Forecast Insight: Parkinson's Disease - Market upgrade following evidence of disease slowing with Azilect

Forecast Insight: Parkinson's Disease - Market upgrade following evidence of disease slowing with Azilect

Introduction

Stimulated by evidence of disease slowing with Teva/Lundbeck's Azilect (rasagiline), and successful reformulation of leading dopamine agonists, the Parkinson's disease market value is set to grow by an compound annual growth rate (CAGR) of 10% over the next 5 years (20072013), peaking at $3.1 billion in 2013.

Scope

*This report gives a strategic analysis of the likely impact that recent events will have on the future Parkinson's disease market

*Includes Parkinson's disease-specific sales forecasts for the key brands and pipeline agents in the seven major markets to 2017

*Provides a global market snapshot by including Parkinson's disease-specific sales analysis for leading brands outside the seven major markets

*Key conclusions are supported by key opinion leader comment

Highlights

Datamonitor has upgraded its forecasts of Teva/Lundbeck's Azilect (rasagiline) following clinical evidence of disease slowing. Over the next 5 years Azilect is expected to become a standard first-line therapy, with sales peaking in 2013, making it the market leading Parkinson's disease drug at this time.

GlaxoSmithKline's Requip XL (ropinirole extended-release) is set to become the market leading dopamine agonist in 2009. The convenience of once-daily dosing, supported by the theoretical clinical advantage of smoother dopamine receptor agonism, will drive switching from the parent compound and Boehringer Ingelheim's Mirapex (pramipexole).

Datamonitor has downgraded its sales forecasts of UCB's Neupro (rotigotine patch) as problems with crystallization of the active ingredient have led to supply issues at a critical phase in its lifecycle. Prescribers are now likely to switch to Requip XL, which arrived on the market at just the right time to take advantage of UCB's misfortune.

Reasons to Purchase

*Understand the impact of recent and anticipated events on the Parkinson's disease market during the forecast period 2008 to 2017

*Quantify the current size of the seven major markets and the trends in the rest of the world

*Assess the impact of events, such as patent expiries and new product launches, on the Parkinson's disease-specific sales of key brands

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 disease market 3
Contributing experts 6
Related reports 6
CHAPTER 2 MARKET DEFINITION AND OVERVIEW 8
Market definition for this report 8
Current seven major market assessment 9
Indication break-down for ATC class N4A-Anti-Parkinson Drugs 9
Rapidly developing restless legs syndrome market in the US 10
Parkinson's disease-specific current market value 11
The 5EU is the largest market for Parkinson disease and is growing at the quickest rate 11
Individual 5EU markets show significant growth 12
Dominance of the 5EU market is driven by demographics 13
Demographics account for the differences among markets 14
Price premium in the US is less evident in Parkinson's disease 15
Key events impacting the Parkinson's disease market 17
Rest of World snapshot 18
Rest of the world (ROW) revenue similar to that generated by the US 18
Growth observed in the rest of the world (ROW) over the last 4 years 19
Leading brand sales in the rest of the world (ROW) 20
Potential for growth in the BRIC (Brazil, Russia, India and China) countries 21
Total elderly population in BRIC is larger than in the seven major markets 22
Growth of the Parkinson's disease market in BRIC countries lags behind total drug spend 23
Future seven major market assessment 25
Azilect and dopamine agonist reformulations drive future growth 25
Key events impacting Datamonitors Parkinson's disease market forecast 27
Shifting drug class dynamics 27
EU market continues to lead Parkinson's disease sales 28
Sales forecasts revised upwards 29
Parkinson's disease market sales forecast overview 30
CHAPTER 3 BRAND DYNAMICS 32
Overview of competitive landscape 32
Current market landscape 32
Future market landscape 33
Key drugs in late-stage development for Parkinson's disease 35
Leading marketed brands 37
Mirapex (pramipexole) and pramipexole extended-release (Boehringer Ingelheim) 37
Competition from Requip XL threatens Mirapex 38
Boehringer Ingelheim developing pramipexole extended-release to combat competition 38
Forecast for the pramipexole franchise 38
Pramipexole extended-release clinical trial program 44
Mirapex instant-release patent situation 45
Requip IR and XL (ropinirole instant-release and extended-release, GlaxoSmithKline) 47
Requip XL development and launch 47
Requip IR is the second most successful dopamine agonist brand 47
Timely life-cycle management strategy 48
Requip IR and XL forecasts 51
Azilect (rasagiline, Teva and Lundbeck) 54
Evidence of disease slowing impacts forecasts 54
Disease slowing proven with ADAGIO trial 55
Switching from selegiline and new patients drives growth 60
Azilect forecast 60
Azilect patent situation - uncertainty expressed in scenario forecasts 63
Stalevo (entacapone/carbidopa/levodopa) and Comtan (entacapone) (Novartis and Orion) 64
Drug overview- Comtan 64
Drug overview- Stalevo 65
Forecast for Comtan and Stalevo 67
Patent situation for Comtan and Stalevo 71
Neupro (rotigotine CDS, UCB) 71
Uptake was strong in the launched markets throughout 2006 and 2007 71
Batch formulation problems 72
GlaxoSmithKline set to benefit from UCB's misfortune 74
Neupro forecast 75
Promising pipeline drugs 77
Safinamide (NW-1015, Merck-Serono and Newron, Phase III) 77
Differentiation from established products difficult 77
Impact of developments over the last 12 months on safinamide's commercial potential 78
Ongoing clinical program 78
Safinamide forecast 79
SLV-308 (pardoprunox, Solvay, Phase III) 80
SLV-308 forecast 82
Pimavanserin (ACP-103, Acadia, Phase III) 83
Competing with off-label antipsychotic use 84
Forecast 86
Lisuride formulations (Nenad, Lisuride SubQ, Axxonis Pharma and Prestwick Pharmaceuticals, pre-registration) 87
Lisuride forecasts 89
Datamonitor comment - safety is the big concern 91
Nenad (Lisuride transdermal patch) - pre-registration in EU 92
Lisuride Sub Q (lisuride subcutaneous infusion) - pre-registration in EU 93
Apomorphine formulations (Aspirair [Vectura], nasal powder [Britannia Pharmaceuticals and Vernalis]) 95
Apomorphine Aspirair inhaler - Phase II 95
Apomorphine nasal powder - Phase III in EU 98
Other pipeline drugs (un-forecasted) 99
Excegran (AD-810N, zonisamide, Dainippon Pharmaceutical, pre-registration in Japan) 99
PD-02 100
V1512 101
Recent discontinuations 104
BIBLIOGRAPHY 105
Journal papers 105
Websites 107
Datamonitor reports 112
APPENDIX A - MARKET ASSUMPTIONS 113
New product launches 113
Patent expiries 114
Data definitions, limitations and assumptions 114
Standard Units 114
Japanese Market Data 114
Derivation of Sales Forecasts and Pricing Trends 115
Forecast methodology 115
APPENDIX B 116
Contributing experts 116
About Datamonitor 116
About Datamonitor Healthcare 116
About the CNS analysis team 117
Disclaimer 118
List of Tables
Table 1: Prevalence of Parkinson's disease in the US and the 5EU markets, 2008 14
Table 2: Comparison of the patient population (2008) and mean price of Parkinson's disease drugs per IMS standard unit (2007) in the US and 5EU 16
Table 3: Leading branded drug sales ($m) for Parkinson's disease in the seven major markets (7MM) and the rest of the world (ROW), 21
Table 4: Sales forecasts in Parkinson's disease in the 7MM ($m), 2007-2017 31
Table 5: Leading branded drug sales ($m) for Parkinson's disease in the seven major markets, 2007-2017 34
Table 6: Key pipeline drugs in late-stage development for Parkinson's disease, 2008 35
Table 7: Key factors impacting sales of Mirapex and pramipexole extended-release, 2008-2017 42
Table 8: Sales forecast for Mirapex IR in the seven major markets, 2007-17 43
Table 9: Sales forecast for pramipexole extended-release in the seven major markets, 2007-17 44
Table 10: Mirapex patent expiry dates, US and 5EU 45
Table 11: Sales forecast for Requip XL in the seven major markets, 2007-17 52
Table 12: Sales forecast for Requip IR in the seven major markets, 2007-17 53
Table 13: Key factors impacting sales of Requip IR and XL, 2008-2017 54
Table 14: Sales forecast for Azilect in the seven major markets, 2007-17 62
Table 15: Key factors impacting sales of Azilect, 2008-2017 62
Table 16: Sales forecast for Comtan in the seven major markets, 2007-17 69
Table 17: Sales forecast for Stalevo in the seven major markets, 2007-17 70
Table 18: Key factors impacting sales of Stalevo and Comtan, 2008-17 70
Table 19: Sales forecast for Neupro in the seven major markets, 2007-17 76
Table 20: Key factors impacting sales of Neupro, 2008-17 76
Table 21: Sales forecast for safinamide in the seven major markets, 2007-17 80
Table 22: Sales forecast for SLV-308 in the seven major markets, 2007-17 83
Table 23: Sales forecast for pimavanserin in the seven major markets, 2007-17 87
Table 24: Sales forecast for Nenad (lisuride patch) in the seven major markets, 2007-17 90
Table 25: Sales forecast for lisuride Sub-Q in the seven major markets, 2007-17 91
Table 26: Sales forecast for apomorphine Aspirair in the seven major markets, 2007-17 98
Table 27: Datamonitor's launch dates for Parkinson's disease products across the seven major markets, 2008-2017 113
Table 28: Patent expiry dates for the approved Parkinson's disease brands in the 7MM, 2007-2017 114
List of Figures
Figure 1: Anti-Parkinson Drug class (N4A) sales value split by indication across the 7MM, 2007 10
Figure 2: Breakdown of ATC class N4A Anti-Parkinson Drug sales by indication in the US, 2005-07 11
Figure 3: Parkinson's disease-specific sales ($ billion) in the US, 5EU and Japan, 2004-07 12
Figure 4: Parkinson's disease-specific sales performance ($m) in the seven major markets by region, 2006-07 13
Figure 5: Percentage of people aged 65 and over in the 5EU and the US, 2005 15
Figure 6: Price difference between the 5EU and US for the ATC class N4A Anti-Parkinson's Drugs and all drug classes, 2007 17
Figure 7: Key events impacting the Parkinson's disease market, 2004-08 18
Figure 8: ROW vs. 7MM split for the Parkinson's disease-specific sales ($m), 2007 19
Figure 9: Parkinson's disease-specific sales ($m) in the rest of Europe, Asia-Pacific, South and Central America, and other countries, 2004-07 20
Figure 10: Percentage of drug spend on ATC class N4A-Anti-Parkinson Drugs in seven major markets and BRIC countries, 2007 22
Figure 11: Market potential in the BRIC countries compared with the 7MM 23
Figure 12: Compound annual growth rate (CAGR) of the ATC class N4A-Anti-Parkinson Drugs and all drug classes, 2004-07 24
Figure 13: Parkinson's disease sales by class in the seven major markets, 2004-2017 26
Figure 14: Impact of key events on the Parkinson's disease market, 2008-2017 27
Figure 15: Market share by drug class for Parkinson's disease in the seven major markets, 2007 and 2017 28
Figure 16: Parkinson's disease sales by market region, 2004-2017 29
Figure 17: Comparison of Datamonitor's updated 2008 Parkinson's disease market forecast with the 2007 market forecast 30
Figure 18: Leading Parkinson's disease brands by sales revenue in the seven major markets ($m), 2007 32
Figure 19: Sales revenue of leading brands for Parkinson's disease ($m), 2004-2017 33
Figure 20: Mirapex (pramipexole instant-release) and pramipexole extended-release Parkinson's disease-specific sales revenue ($m), 2004-2017 39
Figure 21: Parkinson's disease-specific sales revenue for Boehringer Ingelheim's pramipexole franchise ($m), 2004-2017 40
Figure 22: Impact of Boehringer Ingelheim's reformulation strategy for Mirapex, 2010-17 41
Figure 23: Requip IR and XR historical (2004-07) and forecast (2008-2017) Parkinson's disease-specific sales revenue ($m) 51
Figure 24: Lundbeck's use of the ADAGIO trial results as a marketing tool, 2008 59
Figure 25: Parkinson's disease-specific volume (IMS Standard Units, millions) for Azilect and selegiline, 2004-07 60
Figure 26: Azilect (rasagiline) historical (2004-07) and forecast (2008-2017) Parkinson's disease-specific sales revenue ($m). 61
Figure 27: Azilect scenario forecasts for Parkinson's disease-specific sales revenue ($m) in the seven major markets, 2004-2017 64
Figure 28: Parkinson's disease-specific sales revenue ($m) for Novartis/Orion's entacapone franchise of Comtan and Stalevo, 2004-07 67
Figure 29: Comtan and Stalevo Parkinson's disease-specific sales revenue ($m) in the seven major markets, 2004-2017 68
Figure 30: Parkinson's disease-specific sales for Neupro (rotigotine) ($m), 2005-07 72
Figure 31: Datamonitor's 2008 and 2007 Neupro Parkinson's disease-specific sales revenue ($m) forecasts, 2007-2017 75
Figure 32: Safinamide Parkinson's disease-specific sales revenue ($m) forecast to 2017 79
Figure 33: SLV-308 Parkinson's disease-specific sales revenue ($m) forecast to 2017 82
Figure 34: Pimavanserin Parkinson's disease-specific sales revenue ($m) forecast to 2017 86
Figure 35: Lisuride formulations (Nenad and Lisuride SubQ) Parkinson's disease-specific sales revenue ($m) forecast to 2017 89
Figure 36: Apomorphine Aspirair Parkinson's disease-specific sales revenue ($m) forecast to 2017 97
Figure 37: Parkinson's disease-specific sales revenue of melevodopa formulations in Italy ($m), 2004-07 103