Multiple Sclerosis - Continued growth makes the MS market a highly attractive investment
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- About the CNS pharmaceutical analysis team - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Objective of the analysis - page 3
- Datamonitor insight into the multiple sclerosis market - page 3
- Contributing experts - page 4
- Related reports - page 5
- CHAPTER 2 MARKET DEFINITION AND OVERVIEW - page 7
- Market definition for this report - page 7
- Current market situation - page 7
- The seven major MS market continues to grow at a strong rate and exceeded $4.6 billion in 2006 - page 7
- US revenue accounts for over 65% of the seven major MS market - page 8
- Avonex remains clear market leader - page 12
- Tysabri uptake is slower second-time round - page 14
- Strategic scoping and focus - page 14
- CHAPTER 3 COUNTRY MARKET ASSESSMENTS - page 16
- Summary of environmental issues affecting multiple sclerosis market size - page 16
- Seven major markets: opportunities and threats - page 19
- Opportunities - page 19
- Treatments for primary-progressive and secondary-progressive multiple sclerosis remain a significant unmet need - page 19
- Reduced dosing frequency or a less invasive delivery method will significantly increase patient compliance - page 20
- Greater public awareness of MS will speed up presentation to a physician upon the onset of symptoms - page 20
- Improved diagnosis rates will allow treatment to commence earlier - page 22
- Tap into the large untreated population to unlock the full MS patient potential - page 22
- Sharing knowledge on a global platform will increase the understanding of MS - page 23
- Identification of biomarkers will result in a more targeted therapeutic approach - page 24
- Threats - page 25
- Biogeneric threat looms over the multiple sclerosis market - page 25
- Tysabri safety issues may affect the approval of similar pipeline agents - page 26
- Issues with Tysabri-Avonex combination will influence add-on therapy approvals - page 27
- Opportunities - page 19
- US: opportunities and threats - page 28
- Opportunities - page 28
- Patient access programs can increase long-term compliance - page 28
- Mylinax shows that Fast Track status is possible for MS pipeline therapies - page 29
- Company-sponsored nurse service programs show dedicated support to MS patients and increase compliance - page 30
- Threats - page 31
- Reimbursement status is considered a greater influence on prescribing choice than cost - page 31
- Three-year direct-to-consumer advertising ban restricts patient awareness - page 32
- Opportunities - page 28
- Japan: opportunities and threats - page 33
- Opportunities - page 33
- Betaseron and Avonex are the only MS disease-modifiers approved in Japan - page 33
- Governmental funding for clinical trials could benefit research into MS - page 34
- Threats - page 34
- Japanese approval times remains sluggish compared to its US and EU counterparts - page 34
- Opportunities - page 33
- France: opportunities and threats - page 35
- Opportunities - page 35
- Innovative drug development encouraged by price premium and high-level reimbursement - page 35
- Threats - page 35
- After the 2004 French healthcare reforms, pricing stabilization will continue over the foreseeable future - page 35
- New president could impose drive towards private healthcare insurance that may limit patient access to MS treatments - page 37
- Opportunities - page 35
- Germany: opportunities and threats - page 37
- Opportunities - page 37
- Large and growing German market is an attractive region to launch new therapies - page 37
- Threats - page 39
- Parallel importation is on the rise in the German MS market - page 39
- Reimbursement levels will decline if MS disease-modifiers are proven not to be cost effective - page 40
- Opportunities - page 37
- Italy: opportunities and threats - page 41
- Opportunities - page 41
- Initiating early treatment is positively viewed in Italy - page 41
- Innovative drug development rewarded with premium price and 100% reimbursement - page 41
- Threats - page 42
- Implemented price reductions and AIFA payback system restricts market access and limits potential revenue - page 42
- Opportunities - page 41
- Spain: opportunities and threats - page 44
- Opportunities - page 44
- Spanish national formulary will allow health professionals to make better educated treatment decisions - page 44
- Threats - page 44
- The introduction of reference pricing will force MS drug prices down - page 44
- Opportunities - page 44
- UK: opportunities and threats - page 45
- Opportunities - page 45
- NICE Tysabri decision shows promise for pipeline drugs - page 45
- New funding in Wales and Northern Ireland increases access to disease-modifying drugs - page 47
- Diagnosis and treatment rates could increase if NICE guidelines were followed more rigidly - page 48
- Large MS population yet low market value provides scope for significant market growth - page 48
- Threats - page 49
- UK restricts use of disease-modifying drugs based on clinical versus cost-effectiveness - page 49
- The essential role of specialist MS nurses appears uncertain due to the lack of government funding - page 50
- Opportunities - page 45
- CHAPTER 4 FORECAST ANALYSIS - page 52
- Key events - page 52
- New product launches in the US and EU - page 53
- Tysabri launched in the remaining European countries - page 54
- Mylinax (oral cladribine) - page 55
- Fingolimod - page 56
- BG-12 - page 57
- Teriflunomide - page 58
- MBP-8298 - page 58
- Laquinimod - page 60
- Rituxan (rituximab) - page 61
- New product launches in Japan - page 62
- Fingolimod - page 63
- Tysabri - page 63
- Rituxan - page 63
- Reformulations - page 63
- Rebif new-formulation - page 63
- Patent expiries - page 64
- Avonex - page 65
- Rebif - page 66
- Copaxone - page 66
- Tysabri - page 66
- Betaseron - page 66
- New product launches in the US and EU - page 53
- Data definitions, limitations and assumptions - page 67
- Standard units - page 67
- Japanese market data - page 67
- Derivation of sales forecasts and pricing trends - page 67
- Generic erosion and pricing assumptions - page 68
- Forecasts - page 68
- Forecast methodology - page 68
- Key events - page 52
- CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES - page 69
- Introduction - page 69
- How to position a new drug class in the MS market - page 70
- Case study 1: Copaxone - page 71
- Co-marketing agreements in the US and EU strengthened launch platform - page 71
- Definition of a new drug class ensured differentiation - page 72
- MSwatch and Shared Solutions helped promote Copaxone and publicized Teva's patient commitment - page 73
- Improved drug delivery and storage guidelines help maintain year-on-year revenue growth - page 74
- Promotion of Copaxone as both first- and second-line treatment increased targeted patient population - page 75
- Copaxone benefits further as neutralizing antibodies that plague the beta-interferons are shown not to be of issue - page 75
- Double dose of Copaxone showed increased efficacy as Teva looks to compete with high-dose beta-interferons - page 76
- Case study 1: Copaxone - page 71
- Portfolio management strategies that secure long-term growth - page 76
- Case study 2: Biogen Idec - page 77
- Ten years after launch, Avonex is Biogen Idec's leading product and MS remains a principal focus - page 78
- Avonex sales have been driven by timely strategies throughout its lifecycle - page 79
- Tysabri: first follow-on to Avonex - page 84
- Strong and varied pipeline indicates long-term MS market commitment - page 86
- Biogen Idec's MS franchise will continue to grow into the next decade - page 88
- Case study 2: Biogen Idec - page 77
- BIBLIOGRAPHY - page 90
- Journal papers - page 90
- Websites - page 90
- Datamonitor reports - page 93
- APPENDIX A - MARKET DATA AND MAJOR BRAND KEY FACTS - page 94
- Summary of multiple sclerosis market data - page 94
- Beta-interferon market data - page 95
- Others market data - page 98
- APPENDIX B - MARKET FORECAST DATA - page 101
- Seven major markets - page 101
- 5EU market forecasts - page 102
- US market forecasts - page 103
- Japan market forecasts - page 104
- France - page 105
- Germany - page 106
- Italy - page 107
- Spain - page 108
- UK - page 109
- APPENDIX C - page 110
- Contributing experts - page 110
- Report methodology - page 110
- About Datamonitor - page 110
- About Datamonitor Healthcare - page 111
- About the CNS analysis team - page 112
- Disclaimer - page 113
- List of Tables
- Table 1: Key players in the multiple sclerosis market, 2007 - page 11
- Table 2: Summary of environmental issues in the multiple sclerosis market across the seven major markets, 2007 - page 16
- Table 3: Summary of environmental issues in the US and Japanese multiple sclerosis markets, 2007 - page 17
- Table 4: Summary of environmental issues in the 5EU multiple sclerosis markets, 2007 - page 18
- Table 5: Percentage of patients diagnosed with each stage of MS who receive disease-modifying drug therapy across the six major markets, 2006 - page 23
- Table 6: Datamonitor's launch dates for MS products in the 5EU and US, 2007-2016 - page 53
- Table 7: Japan Launch dates for multiple sclerosis disease-modifying pipeline products, 2007-2016 - page 62
- Table 8: Patent expiry dates for the approved multiple sclerosis disease-modifiers in the seven major markets, 2007-2016 - page 65
- Table 9: Biogen Idec's pipeline multiple sclerosis drugs, 2007 - page 87
- Table 10: Multiple sclerosis summary market data, 2006 - page 94
- Table 11: Avonex: key facts - page 95
- Table 12: Betaseron: key facts - page 96
- Table 13: Rebif: key facts - page 97
- Table 14: Copaxone: key facts - page 98
- Table 15: Novantrone: key facts - page 99
- Table 16: Tysabri: key facts - page 100
- Table 17: Seven major market multiple sclerosis drug sales forecasts ($m), 2007-2016 - page 101
- Table 18: 5EU multiple sclerosis drug sales forecasts ($m), 2007-2016 - page 102
- Table 19: US multiple sclerosis drug sales forecasts ($m), 2007-2016 - page 103
- Table 20: Japan multiple sclerosis drug sales forecasts ($m), 2007-2016 - page 104
- Table 21: France multiple sclerosis drug sales forecasts ($m), 2007-2016 - page 105
- Table 22: Germany multiple sclerosis drug sales forecasts ($m), 2007-2016 - page 106
- Table 23: Italy multiple sclerosis drug sales forecasts ($m), 2007-2016 - page 107
- Table 24: Spain multiple sclerosis drug sales forecasts ($m), 2007-2016 - page 108
- Table 25: UK multiple sclerosis drug sales forecasts ($m), 2007-2016 - page 109
- List of Figures
- Figure 1: Multiple sclerosis market value across the seven major markets ($m), 2003-06 - page 8
- Figure 2: Multiple sclerosis market value across the 5EU ($m), 2003-06 - page 9
- Figure 3: Performance of the US, 5EU and Japan multiple sclerosis markets, 2005-06 - page 10
- Figure 4: Timeline: launch dates of disease-modifying therapies for treatment of multiple sclerosis, 1993-2006 - page 12
- Figure 5: Performance of the six disease-modifying multiple sclerosis therapies , 2005-06 - page 13
- Figure 6: Percentage of new patients who suffer from their first symptoms of multiple sclerosis that present to a physician, 2006 - page 21
- Figure 7: Average standard unit price of multiple sclerosis disease-modifying therapies in France, the 5EU and the US ($), 2003-06 - page 36
- Figure 8: 5EU multiple sclerosis market by country, 2003-06 - page 38
- Figure 9: Parallel importation in the German multiple sclerosis market, 2003-06 - page 39
- Figure 10: Standard unit price reduction for the leading multiple sclerosis brands in Italy, 2005-06 - page 43
- Figure 11: Comparison of the standard unit price of multiple sclerosis disease-modifiers in Spain and Italy, 2003-06 - page 45
- Figure 12: Impact of each key event on the global multiple sclerosis market - page 52
- Figure 13: Copaxone sales revenue, 1999-2006 - page 71
- Figure 14: Teva sponsored MSWatch website - page 73
- Figure 15: Shows the prefilled Copaxone syringe and autoinject2 device - page 74
- Figure 16: Forecasted Biogen Idec multiple sclerosis franchise, 2007-2016 - page 77
- Figure 17: Biogen Idec's pipeline multiple sclerosis drugs, June 2007 - page 78
- Figure 18: Avonex sales revenue, 1999-2006 - page 79
- Figure 19: Biogen Idec and Elan sponsored MSActiveSource website - page 80
- Figure 20: Tysabri launch approach, 2006-07 - page 85
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