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Parkinson’s Disease Therapeutics in Major Developed Markets to 2021: Early Pipeline Shifts Towards Disease-Modifying Therapies, while Short Term Growth Driven by Long-Acting Symptomatic Treatments

Parkinson’s Disease Therapeutics in Major Developed Markets to 2021: Early Pipeline Shifts Towards Disease-Modifying Therapies, while Short Term Growth Driven by Long-Acting Symptomatic Treatments

Summary


Parkinson's Disease (PD) is a progressive, chronic neurodegenerative condition, which is currently incurable. It is associated with old age, and characterized by the loss of neurons in the substantia nigra region of the brain. The global Parkinson's Disease (PD) prevalence was estimated at 16.1 million in 2011, and after Alzheimer's disease it is the second most common neurodegenerative disease worldwide.

Parkinson's Disease (PD) is a progressive disease and, although not fatal, it can develop severe symptoms and complications that significantly impact upon the patient's quality of life. Symptoms for each stage can be categorized into early, moderate and advanced stages. Major motor symptoms of Parkinson's Disease (PD) include tremors and difficulty walking. Parkinson's Disease (PD) also gives rise to non-motor symptoms, such as dementia, depression, hallucinations and loss of taste and smell.

There are several different drug classes available to relieve Parkinson's Disease (PD) symptoms. The aim is for treatments to increase dopamine levels, which is substantially diminished in brains affected by Parkinson's Disease (PD). The most common therapies include levodopa, dopamine agonists and Monoamine Oxidase-B (MAO-B) inhibitors, with the choice of therapies dependent on patient symptoms and lifestyle. As the disease develops, the medication will need to be taken more strictly, due to the effect of drugs wearing off (known as off- time), which causes symptoms to return before the next dose.

With the current marketed drugs focusing primarily on symptomatic relief, Parkinson's Disease (PD) remains incurable, with a huge unmet need for disease-modifying therapies. However, due to the lack of clearly established clinical trial methodologies, replication of the benefits demonstrated by neuroprotective agents in the laboratory to human trials has proved challenging. More importantly, due to an incomplete understanding of the underlying mechanisms that cause the disease, a viable therapeutic target to halt or slow disease progression is currently not in scope, which limits the effectiveness of current product development programs.

Scope

  • A brief introduction to Parkinson’s Disease (PD), including pathogenesis, disease staging, diagnosis and treatment algorithms
  • Comprehensive 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 analysis of the pipeline for Parkinson’s Disease (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 thorough analysis of pipeline drug clinical trials by Phase, molecule type, trial size, trial duration, and program failure rate for each molecule type and mechanism of action
  • Multi-scenario market forecast data to 2021, 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 Parkinson’s Disease (PD), by stage of development, molecule type and mechanism of action, as well as analysis of 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 Parkinson’s Disease (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 among clinical Phases and molecule types, and use the clinical trial failure rate analysis to assess the risk profiles of current and/or forthcoming developmental programs for Parkinson’s Disease (PD) therapeutics
  • Observe the trends in clinical trial duration and size among 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 Parkinson’s Disease (PD) therapeutics
  • Assess the potential clinical and commercial impact of current late-stage pipeline molecules on the Parkinson’s Disease (PD) therapeutics market


1 Table of Contents
1.1 List of Tables
1.2 List of Figures
2 Introduction
2.1 Disease Introduction
2.2 Symptoms
2.3 Etiology
2.3.1 Genetic Factors
2.3.2 Environmental Factors
2.3.3 Aging
2.4 Pathophysiology
2.5 Epidemiology
2.6 Disease Stages
2.7 Co-morbidities and Complications
2.8 Diagnosis
2.9 Assessment of Disease Severity
2.9.1 Hoehn and Yahr scale
2.9.2 Unified Parkinson’s Disease Rating Scale
2.10 Treatment
2.10.1 Pharmacological Therapies
2.10.2 Non-pharmacological Treatments
2.11 Treatment Algorithm
2.11.1 Early Parkinson’s Disease
2.11.2 Advanced Parkinson’s Disease
3 Marketed Products
3.1 Overview
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 Other Drugs Targeting Non-motor Symptoms of PD
3.2 Comparative Efficacy and Safety
4 Pipeline for Parkinson’s Disease
4.1 Overview
4.2 Pipeline Distribution by Mechanism of Action/Molecular Target
4.3 Clinical Trials
4.3.1 Failure Rate
4.3.2 Clinical Trial Duration
4.3.3 Clinical Trial Size
4.3.4 Comparison of Average Trial Metrics by Phase and Mechanism of Action
4.4 Promising Pipeline Molecules
4.4.1 Opicapone – Bial
4.4.2 Nuplazid (pimavanserin) – Acadia Pharmaceuticals
4.4.3 Nurelin (Amantadine Hydrochloride Extended-Release) – Adamas Pharmaceuticals
4.4.4 Tozadenant – Biotie Therapies
4.4.5 APL-130277 (apomorphine hydrochloride) – Cynapsus Therapeutics
4.4.6 P2B001 (pramipexole dihydrochloride + rasagiline mesylate) – Pharma Two B
4.4.7 DM-1992 (levodopa + carbidopa extended release) – Depomed
4.4.8 CVT-301 (levodopa) – Acorda Therapeutics
4.4.9 Dipraglurant Immediate-Release– Addex Therapeutics
4.4.10 Accordion Pill (levodopa and carbidopa) – Intec Pharma
4.4.11 ND-0612L (levodopa and carbidopa) – NeuroDerm
4.5 Heatmaps of Safety and Efficacy for Parkinson’s Disease Pipeline and Marketed Products
4.6 Pipeline Product Heat Map and Product Competitiveness Framework
5 Market Forecast to 2021
5.1 Geographical Markets
5.1.1 Global Market
5.1.2 North America
5.1.3 Top Five European Markets
5.1.4 Japan
5.2 Drivers and Barriers
5.2.1 Drivers
5.2.2 Barriers
6 Strategic Consolidations
6.1 Major Co-Development Deals
6.1.1 TechnoPhage Enters into Co-Development Agreement with University of Macau
6.1.2 Dainippon Sumitomo Pharma Enters into Research Agreement with CiRA and Hitachi
6.1.3 MJFF Enters into Agreement with Prothena
6.1.4 Ubiquigent Enters into Co-Development Agreement with UbiQ
6.1.5 23andMe Partners with Genentech
6.2 Major Licensing Deals
6.2.1 Cephalon Enters Into Licensing Agreement With Mesoblast For Regenerative Medicine
6.2.2 Dexcel Pharma Enters into Licensing Agreement with Ramot at Tel Aviv University
6.2.3 Neuropore Therapies Enters into Licensing Agreement with UCB
6.2.4 Catalent Pharma Solutions Enters into Licensing Agreement with Sellas Life Sciences
6.2.5 MedGenesis Therapeutix Enters into Licensing Agreement with Pfizer
7 Appendix
7.1 All Pipeline Drugs by Stage of Development
7.1.1 Discovery
7.1.2 Preclinical
7.1.3 IND/CTA-filed
7.1.4 Phase I
7.1.5 Phase II
7.1.6 Phase III
7.1.7 Pre-registration
7.2 Market Forecasts to 2021
7.2.1 Global
7.2.2 US
7.2.3 Canada
7.2.4 UK
7.2.5 France
7.2.6 Germany
7.2.7 Italy
7.2.8 Spain
7.2.9 Japan
7.3 References
7.4 Abbreviations
7.5 Research Methodology
7.6 Secondary Research
7.7 Marketed Product Profiles
7.8 Late-Stage Pipeline Candidates
7.9 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products
7.10 Product Competitiveness Framework
7.11 Pipeline Analysis
7.11.1 Overall Pipeline
7.11.2 Clinical Trials
7.11.3 Failure Rate
7.11.4 Clinical Trial Size
7.11.5 Clinical Trial Duration
7.11.6 Forecasting Model
7.12 Deals Data Analysis
7.13 Expert Panel Validation
7.14 Contact Us
7.15 Disclaimer
1.1 List of Tables
Table 1: Gene Mutations Related to Parkinson’s Disease and Corresponding Clinical Phenotypes
Table 2: Hoehn and Yahr Scale and the Definition of Disability Stages
Table 3: Unified Parkinson’s Disease Rating Scale
Table 4: All Pipeline Products by Phase, Discovery
Table 5: All Pipeline Products by Phase, Preclinical
Table 6: All Pipeline Products by Phase, IND/CTA-filed
Table 7: All Pipeline Products by Phase, Phase I
Table 8: All Pipeline Products by Phase, Phase II
Table 9: All Pipeline Products by Phase, Phase III
Table 10: All Pipeline Products by Phase, Phase III and Pre-registration
Table 11: Global, Parkinson's Disease Market Forecast, 2014–2021
Table 12: US, Parkinson's Disease Market Forecast, 2014–2021
Table 13: Canada, Parkinson's Disease Market Forecast, 2014–2021
Table 14: UK, Parkinson's Disease Market Forecast, 2014–2021
Table 15: France, Parkinson's Disease Market Forecast, 2014–2021
Table 16: Germany, Parkinson's Disease Market Forecast, 2014–2021
Table 17: Italy, Parkinson's Disease Market Forecast, 2014–2021
Table 18 : Spain, Parkinson's Disease Market Forecast, 2014–2021
Table 19: Japan, Parkinson's Disease Market Forecast, 2014–2021
1.2 List of Figures
Figure 1: Overview of the Basal Ganglia in the Normal State and Parkinson’s Disease State
Figure 2: Parkinson’s Disease Market, Global, Efficacy Heat Map for Marketed Products (Part 1)
Figure 3: Parkinson’s Disease Market, Global, Efficacy Heat Map for Marketed Products (Part 2)
Figure 4: Pipeline for Parkinson’s Disease, Global, 2015
Figure 5: Pipeline for Parkinson’s Disease by Molecular Target, Global, 2015
Figure 6: Pipeline for Parkinson’s Disease by Mechanism of Action, Global, 2015
Figure 7: Parkinson’s Disease, Global, Average Clinical Trial Failure Rate (%), 2006–2015
Figure 8 : Parkinson’s Disease, Global, Clinical Trial Failure Rates for Small Molecules (%), 2006–2015
Figure 9: Parkinson’s Disease, Global, Clinical Trial Failure Rates by Mechanism of Action (%), 2006–2015
Figure 10: Parkinson’s Disease, Global, Clinical Trial Duration by Molecule Type, 2006–2015
Figure 11: Parkinson’s Disease, Global, Clinical Trial Duration by Mechanism of Action, 2006–2015
Figure 12: Parkinson’s Disease, Global, Clinical Trial Size by Molecule Type, 2006–2015
Figure 13: Parkinson’s Disease, Global, Clinical Trial Size by Mechanism of Action, 2006–2015
Figure 14: Pipeline for Parkinson’s Disease, Global, Comparison of Average Trial Metrics by Phase and Mechanism of Action, 2006–2015
Figure 15: Parkinson’s Disease Market, Global, Annual Sales of Opicapone ($m), 2015–2021
Figure 16: Parkinson’s Disease Market, Global, Annual Sales of Nuplazid ($m), 2016–2021
Figure 17 : Parkinson’s Disease Market, Global, Annual Sales of Nurelin ($m), 2016–2021
Figure 18: Parkinson’s Disease Market, Global, Annual Sales of Tozadenant ($m), 2018–2021
Figure 19: Parkinson’s Disease Market, Global, Annual Sales of APL-130277 ($m), 2017–2021
Figure 20: Parkinson’s Disease Market, Global, Annual Sales of P2B001 ($m), 2016–2021
Figure 21: Parkinson’s Disease Market, Global, Annual Sales of DM-1992 ($m), 2018–2021
Figure 22: Parkinson’s Disease Market, Global, Annual Sales of CVT-301 ($m), 2016–2021
Figure 23: Parkinson’s Disease Market, Global, Annual Sales of Dipraglurant IR ($m), 2019–2021
Figure 24: Parkinson’s Disease Market, Global, Annual Sales of the Accordion Pill ($m) 2018–2021
Figure 25: Parkinson’s Disease Market, Global, Annual Sales of ND-0612L ($m) 2019–2021
Figure 26: Parkinson’s Disease Market, Global, Efficacy Heat Map for Pipeline Products
Figure 27: Parkinson’s Disease Market, Global, Efficacy Heat Map for Pipeline Products
Figure 28: Parkinson’s Disease Market, Global, Efficacy Heat Map for Marketed Products
Figure 29: Parkinson’s Disease Market, Global, Efficacy Heat Map for Marketed Products
Figure 30: Parkinson’s Disease Market, Global, Product Competitiveness Early Parkinson’s Disease
Figure 31: Parkinson’s Disease Market, Global, Product Competitiveness Advanced Parkinson’s Disease
Figure 32: Parkinson’s Disease Market, Global, Treatment Patterns by Number of Patients (‘000), 2014–2021
Figure 33: Parkinson’s Disease Market, Global, Market Size ($m), 2014–2021
Figure 34: Parkinson’s Disease Market, US and Canada, Treatment Patterns by Number of Patients (‘000), 2014–2021
Figure 35: Parkinson’s Disease Market, US and Canada, Annual Cost of Therapy ($), 2014–2021
Figure 36: Parkinson’s Disease Market, US and Canada, Market Size ($), 2014–2021
Figure 37: Parkinson’s Disease Market, Top Five EU Countries, Treatment Patterns by Number of Patients (‘000), 2014–2021
Figure 38: Parkinson’s Disease Market, Tope Five EU Countries, Annual Cost of Therapy ($m), 2014–2021
Figure 39: Parkinson’s Disease Market, Top Five EU Countries, Market Size ($m), 2014–2021
Figure 40: Parkinson’s Disease Market, Japan, Treatment Patterns by Number of Patients (‘000) and the Annual Cost of Therapy ($), 2014–2021
Figure 41: Parkinson’s Disease Market, Japan, Market Size ($m), 2014–2021
Figure 42: Parkinson’s Disease Market, Global, Co-development Deals, 2006–2015
Figure 43: Parkinson’s Disease Market, Global, Co-development Deals by Molecule type and Stage of Development, 2006–2015
Figure 44: Parkinson’s Disease Market, Global, Co-development Deals by Mechanism of Action, 2006–2015
Figure 45: Parkinson’s Disease Market, Global, Licensing Deals, 2006–2015
Figure 46: Parkinson’s Disease Market, Global, Licensing Deals by Molecule Type and Stage of Development, 2006–2015
Figure 47: Parkinson’s Disease Market, Global, Licensing Deals by Molecular Targets and Aggregate Deal Value ($), 2006–2015

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