Market Report Source

Overview

Introduction

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.
Scope of this report

• Comprehensive financial strategic analysis of the mAb market out to 2013
• Global sales forecasts to 2013 for marketed and Phase III mAb products
• Analysis of market trends by product, company, therapy area, technology and target type
• Analysis of characteristics of key products and insight into direction of mAb technology evolution and pipeline dynamics

Research and analysis 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.

Key reasons to read this report

• 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

Table of Contents

CHAPTER 1 EXECUTIVE SUMMARY
Key findings
Summary of key changes made to mAb market forecast since last year
Introduction to the PharmaVitae company universe
The prescription pharmaceutical market to 2012
Prescription pharmaceutical market performance 2007-12
Balance of launches and expiries in the prescription pharmaceutical market, 2007-12
Forecast sales performance by molecule type
Industry consequences of molecule type
Prescription pharmaceutical sales by molecule type, 2007-12
Changes in annual sales by molecule type
Sales growth rate by molecule type 2007-13
Average revenue analysis
Monoclonal antibodies are the most attractive product segment in the prescription
pharmaceutical market out to 2012
mAb market performance 2007-13
Product-level sales growth
The two key commercial mAb groups: The ‘Big 5’ and the ‘Emerging 8’
Commercial dominance of the ‘Big 5’ and the ‘Emerging 8’ within the mAb segment
Company level sales growth
Therapy area level sales growth
Technology level sales growth
Target level sales growth
Understanding the forces driving the commercial success of the ‘Big 5’ monoclonal
antibodies
Each monoclonal antibody has achieved a first-to-market ‘land grab’ of a novel target
Subsequent horizontal market expansion
Ever-rising barriers to entry for competitor products
CD20
TNF alfa
HER2
VEGF

CHAPTER 2 MAB TECHNOLOGY OVERVIEW
findings
Introduction
The immune system
B lymphocytes and antibodies
Antibody structure
Hybridoma technique – the production of mAbs
Monoclonal antibodies as therapeutic agents
Targets
Target selection – the importance of an accessible epitope
Production of mAbs
Transgenic mice
Phage display
Future focus
Mode of action
mAb-focused oncology
The effect of the effector region
Blockade
mAbs as a delivery vehicle
Evolution of mAbs
Limitations associated with immunization
Murine
Chimeric and humanized antibodies
Chimeric
Humanized
Fully human
Fragments
Conjugated
Radiolabeled conjugated mAbs
Focus for antibody R&D – oncology immunotoxin drug conjugates
Naked mAbs still dominate
Systematic naming of monoclonal antibodies
The mAb timeline – technology evolution
Manufacturing
Time to market and manufacturing of monoclonal antibodies
Mammalian cell culture – still the most widely-used system

CHAPTER 3 MARKET ANALYSIS
Key findings
Introduction
MAb market: historical performance, 2001-07
MAb market: forecast performance, 2007-13
Product analysis
Historical product analysis, 2001-07
Historical product growth drivers
Remicade (infliximab)
Herceptin (trastuzumab)
Avastin (bevacizumab)
MabThera/Rituxan (rituximab)
Humira (adalimumab)
Forecast product analysis, 2007-13
Forecast product growth drivers
Avastin
Humira
Bapineuzumab
Denosumab
MabThera/Rituxan
Numax
Herceptin
Golimumab
Forecast product growth resistors
Remicade
Synagis
Company analysis
Historical company analysis, 2001-07
Historical company growth drivers
Genentech and Roche
Abbott Laboratories
Johnson & Johnson
Forecast company analysis, 2007-13
Forecast company growth drivers
Genentech and Roche
Abbott
Amgen
Elan & Wyeth
Therapy area analysis
Historical therapy area analysis, 2001-07
Historical therapy area growth drivers
Oncology
Immunology & inflammation
Forecast therapy area analysis, 2007-13
Forecast therapy area growth drivers
Oncology
Immunology & inflammation
Central nervous system
Musculoskeletal
Technology analysis
Historical technology analysis, 2001-07
Historical technology growth drivers
Humanized mAb
Chimeric mAb
Human mAb
Forecast technology analysis, 2007-13
Forecast technology growth drivers
Humanized mAb
Human mAb
Antibody fragment
Chimeric mAb
Target analysis
Historical target analysis, 2001-07
Historical target growth drivers
TNF alfa
VEGF
Her2
CD20
EGFR
Forecast target analysis, 2007-13
Forecast target growth drivers
VEGF
TNF alfa
Amyloid beta
CD20
RANKL
Her2

CHAPTER 4 PIPELINE ANALYSIS
Key findings
Introduction
mAb pipeline overview
Company pipeline analysis
Early-stage company pipeline analysis
Technology pipeline analysis
Human content of mAbs, the future focus
Therapy area pipeline analysis
Target pipeline analysis
Target crowding evident with the late-stage mAbs – with lifecycle management strategies being
employed
Novel target early-stage candidates
Will further launches add to target crowding?
CD20
TNF alfa
Her2 and VEGF

CHAPTER 5 PRODUCT OVERVIEW
Key findings
Oncology
Avastin
Overview
Sales forecast
Rituxan/MabThera
Overview
Sales forecast
Herceptin
Overview
Sales forecast
Erbitux
Overview
Sales forecast
Vectibix
Overview
Sales forecast
Denosumab (oncology)
Overview
Sales forecast
Pertuzumab
Overview
Sales forecast
Lumiliximab
Overview
Sales forecast
Ipilimumab
Overview
Sales forecast
Humax CD20
Overview
Sales forecast
Galiximab
Overview
Sales forecast
Campath/MAB Campath
Overview
Sales forecast
Mylotarg
Overview
Sales forecast
Rencarex
Overview
Sales forecast
Removab
Overview
Sales forecast
Zevalin
Overview
Sales forecast
Humax CD4
Overview
Sales forecast
Bexxar
Overview
Sales forecast
Humax EGFR
Overview
Sales forecast
Inotuzumab ozogamicin
Overview
Sales forecast
Theraloc
Overview
Sales forecast
Abagovomab
Overview
Sales forecast
Proxinium/Vicinium
Overview
Sales forecast
Immunology & inflammation
Humira
Overview
Sales forecast
Remicade
Overview
Sales forecast
Golimumab
Overview
Sales forecast
Actemra
Overview
Sales forecast
Cimzia
Overview
Sales forecast
Ocrelizumab
Overview
Sales forecast
Soliris
Overview
Sales forecast
Ustekinumab
Overview
Sales forecast
Rituxan/MabThera RA
Overview
Sales forecast
Mepolizumab
Overview
Sales forecast
Raptiva
Overview
Sales forecast
Simulect
Overview
Sales forecast
Canakinumab
Overview
Sales forecast
Epratuzumab
Overview
Sales forecast
ABT-874
Overview
Sales forecast
Zenapax
Overview
Sales forecast
Belimumab
Overview
Sales forecast
Reslizumab
CNS
Overview
Sales forecast
Bapineuzumab
Overview
Sales forecast
Tysabri
Overview
Sales forecast
MabThera/Rituxan (CNS)
Overview
Sales forecast
Campath/MAB Campath
Overview
Sales forecast
Other
Lucentis
Overview
Sales forecast
Infectious diseases
Numax
Overview
Sales forecast
Synagis
Overview
Sales forecast
Aurograb
Overview
Sales forecast
Mycograb
Overview
Sales forecast
Musculoskeletal
Denosumab
Overview
Sales forecast
Respiratory
Xolair
Overview
Sales forecast
Cardiovascular
ReoPro
Overview
Sales forecast
Endocrine, metabolic and genetic disorders
Teplizumab
Overview
Sales forecast

CHAPTER 6 APPENDIX
References
Datamonitor reports

List of Tables
Table 1: Summary of key changes
Table 2: PharmaVitae company coverage by peer set
Table 3: Molecule type definitions
Table 4: General characteristics of small molecule drugs vs. biologics
Table 5: Prescription pharmaceutical sales by molecule type, 2007-12
Table 6: Average revenues by molecule type, 2007
Table 7: The ‘Big 5’ (annual revenues >$3 billion in both 2007 and 2013)
Table 8: The emerging eight (>$500m growth 07-13)
Table 9: Overview of a selection of marketed mAbs: technology type and immunogenicity
Table 10: Infix nomenclature for mAbs
Table 11: Manufacturing cell lines for marketed mAbs
Table 12: Historical mAb product sales ($m), 2001-07
Table 13: Forecast mAb product sales ($m), 2007-13
Table 14: Historical mAb sales by company ($m), 2001-07
Table 15: Forecast mAb sales by company ($m), 2007-13
Table 16: Historical sales by therapy area ($m), 2001-07
Table 17: Forecast sales by therapy area ($m), 2007-13
Table 18: Historical sales by technology ($m), 2001-07
Table 19: Forecast sales by technology ($m), 2007-13
Table 20: Historical sales by target ($m), 2001-07
Table 21: Forecast sales by target ($m), 2007-13
Table 22: mAb pipeline overview
Table 23: Count of marketed mAbs
Table 24: Count of Phase III mAb players
Table 25: Count of companies with multiple Phase I-II mAb candidates
Table 26: mAb count split by technology type
Table 27: Count of mAb candidates by therapy area
Table 28: Detailed product/target analysis – late stage
Table 29: Novel late-stage targets
Table 30: Novel early-stage targets
Table 31: Companies with multiple novel early-stage targets
Table 32: The ‘Big 5’ targets and possible future entrants
Table 33: Avastin: overview
Table 34: Avastin global sales ($m), 2007-13
Table 35: Rituxan/MabThera: overview
Table 36: MabThera/Rituxan global sales ($m), 2007-13
Table 37: Herceptin: overview
Table 38: Herceptin global sales ($m), 2007-13
Table 39: Erbitux: overview
Table 40: Erbitux global sales ($m), 2007-13
Table 41: Vectibix: overview
Table 42: Vectibix global sales ($m), 2007-13
Table 43: Denosumab: overview
Table 44: Denosumab (oncology) global sales ($m), 2007-13
Table 45: Pertuzumab: overview
Table 46: Pertuzumab global sales ($m), 2007-13
Table 47: Lumiliximab: overview
Table 48: Lumiliximab global sales ($m), 2007-13
Table 49: Ipilimumab: overview
Table 50: Ipilimumab global sales ($m), 2007-13
Table 51: Humax CD20: overview
Table 52: Humax CD20 global sales ($m), 2007-13
Table 53: Galiximab: overview
Table 54: Galiximab global sales ($m), 2007-13
Table 55: MAB Campath: overview
Table 56: MAB Campath global sales ($m), 2007-13
Table 57: Mylotarg: overview
Table 58: Mylotarg global sales ($m), 2007-13
Table 59: Rencarex: overview
Table 60: Rencarex global sales ($m), 2007-13
Table 61: Removab: overview
Table 62: Removab global sales ($m), 2007-13
Table 63: Zevalin: overview
Table 64: Zevalin global sales ($m), 2007-13
Table 65: Humax CD4: overview
Table 66: Humax CD4 global sales ($m), 2007-13
Table 67: Bexxar: overview
Table 68: Bexxar global sales ($m), 2007-13
Table 69: Humax EGFR: overview
Table 70: Humax EGFR global sales ($m), 2007-13
Table 71: Inotuzumab ozogamicin: overview
Table 72: Inotuzumab ozogamicin global sales ($m), 2007-13
Table 73: Theraloc: overview
Table 74: Theraloc global sales ($m), 2007-13
Table 75: Abagovomab: overview
Table 76: Abagovomab global sales ($m), 2007-13
Table 77: Proxinium/Vicinium: overview
Table 78: Proxinium/Vicinium global sales ($m), 2007-13
Table 79: Humira: overview
Table 80: Humira global sales ($m), 2007-13
Table 81: Remicade: overview
Table 82: Remicade global sales ($m), 2007-13
Table 83: Golimumab: overview
Table 84: Golimumab global sales ($m), 2007-13
Table 85: Actemra: overview
Table 86: Actemra global sales ($m), 2007-13
Table 87: Cimzia: overview
Table 88: Cimzia global sales ($m), 2007-13
Table 89: Ocrelizumab: overview
Table 90: Ocrelizumab global sales ($m), 2007-13
Table 91: Soliris: overview
Table 92: Soliris global sales ($m), 2007-13
Table 93: Ustekinumab: overview
Table 94: Ustekinumab global sales ($m), 2007-13
Table 95: Rituxan/MabThera RA: overview
Table 96: MabThera/Rituxan RA global sales ($m), 2007-13
Table 97: Mepolizumab: overview
Table 98: Mepolizumab global sales ($m), 2007-13
Table 99: Raptiva: overview
Table 100: Raptiva global sales ($m), 2007-13
Table 101: Simulect: overview
Table 102: Simulect global sales ($m), 2007-13
Table 103: Canakinumab: overview
Table 104: Canakinumab global sales ($m), 2007-13
Table 105: Epratuzumab: overview
Table 106: Epratuzumab global sales ($m), 2007-13
Table 107: ABT-874: overview
Table 108: ABT-874 global sales ($m), 2007-13
Table 109: Zenapax: overview
Table 110: Zenapax global sales ($m), 2007-13
Table 111: Belimumab: overview
Table 112: Belimumab global sales ($m), 2007-13
Table 113: Reslizumab: overview
Table 114: Reslizumab global sales ($m), 2007-13
Table 115: Bapineuzumab: overview
Table 116: Bapineuzumab global sales ($m), 2007-13
Table 117: Tysabri: overview
Table 118: Tysabri global sales ($m), 2007-13
Table 119: MabThera/Rituxan (CNS): overview
Table 120: MabThera/Rituxan (CNS) global sales ($m), 2007-13
Table 121: MAB Campath (CNS): overview
Table 122: MAB Campath global sales ($m), 2007-13
Table 123: Lucentis: overview
Table 124: Lucentis global sales ($m), 2007-13
Table 125: Numax: overview
Table 126: Numax global sales ($m), 2007-13
Table 127: Synagis: overview
Table 128: Synagis global sales ($m), 2007-13
Table 129: Aurograb: overview
Table 130: Aurograb global sales ($m), 2007-13
Table 131: Mycograb: overview
Table 132: Mycograb global sales ($m), 2007-13
Table 133: Denosumab: overview
Table 134: Denosumab global sales ($m), 2007-13
Table 135: Xolair: overview
Table 136: Xolair global sales ($m), 2007-13
Table 137: ReoPro: overview
Table 138: ReoPro global sales ($m), 2007-13
Table 139: Teplizumab: overview
Table 140: Teplizumab global sales ($m), 2007-13

List of Figures
Figure 1: Updated mAb market forecast 2007-13
Figure 2: The total pharmaceutical market outlook 2001-13
Figure 3: Balance of launches and expiries in the prescription pharmaceutical market, 2007-12
Figure 4: Absolute growth of PharmaVitae universe by molecule type
Figure 5: 2007-13 CAGRs of PharmaVitae universe by molecule type
Figure 6: Average revenue analysis by molecule type, 2007 ($m)
Figure 7: Sales growth drivers and resistors for mAbs, therapeutic proteins and small molecules
Figure 8: mAb market outlook, sales ($m) and year-on-year growth (%), 2007-13
Figure 9: Product analysis, historical and forecast sales growth ($m), 2001-13
Figure 10: Key product growth drivers & resistors ($m), 2007-13
Figure 11: Total market from the ‘Big 5’, ‘Emerging 8’ and others 2001-13 ($m)
Figure 12: Total market growth from the ‘Big 5’, ‘Emerging 8’ and others 2007-13 ($m)
Figure 13: Percentage contribution to sales from the ‘Big 5’ and ‘Emerging 8’ in 2007 and 2013
Figure 14: Company analysis, historical and forecast sales growth ($m), 2001-13
Figure 15: Therapy area analysis, historical and forecast sales growth ($m), 2001-13
Figure 16: Technology analysis, historical and forecast sales growth ($m), 2001-13
Figure 17: Target analysis, historical and forecast sales growth ($m), 2001-13
Figure 18: CD20
Figure 19: TNF alfa
Figure 21: HER2
Figure 20: VEGF
Figure 22: The structure of an antibody
Figure 23: Types of antibodies
Figure 24: Immunogenicity ranges
Figure 25: Number of marketed mAb technologies
Figure 26: Schematic illustration of antibody fragments
Figure 27: Number of marketed full length mAbs versus fragments
Figure 28: Number of marketed naked and conjugated mAbs
Figure 29: mAb timeline – technology shift
Figure 30: The monoclonal antibody market, 2001-07
Figure 31: The monoclonal antibody market, 2007-13
Figure 32: mAb product sales ($m) 2001-13
Figure 33: Growth driver/resistor products of historical revenue performance ($m), 2001-07
Figure 34: Growth driver/resistor products of forecast revenue performance ($m), 2007-13
Figure 35: mAb company sales ($m), 2001-13
Figure 36: Growth driver/resistor companies of historical revenue performance ($m), 2001-07
Figure 37: Growth driver/resistor companies of forecast revenue performance ($m), 2007-13
Figure 38: mAb therapy area sales ($m) 2001-13
Figure 39: Growth driver/resistor therapy areas of historical revenue performance ($m), 2001-07
Figure 40: Growth driver/resistor therapy areas of forecast revenue performance ($m), 2007-13
Figure 41: mAb technology sales ($m), 2001-13
Figure 42: Growth driver/resistor technologies of historical revenue performance ($m), 2001-07
Figure 43: Growth driver/resistor technologies of historical revenue performance ($m), 2007-13
Figure 44: mAb target sales ($m), 2001-13
Figure 45: Growth driver/resistor targets of historical revenue performance ($m), 2001-07
Figure 46: Growth driver/resistor targets of forecast revenue performance ($m), 2007-13
Figure 47: Count of marketed mAb players
Figure 48: Count of Phase III pipeline mAb players
Figure 49: Count of companies with multiple Phase I-II mAb candidates
Figure 50: Phase I-III pipeline count split by technology
Figure 51: The stepwise evolution of naked mAb technology
Figure 52: Overview of pipeline technology type Phase I-registration
Figure 53: Emerging mAb technologies (% mAb candidates)
Figure 54: Phase I-pre-reg mAb count split by therapy area
Figure 55: Count of the most popular targets in early-stage development