Monoclonal Antibodies: 2010

Introduction
Across the branded prescription pharmaceutical market monoclonal antibodies (MAbs) are forecast to be the strongest performing molecule type, delivering a forecast six year compound annual growth rate of 9.5% over 2009-15, outpacing the growth rates of small molecules, therapeutic proteins and vaccines. As a result, there is a strong correlation between a strong MAbs portfolio and overall company

Features and benefits
Strategic dynamics within the sector are broken down by product, company, geography, therapy area, technology type and target.
The outlook for the sector is compared with other sectors of the pharmaceutical industry: small molecules, therapeutic proteins and vaccines.
The impact of biosimilars on future MAb sales growth is evaluated and compared with small molecule brand sales following genericization
Highlights
While Datamonitor believes biosimilar MAbs will make it onto the major markets, the rate of sales erosion of such a biosimilar MAb will be far less than that experienced by a small molecule upon generic entry.

Your key questions answered
Assess the outlook for the monoclonal antibodies sector through to 2015
Evaluate the impact of monoclonal antibody on company performances across the PharmaVitae universe
Appraise the technological developments being made in the sector and see where monoclonal antibody pipelines are being focussed

[Studien Infos ausblenden]

TABLE OF CONTENTS
ABOUT DATAMONITOR HEALTHCARE 2
About the PharmaVitae team 2
Chapter 1 About this Sector Report 3
PharmaVitae Explorer database 3
Chapter structure 3
Data sourcing 4
Chapter 2 Executive Summary 5
Key findings 5
Introduction to the PharmaVitae company universe 7
The prescription pharmaceutical market to 2015 9
The MAb market will deliver the largest and fastest sales growth across the industry 15
The MAb sector will remain the fastest growing across the pharmaceutical industry 22
Historical market analysis 23
Forecast market analysis 26
Chapter 3 MAb Technology Overview 40
Key findings 40
Introduction 41
Monoclonal antibodies as therapeutic agents 43
Evolution of MAbs 47
Antibody drug conjugates – an alternative ‘combination therapy’ 55
Bispecific antibodies – is now the time for commercial success? 57
Trifunctional antibodies – successful innovation in a niche indication 58
Ablynx’s nanobodies 59
GSK’s acquisition of Domantis gives it ownership of DAbs – will the leading Big Pharma player in inhalable drug delivery echo this into the antibody market? 60
Systematic naming of MAbs 61
The MAb timeline—technology evolution 61
Chapter 4 Market Analysis 67
Key findings 67
Introduction 68
MAb market product analysis, 2003–15 72
MAb market company analysis, 2003–15 88
MAb market therapy area analysis, 2003–15 96
MAb market geographic analysis, 2003–15 105
MAb market technology analysis, 2003–15 110
MAb market target analysis, 2003–15 116
Chapter 5 Pipeline Analysis 121
Key findings 121
Introduction 122
MAb pipeline overview 123
Company pipeline analysis 132
Technology pipeline analysis 141
Therapy area pipeline analysis 145
Target pipeline analysis 148
Chapter 6 Key Products 157
Introduction 157
Oncology 158
Immunology & inflammation 171
Central nervous system 183
Infectious diseases 187
Musculoskeletal 191
Other 193
Chapter 7 Appendix 195
References 195
Abbreviations 197
Exchange rates 198
About Datamonitor 199
Datamonitor consulting 199
Disclaimer 201


TABLE OF TABLES
Table 1: PharmaVitae company coverage by peer set 8
Table 2: Molecule type definitions 11
Table 3: General characteristics of small molecule drugs vs. biologics 13
Table 4: Prescription pharmaceutical sales by molecule type ($m), 2009–15 14
Table 5: Overview of a selection of marketed MAbs: technology type and immunogenicity 49
Table 6: Infix nomenclature for MAbs 61
Table 7: Global top five MAb sales ($m), 2002, 2008 and 2014 70
Table 8: Annual revenues of the Big 5 ($m), 2009 and 2015 71
Table 9: Historical MAb product sales ($m), 2003–09 74
Table 10: Forecast MAb product sales ($m), 2009–15 80
Table 11: Historical MAb sales by company ($m), 2003–09 89
Table 12: Forecast MAb sales by company ($m), 2009–15 92
Table 13: Historical MAb sales by therapy area ($m), 2003–09 97
Table 14: Forecast MAb sales by therapy area ($m), 2009–15 100
Table 15: Historical MAb sales by geography ($m), 2003–09 106
Table 16: Forecast MAb sales by geography ($m), 2009–15 107
Table 17: Historical MAb sales by technology ($m), 2003–09 111
Table 18: Forecast MAb sales by technology ($m), 2009–15 112
Table 19: Historical MAb sales by target ($m), 2003–09 117
Table 20: Forecast MAb sales by target ($m), 2009–15 118
Table 21: MAb pipeline overview, 20010 123
Table 22: Count of marketed mAbs by company, 2010 132
Table 23: Count of Phase III-registration MAb players, 2010 134
Table 24: Count of companies with multiple Phase I–II mAb candidates, 2010 137
Table 25: MAb count split by technology type, 2010 141
Table 26: MAb count split by therapy area, 2010 145
Table 27: Detailed product/target analysis of MAbs in late-stage development, 2010 148
Table 28: Novel late-stage MAb targets, 2010 150
Table 29: Novel early-stage MAb targets, 2010 151
Table 30: MAb market key products overview 157
Table 31: Avastin: overview 158
Table 32: Avastin: sales forecast ($m), 2009–15 159
Table 33: MabThera/Rituxan: overview 160
Table 34: MabThera/Rituxan: sales forecast ($m), 2009–15 161
Table 35: Herceptin: overview 162
Table 36: Herceptin: sales forecast ($m), 2009–15 163
Table 37: Erbitux: overview 164
Table 38: Erbitux: sales forecast ($m), 2009–15 165
Table 39: Prolia (oncology): overview 166
Table 40: Prolia (onco): sales forecast ($m), 2009–15 167
Table 41: Vectibix: overview 168
Table 42: Vectibix : sales forecast ($m), 2009–15 169
Table 43: Arzerra: overview 170
Table 44: Humira: overview 171
Table 45: Humira: sales forecast ($m), 2009–15 172
Table 46: Remicade: overview 173
Table 47: Remicade: sales forecast ($m), 2009–15 174
Table 48: Simponi: overview 175
Table 49: Simponi: sales forecast ($m), 2009–15 176
Table 50: Actemra: overview 177
Table 51: Actemra: sales forecast ($m), 2009–15 178
Table 52: Benlysta: overview 179
Table 53: Benlysta: sales forecast ($m), 2009–15 180
Table 54: Stelara: overview 181
Table 55: Stelara: sales forecast ($m), 2009–15 182
Table 56: Tysabri: overview 183
Table 57: Tysabri: sales forecast ($m), 2009–15 184
Table 58: Bapineuzumab: overview 185
Table 59: Bapineuzumab: sales forecast ($m), 2009–15 186
Table 60: Synagis: overview 187
Table 61: Synagis: sales forecast ($m), 2009–15 188
Table 62: Numax: overview 189
Table 63: Numax: sales forecast ($m), 2009–15 190
Table 64: Prolia: overview 191
Table 65: Prolia (musc): sales forecast ($m), 2009–15 192
Table 66: Lucentis: overview 193
Table 67: Lucentis: sales forecast ($m), 2009–15 194
Table 68: Exchange rates, 2010 198


TABLE OF FIGURES
Figure 1: The PharmaVitae Explorer 3
Figure 2: The total pharmaceutical market outlook, sales ($m) and year-on-year growth rate (%), 2003–15 10
Figure 3: Total sales of the prescription pharmaceutical market ($m), 2003–15 14
Figure 4: Change in annual sales of PharmaVitae universe by molecule type ($m), 2009–15 16
Figure 5: CAGR of PharmaVitae universe by molecule type, 2003-15 17
Figure 6: Launch, core, expiry configuration of small molecules and MAbs, 2009-15 ($m) 18
Figure 7: Volume analysis: small molecule generics versus MAb biosimilars 20
Figure 8: Total sales of the MAb market ($m and %), 2003–15 22
Figure 9: Growth driver/resistor products of historical revenue performance ($m), 2003–09 23
Figure 10: Growth driver/resistor companies of historical revenue performance ($m), 2009–15 25
Figure 11: Total sales of the MAb market ($m), 2003–15 26
Figure 12: Growth driver/resistor products of forecast revenue performance ($m), 2009–15 27
Figure 13: Growth driver/resistor companies of forecast revenue performance ($m), 2009–15 29
Figure 14: Big Pharma peer set net sales growth performance, 2009-15 ($m) 30
Figure 15: The structure of an antibody 42
Figure 16: Types of antibodies 48
Figure 17: Immunogenicity ranges 50
Figure 18: Schematic illustration of antibody fragments 54
Figure 19: MAb timeline – technology shift 62
Figure 20: Total sales of the MAb market ($m and %), 2003–15 69
Figure 21: MAb product sales ($m), 2003–15 72
Figure 22: Growth driver/resistor products of historical revenue performance ($m), 2003–09 76
Figure 23: Growth driver/resistor products of forecast revenue performance ($m), 2009–15 82
Figure 24: MAb sales by company ($m), 2003–15 88
Figure 25: Growth driver/resistor companies of historical revenue performance ($m), 2003–09 90
Figure 26: Growth driver/resistor companies of forecast revenue performance ($m), 2009–15 94
Figure 27: MAb sales by therapy area ($m), 2003–15 96
Figure 28: Growth driver/resistor therapy areas of historical revenue performance ($m), 2003–09 98
Figure 29: Growth driver/resistor therapy areas of forecast revenue performance ($m), 2009–15 101
Figure 30: MAb sales by geography ($m), 2003–15 105
Figure 31: Growth driver/resistor geographies of forecast revenue performance ($m), 2009–15 108
Figure 32: MAb sales by technology ($m), 2003–15 110
Figure 33: Growth driver/resistor technologies of forecast revenue performance ($m), 2009–15 113
Figure 34: MAb sales by target ($m), 2003–15 116
Figure 35: Growth driver/resistor targets of forecast revenue performance ($m), 2009–15 119
Figure 36: Count of marketed mAb players, 2010 133
Figure 37: Count of Phase III pipeline MAb players, 2010 135
Figure 38: Count of companies with multiple Phase I–II mAb candidates, 2010 138
Figure 39: Phase I–III MAb pipeline count split by technology, 2010 142
Figure 40: The stepwise evolution of naked MAb technology 143
Figure 41: Overview of pipeline technology type 144
Figure 42: Phase I–pre-registration mAb count split by therapy area, 2010 146
Figure 43: Count of the most popular novel targets in early-stage development, 2010 156


[Inhaltsverzeichnis ausblenden]