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Therapeutic Monoclonal Antibodies Markets --- Aarkstore Enterprise

Posted Nov 29 2010 11:06am

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 5
1.1 Statement of Report 5
1.2 Objectives of this Report 5
1.3 Scope of the Report 6
1.4 Methodology 7
1.5 Executive Summary 8

2. The State of Therapeutic Monoclonal Antibody Technology 10
2.1 State of the Pharmaceutical Industry 10
2.2 Antibodies as an Alternative Pharmaceutical Agent 16
2.3 Current Status of Antibody Therapeutics 19
2.4 Demands of Antibody Therapeutics Development 23

3. Recent Technology Trends 24
3.1 Classic Design of Antibodies 24
3.1.1 Chimeric Monoclonal Antibodies 25
3.1.2 Humanized Monoclonal Antibodies 25
3.1.3 Totally Human Antibodies 26
3.1.4 Monoclonal Antibody Processing 26
3.2 Monoclonal Antibodies Therapeutics 26
3.2.1 Naked Monoclonal Antibodies 26
3.2.2 Conjugated Monoclonal Antibodies 27
3.3 Synthetic Antibodies, Unique Scaffolds 28
3.4 Screening and Selection of Antibodies 28
3.5 Novel Antibody Modifications: Glycosylation, Pegylation, Polymer Conjugations 29
3.5.1 Miniaturizing and Delivering Antibody Drugs 30
3.5.2 Recombinant Polyclonals 30
3.6 Monoclonal Antibody Purification 31

4. Industry Challenges 32
4.1 Introduction: Challenges Affecting the U.S. Therapeutic Monoclonal Antibodies Market 32
4.2 Increasing Costs and Complexities of Clinical Trials 33
4.3 Long-term Safety and Efficacy 33
4.3.1 Post-marketing Surveillance of Monoclonal Antibodies 34
4.4 High Cost of Monoclonal Antibodies 34
4.5 Restricted Government Healthcare Spending 35
4.6 Intellectual Property Thicket 35
4.7 Government Regulation 36
4.8 Third-party Reimbursement Environment 37

5. Pipeline Analysis 38
5.1 Overview of the Monoclonal Antibodies Pipeline 38
5.1.1 Anti-Cancer Antibodies 41
5.1.2 Profiles of Important Monoclonal Antibodies in Oncology 41
5.1.2.1 Avastin 42
5.1.2.2 Phase I Trials of Anti-EpCAM Antibody Adecatumumab (MT201) in Combination with Chemotherapy 44
5.1.2.3 Adecatumumab (MT201) in Combination with Chemotherapy 45
5.1.2.4 Herceptin 45
5.1.2.5 Pertuzumab, a HER2 Dimerization Inhibitor 46
5.1.2.6 Cetuximab 47
5.1.2.7 Prostate Cancer: Will Vaccines Lead the Way? 47
5.1.2.8 Recent Trial of an Anti-prostate Cancer Monoclonal Antibody 47
5.1.2.9 Anti-melanoma Antibodies 48
5.1.2.10 Other Anti-cancer Monoclonal Antibodies 48
5.1.3 Monoclonal Antibodies in Autoimmune and Inflammatory Disorders 48
5.1.3.1 Type 1 Diabetes 49
5.1.3.2 Rheumatoid Arthritis 49
5.1.4 Monoclonal Antibodies in Organ Transplants 50
5.1.5 Monoclonal Antibodies in Cardiovascular Disorders 50
5.1.5.1 Ablynx 50
5.1.5.2 ThromboGenics/BioInvent International 50
5.1.5.3 Pexelizumab: A Recombinant Humanized Single Chain Monoclonal Antibody 51
5.1.6 Monoclonal Antibodies in Infectious Diseases 51
5.1.7 Monoclonal Antibodies in Miscellaneous Indications 51
5.1.7.1 Alzheimer’s Disease 51
5.1.7.2 Parkinson’s Antibody Therapy 52
5.2 U.S. Therapeutic Monoclonal Antibodies Market 52
5.2.1 Market Dimensions 52

6. Short-term Market Predictions 54
6.1 Total Revenue Forecasts 54
6.2 Segment Revenue Forecast 55
6.2.1 Oncology, Arthritis, Immune and Inflammatory Disorders (AIID) 55
6.3 Competitive Analysis Forecast 56
6.3.1 Competition between Similar Products 57
6.3.2 Competitive Factors 58
6.4 Conclusions 58
6.4.1 A Rocky Road 58
6.4.2 The Only Solution to High Medical Costs is Research 59

7. Antibody Technology Companies: Profiles 61
7.1 Abbott Laboratories 61
7.2 Abgenix 62
7.3 Ablynx 62
7.4 Aeres 62
7.5 Affimed Therapeutics AG 63
7.6 Affitech AS 63
7.7 Agensys 63
7.8 Alexion Pharmaceuticals 63
7.9 Amgen 64
7.10 Antisoma 65
7.11 ApoLife, Inc. 65
7.12 Applied Molecular Evolution, Inc. 66
7.13 Arana Therapeutics 66
7.14 Astellas Pharma 66
7.15 AstraZeneca plc 67
7.16 Biogen Idec, Inc. 68
7.17 BioInvent International AB 69
7.18 Biosite Discovery 70
7.19 Biovation Ltd. 70
7.20 BioWa 70
7.21 Boehringer Ingelheim 71
7.22 Cambridge Antibody Technology Group 71
7.23 Crucell NV 71
7.24 Cytogen 72
7.25 Dyax 72
7.26 Eisai Co., Ltd. 73
7.27 Elan Corporation 73
7.28 Eli Lilly 74
7.29 Elusys Therapeutics 75
7.30 Enzon Pharmaceuticals 75
7.31 Genentech 76
7.32 Genmab A/S 82
7.33 Genovac GmbH 83
7.34 Genzyme Corporation 83
7.35 GlaxoSmithKline plc 84
7.36 ImClone Systems 85
7.37 ImmunoGen 86
7.38 Immunomedics 87
7.39 InNexus Biotechnology, Inc. 89
7.40 Johnson & Johnson 89
7.41 Medarex 91
7.42 MedImmune 92
7.43 Merus BV 92
7.44 Micromet 93
7.45 Millegen 93
7.46 Millennium Pharmaceuticals 94
7.47 MorphoSys AG 94
7.48 Novartis 94
7.49 Peregrine Pharmaceuticals, Inc. 95
7.50 PDL BioPharma 96
7.51 Philogen 97
7.52 Philotec 98
7.53 Phylos 98
7.54 Roche 98
7.55 Sanofi-Aventis 99
7.56 Scil Proteins 101
7.57 Seattle Genetics 101
7.58 Symphogen A/S 103
7.59 Tanox 103
7.60 ThromboGenics NV 103
7.61 Trion Pharma 103
7.62 Viventia Biotech, Inc. 104
7.63 Wyeth 104
7.64 Xcellerex 105
7.65 Xencor, Inc. 105
7.66 Xoma Ltd. 105

References 108


INDEX OF FIGURES

Figure 2.1: Worldwide Pharmaceutical Sales and R&D Expenditures, 2000-2013 11
Figure 2.2: International Per Capita Healthcare Spending by Country 13
Figure 2.3: Total Spending on Healthcare in the U.S., 1960-2007 15
Figure 2.4: Percentage Breakdown of U.S. Healthcare Spending, 2008 15
Figure 3.1: Basic Structure of the Antibody Molecule 25
Figure 5.1: Global Market for Protein Therapeutics, 2007-2013 53
Figure 6.1: Sales of the Five Leading Antibodies, 2008 56


INDEX OF TABLES

Table 2.1: Number of New Drug Applications to the FDA, 2000-2008 11
Table 2.2: New Drug Approvals from FDA, 2000-2008 12
Table 2.3: Percentage of GDP Healthcare Spending by Country, 2008 13
Table 2.4: Life Expectancy Rate by Country, 2008 14
Table 2.5: Development Time for Major Drugs for Top U.S. Pharmaceutical Companies 16
Table 2.6: Number of FDA “Black-box” Warnings, 2003-2007 20
Table 2.7: Collaboration and Mergers 21
Table 2.8: Worldwide Spending of Specialty Pharmaceuticals, 2003-2010 22
Table 2.9: New Drug Development from Existing Drugs 22
Table 3.1: Timeline of Immunological Discoveries 24
Table 3.2: Antibody Screening and Selection Technologies 29
Table 3.3: FDA-Approved Rapid HIV Antibody Screening Tests 29
Table 4.1: Currently Approved Therapeutic Antibodies 32
Table 5.1: Therapeutic Antibodies in the Development Pipeline 38
Table 5.2: Currently Approved Anti-Cancer Antibodies 41
Table 5.3: Status of Clinical Studies Involving Avastin 43
Table 5.4: Market for Avastin Therapeutic Antibodies, 2006-2012 43
Table 5.5: Rise in Herceptin Sales, 1998-2008 45
Table 5.6: Monoclonal Antibodies in Clinical Trials for Cardiovascular Diseases 50
Table 6.1: Projected World Market for Therapeutic Monoclonal Antibodies, 2008-2012 54
Table 6.2: Market Record and Outlook for Oncological Therapeutic Antibodies, 2006-2012 55
Table 6.3: Recorded and Anticipated Sales Growth for Anti-inflammatory Monoclonal Antibodies, 2006-2012 55
Table 7.1: Genentech’s Operating Revenue, 2004-2008 76
Table 7.2: Genentech’s Product Sales, 2006-2008 77
Table 7.3: Genentech’s Product Licensee Products 79
Table 7.4: Genentech’s Products in Development 79

For more information, please visit : http://www.aarkstore.com/reports/Therapeutic-Monoclonal-Antibodies-Markets-19638

Contact :Sanaa

Aarkstore Enterprise

Tel : +912227453309

Mobile No: +919272852585

Email : contact@aarkstore.com

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