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Forecast Insight: Parkinson's Disease - Market Upgrade following Evidence of Disease Slowing with Azilect
Datamonitor, Sep 2008, Pages: 123
CHAPTER 1 EXECUTIVE SUMMARY
Strategic scoping and focus 3
Insight into the disease market 3
Contributing experts 6
Related reports 6
CHAPTER 2 MARKET DEFINITION AND OVERVIEW
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
Parkinsons 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 Parkinsons disease 15
Key events impacting the Parkinsons 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 Parkinsons 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 Parkinsons disease market forecast 27
Shifting drug class dynamics 27
EU market continues to lead Parkinsons disease sales 28
Sales forecasts revised upwards 29
Parkinsons disease market sales forecast overview 30
CHAPTER 3 BRAND DYNAMICS
Overview of competitive landscape 32
Current market landscape 32
Future market landscape 33
Key drugs in late-stage development for Parkinsons 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 UCBs 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 safinamides 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
Journal papers 105
Websites 107
Datamonitor reports 112
APPENDIX A - MARKET ASSUMPTIONS
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
Contributing experts
Disclaimer 118
List of Tables
Table 1: Prevalence of Parkinsons disease in the US and the 5EU markets, 2008 14
Table 2: Comparison of the patient population (2008) and mean price of Parkinsons disease drugs per IMS standard unit (2007) in the US and 5EU 16
Table 3: Leading branded drug sales ($m) for Parkinsons disease in the seven major markets (7MM) and the rest of the world (ROW), 21
Table 4: Sales forecasts in Parkinsons disease in the 7MM ($m), 2007-2017 31
Table 5: Leading branded drug sales ($m) for Parkinsons disease in the seven major markets, 2007-2017 34
Table 6: Key pipeline drugs in late-stage development for Parkinsons 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: Datamonitors launch dates for Parkinsons disease products across the seven major markets, 2008-2017 113
Table 28: Patent expiry dates for the approved Parkinsons 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: Parkinsons disease-specific sales ($ billion) in the US, 5EU and Japan, 2004-07 12
Figure 4: Parkinsons disease-specific sales performance ($m) in the seven major markets by region, 2006-07 13
Figure 5: Percentage of people aged 65 and over in the 5EU and the US, 2005 15
Figure 6: Price difference between the 5EU and US for the ATC class N4A Anti-Parkinsons Drugs and all drug classes, 2007 17
Figure 7: Key events impacting the Parkinsons disease market, 2004-08 18
Figure 8: ROW vs. 7MM split for the Parkinsons disease-specific sales ($m), 2007 19
Figure 9: Parkinsons disease-specific sales ($m) in the rest of Europe, Asia-Pacific, South and Central America, and other countries, 2004-07 20
Figure 10: Percentage of drug spend on ATC class N4A-Anti-Parkinson Drugs in seven major markets and BRIC countries, 2007 22
Figure 11: Market potential in the BRIC countries compared with the 7MM 23
Figure 12: Compound annual growth rate (CAGR) of the ATC class N4A-Anti-Parkinson Drugs and all drug classes, 2004-07 24
Figure 13: Parkinsons disease sales by class in the seven major markets, 2004-2017 26
Figure 14: Impact of key events on the Parkinsons disease market, 2008-2017 27
Figure 15: Market share by drug class for Parkinsons disease in the seven major markets, 2007 and 2017 28
Figure 16: Parkinsons disease sales by market region, 2004-2017 29
Figure 17: Comparison of Datamonitors updated 2008 Parkinsons disease market forecast with the 2007 market forecast 30
Figure 18: Leading Parkinsons disease brands by sales revenue in the seven major markets ($m), 2007 32
Figure 19: Sales revenue of leading brands for Parkinsons disease ($m), 2004-2017 33
Figure 20: Mirapex (pramipexole instant-release) and pramipexole extended-release Parkinsons disease-specific sales revenue ($m), 2004-2017 39
Figure 21: Parkinsons disease-specific sales revenue for Boehringer Ingelheims pramipexole franchise ($m), 2004-2017 40
Figure 22: Impact of Boehringer Ingelheims reformulation strategy for Mirapex, 2010-17 41
Figure 23: Requip IR and XR historical (2004-07) and forecast (2008-2017) Parkinsons disease-specific sales revenue ($m) 51
Figure 24: Lundbecks use of the ADAGIO trial results as a marketing tool, 2008 59
Figure 25: Parkinsons 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) Parkinsons disease-specific sales revenue ($m). 61
Figure 27: Azilect scenario forecasts for Parkinsons disease-specific sales revenue ($m) in the seven major markets, 2004-2017 64
Figure 28: Parkinsons disease-specific sales revenue ($m) for Novartis/Orions entacapone franchise of Comtan and Stalevo, 2004-07 67
Figure 29: Comtan and Stalevo Parkinsons disease-specific sales revenue ($m) in the seven major markets, 2004-2017 68
Figure 30: Parkinsons disease-specific sales for Neupro (rotigotine) ($m), 2005-07 72
Figure 31: Datamonitors 2008 and 2007 Neupro Parkinsons disease-specific sales revenue ($m) forecasts, 2007-2017 75
Figure 32: Safinamide Parkinsons disease-specific sales revenue ($m) forecast to 2017 79
Figure 33: SLV-308 Parkinsons disease-specific sales revenue ($m) forecast to 2017 82
Figure 34: Pimavanserin Parkinsons disease-specific sales revenue ($m) forecast to 2017 86
Figure 35: Lisuride formulations (Nenad and Lisuride SubQ) Parkinsons disease-specific sales revenue ($m) forecast to 2017 89
Figure 36: Apomorphine Aspirair Parkinsons disease-specific sales revenue ($m) forecast to 2017 97
Figure 37: Parkinsons disease-specific sales revenue of melevodopa formulations in Italy ($m), 2004-07 103
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