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Parkinson's Disease Therapeutics Market to 2019 - Pipeline Shows Shift Towards Long Term Disease Management

Summary

GBI Research has released the pharma report “Parkinson's Disease Therapeutics Market to 2019 - Pipeline Shows Shift Towards Long Term Disease Management”. The Parkinson’s Disease (PD) market is dominated by symptomatic treatments targeting functional impairment in PD. Levodopa has remained the gold standard treatment for almost 40 years and has significantly improved patient quality of life. There is currently there is a huge unmet need for disease-modifying treatments that slow progression or have neuroprotective properties. Over the 2012–2019 forecast period, the PD market is anticipated to decline from $3.4 billion in 2012 to $2.9 billion in 2019, as a consequence of upcoming patent expirations of high-profile products such as Azilect, Stalevo and Comtan. Although a few market entrants are anticipated to enter the market over the forecast period, they are not expected to offset the impact of generic erosion. Despite their superior profiles over existing treatments, these new products are not expected to command a premium price as they will be competing against generic products. The current PD pipeline reflects a shift of focus to long-term PD management, marked by the development of key pipeline candidates targeting levodopa-associated motor complications. These products will have the potential to change the future treatment algorithm as side effects of dopaminergic therapies become more manageable.

Scope

- A brief introduction to PD, including pathogenesis, disease staging, diagnosis and treatment algorithms
- In-depth analysis of the drugs available for the treatment of PD, covering their safety, efficacy, treatment patterns, and strengths/weaknesses, as well as a heat map comparing drugs in terms of safety and efficacy
- Comprehensive review of the pipeline for PD therapies, including individual analysis of a number of late-stage pipeline drugs that are likely to enter the market in the forecast period, on the basis of phase distribution, molecule type and molecular target
- Additional in-depth analysis of pipeline drug clinical trials by Phase, molecule type, trial size, trial duration, and program failure rate analyses for each molecule type and mechanism of action
- Multi-scenario market forecast data to 2019, taking into account how it will be affected by the introduction of new drugs, the expiry of key patents on current drugs, and changes in disease epidemiology across the key developed markets of the US, Canada, Japan, Germany, the UK, France, Italy and Spain
- Discussion of the drivers of and barriers to market growth
- Discussion of the licensing and co-development deals landscape in PD, by stage of development, molecule type and mechanism of action, as well as analysis both licensing and co-development deals by year, and network maps of licensing and co-development deals

Reasons to buy

- Understand the different levels of PD therapy from early-stage to advanced
- Understand the vast scope of the pipeline, including which molecule types and mechanisms of action are prominent
- Observe the trends in clinical trial duration and size amongst clinical phases and molecule types, and use the clinical trial failure rate analysis to assess the risk profiles of current and/or future developmental programs for PD therapeutics
- Observe the trends in clinical trial duration and size amongst clinical Phases, between molecule types and mechanisms of action, and use the clinical trial failure rate analysis to assess the risk profiles of current and/or future developmental programs for PD therapeutics
- Assess the potential clinical and commercial impact of current late-stage pipeline molecules on the PD therapeutics market

Table Of Contents

Parkinson’s Disease Therapeutics Market to 2019 - Pipeline Shows Shift Towards Long Term Disease Management
Table of Contents

1 Table of Contents 4
1.1 List of Tables 6
1.2 List of Figures 7
2 Introduction 8
2.1 Overview 8
2.2 Epidemiology 8
2.3 Etiology 9
2.3.1 Loss of Dopaminergic Neurons 9
2.3.2 Genetic Factors 9
2.3.3 Exposure to Environmental Toxins 9
2.4 Pathophysiology 10
2.4.1 Pathophysiological Changes in Basal Ganglia in Parkinson's Disease 12
2.4.2 Pathophysiological Changes Involved in the Rise of Motor Complications in Parkinson's Disease 12
2.5 Symptoms 13
2.6 Co-morbidities and Complications 14
2.7 Diagnosis 14
2.7.1 Classification 15
2.8 Prognosis and Disease Staging 19
2.9 Treatment Options 20
2.9.1 Pharmacological Treatment 20
2.9.2 Non-pharmacological Treatments 22
2.9.3 Treatment Algorithm 23
3 Marketed Products 27
3.1 Therapeutic Landscape 28
3.1.1 Dopamine Replacement Therapies 28
3.1.2 MAO-B inhibitors 32
3.1.3 Dopamine Agonists 34
3.1.4 COMT Inhibitors 44
3.1.5 Nouriast (istradefylline) - Kyowa Hakko Kirin 46
3.1.6 Exelon (rivastigmine tartrate) - Novartis AG 46
3.1.7 Symmetrel (amantadine hydrochloride) - Alliance Pharma Plc 48
3.1.8 Other drugs targeting non-motor symptoms of PD 49
3.2 Comparative Efficacy and Safety 50
3.3 Unmet Need 54
4 Pipeline for Parkinson's Disease 55
4.1 Overall Pipeline 55
4.2 Molecular Targets in Parkinson's Disease Pipeline 57
4.3 Clinical Trials 60
4.3.1 Failure Rate of Developmental Pipeline 60
4.3.2 Clinical Trial Sizes 63
4.3.3 Clinical Trial Duration 64
4.3.4 Summary of Clinical Trial Cost and Risk Analyses 66
4.4 Promising Candidates in Pipeline 67
4.4.1 Rytary (carbidopa, levodopa) - Impax Laboratories, Inc. 67
4.4.2 Safinamide - Newron Pharmaceuticals S.p.A 67
4.4.3 Pimavanserin - Acadia Pharmaceuticals Inc. 68
4.4.4 Tozadenant - Biotie Therapies 69
4.4.5 Mavoglurant - Novartis AG 69
4.4.6 Dipraglurant - Addex Therapeutics 70
4.5 Heat Map of Safety and Efficacy for Parkinson's Disease Pipeline and Marketed Products 71
5 Market Forecast to 2019 75
5.1 Geographical Markets 75
5.1.1 Global Market 76
5.1.2 North America 78
5.1.3 Top Five Countries of Europe 81
5.1.4 Japan 85
5.2 Drivers and Barriers 87
5.2.1 Drivers 87
5.2.2 Barriers 88
6 Deals and Strategic Consolidations 90
6.1 Major Co-development Deals 90
6.1.1 Newron Pharmaceuticals S.p.A. Enter Agreement with Zambon Company S.p.A. 92
6.1.2 QR Pharma, Inc. Enter Research Agreement with Massachusetts General Hospital 93
6.1.3 Ceregene, Inc. Enter Agreement with Genzyme Corporation 93
6.2 Major Licensing Deals 93
6.2.1 Biotie Therapies Corp. Enter Worldwide Agreement with UCB Group 96
6.2.2 Ono Pharmaceutical Co., Ltd. Enter Agreement with Bial - Portela and Ca, S.A 96
6.2.3 Domain Therapeutics S.A. Enter Agreement with Prexton Therapeutics 97
6.2.4 Newron Pharmaceuticals S.p.A. Enter Agreement with Zambon Company S.p.A. 97
6.2.5 Oncodesign SA Enter Agreement with Ipsen S.A. 97
6.2.6 Cephalon, Inc. Enter Licensing Agreement with Mesoblast Limited 97
6.2.7 Shire Pharmaceutical Group Plc Enter Agreement with Heptares Therapeutics Ltd. 98
7 Appendix 99
7.1 All Pipeline Products, by Phase 99
7.2 Sources 116
7.3 Market Definition 125
7.4 Abbreviations 125
7.5 Research Methodology 127
7.5.1 Coverage 127
7.5.2 Secondary Research 127
7.6 Therapeutic Landscape 128
7.7 Epidemiology-Based Forecasting 128
7.8 Market Size by Geography 129
7.9 Geographical Landscape 130
7.10 Pipeline Analysis 130
7.11 Competitive Landscape 130
7.11.1 Expert Panel Validation 130
7.12 Contact Us 130
7.13 Disclaimer 130



List of Tables

Table 1: Definition of the Stages of Disability in Hoehn and Yahr Scale 15
Table 2: Evaluation of Disability by UPDRS 17
Table 3: Definition of the Stages of Disability in Hoehn and Yahr Scale 99
Table 4: Evaluation of Disability by UPDRS 99
Table 5: All Pipeline Products by Phase, Discovery 100
Table 6: All Pipeline Products by Phase, Preclinical 102
Table 7: All Pipeline Products by Phase, IND/CTA Filed and Phase I 110
Table 8: All Pipeline Products by Phase, Phase II 111
Table 9: All Pipeline Products by Phase, Phase III and Pre-registration 112
Table 10: Parkinson's Disease, Global, Market Forecast, 2012-2019 113
Table 11: Parkinson's Disease, US, Market Forecast, 2012-2019 113
Table 12: Parkinson's Disease, Canada, Market Forecast, 2012-2019 114
Table 13: Parkinson's Disease, UK, Market Forecast, 2012-2019 114
Table 14: Parkinson's Disease, France, Market Forecast, 2012-2019 114
Table 15: Parkinson's Disease, Germany, Market Forecast, 2012-2019 115
Table 16: Parkinson's Disease, Italy, Market Forecast, 2012-201 115
Table 17: Parkinson's Disease, Spain, Market Forecast, 2012-2019 115
Table 18: Parkinson's Disease, Japan, Market Forecast, 2012-2019 116



List of Figures

Figure 1: Indirect and Direct Pathway in Basal Ganglia 11
Figure 2: Treatment Algorithm of Parkinson's Disease 24
Figure 3: Treatment Algorithm of Advanced Parkinson's Disease 25
Figure 4: Parkinson's Disease Market, Global, Annual Sales of Madopar ($m), 2008-2012 29
Figure 5: Parkinson's Disease Market, Global, Annual Sales of Stalevo and Comtan ($m), 2005-2012 30
Figure 6: Parkinson's Disease Market, Global, Annual Sales of Azilect ($m), 2006-2012 33
Figure 7: Parkinson's Disease Market, Global, Annual Sales of Requip ($m), 2001-2012 35
Figure 8: Parkinson's Disease Market, Global, Annual Sales of Mirapex ($m), 2005-2010 37
Figure 9: Parkinson's Disease Market, Global, Annual Sales of Neupro ($m), 2007-2012 39
Figure 10: Parkinson's Disease Market, Global, Annual Sales of Apokyn ($m), 2006-2011 41
Figure 11: Parkinson's Disease Market, Global, Annual Sales of Permax ($m), 2009-2012 42
Figure 12: Parkinson's Disease Market, Global, Annual Sales of Exelon ($m), 2002-2012 47
Figure 13: Parkinson's Disease Market, Global, Efficacy Heat Map for Marketed Products, 2012-2019 51
Figure 14: Parkinson's Disease Market, Global, Efficacy Heat Map for Marketed Products, 2012-2019 52
Figure 15: Pipeline for Parkinson's Disease, Global, 2012 56
Figure 16: Pipeline for Parkinson's Disease, Global, 2012 57
Figure 17: Pipeline for Parkinson's Disease, Global, Clinical Trial Failure Rates (%), 2006-2012 61
Figure 18: Pipeline for Parkinson's Disease, Global, Clinical Trial Sizes (Participants), 2006-2012 63
Figure 19: Pipeline for Parkinson's Disease, Global, Clinical Trial Duration (Months), 2006-2012 65
Figure 20: Pipeline for Parkinson's Disease, Global, Mean Number of Clinical Trials Per Pipeline Drug, 2006-2012 66
Figure 21: Parkinson's Disease Market, Global, Efficacy Heat Map for Pipeline Products, 2012-2019 72
Figure 22: Parkinson's Disease Market, Global, Efficacy Heat Map for Marketed Products, 2012-2019 73
Figure 23: Parkinson's Disease Market, Global, Efficacy Heat Map for Marketed Products, 2012-2019 74
Figure 24: Parkinson's Disease Market, Global, Annual Sales ($bn), 2012-2019 76
Figure 25: Parkinson's Disease Market, North America, Treatment Patterns, 2012-2019 78
Figure 26: Parkinson's Disease Market, North America, Annual Cost of Therapy ($), 2012-2019 79
Figure 27: Parkinson's Disease Market, North America, Market Size ($m), 2012-2019 80
Figure 28: Parkinson's Disease Market, Top Five EU Countries, Treatment Patterns, 2012-2019 82
Figure 29: Parkinson's Disease Market, Top Five EU Countries, Annual Cost of Therapy ($), 2012-2019 83
Figure 30: Parkinson's Disease Market, Top Five EU Countries, Market Size ($m), 2012-2019 84
Figure 31: Parkinson's Disease Market, Japan, Treatment Patterns and Annual Cost of Therapy ($), 2012-2019 85
Figure 32: Parkinson's Disease Market, Japan, Market Size ($m), 2012-2019 86
Figure 33: Parkinson's Disease Market, Global, Co-Development Deals, 2006-2013 91
Figure 34: Parkinson's Disease Market, Global, Co-Development Deals, 2006-2013 92
Figure 35: Parkinson's Disease Market, Global, Licensing Deals, 2006-2013 94
Figure 36: Parkinson's Disease Market, Global, Licensing Deals, 2006-2013 95
Figure 37: Parkinson's Disease Market, Global, Breakdown of Licensing Deals in Other Non-dopaminergic Neuromodulatory Targets, 2006-2013 96
Figure 38: GBI Research Market Forecasting Model 129

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