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PharmaPoint: Parkinson’s Disease - Brazil 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 decline in sales is attributed to a private-public partnership (PPP) between Brazil and Boehringer Ingelheim, which will drive down the price of generic pramipexole as the technology to produce the drug is transferred to Brazil’s Oswaldo Cruz Foundation (Fiocruz)/Institute of Drug Technology (Farmanguinhos), which will solely be responsible for the country’s production of the drug by 2017.

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

Table Of Contents

PharmaPoint: Parkinson’s Disease - Brazil 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 27
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 Brazil 36
5 Competitive Assessment 39
5.1 Overview 39
5.2 Strategic Competitor Assessment 41
5.3 Product Profiles - Levodopa Combination Therapy 41
5.3.1 Madopar (levodopa/benserazide) 42
5.3.2 Sinemet (carbidopa/levodopa) 45
5.4 Product Profiles - COMT Inhibitors 49
5.4.1 Stalevo/Comtan (entacapone) 49
5.5 Dopamine Agonists 54
5.5.1 Neupro (rotigotine transdermal patch) 55
5.6 Product Profiles - MAO-B Inhibitors 61
5.6.1 Azilect (rasagiline) 62
5.7 Product Profiles - Other Therapies 67
6 Opportunity and Unmet Need 69
6.1 Overview 69
6.2 Treatment of Motor Complications - Dyskinesias and OFF Episodes 71
6.2.1 Unmet Need 71
6.2.2 Gap Analysis 73
6.2.3 Opportunity 76
6.3 Treatment of Non-Motor Symptoms and Dementia 76
6.3.1 Unmet Need 76
6.3.2 Gap Analysis 77
6.3.3 Opportunity 79
6.4 Neuroprotective/Disease-Modifying Agents 79
6.4.1 Unmet Need 79
6.4.2 Gap Analysis 80
6.4.3 Opportunity 83
6.5 Improved Drug Formulations 84
6.5.1 Unmet Need 84
6.5.2 Gap Analysis 84
6.5.3 Opportunity 85
6.6 Identification of Reliable Biomarkers 85
6.6.1 Unmet Need 85
6.6.2 Gap Analysis 86
6.6.3 Opportunity 87
6.7 Improved Clinical Trial Design 87
6.7.1 Unmet Need 87
6.7.2 Gap Analysis 88
6.7.3 Opportunity 88
7 Pipeline Assessment 89
7.1 Overview 89
7.2 Promising Drugs in Clinical Development 89
7.2.1 Safinamide 89
7.2.2 Mavoglurant/AFQ056 95
7.2.3 CD/LD-GR 99
7.2.4 Other Late-Stage Pipeline Products 103
8 Current and Future Players 104
8.1 Overview 104
8.2 Trends in Corporate Strategy 105
8.3 Company Profiles 106
8.3.1 Merck 106
8.3.2 Roche 108
8.3.3 AbbVie 110
8.3.4 UCB 112
8.3.5 GlaxoSmithKline 113
8.3.6 Novartis 115
8.3.7 Orion 118
8.3.8 Newron 119
8.3.9 Civitas 121
8.3.10 Impax 123
8.3.11 Lundbeck 126
9 Market Outlook 128
9.1 Brazil 128
9.1.1 Forecast 128
9.1.2 Key Events 131
9.1.3 Drivers and Barriers - Global Issues 131
9.1.4 Drivers and Barriers - Brazil 134
10 Appendix 136
10.1 Bibliography 136
10.2 Abbreviations 148
10.3 Methodology 152
10.4 Forecasting Methodology 152
10.4.1 Diagnosed Parkinson's disease Patients 152
10.4.2 Percent Drug-Treated Patients 153
10.4.3 Drugs Included in Each Therapeutic Class 153
10.4.4 Launch and Patent Expiry Dates 154
10.4.5 General Pricing Assumptions 155
10.4.6 Compliance Assumptions 155
10.4.7 Individual Drug Assumptions 156
10.4.8 Generic Erosion 161
10.4.9 Pricing of Pipeline Agents 161
10.5 Physicians and Specialists Included in this Study 162
10.6 About the Authors 164
10.6.1 Author 164
10.6.2 Global Head of Healthcare 165
10.7 About GlobalData 166
10.8 Disclaimer 166

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 - Brazil 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 - Stalevo 51
Table 16: Product Profile - Comtan 52
Table 17: Stalevo/Comtan SWOT Analysis, 2014 54
Table 18: Product Profile - Neupro 57
Table 19: Neupro SWOT Analysis, 2014 61
Table 20: Product Profile - Azilect 63
Table 21: Azilect SWOT Analysis, 2014 67
Table 22: Summary of Alternative Parkinson's Disease Therapies 68
Table 23: Unmet Need and Opportunity in Parkinson's Disease 70
Table 24: Dyskinesia Pipeline, 2014 75
Table 25: Dementia Pipeline, 2014 78
Table 26: Parkinson's Disease-Modifying Therapeutics Pipeline, 2014 82
Table 27: Product Profile - Safinamide 90
Table 28: Summary of Relevant Clinical Trials for Safinamide 92
Table 29: Safinamide SWOT Analysis, 2014 95
Table 30: Product Profile - Mavoglurant 96
Table 31: Mavoglurant SWOT Analysis, 2014 98
Table 32: Product Profile - CD/LD-GR 99
Table 33: Summary of Relevant Clinical Trials for CD/LD-GR 100
Table 34: CD/LD-GR SWOT Analysis, 2014 102
Table 35: Late-Stage Pipeline, 2013 103
Table 36: Key Companies in the Parkinson's Market, 2014 104
Table 37: Merck's Parkinson's Disease Portfolio Assessment, 2014 108
Table 38: Merck's PD SWOT Analysis, 2014 108
Table 39: Roche's Parkinson's Disease Portfolio Assessment, 2014 110
Table 40: Roche's PD SWOT Analysis, 2014 110
Table 41: AbbVie's Parkinson's Disease Portfolio Assessment, 2014 111
Table 42: AbbVie's PD SWOT Analysis, 2014 111
Table 43: UCB's Parkinson's Disease Portfolio Assessment, 2014 112
Table 44: UCB's PD SWOT Analysis, 2014 113
Table 45: GSK's Parkinson's Disease Portfolio Assessment, 2014 115
Table 46: GSK's PD SWOT Analysis, 2014 115
Table 47: Novartis' Parkinson's Disease Portfolio Assessment, 2014 117
Table 48: Novartis' PD SWOT Analysis, 2014 117
Table 49: Orion's Parkinson's Disease Portfolio Assessment, 2014 119
Table 50: Orion's PD SWOT Analysis, 2014 119
Table 51: Newron's Parkinson's Disease Portfolio Assessment, 2014 120
Table 52: Newron's PD SWOT Analysis, 2014 121
Table 53: Civitas' Parkinson's Disease Portfolio Assessment, 2014 122
Table 54: Civitas' PD SWOT Analysis, 2014 123
Table 55: Impax's Parkinson's Disease Portfolio Assessment, 2014 125
Table 56: Impax's PD SWOT Analysis, 2014 125
Table 57: Lundbeck's Disease/Therapy Portfolio Assessment, 2014 127
Table 58: Lundbeck's SWOT Analysis, 2014 127
Table 59: Sales Forecasts ($m) for Parkinson's Disease in Brazil, 2012-2022 129
Table 60: Key Events Impacting Sales for Parkinson's Disease in Brazil, 2012-2022 131
Table 61: Parkinson's Disease Market - Drivers and Barriers, 2012-2022 131
Table 62: Parkinson's Disease Market in Brazil - Drivers and Barriers, 2012-2022 134
Table 63: Key Launch Dates 154
Table 64: Key Patent Expiries 155

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 72
Figure 4: Company Portfolio Gap Analysis in Parkinson's Motor Symptoms, 2012-2022 105
Figure 5: Sales for Parkinson's Disease in Brazil by Drug Class, 2012-2022 130

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