中枢神経系創薬：多発性硬化症

Abstract

The incidence of multiple sclerosis varies throughout the world, although there is a significantly higher incidence of the disease found in the Northern Hemisphere. Find out more in this chapter of CNS Drug Discoveries.

It is estimated that over 350,000 Americans (approximately 1 in 1,000 aged over 30 years) live with multiple sclerosis (MS) and approximately 3 million live with it worldwide. However, the prevalence may be higher because of the uncertainty in diagnosing the condition. Women are twice as susceptible as men and it is more common in people in northern latitudes over the age of 18 years. In addition, siblings of an individual with multiple sclerosis have a higher chance of developing the disease.

The incidence of multiple sclerosis varies throughout the world, although there is a significantly higher incidence of the disease found in the northern hemisphere. Multiple sclerosis is the most common cause of neurological disability in young adults in the UK. It is variable in presentation and progression. Although there is no cure, there are many symptomatic treatments available. However, many patients do not respond to currently available products (30%) and the more chronic forms (secondary-progressive MS) are poorly treated with existing therapies.

Global multiple sclerosis market

The MS market is estimated to be worth US$4.9 billion in 2006 with a growth rate of 8.9% year-on-year. It is the fifth largest segment of the CNS market and has attracted considerable R&D investment from big pharma, biotechnology companies and specialty pharma. The market is currently driven by the use of six disease-modifying agents: Avonex (Biogen Idec), Betaseron/Betaferon (Schering AG), Copaxone (Teva), Novatrone (Schering AG), Rebif (Serono/Pfizer) and Tysabri (Biogen Idec/Elan).

Sales growth will be driven by current drugs gaining broader indications, MS medicine being prescribed earlier in treatment in clinically-defined multiple sclerosis patients and the longer-term use of combination therapies as more classes of drug become available.

Table of Contents

MULTIPLE SCLEROSIS

• EXECUTIVE SUMMARY
• THE FACTS
  • What is MS and why are we interested in it?
• PATIENT STATISTICS
  • Incidence, diagnosis rates and treatment; now and in the future
  • MS categories
    • Types of MS
• PATIENT MODEL
  • The treatable MS patient population will have a CAGR 2005-2012 = 4.6%
    • Summary of patient population forecasts
• DRUG GROWTH DRIVERS
• DRUG GROWTH RISKS/DAMPENERS

GLOBAL MS MARKET

• Global CNS Market (US$68.7 billion)
• GLOBAL SALES SPLIT
  • Global sales split (2005A)
  • US market
    • MS US drugs sales split (2005A)
  • European market
    • MS European drugs sales split (2005A)
  • Japanese market
  • The major players
    • Market share of MS players by sales (Dec 2005A)
  • Players and Products in 2005 & 2006
  • Players and products in 2012
• CURRENT TREATMENTS
  • Leading Brands
    • Comparison of Leading MS Agents
  • Current Products Patent Exposure
    • Patent Exposure of Leading Brands
• ANALYSIS OF LEADING BRANDS
  • Disease-modifying agents
• Disease-modifying agents
  • Avonex (Biogen Idec/Genzyme)
  • Betaferon/Betaseron (Berlex/Schering AG)
  • Copaxone (Teva)
  • Rebif (Serono)
  • Tysabri
  • Novantrone (Serono)
• GLOBAL SALES FORECASTS OF CURRENT TREATMENTS 2005-2012
  • Sales Forecasts of Current Leading MS Drugs
  • Model assumptions
• NEW DRUGS IN R&D
  • Drugs in Development to Treat MS
• ANALYSIS OF PHASE III DRUGS
  • New Drugs in Phase III Development to Treat MS
  • Disease-modifying agents
  • MS Symptoms
  • Campath (Genzyme/Schering AG)
  • FTY720 (Novartis)
  • Laquinimod (Teva/Active Biotech)
  • MBP8298 (BioMS)
  • Mylinax (Serono/Ivax)
  • Rituxan (Genentech/Biogen Idec/Roche/Chugai/Zenyaju Kogyo)
  • Teriflunomide (sanofi-aventis)
• MS Symptoms
  • Neurelan (Elan/Acorda)
    • Trial MS-F202: Timed 25-foot walk response rate of MS patients treated with Fampridine SR
• GLOBAL SALES FORECASTS OF PHASE III MS DRUGS 2006-2012
  • Sales Forecasts of Phase III Developmental MS Drugs
  • Model assumptions
• ANALYSIS OF PHASE II DRUGS
  • New Drugs in Early Clinical Development to Treat MS
  • Disease-modifying agents
  • Vaccines
• Disease-modifying agents
  • ABT-874 (Abbott)
  • ATL1102 (Antisense/ISIS pharmaceuticals)
  • BG-12 (Biogen Idec)
  • Daclizumab (Biogen Idec/BioPharma)
  • SB-683699 (GlaxoSmithKline/Tanabe Seiyaku)
• Vaccines
  • NeuroVax (TIRC)
  • Tovaxin (Opexa Therapeutics)
  • Other Interesting Phase II Drugs
• GLOBAL SALES FORECASTS OF PHASE II MS DRUGS 2006 - 2012
  • Sales Forecasts of Phase II Developmental MS Drugs
  • Model assumptions
• COMPETITOR RATIO ANALYSIS - PRODUCTS
  • CR Analysis of MS Agents Approved by 2012 - Based on Drug Class
• COMPETITOR RATIO ANALYSIS - COMPANIES
  • CR Analysis of MS Agents Approved by 2012 - Based on Company
  • WINNERS & LOSERS
    • Summary of Key Companies and Drugs in the MS Market by 2012
  • Winners
  • Losers
• DISCONTINUATION OF DRUGS
  • MS Drugs Discontinued from Clinical Development
• MS APPENDIX 1
  • Clinical diagnostic test for MS
• MS APPENDIX 2
  • Expanded Disability Status Scale (EDSS)
• MS APPENDIX 3
  • Phase transition probability
    • Probability of launch
• MS APPENDIX 4
  • Patient Model
    • Summary of US MS Patient Population Forecasts
    • Summary of Europe (Tope 5) MS Patient Population Forecasts
    • Summary of Japan MS Patient Population Forecasts
• MS APPENDIX 5
  • Global MS Drugs Sales 2005-20012
    • Global MS Drug Sales 2005A-2012E
• Ms APPENDIX 6
  • Competitor Ratio Analysis Criteria
    • Key MS Drugs on the Market by 2012
• MS GLOSSARY
• MS REFERENCES
• ACRONYMNS