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PharmaPoint: Parkinson’s Disease - Global 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. It is expected that the prevalence of Parkinson’s disease in the 7MM (US, France, Germany, Italy, Spain, UK, and Japan) and Brazil will increase from 3.2m people in 2012 to 4.3m people in 2022, driven by an aging population in all markets. 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.

Highlights

Key Questions Answered

- According to KOLs, what are the most important unmet needs in PD? Will these needs be addressed by pipeline agents? What needs will remain by the end of the forecast period in 2022?
- With five new product launches, three of which address the needs of advanced stage patients, which products are forecast to generate the highest sales over 2012-2022?
- What corporate strategies have been employed for recent product launches? What opportunities remain for new entrants?
- An aging population is expected to increase prevalence of PD in all markets from 2012-2022. How will epidemiological changes impact the growth of the future PD market?
- What governmental developments are likely to affect reimbursement and generic erosion of PD drugs? What type of impact will this have on the markets covered over the forecast period?

Key Findings

- Population increases, especially in the elderly, will be a key driving force in the global PD market.
- With several small biotech and pharmaceutical companies involved in mid-stage development of PD products, there will be ample opportunity for partnerships with Big Pharma.
- Levodopa based therapy will remain the gold standard of care with advancements in administration, including the introduction of slow-release formulations and an emergency use inhaler.
- Several unmet needs are expected to remain after the forecast period, as advancements in the control of non-motor symptoms and in the development of disease-modifying therapies are lagging.

Scope

- Overview of Parkinson’s disease, including etiology, pathophysiology, motor and non-motor symptoms, and quality of life.
- Annualized Parkinson’s disease market revenue, annual cost of therapy and treatment usage pattern data from 2012 and forecast for ten years to 2022.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the PD market.
- Pipeline analysis: comprehensive data split across different Phases and emerging trends, specifically Newron’s safinamide, Biotie and UCB’s tozadenant, Civitas’ CVT-301, Impax’s Rytary (IPX066), Bial’s opicapone, Novartis’ mavoglurant (AFQ056), and Intec’s CD/LD-GR.
- Analysis of the current and future market competition in the global Parkinson’s disease market. Insightful review of the key industry and governmental drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
- Develop business strategies by understanding the trends shaping and driving the PD market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global PD market in the future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
- Track drug sales in the global PD market from 2012-2022.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Table Of Contents

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

2 Introduction 23
2.1 Catalyst 23
2.2 Related Reports 23
3 Disease Overview 24
3.1 Etiology and Pathophysiology 24
3.1.1 Etiology 24
3.1.2 Pathophysiology 27
3.1.3 Prognosis 29
3.1.4 Quality of Life 30
3.2 Symptoms 30
4 Epidemiology 32
4.1 Disease Background 32
4.2 Risk Factors and Comorbidities 32
4.2.1 The risk of developing Parkinson's disease progressively increases with age 33
4.2.2 The risk for Parkinson's disease is increased with Parkinson's disease-causing mutations 34
4.2.3 Men are 1.5 times more likely to develop Parkinson's disease than women, though the difference may be the result of varying exposures to environmental factors 34
4.2.4 Chemicals, along with exposure to other environmental factors, increase the risk of developing Parkinson's disease 35
4.2.5 38% of Parkinson's disease cases experienced depression and/or anxiety compared with only 8% of controls 35
4.3 Global and Historical Trends 36
4.3.1 US 36
4.3.2 5EU 37
4.3.3 Japan 37
4.3.4 Brazil 38
4.4 Forecast Methodology 39
4.4.1 Sources Used 40
4.4.2 Sources Not Used 43
4.4.3 Forecast Assumptions and Methods 43
4.5 Epidemiological Forecast of Parkinson's Disease (2012-2022) 44
4.5.1 Prevalent Cases of Parkinson's Disease 44
4.5.2 Age-Specific Prevalent Cases of Parkinson's Disease 46
4.5.3 Sex-Specific Prevalent Cases of Parkinson's Disease 48
4.5.4 Age-Standardized Prevalence of Parkinson's Disease 49
4.6 Discussion 50
4.6.1 Epidemiological Forecast Insight 50
4.6.2 Limitations of the Analysis 51
4.6.3 Strengths of the Analysis 52
5 Disease Management 53
5.1 Overview 53
5.1.1 Diagnosis - The UK Brain Bank Criteria 53
5.1.2 Treatment Guidelines and Leading Prescribed Drugs 54
5.2 Treatment Synopsis 57
5.2.1 Dopaminergic Therapy Classes 57
5.2.2 Treatment of Parkinson's Disease by Stage 59
5.2.3 Other Treatment Options 62
5.3 Parkinson's Disease Assessment Scales 62
5.3.1 Unified Parkinson's Disease Rating Scale (UPDRS) 63
5.3.2 Hoehn and Yahr Clinical Staging 65
5.3.3 Other Clinical Assessments 66
5.4 Diagnosis and Treatment of Parkinson's Disease by Country 66
5.4.1 US 66
5.4.2 France 68
5.4.3 Germany 70
5.4.4 Italy 72
5.4.5 Spain 75
5.4.6 UK 77
5.4.7 Japan 78
5.4.8 Brazil 81
6 Competitive Assessment 84
6.1 Overview 84
6.2 Strategic Competitor Assessment 86
6.3 Product Profiles - Levodopa Combination Therapy 87
6.3.1 Madopar (levodopa/benserazide) 88
6.3.2 Sinemet (carbidopa/levodopa) 93
6.3.3 Duodopa (carbidopa/levodopa intestinal gel) 99
6.4 Product Profiles - COMT Inhibitors 103
6.4.1 Stalevo/Comtan (entacapone) 103
6.5 Dopamine Agonists 109
6.5.1 Neupro (rotigotine transdermal patch) 110
6.5.2 Requip/Requip XL (ropinirole) 117
6.5.3 Apokyn (apomorphine) 121
6.6 Product Profiles - MAO-B Inhibitors 126
6.6.1 Azilect (rasagiline) 127
6.7 Product Profiles - Adenosine 2A Inhibitor 133
6.7.1 Nouriast (istradefylline) 134
6.8 Product Profiles - Other Therapies 137
7 Opportunity and Unmet Need 139
7.1 Overview 139
7.2 Treatment of Motor Complications - Dyskinesias and OFF Episodes 141
7.2.1 Unmet Need 141
7.2.2 Gap Analysis 143
7.2.3 Opportunity 146
7.3 Treatment of Non-Motor Symptoms and Dementia 146
7.3.1 Unmet Need 146
7.3.2 Gap Analysis 147
7.3.3 Opportunity 149
7.4 Neuroprotective/Disease-Modifying Agents 149
7.4.1 Unmet Need 149
7.4.2 Gap Analysis 150
7.4.3 Opportunity 153
7.5 Improved Drug Formulations 154
7.5.1 Unmet Need 154
7.5.2 Gap Analysis 154
7.5.3 Opportunity 155
7.6 Identification of Reliable Biomarkers 155
7.6.1 Unmet Need 155
7.6.2 Gap Analysis 156
7.6.3 Opportunity 157
7.7 Improved Clinical Trial Design 157
7.7.1 Unmet Need 157
7.7.2 Gap Analysis 158
7.7.3 Opportunity 158
8 Pipeline Assessment 159
8.1 Overview 159
8.2 Clinical Trial Mapping 159
8.2.1 Clinical Trials by Class/Patient Population/Biomarkers/Line of Therapy 159
8.3 Promising Drugs in Clinical Development 161
8.3.1 Safinamide 163
8.3.2 Tozadenant 171
8.3.3 CVT-301 175
8.3.4 Rytary/IPX066 181
8.3.5 Opicapone 188
8.3.6 Mavoglurant/AFQ056 193
8.3.7 CD/LD-GR 196
8.3.8 Other Late-Stage Pipeline Products 201
9 Current and Future Players 202
9.1 Overview 202
9.2 Trends in Corporate Strategy 203
9.3 Company Profiles 204
9.3.1 Merck 204
9.3.2 Roche 206
9.3.3 AbbVie 208
9.3.4 UCB 210
9.3.5 GlaxoSmithKline 211
9.3.6 Novartis 213
9.3.7 Orion 216
9.3.8 Newron 217
9.3.9 Civitas 219
9.3.10 Impax 221
9.3.11 Lundbeck 223
10 Market Outlook 226
10.1 Global Markets 226
10.1.1 Forecast 226
10.1.2 Drivers and Barriers - Global Issues 230
10.2 US 232
10.2.1 Forecast 232
10.2.2 Key Events 237
10.2.3 Drivers and Barriers 237
10.3 France 239
10.3.1 Forecast 239
10.3.2 Key Events 243
10.3.3 Drivers and Barriers 243
10.4 Germany 245
10.4.1 Forecast 245
10.4.2 Key Events 249
10.4.3 Drivers and Barriers 249
10.5 Italy 251
10.5.1 Forecast 251
10.5.2 Key Events 255
10.5.3 Drivers and Barriers 255
10.6 Spain 257
10.6.1 Forecast 257
10.6.2 Key Events 262
10.6.3 Drivers and Barriers 262
10.7 UK 264
10.7.1 Forecast 264
10.7.2 Key Events 268
10.7.3 Drivers and Barriers 268
10.8 Japan 270
10.8.1 Forecast 270
10.8.2 Key Events 274
10.8.3 Drivers and Barriers 274
10.9 Brazil 276
10.9.1 Forecast 276
10.9.2 Key Events 280
10.9.3 Drivers and Barriers 280
11 Appendix 282
11.1 Bibliography 282
11.2 Abbreviations 300
11.3 Methodology 305
11.4 Forecasting Methodology 305
11.4.1 Diagnosed Parkinson's Disease Patients 305
11.4.2 Percent Drug-Treated Patients 306
11.4.3 Drugs Included in Each Therapeutic Class 306
11.4.4 Launch and Patent Expiry Dates 307
11.4.5 General Pricing Assumptions 308
11.4.6 Compliance Assumptions 309
11.4.7 Individual Drug Assumptions 310
11.4.8 Generic Erosion 320
11.4.9 Pricing of Pipeline Agents 320
11.5 Physicians and Specialists Included in this Study 321
11.6 About the Authors 323
11.6.1 Author 323
11.6.2 Epidemiologist 324
11.6.3 Global Head of Healthcare 325
11.7 About GlobalData 326
11.8 Disclaimer 326

1.1 List of Tables

Table 1: Symptoms of Parkinson's Disease 31
Table 2: Risk Factors and Comorbidities for Parkinson's Disease 33
Table 3: Sources of Diagnosed Prevalence Data Used in the Epidemiology Forecast 40
Table 4: 8MM, Diagnosed Prevalent Cases of Parkinson's Disease, Ages ?65 Years, Both Sexes, N, Select Years, 2012-2022 45
Table 5: 8MM, Diagnosed Prevalent Cases of Parkinson's Disease, by Age, N (Row %), 2012 47
Table 6: 8MM, Diagnosed Prevalent Cases of Parkinson's Disease, by Sex, N (Row %), 2012 48
Table 7: UK Brain Bank Diagnostic Criteria 54
Table 8: Diagnosis and Treatment Guidelines for Parkinson's Disease 55
Table 9: Most Prescribed Drugs for Parkinson's Disease by Class in the Global Markets, 2014 56
Table 10: Dopaminergic Therapy in Parkinson's Disease 59
Table 11: UPDRS Clinical Assessment of Disease Severity 64
Table 12: Parkinson's Disease Assessment Scales Used in Clinical Trials 66
Table 13: Parkinson's Disease, Country Profile - US 68
Table 14: Parkinson's Disease, Country Profile - France 70
Table 15: Parkinson's Disease, Country Profile - Germany 72
Table 16: Parkinson's Disease, Country Profile - Italy 74
Table 17: Parkinson's Disease, Country Profile - Spain 76
Table 18: Parkinson's Disease, Country Profile - UK 78
Table 19: Parkinson's Disease, Country Profile - Japan 81
Table 20: Parkinson's Disease, Country Profile - Brazil 83
Table 21: Treatment of Motor Symptoms in Parkinson's Disease 85
Table 22: Leading Treatments for Parkinson's Disease, 2014 87
Table 23: Product Profile - Madopar 89
Table 24: Madopar SWOT Analysis, 2014 91
Table 25: Global Sales Forecasts ($m) for Madopar, 2012-2022 92
Table 26: Global Sales Forecasts ($m) for Madopar CR, 2012-2022 93
Table 27: Product Profile - Sinemet 95
Table 28: Sinemet SWOT Analysis, 2014 97
Table 29: Global Sales Forecasts ($m) for Sinemet, 2012-2022 98
Table 30: Global Sales Forecasts ($m) for Sinemet CR, 2012-2022 99
Table 31: Product Profile - Duodopa 100
Table 32: Duodopa SWOT Analysis, 2014 102
Table 33: Global Sales Forecasts ($m) for Duodopa, 2012-2022 103
Table 34: Product Profile - Stalevo 105
Table 35: Product Profile - Comtan 106
Table 36: Stalevo/Comtan SWOT Analysis, 2014 108
Table 37: Global Sales Forecasts ($m) for Stalevo/Comtan, 2012-2022 109
Table 38: Product Profile - Neupro 112
Table 39: Neupro SWOT Analysis, 2014 116
Table 40: Global Sales Forecasts ($m) for Neupro, 2012-2022 117
Table 41: Product Profile - Requip/Requip XL 118
Table 42: Requip/Requip XL SWOT Analysis, 2014 120
Table 43: Global Sales Forecasts ($m) for Requip/Requip XL, 2012-2022 121
Table 44: Product Profile - Apokyn 123
Table 45: Apokyn SWOT Analysis, 2014 125
Table 46: Global Sales Forecasts ($m) for Apokyn Continuous Infusion, 2012-2022 126
Table 47: Global Sales Forecasts ($m) for Apokyn Pen, 2012-2022 126
Table 48: Product Profile - Azilect 128
Table 49: Azilect SWOT Analysis, 2014 132
Table 50: Global Sales Forecasts ($m) for Azilect, 2012-2022 133
Table 51: Product Profile - Nouriast 135
Table 52: Nouriast SWOT Analysis, 2014 136
Table 53: Global Sales Forecasts ($m) for Nouriast, 2012-2022 137
Table 54: Summary of Alternative Parkinson's Disease Therapies 138
Table 55: Unmet Need and Opportunity in Parkinson's Disease 140
Table 56: Dyskinesia Pipeline, 2014 145
Table 57: Dementia Pipeline, 2014 148
Table 58: Parkinson's Disease-Modifying Therapeutics Pipeline, 2014 152
Table 59: Product Profile - Safinamide 165
Table 60: Summary of Relevant Clinical Trials for Safinamide 166
Table 61: Safinamide SWOT Analysis, 2014 169
Table 62: Global Sales Forecasts ($m) for Safinamide, 2012-2022 170
Table 63: Product Profile - Tozadenant 172
Table 64: Tozadenant SWOT Analysis, 2014 174
Table 65: Global Sales Forecasts ($m) for Tozadenant, 2012-2022 175
Table 66: Product Profile - CVT-301 177
Table 67: CVT-301 SWOT Analysis, 2014 180
Table 68: Global Sales Forecasts ($m) for CVT-301, 2012-2022 181
Table 69: Product Profile - Rytary 182
Table 70: Rytary SWOT Analysis, 2014 187
Table 71: Global Sales Forecasts ($m) for Rytary, 2012-2022 188
Table 72: Product Profile - Opicapone 189
Table 73: Opicapone SWOT Analysis, 2014 191
Table 74: Global Sales Forecasts ($m) for Opicapone, 2012-2022 192
Table 75: Product Profile - Mavoglurant 194
Table 76: Mavoglurant SWOT Analysis, 2014 196
Table 77: Product Profile - CD/LD-GR 197
Table 78: Summary of Relevant Clinical Trials for CD/LD-GR 198
Table 79: CD/LD-GR SWOT Analysis, 2014 200
Table 80: Late-Stage Pipeline, 2013 201
Table 81: Key Companies in the Parkinson's Market, 2014 202
Table 82: Merck's Parkinson's Disease Portfolio Assessment, 2014 206
Table 83: Merck's PD SWOT Analysis, 2014 206
Table 84: Roche's Parkinson's Disease Portfolio Assessment, 2014 208
Table 85: Roche's PD SWOT Analysis, 2014 208
Table 86: AbbVie's Parkinson's Disease Portfolio Assessment, 2014 209
Table 87: AbbVie's PD SWOT Analysis, 2014 209
Table 88: UCB's Parkinson's Disease Portfolio Assessment, 2014 210
Table 89: UCB's PD SWOT Analysis, 2014 211
Table 90: GSK's Parkinson's Disease Portfolio Assessment, 2014 213
Table 91: GSK's PD SWOT Analysis, 2014 213
Table 92: Novartis' Parkinson's Disease Portfolio Assessment, 2014 215
Table 93: Novartis' PD SWOT Analysis, 2014 215
Table 94: Orion's Parkinson's Disease Portfolio Assessment, 2014 217
Table 95: Orion's PD SWOT Analysis, 2014 217
Table 96: Newron's Parkinson's Disease Portfolio Assessment, 2014 218
Table 97: Newron's PD SWOT Analysis, 2014 219
Table 98: Civitas' Parkinson's Disease Portfolio Assessment, 2014 220
Table 99: Civitas' PD SWOT Analysis, 2014 221
Table 100: Impax's Parkinson's Disease Portfolio Assessment, 2014 223
Table 101: Impax's PD SWOT Analysis, 2014 223
Table 102: Lundbeck's Disease/Therapy Portfolio Assessment, 2014 225
Table 103: Lundbeck's SWOT Analysis, 2014 225
Table 104: Global Sales Forecasts ($m) for Parkinson's Disease, 2012-2022 228
Table 105: Parkinson's Disease Market - Drivers and Barriers, 2012-2022 230
Table 106: Sales Forecasts ($m) for Parkinson's Disease in the US, 2012-2022 235
Table 107: Key Events Impacting Sales for Parkinson's Disease in the US, 2012-2022 237
Table 108: Parkinson's Disease Market in the US - Drivers and Barriers, 2012-2022 237
Table 109: Sales Forecasts ($m) for Parkinson's Disease in France, 2012-2022 241
Table 110: Key Events Impacting Sales for Parkinson's Disease in France, 2012-2022 243
Table 111: Parkinson's Disease Market in France - Drivers and Barriers, 2012-2022 243
Table 112: Sales Forecasts ($m) for Parkinson's Disease in Germany, 2012-2022 247
Table 113: Key Events Impacting Sales for Parkinson's Disease in Germany, 2012-2022 249
Table 114: Parkinson's Disease Market in Germany - Drivers and Barriers, 2012-2022 249
Table 115: Sales Forecasts ($) for Parkinson's Disease in Italy, 2012-2022 253
Table 116: Key Events Impacting Sales for Parkinson's Disease in Italy, 2012-2022 255
Table 117: Parkinson's Disease Market in Italy - Drivers and Barriers, 2012-2022 255
Table 118: Sales Forecasts ($m) for Parkinson's Disease in Spain, 2012-2022 260
Table 119: Key Events Impacting Sales for Parkinson's Disease in Spain, 2012-2022 262
Table 120: Parkinson's Disease Market in Spain - Drivers and Barriers, 2012-2022 262
Table 121: Sales Forecasts ($m) for Parkinson's Disease in the UK, 2012-2022 266
Table 122: Key Events Impacting Sales for Parkinson's Disease in the UK, 2012-2022 268
Table 123: Parkinson's Disease Market in the UK - Drivers and Barriers, 2012-2022 268
Table 124: Sales Forecasts ($m) for Parkinson's Disease in Japan, 2012-2022 272
Table 125: Key Events Impacting Sales for Parkinson's Disease in Japan, 2012-2022 274
Table 126: Parkinson's Disease Market in Japan - Drivers and Barriers, 2012-2022 274
Table 127: Sales Forecasts ($m) for Parkinson's Disease in Brazil, 2012-2022 278
Table 128: Key Events Impacting Sales for Parkinson's Disease in Brazil, 2012-2022 280
Table 129: Parkinson's Disease Market in Brazil - Drivers and Barriers, 2012-2022 280
Table 130: Key Launch Dates 307
Table 131: Key Patent Expiries 308

1.2 List of Figures
Figure 1: 8MM, Age-Adjusted Mortality Rate of Parkinson's Disease, Both Sexes, N, 2011 39
Figure 2: 8MM, Diagnosed Prevalent Cases of Parkinson's Disease, Ages ?65 Years, Both Sexes, N, Select Years, 2012-2022 46
Figure 3: 8MM, Diagnosed Prevalent Cases of Parkinson's Disease, by Age, N, 2012 47
Figure 4: 8MM, Diagnosed Prevalent Cases of Parkinson's Disease, by Sex, N, 2012 49
Figure 5: 8MM, Age-Standardized Prevalence (%) of Parkinson's Disease, 2012 50
Figure 6: Overview - L-dopa Metabolism and Inhibitor Classes 58
Figure 7: Overview - Treatment of Motor Symptoms of Parkinson's Disease 60
Figure 8: Pharmacokinetics of Levodopa 142
Figure 9: Clinical Trials for Parkinson's Disease by Class and Therapeutic Strategy, 2014 161
Figure 10: Parkinson's Disease - Phase II-III Pipeline, Segmented by Indication, 2014 162
Figure 11: Competitive Assessment of Late-Stage Pipeline Agents in Parkinson's Disease, 2012-2022 163
Figure 12: Company Portfolio Gap Analysis in Parkinson's Motor Symptoms, 2012-2022 203
Figure 13: Global Sales for Parkinson's Disease by Region, 2012-2022 229
Figure 14: Sales for Parkinson's Disease in the US by Drug Class, 2012-2022 236
Figure 15: Sales for Parkinson's Disease in France by Drug Class, 2012-2022 242
Figure 16: Sales for Parkinson's Disease in Germany by Drug Class, 2012-2022 248
Figure 17: Sales for Parkinson's Disease in Italy by Drug Class, 2012-2022 254
Figure 18: Sales for Parkinson's Disease in Spain by Drug Class, 2012-2022 261
Figure 19: Sales for Parkinson's Disease in the UK by Drug Class, 2012-2022 267
Figure 20: Sales for Parkinson's Disease in Japan by Drug Class, 2012-2022 273
Figure 21: Sales for Parkinson's Disease in Brazil by Drug Class, 2012-2022 279

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