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





Published: December 2013 | Pages: 130 | Format: PDF

 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 

 

 Additional Information 

 Impact of Patent Expiration Unlikely to Be Diminished by New Market Entrants 

 Due to upcoming patent expirations for four high-profile drugs, the global Parkinson’s Disease (PD) market is expected to decline over the forecast period from $3.4 billion in 2012 to $2.9 billion in 2019. However, due to the time delay in drug submission in Canada and Japan, the impact of patent expirations will not be as immediate as in the US and European Union (EU). These patent expirations include Azilect (rasagiline mesylate), Stalevo (levodopa, carbidopa, entacapone) and Comtan (entacapone). Generic alternatives for these drugs have already been approved, which will result in future generic competition over the forecast period. In addition, the impact of the patent expiration of Mirapex (pramipexole dihydrochloride) and Exelon (rivastigmine tartrate) in 2010 and 2012 will continue to halt the market growth over the forecast period. 

 Although the approval of a few market entrants is anticipated over the forecast period, this is not expected to be significant enough to diminish the impact of generic erosion. As new entrants will be competing against cheaper generic products, they are not expected to demand a premium price. An example is Rytary (carbidopa, levodopa) which was developed by Impax Laboratories. The extended-release formulation of levodopa/carbidopa will face intense competition against generic alternatives to Sinemet if approved.  

 Shifting Focus of Pipeline to Long-Term Management of Parkinson’s Disease 

 One of the limitations of existing dopaminergic therapies is the motor complications that arise after several years of treatment. Levodopa-associated motor complications such as the wearing-off phenomenon and dyskinesia can profoundly affect the quality of life in patients with PD. Around 50% of patients develop motor complications after five years of levodopa treatment (Lang and Lozano, 1998). However, current treatment options for these complications remain very limited.  

 As reflected in the pipeline, treatments focusing on improving levodopa-associated complications have received a considerable amount of attention in recent years. Key pipeline candidates have been under investigation for treating wearing-off and Levodopa-Induced Dyskinesia (LID). They include tozadenant, mavoglurant and dipraglurant, which are developed by Biotie Therapies, Novartis and Addex Therapeutics, respectively. In particular, mavoglurant and dipraglurant have demonstrated promising antidyskinesia effects in Phase II. These new developments may potentially bring changes in the future treatment algorithm as side effects of dopaminergic therapies become more manageable.  

 High Number of Neuroprotective Targets in Early Pipeline 

 With existing products focusing on symptomatic relief, a disease-modifying treatment remains an urgent unmet need in PD. The current PD pipeline is made up of 21% neuroprotective targets. The majority, 87%, are currently in discovery and Preclinical development, while the remaining molecules are distributed in Phase I and II. These targets represent innovation in the pipeline and could become an effective disease-modifying treatment in the future.  

 However, that development of such treatment remains challenging, with several obstacles yet to be overcome. The absence of neuroprotective candidates in the late pipeline has been a recurring issue. Of all the challenges, the most urgent is the need for a reliable biomarker for PD that can accelerate the development of treatment. 

 Country  

 Global 

 Sector  

 Central Nervous System 

 1 Table of Contents 

 1.1 List of Tables 

 1.2 List of Figures 

 2 Introduction 

 2.1 Overview 

 2.2 Epidemiology 

 2.3 Etiology 

 2.3.1 Loss of Dopaminergic Neurons 

 2.3.2 Genetic Factors 

 2.3.3 Exposure to Environmental Toxins 

 2.4 Pathophysiology 

 2.4.1 Pathophysiological Changes in Basal Ganglia in Parkinson’s Disease 

 2.4.2 Pathophysiological Changes Involved in the Rise of Motor Complications in Parkinson’s Disease 

 2.5 Symptoms 

 2.6 Co-morbidities and Complications 

 2.7 Diagnosis 

 2.7.1 Classification 

 2.8 Prognosis and Disease Staging 

 2.9 Treatment Options 

 2.9.1 Pharmacological Treatment 

 2.9.2 Non-pharmacological Treatments 

 2.9.3 Treatment Algorithm 

 3 Marketed Products 

 3.1 Therapeutic Landscape 

 3.1.1 Dopamine Replacement Therapies 

 3.1.2 MAO-B inhibitors 

 3.1.3 Dopamine Agonists 

 3.1.4 COMT Inhibitors 

 3.1.5 Nouriast (istradefylline) - Kyowa Hakko Kirin 

 3.1.6 Exelon (rivastigmine tartrate) - Novartis AG 

 3.1.7 Symmetrel (amantadine hydrochloride) - Alliance Pharma Plc 

 3.1.8 Other drugs targeting non-motor symptoms of PD 

 3.2 Comparative Efficacy and Safety 

 3.3 Unmet Need 

 4 Pipeline for Parkinson’s Disease 

 4.1 Overall Pipeline 

 4.2 Molecular Targets in Parkinson’s Disease Pipeline 

 4.3 Clinical Trials 

 4.3.1 Failure Rate of Developmental Pipeline 

 4.3.2 Clinical Trial Sizes 

 4.3.3 Clinical Trial Duration 

 4.3.4 Summary of Clinical Trial Cost and Risk Analyses 

 4.4 Promising Candidates in Pipeline 

 4.4.1 Rytary (carbidopa, levodopa) - Impax Laboratories, Inc. 

 4.4.2 Safinamide - Newron Pharmaceuticals S.p.A 

 4.4.3 Pimavanserin - Acadia Pharmaceuticals Inc. 

 4.4.4 Tozadenant - Biotie Therapies 

 4.4.5 Mavoglurant - Novartis AG 

 4.4.6 Dipraglurant - Addex Therapeutics 

 4.5 Heat Map of Safety and Efficacy for Parkinson’s Disease Pipeline and Marketed Products 

 5 Market Forecast to 2019 

 5.1 Geographical Markets 

 5.1.1 Global Market 

 5.1.2 North America 

 5.1.3 Top Five Countries of Europe 

 5.1.4 Japan 

 5.2 Drivers and Barriers 

 5.2.1 Drivers 

 5.2.2 Barriers 

 6 Deals and Strategic Consolidations 

 6.1 Major Co-development Deals 

 6.1.1 Newron Pharmaceuticals S.p.A. Enter Agreement with Zambon Company S.p.A. 

 6.1.2 QR Pharma, Inc. Enter Research Agreement with Massachusetts General Hospital 

 6.1.3 Ceregene, Inc. Enter Agreement with Genzyme Corporation 

 6.2 Major Licensing Deals 

 6.2.1 Biotie Therapies Corp. Enter Worldwide Agreement with UCB Group 

 6.2.2 Ono Pharmaceutical Co., Ltd. Enter Agreement with Bial - Portela & Ca, S.A 

 6.2.3 Domain Therapeutics S.A. Enter Agreement with Prexton Therapeutics 

 6.2.4 Newron Pharmaceuticals S.p.A. Enter Agreement with Zambon Company S.p.A. 

 6.2.5 Oncodesign SA Enter Agreement with Ipsen S.A. 

 6.2.6 Cephalon, Inc. Enter Licensing Agreement with Mesoblast Limited 

 6.2.7 Shire Pharmaceutical Group Plc Enter Agreement with Heptares Therapeutics Ltd. 

 7 Appendix 

 7.1 All Pipeline Products, by Phase 

 7.2 Sources 

 7.3 Market Definition 

 7.4 Abbreviations 

 7.5 Research Methodology 

 7.5.1 Coverage 

 7.5.2 Secondary Research 

 7.6 Therapeutic Landscape 

 7.7 Epidemiology-Based Forecasting 

 7.8 Market Size by Geography 

 7.9 Geographical Landscape 

 7.10 Pipeline Analysis 

 7.11 Competitive Landscape 

 7.11.1 Expert Panel Validation 

 7.12 Contact Us 

 7.13 Disclaimer 

 1.1 List of Tables 

 Table 1: Definition of the Stages of Disability in Hoehn and Yahr Scale 

 Table 2: Evaluation of Disability by UPDRS 

 Table 3: Definition of the Stages of Disability in Hoehn and Yahr Scale 

 Table 4: Evaluation of Disability by UPDRS 

 Table 5: All Pipeline Products by Phase, Discovery 

 Table 6: All Pipeline Products by Phase, Preclinical 

 Table 7: All Pipeline Products by Phase, IND/CTA Filed and Phase I 

 Table 8: All Pipeline Products by Phase, Phase II 

 Table 9: All Pipeline Products by Phase, Phase III and Pre-registration 

 Table 10: Parkinson’s Disease, Global, Market Forecast, 2012-2019 

 Table 11: Parkinson’s Disease, US, Market Forecast, 2012-2019 

 Table 12: Parkinson’s Disease, Canada, Market Forecast, 2012-2019 

 Table 13: Parkinson’s Disease, UK, Market Forecast, 2012-2019 

 Table 14: Parkinson’s Disease, France, Market Forecast, 2012-2019 

 Table 15: Parkinson’s Disease, Germany, Market Forecast, 2012-2019 

 Table 16: Parkinson’s Disease, Italy, Market Forecast, 2012-201 

 Table 17: Parkinson’s Disease, Spain, Market Forecast, 2012-2019 

 Table 18: Parkinson’s Disease, Japan, Market Forecast, 2012-2019 

 1.2 List of Figures 

 Figure 1: Indirect and Direct Pathway in Basal Ganglia 

 Figure 2: Treatment Algorithm of Parkinson’s Disease 

 Figure 3: Treatment Algorithm of Advanced Parkinson’s Disease 

 Figure 4: Parkinson’s Disease Market, Global, Annual Sales of Madopar ($m), 2008-2012 

 Figure 5: Parkinson’s Disease Market, Global, Annual Sales of Stalevo and Comtan ($m), 2005-2012 

 Figure 6: Parkinson’s Disease Market, Global, Annual Sales of Azilect ($m), 2006-2012 

 Figure 7: Parkinson’s Disease Market, Global, Annual Sales of Requip ($m), 2001-2012 

 Figure 8: Parkinson’s Disease Market, Global, Annual Sales of Mirapex ($m), 2005-2010 

 Figure 9: Parkinson’s Disease Market, Global, Annual Sales of Neupro ($m), 2007-2012 

 Figure 10: Parkinson’s Disease Market, Global, Annual Sales of Apokyn ($m), 2006-2011 

 Figure 11: Parkinson’s Disease Market, Global, Annual Sales of Permax ($m), 2009-2012 

 Figure 12: Parkinson’s Disease Market, Global, Annual Sales of Exelon ($m), 2002-2012 

 Figure 13: Parkinson’s Disease Market, Global, Efficacy Heat Map for Marketed Products, 2012-2019 

 Figure 14: Parkinson’s Disease Market, Global, Efficacy Heat Map for Marketed Products, 2012-2019 

 Figure 15: Pipeline for Parkinson’s Disease, Global, 2012 

 Figure 16: Pipeline for Parkinson’s Disease, Global, 2012 

 Figure 17: Pipeline for Parkinson’s Disease, Global, Clinical Trial Failure Rates (%), 2006-2012 

 Figure 18: Pipeline for Parkinson’s Disease, Global, Clinical Trial Sizes (Participants), 2006-2012 

 Figure 19: Pipeline for Parkinson’s Disease, Global, Clinical Trial Duration (Months), 2006-2012 

 Figure 20: Pipeline for Parkinson’s Disease, Global, Mean Number of Clinical Trials Per Pipeline Drug, 2006-2012 

 Figure 21: Parkinson’s Disease Market, Global, Efficacy Heat Map for Pipeline Products, 2012-2019 

 Figure 22: Parkinson’s Disease Market, Global, Efficacy Heat Map for Marketed Products, 2012-2019 

 Figure 23: Parkinson’s Disease Market, Global, Efficacy Heat Map for Marketed Products, 2012-2019 

 Figure 24: Parkinson’s Disease Market, Global, Annual Sales ($bn), 2012-2019 

 Figure 25: Parkinson’s Disease Market, North America, Treatment Patterns, 2012-2019 

 Figure 26: Parkinson’s Disease Market, North America, Annual Cost of Therapy ($), 2012-2019 

 Figure 27: Parkinson’s Disease Market, North America, Market Size ($m), 2012-2019 

 Figure 28: Parkinson’s Disease Market, Top Five EU Countries, Treatment Patterns, 2012-2019 

 Figure 29: Parkinson’s Disease Market, Top Five EU Countries, Annual Cost of Therapy ($), 2012-2019 

 Figure 30: Parkinson’s Disease Market, Top Five EU Countries, Market Size ($m), 2012-2019 

 Figure 31: Parkinson’s Disease Market, Japan, Treatment Patterns and Annual Cost of Therapy ($), 2012-2019 

 Figure 32: Parkinson’s Disease Market, Japan, Market Size ($m), 2012-2019 

 Figure 33: Parkinson’s Disease Market, Global, Co-Development Deals, 2006-2013 

 Figure 34: Parkinson’s Disease Market, Global, Co-Development Deals, 2006-2013 

 Figure 35: Parkinson’s Disease Market, Global, Licensing Deals, 2006-2013 

 Figure 36: Parkinson’s Disease Market, Global, Licensing Deals, 2006-2013 

 Figure 37: Parkinson’s Disease Market, Global, Breakdown of Licensing Deals in Other Non-dopaminergic Neuromodulatory Targets, 2006-2013 

 Figure 38: GBI Research Market Forecasting Model