Commercial Insight: Multiple Sclerosis

Summary

The dynamic MS market continues to grow unabated; seven major market revenues increased 14.7% from 2005 to $4.6 billion in 2006. Growth is driven by the highly successful beta-interferon brands, Teva's Copaxone (glatiramer acetate), and the recent relaunch of Tysabri; the first launch of a new MS treatment for six years.

• This report focuses on the leading disease-modifying therapies used to treat MS, with seven major market (7MM) sales and volume forecasts to 2016
• Assessment of current and future opportunities and threats in the MS market across the 7MMs
• Future market events that are expected to affect drug revenues are discussed and quantified for each of the 7MMs
• Lifecycle management case studies show how previously successful strategies should be applied in the current and future MS market

Despite the comparatively large MS population, the UK only accounted for 1.1% of the 7MM total in 2006. Datamonitor believes the UK has potential to be a much more profitable and attractive MS market. If treatment rates were on par with Germany, the UK market could have been worth $293m in 2006almost six times higher than the actual value.

In order to successfully position a new drug class in the market, future market players must have a clear and focused marketing strategy. With Copaxonelaunched in 1997Teva has set the benchmark, and by utilizing similar tactics, future MS players can successfully position novel therapies in the market.

There remains a large opportunity for current and future players to cement and develop their positions in the MS market. To ensure continued revenue and to minimize franchise risk companies can follow Biogen Idec's strategy to market two or more products and show commitment to the MS community through long-term franchise investment.

• Assess the impact of events such as patent expiries and new product launches on the sales of key marketed brands
• Quantify the future size of the MS market, in terms of volume and value, in each of the 7MM
• Identify key lifecycle management strategies that can ensure growth in the competitive MS market

Contents

• 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