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Published by: CHI Insight Pharma Reports
Published: Aug. 1, 2009 - 212 Pages
Table of Contents
- Executive Summary
- 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 35 Years of Monoclonal Antibody
- Development
- Murine-Derived Monoclonal Antibodies
- Chimeric Monoclonal Antibodies
- Humanized Monoclonal Antibodies
- Fully Human Monoclonal Antibodies
- Antibody Fragments
- Antibody Conjugates
- 2.2. Monoclonal Antibody Libraries and Display Technologies
- Phage Display
- MedImmune (AstraZeneca)
- Dyax
- Crucell
- MorphoSys
- Affitech
- Biosite (Inverness Medical Innovations)
- Affimed Therapeutics
- XOMA
- Ribosome Display
- MedImmune (AstraZeneca)
- Discerna
- Other Library-Based Technologies
- Alexion Pharmaceuticals
- BioInvent International
- viii • www.InsightPharmaReports.com • Reproduction prohibited
- Table of Contents
- Adimab
- MSM Protein Technologies
- Vaccinex
- Morphotek (Eisai Corp. of North America)
- AnaptysBio
- Sorrento Therapeutics
- 2.3. Other Technologies for Designing Monoclonal Antibodies
- Techniques for Improving Hybridoma Production
- Abeome
- New Techniques for Generating Animal-Derived Monoclonal
- Antibodies
- GENOVAC (Aldevron)
- Epitomics
- North Coast Biologics
- Xori
- Chiome Bioscience
- Humanization Technology
- Abmaxis (Merck)
- Arana Therapeutics
- MRC Technology
- ImmunoGen
- KaloBios Pharmaceuticals
- PDL BioPharma
- XOMA
- Antitope
- Xencor
- Massachusetts Institute of Technology
- Transgenic Mice
- Amgen
- Medarex
- AVANIR Pharmaceuticals
- Regeneron Pharmaceuticals
- Human Hybridoma Technology
- Morphotek (Eisai Corp. of North America)
- Patrys
- Kenta Biotech
- 2.4. Alternative Antibody Formats
- Antibody Fragments
- ESBATech
- MacroGenics
- Genmab
- Synthetic Antibodies
- Ablynx
- Affibody
- Domantis (GlaxoSmithKline)
- AdAlta
- Enzon Pharmaceuticals/Micromet
- Arana Therapeutics
- Bispecific Antibodies
- Elusys Therapeutics
- Monoclonal Antibodies: Pipeline Analysis and Competitive Assessment
- Micromet
- TRION Pharma
- Affimed Therapeutics
- Affitech/Pharmexa
- Biotecnol
- Other Antibodies That Enhance Effector Function
- BioWa
- MacroGenics
- Tolerx
- Vaccibody
- InNexus Biotechnology
- Xencor
- 2.5. Antibody Conjugates
- Antibody-Radioisotope Conjugates
- Affibody
- PBL Therapeutics
- Aduro BioTech
- Antibody-Drug Conjugates
- Medarex
- HERMES Biosciences
- Celldex Therapeutics
- Scancell
- Paladin Labs
- Antibody-Toxin Conjugates
- 2.6. Technologies for Improving Monoclonal Antibody
- Characteristics
- Protein Engineering
- Applied Molecular Evolution (Eli Lilly)
- Arana Therapeutics
- Morphotek
- MilleGen/Accuro Biologics
- Facet Biotech
- Xencor
- Merus
- Algonomics
- f-star
- PEGylation
- Alternatives to PEGylation
- Glycosylation
- GlycArt (Roche)
- GlycoFi (Merck)
- Glycotope
- Synageva BioPharma
- LFB
- Alternative Modes of Administration
- Altus Pharmaceuticals
- Baxter BioPharma Solutions
- Chapter 3
- MARKETED AND EMERGING MONOCLONAL
- ANTIBODIES: PRESENT AND FUTURE
- THERAPEUTICS
- 3.1. Approved Therapeutic Monoclonal Antibodies
- Profiles of Therapeutic Monoclonal Antibodies Approved for
- Marketing
- Orthoclone OKT3 (Muromonab-CD3) (1986)
- ReoPro (Abciximab) (1994)
- Rituxan (Rituximab) (1997)
- Zenapax (Daclizumab) (1997)
- Simulect (Basiliximab) (1998)
- Synagis (Palivizumab) (1998)
- Remicade (Infliximab) (1998)
- Herceptin (Trastuzumab) (1998)
- Mylotarg (Gemtuzumab Ozogamicin) (2000)
- Campath (Alemtuzumab) (2001)
- Zevalin (Ibritumomab Tiuxetan) (2002)
- Humira (Adalimumab) (2002)
- Xolair (Omalizumab) (2003)
- Bexxar (Tositumomab) (2003)
- Raptiva (Efalizumab) (2003)
- Erbitux (Cetuximab) (2004)
- Avastin (Bevacizumab) (2004)
- Tysabri (Natalizumab) (2006)
- Lucentis (Ranibizumab) (2006)
- Vectibix (Panitumumab) (2006)
- Soliris (Eculizumab) (2007)
- Cimzia (Certolizumab Pegol) (2008)
- Ilaris (Canakinumab) (2009)
- 3.2. Monoclonal Antibodies in Development for Cancer
- Unconjugated Monoclonal Antibodies for Cancer
- Genmab
- Medarex
- Biogen Idec
- Genentech
- Human Genome Sciences
- Pfizer
- Wilex
- Immunomedics
- ImClone Systems (Eli Lilly)
- Morphotek (Eisai Corp. of North America)
- Antisoma
- Micromet
- UCB
- AVEO Pharmaceuticals
- Lpath
- Northwest Biotherapeutics
- Anti-idiotype Monoclonal Antibodies for Cancer
- Monoclonal Antibodies: Pipeline Analysis and Competitive Assessment
- Menarini Group
- Onyvax
- Conjugated Monoclonal Antibodies for Cancer
- Active Biotech
- Antisoma
- ImmunoGen
- Immunomedics
- MedImmune
- Seattle Genetics
- Merck Serono
- Celldex Therapeutics/Curagen
- 3.3. Monoclonal Antibodies in Development for Immunological
- Diseases
- Human Genome Sciences
- Novartis
- UCB
- Amgen
- Biogen Idec/Genentech
- MedImmune
- Genmab
- Millennium Pharmaceuticals (Takeda Pharmaceutical)
- Medarex
- NovImmune
- BioTie Therapies
- Micromet
- ZymoGenetics/Novo Nordisk
- Glenmark Pharmaceuticals
- CSL
- LigoCyte Pharmaceuticals
- Sanofi-Aventis/Kyowa Hakko Kirin
- 3.4. Monoclonal Antibodies in Development for Infectious Diseases
- Novartis
- MedImmune
- Human Genome Sciences
- Taimed Biologics
- Medarex
- Elusys Therapeutics
- Emergent BioSolutions
- Crucell
- Progenics Pharmaceuticals
- Roche
- Genmab
- Theraclone Sciences
- iBioPharma
- 3.5. Monoclonal Antibodies in Development for Cardiovascular
- Diseases
- Ablynx
- ThromboGenics/BioInvent International
- Affimed Therapeutics
- Table of Contents
- Lexicon Pharmaceuticals
- 3.6. Other Therapeutic Antibodies in Development
- Amgen
- Elan/Wyeth
- Eli Lilly
- Pfizer
- Others
- Chapter 4
- BUSINESS AND STRATEGIC OUTLOOK: MARKET
- POTENTIAL FOR MONOCLONAL ANTIBODIES AND
- TRENDS IN THE FIELD
- 4.1. General Trends
- 4.2. The Market for Therapeutic Monoclonal Antibodies
- Cancer: Solid Tumors
- Cancer: Non-Hodgkin’s Lymphoma
- Immune and Inflammatory Diseases
- Transplant Rejection
- Rheumatoid Arthritis
- Crohn’s Disease
- Psoriasis
- Lupus
- Multiple Sclerosis
- Asthma
- Other Emerging Markets
- Age-Related Macular Degeneration
- HIV
- Alzheimer’s Disease
- Chapter 5
- CHI INSIGHT PHARMA REPORTS MONOCLONAL
- ANTIBODIES SURVEY—JULY 2009
- References
- Company Index with Web Addreses
- Monoclonal Antibodies: Pipeline Analysis and Competitive Assessment
- Tables
- Table 3.1. FDA-Approved Therapeutic Monoclonal Antibodies
- Table 3.2. Unconjugated Monoclonal Antibodies in Clinical Trials for Cancer
- Table 3.3. Conjugated Monoclonal Antibodies in Clinical Trials for Cancer
- Table 3.4. Monoclonal Antibodies in Clinical Trials for Immunological Diseases
- Table 3.5. Monoclonal Antibodies in Clinical Trials for Infectious Diseases
- Table 3.6. Monoclonal Antibodies in Clinical Trials for Cardiovascular Diseases
- Table 3.7. Other Therapeutic Monoclonal Antibodies in Clinical Development
- Table 4.1. Worldwide Sales of Therapeutic Monoclonal Antibodies,2007 and 2008
- Table 4.2. Estimated New Cancer Cases in United States, Total and Selected Types, 2009
- Figures
- Figure 1.1. Structure of an Antibody
- Figure 2.1. Monoclonal Antibody Production
- Figure 2.2. Antibody Engineering
- Figure 2.3. Engineered Forms of Antibodies
- Figure 1A. Please classify your organization
- Figure 2A. Focus of Respondents’ Organizations
- Figure 3A. Professional Responsibilities of Respondents
- Figure 4A. Changes in mAb Pipelines
- Figure 5A. Magnitude of Increase in mAb Pipelines
- Figure 6A. Recent Changes in Level of Activity Related to mAbs
- Figure 7A. Future Changes in Level of Activity Related to mAbs
- Figure 8A. Rate of New mAb Approvals
- Figure 9A. Challenges to mAb Development
- Figure 10A. Key Technologies
- Figure 11A. Future Improvements to mAbs
- Figure 12A. Relevant Disease Areas
AbstractIn the nearly 35 years since the first process for creating mAbs was introduced, they have remained a centerpiece of the growing biotechnology industry. Thirty therapeutic mAbs have been approved around the world, including 23 in the United States. A number of these drugs have attained blockbuster status, with sales reaching the coveted billion-dollar mark and well beyond. Rituxan, Remicade, Avastin, Herceptin, and Humira alone generated sales of over $4 billion each in 2008, and global sales for this entire sector surpassed $30 billion last year.
Key challenges and implications presented in this new report include:
- Future products and their indications
- Merits of human versus chimeric structures
- Costs of mAb therapy and the US healthcare debate
- Clinical pipeline with over 250 candidates
- A focus on "engineered" antibodies
Monoclonal Antibodies: Pipeline Analysis and Competitive Assessment reviews the broad drug development effort that is focused on bringing improved mAb-based products to the market, concentrating on those used for therapeutic applications. It surveys the latest technologies being applied to the development of these compounds and profiles the major companies, drugs, and projects. It then draws conclusions about the future market potential for mAbs and discusses the major challenges faced by the industry.
The biotech industry devoted years to reducing the immunogenicity of mAbs, developing the technologies—detailed in this report—to progress from chimeric, to humanized, to fully human antibodies. These succeeding generations of mAbs have demonstrated incremental improvements in safety and activity, and the industry is currently in the middle of a major shift toward humanized and human products.
Much work has also been done on altering antibodies’ outward form to boost their efficacy, enabling them to more readily penetrate tumors, enhancing their ability to stimulate beneficial immune responses, or otherwise improving their characteristics. Into this realm fall such constructions as antibody fragments, diabodies, synthetic antibodies, bispecific antibodies, and antibody conjugates. This report looks at some of the engineered forms of antibodies and the companies that are leading the way in this research. Other complementary technologies, such as PEGylation and glycosylation, are also presented.
Monoclonal Antibodies: Pipeline Analysis and Competitive Assessment presents an analysis for the current state of mAb drug development. It identifies more than 250 therapeutic products now in clinical trials, which are largely concentrated in the areas of cancer, immunological and inflammatory diseases, as well as infectious diseases. Beyond these, hundreds more candidates are at the preclinical stage of development. Reviewed here are the products that are already available, those in clinical development, and those still at the preclinical stage that are likely to play an important role in the advancement of the field.
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