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PharmaPoint: Parkinson’s Disease - Global Drug Forecast and Market Analysis to 2022 - Event-Driven Update

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 the recent launch of Xadago and Rytary and an additional four drugs in the late-stage pipeline, 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 Biotie’s tozadenant, Acorda’s CVT-301, Bial’s opicapone, and Intec’s CD/LD-GR, and well as the recently launched drugs: Newron/Zambon’s Xadago and Impax’s Rytary (IPX066).
- 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 - Event-Driven Update
1 Table of Contents
1 Table of Contents 9
1.1 List of Tables 16
1.2 List of Figures 22
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 38
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) 45
4.5.1 Prevalent Cases of Parkinson's Disease 45
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 73
5.4.5 Spain 75
5.4.6 UK 77
5.4.7 Japan 79
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) 87
6.3.2 Sinemet (carbidopa/levodopa) 93
6.3.3 Rytary 98
6.3.4 Duodopa (carbidopa/levodopa intestinal gel) 103
6.4 Product Profiles - COMT Inhibitors 107
6.4.1 Stalevo/Comtan (entacapone) 107
6.5 Dopamine Agonists 113
6.5.1 Neupro (rotigotine transdermal patch) 114
6.5.2 Requip/Requip XL (ropinirole) 121
6.5.3 Apokyn (apomorphine) 125
6.6 Product Profiles - MAO-B Inhibitors 130
6.6.1 Azilect (rasagiline) 131
6.6.2 Xadago (safinamide) 137
6.7 Product Profiles - Adenosine 2A Inhibitor 143
6.7.1 Nouriast (istradefylline) 144
6.8 Product Profiles - Other Therapies 148
7 Opportunity and Unmet Need 149
7.1 Overview 149
7.2 Treatment of Motor Complications - Dyskinesias and OFF Episodes 151
7.2.1 Unmet Need 151
7.2.2 Gap Analysis 153
7.2.3 Opportunity 156
7.3 Treatment of Non-Motor Symptoms and Dementia 156
7.3.1 Unmet Need 156
7.3.2 Gap Analysis 157
7.3.3 Opportunity 159
7.4 Neuroprotective/Disease-Modifying Agents 159
7.4.1 Unmet Need 159
7.4.2 Gap Analysis 160
7.4.3 Opportunity 163
7.5 Improved Drug Formulations 164
7.5.1 Unmet Need 164
7.5.2 Gap Analysis 164
7.5.3 Opportunity 165
7.6 Identification of Reliable Biomarkers 165
7.6.1 Unmet Need 165
7.6.2 Gap Analysis 166
7.6.3 Opportunity 167
7.7 Improved Clinical Trial Design 167
7.7.1 Unmet Need 167
7.7.2 Gap Analysis 168
7.7.3 Opportunity 168
8 Pipeline Assessment 169
8.1 Overview 169
8.2 Clinical Trial Mapping 169
8.2.1 Clinical Trials by Class/Patient Population/Biomarkers/Line of Therapy 169
8.3 Promising Drugs in Clinical Development 171
8.3.1 Tozadenant 173
8.3.2 CVT-301 177
8.3.3 Opicapone 183
8.3.4 AP - CD/LD 188
8.3.5 Other Late-Stage Pipeline Products 192
9 Current and Future Players 193
9.1 Overview 193
9.2 Trends in Corporate Strategy 194
9.3 Company Profiles 195
9.3.1 Merck 195
9.3.2 Roche 197
9.3.3 AbbVie 199
9.3.4 UCB 200
9.3.5 GlaxoSmithKline 202
9.3.6 Novartis 204
9.3.7 Orion 206
9.3.8 Newron 207
9.3.9 Impax 209
9.3.10 Lundbeck 211
10 Market Outlook 214
10.1 Global Markets 214
10.1.1 Forecast 214
10.1.2 Drivers and Barriers - Global Issues 218
10.2 US 221
10.2.1 Forecast 221
10.2.2 Key Events 225
10.2.3 Drivers and Barriers 225
10.3 France 227
10.3.1 Forecast 227
10.3.2 Key Events 231
10.3.3 Drivers and Barriers 231
10.4 Germany 233
10.4.1 Forecast 233
10.4.2 Key Events 237
10.4.3 Drivers and Barriers 237
10.5 Italy 239
10.5.1 Forecast 239
10.5.2 Key Events 243
10.5.3 Drivers and Barriers 243
10.6 Spain 246
10.6.1 Forecast 246
10.6.2 Key Events 250
10.6.3 Drivers and Barriers 250
10.7 UK 252
10.7.1 Forecast 252
10.7.2 Key Events 256
10.7.3 Drivers and Barriers 256
10.8 Japan 258
10.8.1 Forecast 258
10.8.2 Key Events 261
10.8.3 Drivers and Barriers 261
10.9 Brazil 264
10.9.1 Forecast 264
10.9.2 Key Events 267
10.9.3 Drivers and Barriers 267
11 Appendix 269
11.1 Bibliography 269
11.2 Abbreviations 289
11.3 Methodology 294
11.4 Forecasting Methodology 294
11.4.1 Diagnosed Parkinson's Disease Patients 294
11.4.2 Percent Drug-Treated Patients 295
11.4.3 Drugs Included in Each Therapeutic Class 295
11.4.4 Launch and Patent Expiry Dates 296
11.4.5 General Pricing Assumptions 297
11.4.6 Compliance Assumptions 298
11.4.7 Individual Drug Assumptions 299
11.4.8 Generic Erosion 310
11.4.9 Pricing of Pipeline Agents 310
11.5 Physicians and Specialists Included in this Study 312
11.6 About the Authors 314
11.6.1 Author 314
11.6.2 Epidemiologist 316
11.6.3 Global Head of Healthcare 316
11.7 About GlobalData 317
11.8 Disclaimer 317

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 86
Table 23: Product Profile - Madopar 88
Table 24: Madopar SWOT Analysis, 2014 90
Table 25: Global Sales Forecasts ($m) for Madopar, 2012-2022 92
Table 26: Global Sales Forecasts ($m) for Madopar CR, 2012-2022 92
Table 27: Product Profile - Sinemet 94
Table 28: Sinemet SWOT Analysis, 2014 96
Table 29: Global Sales Forecasts ($m) for Sinemet, 2012-2022 97
Table 30: Global Sales Forecasts ($m) for Sinemet CR, 2012-2022 97
Table 31: Product Profile - Rytary 99
Table 32: Rytary SWOT Analysis, 2014 102
Table 33: Global Sales Forecasts ($m) for Rytary, 2012-2022 103
Table 34: Product Profile - Duodopa 104
Table 35: Duodopa SWOT Analysis, 2014 106
Table 36: Global Sales Forecasts ($m) for Duodopa, 2012-2022 107
Table 37: Product Profile - Stalevo 109
Table 38: Product Profile - Comtan 110
Table 39: Stalevo/Comtan SWOT Analysis, 2014 112
Table 40: Global Sales Forecasts ($m) for Stalevo/Comtan, 2012-2022 113
Table 41: Product Profile - Neupro 116
Table 42: Neupro SWOT Analysis, 2014 120
Table 43: Global Sales Forecasts ($m) for Neupro, 2012-2022 121
Table 44: Product Profile - Requip/Requip XL 122
Table 45: Requip/Requip XL SWOT Analysis, 2014 124
Table 46: Global Sales Forecasts ($m) for Requip/Requip XL, 2012-2022 125
Table 47: Product Profile - Apokyn 127
Table 48: Apokyn SWOT Analysis, 2014 128
Table 49: Global Sales Forecasts ($m) for Apokyn Continuous Infusion, 2012-2022 129
Table 50: Global Sales Forecasts ($m) for Apokyn Pen, 2012-2022 130
Table 51: Product Profile - Azilect 132
Table 52: Azilect SWOT Analysis, 2014 136
Table 53: Global Sales Forecasts ($m) for Azilect, 2012-2022 137
Table 54: Product Profile - Xadago 139
Table 55: Summary of Relevant Clinical Trials for Xadago 140
Table 56: Xadago SWOT Analysis, 2014 142
Table 57: Global Sales Forecasts ($m) for Xadago, 2012-2022 143
Table 58: Product Profile - Nouriast 145
Table 59: Nouriast SWOT Analysis, 2014 146
Table 60: Global Sales Forecasts ($m) for Nouriast, 2012-2022 147
Table 61: Summary of Alternative Parkinson's Disease Therapies 148
Table 62: Unmet Need and Opportunity in Parkinson's Disease 150
Table 63: Dyskinesia Pipeline, 2014 155
Table 64: Dementia Pipeline, 2014 158
Table 65: Parkinson's Disease-Modifying Therapeutics Pipeline, 2014 162
Table 66: Product Profile - Tozadenant 174
Table 67: Tozadenant SWOT Analysis, 2014 176
Table 68: Global Sales Forecasts ($m) for Tozadenant, 2012-2022 177
Table 69: Product Profile - CVT-301 179
Table 70: CVT-301 SWOT Analysis, 2014 182
Table 71: Global Sales Forecasts ($m) for CVT-301, 2012-2022 183
Table 72: Product Profile - Opicapone 184
Table 73: Opicapone SWOT Analysis, 2014 186
Table 74: Global Sales Forecasts ($m) for Opicapone, 2012-2022 187
Table 75: Product Profile - AP - CD/LD 188
Table 76: Summary of Relevant Clinical Trials for AP - CD/LD 189
Table 77: AP - CD/LD SWOT Analysis, 2014 191
Table 78: Late-Stage Pipeline, 2015 192
Table 79: Key Companies in the Parkinson's Market, 2015 193
Table 80: Merck's Parkinson's Disease Portfolio Assessment, 2014 197
Table 81: Merck's PD SWOT Analysis, 2014 197
Table 82: Roche's Parkinson's Disease Portfolio Assessment, 2014 199
Table 83: Roche's PD SWOT Analysis, 2014 199
Table 84: AbbVie's Parkinson's Disease Portfolio Assessment, 2014 200
Table 85: AbbVie's PD SWOT Analysis, 2014 200
Table 86: UCB's Parkinson's Disease Portfolio Assessment, 2014 201
Table 87: UCB's PD SWOT Analysis, 2014 201
Table 88: GSK's Parkinson's Disease Portfolio Assessment, 2014 203
Table 89: GSK's PD SWOT Analysis, 2014 203
Table 90: Novartis' Parkinson's Disease Portfolio Assessment, 2014 205
Table 91: Novartis' PD SWOT Analysis, 2014 205
Table 92: Orion's Parkinson's Disease Portfolio Assessment, 2014 207
Table 93: Orion's PD SWOT Analysis, 2014 207
Table 94: Newron's Parkinson's Disease Portfolio Assessment, 2014 208
Table 95: Newron's PD SWOT Analysis, 2014 209
Table 96: Impax's Parkinson's Disease Portfolio Assessment, 2014 210
Table 97: Impax's PD SWOT Analysis, 2014 211
Table 98: Lundbeck's Disease/Therapy Portfolio Assessment, 2014 212
Table 99: Lundbeck's SWOT Analysis, 2014 213
Table 100: Global Sales Forecasts ($m) for Parkinson's Disease, 2012-2022 216
Table 101: Parkinson's Disease Market - Drivers and Barriers, 2012-2022 218
Table 102: Sales Forecasts ($m) for Parkinson's Disease in the US, 2012-2022 223
Table 103: Key Events Impacting Sales for Parkinson's Disease in the US, 2012-2022 225
Table 104: Parkinson's Disease Market in the US - Drivers and Barriers, 2012-2022 225
Table 105: Sales Forecasts ($m) for Parkinson's Disease in France, 2012-2022 229
Table 106: Key Events Impacting Sales for Parkinson's Disease in France, 2012-2022 231
Table 107: Parkinson's Disease Market in France - Drivers and Barriers, 2012-2022 231
Table 108: Sales Forecasts ($m) for Parkinson's Disease in Germany, 2012-2022 235
Table 109: Key Events Impacting Sales for Parkinson's Disease in Germany, 2012-2022 237
Table 110: Parkinson's Disease Market in Germany - Drivers and Barriers, 2012-2022 237
Table 111: Sales Forecasts ($) for Parkinson's Disease in Italy, 2012-2022 241
Table 112: Key Events Impacting Sales for Parkinson's Disease in Italy, 2012-2022 243
Table 113: Parkinson's Disease Market in Italy - Drivers and Barriers, 2012-2022 243
Table 114: Sales Forecasts ($m) for Parkinson's Disease in Spain, 2012-2022 248
Table 115: Key Events Impacting Sales for Parkinson's Disease in Spain, 2012-2022 250
Table 116: Parkinson's Disease Market in Spain - Drivers and Barriers, 2012-2022 250
Table 117: Sales Forecasts ($m) for Parkinson's Disease in the UK, 2012-2022 254
Table 118: Key Events Impacting Sales for Parkinson's Disease in the UK, 2012-2022 256
Table 119: Parkinson's Disease Market in the UK - Drivers and Barriers, 2012-2022 256
Table 120: Sales Forecasts ($m) for Parkinson's Disease in Japan, 2012-2022 259
Table 121: Key Events Impacting Sales for Parkinson's Disease in Japan, 2012-2022 261
Table 122: Parkinson's Disease Market in Japan - Drivers and Barriers, 2012-2022 261
Table 123: Sales Forecasts ($m) for Parkinson's Disease in Brazil, 2012-2022 265
Table 124: Key Events Impacting Sales for Parkinson's Disease in Brazil, 2012-2022 267
Table 125: Parkinson's Disease Market in Brazil - Drivers and Barriers, 2012-2022 267
Table 126: Key Launch Dates 296
Table 127: Key Patent Expiries 297

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 152
Figure 9: Clinical Trials for Parkinson's Disease by Class and Therapeutic Strategy, 2014 171
Figure 10: Parkinson's Disease - Phase II-III Pipeline, Segmented by Indication, 2014 172
Figure 11: Competitive Assessment of Late-Stage Pipeline Agents in Parkinson's Disease, 2012-2022 172
Figure 12: Company Portfolio Gap Analysis in Parkinson's Motor Symptoms, 2012-2022 194
Figure 13: Global Sales for Parkinson's Disease by Country, 2012-2022 217
Figure 14: Sales for Parkinson's Disease in the US by Drug Class, 2012-2022 224
Figure 15: Sales for Parkinson's Disease in France by Drug Class, 2012-2022 230
Figure 16: Sales for Parkinson's Disease in Germany by Drug Class, 2012-2022 236
Figure 17: Sales for Parkinson's Disease in Italy by Drug Class, 2012-2022 242
Figure 18: Sales for Parkinson's Disease in Spain by Drug Class, 2012-2022 249
Figure 19: Sales for Parkinson's Disease in the UK by Drug Class, 2012-2022 255
Figure 20: Sales for Parkinson's Disease in Japan by Drug Class, 2012-2022 260
Figure 21: Sales for Parkinson's Disease in Brazil by Drug Class, 2012-2022 266

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