure 5.11: Market share of key players by sales value, 2007 173
Figure 5.12: Projected market share of key players by sales value, 2013 175
Figure 5.13: Market share and ranking of leading players in the global CNS disorders market,
2007–2013 176
Figure 5.14: J&J’s CNS portfolio sales by indication, 2007 179
Figure 5.15: Eli Lilly’s CNS portfolio sales by indication, 2007 184
Figure 5.16: GSK’s CNS portfolio sales by indication, 2007 189
Figure 5.17: Pfizer’s CNS portfolio sales by indication, 2007 194
Figure 5.18: AstraZeneca’s portfolio sales by indication, 2007 199
Figure 5.19: Novartis’ portfolio sales by indication, 2007 203
Figure 5.20: Sanofi-Aventis’ portfolio sales by indication, 2007 207
Figure 5.21: Wyeth’s portfolio sales by indication, 2007 212
Figure 5.22: Forest’s portfolio sales by indication, 2007 216
Figure 5.23: Eisai’s portfolio sales by indication, 2007 220
x
List of Tables
Table 2.1: Estimated prevalence of CNS disorders across the seven major 27
Table 2.2: Estimated prevalence of schizophrenia across the seven major markets, 2007 31
Table 2.3: Forecast epidemiology of schizophrenia across the seven major markets, 2007–2013 32
Table 2.4: Estimated prevalence of MDD across the seven major markets, 2007 35
Table 2.5: Estimated prevalence of MDD across the seven major markets, 2007 36
Table 2.6: Estimated prevalence of epilepsy across the seven major markets, 2007 39
Table 2.7: Forecast epidemiology of epilepsy across the seven major markets, 2007–2013 40
Table 2.8: Estimated prevalence of Alzheimer's disease across the seven major markets, 2007 44
Table 2.9: Forecast epidemiology of AD across the seven major markets, 2007–2013 45
Table 2.10: Estimated prevalence of insomnia across the seven major markets, 2007 47
Table 2.11: Estimated prevalence of Parkinson's disease across the seven major markets, 2007 49
Table 2.12: Estimated prevalence of Parkinson's disease across the seven major markets, 2007 50
Table 2.13: Estimated prevalence of migraine across the seven major markets, 2007 53
Table 2.14: Forecast epidemiology of migraine across the seven major markets, 2007–2013 54
Table 2.15: Estimated prevalence of ADHD in adults across the seven major markets, 2008 56
Table 2.16: Estimated prevalence of ADHD in children across the seven major markets, 2008 56
Table 3.17: Breakdown of the global CNS market by drug class, $m, 2006–2007 61
Table 3.18: Leading brands in the global CNS market, $m, 2006–2007 63
Table 3.19: Breakdown of the global schizophrenia market by drug class, $m, 2006–2007 69
Table 3.20: Leading antipsychotic medications in the CNS market, $m, 2006–2007 70
Table 3.21: Antipsychotic products sales forecast, $m, 2007–2013 76
Table 3.22: Breakdown of the global antidepressant market by drug class, $m, 2006–2007 77
Table 3.23: Leading antipsychotic medications in the CNS market, $m, 2006–2007 78
Table 3.24: Leading SSRIs in the MDD market, $m, 2006–2007 80
Table 3.25: Leading SNRIs in the MDD market, $m, 2006–2007 82
Table 3.26: Antidepressants sales forecast, $m, 2007–2013 85
Table 3.27: Global epilepsy market, $m, 2006–2007 86
Table 3.28: Leading anti-epileptic medications in the CNS market, $m, 2006–2007 87
Table 3.29: Anti-epileptics sales forecast, $m, 2007–2013 92
Table 3.30: Breakdown of the global anti-alzheimer’s market by drug class, $m, 2006–2007 93
Table 3.31: Leading anti-alzheimer drugs in the global CNS market by drug class, $m, 2006–2007
94
Table 3.32: Leading cholinesterase inhibitors in the global anti-alzheimer’s market by drug class,
$m, 2006–2007 95
Table 3.33: Leading NMDA receptor antagonists in the global anti-alzheimer’s market by drug
class, $m, 2006–2007 98
Table 3.34: Anti-alzheimer's products sales forecast, $m, 2007–2013 100
Table 3.35: Breakdown of the global insomnia market by drug class, $m, 2006–2007 101
Table 3.36: Leading insomnia drugs in the global CNS market by drug class, $m, 2006–2007 102
Table 3.37: Anti-insomnia products sales forecast, $m, 2007–2013 106
Table 3.38: Global anti-parkinson’s disease market, $m, 2006–2007 107
Table 3.39: Leading anti-parkinson drugs in the global CNS market by drug class, $m, 2006–2007
108
Table 3.40: Anti-parkinson drugs sales forecast, $m, 2007–2013 112
Table 3.41: Breakdown of the global anti-migraine market by drug class, $m, 2006–2007 113
Table 3.42: Leading anti-migraine medications in the CNS market, $m, 2006–2007 114
xi
Table 3.43: Anti-migraine products sales forecast, $m, 2007–2013 118
Table 3.44: Breakdown of the global ADHD market by drug class, $m, 2006–2007 119
Table 3.45: Leading ADHD medications in the CNS market, $m, 2006–2007 120
Table 3.46: Anti-ADHD products sales forecast, $m, 2007–2013 123
Table 3.47: CNS Market sales forecast by drug class, $m, 2007–2013 124
Table 4.48: CNS pipeline by indication and stage of development, 1H2008 133
Table 4.49: An overview of Invega 137
Table 4.50: An overview of Pristiq 140
Table 4.51: An overview of Treximet 142
Table 4.52: An overview of Vyvanse 144
Table 4.53: An overview of Asenapine 146
Table 4.54: An overview of Inovelon 148
Table 4.55: An overview of Paliperidone Palmitate 149
Table 4.56: An overview of Vimpat 151
Table 4.57: An overview of Almorexant (ACT-078573) 152
Table 4.58: An overview of Amibegron (SR-58611) 154
Table 4.59: An overview of Bapineuzumab (AAB-001) 156
Table 4.60: An overview of Eplivanserin (SR-46349) 158
Table 4.61: An overview of Saredutant (SR-48968) 160
Table 4.62: An overview of Semagacestat (LY-450139) 161
Table 4.63: An overview of Telcagepant (MK-0974) 163
Table 4.64: CNS disorders pipeline forecast, 2008–2013 ($m) 166
Table 5.65: Leading players in the global CNS disorders market, 2007–2013 ($m) 171
Table 5.66: J&J’s CNS product portfolio, 2006–2007 180
Table 5.67: J&J’s CNS R&D product pipeline, 2007 182
Table 5.68: Eli Lilly’s CNS product portfolio, 2006–2007 185
Table 5.69: Eli Lilly's CNS R&D product pipeline, 2007 187
Table 5.70: GSK’s CNS product portfolio, 2006–2007 190
Table 5.71: GSK's CNS R&D product pipeline, 2007 192
Table 5.72: Pfizer’s CNS product portfolio, 2006–2007 194
Table 5.73: Pfizer's CNS R&D product pipeline, 2007 197
Table 5.74: AstraZeneca’s CNS product portfolio, 2006–2007 200
Table 5.75: AstraZeneca's CNS R&D product pipeline, 2007 202
Table 5.76: Novartis’ CNS product portfolio, 2006–2007 204
Table 5.77: Novartis' CNS R&D product pipeline, 2007 206
Table 5.78: Sanofi-Aventis’ CNS product portfolio, 2006–2007 208
Table 5.79: Sanofi-Aventis' CNS R&D product pipeline, 2007 210
Table 5.80: Wyeth’s CNS product portfolio, 2006–2007 213
Table 5.81: Wyeth's CNS R&D product pipeline, 2007 214
Table 5.82: Forest’s CNS product portfolio, 2006–2007 217
Table 5.83: Forests' CNS R&D product pipeline, 2007 218
Table 5.84: Eisai’s CNS product portfolio, 2006–2007 221
Table 5.85: Eisai's CNS R&D product pipeline, 2007 222
12