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PharmaPoint: Parkinson’s Disease - US 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.

This market is expected to grow faster than any other market, including the 5EU, due in part to the introduction of two brands already in use in the 5EU, Neupro and Duodopa, launched in the US at the beginning of the forecast in 2012 and 2014, respectively. Other factors responsible for growth in this market are an aging population that contributes to an increased prevalence of Parkinson’s disease in the US and the launch of six new pipeline agents (in addition to Duodopa and Neupro).

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

Table Of Contents

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

2 Introduction 14
2.1 Catalyst 14
2.2 Related Reports 14
3 Disease Overview 17
3.1 Etiology and Pathophysiology 17
3.1.1 Etiology 17
3.1.2 Pathophysiology 20
3.1.3 Prognosis 22
3.1.4 Quality of Life 23
3.2 Symptoms 23
4 Disease Management 25
4.1 Overview 25
4.1.1 Diagnosis - The UK Brain Bank Criteria 25
4.1.2 Treatment Guidelines and Leading Prescribed Drugs 26
4.2 Treatment Synopsis 27
4.2.1 Dopaminergic Therapy Classes 28
4.2.2 Treatment of Parkinson's disease by Stage 30
4.2.3 Other Treatment Options 33
4.3 Parkinson's Disease Assessment Scales 33
4.3.1 Unified Parkinson's Disease Rating Scale (UPDRS) 34
4.3.2 Hoehn and Yahr Clinical Staging 36
4.3.3 Other Clinical Assessments 37
4.4 Diagnosis and Treatment of Parkinson's Disease by Country 37
4.4.1 US 37
5 Competitive Assessment 40
5.1 Overview 40
5.2 Strategic Competitor Assessment 42
5.3 Product Profiles - Levodopa Combination Therapy 43
5.3.1 Sinemet (carbidopa/levodopa) 44
5.3.2 Duodopa (carbidopa/levodopa intestinal gel) 48
5.4 Product Profiles - COMT Inhibitors 52
5.4.1 Stalevo/Comtan (entacapone) 52
5.5 Dopamine Agonists 57
5.5.1 Neupro (rotigotine transdermal patch) 58
5.5.2 Requip/Requip XL (ropinirole) 64
5.5.3 Apokyn (apomorphine) 68
5.6 Product Profiles - MAO-B Inhibitors 71
5.6.1 Azilect (rasagiline) 72
5.7 Product Profiles - Adenosine 2A Inhibitor 77
5.7.1 Nouriast (istradefylline) 78
5.8 Product Profiles - Other Therapies 81
6 Opportunity and Unmet Need 82
6.1 Overview 82
6.2 Treatment of Motor Complications - Dyskinesias and OFF Episodes 84
6.2.1 Unmet Need 84
6.2.2 Gap Analysis 86
6.2.3 Opportunity 89
6.3 Treatment of Non-Motor Symptoms and Dementia 89
6.3.1 Unmet Need 89
6.3.2 Gap Analysis 90
6.3.3 Opportunity 92
6.4 Neuroprotective/Disease-Modifying Agents 92
6.4.1 Unmet Need 92
6.4.2 Gap Analysis 93
6.4.3 Opportunity 96
6.5 Improved Drug Formulations 97
6.5.1 Unmet Need 97
6.5.2 Gap Analysis 97
6.5.3 Opportunity 98
6.6 Identification of Reliable Biomarkers 98
6.6.1 Unmet Need 98
6.6.2 Gap Analysis 99
6.6.3 Opportunity 100
6.7 Improved Clinical Trial Design 100
6.7.1 Unmet Need 100
6.7.2 Gap Analysis 101
6.7.3 Opportunity 101
7 Pipeline Assessment 102
7.1 Overview 102
7.2 Promising Drugs in Clinical Development 102
7.2.1 Safinamide 104
7.2.2 Tozadenant 111
7.2.3 CVT-301 114
7.2.4 Rytary/IPX066 119
7.2.5 Opicapone 125
7.2.6 Mavoglurant/AFQ056 129
7.2.7 CD/LD-GR 132
7.2.8 Other Late-Stage Pipeline Products 137
8 Current and Future Players 138
8.1 Overview 138
8.2 Trends in Corporate Strategy 139
8.3 Company Profiles 140
8.3.1 Merck 140
8.3.2 Roche 142
8.3.3 AbbVie 144
8.3.4 UCB 146
8.3.5 GlaxoSmithKline 147
8.3.6 Novartis 149
8.3.7 Orion 152
8.3.8 Newron 153
8.3.9 Civitas 155
8.3.10 Impax 157
8.3.11 Lundbeck 159
9 Market Outlook 162
9.1 US 162
9.1.1 Forecast 162
9.1.2 Key Events 166
9.1.3 Drivers and Barriers - Global Issues 166
9.1.4 Drivers and Barriers 169
10 Appendix 171
10.1 Bibliography 171
10.2 Abbreviations 186
10.3 Methodology 190
10.4 Forecasting Methodology 190
10.4.1 Diagnosed Parkinson's Disease Patients 190
10.4.2 Percent Drug-Treated Patients 191
10.4.3 Drugs Included in Each Therapeutic Class 191
10.4.4 Launch and Patent Expiry Dates 192
10.4.5 General Pricing Assumptions 193
10.4.6 Compliance Assumptions 193
10.4.7 Individual Drug Assumptions 194
10.4.8 Generic Erosion 202
10.4.9 Pricing of Pipeline Agents 202
10.5 Physicians and Specialists Included in this Study 204
10.6 About the Authors 206
10.6.1 Author 206
10.6.2 Global Head of Healthcare 207
10.7 About GlobalData 208
10.8 Disclaimer 208

1.1 List of Tables

Table 1: Symptoms of Parkinson's Disease 24
Table 2: UK Brain Bank Diagnostic Criteria 26
Table 3: Diagnosis and Treatment Guidelines for Parkinson's Disease 27
Table 4: Most Prescribed Drugs for Parkinson's Disease by Class in the Global Markets, 2014 27
Table 5: Dopaminergic Therapy in Parkinson's Disease 30
Table 6: UPDRS Clinical Assessment of Disease Severity 35
Table 7: Parkinson's Disease Assessment Scales Used in Clinical Trials 37
Table 8: Parkinson's Disease, Country Profile - US 39
Table 9: Treatment of Motor Symptoms in Parkinson's Disease 41
Table 10: Leading Treatments for Parkinson's Disease, 2014 43
Table 11: Product Profile - Sinemet 46
Table 12: Sinemet SWOT Analysis, 2014 48
Table 13: Product Profile - Duodopa 50
Table 14: Duodopa SWOT Analysis, 2014 52
Table 15: Product Profile - Stalevo 54
Table 16: Product Profile - Comtan 55
Table 17: Stalevo/Comtan SWOT Analysis, 2014 57
Table 18: Product Profile - Neupro 59
Table 19: Neupro SWOT Analysis, 2014 63
Table 20: Product Profile - Requip/Requip XL 65
Table 21: Requip/Requip XL SWOT Analysis, 2014 67
Table 22: Product Profile - Apokyn 69
Table 23: Apokyn SWOT Analysis, 2014 71
Table 24: Product Profile - Azilect 73
Table 25: Azilect SWOT Analysis, 2014 77
Table 26: Product Profile - Nouriast 79
Table 27: Nouriast SWOT Analysis, 2014 80
Table 28: Summary of Alternative Parkinson's Disease Therapies 81
Table 29: Unmet Need and Opportunity in Parkinson's Disease 83
Table 30: Dyskinesia Pipeline, 2014 88
Table 31: Dementia Pipeline, 2014 91
Table 32: Parkinson's Disease-Modifying Therapeutics Pipeline, 2014 95
Table 33: Product Profile - Safinamide 106
Table 34: Summary of Relevant Clinical Trials for Safinamide 107
Table 35: Safinamide SWOT Analysis, 2014 110
Table 36: Product Profile - Tozadenant 112
Table 37: Tozadenant SWOT Analysis, 2014 114
Table 38: Product Profile - CVT-301 116
Table 39: CVT-301 SWOT Analysis, 2014 119
Table 40: Product Profile - Rytary 121
Table 41: Rytary SWOT Analysis, 2014 125
Table 42: Product Profile - Opicapone 126
Table 43: Opicapone SWOT Analysis, 2014 128
Table 44: Product Profile - Mavoglurant 130
Table 45: Mavoglurant SWOT Analysis, 2014 132
Table 46: Product Profile - CD/LD-GR 133
Table 47: Summary of Relevant Clinical Trials for CD/LD-GR 134
Table 48: CD/LD-GR SWOT Analysis, 2014 136
Table 49: Late-Stage Pipeline, 2013 137
Table 50: Key Companies in the Parkinson's Market, 2014 138
Table 51: Merck's Parkinson's Disease Portfolio Assessment, 2014 142
Table 52: Merck's PD SWOT Analysis, 2014 142
Table 53: Roche's Parkinson's Disease Portfolio Assessment, 2014 144
Table 54: Roche's PD SWOT Analysis, 2014 144
Table 55: AbbVie's Parkinson's Disease Portfolio Assessment, 2014 145
Table 56: AbbVie's PD SWOT Analysis, 2014 145
Table 57: UCB's Parkinson's Disease Portfolio Assessment, 2014 146
Table 58: UCB's PD SWOT Analysis, 2014 147
Table 59: GSK's Parkinson's Disease Portfolio Assessment, 2014 149
Table 60: GSK's PD SWOT Analysis, 2014 149
Table 61: Novartis' Parkinson's Disease Portfolio Assessment, 2014 151
Table 62: Novartis' PD SWOT Analysis, 2014 151
Table 63: Orion's Parkinson's Disease Portfolio Assessment, 2014 153
Table 64: Orion's PD SWOT Analysis, 2014 153
Table 65: Newron's Parkinson's Disease Portfolio Assessment, 2014 154
Table 66: Newron's PD SWOT Analysis, 2014 155
Table 67: Civitas' Parkinson's Disease Portfolio Assessment, 2014 156
Table 68: Civitas' PD SWOT Analysis, 2014 157
Table 69: Impax's Parkinson's Disease Portfolio Assessment, 2014 159
Table 70: Impax's PD SWOT Analysis, 2014 159
Table 71: Lundbeck's Disease/Therapy Portfolio Assessment, 2014 161
Table 72: Lundbeck's SWOT Analysis, 2014 161
Table 73: Sales Forecasts ($m) for Parkinson's Disease in the US, 2012-2022 164
Table 74: Key Events Impacting Sales for Parkinson's Disease in the US, 2012-2022 166
Table 75: Parkinson's Disease Market - Drivers and Barriers, 2012-2022 166
Table 76: Parkinson's Disease Market in the US - Drivers and Barriers, 2012-2022 169
Table 77: Key Launch Dates 192
Table 78: Key Patent Expiries 193

1.2 List of Figures

Figure 1: Overview - L-dopa Metabolism and Inhibitor Classes 29
Figure 2: Overview - Treatment of Motor Symptoms of Parkinson's Disease 31
Figure 3: Pharmacokinetics of Levodopa 85
Figure 4: Parkinson's Disease - Phase II-III Pipeline, Segmented by Indication, 2014 103
Figure 5: Competitive Assessment of Late-Stage Pipeline Agents in Parkinson's Disease, 2012-2022 104
Figure 6: Company Portfolio Gap Analysis in Parkinson's Motor Symptoms, 2012-2022 139
Figure 7: Sales for Parkinson's Disease in the US by Drug Class, 2012-2022 165

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