喘息治療におけるモノクローナル抗体

Abstract

Overview

Introduction

Although only 5% of asthma suffers have severe asthma, these patients account for a disproportionately high percentage of healthcare spending, as asthma-related hospitalizations and emergency room visits are two of the costliest outcomes, which highlights the significant unmet need in this market.

Scope

• Evaluation of the market potential and dynamics of Xolair, currently the only marketed respiratory monoclonal antibody
• Examination of the key mediators in asthma and the evidence supporting their role
• Identification and evaluation of fifteen monoclonal antibodies currently in preclinical or clinical development to treat asthma
• Assessment of drivers and resistors of using monoclonal antibodies in the severe asthma market

Report Highlights

Xolair is set to dominate the respiratory monoclonal antibody market through to 2010, and data from the TENOR study may help Genentech and Novartis to further increase market penetration if a role for IgE in non-atopic asthma is identified.

Th2 mediators are the target of most respiratory monoclonal antibody programmes, of which IL-13 is generating the greatest interest, with one third of programmes targeting this mediator.

Although there is a significant unmet need among severe asthma patients who are non-responsive to corticosteroids, the price point of respiratory monoclonal antibodies will limit penetration in cost-conscious Europe, transforming the US into the dominant revenue-creation market.

Reasons to Purchase

• Evaluate the current state of the monoclonal antibodies market and the market capture potential for these products in severe asthma
• Assess the key technological trends to capitalize on opportunities in the respiratory monoclonal antibody sector
• Identify possible targets to focus monoclonal antibody design

Table of Contents

• ABOUT DATAMONITOR HEALTHCARE
  • About the Infectious Diseases pharmaceutical analysis team
• CHAPTER 1 EXECUTIVE SUMMARY
  • Introduction
  • Scope and coverage of the Brief
  • Key findings from this Brief
• CHAPTER 2 DISEASE CLASSIFICATION AND EPIDEMIOLOGY
  • Asthma is a significant global health problem
  • Characterising asthma pathophysiology: the role of the Th2 pathway in asthma symptoms
    • The Th2 pathway plays a central role in asthma
    • A series of complex events underlie asthma symptoms
    • A broad range of mediators are involved in asthma pathophysiology
    • Asthma attacks are triggered by a wide variety of factors
  • Asthma is a collection of inflammatory respiratory conditions
    • Eosinophilic/mast cell asthma, and neutrophilic asthma
    • Atopic vs. non-atopic asthma and how it ties in with early-onset vs. late-onset asthma
    • Characterizing asthma by symptom frequency and severity
      • Characteristics of the severe asthma patient population
  • Corticosteroids and bronchodilators are currently the most common asthma treatments
• CHAPTER 3 USING MONOCLONAL ANTIBODIES TO TREAT ASTHMA
  • The evolution of the whole mAbs sector into a $10 billion market
    • Business model evolution
    • Therapy area evolution
  • Market potential for respiratory mAbs: the pros and cons with using mAbs for asthma
• CHAPTER 4 CURRENT RESPIRATORY MONOCLONAL ANTIBODY TREATMENTS FOR ASTHMA: XOLAIR
  • What is the rationale behind targeting IgE in asthma?
  • Xolair: a $1 billion market potential by 2015
  • Xolair's path to approval: what do other mAbs need to demonstrate?
  • Xolair label extension: opportunity in non-atopic asthma
• CHAPTER 5 PIPELINE INNOVATIONS AND POTENTIAL TARGETS
  • Targeting mediators that underlie asthma symptoms
    • The development of mAbs that target these mediators: the pipeline
    • Pipeline evaluation: IL-13 set to drive interest
  • Technology evolution: development of humanized and fully human mAbs set to drive market growth
  • Maximizing market potential by effective patient population capture: addressing clinical trial design issues
• APPENDIX
  • Bibliography
    • Papers
    • Miscellaneous
  • About Datamonitor
    • About Datamonitor Healthcare
    • Datamonitor Healthcare's research and analysis methodologies
  • Disclaimer
  • List of Tables
    • Table 1: Classification of asthma by symptom frequency and severity
    • Table 2: Xolair has demonstrated a range of effects in clinical trials
    • Table 3: Mediators thought to play a role in the aetiology of asthma
    • Table 4: Asthma mAbs currently in development
  • List of Figures
    • Figure 1: Key mediators and cells playing a role in the pathophysiology of asthma
    • Figure 2: Eosinophilic/mast cell and neutrophilic pathways
    • Figure 3: Characteristics of eosinophil positive and negative asthma
    • Figure 4: Percentage of asthma population with early or late-onset asthma
    • Figure 5: Severe persistent asthma makes up approximately one fifth of asthma incidence in Europe
    • Figure 6: Categorizing patients with severe asthma
    • Figure 7: Evolution of mAb developers towards fully-integrated status
    • Figure 8: Respiratory represents only a small percentage of mAb sales through to 2010
    • Figure 9: mAbs and anticholinergics power market growth
    • Figure 10: The pros and cons of using mAbs to treat asthma
    • Figure 11: 74,000 patients treated with Xolair by 2010, 74% in US market
    • Figure 12: Non-atopic is currently a significant untapped market for respiratory mAbs
    • Figure 13: Timeframe of asthma mAb development, based on mAb target