Table of Contents
1. Introduction
- 1.1 Statement of Report
- 1.2 Objectives of this Report
- 1.3 Scope of the Report
- 1.4 Methodology
- 1.5 Executive Summary
2. Introduction: The State of Therapeutic Monoclonal Antibody Technology
- 2.1 State of the Pharmaceutical Industry
- 2.2 Antibodies as an Alternative Pharmaceutical Agent
- 2.3 Current Status of Antibody Therapeutics
- 2.4 Demands of Antibody Therapeutics Development
3. Recent Technology Trends
- 3.1 Classic Design of Antibodies
- 3.1.1 Chimeric Monoclonal Antibodies
- 3.1.2 Humanized Monoclonal Antibodies
- 3.1.3 Totally Human Antibodies
- 3.1.4 Monoclonal Antibody Processing
- 3.2 Monoclonal Antibodies Therapeutics
- 3.2.1 Naked Monoclonal Antibodies
- 3.2.2 Conjugated Monoclonal Antibodies
- 3.3 Synthetic Antibodies, Unique Scaffolds
- 3.4 Screening and Selection of Antibodies
- 3.5 Novel Antibody Modifications: Glycosylation, Pegylation, Polymer
Conjugations
- 3.5.1 Miniaturizing and Delivering Antibody Drugs
- 3.5.2 Recombinant Polyclonals
- 3.6 Monoclonal Antibody Purification
4. Industry Challenges
- 4.1 Introduction: Challenges Affecting the U.S. Therapeutic Monoclonal
Antibodies Market
- 4.2 Increasing Costs and Complexities of Clinical Trials
- 4.3 Long-term Safety and Efficacy
- 4.3.1 Post-marketing Surveillance of Monoclonal Antibodies
- 4.4 High Cost of Monoclonal Antibodies
- 4.5 Restricted Government Healthcare Spending
- 4.6 Intellectual Property Thicket
- 4.7 Government Regulation
- 4.8 Third-party Reimbursement Environment
5. Pipeline Analysis
- 5.1 Overview of the Monoclonal Antibodies Pipeline
- 5.1.1 Anti-Cancer Antibodies
- 5.1.2 Profiles of Important Monoclonal Antibodies in Oncology
- 5.1.2.1 Avastin
- 5.1.2.2 Phase I Trials of Anti-EpCAM Antibody Adecatumumab (MT201) in
Combination with Chemotherapy
- 5.1.2.3 Adecatumumab (MT201) in Combination with Chemotherapy
- 5.1.2.4 Herceptin
- 5.1.2.5 Pertuzumab, a HER2 Dimerization Inhibitor
- 5.1.2.6 Cetuximab
- 5.1.2.7 Prostate Cancer: Will Vaccines Lead the Way?
- 5.1.2.8 Recent Trial of an Anti-prostate Cancer Monoclonal Antibody
- 5.1.2.9 Anti-melanoma Antibodies
- 5.1.2.10 Other Anti-cancer Monoclonal Antibodies
- 5.1.3 Monoclonal Antibodies in Autoimmune and Inflammatory Disorders
- 5.1.3.1 Type 1 Diabetes
- 5.1.3.2 Rheumatoid Arthritis
- 5.1.4 Monoclonal Antibodies in Organ Transplants
- 5.1.5 Monoclonal Antibodies in Cardiovascular Disorders
- 5.1.5.1 Ablynx
- 5.1.5.2 ThromboGenics/BioInvent International
- 5.1.5.3 Pexelizumab: A Recombinant Humanized Single Chain Monoclonal
Antibody
- 5.1.6 Monoclonal Antibodies in Infectious Diseases
- 5.1.7 Monoclonal Antibodies in Miscellaneous Indications
- 5.1.7.1 Alzheimer' s Disease
- 5.1.7.2 Parkinson' s Antibody Therapy
- 5.2 U.S. Therapeutic Monoclonal Antibodies Market
6. Short-term Market Predictions
- 6.1 Total Revenue Forecasts
- 6.2 Segment Revenue Forecast
- 6.2.1 Oncology, Arthritis, Immune and Inflammatory Disorders (AIID)
- 6.3 Competitive Analysis Forecast
- 6.3.1 Competition between Similar Products
- 6.3.2 Competitive Factors
- 6.4 Conclusions
- 6.4.1 A Rocky Road
- 6.4.2 The Only Solution to High Medical Costs is Research
7. Antibody Technology Companies: Profiles
- 7.1 Abbott Laboratories
- 7.2 Abgenix
- 7.3 Ablynx
- 7.4 Aeres
- 7.5 Affimed Therapeutics AG
- 7.6 Affitech AS
- 7.7 Agensys
- 7.8 Alexion Pharmaceuticals
- 7.9 Amgen
- 7.10 Antisoma
- 7.11 ApoLife, Inc.
- 7.12 Applied Molecular Evolution, Inc.
- 7.13 Arana Therapeutics
- 7.14 Astellas Pharma
- 7.15 AstraZeneca plc
- 7.16 Biogen Idec, Inc.
- 7.17 BioInvent International AB
- 7.18 Biosite Discovery
- 7.19 Biovation Ltd.
- 7.20 BioWa
- 7.21 Boehringer Ingelheim
- 7.22 Cambridge Antibody Technology Group
- 7.23 Celltech
- 7.24 Corixa
- 7.25 Crucell NV
- 7.26 Cytogen
- 7.27 Dyax
- 7.28 Eisai Co., Ltd.
- 7.29 Elan Corporation
- 7.30 Eli Lilly
- 7.31 Elusys Therapeutics
- 7.32 Enzon Pharmaceuticals
- 7.33 Genentech
- 7.34 Genmab A/S
- 7.35 Genovac GmbH
- 7.36 Genzyme Corporation
- 7.37 GlaxoSmithKline plc
- 7.38 GlycArt
- 7.39 ILEX Oncology
- 7.40 ImClone Systems
- 7.41 ImmunoGen
- 7.42 Immunomedics
- 7.43 InNexus Biotechnology, Inc.
- 7.44 Johnson & Johnson
- 7.45 Lexigen
- 7.46 Medarex
- 7.47 MedImmune
- 7.48 Merus BV
- 7.49 Micromet
- 7.50 Millegen
- 7.51 Millennium Pharmaceuticals
- 7.52 MorphoSys AG
- 7.53 Novartis
- 7.54 Peregrine Pharmaceuticals, Inc.
- 7.55 PDL BioPharma
- 7.56 Philogen
- 7.57 Philotec
- 7.58 Phylos
- 7.59 Roche
- 7.60 Sanofi-Aventis
- 7.61 Scil Proteins
- 7.62 Seattle Genetics
- 7.63 Symphogen A/S
- 7.64 Tanox
- 7.65 ThromboGenics NV
- 7.66 Trion Pharma
- 7.67 Viventia Biotech, Inc.
- 7.68 Wyeth
- 7.69 Xcellerex
- 7.70 Xencor, Inc.
- 7.71 Xoma Ltd.
References
INDEX OF FIGURES
- Figure 2.1: Worldwide Pharmaceutical Sales and R&D Expenditures, 2000-2013
- Figure 2.2: International Per Capita Healthcare Spending by Country
- Figure 2.3: Total Spending on Healthcare in the U.S., 1960-2007
- Figure 2.4: Percentage Breakdown of U.S. Healthcare Spending, 2008
- Figure 3.1: Basic Structure of the Antibody Molecule
- Figure 5.1: Global Market for Protein Therapeutics, 2007-2013
- Figure 6.1: Sales of the Five Leading Antibodies, 2008
INDEX OF TABLES
- Table 2.1: Number of New Drug Applications to the FDA, 2000-2008
- Table 2.2: New Drug Approvals from FDA, 2000-2008
- Table 2.3: Percentage of GDP Healthcare Spending by Country, 2008
- Table 2.4: Life Expectancy Rate by Country, 2008
- Table 2.5: Development Time for Major Drugs for Top U.S. Pharmaceutical
Companies
- Table 2.6: Number of FDA “Black-box” Warnings, 2003-2007
- Table 2.7: Collaboration and Mergers
- Table 2.8: Worldwide Spending of Specialty Pharmaceuticals, 2003-2010
- Table 2.9: New Drug Development from Existing Drugs
- Table 3.1: Timeline of Immunological Discoveries
- Table 3.2: Antibody Screening and Selection Technologies
- Table 3.3: FDA-Approved Rapid HIV Antibody Screening Tests
- Table 4.1: Currently Approved Therapeutic Antibodies
- Table 5.1: Therapeutic Antibodies in the Development Pipeline
- Table 5.2: Currently Approved Anti-Cancer Antibodies
- Table 5.3: Status of Clinical Studies Involving Avastin
- Table 5.4: Market for Avastin Therapeutic Antibodies, 2006-2012
- Table 5.5: Rise in Herceptin Sales, 1998-2008
- Table 5.6: Monoclonal Antibodies in Clinical Trials for Cardiovascular
Diseases
- Table 6.1: Projected World Market for Therapeutic Monoclonal Antibodies,
2008-2012
- Table 6.2: Market Record and Outlook for Oncological Therapeutic
Antibodies, 2006-2012
- Table 6.3: Recorded and Anticipated Sales Growth for Anti-inflammatory
Monoclonal Antibodies, 2006-2012
- Table 7.1: Genentech' s Operating Revenue, 2004-2008
- Table 7.2: Genentech' s Product Sales, 2006-2008
- Table 7.3: Genentech' s Product Licensee Products
- Table 7.4: Genentech' s Products in Development 80
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