Commercial Insight: Parkinson's Disease - Japan and Europe to drive total market growth

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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

  1. 1. Find Industry reports, Company profilesReportLinker and Market Statistics >> Get this Report Now by email!Commercial Insight: Parkinsons Disease - Japan and Europe todrive total market growthPublished on October 2009 Report SummaryIntroductionThe Parkinsons disease market is approaching maturity, with the threat of generic incursion evident in each drug class. Althoughgrowth will be stifled by generic launches, relatively successful lifecycle management strategies and new product launches see theParkinsons 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 Parkinsons disease market across the US, Japan, France, Germany, Italy, Spain and theUK.*Parkinsons disease-specific sales forecasts for brands and generics from 2008 to 2018.*Assessment of the leading Parkinsons disease brands and drug classes to identify key success factors within this market.*Evaluation of the strategies of leading players in the Parkinsons disease market.HighlightsStalevos clear convenience and compliance benefit will see the combination therapy emerge as the market leading brand between2011 and 2013.Although Boehringer Ingelheim is relatively late to the market with a once-daily reformulation, Mirapex/Sifrols (pramipexole) dominantshare of some geographic markets will facilitate a successful launch in 2010.Over the 10-year forecast period the US market will lose significance for Parkinsons disease market players as demographicchanges and a less competitive commercial environment will see the European and Japanese markets emerge as key generators ofgrowth.Reasons to Purchase*Quantify the performance of each of the marketed Parkinsons disease drugs in the seven major markets over the period 2008 to2018.*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.Commercial Insight: Parkinsons Disease - Japan and Europe to drive total market growth Page 1/10
  2. 2. Find Industry reports, Company profilesReportLinker and Market Statistics Table of ContentABOUT DATAMONITOR HEALTHCARE 2About the CNS pharmaceutical analysis team 2CHAPTER 1 EXECUTIVE SUMMARY 3Strategic scoping and focus 3Datamonitor insight into the Parkinsons disease market 3Related reports 6Upcoming reports 6CHAPTER 2 MARKET DEFINITION 8Market definition for this report 8CHAPTER 3 MARKET OVERVIEW 9Seven major markets 10Current and future market overview 10Opportunities and threats 17Opportunity - Aging population 17Opportunity - Better symptomatic treatment 19Opportunity - Development of neuroprotectants 25Opportunity - Patch formulations 26Threat - Maturing drug classes 28Threat - Global economic downturn 28US 29Current and future market assessment 29Opportunities and threats 34Opportunity - Quicker accurate diagnosis 34Opportunity - High public awareness drives access to funding 36Opportunity - Extra NIH funding 36Opportunity - Stem cell therapy research 37Threat - Generic incursion of the dopamine agonist class 37Threat - Growing number of unemployed patients in the US 39Japan 40Current and future market assessment 40Opportunities and threats 45Opportunity - Large and growing elderly population 45Opportunity - Entry into an underdeveloped market 46Threat - Greater generic incursion expected over the forecast period 47Five major European markets (5EU) 49Current and future market assessment 49Opportunities and threats 54Opportunity - Price premium for diseases with high unmet need 54Opportunity - Get it on time campaign 55Threat - Immature generics markets to grow 56Threat - EU Commission reviews online drug information 56Threat - Regulatory changes may facilitate entry of generics 57France 58Current and future market assessment 58Germany 60Current and future market assessment 60Commercial Insight: Parkinsons Disease - Japan and Europe to drive total market growth Page 2/10
  3. 3. Find Industry reports, Company profilesReportLinker and Market StatisticsItaly 62Current and future market assessment 62Spain 64Current and future market assessment 64UK 66Current and future market assessment 66Rest of the world snapshot 67Current market assessment 67CHAPTER 4 BRAND DYNAMICS 71Overview of competitive landscape 71Patient acquisition process 73Introduction 73Patient care path 73Points of influence in the patient care path 74Early incorporation of Azilect (rasagaline, Lundbeck/Teva) into the treatment algorithm 74Dopamine agonist or levodopa therapy 75Add Comtan or switch to Stalevo 75Apomorphine or Duodopa (Carbidopa, Solvay) 76Drivers of brand choice 77Ability to control motor symptoms 77Cost 79Side-effect profile 80Patient convenience 80Potential neuroprotective properties 81US formulary tier status for leading brands 82Mirapex and pramipexole ER (pramipexole, Boehringer Ingelheim) 83Drug overview 83Drug profile 84Product positioning 85Movement from supportive to monotherapy role 85Development of pramipexole extended-release 86SWOT analysis 91Brand forecast to 2018 92Generic set to enter the market earlier than patent expiry 92Requip and Requip XL (ropinirole extended-release; GlaxoSmithKline) 94Drug overview 94Drug profile 100Product positioning 100Movement from supportive to monotherapy role 100Superiority of XL version to IR version suggested 102SWOT analysis 103Brand forecast to 2018 105Switching from Mirapex to Requip XL 10510-year forecast 106Neupro (rotigotine CDS, UCB) 107Drug overview 107Drug profile 110Product positioning 111SWOT analysis 111Brand forecast to 2018 112Commercial Insight: Parkinsons Disease - Japan and Europe to drive total market growth Page 3/10
  4. 4. Find Industry reports, Company profilesReportLinker and Market StatisticsAzilect (rasagiline, Teva/Lundbeck) 115Drug overview 115Drug profile 116Mechanism of action 117Product positioning 117Disease-slowing proven with ADAGIO trial 119General side effects 124No cheese effect 124SWOT analysis 126Brand forecast to 2018 127Comtan (entacapone, Novartis/Orion) 129Drug overview 129Drug profile 130Mechanism of action 131Product positioning 132SWOT analysis 132Brand forecast to 2018 133Stalevo (entacapone/carbidopa/levodopa, Novartis/Orion) 134Drug overview 134Drug profile 135Mechanism of action 135Product positioning 136Expansion of Stalevos label 137SWOT analysis 139Brand forecast to 2018 140Duodopa (carbidopa, levodopa intestinal gel, Solvay) 142Drug overview 142Drug profile 143Product positioning 144SWOT analysis 145Brand forecast to 2018 147Other dopamergic brands - levodopa and decarboxylase inhibitors 148Other dopamergic brand profiles 148Sinemet (carbidopa, levodopa, Bristol-Myers Squibb) 148Madopar (levodopa, benserazide hydrochloride, Roche) 149Parcopa - (carbidopa, levodopa orally disintegrating tablets, UCB) 150Levodopa and decarboxylase inhibitor product positioning 152Brand forecast to 2018 153Safinamide (NW-1015, Merck Serono and Newron, Phase III) 154Drug overview 154Drug profile 155Development overview 155Clinical trial program 155Clinical trial data 158Product positioning 162Differentiation from established products is difficult 162Drug forecast to 2018 165Short exclusivity protection 165Clinical trial program 165CHAPTER 5 KEY DEVELOPERS 168Commercial Insight: Parkinsons Disease - Japan and Europe to drive total market growth Page 4/10
  5. 5. Find Industry reports, Company profilesReportLinker and Market StatisticsStrategic overview 168Trends in corporate strategy 170Recent strategic partnerships/deals 170Boehringer Ingelheim 172Corporate strategy 172Parkinsons disease portfolio assessment 172Novartis 174Corporate strategy 174Parkinsons disease portfolio assessment 175UCB 177Corporate strategy 177UCB strengthens its CNS portfolio through the purchase of Schwarz Pharma 177Parkinsons disease portfolio assessment 178CHAPTER 6 CASE STUDIES 180Introduction 180Dopaminergic drug delivery strategies in advanced Parkinsons disease 180Large population which is inadequately controlled 180Inadequately controlled with current treatment options 181Large patient population 181Add-on therapy is growing in advanced Parkinsons disease market 182Current dopaminergic drug delivery approaches in advanced Parkinsons disease 184Subcutaneous - Apokyn (apomorphine, Ipsen) and APO-go (apomorphine, Britannia Pharma) 184Continuous infusion pump - APO-go (apomorphine) 185Continuous infusion pump - Duodopa (carbidopa/levodopa) 186Pipeline dopaminergic drug delivery approaches in advanced Parkinsons disease 188Inhaler - apomorphine 188Intranasal - apomorphine 189Transdermal patch - lisuride 190Datamonitor comment - safety is the big concern 193Subcutaneous - lisuride 193Gene therapies employed as a novel delivery mechanism for dopamine 194Competition for companies targeting dopaminergic drug delivery approaches in advanced Parkinsons disease 196Amantadine remains the most popular therapy for dyskinesia 196Surgery is the last resort 197BIBLIOGRAPHY 199Journal papers 199Websites 201Datamonitor reports 206APPENDIX A - MARKET ASSUMPTIONS 208New product launches 208Patent expiries 208Data definitions, limitations and assumptions 209Standard units 209Japanese market data 209Rest of World 209Derivation of sales forecasts and pricing trends 209Forecast methodology 210APPENDIX B 211Contributing experts 211Conferences attended 211Commercial Insight: Parkinsons Disease - Japan and Europe to drive total market growth Page 5/10
  6. 6. Find Industry reports, Company profilesReportLinker and Market StatisticsReport methodology 211About Datamonitor 212About Datamonitor Healthcare 212About the CNS analysis team 213Disclaimer 214List of TablesTable 1: Sales and growth of drug classes for Parkinsons diseases in the seven major markets, 2008-2018 15Table 2: Sales forecasts in Parkinsons disease in the seven major markets ($m), 2008-2018 16Table 3: Summary of opportunities and threats in the Parkinsons disease market across the seven major pharmaceutical markets,2009-2018 17Table 4: Prevalence of psychotic symptoms or hallucinations in Parkinsons disease 22Table 5: Sales and growth of drug classes for Parkinsons diseases in the US, 2008-2018 31Table 6: Sales forecasts in Parkinsons disease in the US ($m), 2008-2018 33Table 7: Summary of opportunities and threats in the Parkinsons disease market in the US, 2009-2018 34Table 8: Sales and growth of drug classes for Parkinsons diseases in Japan, 2008-2018 42Table 9: Sales forecasts in Parkinsons disease in Japan ($m), 2008-2018 44Table 10: Summary of opportunities and threats in the Parkinsons disease market in Japan, 2009-2018 45Table 11: Sales and growth of drug classes for Parkinsons diseases in the 5EU, 2008-2018 51Table 12: Sales forecasts in Parkinsons disease across the 5EU ($m), 2008-2018 53Table 13: Summary of opportunities and threats in the Parkinsons disease market in the 5EU, 2009 54Table 14: Sales and growth of drug classes for Parkinsons diseases in France, 2008-2018 59Table 15: Sales and growth of drug classes for Parkinsons diseases in Germany, 2008-2018 61Table 16: Sales and growth of drug classes for Parkinsons diseases in Italy, 2008-2018 63Table 17: Sales and growth of drug classes for Parkinsons diseases in Spain, 2008-2018 65Table 18: Sales and growth of drug classes for Parkinsons diseases in the UK, 2008-2018 67Table 19: Global Parkinsons disease-specific sales by region ($m), 2005-08 70Table 20: Leading branded drug sales for Parkinsons disease in the seven major markets ($m), 2008-2018 73Table 21: Representative formulary tier status in the US for leading brands in Parkinsons disease, 2009 83Table 22: Mirapex - Drug profile, 2009 84Table 23: Clinical trial summary for pramipexole extended-release 90Table 24: Key impacting factors on the revenues of Mirapex and pramipexole extended-release, 2009-2018 93Table 25: Requip XL- Drug profile, 2009 100Table 26: Key impacting factors on the revenues of Requip and Requip extended-release, 2009-2018 105Table 27: Neupro - Drug profile, 2009 110Table 28: Key impacting factors on the revenues of Neupro, 2009-2018 114Table 29: Azilect - Drug profile, 2009 116Table 30: Key impacting factors on the revenues of Azilect, 2009-2018 128Table 31: Comtan - Drug profile, 2009 130Table 32: Key impacting factors on the revenues of Comtan, 2009-2018 133Table 33: Stalevo - Drug profile, 2009 135Table 34: Key impacting factors on the revenues of Stalevo, 2009-2018 141Table 35: Duodopa- Drug profile, 2009 143Table 36: Key impacting factors on the revenues of Duodopa, 2009-2018 147Table 37: Dopamergic drug profiles, 2009 151Table 38: Safinamide - Drug profile, 2009 155Table 39: Clinical trial summary for safinamide, 2009 157Table 40: Key impacting factors on the revenues of safinamide, 2009-2018 166Table 41: Top 10 global N4A0 Anti-Parkinson ATC (Anatomical Therapeutic Chemical) class market players, 2008 169Table 42: Key strategic deals in the Parkinsons disease market, 2008-09 171Table 43: Global sales for Boehringer Ingelheims N4A0 Anti-Parkinson ATC class drugs ($m), 2008 173Commercial Insight: Parkinsons Disease - Japan and Europe to drive total market growth Page 6/10
  7. 7. Find Industry reports, Company profilesReportLinker and Market StatisticsTable 44: Global sales for Novartiss 10 leading N4A0 Anti-Parkinson ATC class drugs ($m), 2008 175Table 45: Prevalence of advanced Parkinsons disease across the seven major markets, 2009 182Table 46: Phase II gene therapies in development for Parkinsons disease, 2009 196Table 47: Datamonitors launch dates for Parkinsons disease products across the seven major markets, 2008-2017 208Table 48: Patent expiry dates or generic launch dates for the approved Parkinsons disease brands in the 7MM, 2007-2017 208List of FiguresFigure 1: Parkinsons disease-specific sales by country in the seven major markets, 2005-2018 11Figure 2: Growth and market share amongst the seven major markets, 2005-08 12Figure 3: Parkinsons disease-specific sales by class in the seven major markets, 2005-2018 13Figure 4: Performance of drug classes for Parkinsons disease in the seven major markets, 2008 vs. 2018 14Figure 5: Demographic changes in the general US population, 2005-2018 18Figure 6: Percentage change in the 60 years and older population in the seven major markets and BRIC countries, 2009-2018 19Figure 7: US Parkinsons disease-specific sales by class, 2005-2018 29Figure 8: Performance of drug classes for Parkinsons disease in the US, 2008 vs. 2018 32Figure 9: Generic incursion on Requip (ropinirole) in the US, Q2 2008-Q4 2008 38Figure 10: Mirapex sales volume (IMS Standard Units sold) in the US, Q1 2008-Q4 2008 39Figure 11: Japan Parkinsons disease-specific sales by class, 2005-2018 41Figure 12: Performance of drug classes for Parkinsons disease in Japan, 2008 vs. 2018 43Figure 13: Percentage of the population aged over 60 in Japan, the US and 5EU, 2009-2018 46Figure 14: Parkinsons disease-specific sales by class across the 5EU, 2005-2018 49Figure 15: Performance of drug classes for Parkinsons disease in the five major European markets, 2008 vs. 2018 52Figure 16: AIFA drug innovation evaluation criteria in Italy, 2008 55Figure 17: French Parkinsons disease-specific sales by class, 2005-2018 58Figure 18: German Parkinsons disease-specific sales by class, 2005-2018 60Figure 19: Italian Parkinsons disease-specific sales by class, 2005-2018 62Figure 20: Spanish Parkinsons disease-specific sales by class, 2005-2018 64Figure 21: UK Parkinsons disease-specific sales by class, 2005-20 66Figure 22: Rest of the world versus seven major market sales split in the Parkinsons disease market ($m), 2008 68Figure 23: Global Parkinsons disease-specific sales ($m), 2005-08 69Figure 24: Parkinsons disease-specific sales ($m) for key brands in the seven major pharmaceutical markets, 2005-2018 72Figure 25: Parkinsons disease patient care pathway, 2009 74Figure 26: Drivers of brand choice for Parkinsons disease, 2009 77Figure 27: Positioning of Mirapex (or pramipexole extended-release) as a dopamine agonist in Parkinsons disease treatment 85Figure 28: Double-blind evaluation of pramipexole extended-release (ER) in early Parkinsons disease 87Figure 29: Double-blind evaluation of maintenance of efficacy of pramipexole extended-release (ER) in early Parkinsons disease 88Figure 30: Overnight switching from immediate- to extended-release pramipexole in early Parkinsons disease 89Figure 31: SWOT analysis for Mirapex (pramipexole), 2009 91Figure 32: Mirapex and pramipexole extended-release Parkinsons disease-specific sales ($m) across the seven major markets,2005-2018 94Figure 33: Quarterly Parkinsons disease-specific sales value ($m) for the Requip (ropinirole) franchise in the US and 5EU, 2008 97Figure 34: Quarterly Parkinsons disease-specific sales volume (IMS Standard Units sold, millions) for the Requip (ropinirole)franchise in the US and 5EU, 2008 98Figure 35: Company reported and Datamonitor projected total brand sales for the Requip franchise in the US, Q3 2006-Q4 2009 99Figure 36: Positioning of Requip (IR or XL) as a dopamine agonist in Parkinsons disease treatment 101Figure 37: SWOT analysis for the Requip franchise (ropinirole), 2009 104Figure 38: Requip and Requip XL Parkinsons disease-specific sales ($m) across the seven major markets, 2005-2018 107Figure 39: Positioning of Neupro in Parkinsons disease treatment 111Figure 40: SWOT analysis for Neupro (rotigotine patch), 2009 112Figure 41: Neupro Parkinsons disease-specific sales ($m) across the seven major markets, 2005-2018 115Figure 42: Azilect mechanism of action in Parkinsons disease 117Commercial Insight: Parkinsons Disease - Japan and Europe to drive total market growth Page 7/10
  8. 8. Find Industry reports, Company profilesReportLinker and Market StatisticsFigure 43: Positioning of Azilect in Parkinsons disease treatment 118Figure 44: Quarterly Parkinsons disease-specific sales volume (million Standard Units) for Azilect (rasagaline) in the US and 5EU, Q22005-Q4 2008 119Figure 45: Azilect clinical pharmacology study design 126Figure 46: SWOT analysis for Azilect (rasagiline), 2009 127Figure 47: Azilect Parkinsons disease-specific sales across the seven major markets ($m), 2005-2018 129Figure 48: Comtans mechanism of action in Parkinsons disease 131Figure 49: Positioning of Comtan in Parkinsons disease treatment 132Figure 50: SWOT analysis for Comtan (entacapone), 2009 133Figure 51: Comtan Parkinsons disease-specific sales ($m) across the seven major markets, 2005-2018 134Figure 52: Stalevos mechanism of action in Parkinsons disease 136Figure 53: Positioning of Stalevo in Parkinsons disease treatment 137Figure 54: Responder rate in the FIRST-STEP Stalevo clinical trial 138Figure 55: SWOT analysis for Stalevo (levodopa/carbidopa/entacapone), 2009 140Figure 56: Stalevo Parkinsons disease-specific sales across the seven major markets($m), 2005-2018 142Figure 57: Duodopas mechanism of action in Parkinsons disease 144Figure 58: Positioning of Duodopa (intestinal levodopa/carbidopa) in Parkinsons disease treatment 145Figure 59: SWOT analysis for Duodopa (levodopa/carbidopa), 2009 146Figure 60: Duodopa Parkinsons disease-specific sales ($m) seven major markets, 2005-2018 148Figure 61: Levodopa and decarboxylase inhibitor brands mechanism of action in Parkinsons disease 152Figure 62: Positioning of levodopa/carbidopa formulations in Parkinsons disease treatment 153Figure 63: Sinemet, Madopar and Parcopa Parkinsons disease-specific sales ($m) across the seven major markets, 2005-2018 154Figure 64: Safinamide in Parkinsons disease clinical program, 2009 156Figure 65: Study design for study 16, add-on to levodopa in mid-to-late stage patients 159Figure 66: Positioning of safinamide in Parkinsons disease treatment 163Figure 67: Safinamide Parkinsons disease-specific sales ($m) across the US and 5EU, 2011-18 167Figure 68: Novartiss entacapone franchise sales ($m) across the seven major pharmaceutical markets, 2005-2018 176Figure 69: Percentage of patients adequately controlled at each severity 181Figure 70: Second-line advanced Parkinsons disease market, 2005-08 183Figure 71: Second-line advanced Parkinsons disease market, 2005-2018 184Figure 72: APO-go prefilled multiple dose pen device 185Figure 73: Crono APO-go pump 186Figure 74: Duodopa delivery system for Parkinsons disease 187Figure 75: Aspirair single unit-dose inhaler 188Figure 76: Percentage of Parkinsons disease patients undergoing surgical procedures in the seven major markets, 2007 197Commercial Insight: Parkinsons Disease - Japan and Europe to drive total market growth Page 8/10
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