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New report examines the parkinson’s disease therapeutics in major developed markets to 2021

New report examines the parkinson’s disease therapeutics in major developed markets to 2021

Ethocle Reports has published its latest Market Research Report on Parkinson’s Disease Therapeutics in Major Developed Markets to 2021. 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. Browse market data tables and figures. Learn details of the Early Pipeline Shifts Towards Disease-Modifying Therapies, while Short Term Growth Driven by Long-Acting Symptomatic Treatments

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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.

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There are several different drug classes available to relieve Parkinson's Disease (PD) symptoms.

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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.

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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 access

- 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

 Table of Contents

 1.1 List of Tables 7

1.2 List of Figures 7

2 Introduction 9

2.1 Disease Introduction 9

2.2 Symptoms 9

2.3 Etiology 10

2.3.1 Genetic Factors 10

2.3.2 Environmental Factors 11

2.3.3 Aging 11

2.4 Pathophysiology 12

2.5 Epidemiology 13

2.6 Disease Stages 14

2.7 Co-morbidities and Complications 15

2.8 Diagnosis 15

2.9 Assessment of Disease Severity 16

2.9.1 Hoehn and Yahr scale 16

2.9.2 Unified Parkinson’s Disease Rating Scale 16

2.10 Treatment 17

2.10.1 Pharmacological Therapies 18

2.10.2 Non-pharmacological Treatments 20

2.11 Treatment Algorithm 21

2.11.1 Early Parkinson’s Disease 21

2.11.2 Advanced Parkinson’s Disease 22

3 Marketed Products 25

3.1 Overview 25

3.1.1 Dopamine Replacement Therapies 25

3.1.2 MAO-B Inhibitors 28

3.1.3 Dopamine Agonists 30

3.1.4 COMT Inhibitors 35

3.1.5 Other Drugs Targeting Non-motor Symptoms of PD 39

3.2 Comparative Efficacy and Safety 40

4 Pipeline for Parkinson’s Disease 44

4.1 Overview 44

4.2 Pipeline Distribution by Mechanism of Action/Molecular Target 46

4.3 Clinical Trials 49

4.3.1 Failure Rate 49

4.3.2 Clinical Trial Duration 51

4.3.3 Clinical Trial Size 53

4.3.4 Comparison of Average Trial Metrics by Phase and Mechanism of Action 55

4.4 Promising Pipeline Molecules 56

4.4.1 Opicapone – Bial 56

4.4.2 Nuplazid (pimavanserin) – Acadia Pharmaceuticals 58

4.4.3 Nurelin (Amantadine Hydrochloride Extended-Release) – Adamas Pharmaceuticals 59

4.4.4 Tozadenant – Biotie Therapies 60

4.4.5 APL-130277 (apomorphine hydrochloride) – Cynapsus Therapeutics 61

4.4.6 P2B001 (pramipexole dihydrochloride + rasagiline mesylate) – Pharma Two B 63

4.4.7 DM-1992 (levodopa + carbidopa extended release) – Depomed 63

4.4.8 CVT-301 (levodopa) – Acorda Therapeutics 65

4.4.9 Dipraglurant Immediate-Release– Addex Therapeutics 65

4.4.10 Accordion Pill (levodopa and carbidopa) – Intec Pharma 66

4.4.11 ND-0612L (levodopa and carbidopa) – NeuroDerm 67

4.5 Heatmaps of Safety and Efficacy for Parkinson’s Disease Pipeline and Marketed Products 69

4.6 Pipeline Product Heat Map and Product Competitiveness Framework 73

5 Market Forecast to 2021 74

5.1 Geographical Markets 74

5.1.1 Global Market 74

5.1.2 North America 76

5.1.3 Top Five European Markets 79

5.1.4 Japan 84

5.2 Drivers and Barriers 85

5.2.1 Drivers 85

5.2.2 Barriers 86

6 Strategic Consolidations 88

6.1 Major Co-Development Deals 88

6.1.1 TechnoPhage Enters into Co-Development Agreement with University of Macau 90

6.1.2 Dainippon Sumitomo Pharma Enters into Research Agreement with CiRA and Hitachi 90

6.1.3 MJFF Enters into Agreement with Prothena 90

6.1.4 Ubiquigent Enters into Co-Development Agreement with UbiQ 91

6.1.5 23andMe Partners with Genentech 91

6.2 Major Licensing Deals 91

6.2.1 Cephalon Enters Into Licensing Agreement With Mesoblast For Regenerative Medicine 93

6.2.2 Dexcel Pharma Enters into Licensing Agreement with Ramot at Tel Aviv University 94

6.2.3 Neuropore Therapies Enters into Licensing Agreement with UCB 94

6.2.4 Catalent Pharma Solutions Enters into Licensing Agreement with Sellas Life Sciences 94

6.2.5 MedGenesis Therapeutix Enters into Licensing Agreement with Pfizer 95

7 Appendix 96

7.1 All Pipeline Drugs by Stage of Development 96

7.1.1 Discovery 96

7.1.2 Preclinical 100

7.1.3 IND/CTA-filed 112

7.1.4 Phase I 113

7.1.5 Phase II 115

7.1.6 Phase III 117

7.1.7 Pre-registration 118

7.2 Market Forecasts to 2021 118 ….Continued

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