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PharmaPoint: Parkinson’s Disease - Japan 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.

The aging population in Japan is growing at an accelerated rate compared with other countries forecast in this report, accounting for the significant hike in sales during the 10-year forecast, along with low rates of generic substitution. Several products will be launched between 2012 and 2016, with some losing patent life during the same forecast period.

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

Table Of Contents

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

2 Introduction 13
2.1 Catalyst 13
2.2 Related Reports 13
3 Disease Overview 16
3.1 Etiology and Pathophysiology 16
3.1.1 Etiology 16
3.1.2 Pathophysiology 19
3.1.3 Prognosis 21
3.1.4 Quality of Life 22
3.2 Symptoms 22
4 Disease Management 24
4.1 Overview 24
4.1.1 Diagnosis - The UK Brain Bank Criteria 24
4.1.2 Treatment Guidelines and Leading Prescribed Drugs 25
4.2 Treatment Synopsis 26
4.2.1 Dopaminergic Therapy Classes 27
4.2.2 Treatment of Parkinson's disease by Stage 29
4.2.3 Other Treatment Options 32
4.3 Parkinson's Disease Assessment Scales 32
4.3.1 Unified Parkinson's Disease Rating Scale (UPDRS) 33
4.3.2 Hoehn and Yahr Clinical Staging 35
4.3.3 Other Clinical Assessments 36
4.4 Diagnosis and Treatment of Parkinson's Disease by Country 36
4.4.1 Japan 36
5 Competitive Assessment 39
5.1 Overview 39
5.2 Strategic Competitor Assessment 41
5.3 Product Profiles - Levodopa Combination Therapy 42
5.3.1 Madopar (levodopa/benserazide) 42
5.3.2 Sinemet (carbidopa/levodopa) 46
5.3.3 Duodopa (carbidopa/levodopa intestinal gel) 49
5.4 Product Profiles - COMT Inhibitors 52
5.4.1 Stalevo/Comtan (entacapone) 53
5.5 Dopamine Agonists 58
5.5.1 Neupro (rotigotine transdermal patch) 59
5.5.2 Requip/Requip XL (ropinirole) 65
5.5.3 Apokyn (apomorphine) 68
5.6 Product Profiles - Adenosine 2A Inhibitor 72
5.6.1 Nouriast (istradefylline) 73
5.7 Product Profiles - Other Therapies 76
6 Opportunity and Unmet Need 77
6.1 Overview 77
6.2 Treatment of Motor Complications - Dyskinesias and OFF Episodes 79
6.2.1 Unmet Need 79
6.2.2 Gap Analysis 81
6.2.3 Opportunity 84
6.3 Treatment of Non-Motor Symptoms and Dementia 84
6.3.1 Unmet Need 84
6.3.2 Gap Analysis 85
6.3.3 Opportunity 87
6.4 Neuroprotective/Disease-Modifying Agents 87
6.4.1 Unmet Need 87
6.4.2 Gap Analysis 88
6.4.3 Opportunity 91
6.5 Improved Drug Formulations 92
6.5.1 Unmet Need 92
6.5.2 Gap Analysis 92
6.5.3 Opportunity 93
6.6 Identification of Reliable Biomarkers 93
6.6.1 Unmet Need 93
6.6.2 Gap Analysis 94
6.6.3 Opportunity 95
6.7 Improved Clinical Trial Design 95
6.7.1 Unmet Need 95
6.7.2 Gap Analysis 96
6.7.3 Opportunity 96
7 Pipeline Assessment 97
7.1 Overview 97
7.2 Promising Drugs in Clinical Development 97
7.2.1 Mavoglurant/AFQ056 97
7.2.2 CD/LD-GR 101
7.2.3 Other Late-Stage Pipeline Products 105
8 Current and Future Players 106
8.1 Overview 106
8.2 Trends in Corporate Strategy 107
8.3 Company Profiles 108
8.3.1 Merck 108
8.3.2 Roche 110
8.3.3 AbbVie 112
8.3.4 UCB 114
8.3.5 GlaxoSmithKline 115
8.3.6 Novartis 117
8.3.7 Orion 120
8.3.8 Newron 121
8.3.9 Civitas 123
8.3.10 Impax 125
8.3.11 Lundbeck 127
9 Market Outlook 130
9.1 Japan 130
9.1.1 Forecast 130
9.1.2 Key Events 133
9.1.3 Drivers and Barriers - Global Issues 133
9.1.4 Drivers and Barriers - Japan 136
10 Appendix 139
10.1 Bibliography 139
10.2 Abbreviations 151
10.3 Methodology 155
10.4 Forecasting Methodology 155
10.4.1 Diagnosed Parkinson's disease Patients 155
10.4.2 Percent Drug-Treated Patients 156
10.4.3 Drugs Included in Each Therapeutic Class 156
10.4.4 Launch and Patent Expiry Dates 157
10.4.5 General Pricing Assumptions 158
10.4.6 Compliance Assumptions 159
10.4.7 Individual Drug Assumptions 159
10.4.8 Generic Erosion 164
10.5 Physicians and Specialists Included in this Study 165
10.6 About the Authors 167
10.6.1 Author 167
10.6.2 Global Head of Healthcare 168
10.7 About GlobalData 169
10.8 Disclaimer 169

1.1 List of Tables

Table 1: Symptoms of Parkinson's Disease 23
Table 2: UK Brain Bank Diagnostic Criteria 25
Table 3: Diagnosis and Treatment Guidelines for Parkinson's Disease 26
Table 4: Most Prescribed Drugs for Parkinson's Disease by Class in the Global Markets, 2014 26
Table 5: Dopaminergic Therapy in Parkinson's Disease 29
Table 6: UPDRS Clinical Assessment of Disease Severity 34
Table 7: Parkinson's Disease Assessment Scales Used in Clinical Trials 36
Table 8: Parkinson's Disease, Country Profile - Japan 38
Table 9: Treatment of Motor Symptoms in Parkinson's Disease 40
Table 10: Leading Treatments for Parkinson's Disease, 2014 41
Table 11: Product Profile - Madopar 43
Table 12: Madopar SWOT Analysis, 2014 45
Table 13: Product Profile - Sinemet 47
Table 14: Sinemet SWOT Analysis, 2014 49
Table 15: Product Profile - Duodopa 50
Table 16: Duodopa SWOT Analysis, 2014 52
Table 17: Product Profile - Stalevo 55
Table 18: Product Profile - Comtan 56
Table 19: Stalevo/Comtan SWOT Analysis, 2014 58
Table 20: Product Profile - Neupro 60
Table 21: Neupro SWOT Analysis, 2014 64
Table 22: Product Profile - Requip/Requip XL 66
Table 23: Requip/Requip XL SWOT Analysis, 2014 68
Table 24: Product Profile - Apokyn 70
Table 25: Apokyn SWOT Analysis, 2014 72
Table 26: Product Profile - Nouriast 74
Table 27: Nouriast SWOT Analysis, 2014 75
Table 28: Summary of Alternative Parkinson's Disease Therapies 76
Table 29: Unmet Need and Opportunity in Parkinson's Disease 78
Table 30: Dyskinesia Pipeline, 2014 83
Table 31: Dementia Pipeline, 2014 86
Table 32: Parkinson's Disease-Modifying Therapeutics Pipeline, 2014 90
Table 33: Product Profile - Mavoglurant 98
Table 34: Mavoglurant SWOT Analysis, 2014 100
Table 35: Product Profile - CD/LD-GR 101
Table 36: Summary of Relevant Clinical Trials for CD/LD-GR 102
Table 37: CD/LD-GR SWOT Analysis, 2014 104
Table 38: Late-Stage Pipeline, 2013 105
Table 39: Key Companies in the Parkinson's Market, 2014 106
Table 40: Merck's Parkinson's Disease Portfolio Assessment, 2014 110
Table 41: Merck's PD SWOT Analysis, 2014 110
Table 42: Roche's Parkinson's Disease Portfolio Assessment, 2014 112
Table 43: Roche's PD SWOT Analysis, 2014 112
Table 44: AbbVie's Parkinson's Disease Portfolio Assessment, 2014 113
Table 45: AbbVie's PD SWOT Analysis, 2014 113
Table 46: UCB's Parkinson's Disease Portfolio Assessment, 2014 114
Table 47: UCB's PD SWOT Analysis, 2014 115
Table 48: GSK's Parkinson's Disease Portfolio Assessment, 2014 117
Table 49: GSK's PD SWOT Analysis, 2014 117
Table 50: Novartis' Parkinson's Disease Portfolio Assessment, 2014 119
Table 51: Novartis' PD SWOT Analysis, 2014 119
Table 52: Orion's Parkinson's Disease Portfolio Assessment, 2014 121
Table 53: Orion's PD SWOT Analysis, 2014 121
Table 54: Newron's Parkinson's Disease Portfolio Assessment, 2014 122
Table 55: Newron's PD SWOT Analysis, 2014 123
Table 56: Civitas' Parkinson's Disease Portfolio Assessment, 2014 124
Table 57: Civitas' PD SWOT Analysis, 2014 125
Table 58: Impax's Parkinson's Disease Portfolio Assessment, 2014 127
Table 59: Impax's PD SWOT Analysis, 2014 127
Table 60: Lundbeck's Disease/Therapy Portfolio Assessment, 2014 129
Table 61: Lundbeck's SWOT Analysis, 2014 129
Table 62: Sales Forecasts ($m) for Parkinson's Disease in Japan, 2012-2022 131
Table 63: Key Events Impacting Sales for Parkinson's Disease in Japan, 2012-2022 133
Table 64: Parkinson's Disease Market - Drivers and Barriers, 2012-2022 133
Table 65: Parkinson's Disease Market in Japan - Drivers and Barriers, 2012-2022 136
Table 66: Key Launch Dates 157
Table 67: Key Patent Expiries 158

1.2 List of Figures

Figure 1: Overview - L-dopa Metabolism and Inhibitor Classes 28
Figure 2: Overview - Treatment of Motor Symptoms of Parkinson's Disease 30
Figure 3: Pharmacokinetics of Levodopa 80
Figure 4: Company Portfolio Gap Analysis in Parkinson's Motor Symptoms, 2012-2022 107
Figure 5: Sales for Parkinson's Disease in Japan by Drug Class, 2012-2022 132

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