Market Report Source

Overview

Introduction

Parkinson’s disease (PD) is a progressive, degenerative condition of the central nervous system (CNS), caused by the degeneration of dopaminergic neurons in the substantia nigra of the midbrain. The PD market grew by 6.9% to $1.8 billion between 2004 and 2005. In the absence of conclusive evidence for a neuroprotective compound, the focus on the market remains on symptomatic treatment.

Scope

Assessment of patient size across the seven major markets (US, Japan, France, Germany, Italy, Spain, UK) including prevalence of co-morbid conditions.

Overview of Parkinson’s disease market dynamics, discussing market share across the seven major markets, drug classes and brands.

Qualitative interviews with key international opinion leaders.

Case study analysis of new market entrants which target different disease stages, leading to recommendations to companies entering the market.

Report Highlights

Manufacturers of neuroprotective products will benefit from driving research and awareness of new diagnostic technologies such as genetic testing to better identify patients in the very early stages of PD or those at risk of the disease.

Companies developing improved delivery technologies including continuous transdermal dopamine agonist stimulation and smooth delivery of levodopa will be at a competitive advantage and that novel formulations will become an increasingly important product differentiating strategy.

The major unmet need in the treatment in advanced PD is the reduction of OFF periods. Few companies have investigated this area since advanced patient opportunities represent a very small market and Vernalis’ Apokyn (apomorphine) is presently the only drug available for this specific use.

Reasons to Purchase

Understand key opinion leaders (KOL) views on hot issues in Parkinson’s disease diagnosis, treatment, and unmet needs.

Identify the opportunities and threats for Azilect (rasagiline), Neupro (rotigotine CDS), and Apokyn (apomorphine) in the market.

Identify future challenges to Parkinson’s disease drugs and best method of overcoming these.

Table of Contents

ABOUT DATAMONITOR HEALTHCARE

About the CNS pharmaceutical analysis team

CHAPTER 1 EXECUTIVE SUMMARY

Objective of the analysis

Datamonitor insight into the Parkinson’s disease market

CHAPTER 2 MARKET OVERVIEW

Market definition for this report

Epidemiology

The key age group for PD will double by 2050

Recent studies indicate PD is potentially more common in men than women

Co-morbid conditions are prevalent in PD

Depression- accurate diagnosis is a challenge

Risk for developing dementia is greater in PD than in the general population

Psychosis occurs throughout all stages of PD

Sleep disorders are most common in advanced PD

Market segmentation; two key clinical scales are used to categorize stages of PD

The Hoehn and Yahr staging is widely used in clinical trials

Unified Parkinson’s Disease Rating Scale (UPDRS) offers a more comprehensive measure of PD progression

Advances being made in diagnostic tools for PD

Greater use of neuro-imaging has led to improvement in early PD diagnosis

Increase in primary care physicians diagnosing PD in the UK

Genetic testing is set to become more widespread

Treatment of PD is highly individualized and varies by disease stage

Potential neuroprotective and levodopa-sparing effects put MAOIs in the first line for early patients

Dopamine agonists positioned as levodopa-sparing monotherapies

Levodopa remains the gold-standard treatment of PD

COMT inhibitors aim to decrease OFF time and increase ON time in “wearing-off” patients

Current market situation

Japan and EU drive growth of global market

Dopamine agonists drive market growth

Mirapex leadsthe PD market

CHAPTER 3 CASE STUDY ANALYSIS

Opportunities in early treatment require increasing awareness of PD

Case study: Azilect-promoting the “neuroprotective” ability to capture more patients sooner

Azilect is not metabolized to amphetamine derivatives

Three trials demonstrate efficacy and good tolerability over a six month period

Scenario analysis of ADAGIO trial outcome

KOLs believe neurologists will prescribe Azilect as a levodopa-sparing strategy

Sales of Azilect hang on results of ADAGIO study

Marketing strategies: using the internet to promote simplicity, safety and efficacy

Azilect strategic analysis

Key conclusions drawn from Azilect case study

Improved drug formulations and delivery technologies

Patch (transdermal) formulations

Case study-Neupro (rotigotine CDS)

Clinical trial data demonstrate improvement in motor function and ADLs

Neupro used for non-compliant patients

Neupro strategic analysis

Key conclusions drawn from Neupro case study

Managing levodopa complications

Growing trend towards continuous dopamine stimulation

Case study: Stalevo and the role of levodopa combinations

Clinical trials demonstrate that Stalevo increases ON time, reduces OFF time and improves motor function

Stalevo strategic analysis

Key conclusions drawn from Neupro case study

Advanced-stage patient treatment opportunities

Rescue therapy-a small market niche

Case study: Apokyn- targeting a niche cohort of patients

Apokyn is effective in providing rapid relief from OFF periods in advanced PD and is well tolerated

Sales of Apokyn

Apokyn strategic analysis

Key conclusions drawn from Apokyn case study

Co-morbidities

Depression- an under-diagnosed co-morbid condition of PD

Tricyclic antidepressants: side effects outweigh therapeutic benefits

Dementia- a prevalent yet poorly-treated co-morbid condition

Exelon is the first medication available for PD dementia

Exelon provides moderate improvements in dementia associated with PD

Exelon strategic analysis

Psychosis- treatment is characterized by off-label prescribing

Off-label use of clozapine is effective in reducing psychotic symptoms in PD

Acadia’s ACP-103 in development for PD psychosis

Sleep disorders- subtypes of sleep disorders represent niche opportunities

Seroquel (quetiapine, AstraZeneca) a potential safe and effective treatment for insomnia in PD patients

Lunesta (eszopiclone, Sepracor) under investigation for the treatment of insomnia in PD patients

Provigil (modafinil, Cephalon) recommended for treating hypersomnolence in PD

Key conclusions drawn from examination of co-morbidities

APPENDIX

Contributing experts

Bibliography

References

Websites

Report methodology

Market sizing caveats

Sales calculations

About Datamonitor

About Datamonitor Healthcare

About the CNS analysis team

Disclaimer

List of Tables

Table 1: Prevalence and incidence of Parkinson’s disease (PD) according to key epidemiology studies

Table 2: Prevalence of PD across the seven major markets, 2006

Table 3: Analysis of key brands in the PD market, 2006

Table 4: Percentage of total value accounted for by Parkinson’s disease diagnosis, for marketed brands and generics, 2005

List of Figures

Figure 1: Projection of the population over 65 across the seven major markets, 2005-50

Figure 2: Prevalence of depression in PD by Hoehn and Yahr scale

Figure 3: The five stages of PD according to the Hoehn and Yahr scale

Figure 4: Treatment algorithm for PD

Figure 5: Advantages and disadvantages of selegiline for initial treatment of PD

Figure 6: Advantages and disadvantages of dopamine agonists for the treatment of PD

Figure 7: Advantages and disadvantages of levodopa for the treatment of PD

Figure 8: Advantages and disadvantages of COMT inhibitors for the treatment of PD

Figure 9: Dynamics of the PD market by region 2004-05

Figure 10: The PD market by region, 2002-05

Figure 11: Dynamics of PD drug classes, 2004-05

Figure 12: Breakdown of the PD dollar market by leading brand, 2006

Figure 13: Teva Neuroscience and Eisai’s PD information website

Figure 14: Lundbeck’s website for Azilect, 2006

Figure 15: SWOT analysis for Azilect, 2006

Figure 16: SWOT analysis for Neupro, 2006

Figure 17: SWOT analysis for Stalevo, 2006

Figure 18: SWOT analysis for Apokyn (apomorphine), 2006

Figure 19: Advantages and disadvantages of the use of TCAs in the treatment of depression in PD

Figure 20: Advantages and disadvantages of the use of SSRIs in the treatment of depression in PD

Figure 21: SWOT analysis for Exelon, 2006