TABLE OF CONTENTS
CHAPTER 1 EXECUTIVE SUMMARY 3
Objective of the analysis 3
Datamonitor insight into the multiple sclerosis market 3
Contributing experts 4
Related reports 5
CHAPTER 2 MARKET DEFINITION AND OVERVIEW 14
Market definition for this report 14
Current market situation 14
The seven major MS market continues to grow at a strong rate and exceeded $4.6 billion in 2006 14
US revenue accounts for over 65% of the seven major MS market 15
Avonex remains clear market leader 19
Tysabri uptake is slower second-time round 21
Strategic scoping and focus 21
CHAPTER 3 COUNTRY MARKET ASSESSMENTS 23
Summary of environmental issues affecting multiple sclerosis market size 23
Seven major markets: opportunities and threats 26
Opportunities 26
Treatments for primary-progressive and secondary-progressive multiple sclerosis remain a significant unmet need 26
Reduced dosing frequency or a less invasive delivery method will significantly increase patient compliance 27
Greater public awareness of MS will speed up presentation to a physician upon the onset of symptoms 27
Improved diagnosis rates will allow treatment to commence earlier 29
Tap into the large untreated population to unlock the full MS patient potential 29
Sharing knowledge on a global platform will increase the understanding of MS 30
Identification of biomarkers will result in a more targeted therapeutic approach 31
Threats 32
Biogeneric threat looms over the multiple sclerosis market 32
Tysabri safety issues may affect the approval of similar pipeline agents 33
Issues with Tysabri-Avonex combination will influence add-on therapy approvals 34
US: opportunities and threats 35
Opportunities 35
Patient access programs can increase long-term compliance 35
Mylinax shows that Fast Track status is possible for MS pipeline therapies 36
Company-sponsored nurse service programs show dedicated support to MS patients and increase compliance 37
Threats 38
Reimbursement status is considered a greater influence on prescribing choice than cost 38
Three-year direct-to-consumer advertising ban restricts patient awareness 39
Japan: opportunities and threats 40
Opportunities 40
Betaseron and Avonex are the only MS disease-modifiers approved in Japan 40
Governmental funding for clinical trials could benefit research into MS 41
Threats 41
Japanese approval times remains sluggish compared to its US and EU counterparts 41
France: opportunities and threats 42
Opportunities 42
Innovative drug development encouraged by price premium and high-level reimbursement 42
Threats 42
After the 2004 French healthcare reforms, pricing stabilization will continue over the foreseeable future 42
New president could impose drive towards private healthcare insurance that may limit patient access to MS treatments 44
Germany: opportunities and threats 44
Opportunities 44
Large and growing German market is an attractive region to launch new therapies 44
Threats 46
Parallel importation is on the rise in the German MS market 46
Reimbursement levels will decline if MS disease-modifiers are proven not to be cost effective 47
Italy: opportunities and threats 48
Opportunities 48
Initiating early treatment is positively viewed in Italy 48
Innovative drug development rewarded with premium price and 100% reimbursement 48
Threats 49
Implemented price reductions and AIFA payback system restricts market access and limits potential revenue 49
Spain: opportunities and threats 51
Opportunities 51
Spanish national formulary will allow health professionals to make better educated treatment decisions 51
Threats 51
The introduction of reference pricing will force MS drug prices down 51
UK: opportunities and threats 52
Opportunities 52
New funding in Wales and Northern Ireland increases access to disease-modifying drugs 52
Diagnosis and treatment rates could increase if NICE guidelines were followed more rigidly 53
Large MS population yet low market value provides scope for significant market growth 54
Threats 54
UK restricts use of disease-modifying drugs based on clinical versus cost-effectiveness 54
The essential role of specialist MS nurses appears uncertain due to the lack of government funding 55
NICE Tysabri decision highlights reimbursement hurdles in the UK 56
CHAPTER 4 FORECAST ANALYSIS 58
Key events 58
New product launches in the US and EU 59
Tysabri in the remaining European countries 60
Mylinax (oral cladribine) 61
Fingolimod 62
BG-12 63
Teriflunomide 63
MBP-8298 64
Laquinimod 66
Rituxan (rituximab) 67
New product launches in Japan 68
Fingolimod 69
Tysabri 69
Rituxan 69
Reformulations 69
Rebif new-formulation 69
Patent expiries 70
Avonex 71
Rebif 72
Copaxone 72
Tysabri 72
Betaseron 72
Data definitions, limitations and assumptions 73
Standard units 73
Japanese market data 73
Derivation of sales forecasts and pricing trends 73
Generic erosion and pricing assumptions 74
Forecasts 74
Forecast methodology 74
CHAPTER 5 COMMERCIAL IMPACT AND LIFECYCLE MANAGEMENT: CASE STUDIES 75
Introduction 75
How to position a new drug class in the MS market 76
Case study 1: Copaxone 77
Co-marketing agreements in the US and EU strengthened launch platform 77
Definition of a new drug class ensured differentiation 78
MSwatch and Shared Solutions helped promote Copaxone and publicized Teva’s patient commitment 79
Improved drug delivery and storage guidelines help maintain year-on-year revenue growth 80
Promotion of Copaxone as both first- and second-line treatment increased targeted patient population 81
Copaxone benefits further as neutralizing antibodies that plague the beta-interferons are shown not to be of issue 81
Double dose of Copaxone showed increased efficacy as Teva looks to compete with high-dose beta-interferons 82
Portfolio management strategies that secure long-term growth 82
Case study 2: Biogen Idec 83
Ten years after launch, Avonex is Biogen Idec’s leading product and MS remains a principal focus 84
Avonex sales have been driven by timely strategies throughout its lifecycle 85
Tysabri: first follow-on to Avonex 90
Strong and varied pipeline indicates long-term MS market commitment 92
Biogen Idec’s MS franchise will continue to grow into the next decade 93
BIBLIOGRAPHY 96
Journal papers 96
Websites 96
Datamonitor reports 99
APPENDIX A – MARKET DATA AND MAJOR BRAND KEY FACTS 100
Summary of multiple sclerosis market data 100
Beta-interferon market data 101
Others market data 104
APPENDIX B – MARKET FORECAST DATA 107
Seven major markets 107
5EU market forecasts 108
US market forecasts 109
Japan market forecasts 110
France 111
Germany 112
Italy 113
Spain 114
UK 115
APPENDIX C 116
Contributing experts 116
Report methodology 116
About Datamonitor 116
About Datamonitor Healthcare 117
About the CNS analysis team 118
Disclaimer 119