Abstract
Antibodies are proteins in the immune system that help the body defend against
foreign invasion, particularly from pathogens and toxins. As such, a
human-engineered therapeutic monoclonal antibody (mAb) is protein derived from
the immune system through recombinant DNA technology that has the ability to
combine specifically with a target protein that plays a role in a disease
process. With this unique ability to specifically target diseased cells while
leaving healthy cells unaffected, monoclonal antibodies can serve to diagnose
and treat a wide range of medical conditions. Areas such as breast cancer
therapy have benefited greatly since the advent of drugs like Herceptin
(trastuzumab) that interferes with the HER2/neu receptor. Indeed, the field of
therapeutic monoclonal antibodies potentially has far-reaching and
paradigm-shifting implications for biology, drug discovery, and medical
treatment of disease. The discipline has already yielded discoveries that have
been used for drug delivery and diagnostic purposes, and other exciting new
therapeutic applications. This TriMark Publications report reviews the market
for medical products based on emerging therapeutic monoclonal antibodies. It
defines the dollar volume of sales in the U.S. and worldwide, and it analyzes
the factors that influence the size and the growth of the market segments. The
study goes on to discuss in detail the trends that have developed which have
stimulated this market and surveys many of the companies marketing,
manufacturing or developing monoclonal antibodies therapies. Monoclonal
antibodies for non-therapeutic purposes--used primarily in life science and
research applications--are not discussed in this review. Moreover, antibody
process technology is not covered. Special effort was made to include mention
of smaller companies that are or potentially could have an impact on their
industry far in excess of their current size. Each company is discussed in
depth with a section on the history of the company, the product line, business
and marketing analysis, and a subjective commentary of the position of the
company in its market.
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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