About This Report
Across the branded prescription pharmaceutical industry monoclonal antibodies (MAbs) are projection to be the strongest performing molecule type, delivering a projection six year 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 firm
What's Included in This Report?
Strategic dynamics within the segment are broken down by product, firm, geography, therapy area, technology type and target.
The outlook for the segment is compared with other segments of the pharmaceutical market : 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
Key Market Facts
While Datamonitor believes biosimilar MAbs will make it onto the major industries, the rate of sales erosion of such a biosimilar MAb will be far less than that experienced by a small molecule upon generic entry.
Why Should You Buy This Report?
Assess the outlook for the monoclonal antibodies segment through to 2015
Evaluate the impact of monoclonal antibody on industry player performances across the PharmaVitae universe
Appraise the technological developments being made in the segment and see where monoclonal antibody pipelines are being focussed
In Vitro Diagnostic Industry
TABLE OF CONTENTS
ABOUT DATAMONITOR HEALTHCARE 2
About the PharmaVitae team 2
Chapter 1 About this Segment Report 3
PharmaVitae Explorer database 3
Chapter structure 3
Data sourcing 4
Part I Summary 5
Main Facts 5
Introduction to the PharmaVitae industry player universe 7
The prescription pharmaceutical industry to 2015 9
The MAb industry will deliver the largest and fastest sales growth across the market 15
The MAb segment will remain the fastest growing across the pharmaceutical market 22
Historical industry analysis 23
Forecast industry analysis 26
Part III MAb Technology Overview 40
Main Facts 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 take over of Domantis gives it ownership of DAbs – will the leading Big Pharma player in inhalable drug delivery echo this into the antibody industry ? 60
Systematic naming of MAbs 61
The MAb timeline—technology evolution 61
Part IV Industry Analysis 67
Main Facts 67
Introduction 68
MAb industry product analysis, 2003–15 72
MAb industry industry player analysis, 2003–15 88
MAb industry therapy area analysis, 2003–15 96
MAb industry geographic analysis, 2003–15 105
MAb industry technology analysis, 2003–15 110
MAb industry target analysis, 2003–15 116
Part V Pipeline Analysis 121
Main Facts 121
Introduction 122
MAb pipeline overview 123
Company pipeline analysis 132
Technology pipeline analysis 141
Therapy area pipeline analysis 145
Target pipeline analysis 148
Part VI Key Products 157
Introduction 157
Oncology 158
Immunology & inflammation 171
Central nervous system 183
Infectious diseases 187
Musculoskeletal 191
Other 193
Part VII Appendix 195
References 195
Abbreviations 197
Exchange rates 198
About Datamonitor 199
Datamonitor consulting 199
Disclaimer 201
TABLE OF TABLES
Data table 1: PharmaVitae industry player coverage by peer set 8
Data table 2: Molecule type definitions 11
Data table 3: General characteristics of small molecule drugs vs. biologics 13
Data table 4: Prescription pharmaceutical sales by molecule type ($m), 2009–15 14
Data table 5: Overview of a selection of industry ed MAbs: technology type and immunogenicity 49
Data table 6: Infix nomenclature for MAbs 61
Data table 7: Global top five MAb sales ($m), 2002, 2008 and 2014 70
Data table 8: Annual revenues of the Big 5 ($m), 2009 and 2015 71
Data table 9: Historical MAb product sales ($m), 2003–09 74
Data table 10: Projection MAb product sales ($m), 2009–15 80
Data table 11: Historical MAb sales by industry player ($m), 2003–09 89
Data table 12: Projection MAb sales by industry player ($m), 2009–15 92
Data table 13: Historical MAb sales by therapy area ($m), 2003–09 97
Data table 14: Projection MAb sales by therapy area ($m), 2009–15 100
Data table 15: Historical MAb sales by geography ($m), 2003–09 106
Data table 16: Projection MAb sales by geography ($m), 2009–15 107
Data table 17: Historical MAb sales by technology ($m), 2003–09 111
Data table 18: Projection MAb sales by technology ($m), 2009–15 112
Data table 19: Historical MAb sales by target ($m), 2003–09 117
Data table 20: Projection MAb sales by target ($m), 2009–15 118
Data table 21: MAb pipeline overview, 20010 123
Data table 22: Count of industry ed mAbs by firm, 2010 132
Data table 23: Count of Phase III-registration MAb players, 2010 134
Data table 24: Count of industry players with multiple Phase I–II mAb candidates, 2010 137
Data table 25: MAb count split by technology type, 2010 141
Data table 26: MAb count split by therapy area, 2010 145
Data table 27: Detailed product/target analysis of MAbs in late-stage development, 2010 148
Data table 28: Novel late-stage MAb targets, 2010 150
Data table 29: Novel early-stage MAb targets, 2010 151
Data table 30: MAb industry key products overview 157
Data table 31: Avastin: overview 158
Data table 32: Avastin: sales projection ($m), 2009–15 159
Data table 33: MabThera/Rituxan: overview 160
Data table 34: MabThera/Rituxan: sales projection ($m), 2009–15 161
Data table 35: Herceptin: overview 162
Data table 36: Herceptin: sales projection ($m), 2009–15 163
Data table 37: Erbitux: overview 164
Data table 38: Erbitux: sales projection ($m), 2009–15 165
Data table 39: Prolia (oncology): overview 166
Data table 40: Prolia (onco): sales projection ($m), 2009–15 167
Data table 41: Vectibix: overview 168
Data table 42: Vectibix : sales projection ($m), 2009–15 169
Data table 43: Arzerra: overview 170
Data table 44: Humira: overview 171
Data table 45: Humira: sales projection ($m), 2009–15 172
Data table 46: Remicade: overview 173
Data table 47: Remicade: sales projection ($m), 2009–15 174
Data table 48: Simponi: overview 175
Data table 49: Simponi: sales projection ($m), 2009–15 176
Data table 50: Actemra: overview 177
Data table 51: Actemra: sales projection ($m), 2009–15 178
Data table 52: Benlysta: overview 179
Data table 53: Benlysta: sales projection ($m), 2009–15 180
Data table 54: Stelara: overview 181
Data table 55: Stelara: sales projection ($m), 2009–15 182
Data table 56: Tysabri: overview 183
Data table 57: Tysabri: sales projection ($m), 2009–15 184
Data table 58: Bapineuzumab: overview 185
Data table 59: Bapineuzumab: sales projection ($m), 2009–15 186
Data table 60: Synagis: overview 187
Data table 61: Synagis: sales projection ($m), 2009–15 188
Data table 62: Numax: overview 189
Data table 63: Numax: sales projection ($m), 2009–15 190
Data table 64: Prolia: overview 191
Data table 65: Prolia (musc): sales projection ($m), 2009–15 192
Data table 66: Lucentis: overview 193
Data table 67: Lucentis: sales projection ($m), 2009–15 194
Data table 68: Exchange rates, 2010 198
TABLE OF FIGURES
Chart 1: The PharmaVitae Explorer 3
Chart 2: The total pharmaceutical industry outlook, sales ($m) and year-on-year growth rate (%), 2003–15 10
Chart 3: Total sales of the prescription pharmaceutical industry ($m), 2003–15 14
Chart 4: Change in annual sales of PharmaVitae universe by molecule type ($m), 2009–15 16
Chart 5: CAGR of PharmaVitae universe by molecule type, 2003-15 17
Chart 6: Launch, core, expiry configuration of small molecules and MAbs, 2009-15 ($m) 18
Chart 7: Market Analysis (Volume) : small molecule generics drugs versus MAb biosimilars 20
Chart 8: Total sales of the MAb industry ($m and %), 2003–15 22
Chart 9: Growth driver/resistor products of historical revenue performance ($m), 2003–09 23
Chart 10: Growth driver/resistor industry players of historical revenue performance ($m), 2009–15 25
Chart 11: Total sales of the MAb industry ($m), 2003–15 26
Chart 12: Growth driver/resistor products of projection revenue performance ($m), 2009–15 27
Chart 13: Growth driver/resistor industry players of projection revenue performance ($m), 2009–15 29
Chart 14: Big Pharma peer set net sales growth performance, 2009-15 ($m) 30
Chart 15: The structure of an antibody 42
Chart 16: Types of antibodies 48
Chart 17: Immunogenicity ranges 50
Chart 18: Schematic illustration of antibody fragments 54
Chart 19: MAb timeline – technology shift 62
Chart 20: Total sales of the MAb industry ($m and %), 2003–15 69
Chart 21: MAb product sales ($m), 2003–15 72
Chart 22: Growth driver/resistor products of historical revenue performance ($m), 2003–09 76
Chart 23: Growth driver/resistor products of projection revenue performance ($m), 2009–15 82
Chart 24: MAb sales by industry player ($m), 2003–15 88
Chart 25: Growth driver/resistor industry players of historical revenue performance ($m), 2003–09 90
Chart 26: Growth driver/resistor industry players of projection revenue performance ($m), 2009–15 94
Chart 27: MAb sales by therapy area ($m), 2003–15 96
Chart 28: Growth driver/resistor therapy areas of historical revenue performance ($m), 2003–09 98
Chart 29: Growth driver/resistor therapy areas of projection revenue performance ($m), 2009–15 101
Chart 30: MAb sales by geography ($m), 2003–15 105
Chart 31: Growth driver/resistor geographies of projection revenue performance ($m), 2009–15 108
Chart 32: MAb sales by technology ($m), 2003–15 110
Chart 33: Growth driver/resistor technologies of projection revenue performance ($m), 2009–15 113
Chart 34: MAb sales by target ($m), 2003–15 116
Chart 35: Growth driver/resistor targets of projection revenue performance ($m), 2009–15 119
Chart 36: Count of industry ed mAb players, 2010 133
Chart 37: Count of Phase III pipeline MAb players, 2010 135
Chart 38: Count of industry players with multiple Phase I–II mAb candidates, 2010 138
Chart 39: Phase I–III MAb pipeline count split by technology, 2010 142
Chart 40: The stepwise evolution of naked MAb technology 143
Chart 41: Overview of pipeline technology type 144
Chart 42: Phase I–pre-registration mAb count split by therapy area, 2010 146
Chart 43: Count of the most popular novel targets in early-stage development, 2010 156
