Market Report Source

Overview

Introduction
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.

Scope

• 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

Highlights
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.

Reasons to Purchase

• 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

Table of Contents

TABLE OF 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