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Monoclonal Antibodies Report: 2008 Update
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| Zahlen und Fakten zur Studie: |
*Assess the key products that will drive sales growth in the mAb market to 2013 *Understand the challenges and barriers to entry for new players seeking to venture into the mAb market *Understand the nature of the generic threat across different molecule types and the insulation of mAb products from biosimilars 363 pages | |||||||||||
| Inhalt der Studie: |
The report provides a comprehensive financial and strategic analysis of the mAb market, forecasting its commercial evolution out to 2013 and assessing trends by product, company, therapy area, technol.....
The report provides a comprehensive financial and strategic analysis of the mAb market, forecasting its commercial evolution out to 2013 and assessing trends by product, company, therapy area, technology and target type. It also provides an insight into the direction of mAb technology evolution and an analysis of pipeline dynamics. Report Highlights The overall prescription pharmaceutical market is expected to face a decline in sales over 2011 to 2012 as a result of the 'patent cliff'. The patent cliff will impact the small molecule market, in contrast, the mAb market segment will continue to record robust growth. Over the forecast period monoclonal antibodies are predicted to enjoy double-digit growth while small molecule drugs face declining growth rates. The main barrier to sales growth for small molecules is exposure to material generic competition, which will have no effect on mAbs out to 2013. mAbs currently command a three-fold average revenue per product premium over small molecules. Positive factors supporting this premium include a higher demand due to addressing therapy areas of high unmet need and lower competitive intensity due to accessing novel target space. [Studien Infos ausblenden] |
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About the PharmaVitae team 3 Scope of the report 4 CHAPTER 1 EXECUTIVE SUMMARY 5 Key findings 5 Total market outlook 5 Monoclonal antibody market outlook 6 Summary of key changes made to mAb market forecast since 2007 report 8 Introduction to the PharmaVitae company universe 10 The prescription pharmaceutical market to 2012 13 Prescription pharmaceutical market performance, 2007-12 13 Balance of launches and expiries in the prescription pharmaceutical market, 2007-12 14 Forecast sales performance by molecule type 15 Small molecules 16 Therapeutic proteins 17 Monoclonal antibodies 17 Vaccines 17 Industry consequences of molecule type 18 Prescription pharmaceutical sales by molecule type, 2007-12 20 Changes in annual sales by molecule type 21 Sales growth rate by molecule type, 2007-13 22 Average revenue analysis 23 Monoclonal antibodies are the most attractive product segment in the prescription pharmaceutical market out to 2012 25 mAb market to 2013 28 mAb market performance, 2007-13 28 Product analysis (size) 29 Product analysis (growth) 31 The two key commercial mAb groups: The 'Big 5' and the 'Emerging 8' 32 The 'Big 5' mAbs 33 The 'Emerging 8' mAbs 35 Commercial dominance of the 'Big 5' and the 'Emerging 8' within the mAb segment 37 Company level sales growth 40 Therapy area level sales growth 42 Technology level sales growth 44 Target level sales growth 45 Scientific and market forces driving mAb success 46 Understanding the forces driving the commercial success of the 'Big 5' monoclonal antibodies 46 Each monoclonal antibody has achieved a first-to-market 'land grab' of a novel target 47 Subsequent horizontal market expansion 47 Ever-rising barriers to entry for competitor products 48 Idealized representation of 'Big 5' evolution 49 Case studies of 'Big 5' mAb commercial evolution 52 Tyrosine kinase domain provide a route to receptor targets 53 Summary - The 'mAb landscape' in 2013 57 How the mAb landscape map was created 57 Key feature 1 of the mAb landscape - the 'Big 5' mAbs 59 Key feature 2 of the mAb landscape - novel targets within the 'Emerging 8' 59 Key feature 3 of the mAb landscape - spanning multiple therapy areas 59 Key feature 4 of the mAb landscape - small molecule incursion 59 CHAPTER 2 MAB TECHNOLOGY OVERVIEW 64 Key findings 64 Introduction 65 The immune system 65 B lymphocytes and antibodies 65 Antibody structure 65 Hybridoma technique - the production of mAbs 67 Monoclonal antibodies as therapeutic agents 67 Targets 68 Target selection - the importance of an accessible epitope 68 Production of mAbs 69 Transgenic mice 69 Phage display 70 Future focus 70 Mode of action 71 mAb-focused oncology 71 The effect of the effector region 72 Blockade 72 mAbs as a delivery vehicle 72 Evolution of mAbs 73 Limitations associated with immunization 73 Murine 78 Chimeric and humanized antibodies 79 Chimeric 79 Humanized 80 Fully human 81 Fragments 81 Conjugated 84 Radiolabeled conjugated mAbs 84 Focus for antibody R&D - oncology immunotoxin drug conjugates 85 Naked mAbs still dominate 87 Systematic naming of monoclonal antibodies 88 The mAb timeline - technology evolution 89 Manufacturing 95 Time to market and manufacturing of monoclonal antibodies 95 Mammalian cell culture - still the most widely-used system 96 CHAPTER 3 MARKET ANALYSIS 99 Key findings 99 Introduction 100 mAb market: historical performance, 2001-07 100 mAb market: forecast performance, 2007-13 103 Product analysis 104 Historical product analysis, 2001-07 105 Historical product growth drivers 108 Remicade (infliximab) 108 Herceptin (trastuzumab) 109 Avastin (bevacizumab) 110 MabThera/Rituxan (rituximab) 110 Humira (adalimumab) 111 Forecast product analysis, 2007-13 112 Forecast product growth drivers 115 Avastin 115 Humira 117 Bapineuzumab 118 Denosumab 119 MabThera/Rituxan 120 Numax 121 Herceptin 122 Golimumab 123 Forecast product growth resistors 124 Remicade 124 Synagis 125 Company analysis 126 Historical company analysis, 2001-07 127 Historical company growth drivers 129 Genentech and Roche 129 Abbott Laboratories 133 Johnson & Johnson 133 Forecast company analysis, 2007-13 134 Forecast company growth drivers 137 Genentech and Roche 137 Abbott 138 Amgen 139 Elan & Wyeth 140 Therapy area analysis 141 Historical therapy area analysis, 2001-07 142 Historical therapy area growth drivers 144 Oncology 144 Immunology & inflammation 145 Forecast therapy area analysis, 2007-13 146 Forecast therapy area growth drivers 147 Oncology 147 Immunology & inflammation 149 Central nervous system 150 Musculoskeletal 150 Technology analysis 151 Historical technology analysis, 2001-07 152 Historical technology growth drivers 154 Humanized mAb 154 Chimeric mAb 154 Human mAb 154 Forecast technology analysis, 2007-13 155 Forecast technology growth drivers 157 Humanized mAb 157 Human mAb 157 Antibody fragment 158 Chimeric mAb 158 Target analysis 159 Historical target analysis, 2001-07 159 Historical target growth drivers 161 TNF alfa 161 VEGF 162 HER2 163 CD20 163 EGFR 163 Forecast target analysis, 2007-13 164 Forecast target growth drivers 166 VEGF 166 TNF alfa 167 Amyloid beta 167 CD20 168 RANKL 168 HER2 169 CHAPTER 4 PIPELINE ANALYSIS 170 Key findings 170 Introduction 171 mAb pipeline overview 172 Company pipeline analysis 178 Early-stage company pipeline analysis 184 Technology pipeline analysis 189 Human content of mAbs, the future focus 194 Therapy area pipeline analysis 195 Target pipeline analysis 198 Target crowding evident with the late-stage mAbs - with lifecycle management strategies being employed 199 Novel target early-stage candidates 202 Will further launches add to target crowding? 209 CD20 210 TNF alfa 211 HER2 and VEGF 212 CHAPTER 5 PRODUCT OVERVIEW 213 Key findings 213 Oncology 214 Avastin 214 Overview 214 Sales forecast 215 Rituxan/MabThera 216 Overview 216 Sales forecast 216 Herceptin 218 Overview 218 Sales forecast 218 Erbitux 220 Overview 220 Sales forecast 220 Vectibix 222 Overview 222 Sales forecast 222 Denosumab (oncology) 224 Overview 224 Sales forecast 224 Pertuzumab 227 Overview 227 Sales forecast 228 Lumiliximab 229 Overview 229 Sales forecast 229 Ipilimumab 231 Overview 231 Sales forecast 231 Humax CD20 233 Overview 233 Sales forecast 233 Galiximab 235 Overview 235 Sales forecast 236 Campath/MAB Campath 237 Overview 237 Sales forecast 237 Mylotarg 239 Overview 239 Sales forecast 239 Rencarex 241 Overview 241 Sales forecast 241 Removab 243 Overview 243 Sales forecast 243 Zevalin 245 Overview 245 Sales forecast 245 Humax CD4 247 Overview 247 Sales forecast 247 Bexxar 249 Overview 249 Sales forecast 249 Humax EGFR 251 Overview 251 Sales forecast 251 Inotuzumab ozogamicin 253 Overview 253 Sales forecast 253 Theraloc 255 Overview 255 Sales forecast 255 Abagovomab 257 Overview 257 Sales forecast 257 Proxinium/Vicinium 259 Overview 259 Sales forecast 259 Immunology & inflammation 261 Humira 261 Overview 261 Sales forecast 261 Remicade 264 Overview 264 Sales forecast 264 Golimumab 267 Overview 267 Sales forecast 267 Actemra 269 Overview 269 Sales forecast 269 Cimzia 271 Overview 271 Sales forecast 271 Ocrelizumab 273 Overview 273 Sales forecast 273 Soliris 275 Overview 275 Sales forecast 275 Ustekinumab 277 Overview 277 Sales forecast 277 Rituxan/MabThera RA 279 Overview 279 Sales forecast 279 Mepolizumab 281 Overview 281 Sales forecast 281 Raptiva 283 Overview 283 Sales forecast 283 Simulect 285 Overview 285 Sales forecast 285 Canakinumab 287 Overview 287 Sales forecast 287 Epratuzumab 289 Overview 289 Sales forecast 289 ABT-874 291 Overview 291 Sales forecast 291 Zenapax 293 Overview 293 Sales forecast 293 Belimumab 295 Overview 295 Sales forecast 295 Reslizumab 297 Overview 297 Sales forecast 297 CNS 299 Bapineuzumab 299 Overview 299 Sales forecast 300 Tysabri 302 Overview 302 Sales forecast 302 MabThera/Rituxan (CNS) 304 Overview 304 Sales forecast 304 Campath/MAB Campath (CNS) 306 Overview 306 Sales forecast 306 Other 308 Lucentis 308 Overview 308 Sales forecast 309 Infectious diseases 311 Numax 311 Overview 311 Sales forecast 311 Synagis 313 Overview 313 Sales forecast 313 Aurograb 315 Overview 315 Sales forecast 315 Mycograb 317 Overview 317 Sales forecast 317 Musculoskeletal 319 Denosumab 319 Overview 319 Sales forecast 319 Respiratory 321 Xolair 321 Overview 321 Sales forecast 322 Cardiovascular 324 ReoPro 324 Overview 324 Sales forecast 325 Endocrine, metabolic and genetic disorders 326 Teplizumab 326 Overview 326 Sales forecast 327 CHAPTER 6 APPENDIX 328 Case studies: 'Big 5' mAb commercial evolution 328 Commercial evolution of Rituxan (CD20 market) 329 Commercial evolution of Remicade and Humira (TNF alfa market) 332 Commercial evolution of Herceptin (HER2 market) 336 Commercial evolution of Avastin (VEGF market) 339 Commercial evolution of the EGFR market 344 References 346 Datamonitor reports 346 [Inhaltsverzeichnis ausblenden] |
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Table 1: Summary of key changes 8 Table 2: PharmaVitae company coverage by peer set 11 Table 3: Molecule type definitions 16 Table 4: General characteristics of small molecule drugs vs. biologics 18 Table 5: Prescription pharmaceutical sales ($m) by molecule type, 2007-12 20 Table 6: Average revenues by molecule type, 2007 23 Table 7: The 'Big 5' (annual revenues >$3 billion in both 2007 and 2013) 33 Table 8: The 'Emerging 8' (>$500m growth 07-13) 35 Table 9: Overview of a selection of marketed mAbs: technology type and immunogenicity 75 Table 10: Infix nomenclature for mAbs 88 Table 11: Manufacturing cell lines for marketed mAbs 97 Table 12: Historical mAb product sales ($m), 2001-07 106 Table 13: Forecast mAb product sales ($m), 2007-13 112 Table 14: Historical mAb sales by company ($m), 2001-07 128 Table 15: Forecast mAb sales by company ($m), 2007-13 135 Table 16: Historical sales by therapy area ($m), 2001-07 143 Table 17: Forecast sales by therapy area ($m), 2007-13 146 Table 18: Historical sales by technology ($m), 2001-07 152 Table 19: Forecast sales by technology ($m), 2007-13 155 Table 20: Historical sales by target ($m), 2001-07 160 Table 21: Forecast sales by target ($m), 2007-13 165 Table 22: mAb pipeline overview 172 Table 23: Count of marketed mAbs 178 Table 24: Count of Phase III mAb players 181 Table 25: Count of companies with multiple Phase I-II mAb candidates 185 Table 26: mAb count split by technology type 189 Table 27: Count of mAb candidates by therapy area 195 Table 28: Detailed product/target analysis - late stage 198 Table 29: Novel late-stage targets 201 Table 30: Novel early-stage targets 203 Table 31: Companies with multiple novel early-stage targets 207 Table 32: The 'Big 5' targets and possible future entrants 209 Table 33: Avastin: overview 214 Table 34: Avastin global sales ($m), 2007-13 215 Table 35: Rituxan/MabThera: overview 216 Table 36: MabThera/Rituxan global sales ($m), 2007-13 216 Table 37: Herceptin: overview 218 Table 38: Herceptin global sales ($m), 2007-13 218 Table 39: Erbitux: overview 220 Table 40: Erbitux global sales ($m), 2007-13 220 Table 41: Vectibix: overview 222 Table 42: Vectibix global sales ($m), 2007-13 222 Table 43: Denosumab: overview 224 Table 44: Denosumab (oncology) global sales ($m), 2007-13 224 Table 45: Pertuzumab: overview 227 Table 46: Pertuzumab global sales ($m), 2007-13 228 Table 47: Lumiliximab: overview 229 Table 48: Lumiliximab global sales ($m), 2007-13 229 Table 49: Ipilimumab: overview 231 Table 50: Ipilimumab global sales ($m), 2007-13 231 Table 51: Humax CD20: overview 233 Table 52: Humax CD20 global sales ($m), 2007-13 233 Table 53: Galiximab: overview 235 Table 54: Galiximab global sales ($m), 2007-13 236 Table 55: MAB Campath: overview 237 Table 56: MAB Campath global sales ($m), 2007-13 237 Table 57: Mylotarg: overview 239 Table 58: Mylotarg global sales ($m), 2007-13 239 Table 59: Rencarex: overview 241 Table 60: Rencarex global sales ($m), 2007-13 241 Table 61: Removab: overview 243 Table 62: Removab global sales ($m), 2007-13 243 Table 63: Zevalin: overview 245 Table 64: Zevalin global sales ($m), 2007-13 245 Table 65: Humax CD4: overview 247 Table 66: Humax CD4 global sales ($m), 2007-13 247 Table 67: Bexxar: overview 249 Table 68: Bexxar global sales ($m), 2007-13 249 Table 69: Humax EGFR: overview 251 Table 70: Humax EGFR global sales ($m), 2007-13 251 Table 71: Inotuzumab ozogamicin: overview 253 Table 72: Inotuzumab ozogamicin global sales ($m), 2007-13 253 Table 73: Theraloc: overview 255 Table 74: Theraloc global sales ($m), 2007-13 255 Table 75: Abagovomab: overview 257 Table 76: Abagovomab global sales ($m), 2007-13 257 Table 77: Proxinium/Vicinium: overview 259 Table 78: Proxinium/Vicinium global sales ($m), 2007-13 259 Table 79: Humira: overview 261 Table 80: Humira global sales ($m), 2007-13 261 Table 81: Remicade: overview 264 Table 82: Remicade global sales ($m), 2007-13 264 Table 83: Golimumab: overview 267 Table 84: Golimumab global sales ($m), 2007-13 267 Table 85: Actemra: overview 269 Table 86: Actemra global sales ($m), 2007-13 269 Table 87: Cimzia: overview 271 Table 88: Cimzia global sales ($m), 2007-13 271 Table 89: Ocrelizumab: overview 273 Table 90: Ocrelizumab global sales ($m), 2007-13 273 Table 91: Soliris: overview 275 Table 92: Soliris global sales ($m), 2007-13 275 Table 93: Ustekinumab: overview 277 Table 94: Ustekinumab global sales ($m), 2007-13 277 Table 95: Rituxan/MabThera RA: overview 279 Table 96: MabThera/Rituxan RA global sales ($m), 2007-13 279 Table 97: Mepolizumab: overview 281 Table 98: Mepolizumab global sales ($m), 2007-13 281 Table 99: Raptiva: overview 283 Table 100: Raptiva global sales ($m), 2007-13 283 Table 101: Simulect: overview 285 Table 102: Simulect global sales ($m), 2007-13 285 Table 103: Canakinumab: overview 287 Table 104: Canakinumab global sales ($m), 2007-13 287 Table 105: Epratuzumab: overview 289 Table 106: Epratuzumab global sales ($m), 2007-13 289 Table 107: ABT-874: overview 291 Table 108: ABT-874 global sales ($m), 2007-13 291 Table 109: Zenapax: overview 293 Table 110: Zenapax global sales ($m), 2007-13 293 Table 111: Belimumab: overview 295 Table 112: Belimumab global sales ($m), 2007-13 295 Table 113: Reslizumab: overview 297 Table 114: Reslizumab global sales ($m), 2007-13 297 Table 115: Bapineuzumab: overview 299 Table 116: Bapineuzumab global sales ($m), 2007-13 300 Table 117: Tysabri: overview 302 Table 118: Tysabri global sales ($m), 2007-13 302 Table 119: MabThera/Rituxan (CNS): overview 304 Table 120: MabThera/Rituxan (CNS) global sales ($m), 2007-13 304 Table 121: MAB Campath (CNS): overview 306 Table 122: MAB Campath global sales ($m), 2007-13 306 Table 123: Lucentis: overview 308 Table 124: Lucentis global sales ($m), 2007-13 309 Table 125: Numax: overview 311 Table 126: Numax global sales ($m), 2007-13 311 Table 127: Synagis: overview 313 Table 128: Synagis global sales ($m), 2007-13 313 Table 129: Aurograb: overview 315 Table 130: Aurograb global sales ($m), 2007-13 315 Table 131: Mycograb: overview 317 Table 132: Mycograb global sales ($m), 2007-13 317 Table 133: Denosumab: overview 319 Table 134: Denosumab global sales ($m), 2007-13 319 Table 135: Xolair: overview 321 Table 136: Xolair global sales ($m), 2007-13 322 Table 137: ReoPro: overview 324 Table 138: ReoPro global sales ($m), 2007-13 325 Table 139: Teplizumab: overview 326 Table 140: Teplizumab global sales ($m), 2007-13 327 Table 141: Remicade vs. Enbrel key approvals 333 Table 142: Remicade vs. Enbrel key approvals 334 Table 143: The VEGF ligand and receptor targeting therapeutics 341 Figure 1: Updated mAb market forecast ($m), 2007-13 9 Figure 2: The total pharmaceutical market outlook, sales ($m) and year-on-year growth rate (%), 2001-13 13 Figure 3: Balance of launches and expiries in the prescription pharmaceutical market ($m), 2007-12 14 Figure 4: Absolute growth ($m) of PharmaVitae universe by molecule type 21 Figure 5: 2007-13 CAGRs of PharmaVitae universe by molecule type 22 Figure 6: Average revenue analysis by molecule type ($m), 2007 24 Figure 7: Sales growth drivers and resistors for mAbs, therapeutic proteins and small molecules 26 Figure 8: mAb market outlook, sales ($m) and year-on-year growth (%), 2007-13 28 Figure 9: Product analysis, historical and forecast sales growth ($m), 2001-13 29 Figure 10: Key mAb growth drivers & resistors ($m), 2007-13 31 Figure 11: Total market ($m) from the 'Big 5', 'Emerging 8' and others, 2001-13 37 Figure 12: Total market growth ($m) from the 'Big 5', 'Emerging 8' and others, 2007-13 38 Figure 13: Percentage contribution to sales from the 'Big 5' and 'Emerging 8' in 2007 and 2013 39 Figure 14: Company analysis, historical and forecast sales growth ($m), 2001-13 40 Figure 15: Therapy area analysis, historical and forecast sales growth ($m), 2001-13 42 Figure 16: Technology analysis, historical and forecast sales growth ($m), 2001-13 44 Figure 17: Target analysis, historical and forecast sales growth ($m), 2001-13 45 Figure 18: Idealized mAb model 51 Figure 19: Protein domain structures of key receptor/ligand pairs in the mAb market 55 Figure 20: Conceptual map of the commercial mAb landscape in 2013 58 Figure 21: The structure of an antibody 66 Figure 22: Types of antibodies 74 Figure 23: Immunogenicity ranges 76 Figure 24: Number of marketed mAb technologies 77 Figure 25: Schematic illustration of antibody fragments 83 Figure 26: Number of marketed full length mAbs versus fragments 84 Figure 27: Number of marketed naked and conjugated mAbs 87 Figure 28: mAb timeline - technology shift 90 Figure 29: The monoclonal antibody market, 2001-07 102 Figure 30: The monoclonal antibody market, 2007-13 103 Figure 31: mAb product sales ($m) 2001-13 104 Figure 32: Growth driver/resistor products of historical revenue performance ($m), 2001-07 108 Figure 33: Growth driver/resistor products of forecast revenue performance ($m), 2007-13 115 Figure 34: mAb company sales ($m), 2001-13 126 Figure 35: Growth driver/resistor companies of historical revenue performance ($m), 2001-07 129 Figure 36: Growth driver/resistor companies of forecast revenue performance ($m), 2007-13 137 Figure 37: mAb therapy area sales ($m) 2001-13 141 Figure 38: Growth driver/resistor therapy areas of historical revenue performance ($m), 2001-07 144 Figure 39: Growth driver/resistor therapy areas of forecast revenue performance ($m), 2007-13 147 Figure 40: mAb technology sales ($m), 2001-13 151 Figure 41: Growth driver/resistor technologies of historical revenue performance ($m), 2001-07 153 Figure 42: Growth driver/resistor technologies of historical revenue performance ($m), 2007-13 156 Figure 43: mAb target sales ($m), 2001-13 159 Figure 44: Growth driver/resistor targets of historical revenue performance ($m), 2001-07 161 Figure 45: Growth driver/resistor targets of forecast revenue performance ($m), 2007-13 166 Figure 46: Count of marketed mAb players 179 Figure 47: Count of Phase III pipeline mAb players 182 Figure 48: Count of companies with multiple Phase I-II mAb candidates 186 Figure 49: Phase I-III pipeline count split by technology 190 Figure 50: The stepwise evolution of naked mAb technology 191 Figure 51: Overview of pipeline technology type Phase I-registration 192 Figure 52: Emerging mAb technologies (% mAb candidates) 194 Figure 53: Phase I-pre-reg mAb count split by therapy area 196 Figure 54: Count of the most popular targets in early-stage development 206 Figure 55: Commercial evolution of the CD20 market 329 Figure 56: Commercial evolution of the TNF alfa market 332 Figure 57: Commercial evolution of the HER2 market 336 Figure 58: Commercial evolution of the VEGF/VEGFR market 339 Figure 59: Commercial evolution of the EGFR market 344 [Tabellenverzeichnis ausblenden] |
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