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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.

1. 1. Introduction 5
2. 1.1 Statement of Report 5
3. 1.2 Objectives of this Report 5
4. 1.3 Scope of the Report 6
5. 1.4 Methodology 7
6. 1.5 Executive Summary 8
8. 2. The State of Therapeutic Monoclonal Antibody Technology 10
9. 2.1 State of the Pharmaceutical Industry 10
10. 2.2 Antibodies as an Alternative Pharmaceutical Agent 16
11. 2.3 Current Status of Antibody Therapeutics 19
12. 2.4 Demands of Antibody Therapeutics Development 23
14. 3. Recent Technology Trends 24
15. 3.1 Classic Design of Antibodies 24
16. 3.1.1 Chimeric Monoclonal Antibodies 25
17. 3.1.2 Humanized Monoclonal Antibodies 25
18. 3.1.3 Totally Human Antibodies 26
19. 3.1.4 Monoclonal Antibody Processing 26
20. 3.2 Monoclonal Antibodies Therapeutics 26
21. 3.2.1 Naked Monoclonal Antibodies 26
22. 3.2.2 Conjugated Monoclonal Antibodies 27
23. 3.3 Synthetic Antibodies, Unique Scaffolds 28
24. 3.4 Screening and Selection of Antibodies 28
25. 3.5 Novel Antibody Modifications: Glycosylation, Pegylation, Polymer Conjugations 29
26. 3.5.1 Miniaturizing and Delivering Antibody Drugs 30
27. 3.5.2 Recombinant Polyclonals 30
28. 3.6 Monoclonal Antibody Purification 31
30. 4. Industry Challenges 32
31. 4.1 Introduction: Challenges Affecting the U.S. Therapeutic Monoclonal Antibodies Market 32
32. 4.2 Increasing Costs and Complexities of Clinical Trials 33
33. 4.3 Long-term Safety and Efficacy 33
34. 4.3.1 Post-marketing Surveillance of Monoclonal Antibodies 34
35. 4.4 High Cost of Monoclonal Antibodies 34
36. 4.5 Restricted Government Healthcare Spending 35
37. 4.6 Intellectual Property Thicket 35
38. 4.7 Government Regulation 36
39. 4.8 Third-party Reimbursement Environment 37
41. 5. Pipeline Analysis 38
42. 5.1 Overview of the Monoclonal Antibodies Pipeline 38
43. 5.1.1 Anti-Cancer Antibodies 41
44. 5.1.2 Profiles of Important Monoclonal Antibodies in Oncology 41
45. 5.1.2.1 Avastin 42
46. 5.1.2.2 Phase I Trials of Anti-EpCAM Antibody Adecatumumab (MT201) in Combination with Chemotherapy 44
47. 5.1.2.3 Adecatumumab (MT201) in Combination with Chemotherapy 45
48. 5.1.2.4 Herceptin 45
49. 5.1.2.5 Pertuzumab, a HER2 Dimerization Inhibitor 46
50. 5.1.2.6 Cetuximab 47
51. 5.1.2.7 Prostate Cancer: Will Vaccines Lead the Way? 47
52. 5.1.2.8 Recent Trial of an Anti-prostate Cancer Monoclonal Antibody 47
53. 5.1.2.9 Anti-melanoma Antibodies 48
54. 5.1.2.10 Other Anti-cancer Monoclonal Antibodies 48
55. 5.1.3 Monoclonal Antibodies in Autoimmune and Inflammatory Disorders 48
56. 5.1.3.1 Type 1 Diabetes 49
57. 5.1.3.2 Rheumatoid Arthritis 49
58. 5.1.4 Monoclonal Antibodies in Organ Transplants 50
59. 5.1.5 Monoclonal Antibodies in Cardiovascular Disorders 50
60. 5.1.5.1 Ablynx 50
61. 5.1.5.2 ThromboGenics/BioInvent International 50
62. 5.1.5.3 Pexelizumab: A Recombinant Humanized Single Chain Monoclonal Antibody 51
63. 5.1.6 Monoclonal Antibodies in Infectious Diseases 51
64. 5.1.7 Monoclonal Antibodies in Miscellaneous Indications 51
65. 5.1.7.1 Alzheimer's Disease 51
66. 5.1.7.2 Parkinson's Antibody Therapy 52
67. 5.2 U.S. Therapeutic Monoclonal Antibodies Market 52
68. 5.2.1 Market Dimensions 52
70. 6. Short-term Market Predictions 54
71. 6.1 Total Revenue Forecasts 54
72. 6.2 Segment Revenue Forecast 55
73. 6.2.1 Oncology, Arthritis, Immune and Inflammatory Disorders (AIID) 55
74. 6.3 Competitive Analysis Forecast 56
75. 6.3.1 Competition between Similar Products 57
76. 6.3.2 Competitive Factors 58
77. 6.4 Conclusions 58
78. 6.4.1 A Rocky Road 58
79. 6.4.2 The Only Solution to High Medical Costs is Research 59
81. 7. Antibody Technology Companies: Profiles 61
82. 7.1 Abbott Laboratories 61
83. 7.2 Abgenix 62
84. 7.3 Ablynx 62
85. 7.4 Aeres 62
86. 7.5 Affimed Therapeutics AG 63
87. 7.6 Affitech AS 63
88. 7.7 Agensys 63
89. 7.8 Alexion Pharmaceuticals 63
90. 7.9 Amgen 64
91. 7.10 Antisoma 65
92. 7.11 ApoLife, Inc. 65
93. 7.12 Applied Molecular Evolution, Inc. 66
94. 7.13 Arana Therapeutics 66
95. 7.14 Astellas Pharma 66
96. 7.15 AstraZeneca plc 67
97. 7.16 Biogen Idec, Inc. 68
98. 7.17 BioInvent International AB 69
99. 7.18 Biosite Discovery 70
100. 7.19 Biovation Ltd. 70
101. 7.20 BioWa 70
102. 7.21 Boehringer Ingelheim 71
103. 7.22 Cambridge Antibody Technology Group 71
104. 7.23 Crucell NV 71
105. 7.24 Cytogen 72
106. 7.25 Dyax 72
107. 7.26 Eisai Co., Ltd. 73
108. 7.27 Elan Corporation 73
109. 7.28 Eli Lilly 74
110. 7.29 Elusys Therapeutics 75
111. 7.30 Enzon Pharmaceuticals 75
112. 7.31 Genentech 76
113. 7.32 Genmab A/S 82
114. 7.33 Genovac GmbH 83
115. 7.34 Genzyme Corporation 83
116. 7.35 GlaxoSmithKline plc 84
117. 7.36 ImClone Systems 85
118. 7.37 ImmunoGen 86
119. 7.38 Immunomedics 87
120. 7.39 InNexus Biotechnology, Inc. 89
121. 7.40 Johnson & Johnson 89
122. 7.41 Medarex 91
123. 7.42 MedImmune 92
124. 7.43 Merus BV 92
125. 7.44 Micromet 93
126. 7.45 Millegen 93
127. 7.46 Millennium Pharmaceuticals 94
128. 7.47 MorphoSys AG 94
129. 7.48 Novartis 94
130. 7.49 Peregrine Pharmaceuticals, Inc. 95
131. 7.50 PDL BioPharma 96
132. 7.51 Philogen 97
133. 7.52 Philotec 98
134. 7.53 Phylos 98
135. 7.54 Roche 98
136. 7.55 Sanofi-Aventis 99
137. 7.56 Scil Proteins 101
138. 7.57 Seattle Genetics 101
139. 7.58 Symphogen A/S 103
140. 7.59 Tanox 103
141. 7.60 ThromboGenics NV 103
142. 7.61 Trion Pharma 103
143. 7.62 Viventia Biotech, Inc. 104
144. 7.63 Wyeth 104
145. 7.64 Xcellerex 105
146. 7.65 Xencor, Inc. 105
147. 7.66 Xoma Ltd. 105
149. References 108
152. INDEX OF FIGURES
154. Figure 2.1: Worldwide Pharmaceutical Sales and R&D Expenditures, 2000-2013 11
155. Figure 2.2: International Per Capita Healthcare Spending by Country 13
156. Figure 2.3: Total Spending on Healthcare in the U.S., 1960-2007 15
157. Figure 2.4: Percentage Breakdown of U.S. Healthcare Spending, 2008 15
158. Figure 3.1: Basic Structure of the Antibody Molecule 25
159. Figure 5.1: Global Market for Protein Therapeutics, 2007-2013 53
160. Figure 6.1: Sales of the Five Leading Antibodies, 2008 56
164. INDEX OF TABLES
166. Table 2.1: Number of New Drug Applications to the FDA, 2000-2008 11
167. Table 2.2: New Drug Approvals from FDA, 2000-2008 12
168. Table 2.3: Percentage of GDP Healthcare Spending by Country, 2008 13
169. Table 2.4: Life Expectancy Rate by Country, 2008 14
170. Table 2.5: Development Time for Major Drugs for Top U.S. Pharmaceutical Companies 16
171. Table 2.6: Number of FDA "Black-box" Warnings, 2003-2007 20
172. Table 2.7: Collaboration and Mergers 21
173. Table 2.8: Worldwide Spending of Specialty Pharmaceuticals, 2003-2010 22
174. Table 2.9: New Drug Development from Existing Drugs 22
175. Table 3.1: Timeline of Immunological Discoveries 24
176. Table 3.2: Antibody Screening and Selection Technologies 29
177. Table 3.3: FDA-Approved Rapid HIV Antibody Screening Tests 29
178. Table 4.1: Currently Approved Therapeutic Antibodies 32
179. Table 5.1: Therapeutic Antibodies in the Development Pipeline 38
180. Table 5.2: Currently Approved Anti-Cancer Antibodies 41
181. Table 5.3: Status of Clinical Studies Involving Avastin 43
182. Table 5.4: Market for Avastin Therapeutic Antibodies, 2006-2012 43
183. Table 5.5: Rise in Herceptin Sales, 1998-2008 45
184. Table 5.6: Monoclonal Antibodies in Clinical Trials for Cardiovascular Diseases 50
185. Table 6.1: Projected World Market for Therapeutic Monoclonal Antibodies, 2008-2012 54
186. Table 6.2: Market Record and Outlook for Oncological Therapeutic Antibodies, 2006-2012 55
187. Table 6.3: Recorded and Anticipated Sales Growth for Anti-inflammatory Monoclonal Antibodies, 2006-2012 55
188. Table 7.1: Genentech's Operating Revenue, 2004-2008 76
189. Table 7.2: Genentech's Product Sales, 2006-2008 77
190. Table 7.3: Genentech's Product Licensee Products 79
191. Table 7.4: Genentech's Products in Development 79