ブランドと戦略：多発性硬化症

Abstract

In This Issue...

The market for multiple sclerosis (MS) therapies is dominated by a handful of key players-Biogen Idec, Serono, Schering AG, and Teva-who produce premium priced therapies including interferon-beta (Biogen Idec' s Avonex, Serono' s Rebif, and Schering AG' s Betaseron) and Teva' s Copaxone. Despite the commercial success of existing drugs, a high level of unmet clinical need exists, providing ample market opportunity for new treatments that demonstrate improved efficacy, tolerability, and convenience in comparison to currently available treatments.

Questions Answered in This Report

• Competitive dynamics: Market-leading recombinant interferon-beta therapies, such as Biogen Idec' s Avonex, Serono' s Rebif, and Schering AG' s Betaseron, are involved in an intensely competitive arena-from both a within-class perspective and from the other leading MS agent, Teva' s altered peptide ligand, Copaxone. How have the leading competitors positioned their brands for success? Which interferon-beta drugs will continue to succeed in the market?
• Market dynamics: The introduction of guidelines for the approval of biosimilar medicinal products in Europe will dramatically affect the market for recombinant interferon-beta. When will biosimilar interferon-beta launch in the major markets? What level of uptake will biosimilars experience and which branded drugs will be most affected?
• Brand dynamics: Following its withdrawal over safety concerns, Biogen Idec' s Tysabri has relaunched following an in-depth review of the drug by US and European regulators. How will Tysabri' s availability impact the MS market? What effect will safety concerns have on Tysabri' s commercial success?
• Key events: Few new drugs have been successfully developed for the treatment of MS in recent years, leaving the market to established competitors. What new drugs are forecast to enter the MS market between 2005 and 2010 and when will they launch? What products are being developed in the major MS competitors' pipelines?

Scope

• Markets Covered: United States, France, Germany, Italy, Spain, United Kingdom, and Japan.
• Market Analysis: Annualized 5-year sales forecasts presented by region, drug class, molecule, and brand for 2005 to 2010, including a breakdown of branded versus generic sales for each market and the impact of key events during the forecast period. Annualized forecast of total prevalent and diagnosed cases for each of the major markets from 2005 to 2010.
• Company Analysis: Detailed discussion of major competitors including Biogen Idec, Teva Pharmaceuticals, Serono, and Schering AG. Includes analysis of each company' s MS product portfolio, strategic positioning, licensing strategy, post-marketing clinical trials, and development pipeline.
• Brand Analysis: The report features an in-depth discussion of leading brands in the MS market, including approval history, sales and market position, SWOT analysis, annualized sales forecast, promotional efforts, and on-going life cycle management initiatives.

Table of Contents

Table of Contents

Table of Exhibits

Executive Summary

Section 1: Multiple Sclerosis Patient Populations

• Background
• Multiple Sclerosis Prevalence and Diagnosis
• US
• Europe
• Japan

Section 2: Multiple Sclerosis Treatment Overview

• Major Competitors
• Exisiting Treatments
  • Recombinant Interferon-β
  • Altered Peptide Ligands
  • Chemotherapeutics
  • Monoclonal Antibodies
  • Corticosteroids
  • Immunosuppressants

Section 3: Major Markets for Multiple Sclerosis Treatment

• Market Overview
  • MS Drug Sales by Region
  • MS Drug Sales by Class
• Market Forecast
  • Key Events
  • Drug Pricing
  • Formulary Placement
  • Recombinant Interferon-β Market
  • Altered Peptide Ligand Market
  • Chemotherapeutic Market
  • Monoclonal Antibody Market
  • Corticosteroid Market
  • Immunosuppressant Market

Section 4: Competitive Analysis

• Overview
• Competitive Landscape
  • MS Market by Competitor
  • Promotional Spending

Biogen Idec

• Product Portfolio
• Strategic Positioning
• Avonex
  • Approval History
  • Sales and Market Position
  • Avonex Competitive Analysis
  • Promotional Spending
  • Life Cycle Management
• Tysabri
  • Approval History
  • Sales and Market Position
  • Tysabri Competitive Analysis
  • Promotional Spending
  • Life Cycle Management
• Biogen Idec MS Pipeline
  • Daclizumab
  • Rituximab
  • BG-12
  • Pegylated Inferferon-β-1a
  • LINGO-1 Inhibitor

Teva Pharmaceuticals

• Product Portfolio
• Strategic Positioning
• Copaxone
  • Approval History
  • Sales and Market Position
  • Copaxone Competitive Analysis
  • Promotional Spending
  • Life Cycle Management
• Teva Pharmaceuticals MS Pipeline
  • Laquinimod
  • TV-5010
  • Oral Copaxone

Serono SA

• Product Portfolio
• Strategic Positioning
• Rebif
  • Approval History
  • Sales and Market Position
  • Rebif Competitive Analysis
  • Promotional Spending
  • Life Cycle Management
• Novantrone
  • Approval History
  • Sales and Market Position
  • Novantrone Competitive Analysis
  • Promotional Spending
  • Life Cycle Management
• Serono MS Product Pipeline
  • Oral Cladribine
  • MMP-12 Inhibitor
  • JNK Inhibitor
  • Interferon-β:Fc
  • Osteopontin

Schering AG

• Product Portfolio
• Strategic Position
• Betaseron
  • Approval History
  • Sales and Market Position
  • Betaseron Competitive Analysis
  • Promotional Spending
  • Life Cycle Management
• Schering AG MS Pipeline
  • Alemtuzumab

Section 5: Supplementary Market Analysis

Acronyms and Initialisms

Methodology

• Epidemiological Forecast Methodology
• Market Forecast Methodology
• Competitive Analysis Methodology

Table of Exhibits

Executive Summary

• Exhibit ES-1: MS Market Value, Major Markets, 2005-2010
• Exhibit ES-2: MS Market by Competitor, 2005 and 2010

Section 1: Multiple Sclerosis Patient Populations

• Prevalent and Diagnosed MS Cases (Thousands), Major Markets, 2005-2010
• Prevalent and Diagnosed MS Cases (Thousands), US, 2005-2010
• Total Prevalent Cases of MS (Thousands), by Country, Europe, 2005-2010
• Prevalent and Diagnosed MS Cases, Japan, 2005-2010

Section 2: Multiple Sclerosis Treatment Overview

• Exhibit 2-1: MS Drugs, by Major Competitor
• Exhibit 2-2: MS Drugs, by Drug Class

Section 3: Major Markets for Multiple Sclerosis Treatment

• Exhibit 3-1: MS Market ($US), Major Markets, 2005-2010 (Graphical Format)
• Exhibit 3-2: MS Market ($US), Major Markets, 2005-2010 (Tabular Format)
• Exhibit 3-3: MS Market ($US), by Country, 2005-2010
• Exhibit 3-4: MS Market, by Country as a % of Total, 2005 and 2010
• Exhibit 3-5: MS Market ($US), by Drug Class, 2005-2010
• Exhibit 3-6: Key Events , MS Market, 2005-2010
• Exhibit 3-7: Price to Treat per Day ($US), Recombinant Interferon-β, 2005-2010
• Exhibit 3-8: Recombinant Interferon-β Pricing ($US), Brand vs. Generic Price, 2005
• Exhibit 3-9: Price to Treat per Day ($US), Altered Peptide Ligands, 2005-2010
• Exhibit 3-10: Price to Treat per Day ($US), Chemotherapeutics, 2005-2010
• Exhibit 3-11: Chemotherapeutic Pricing ($US), Brand vs. Generic Price, 2005
• Exhibit 3-12: Price to Treat per Day ($US), Monoclonal Antibodies, 2005-2010
• Exhibit 3-13: Price to Treat per Day ($US), Corticosteroids, 2005-2010
• Exhibit 3-14: Corticosteroid Pricing ($US), Brand vs. Generic Price, 2005
• Exhibit 3-15: Price to Treat per Day ($US), Immunosuppressants, 2005-2010
• Exhibit 3-16: Immunosuppressant Pricing ($US), Brand vs. Generic Price, 2005
• Exhibit 3-17: US Formulary Placement of MS-Indicated Therapies
• Exhibit 3-18: Recombinant Interferon-β Market ($US), 2005-2010
• Exhibit 3-19: Recombinant Interferon-β Market ($US), by Country, 2005-2010
• Exhibit 3-20: Recombinant Interferon-β Market ($US), by Drug, 2005-2010
• Exhibit 3-21: Recombinant Interferon-β Branded Market Share, by Brand and Country, 2005 and 2010
• Exhibit 3-22: Altered Peptide Ligand Market ($US), 2005-2010
• Exhibit 3-23: Altered Peptide Ligand Market ($US), by Country, 2005-2010
• Exhibit 3-24: Chemotherapeutics Market ($US), 2005-2010
• Exhibit 3-25: Chemotherapeutics Market ($US), by Country, 2005-2010
• Exhibit 3-26: Chemotherapeutics Market ($US), by Drug, 2005-2010
• Exhibit 3-27: Monoclonal Antibody Market ($US), 2005-2010
• Exhibit 3-28: Monoclonal Antibody Market ($US), by Country, 2005-2010
• Exhibit 3-29: Monoclonal Antibody Market ($US), by Drug, 2005-2010
• Exhibit 3-30: Corticosteroid Market ($US), 2005-2010
• Exhibit 3-31: Corticosteroid Market ($US), by Country, 2005-2010
• Exhibit 3-32: Corticosteroid Market ($US), by Drug, 2005-2010
• Exhibit 3-33: Immunosuppressant Market ($US), 2005-2010
• Exhibit 3-34: Immunosuppressant Market ($US), by Country, 2005-2010
• Exhibit 3-35: Imuran Market ($US) by Drug, 2005-2010

Section 4: Competitive Analysis

• Exhibit 4-1: MS Market Competitive Position, 2005 and 2010
• Exhibit 4-2: MS Market ($US), by Company, 2005-2010
• Exhibit 4-3: Promotional Spend for MS Therapies, by Company, 2005
• Exhibit 4-4: Promotional Spending Among First-Line MS Therapies, 2005
• Exhibit 4-5: Summary of Biogen Idec' s MS Product Portfolio
• Exhibit 4-6: Biogen Idec MS Revenues ($US), by Brand, 2005-2010
• Exhibit 4-7: Timeline of Avonex Regulatory Approvals in the Seven Major Pharmaceutical Markets
• Exhibit 4-8: Key Clinical Trials Supporting Avonex' Regulatory Approvals
• Exhibit 4-9: Timeline of Tysabri Regulatory Approvals in the Seven Major Pharmaceutical Markets
• Exhibit 4-10: Key Clinical Trials Supporting Tysabri' s Regulatory Approvals
• Exhibit 4-11: Summary of Teva Pharmaceuticals MS Product Portfolio
• Exhibit 4-12: Timeline of Copaxone Regulatory Approvals in the Seven Major Pharmaceutical Markets
• Exhibit 4-13: Key Clinical Trials Supporting Copaxone' s Regulatory Approvals
• Exhibit 4-14: Summary of Serono SA' s MS Product Portfolio
• Exhibit 4-15: Timeline of Rebif Regulatory Approvals in the Seven Major Pharmaceutical Markets
• Exhibit 4-16: Key Clinical Trials Supporting Rebif' s Regulatory Approvals
• Exhibit 4-17: Key Clinical Trials Supporting Novantrone' s Regulatory Approvals
• Exhibit 4-18: Summary of Schering AG' s MS Product Portfolio
• Exhibit 4-19: Timeline of Betaseron Regulatory Approvals in the Seven Major Pharmaceutical Markets
• Exhibit 4-20: Key Clinical Trials Supporting Betaseron' s Regulatory Approvals
• Exhibit 4-21: Key Clinical Trials Supporting Betaseron' s Regulatory Approvals, Continued

Section 5: Supplementary Market Analysis

• Exhibit 5-1: Total Interferon-β-1a (IM) Market ($US), by Country, 2005-2010
• Exhibit 5-2: Avonex Market ($US), by Country, 2005-2010
• Exhibit 5-3: Total Interferon-β-1a (SC) Market ($US), by Country, 2005-2010
• Exhibit 5-4: Rebif Market ($US), by Country, 2005-2010
• Exhibit 5-5: Total Interferon-β-1b Market ($US), by Country, 2005-2010
• Exhibit 5-6: Betaseron Market ($US), by Country, 2005-2010
• Exhibit 5-7: Total Mitoxantrone Market ($US), by Country, 2005-2010
• Exhibit 5-8: Novantrone Market ($US), by Country, 2005-2010
• Exhibit 5-9: Total Cyclophosphamide Market ($US), by Country, 2005-2010
• Exhibit 5-10: Cytoxan Market ($US), by Country, 2005-2010
• Exhibit 5-11: Total Methotrexate Market ($US), by Country, 2005-2010
• Exhibit 5-12: Rheumatrex Market ($US), by Country, 2005-2010
• Exhibit 5-13: Methylprednisolone Market ($US), by Drug, 2005-2010
• Exhibit 5-14: Solu-Medrol Market ($US), by Country, 2005-2010
• Exhibit 5-15: Total Prednisone Market ($US), by Country, 2005-2010
• Exhibit 5-16: Deltasone Market ($US), by Country, 2005-2010
• Exhibit 5-17: Total Azathioprine Market ($US), by Country, 2005-2010
• Exhibit 5-18: Imuran Market ($US), by Country, 2005-2010