IntroductionThe Parkinson's disease market is approaching maturity, with the threat of generic incursion evident in each drug class. Although growth will be stifled by generic launches, relatively successful lifecycle management strategies and new product launches see the Parkinson's disease market grow at a compound annual growth rate (CAGR) of 2.6% over the next 10 years (20082018).Scope*In-depth analysis of the current and future Parkinson's disease market across the US, Japan, France, Germany, Italy, Spain and the UK.*Parkinson's disease-specific sales forecasts for brands and generics from 2008 to 2018.*Assessment of the leading Parkinson's disease brands and drug classes to identify key success factors within this market.*Evaluation of the strategies of leading players in the Parkinson's disease market.HighlightsStalevo's clear convenience and compliance benefit will see the combination therapy emerge as the market leading brand between 2011 and 2013.Although Boehringer Ingelheim is relatively late to the market with a once-daily reformulation, Mirapex/Sifrol's (pramipexole) dominant share of some geographic markets will facilitate a successful launch in 2010.Over the 10-year forecast period the US market will lose significance for Parkinson's disease market players as demographic changes and a less competitive commercial environment will see the European and Japanese markets emerge as key generators of growth.Reasons to Purchase*Quantify the performance of each of the marketed Parkinson's disease drugs in the seven major markets over the period 2008 to 2018.*Assess the changing key opportunities and threats affecting current market players and prospective new entrants.*Identify the leading brands in this market over the next 10 years and understand the key factors driving their success.

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Commercial Insight: Parkinson's Disease - Japan and Europe to
drive total market growth
Published on October 2009
Report Summary
Introduction
The Parkinson's disease market is approaching maturity, with the threat of generic incursion evident in each drug class. Although
growth will be stifled by generic launches, relatively successful lifecycle management strategies and new product launches see the
Parkinson's disease market grow at a compound annual growth rate (CAGR) of 2.6% over the next 10 years (20082018).
Scope
*In-depth analysis of the current and future Parkinson's disease market across the US, Japan, France, Germany, Italy, Spain and the
UK.
*Parkinson's disease-specific sales forecasts for brands and generics from 2008 to 2018.
*Assessment of the leading Parkinson's disease brands and drug classes to identify key success factors within this market.
*Evaluation of the strategies of leading players in the Parkinson's disease market.
Highlights
Stalevo's clear convenience and compliance benefit will see the combination therapy emerge as the market leading brand between
2011 and 2013.
Although Boehringer Ingelheim is relatively late to the market with a once-daily reformulation, Mirapex/Sifrol's (pramipexole) dominant
share of some geographic markets will facilitate a successful launch in 2010.
Over the 10-year forecast period the US market will lose significance for Parkinson's disease market players as demographic
changes and a less competitive commercial environment will see the European and Japanese markets emerge as key generators of
growth.
Reasons to Purchase
*Quantify the performance of each of the marketed Parkinson's disease drugs in the seven major markets over the period 2008 to
2018.
*Assess the changing key opportunities and threats affecting current market players and prospective new entrants.
*Identify the leading brands in this market over the next 10 years and understand the key factors driving their success.
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Table of Content
ABOUT DATAMONITOR HEALTHCARE 2
About the CNS pharmaceutical analysis team 2
CHAPTER 1 EXECUTIVE SUMMARY 3
Strategic scoping and focus 3
Datamonitor insight into the Parkinson's disease market 3
Related reports 6
Upcoming reports 6
CHAPTER 2 MARKET DEFINITION 8
Market definition for this report 8
CHAPTER 3 MARKET OVERVIEW 9
Seven major markets 10
Current and future market overview 10
Opportunities and threats 17
Opportunity - Aging population 17
Opportunity - Better symptomatic treatment 19
Opportunity - Development of neuroprotectants 25
Opportunity - Patch formulations 26
Threat - Maturing drug classes 28
Threat - Global economic downturn 28
US 29
Current and future market assessment 29
Opportunities and threats 34
Opportunity - Quicker accurate diagnosis 34
Opportunity - High public awareness drives access to funding 36
Opportunity - Extra NIH funding 36
Opportunity - Stem cell therapy research 37
Threat - Generic incursion of the dopamine agonist class 37
Threat - Growing number of unemployed patients in the US 39
Japan 40
Current and future market assessment 40
Opportunities and threats 45
Opportunity - Large and growing elderly population 45
Opportunity - Entry into an underdeveloped market 46
Threat - Greater generic incursion expected over the forecast period 47
Five major European markets (5EU) 49
Current and future market assessment 49
Opportunities and threats 54
Opportunity - Price premium for diseases with high unmet need 54
Opportunity - 'Get it on time' campaign 55
Threat - Immature generics markets to grow 56
Threat - EU Commission reviews online drug information 56
Threat - Regulatory changes may facilitate entry of generics 57
France 58
Current and future market assessment 58
Germany 60
Current and future market assessment 60
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Italy 62
Current and future market assessment 62
Spain 64
Current and future market assessment 64
UK 66
Current and future market assessment 66
Rest of the world snapshot 67
Current market assessment 67
CHAPTER 4 BRAND DYNAMICS 71
Overview of competitive landscape 71
Patient acquisition process 73
Introduction 73
Patient care path 73
Points of influence in the patient care path 74
Early incorporation of Azilect (rasagaline, Lundbeck/Teva) into the treatment algorithm' 74
Dopamine agonist or levodopa therapy' 75
Add Comtan or switch to Stalevo' 75
Apomorphine or Duodopa (Carbidopa, Solvay)' 76
Drivers of brand choice 77
Ability to control motor symptoms 77
Cost 79
Side-effect profile 80
Patient convenience 80
Potential neuroprotective properties 81
US formulary tier status for leading brands 82
Mirapex and pramipexole ER (pramipexole, Boehringer Ingelheim) 83
Drug overview 83
Drug profile 84
Product positioning 85
Movement from supportive to monotherapy role 85
Development of pramipexole extended-release 86
SWOT analysis 91
Brand forecast to 2018 92
Generic set to enter the market earlier than patent expiry 92
Requip and Requip XL (ropinirole extended-release; GlaxoSmithKline) 94
Drug overview 94
Drug profile 100
Product positioning 100
Movement from supportive to monotherapy role 100
Superiority of XL version to IR version suggested 102
SWOT analysis 103
Brand forecast to 2018 105
Switching from Mirapex to Requip XL 105
10-year forecast 106
Neupro (rotigotine CDS, UCB) 107
Drug overview 107
Drug profile 110
Product positioning 111
SWOT analysis 111
Brand forecast to 2018 112
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Azilect (rasagiline, Teva/Lundbeck) 115
Drug overview 115
Drug profile 116
Mechanism of action 117
Product positioning 117
Disease-slowing proven with ADAGIO trial 119
General side effects 124
No 'cheese effect' 124
SWOT analysis 126
Brand forecast to 2018 127
Comtan (entacapone, Novartis/Orion) 129
Drug overview 129
Drug profile 130
Mechanism of action 131
Product positioning 132
SWOT analysis 132
Brand forecast to 2018 133
Stalevo (entacapone/carbidopa/levodopa, Novartis/Orion) 134
Drug overview 134
Drug profile 135
Mechanism of action 135
Product positioning 136
Expansion of Stalevo's label 137
SWOT analysis 139
Brand forecast to 2018 140
Duodopa (carbidopa, levodopa intestinal gel, Solvay) 142
Drug overview 142
Drug profile 143
Product positioning 144
SWOT analysis 145
Brand forecast to 2018 147
Other dopamergic brands - levodopa and decarboxylase inhibitors 148
Other dopamergic brand profiles 148
Sinemet (carbidopa, levodopa, Bristol-Myers Squibb) 148
Madopar (levodopa, benserazide hydrochloride, Roche) 149
Parcopa - (carbidopa, levodopa orally disintegrating tablets, UCB) 150
Levodopa and decarboxylase inhibitor product positioning 152
Brand forecast to 2018 153
Safinamide (NW-1015, Merck Serono and Newron, Phase III) 154
Drug overview 154
Drug profile 155
Development overview 155
Clinical trial program 155
Clinical trial data 158
Product positioning 162
Differentiation from established products is difficult 162
Drug forecast to 2018 165
Short exclusivity protection 165
Clinical trial program 165
CHAPTER 5 KEY DEVELOPERS 168
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Strategic overview 168
Trends in corporate strategy 170
Recent strategic partnerships/deals 170
Boehringer Ingelheim 172
Corporate strategy 172
Parkinson's disease portfolio assessment 172
Novartis 174
Corporate strategy 174
Parkinson's disease portfolio assessment 175
UCB 177
Corporate strategy 177
UCB strengthens its CNS portfolio through the purchase of Schwarz Pharma 177
Parkinson's disease portfolio assessment 178
CHAPTER 6 CASE STUDIES 180
Introduction 180
Dopaminergic drug delivery strategies in advanced Parkinson's disease 180
Large population which is inadequately controlled 180
Inadequately controlled with current treatment options 181
Large patient population 181
Add-on therapy is growing in advanced Parkinson's disease market 182
Current dopaminergic drug delivery approaches in advanced Parkinson's disease 184
Subcutaneous - Apokyn (apomorphine, Ipsen) and APO-go (apomorphine, Britannia Pharma) 184
Continuous infusion pump - APO-go (apomorphine) 185
Continuous infusion pump - Duodopa (carbidopa/levodopa) 186
Pipeline dopaminergic drug delivery approaches in advanced Parkinson's disease 188
Inhaler - apomorphine 188
Intranasal - apomorphine 189
Transdermal patch - lisuride 190
Datamonitor comment - safety is the big concern 193
Subcutaneous - lisuride 193
Gene therapies employed as a novel delivery mechanism for dopamine 194
Competition for companies targeting dopaminergic drug delivery approaches in advanced Parkinson's disease 196
Amantadine remains the most popular therapy for dyskinesia 196
Surgery is the last resort 197
BIBLIOGRAPHY 199
Journal papers 199
Websites 201
Datamonitor reports 206
APPENDIX A - MARKET ASSUMPTIONS 208
New product launches 208
Patent expiries 208
Data definitions, limitations and assumptions 209
Standard units 209
Japanese market data 209
Rest of World 209
Derivation of sales forecasts and pricing trends 209
Forecast methodology 210
APPENDIX B 211
Contributing experts 211
Conferences attended 211
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Report methodology 211
About Datamonitor 212
About Datamonitor Healthcare 212
About the CNS analysis team 213
Disclaimer 214
List of Tables
Table 1: Sales and growth of drug classes for Parkinson's diseases in the seven major markets, 2008-2018 15
Table 2: Sales forecasts in Parkinson's disease in the seven major markets ($m), 2008-2018 16
Table 3: Summary of opportunities and threats in the Parkinson's disease market across the seven major pharmaceutical markets,
2009-2018 17
Table 4: Prevalence of psychotic symptoms or hallucinations in Parkinson's disease 22
Table 5: Sales and growth of drug classes for Parkinson's diseases in the US, 2008-2018 31
Table 6: Sales forecasts in Parkinson's disease in the US ($m), 2008-2018 33
Table 7: Summary of opportunities and threats in the Parkinson's disease market in the US, 2009-2018 34
Table 8: Sales and growth of drug classes for Parkinson's diseases in Japan, 2008-2018 42
Table 9: Sales forecasts in Parkinson's disease in Japan ($m), 2008-2018 44
Table 10: Summary of opportunities and threats in the Parkinson's disease market in Japan, 2009-2018 45
Table 11: Sales and growth of drug classes for Parkinson's diseases in the 5EU, 2008-2018 51
Table 12: Sales forecasts in Parkinson's disease across the 5EU ($m), 2008-2018 53
Table 13: Summary of opportunities and threats in the Parkinson's disease market in the 5EU, 2009 54
Table 14: Sales and growth of drug classes for Parkinson's diseases in France, 2008-2018 59
Table 15: Sales and growth of drug classes for Parkinson's diseases in Germany, 2008-2018 61
Table 16: Sales and growth of drug classes for Parkinson's diseases in Italy, 2008-2018 63
Table 17: Sales and growth of drug classes for Parkinson's diseases in Spain, 2008-2018 65
Table 18: Sales and growth of drug classes for Parkinson's diseases in the UK, 2008-2018 67
Table 19: Global Parkinson's disease-specific sales by region ($m), 2005-08 70
Table 20: Leading branded drug sales for Parkinson's disease in the seven major markets ($m), 2008-2018 73
Table 21: Representative formulary tier status in the US for leading brands in Parkinson's disease, 2009 83
Table 22: Mirapex - Drug profile, 2009 84
Table 23: Clinical trial summary for pramipexole extended-release 90
Table 24: Key impacting factors on the revenues of Mirapex and pramipexole extended-release, 2009-2018 93
Table 25: Requip XL- Drug profile, 2009 100
Table 26: Key impacting factors on the revenues of Requip and Requip extended-release, 2009-2018 105
Table 27: Neupro - Drug profile, 2009 110
Table 28: Key impacting factors on the revenues of Neupro, 2009-2018 114
Table 29: Azilect - Drug profile, 2009 116
Table 30: Key impacting factors on the revenues of Azilect, 2009-2018 128
Table 31: Comtan - Drug profile, 2009 130
Table 32: Key impacting factors on the revenues of Comtan, 2009-2018 133
Table 33: Stalevo - Drug profile, 2009 135
Table 34: Key impacting factors on the revenues of Stalevo, 2009-2018 141
Table 35: Duodopa- Drug profile, 2009 143
Table 36: Key impacting factors on the revenues of Duodopa, 2009-2018 147
Table 37: Dopamergic drug profiles, 2009 151
Table 38: Safinamide - Drug profile, 2009 155
Table 39: Clinical trial summary for safinamide, 2009 157
Table 40: Key impacting factors on the revenues of safinamide, 2009-2018 166
Table 41: Top 10 global N4A0 Anti-Parkinson ATC (Anatomical Therapeutic Chemical) class market players, 2008 169
Table 42: Key strategic deals in the Parkinson's disease market, 2008-09 171
Table 43: Global sales for Boehringer Ingelheim's N4A0 Anti-Parkinson ATC class drugs ($m), 2008 173
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Table 44: Global sales for Novartis's 10 leading N4A0 Anti-Parkinson ATC class drugs ($m), 2008 175
Table 45: Prevalence of advanced Parkinson's disease across the seven major markets, 2009 182
Table 46: Phase II gene therapies in development for Parkinson's disease, 2009 196
Table 47: Datamonitor's launch dates for Parkinson's disease products across the seven major markets, 2008-2017 208
Table 48: Patent expiry dates or generic launch dates for the approved Parkinson's disease brands in the 7MM, 2007-2017 208
List of Figures
Figure 1: Parkinson's disease-specific sales by country in the seven major markets, 2005-2018 11
Figure 2: Growth and market share amongst the seven major markets, 2005-08 12
Figure 3: Parkinson's disease-specific sales by class in the seven major markets, 2005-2018 13
Figure 4: Performance of drug classes for Parkinson's disease in the seven major markets, 2008 vs. 2018 14
Figure 5: Demographic changes in the general US population, 2005-2018 18
Figure 6: Percentage change in the 60 years and older population in the seven major markets and BRIC countries, 2009-2018 19
Figure 7: US Parkinson's disease-specific sales by class, 2005-2018 29
Figure 8: Performance of drug classes for Parkinson's disease in the US, 2008 vs. 2018 32
Figure 9: Generic incursion on Requip (ropinirole) in the US, Q2 2008-Q4 2008 38
Figure 10: Mirapex sales volume (IMS Standard Units sold) in the US, Q1 2008-Q4 2008 39
Figure 11: Japan Parkinson's disease-specific sales by class, 2005-2018 41
Figure 12: Performance of drug classes for Parkinson's disease in Japan, 2008 vs. 2018 43
Figure 13: Percentage of the population aged over 60 in Japan, the US and 5EU, 2009-2018 46
Figure 14: Parkinson's disease-specific sales by class across the 5EU, 2005-2018 49
Figure 15: Performance of drug classes for Parkinson's disease in the five major European markets, 2008 vs. 2018 52
Figure 16: AIFA drug innovation evaluation criteria in Italy, 2008 55
Figure 17: French Parkinson's disease-specific sales by class, 2005-2018 58
Figure 18: German Parkinson's disease-specific sales by class, 2005-2018 60
Figure 19: Italian Parkinson's disease-specific sales by class, 2005-2018 62
Figure 20: Spanish Parkinson's disease-specific sales by class, 2005-2018 64
Figure 21: UK Parkinson's disease-specific sales by class, 2005-20 66
Figure 22: Rest of the world versus seven major market sales split in the Parkinson's disease market ($m), 2008 68
Figure 23: Global Parkinson's disease-specific sales ($m), 2005-08 69
Figure 24: Parkinson's disease-specific sales ($m) for key brands in the seven major pharmaceutical markets, 2005-2018 72
Figure 25: Parkinson's disease patient care pathway, 2009 74
Figure 26: Drivers of brand choice for Parkinson's disease, 2009 77
Figure 27: Positioning of Mirapex (or pramipexole extended-release) as a dopamine agonist in Parkinson's disease treatment 85
Figure 28: Double-blind evaluation of pramipexole extended-release (ER) in early Parkinson's disease 87
Figure 29: Double-blind evaluation of maintenance of efficacy of pramipexole extended-release (ER) in early Parkinson's disease 88
Figure 30: Overnight switching from immediate- to extended-release pramipexole in early Parkinson's disease 89
Figure 31: SWOT analysis for Mirapex (pramipexole), 2009 91
Figure 32: Mirapex and pramipexole extended-release Parkinson's disease-specific sales ($m) across the seven major markets,
2005-2018 94
Figure 33: Quarterly Parkinson's disease-specific sales value ($m) for the Requip (ropinirole) franchise in the US and 5EU, 2008 97
Figure 34: Quarterly Parkinson's disease-specific sales volume (IMS Standard Units sold, millions) for the Requip (ropinirole)
franchise in the US and 5EU, 2008 98
Figure 35: Company reported and Datamonitor projected total brand sales for the Requip franchise in the US, Q3 2006-Q4 2009 99
Figure 36: Positioning of Requip (IR or XL) as a dopamine agonist in Parkinson's disease treatment 101
Figure 37: SWOT analysis for the Requip franchise (ropinirole), 2009 104
Figure 38: Requip and Requip XL Parkinson's disease-specific sales ($m) across the seven major markets, 2005-2018 107
Figure 39: Positioning of Neupro in Parkinson's disease treatment 111
Figure 40: SWOT analysis for Neupro (rotigotine patch), 2009 112
Figure 41: Neupro Parkinson's disease-specific sales ($m) across the seven major markets, 2005-2018 115
Figure 42: Azilect mechanism of action in Parkinson's disease 117
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Figure 43: Positioning of Azilect in Parkinson's disease treatment 118
Figure 44: Quarterly Parkinson's disease-specific sales volume (million Standard Units) for Azilect (rasagaline) in the US and 5EU, Q2
2005-Q4 2008 119
Figure 45: Azilect clinical pharmacology study design 126
Figure 46: SWOT analysis for Azilect (rasagiline), 2009 127
Figure 47: Azilect Parkinson's disease-specific sales across the seven major markets ($m), 2005-2018 129
Figure 48: Comtan's mechanism of action in Parkinson's disease 131
Figure 49: Positioning of Comtan in Parkinson's disease treatment 132
Figure 50: SWOT analysis for Comtan (entacapone), 2009 133
Figure 51: Comtan Parkinson's disease-specific sales ($m) across the seven major markets, 2005-2018 134
Figure 52: Stalevo's mechanism of action in Parkinson's disease 136
Figure 53: Positioning of Stalevo in Parkinson's disease treatment 137
Figure 54: Responder rate in the FIRST-STEP Stalevo clinical trial 138
Figure 55: SWOT analysis for Stalevo (levodopa/carbidopa/entacapone), 2009 140
Figure 56: Stalevo Parkinson's disease-specific sales across the seven major markets($m), 2005-2018 142
Figure 57: Duodopa's mechanism of action in Parkinson's disease 144
Figure 58: Positioning of Duodopa (intestinal levodopa/carbidopa) in Parkinson's disease treatment 145
Figure 59: SWOT analysis for Duodopa (levodopa/carbidopa), 2009 146
Figure 60: Duodopa Parkinson's disease-specific sales ($m) seven major markets, 2005-2018 148
Figure 61: Levodopa and decarboxylase inhibitor brands' mechanism of action in Parkinson's disease 152
Figure 62: Positioning of levodopa/carbidopa formulations in Parkinson's disease treatment 153
Figure 63: Sinemet, Madopar and Parcopa Parkinson's disease-specific sales ($m) across the seven major markets, 2005-2018 154
Figure 64: Safinamide in Parkinson's disease clinical program, 2009 156
Figure 65: Study design for study 16, add-on to levodopa in mid-to-late stage patients 159
Figure 66: Positioning of safinamide in Parkinson's disease treatment 163
Figure 67: Safinamide Parkinson's disease-specific sales ($m) across the US and 5EU, 2011-18 167
Figure 68: Novartis's entacapone franchise sales ($m) across the seven major pharmaceutical markets, 2005-2018 176
Figure 69: Percentage of patients adequately controlled at each severity 181
Figure 70: Second-line advanced Parkinson's disease market, 2005-08 183
Figure 71: Second-line advanced Parkinson's disease market, 2005-2018 184
Figure 72: APO-go prefilled multiple dose pen device 185
Figure 73: Crono APO-go pump 186
Figure 74: Duodopa delivery system for Parkinson's disease 187
Figure 75: Aspirair single unit-dose inhaler 188
Figure 76: Percentage of Parkinson's disease patients undergoing surgical procedures in the seven major markets, 2007 197
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