Stakeholder Insight: Multiple Sclerosis

Next generation therapies signal the start of a new era

Product Code DAT03292
Publication Date July 2010
Publisher Datamonitor
Product Type Report
Pages 175
ISBN Number not applicable
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Stakeholder Insight: Multiple Sclerosis

Next generation therapies signal the start of a new era

Introduction

With FDA advisory board support for Gilenia (fingolimod), Novartis will move ahead of Merck Serono's oral cladribine in the race to become the first oral multiple sclerosis therapy. Although growth will be stifled by biosimilars, these new product launches will see the multiple sclerosis market grow at a compound annual growth rate (CAGR) of 2.3% over the next 10 years (20092019).

Scope of this research

  • In-depth analysis of the current and future multiple sclerosis therapies across the US, Japan, France, Germany, Italy, Spain and the UK.
  • Country-specific total brand sales forecasts for key products, biosimilars and pipeline agents across the seven major markets to 2019.
  • Assessment of the commercial opportunities and threats present in the multiple sclerosis market, with analysis of trends in emerging markets.
  • Evaluation of the strategies of leading players in the multiple sclerosis disease market.

Research and analysis highlights

Datamonitor expects Novartis's Gilenia (fingolimod) to launch at the end of 2010 as a first-line therapy, while Merck Serono's oral cladribine is anticipated to launch at the start of 2011. These drugs offer improved efficacy and a less invasive method of administration than current treatments.

Datamonitor expects entry of biosimilar drugs from 2014. The introduction of cost competition will force current market players to cease raising the price of their drugs above the norm; a strategy that has helped them to substantially increase revenues in recent years.

Novartis is set to usurp Biogen Idec and become the market leading player by the end of the forecast period in 2019. In addition to Gilenia and Extavia (interferon beta 1b), Novartis is developing two multiple sclerosis candidates; PI-230 (Phase I) and BAF312 (Phase II), illustrating its commitment to growing its presence in the marketplace

Key reasons to purchase this research

  • Quantify the current and future size of the multiple sclerosis drug class market and understand the main commercial opportunities and threats
  • Assess key marketed and pipeline drugs, including new oral agents, Acorda's Ampyra (dalfampridine) and GW Pharmaceuticals' Sativex (nabiximols).
  • Understand the country-specific impact of key events in the multiple sclerosis market during the forecast period 2010 to 2019.

Introduction

The disease-modifying drugs are considered by physicians to represent a significant advance for the management of MS. However, none is fully effective and there are problems with regards to side effects, dosing regimens and cost. Tysabri, a novel once-monthly drug is expected to be an improvement in terms of efficacy; however, there remains a concern over side effects and long-term safety.

Scope

  • Overview of epidemiology, presentation, referral and diagnostic assessment in MS
  • Breakdown of first-line to fourth-line treatment regimens and treatment choice according to disease category
  • Influences on treatment choice and perception of current drug therapies
  • Evaluation of unmet needs and future outlook

Highlights

Multiple sclerosis affects less than 1% of the population in the US and Europe. Despite the high level of general awareness of the disease, neurologists estimate less than half of individuals present at the time they suffer from first symptoms and it can take more than one year to receive an accurate diagnosis.

Numerous strategies, including switching to an alternative interferon beta, are adopted as second-line therapy. Although not favored by opinion leaders or US neurologists, combining two disease-modifying drugs is popular in the 5EU markets. Given the willingness of neurologists to try this strategy, further trials are required.

Tysabri is perceived by neurologists as offering a clear improvement in terms of disease-modifying efficacy. However, a lack of long-term safety data will ensure for the moment it remains positioned as a last-line therapy for relapse-remitting patients who have failed first- and second-line treatment with interferon beta or glatiramer acetate.

Reasons to Purchase

  • Target prescribers more effectively, through an understanding of prescribing behavior and its influences
  • Validate new product forecasting based on diagnosis and treatment rates, and the likely rate of uptake for new products
  • Benchmark brand awareness and perceptions surrounding product positioning in order to formulate competitive lifecycle management strategies

Contents

  • OVERVIEW
    • Catalyst
    • Summary
  • EXECUTIVE SUMMARY
    • Strategic scoping and focus
    • Datamonitor insight into the multiple sclerosis market
    • Related reports
  • 1. MARKET DEFINITION
    • Market definition for this report
  • 2. MARKET OVERVIEW
    • Seven major markets
      • Current market assessment
      • Future market assessment
      • Opportunities and threats
    • US
      • Current and future market assessment
      • Opportunities and threats
    • Japan
      • Current and future market assessment
      • Opportunities and threats
    • Five major EU markets (5EU)
      • Current and future market assessment
      • Opportunities and threats
    • France
      • Current and future market assessment
    • Germany
      • Current and future market assessment
    • Italy
      • Current and future market assessment
    • Spain
      • Current and future market assessment
    • UK
      • Current and future market assessment
    • Rest of the world snapshot
      • Current market assessment
      • Opportunities and threats
  • 3. BRAND DYNAMICS
    • Overview of competitive landscape
      • Oral therapies set to outstrip traditional market leaders
    • Patient acquisition process
      • Introduction
      • Patient care path
      • Points of influence in the patient care path
    • Drivers of brand choice
      • Disease-modifying efficacy and safety are the most influential factors in prescription
      • Number one influential factor is disease-modifying efficacy
      • Side effects are second major attribute driving brand choice
      • Compliance dependant on efficacy and side effects
      • Disease modifying therapy cost is high
    • US formulary tier status for leading brands
      • Disease modifying multiple sclerosis drugs are in the highest co-payment tiers
    • Trends in marketing strategies
      • Marketing strategy for leading brands
      • Sponsorship/disease awareness campaigns
    • Marketed brands overview – disease-modifying drugs
    • Avonex (interferon beta-1a; Biogen Idec and Genzyme) – the gold standard
      • Drug profile
      • Product positioning
      • SWOT analysis
      • Brand forecast to 2019
    • Betaseron (interferon beta-1b; Bayer Schering)
      • Drug profile
      • Product positioning
      • SWOT analysis
      • Brand forecast to 2019
    • Rebif (interferon beta-1a; Merck Serono and Pfizer)
      • Drug profile
      • Product positioning
      • SWOT analysis
      • Brand forecast to 2019
    • Extavia (interferon beta-1a; Novartis)
      • Drug profile
      • Product positioning
      • SWOT analysis
      • Brand forecast to 2019
    • Copaxone (glatiramer acetate; Teva and Sanofi-Aventis)
      • Drug profile
      • Product positioning
      • SWOT analysis
      • Brand forecast to 2019
    • Tysabri (natalizumab; Biogen Idec and Elan)
      • Drug profile
      • Product positioning
      • SWOT analysis
      • Brand forecast to 2019
    • Novantrone (mitoxantrone, Merck Serono);
    • Pipeline brands overview
    • Gilenia (fingolimod, Novartis & Mitsubishi Tanabe Pharma)
      • Drug profile
      • Development overview
      • Product positioning
      • SWOT analysis
      • Drug forecast to 2019
    • Oral cladribine (Merck Serono)
      • Drug profile
      • Development overview
      • Product positioning
      • SWOT analysis
      • Drug forecast to 2019
    • Marketed brands overview – key multiple sclerosis-specific symptomatic drugs
    • Ampyra (dalfampridine; Acorda therapeutics)
      • Drug profile
      • Product positioning
      • SWOT analysis
      • Drug forecast to 2019
    • Sativex (nabiximols; GW Pharmaceuticals)
      • Drug profile
      • Development overview
      • Drug evaluation
      • Drug forecast to 2019
  • 4. KEY DEVELOPERS
    • Strategic overview
    • Trends in corporate strategy
      • Licensing deals represent an essential tactic to bolster pipeline agents
    • Recent strategic partnerships and deals
      • Abbott acquire Facet Biotech
    • Novartis
      • Corporate strategy
      • Multiple sclerosis portfolio assessment
    • Biogen Idec
      • Corporate strategy
      • Biogen Idec’s will remain a leading multiple sclerosis developer through reformulations and novel candidates
      • Multiple sclerosis portfolio assessment
    • Merck Serono
      • Corporate strategy
      • Multiple sclerosis portfolio assessment
    • Teva
      • Corporate strategy
      • Multiple sclerosis portfolio assessment
    • Portfolio assessment of other leading companies
      • Bayer Schering
  • 5. CASE STUDIES
    • Introduction
    • Case study
      • Price increases higher than for other autoimmune disorders
      • Price increases in US the highest across the seven major markets
  • BIBLIOGRAPHY
    • Journal papers
    • Websites
    • Other sources
    • Datamonitor reports
  • APPENDIX A – MARKET ASSUMPTIONS
    • Forecasting assumptions
      • New product launches
      • Patent expiries
    • Data definitions, limitations and assumptions
      • Standard units
      • Country group definitions
    • Derivation of sales forecasts and pricing trends
    • Forecast methodology
      • Methodology for symptomatic market forecast
  • APPENDIX B
    • Contributing experts
    • Report methodology
    • About Datamonitor
  • TABLES
    • Table: Sales and growth of key multiple sclerosis brands across the seven major markets ($m and %), 2009–19
    • Table: Sales forecasts of branded multiple sclerosis drugs across the seven major markets ($m), 2009–19
    • Table: Summary of opportunities and threats in the multiple sclerosis market across the seven major markets, 2010–19
    • Table: Categorization of multiple sclerosis-related symptoms by severity
    • Table: Prevalence and treatment of multiple sclerosis symptoms , 2010
    • Table: Sales and growth of key multiple sclerosis brands in the US ($m and %), 2009–19
    • Table: Sales forecasts of branded multiple sclerosis drugs in the US ($m), 2009–19
    • Table: Summary of opportunities and threats in the multiple sclerosis market in the US, 2010–19
    • Table: Sales and growth of key multiple sclerosis brands in Japan ($m and %), 2009–19
    • Table: Sales forecasts of branded multiple sclerosis drugs in Japan ($m), 2009–19
    • Table: Summary of opportunities and threats in the multiple sclerosis market in Japan, 2010–19
    • Table: Sales and growth of key multiple sclerosis brands in the five major EU markets ($m and %), 2009–19
    • Table: Sales forecasts of branded multiple sclerosis drugs in the five major EU markets ($m), 2009–19
    • Table: Summary of opportunities and threats in the multiple sclerosis market in the five major EU markets, 2010–19
    • Table: Sales and growth of key multiple sclerosis brands in France ($m and %), 2009–19
    • Table: Sales forecasts of branded multiple sclerosis drugs in France ($m), 2009–19
    • Table: Sales and growth of key multiple sclerosis brands in Germany ($m and %), 2009–19
    • Table: Sales forecasts of branded multiple sclerosis drugs in Germany ($m), 2009–19
    • Table: Sales and growth of key multiple sclerosis brands in Italy ($m and %), 2009–19
    • Table: Sales forecasts of branded multiple sclerosis drugs in Italy ($m), 2009–19
    • Table: Sales and growth of key multiple sclerosis brands in Spain (Sm and %), 2009–19
    • Table: Sales forecasts of branded multiple sclerosis drugs in Spain ($m), 2009–19
    • Table: Sales and growth of key multiple sclerosis brands in the UK ($m and %), 2009–19
    • Table: Sales forecasts of branded multiple sclerosis drugs in the UK ($m), 2009–19
    • Table: Global sales dynamics of the multiple sclerosis market by region ($m), 2005–09
    • Table: Sales value of multiple sclerosis brands in the US, five major EU markets and the rest of the world ($m), 2005–09
    • Table: Sales of leading multiple sclerosis brands in the seven major markets ($m), 2009–19
    • Table: Key products in late-stage R&D pipeline for multiple sclerosis, 2010
    • Table: Side effects demonstrated by current multiple sclerosis brands, 2010
    • Table: Cost analysis of disease-modifying therapies, based on annual cost per patient ($), 2009
    • Table: Representative formulary tier status in the US for leading brands in multiple sclerosis, 2010
    • Table: Marketing strategies employed by the companies behind the top three multiple sclerosis market brands, 2010
    • Table: Avonex (interferon beta-1a; Biogen Idec and Genzyme) – drug profile , 2010
    • Table: Key events and launch dates impacting Avonex’s revenue forecasts in the seven major markets, 2010–19
    • Table: Betaseron (interferon beta-1b; Bayer Schering) – drug profile , 2010
    • Table: Key events and launch dates impacting Betaseron’s revenue forecasts in the seven major markets, 2010–19
    • Table: Rebif (interferon beta-1a; Merck Serono) – drug profile , 2010
    • Table: Key events and launch dates impacting Rebif’s revenue forecasts in the seven major markets, 2010–19
    • Table: Extavia (interferon beta-1b; Novartis) – drug profile , 2010
    • Table: Key events and launch dates impacting Extavia’s revenue forecasts in the seven major markets, 2010–19
    • Table: Copaxone (glatiramer acetate; Teva and Sanofi-Aventis) – drug profile , 2010
    • Table: Key events and launch dates impacting Copaxone’s revenue forecasts in the seven major markets, 2010–19
    • Table: Tysabri (natalizumab; Biogen Idec and Elan) – drug profile , 2010
    • Table: Key events and launch dates impacting Tysabri’s revenue forecasts in the seven major markets, 2010–19
    • Table: Key late-stage m ultiple sclerosis disease-modifying drug development pipeline, 2010
    • Table: Gilenia (fingolimod; Novartis) – drug profile, 2010
    • Table: Key ongoing fingolimod multiple sclerosis studies, 2010
    • Table: Key events and launch dates impacting Gilenia’s revenue forecast for multiple sclerosis in the seven major markets, 2010–19
    • Table: Oral cladribine (Merck Serono)– drug profile, 2010
    • Table: Key ongoing oral cladribine multiple sclerosis studies, 2010
    • Table: Key events and launch dates impacting oral cladribine’s revenue forecast for multiple sclerosis in the seven major markets, 2010–19
    • Table: Ampyra (dalfampridine; Acorda therapeutics) – drug profile , 2010
    • Table: Sativex (nabiximols; GW Pharmaceuticals) – drug profile , 2010
    • Table: Leading companies in the seven major multiple sclerosis markets, 2009–19
    • Table: Overview of key players with marketed and pipeline drugs in multiple sclerosis market, 2010
    • Table: Summary of licensing partnerships of key therapies, 2010
    • Table: Novartis’s multiple sclerosis portfolio, 2010
    • Table: Biogen Idec’s key multiple sclerosis portfolio, 2010
    • Table: Merck Serono’s multiple sclerosis portfolio, 2010
    • Table: Teva’s multiple sclerosis portfolio, 2010
    • Table: Price ($) per dose for multiple sclerosis disease-modifying drugs across the seven major markets ($/SU)*, 2005–09
    • Table: Datamonitor’s estimated launch dates for multiple sclerosis products in the US, Japan and 5EU, 2009–19
    • Table: Anticipated patent expiry dates for multiple sclerosis brands in the US, Japan and 5EU, 2009-19
  • FIGURES
    • Figure: Timeline: launch dates of disease-modifying therapies for treatment of multiple sclerosis, 1993–2009
    • Figure: Multiple sclerosis disease-modifying-specific sales in the seven major markets by region ($ billion), 2005–09
    • Figure: Multiple sclerosis disease-modifying specific volume sales in the seven major markets by region ($m), 2005–09
    • Figure: Multiple sclerosis disease-modifying drug sales by molecule in the seven major markets ($ billion), 2005–09
    • Figure: Performance of the key disease-modifying multiple sclerosis therapies in the seven major markets ($m), 2005–09
    • Figure: Key events impacting the multiple sclerosis market, 2010–19
    • Figure: Sales forecasts for multiple sclerosis market across the seven major markets ($m), 2009–19
    • Figure: Relative proportions of multiple sclerosis subtypes
    • Figure: Multiple sclerosis prescription volume and sales split by treatment type across the seven major markets, 2010
    • Figure: A global perspective on biosimilars, 2010
    • Figure: Multiple sclerosis market sales value in US ($m), 2005–09
    • Figure: Sales forecasts for multiple sclerosis market in the US ($m),, 2009–19
    • Figure: Multiple sclerosis market sales value in Japan ($m), 2005–09
    • Figure: Dynamics of the key multiple sclerosis therapies in Japan, 2006–09
    • Figure: Sales forecasts for the multiple sclerosis market in Japan ($m), 2009–19
    • Figure: Multiple sclerosis market sales value in the five major EU markets ($m), 2005–09
    • Figure: Sales forecasts for multiple sclerosis market in the five major EU markets ($m), 2009–19
    • Figure: Biosimilar impact on the multiple sclerosis market in the five major EU markets, 2009–19
    • Figure: Impact of parallel importation on the German multiple sclerosis market, 2009
    • Figure: Price difference per unit of branded multiple sclerosis drugs compared to parallel import in Germany, 2010
    • Figure: Multiple sclerosis market sales value in France ($m), 2005–09
    • Figure: Sales forecasts for multiple sclerosis market in France ($m), 2009–19
    • Figure: Multiple sclerosis market sales value in Germany ($m), 2005–09
    • Figure: Sales forecasts for multiple sclerosis market in Germany ($m), 2009–19
    • Figure: Multiple sclerosis market sales value in Italy ($m), 2005–09
    • Figure: Sales forecasts for multiple sclerosis market in Italy ($m), 2009–19
    • Figure: Multiple sclerosis market sales value in Spain ($m), 2005–09
    • Figure: Sales forecasts for multiple sclerosis market in Spain ($m), 2005–09
    • Figure: Multiple sclerosis market sales value in the UK ($m), 2005–09
    • Figure: Sales forecasts for multiple sclerosis market in the UK ($m), 2009–19
    • Figure: Global multiple sclerosis market sales value by region ($ billion), 2005–09
    • Figure: Global multiple sclerosis market sales dynamics by major region ($m), 2005–09
    • Figure: Global multiple sclerosis market sales volume (IMS standard units sold) and sales value ($) by region, 2009
    • Figure: Dynamics of the global multiple sclerosis market sales by region ($m), 2005–09
    • Figure: UK multiple sclerosis patient care pathway, 2010
    • Figure: Treatment of relapse remitting multiple sclerosis (RRMS), 2010
    • Figure: Treatment of secondary progressive multiple sclerosis (SPMS), 2010
    • Figure: Treatment of primary progressive multiple sclerosis (PPMS), 2010
    • Figure: Treatment of primary relapsing multiple sclerosis (PRMS), 2010
    • Figure: Key drivers of brand choice for multiple sclerosis
    • Figure: Multiple sclerosis marketing process, 2010
    • Figure: Support group websites sponsored and run by Multiple Sclerosis drug developers, 2010
    • Figure: Position of Avonex (interferon beta-1a) in the multiple sclerosis treatment algorithm, 2010
    • Figure: Avonex (interferon beta-1a; Biogen Idec): SWOT analysis in multiple sclerosis (MS), 2010
    • Figure: Avonex (interferon beta-1a; Biogen Idec) sales in multiple sclerosis by country in the seven major markets ($m), 2009–19
    • Figure: Position of Betaseron (interferon beta-1b) in the multiple sclerosis treatment algorithm, 2010
    • Figure: Betaseron (interferon beta-1b, Bayer Schering): SWOT analysis in multiple sclerosis (MS), 2010
    • Figure: Betaseron sales in multiple sclerosis by country in the seven major markets ($m), 2009–19
    • Figure: Position of Rebif (interferon beta-1a) in the multiple sclerosis treatment algorithm, 2010
    • Figure: Rebif (interferon beta-1a, Merck Serono): SWOT analysis in multiple sclerosis (MS), 2010
    • Figure: Rebif sales in multiple sclerosis by country in the seven major markets ($m), 2009–19
    • Figure: Position of Extavia (interferon beta 1b) in the multiple sclerosis treatment algorithm, 2010
    • Figure: Extavia (interferon beta-1b, Novartis): SWOT analysis in multiple sclerosis (MS), 2010
    • Figure: Extavia sales in multiple sclerosis by country in the seven major markets ($m), 2009–19
    • Figure: Position of Copaxone (Glatiramer acetate) in the multiple sclerosis (MS) treatment algorithm, 2010
    • Figure: Copaxone (glatiramer acetate, Teva and Sanofi Aventis): SWOT analysis in multiple sclerosis (MS), 2010
    • Figure: Copaxone sales in multiple sclerosis by country in the seven major markets ($m), 2009–19
    • Figure: Position of Tysabri (natalizumab) in the multiple sclerosis treatment algorithm, 2010
    • Figure: Tysabri (natalizumab, Biogen Idec and Elan): SWOT analysis in multiple sclerosis (MS), 2010
    • Figure: Tysabri sales in multiple sclerosis by country in the seven major markets ($m), 2009–19
    • Figure: Position of Novantrone (mitoxantrone) in the multiple sclerosis treatment algorithm, 2010
    • Figure: Novantrone sales in multiple sclerosis by country in the seven major markets ($m), 2009–19
    • Figure: Gilenia (fingolimod, Novartis): SWOT analysis in multiple sclerosis (MS), 2010
    • Figure: Datamonitor’s forecast sales for Gilenia across the seven major markets for multiple sclerosis ($m), 2011–19
    • Figure: Oral cladribine SWOT analysis, 2010
    • Figure: Datamonitor’s forecast sales for oral cladribine across the seven major markets for multiple sclerosis ($m), 2011–19
    • Figure: Ampyra (dalfampridine; Acorda Therapeutics): SWOT analysis, 2010
    • Figure: Datamonitor’s forecast sales for Ampyra across the seven major markets for multiple sclerosis ($m), 2010–19
    • Figure: Phase III study into Sativex on the relief of spasticity due to multiple sclerosis
    • Figure: Datamonitor’s forecast sales for Sativex (nabiximols; GW Pharmaceuticals) across the seven major markets for multiple sclerosis ($m), 2010–19
    • Figure: Price increases of branded multiple sclerosis disease-modifying therapies across the seven major markets (%), 2005–09
    • Figure: Price increases of Copaxone compared to key autoimmune brands across the seven major markets (%), 2005–09
    • Figure: Average price increases of branded multiple sclerosis disease-modifying therapies by country (%), 2005–09
    • Figure: Estimated US sales revenue if drug developers had increased prices in line with inflation compared to historical sales ($m), 2005–09