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Clinical Trials

New Directions in Monoclonal Antibodies

Technologies, Markets, Competition

Publication Date   October 2004
Publisher   Cambridge Healthtech Advisors
Product Type   Report
Pages   202
ISBN Number   not applicable
Product Code   CHA007
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Summary


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. It surveys the latest technologies being applied to the development of these compounds, profiles the major companies, drugs, and projects, and assesses the future market potential for mAbs, taking into account some of the major challenges faced by the industry.

New Directions in Monoclonal Antibodies: Technologies, Markets, Competition 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.

Content


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-Hodgkin’s 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
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.