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PharmaPoint: Parkinson’s Disease - 5EU Drug Forecast and Market Analysis to 2022

Summary

Parkinson’s disease is a progressive condition that is characterized by bradykinesia, muscular rigidity, tremor, and postural instability. As the second most common neurodegenerative disorder, Parkinson’s disease may affect individuals of any age but prevalence is increased with age and it is most common in the elderly. Dopaminergic therapies have been fairly effective in treating bradykinesia, but several unmet needs remain. Some needs will be met during the forecast period from 2012-2022, while others, such as the need for disease-modifying drugs, will remain. GlobalData expects that advancements will be made in levodopa administration and that four new molecular entities will be introduced to the market by 2022, these factors along with increased patient numbers from an aging population will drive the market during the forecast period.

Although France has a lower-than-average rate of generic substitution compared with other parts of Europe, increasing pressures from its aging population and increased disease burden are forcing governments to institute cost-saving measures. The market leader therapies in Germany are all no longer patent protected and include the class of oral dopamine agonists. While the overall pharmaceutical market in Italy is shrinking, the medical device market in Italy is growing. This market growth will be driven by six new product launches, and by an aging population, resulting in an increased prevalence of Parkinson’s disease in Spain. Population growth and the aging population will continue to build steady growth in the UK Parkinson’s disease market and six additional product launches, including the introduction of A2A antagonists in 2019, will bring in an extra $24.7m in sales in 2022.

Scope

- Overview of Parkinson’s Disease 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 5EU including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for the top drugs in 5EU from 2012-2022.
- Analysis of the impact of key events as well the drivers and restraints affecting the 5EU Parkinson’s Disease 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 Parkinson’s Disease
- 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 2012-2022 in 5EU

Table Of Contents

PharmaPoint: Parkinson’s Disease - 5EU Drug Forecast and Market Analysis to 2022
1 Table of Contents

2 Introduction 16
2.1 Catalyst 16
2.2 Related Reports 16
3 Disease Overview 19
3.1 Etiology and Pathophysiology 19
3.1.1 Etiology 19
3.1.2 Pathophysiology 22
3.1.3 Prognosis 24
3.1.4 Quality of Life 25
3.2 Symptoms 25
4 Disease Management 27
4.1 Overview 27
4.1.1 Diagnosis - The UK Brain Bank Criteria 27
4.1.2 Treatment Guidelines and Leading Prescribed Drugs 28
4.2 Treatment Synopsis 30
4.2.1 Dopaminergic Therapy Classes 31
4.2.2 Treatment of Parkinson's disease by Stage 33
4.2.3 Other Treatment Options 36
4.3 Parkinson's Disease Assessment Scales 36
4.3.1 Unified Parkinson's Disease Rating Scale (UPDRS) 37
4.3.2 Hoehn and Yahr Clinical Staging 39
4.3.3 Other Clinical Assessments 40
4.4 Diagnosis and Treatment of Parkinson's Disease by Country 40
4.4.1 France 40
4.4.2 Germany 42
4.4.3 Italy 44
4.4.4 Spain 47
4.4.5 UK 49
5 Competitive Assessment 51
5.1 Overview 51
5.2 Strategic Competitor Assessment 53
5.3 Product Profiles - Levodopa Combination Therapy 54
5.3.1 Madopar (levodopa/benserazide) 54
5.3.2 Sinemet (carbidopa/levodopa) 58
5.3.3 Duodopa (carbidopa/levodopa intestinal gel) 61
5.4 Product Profiles - COMT Inhibitors 65
5.4.1 Stalevo/Comtan (entacapone) 65
5.5 Dopamine Agonists 70
5.5.1 Neupro (rotigotine transdermal patch) 71
5.5.2 Requip/Requip XL (ropinirole) 77
5.5.3 Apokyn (apomorphine) 81
5.6 Product Profiles - MAO-B Inhibitors 84
5.6.1 Azilect (rasagiline) 85
5.7 Product Profiles - Adenosine 2A Inhibitor 90
5.7.1 Nouriast (istradefylline) 91
5.8 Product Profiles - Other Therapies 94
6 Opportunity and Unmet Need 95
6.1 Overview 95
6.2 Treatment of Motor Complications - Dyskinesias and OFF Episodes 97
6.2.1 Unmet Need 97
6.2.2 Gap Analysis 99
6.2.3 Opportunity 101
6.3 Treatment of Non-Motor Symptoms and Dementia 102
6.3.1 Unmet Need 102
6.3.2 Gap Analysis 103
6.3.3 Opportunity 105
6.4 Neuroprotective/Disease-Modifying Agents 105
6.4.1 Unmet Need 105
6.4.2 Gap Analysis 106
6.4.3 Opportunity 109
6.5 Improved Drug Formulations 110
6.5.1 Unmet Need 110
6.5.2 Gap Analysis 110
6.5.3 Opportunity 111
6.6 Identification of Reliable Biomarkers 111
6.6.1 Unmet Need 111
6.6.2 Gap Analysis 112
6.6.3 Opportunity 113
6.7 Improved Clinical Trial Design 113
6.7.1 Unmet Need 113
6.7.2 Gap Analysis 114
6.7.3 Opportunity 114
7 Pipeline Assessment 115
7.1 Overview 115
7.2 Promising Drugs in Clinical Development 115
7.2.1 Safinamide 117
7.2.2 Tozadenant 123
7.2.3 CVT-301 127
7.2.4 Rytary/IPX066 132
7.2.5 Opicapone 138
7.2.6 Mavoglurant/AFQ056 142
7.2.7 CD/LD-GR 145
7.2.8 Other Late-Stage Pipeline Products 150
8 Current and Future Players 151
8.1 Overview 151
8.2 Trends in Corporate Strategy 152
8.3 Company Profiles 153
8.3.1 Merck 153
8.3.2 Roche 155
8.3.3 AbbVie 157
8.3.4 UCB 159
8.3.5 GlaxoSmithKline 160
8.3.6 Novartis 162
8.3.7 Orion 165
8.3.8 Newron 166
8.3.9 Civitas 168
8.3.10 Impax 170
8.3.11 Lundbeck 172
9 Market Outlook 175
9.1 Drivers and Barriers - Global Issues 175
9.1.1 Driver: Aging Population 175
9.1.2 Driver: Launch of Products that Will Add Patient Share 175
9.1.3 Driver: High Compliance Rates 176
9.1.4 Driver: History of Success in PD Market 176
9.1.5 Driver: Innovation and Technological Advances 176
9.1.6 Driver: High Degree of Polypharmacy 176
9.1.7 Barrier: Lack of Understanding of Pathophysiology 177
9.1.8 Barrier: Lack of Efficacy of New Compounds 177
9.1.9 Barrier: Strategic Decisions to Leave CNS Space for Several Large Pharma Companies 177
9.2 France 178
9.2.1 Forecast 178
9.2.2 Key Events 182
9.2.3 Drivers and Barriers 182
9.3 Germany 184
9.3.1 Forecast 184
9.3.2 Key Events 188
9.3.3 Drivers and Barriers 188
9.4 Italy 190
9.4.1 Forecast 190
9.4.2 Key Events 194
9.4.3 Drivers and Barriers 194
9.5 Spain 196
9.5.1 Forecast 196
9.5.2 Key Events 201
9.5.3 Drivers and Barriers 201
9.6 UK 203
9.6.1 Forecast 203
9.6.2 Key Events 207
9.6.3 Drivers and Barriers 207
10 Appendix 209
10.1 Bibliography 209
10.2 Abbreviations 224
10.3 Methodology 228
10.4 Forecasting Methodology 228
10.4.1 Diagnosed Parkinson's Disease Patients 228
10.4.2 Percent Drug-Treated Patients 229
10.4.3 Drugs Included in Each Therapeutic Class 229
10.4.4 Launch and Patent Expiry Dates 230
10.4.5 General Pricing Assumptions 231
10.4.6 Compliance Assumptions 232
10.4.7 Individual Drug Assumptions 233
10.4.8 Generic Erosion 243
10.4.9 Pricing of Pipeline Agents 243
10.5 Physicians and Specialists Included in this Study 244
10.6 About the Authors 246
10.6.1 Author 246
10.6.2 Global Head of Healthcare 247
10.7 About GlobalData 248
10.8 Disclaimer 248

1.1 List of Tables

Table 1: Symptoms of Parkinson's Disease 26
Table 2: UK Brain Bank Diagnostic Criteria 28
Table 3: Diagnosis and Treatment Guidelines for Parkinson's Disease 29
Table 4: Most Prescribed Drugs for Parkinson's Disease by Class in the Global Markets, 2014 30
Table 5: Dopaminergic Therapy in Parkinson's Disease 33
Table 6: UPDRS Clinical Assessment of Disease Severity 38
Table 7: Parkinson's Disease Assessment Scales Used in Clinical Trials 40
Table 8: Parkinson's Disease, Country Profile - France 42
Table 9: Parkinson's Disease, Country Profile - Germany 44
Table 10: Parkinson's Disease, Country Profile - Italy 46
Table 11: Parkinson's Disease, Country Profile - Spain 48
Table 12: Parkinson's Disease, Country Profile - UK 50
Table 13: Treatment of Motor Symptoms in Parkinson's Disease 52
Table 14: Leading Treatments for Parkinson's Disease, 2014 53
Table 15: Product Profile - Madopar 55
Table 16: Madopar SWOT Analysis, 2014 57
Table 17: Product Profile - Sinemet 59
Table 18: Sinemet SWOT Analysis, 2014 61
Table 19: Product Profile - Duodopa 62
Table 20: Duodopa SWOT Analysis, 2014 64
Table 21: Product Profile - Stalevo 67
Table 22: Product Profile - Comtan 68
Table 23: Stalevo/Comtan SWOT Analysis, 2014 70
Table 24: Product Profile - Neupro 73
Table 25: Neupro SWOT Analysis, 2014 77
Table 26: Product Profile - Requip/Requip XL 78
Table 27: Requip/Requip XL SWOT Analysis, 2014 80
Table 28: Product Profile - Apokyn 82
Table 29: Apokyn SWOT Analysis, 2014 84
Table 30: Product Profile - Azilect 86
Table 31: Azilect SWOT Analysis, 2014 90
Table 32: Product Profile - Nouriast 92
Table 33: Nouriast SWOT Analysis, 2014 93
Table 34: Summary of Alternative Parkinson's Disease Therapies 94
Table 35: Unmet Need and Opportunity in Parkinson's Disease 96
Table 36: Dyskinesia Pipeline, 2014 101
Table 37: Dementia Pipeline, 2014 104
Table 38: Parkinson's Disease-Modifying Therapeutics Pipeline, 2014 108
Table 39: Product Profile - Safinamide 119
Table 40: Summary of Relevant Clinical Trials for Safinamide 120
Table 41: Safinamide SWOT Analysis, 2014 123
Table 42: Product Profile - Tozadenant 125
Table 43: Tozadenant SWOT Analysis, 2014 127
Table 44: Product Profile - CVT-301 129
Table 45: CVT-301 SWOT Analysis, 2014 132
Table 46: Product Profile - Rytary 134
Table 47: Rytary SWOT Analysis, 2014 138
Table 48: Product Profile - Opicapone 139
Table 49: Opicapone SWOT Analysis, 2014 141
Table 50: Product Profile - Mavoglurant 143
Table 51: Mavoglurant SWOT Analysis, 2014 145
Table 52: Product Profile - CD/LD-GR 146
Table 53: Summary of Relevant Clinical Trials for CD/LD-GR 147
Table 54: CD/LD-GR SWOT Analysis, 2014 149
Table 55: Late-Stage Pipeline, 2013 150
Table 56: Key Companies in the Parkinson's Market, 2014 151
Table 57: Merck's Parkinson's Disease Portfolio Assessment, 2014 155
Table 58: Merck's PD SWOT Analysis, 2014 155
Table 59: Roche's Parkinson's Disease Portfolio Assessment, 2014 157
Table 60: Roche's PD SWOT Analysis, 2014 157
Table 61: AbbVie's Parkinson's Disease Portfolio Assessment, 2014 158
Table 62: AbbVie's PD SWOT Analysis, 2014 158
Table 63: UCB's Parkinson's Disease Portfolio Assessment, 2014 159
Table 64: UCB's PD SWOT Analysis, 2014 160
Table 65: GSK's Parkinson's Disease Portfolio Assessment, 2014 162
Table 66: GSK's PD SWOT Analysis, 2014 162
Table 67: Novartis' Parkinson's Disease Portfolio Assessment, 2014 164
Table 68: Novartis' PD SWOT Analysis, 2014 164
Table 69: Orion's Parkinson's Disease Portfolio Assessment, 2014 166
Table 70: Orion's PD SWOT Analysis, 2014 166
Table 71: Newron's Parkinson's Disease Portfolio Assessment, 2014 167
Table 72: Newron's PD SWOT Analysis, 2014 168
Table 73: Civitas' Parkinson's Disease Portfolio Assessment, 2014 169
Table 74: Civitas' PD SWOT Analysis, 2014 170
Table 75: Impax's Parkinson's Disease Portfolio Assessment, 2014 172
Table 76: Impax's PD SWOT Analysis, 2014 172
Table 77: Lundbeck's Disease/Therapy Portfolio Assessment, 2014 174
Table 78: Lundbeck's SWOT Analysis, 2014 174
Table 79: Parkinson's Disease Market - Drivers and Barriers, 2012-2022 175
Table 80: Sales Forecasts ($m) for Parkinson's Disease in France, 2012-2022 180
Table 81: Key Events Impacting Sales for Parkinson's Disease in France, 2012-2022 182
Table 82: Parkinson's Disease Market in France - Drivers and Barriers, 2012-2022 182
Table 83: Sales Forecasts ($m) for Parkinson's Disease in Germany, 2012-2022 186
Table 84: Key Events Impacting Sales for Parkinson's Disease in Germany, 2012-2022 188
Table 85: Parkinson's Disease Market in Germany - Drivers and Barriers, 2012-2022 188
Table 86: Sales Forecasts ($) for Parkinson's Disease in Italy, 2012-2022 192
Table 87: Key Events Impacting Sales for Parkinson's Disease in Italy, 2012-2022 194
Table 88: Parkinson's Disease Market in Italy - Drivers and Barriers, 2012-2022 194
Table 89: Sales Forecasts ($m) for Parkinson's Disease in Spain, 2012-2022 199
Table 90: Key Events Impacting Sales for Parkinson's Disease in Spain, 2012-2022 201
Table 91: Parkinson's Disease Market in Spain - Drivers and Barriers, 2012-2022 201
Table 92: Sales Forecasts ($m) for Parkinson's Disease in the UK, 2012-2022 205
Table 93: Key Events Impacting Sales for Parkinson's Disease in the UK, 2012-2022 207
Table 94: Parkinson's Disease Market in the UK - Drivers and Barriers, 2012-2022 207
Table 95: Key Launch Dates 230
Table 96: Key Patent Expiries 231

1.2 List of Figures
Figure 1: Overview - L-dopa Metabolism and Inhibitor Classes 32
Figure 2: Overview - Treatment of Motor Symptoms of Parkinson's Disease 34
Figure 3: Pharmacokinetics of Levodopa 98
Figure 4: Parkinson's Disease - Phase II-III Pipeline, Segmented by Indication, 2014 116
Figure 5: Competitive Assessment of Late-Stage Pipeline Agents in Parkinson's Disease, 2012-2022 117
Figure 6: Company Portfolio Gap Analysis in Parkinson's Motor Symptoms, 2012-2022 152
Figure 7: Sales for Parkinson's Disease in France by Drug Class, 2012-2022 181
Figure 8: Sales for Parkinson's Disease in Germany by Drug Class, 2012-2022 187
Figure 9: Sales for Parkinson's Disease in Italy by Drug Class, 2012-2022 193
Figure 10: Sales for Parkinson's Disease in Spain by Drug Class, 2012-2022 200
Figure 11: Sales for Parkinson's Disease in the UK by Drug Class, 2012-2022 206

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