Commercial Insight: Multiple Sclerosis Continued growth makes the MS market a highly attractive investment

Table of Contents

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