October 6, 2008
Parkinson’s Disease Latest Update: Market Upgrade Following Evidence of Disease Slowing With Azilect
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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.
- 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
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.
- 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
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