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
- 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
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