Parkinson's Disease (Event Driven)

Decision Resources, Inc, December 2011, Pages: 274

Parkinson’s disease (PD) is one of the most common chronic neurodegenerative diseases in the elderly, and its prevalence is expected to grow as the general population ages. The PD therapy market features a high rate of polypharmacy that is unique among neurological disorders, driven by the need to manage primary motor symptoms and nonmotor symptoms of the disease as well as the need to manage complications associated with levodopa (multiple brand, generics), the drug that remains at the core of PD treatment. High drug-treatment rates, the high rate of polypharmacy and several key areas of unmet need combine to make the PD market one of high-growth opportunity.

Executive Summary
What are the key parameters of the Parkinson’s disease market?
What factors are driving the market for Parkinson’s disease therapies?
What factors are constraining the market for Parkinson’s disease therapies?
What are the drug development activities of note in Parkinson’s disease?
What do the experts say?
What key challenges and opportunities remain?

1 Etiology and Pathophysiology
Overview
Anatomy
Etiology
Risk Factors
Genetics
Protective Factors
Pathophysiology
Regional Neuronal Damage in Parkinson’s Disease
Mechanisms of Neuronal Cell Death
Oxidative Stress and Mitochondrial Dysfunction
Impaired Protein Processing
Role of Lewy Body Inclusions
Prion-Type Disease Mechanism
Inflammation
Dysregulation of Neurotrophic Growth Factors
Interaction of Cytosolic Dopamine, Calcium, and Alpha-Synuclein

2 Epidemiology and Patient Populations
Overview
Disease Definition
Methods
Total Prevalence
Hoehn and Yahr Stage
Dementia Status
Diagnosed and Drug-Treated Populations
Percentage Diagnosed
Percentage Drug-Treated

3 Current Therapies and Medical Practice
Diagnosis
Treatment Providers
Goals of Treatment
Currently Marketed Products
Dopamine Precursors
Dopamine Agonists
Monoamine Oxidase Type B Inhibitors
Catechol-O-Methyltransferase Inhibitors
Antiglutamatergic and Anticholinergic Agents
Acetylcholinesterase Inhibitors
Antipsychotic Agents
Treatment Guidelines and Factors Influencing Drug Selection
Treatment Algorithm
Treatment of Motor Symptoms
Early Parkinson’s Disease
Intermediate-Stage Parkinson’s Disease
Advanced-Stage Parkinson’s Disease
Treatment of Nonmotor Symptoms
Dementia
Depression
Psychosis
Country-Specific Prescribing Trends
Country-Specific Reimbursement Issues

4 Unmet Needs
Overview
Disease-Modifying/Neuroprotective Therapies
Diagnostic Markers for Early Detection of Parkinson’s Disease
Treatment of Parkinson’s Disease-Related Dementia
Control of Levodopa-Induced Motor Response Complications
Control of Gait Dysfunction, Freezing, and Postural Imbalance
Treatment of Parkinson’s Disease-Related Psychosis

5 Emerging Therapies
Overview
Future Positioning of Key Competitors
Early-Stage Therapies
Drug Development and Regulatory Hurdles
Dopamine Precursors
Overview
Mechanism of Action
IPX-066
XP-21279
Dopamine Agonists
Overview
Mechanism of Action
Pardoprunox
Novel Formulations of Apomorphine
Monoamine Oxidase-B Inhibitors
Overview
Mechanism of Action
Safinamide
Metabotropic Glutamate Receptor Modulators
Overview
Mechanism of Action
AFQ-056 (mavoglurant)
Dipraglurant (ADX-48621)
Adenosine A2A Receptor Antagonists
Overview
Mechanism of Action
Istradefylline
Preladenant
Alpha 2A Adrenergic Receptor Antagonists
Overview
Mechanism of Action
Fipamezole
Selective 5-HT
Receptor Inverse Agonists
Overview
Mechanism of Action
Pimavanserin
Antiapoptotic Agents/Neuroprotectants
Overview
Mechanism of Action
PD-02
Gene Therapies
Overview
Mechanism of Action
AV-201
ProSavin
NLX-P101
Cere-120

6 Market Outlook
Overview
Drug-Class-Specific Trends
Dopamine Agonists
Dopamine Precursors
COMT Inhibitors
MAO-B Inhibitors
Anti-Dementia Agents
Antipsychotic Agents
Adenosine A2A Receptor Antagonists

Appendix A Bibliography—Parkinson’s Disease

Appendix B Market Forecast Methodology
Bottom-Up Market Forecasting Overview
Patient Populations
Drug-Specific Assumptions
General Sources of Data
Agents Included in Our Market Analysis
Pricing, Dosing, Days of Therapy, and Compliance Assumptions
General Statements About Pricing
Dosing, Days of Therapy and Compliance
Generic Erosion
Emerging Therapy Prices

Appendix C Experts Interviewed—Parkinson’s Disease

Appendix D Supplemental Epidemiology Bibliography

Tables and Figures

Table 1-1 Expert Commentary: Drug Targets in Parkinson’s Disease

Table 1-2 Known and Suspected Risk Factors in Parkinson’s Disease

Table 1-3 Genetic Loci Linked to Familial and/or Sporadic Parkinson’s Disease

Table 1-4 Known and Putative Protective Factors in Parkinson’s Disease

Table 2-1 Number of Total, Diagnosed, and Drug-Treated Prevalent Cases of Parkinson’s Disease in the Major Pharmaceutical Markets, 2010-2020

Table 2-2 Number of Diagnosed Prevalent Cases of Parkinson’s Disease in the Major Pharmaceutical Markets by Hoehn and Yahr Stage, 2010-2020

Table 2-3 Number of Diagnosed Prevalent Cases of Parkinson’s Disease in the Major Pharmaceutical Markets by Dementia Status, 2010-2020

Table 2-4 Key Sources for Parkinson’s Disease Epidemiology and Model Parameters

Table 3-1 Parkinson’s Disease Treatment Providers and Referral Patterns by Market

Table 3-2 Key End Points Used in Clinical Trials for Parkinson’s Disease

Table 3-3 Motor Response Complications Associated with Long-Term Levodopa Therapy

Table 3-4 Current Therapies Used for Parkinson’s Disease

Table 3-5 Current Classes Used for Parkinson’s Disease—Mechanism of Action

Table 3-6 Clinical Efficacy of Parkinson’s Disease Therapies Used as Monotherapies

Table 3-7 Clinical Efficacy of Parkinson’s Disease Therapies Used as Adjuncts to Levodopa

Table 3-8 Clinical Efficacy of Therapies Addressing Nonmotor Symptoms of Parkinson’s Disease

Table 3-9 Comparison of Current Therapies for Parkinson’s Disease

Table 3-10 Differentiating Features of Leading Drugs in Parkinson’s Disease

Table 3-11 Expert Insight: Leading Drugs in Parkinson’s Disease

Table 3-12 Parkinson’s Disease Treatment Guidelines, by Market

Table 3-13 Factors Influencing Drug Selection in Parkinson’s Disease by Disease Severity

Table 3-14 Expert Insight on Prescribing Practices for Parkinson’s Disease, by Market

Table 3-15 Therapies Used to Treat Nonmotor Neuropsychiatric Symptoms in Parkinson’s Disease

Table 3-16 Reimbursement Environment for Parkinson’s Disease, by Market

Table 4-1 Expert Commentary: Unmet Needs

Table 5-1 Therapies in Development for Parkinson’s Disease

Table 5-2 Estimated Launch Dates for Key Emerging Therapies for the Treatment of Parkinson’s Disease

Table 5-3 Disease-Modifying Therapies in Early-Stage Development for Parkinson’s Disease

Table 5-4 Symptomatic Therapies in Early-Stage Development for Parkinson’s Disease

Table 5-5 Discontinued Parkinson’s Disease Therapies in Advanced Clinical Development

Table 5-6 Select Clinical Trials of Safinamide

Table 5-7 Gene Therapies in Clinical Development for Parkinson’s Disease

Table 6-1 Sales of Drugs to Treat Parkinson’s Disease (all populations) in the Major Pharmaceutical Markets, 2010-2020

Table 6-2 Timeline of Key Market Events for Parkinson’s Disease

Table 6-3 Alternative Market Scenarios for the Parkinson’s Disease Market Through 2020

Table B-1 Sources for Drug Prices

Figure 1-1 Brain Structures Implicated in Movement and Parkinson’s Disease

Figure 1-2 Neuronal Circuits Within the Basal Ganglia Implicated in Control of Normal Movement

Figure 1-3 Changes in Basal Ganglia Circuitry Following Loss of Substantia Nigra Dopaminergic Neurons Leading to Motor Symptoms of Parkinson’s Disease

Figure 1-4 Role of Protein Folding and Degradation in Parkinson’s Disease

Figure 1-5 Drug Targets in the Treatment of Parkinson’s Disease

Figure 1-6 Braak Staging System
Figure 1-7 Neuronal Aging Model for Sporadic Parkinson’s Disease

Figure 1-8 Possible Pathophysiological Roles of Mutant Genes Linked to Parkinson’s Disease

Figure 2-1 Distribution of Diagnosed Prevalent PD Cases by Hoehn and Yahr Stage, 2010

Figure 3-1 Treatment Algorithm for the Management of Parkinson’s Disease

Figure 4-1 Unmet Needs: Attainment and Remaining Opportunity in Parkinson’s Disease

Figure 6-1 Parkinson’s Disease Therapies, 2010-2020: Market Share

Figure 6-2 Timeline of Near-Term Events in Parkinson’s Disease

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