New Directions in Monoclonal Antibodies: Technologies, Markets, Competition

This publication has been discontinued on July 19, 2011.

Introduction

Abstract

New Directions in Monoclonal Antibodies: Technologies, Markets, Competition reviews the broad drug development effort that is focused on bringing improved mAb-based products to the market, including those used for drug discovery research, in vivo diagnostics, and therapeutic applications.

The monoclonal antibody market has experienced explosive growth in the nearly 30 years since the process for creating mAbs was introduced. More than fifteen therapeutic mAbs have been approved, several of which have reached blockbuster status. Numerous diagnostic mAbs have also been approved, making this one of the fastest growing fields in biotechnology. Today, the industry is working as furiously as ever to perfect the design and production of mAbs for therapeutic, diagnostic, and other purposes. This report evaluates the salient issues in these endeavors.

New Directions in Monoclonal Antibodies examines the more than 110 mAb products currently in clinical trials, as well as the products that are already available and those still at the preclinical stage that are likely to play an important role in the advancement of the field.

The report presents further analysis to evaluate the market potential for monoclonal antibodies in development for a variety of diseases. It reviews some general observations concerning commercialization of mAbs, then addresses the major disease categories, including patient numbers for diseases of interest; competing therapeutics already on the market, particularly those that have recently gained regulatory approval; and, where available, estimates of market sizes in dollars. Only those conditions for which drug candidates have been identified or which have been prominently mentioned as potential markets by pharmaceutical companies in the field are covered.

Table of Contents

• Chapter 1. Background and Scientific Overview: Antibodies and Monoclonal Antibodies
  • 1.1. What Is an Antibody?
  • 1.2. What is a Monoclonal Antibody?
• Chapter 2. Current and Emerging Technologies: Improving Monoclonal Antibody Design and Production
  • 2.1. Key Breakthroughs in the First 30 Years of Monoclonal Antibody Development
    • -Murine-Derived Monoclonal Antibodies
    • -Chimeric Monoclonal Antibodies
    • -Humanized Monoclonal Antibodies
    • -Fully Human Monoclonal Antibodies
      • --A Dissenting View on Humanization
    • -Antibody Fragments
    • -Antibody Conjugates
  • 2.2. Monoclonal Antibody Libraries and Display Technologies
    • -Phage Display
    • -Ribosome Display
    • -Other Library-Based Technologies
  • 2.3. Other Technologies for Designing Monoclonal Antibodies
    • -New Techniques for Generating Animal-Derived Monoclonal Antibodies
    • -Humanization Technology
    • -Transgenic Mice
  • 2.4. Alternative Antibody Formats
    • -Antibody Fragments
    • -Synthetic Antibodies
    • -Bispecific Antibodies
    • -Other Antibodies That Enhance Effector Function
    • -Antibody Conjugates
  • 2.5. Technologies for Improving Monoclonal Antibody Characteristics
    • -Protein Engineering
    • -Pegylation
    • -Glycosylation
    • -Reducing Immunogenicity
    • -Alternative Modes of Administration
  • 2.6. Technologies for Improving Monoclonal Antibody Production
    • -Increasing Yields in Mammalian Cultures
    • -Transgenic Animals
    • -Transgenic Plants
• Chapter 3. Marketed and Emerging Monoclonal Antibodies: Present and Future Therapeutics and In Vivo Diagnostics
  • 3.1. Approved Therapeutic Monoclonal Antibodies
    • -Profiles of Therapeutic Monoclonal Antibodies Approved for Marketing
  • 3.2. Monoclonal Antibodies in Development for Cancer
    • -Unconjugated Monoclonal Antibodies for Cancer
    • -Anti-Idiotype Monoclonal Antibodies for Cancer
    • -Conjugated Monoclonal Antibodies for Cancer
  • 3.3. Monoclonal Antibodies in Development for Immunologic Diseases
  • 3.4. Monoclonal Antibodies in Development for Infectious Diseases
  • 3.5. Antibodies in Development for Cardiovascular Diseases
  • 3.6. Other Therapeutic Antibodies in Development
  • 3.7. Approved and Developmental Diagnostic Antibodies
    • -Profiles of Diagnostic Monoclonal Antibodies Approved for Marketing
    • -Companies Developing Diagnostic Monoclonal Antibodies
• Chapter 4. Business and Strategic Outlook: Market Potential for Monoclonal Antibodies and Trends in the Field
  • 4.1. General Trends
    • -Addressing the Manufacturing Shortfall
  • 4.2. The Market for Therapeutic Monoclonal Antibodies
    • -Cancer--Solid Tumors
    • -Cancer--Non-Hodgkins Lymphoma
    • -Immune and Inflammatory Diseases
    • -Other Emerging Markets
  • 4.3. The Market for Diagnostic Monoclonal Antibodies
  • 4.4. Company Profiles
    • -AERES Biomedical Ltd.
    • -Affibody
    • -ARIUS Research Inc.
    • -Biogen Idec
    • -BioInvent
    • -Biovation Limited
    • -Centocor, Inc.
    • -Crucell
    • -Discerna UK
    • -Domantis
    • -Epitomics, Inc.
    • -Genentech, Inc.
    • -Genmab A/S
    • -GTC Biotherapeutics
    • -Human Genome Sciences, Inc.
    • -ImmunoGen, Inc.
    • -Raven Biotechnologies, Inc.
  • 4.5. Expert Commentaries
    • -Walter Blattler, Ph.D., ImmunoGen, Inc.
    • -Carl Borrebaeck, BioInvent
    • -Rathin Das, Affitech A/S
    • -Robert Ladner, Dyax Corp.
    • -Nils Lonberg, Medarex
    • -Simon Moroney, MorphoSys
    • -Clay B. Siegall, Seattle Genetics, Inc.
    • -Stephen Worsley, Raven Biotechnologies, Inc.
    • -Geoff Yarranton, KaloBios Pharmaceuticals Inc.

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