Report: Monoclonal Antibodies Report Part I TOC

About the PharmaVitae team
- Scope of the report
CHAPTER 1 EXECUTIVE SUMMARY
- Key findings
  - Total market outlook
  - Monoclonal antibody market outlook
- Introduction to the PharmaVitae universe
- The prescription pharmaceutical market to 2012
  - Prescription pharmaceutical market performance, 2006-12
  - Balance of launches and expiries in the prescription pharmaceutical market, 2006-12
  - The majority of expiry-driven sales occurs between 2011 and 2012
  - Forecast sales performance by molecule type
    - Molecule type definitions
    - Industry consequences of molecule type
  - Prescription pharmaceutical sales by molecule type, 2006-12
  - Change in annual sales by molecule type
  - Sales growth rate by molecule type, 2006-12
    - The 2011-12 ' patent cliff' - insight from molecule type analysis
  - The lack of a biosimilar/generic protein product threat for mAbs
    - Introduction to the issues
    - FDA view on generic protein products
    - Consequences for mAb market performance
    - Regulatory environment
    - Intellectual property- timing and complexity barrier
    - Technology barrier
    - Biosimilars - conclusion
    - Average revenue analysis
    - Monoclonal antibodies address disease areas of high unmet need
    - Monoclonal antibodies access ' novel target space'
    - ECS targets account for the majority of mAb sales
    - Novel target space reduces competitive pressures
  - Monoclonal antibodies are the most attractive product segment in the prescription pharmaceutical market out to 2012
- mAb market performance, 2006-12
  - mAb market growth
    - Product-level sales growth
    - Company level sales growth
    - Therapy level sales growth
    - mAb technology level sales growth
    - mAb target level sales growth
  - The recurring mAb market theme: dominance of ' the big 5'
  - ' Big 5' revenue preeminence to 2012
  - ' Big 5' contribute majority of sales growth to 2012
  - ' Big 5' command highest revenues per product in segment
  - Are mAbs always commercially more attractive than small molecules?
  - Factors determining evolution of a mAb market dominated by ' big 5'
    - Why do the Big 5 dominate the mAb market?
    - Factors driving oncology product dominance
    - Factors Driving AIID product dominance
CHAPTER 2 MAB TECHNOLOGY OVERVIEW
- Key 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, 2003-06
- mAb market: forecast performance, 2006-12
- Historical product analysis, 2003-06
  - Avastin (bevacizumab)
  - Herceptin (trastuzumab)
  - Remicade (infliximab)
  - MabThera/Rituxan (rituximab)
  - Humira (adalimumab)
  - Erbitux (cetuximab)
- Forecast product analysis, 2006-12
  - Growth drivers
    - Avastin
    - MabThera/Rituxan
    - Humira
    - Herceptin
    - Lucentis (ranibizumab)
    - Numax
  - Growth resistors
    - Synagis
- Historical company analysis, 2003-06
  - Genentech and Roche
  - Abbott
  - Johnson & Johnson
- Forecast company analysis, 2006-12
  - Growth drivers
    - Genentech & Roche
    - Abbott
    - Amgen
    - Biogen IDEC
    - UCB Schwarz
    - Johnson & Johnson
    - Novartis
- Historical therapy area analysis, 2003-06
  - Oncology
  - AIID
  - Other therapy areas
- Forecast therapy area analysis, 2006-12
  - Growth drivers
    - Oncology
    - AIID
    - Ophthalmology
    - Others
- Historical technology analysis, 2003-06
  - Humanized
  - Chimeric
  - Human
  - Others
- Forecast technology analysis, 2006-12
  - Growth drivers
    - Humanized
    - Human
    - Chimeric
    - Antibody fragment
- Historical target analysis, 2003-06
  - TNF alpha
    - VEGF
    - Her2
    - CD20
    - EGFR
- Forecast target analysis, 2006-12
  - Growth drivers
    - VEGF
    - TNF alpha
    - CD20
    - EGFR
    - Her2
    - Integrin alpha-4/beta-1
CHAPTER 4 PIPELINE ANALYSIS
- Key findings
- Introduction
- mAb pipeline overview
- Company pipeline analysis
  - Emerging mAb players
- Technology pipeline analysis
  - Human content of mAbs, the future focus
- Therapy area pipeline analysis
  - Oncology focus remains
- Target pipeline analysis
  - Target crowding evident with late-stage mAbs
  - Novel late-stage targets
  - Novel target early-stage candidates
  - TNF alpha and CD20 - target crowding from further pipeline launches?
CHAPTER 5 PRODUCT OVERVIEW
- Key findings
- Oncology
  - Avastin
    - Overview
    - Sales forecast
    - News flow
  - Rituxan/MabThera
    - Overview
    - Sales forecast
    - News flow
  - Herceptin
    - Overview
    - Sales forecast
    - News flow
  - Erbitux
    - Overview
    - Sales forecast
    - News flow
  - Vectibix
    - Overview
    - Sales forecast
    - News flow
  - Pertuzumab
    - Overview
    - Sales forecast
    - News flow
  - Ticilimumab
    - Overview
    - Sales forecast
    - News flow
  - Ipilimumab
    - Overview
    - Sales forecast
    - News flow
  - Humax CD20
    - Overview
    - Sales forecast
    - News flow
  - Lumiliximab
    - Overview
    - Sales forecast
    - News flow
  - Rencarex
    - Overview
    - Sales forecast
    - News flow
  - Mylotarg
    - Overview
    - Sales forecast
    - News flow
  - Campath/MAB Campath
    - Overview
    - Sales forecast
    - News flow
  - Zevalin
    - Overview
    - Sales forecast
    - News flow
  - Bexxar
    - Overview
    - Sales forecast
    - News flow
  - Zalutumumab
    - Overview
    - Sales forecast
    - News flow
  - Zanolimumab
    - Overview
    - Sales forecast
    - News flow
  - Proxinium/Vicinium
    - Overview
    - Sales forecast
    - News flow
  - Catumaxomab
    - Overview
    - Sales forecast
    - News flow
- AIID
  - Humira
    - Overview
    - Sales forecast
    - News flow
  - Remicade
    - Overview
    - Sales forecast
    - News flow
  - Cimzia
    - Overview
    - Sales forecast
    - News flow
  - Rituxan/MabThera RA
    - Overview
    - Sales forecast
    - News flow
  - Actemra
    - Overview
    - Sales forecast
    - News flow
  - Golimumab
    - Overview
    - Sales forecast
    - News flow
  - Raptiva
    - Overview
    - Sales forecast
    - News flow
  - CNTO-1275
    - Overview
    - Sales forecast
    - News flow
  - Mepolizumab
    - Overview
    - Sales forecast
    - News flow
  - Simulect
    - Overview
    - Sales Forecast
    - News flow
  - Lymphocide
    - Overview
    - Sales forecast
    - News flow
  - Zenapax
    - Overview
    - Sales forecast
    - News flow
  - Nuvion
    - Overview
    - Sales forecast
    - News flow
  - Leukotac
    - Overview
    - Sales forecast
    - News flow
- CNS
  - Tysabri
    - Overview
    - Sales forecast
    - News flow
- Cardiovascular
  - ReoPro
    - Overview
    - Sales forecast
    - News flow
- Respiratory
  - Xolair
    - Overview
    - Sales forecast
    - News flow
- Ophthalmology
  - Lucentis
    - Overview
    - Sales forecast
    - News flow
- Hematology
  - Soliris
    - Overview
    - Sales forecast
    - News flow
  - AMG-531
    - Overview
    - Sales forecast
    - News flow
- Women' s health
  - Denosumab
    - Overview
    - Sales forecast
    - News flow
- Infectious disease
  - Numax
    - Overview
    - Sales forecast
    - News flow
  - Mycograb
    - Overview
    - Sales forecast
    - News flow
  - Aurograb
    - Overview
    - Sales forecast
    - News flow
  - Synagis
    - Overview
    - Sales forecast
    - News flow
CHAPTER 6 APPENDIX
- References
  - Datamonitor reports
- List of Tables
  - Table 1: PharmaVitae company coverage by peer set
  - Table 2: Molecule type definitions
  - Table 3: General characteristics of small molecule drugs vs. biologics
  - Table 4: Forecast sales by molecule type ($m), 2006-12
  - Table 5: Top 25 sales growth resistors ($m), 2011-12
  - Table 6: Average revenues, 2006
  - Table 7: Average operating cost ratios and operating profit margin for small molecule, therapeutic protein and mAb specialists (%), 2002-06
  - Table 8: Target family classification
  - Table 9: mAb ' big 5' in 2003, 2006 and 2012
  - Table 10: Overview of a selection of marketed mAbs: technology type and immunogenicity
  - Table 11: Infix nomenclature for mAbs
  - Table 12: Manufacturing cell lines for marketed mAbs
  - Table 13: Forecast product sales ($m), 2006-12
  - Table 14: Forecast mAb sales by company ($m), 2006-12
  - Table 15: Forecast sales by therapy area ($m), 2006-12
  - Table 16: Forecast sales by mAb technology type ($m), 2006-12
  - Table 17: Forecast sales by target ($m), 2006-12
  - Table 18: mAb pipeline Phase I-pre-registration overview
  - Table 19: Count of marketed mAbs
  - Table 20: Count of Phase III mAb players
  - Table 21: Count of companies with more than one Phase I-II pipeline candidates
  - Table 22: mAb count split by technology type
  - Table 23: Count of mAb candidates by therapy area
  - Table 24: Detailed product/target analysis
  - Table 25: Novel late-stage targets
  - Table 26: Novel early-stage candidates
  - Table 27: Companies with multiple novel early-stage targets
  - Table 28: TNF alpha-targeting mAbs
  - Table 29: CD20-targeting mAbs
  - Table 30: Avastin: overview
  - Table 31: Avastin global sales ($m), 2006-12
  - Table 32: Avastin: news flow
  - Table 33: Rituxan/MabThera: overview
  - Table 34: Rituxan/MabThera global sales ($m), 2006-12
  - Table 35: Rituxan/MabThera: news flow
  - Table 36: Herceptin: overview
  - Table 37: Herceptin global sales ($m), 2006-12
  - Table 38: Herceptin: news flow
  - Table 39: Erbitux: overview
  - Table 40: Erbitux global sales ($m), 2006-12
  - Table 41: Erbitux: news flow
  - Table 42: Vectibix: overview
  - Table 43: Vectibix global sales ($m), 2006-12
  - Table 44: Vectibix: news flow
  - Table 45: Pertuzumab: overview
  - Table 46: Pertuzumab global sales ($m), 2006-12
  - Table 47: Pertuzumab: news flow
  - Table 48: Ticilimumab: overview
  - Table 49: Ticilimumab global sales forecast ($m), 2006-12
  - Table 50: Ticilimumab: news flow
  - Table 51: Ipilimumab: overview
  - Table 52: Ipilimumab global sales ($m), 2006-12
  - Table 53: Ipilimumab: news flow
  - Table 54: Humax CD20: overview
  - Table 55: Humax CD20 global sales ($m), 2006-12
  - Table 56: HuMax CD20: news flow
  - Table 57: Lumiliximab: overview
  - Table 58: Lumiliximab global sales ($m), 2006-12
  - Table 59: Lumiliximab: news flow
  - Table 60: Rencarex: overview
  - Table 61: Rencarex global sales ($m), 2006-12
  - Table 62: Rencarex: news flow
  - Table 63: Mylotarg: overview
  - Table 64: Mylotarg global sales ($m), 2006-12
  - Table 65: Mylotarg: news flow
  - Table 66: MAB Campath: overview
  - Table 67: MAB Campath global sales ($m), 2006-12
  - Table 68: MAB Campath: news flow
  - Table 69: Zevalin: overview
  - Table 70: Zevalin global sales ($m), 2006-12
  - Table 71: Zevalin: news flow
  - Table 72: Bexxar: overview
  - Table 73: Bexxar global sales ($m), 2006-12
  - Table 74: Bexxar: news flow
  - Table 75: Zalutumumab: overview
  - Table 76: Zalutumumab global sales ($m), 2006-12
  - Table 77: Zalutumumab: news flow
  - Table 78: Zanolimumab: overview
  - Table 79: Zanolimumab global sales ($m), 2006-12
  - Table 80: Zanolimumab: news flow
  - Table 81: Proxinium/Vicinium: overview
  - Table 82: Proxinium/Vicinium: news flow
  - Table 83: Catumaxomab: overview
  - Table 84: Catumaxomab: news flow
  - Table 85: Humira: overview
  - Table 86: Humira global sales ($m), 2006-12
  - Table 87: Humira: news flow
  - Table 88: Remicade: overview
  - Table 89: Remicade global sales ($m), 2006-12
  - Table 90: Remicade: news flow
  - Table 91: Product: overview
  - Table 92: Cimzia global sales ($m), 2006-12
  - Table 93: Product: news flow
  - Table 94: Rituxan/MabThera RA: overview
  - Table 95: Rituxan/MabThera global sales ($m), 2006-12
  - Table 96: Rituxan/MabThera RA: news flow
  - Table 97: Actemra: overview
  - Table 98: Actemra global sales ($m), 2006-12
  - Table 99: Actemra: news flow
  - Table 100: Golimumab: overview
  - Table 101: Golimumab global sales ($m), 2006-12
  - Table 102: Golimumab: news flow
  - Table 103: Raptiva: overview
  - Table 104: Raptiva global sales ($m), 2006-12
  - Table 105: Raptiva: news flow
  - Table 106: CNTO-1275: overview
  - Table 107: CNTO-1275 global sales ($m), 2006-12
  - Table 108: CNTO-1275: news flow
  - Table 109: Mepolizumab: overview
  - Table 110: Mepolizumab global sales ($m), 2006-12
  - Table 111: Product: news flow
  - Table 112: Simulect: overview
  - Table 113: Simulect global sales ($m), 2006-12
  - Table 114: Simulect: news flow
  - Table 115: Lymphocide: overview
  - Table 116: Lymphocide global sales ($m), 2006-12
  - Table 117: Lymphocide: news flow
  - Table 118: Zenapax: overview
  - Table 119: Zenapax global sales ($m), 2006-12
  - Table 120: Zenapax: news flow
  - Table 121: Nuvion: overview
  - Table 122: Nuvion global sales ($m), 2006-12
  - Table 123: Nuvion: news flow
  - Table 124: Leukotac: overview
  - Table 125: Leukotac: news flow
  - Table 126: Tysabri: overview
  - Table 127: Tysabri global sales ($m), 2006-12
  - Table 128: Tysabri: news flow
  - Table 129: ReoPro: overview
  - Table 130: ReoPro global sales ($m), 2006-12
  - Table 131: ReoPro: news flow
  - Table 132: Xolair: overview
  - Table 133: Xolair global sales ($m), 2006-12
  - Table 134: Xolair: news flow
  - Table 135: Lucentis: overview
  - Table 136: Lucentis global sales ($m), 2006-12
  - Table 137: Lucentis: news flow
  - Table 138: Soliris: overview
  - Table 139: Soliris global sales ($m), 2006-12
  - Table 140: Soliris: news flow
  - Table 141: AMG-531: overview
  - Table 142: AMG-531 global sales ($m), 2006-12
  - Table 143: AMG-531: news flow
  - Table 144: Denosumab: overview
  - Table 145: Denosumab global sales ($m), 2006-12
  - Table 146: Denosumab: news flow
  - Table 147: Numax: overview
  - Table 148: Numax global sales ($m), 2006-12
  - Table 149: Numax: news flow
  - Table 150: Mycograb: overview
  - Table 151: Mycograb global sales ($m), 2006-12
  - Table 152: Mycograb: news flow
  - Table 153: Aurograb: overview
  - Table 154: Aurograb global sales ($m), 2006-12
  - Table 155: Aurograb: news flow
  - Table 156: Synagis: overview
  - Table 157: Synagis global sales ($m), 2006-12
  - Table 158: Synagis: news flow
- List of Figures
  - Figure 1: Pharmaceutical market performance, sales ($m) and year-on-year growth (%), 2006-12
  - Figure 2: Sales growth by launch, core & expiry (ethical sales $m), 2006-12
  - Figure 3: Expiry portfolio, year-on-year change in annual sales ($m), 2006-12
  - Figure 4: Launch, core and expiry portfolio year-on-year change in annual sales ($m), 2006-12
  - Figure 5: Forecast sales by molecule type ($m), 2006-12
  - Figure 6: Change in annual sales ($m) by molecule type, 2006-12
  - Figure 7: Sales compound annual growth rate (CAGR) by molecule type, 2006-12
  - Figure 8: Levels of structural similarity by drug type
  - Figure 9: Average revenues per product ($m), 2006
  - Figure 10: Percentage of oncology and AIID sales by molecule type, 2006
  - Figure 11: Percentage of oncology and AIID sales by molecule type, 2012
  - Figure 12: The role of drug targets in disease treatment
  - Figure 13: Molecule type sales by target family, 2006
  - Figure 14: Total market sales growth (CAGR %) by target family, 2006-12
  - Figure 15: Sales growth drivers and resistors for mAbs, therapeutic proteins and small molecules
  - Figure 16: mAb market outlook, sales ($m) and year-on-year growth (%), 2006-12
  - Figure 17: Product analysis, historical and forecast sales growth ($m), 2006-12
  - Figure 18: Product growth drivers and resistors ($m), 2006-12
  - Figure 19: Company analysis, historical and forecast sales growth ($m), 2006-12
  - Figure 20: Company growth drivers and resistors ($m), 2006-12
  - Figure 21: Therapy analysis, historical and forecast sales growth ($m), 2006-12
  - Figure 22: Therapy area growth drivers and resistors ($m), 2006-12
  - Figure 23: Technology analysis, historical and forecast sales growth ($m), 2006-12
  - Figure 24: Technology growth drivers and resistors ($m), 2006-12
  - Figure 25: Target analysis, historical and forecast sales growth ($m), 2006-12
  - Figure 26: Target growth drivers and resistors ($m), 2006-12
  - Figure 27: The ' big 5' mAbs have held over 70% of mAb sales since 2003 and are forecast to retain this market dominance until 2012
  - Figure 28: Total mAb sales ($m) of the ' big 5' vs. ' the rest'
  - Figure 29: Absolute growth of the ' big 5' mAbs vs. ' the rest'
  - Figure 30: Average revenues per product in 2006 of the ' big 5' mAbs and ' the rest'
  - Figure 31: Quartile analysis, average 2006 revenues per product ($m)
  - Figure 32: Dominance of the oncology mAb segment by Avastin, Rituxan and Herceptin
  - Figure 33: Dominance of AIID biologic market by Remicade, Humira and Enbrel
  - Figure 34: The structure of an antibody
  - Figure 35: Types of antibodies
  - Figure 36: Immunogenicity ranges
  - Figure 37: Number of marketed mAb technologies
  - Figure 38: Schematic illustration of antibody fragments
  - Figure 39: Number of marketed full length mAbs versus fragments
  - Figure 40: Number of Phase I-marketed mAb fragments
  - Figure 41: Number of marketed naked and conjugated mAbs
  - Figure 42: mAb timeline - technology shift
  - Figure 43: Ethical sales ($m) and year-on-year growth rate (%), 2003-06
  - Figure 44: Ethical sales ($m) and year-on-year growth rate (%), 2006-12
  - Figure 45: Absolute sales growth rate (ethical sales) ($m), 2003-12
  - Figure 46: mAb CAGRs (%), 2003-12
  - Figure 47: Growth drivers/resistor products of historical revenue performance ($m), 2003-06
  - Figure 48: Product analysis, historical and forecast sales growth ($m), 2003-12
  - Figure 49: mAb count and average mAb sales per mAb, 2003-12
  - Figure 50: Product growth drivers and resistors ($m), 2006-12
  - Figure 51: Key growth driver companies by historical revenue performance ($m), 2003-06
  - Figure 52: Company analysis, historical and forecast sales growth ($m), 2003-12
  - Figure 53: Company growth drivers and resistors ($m), 2006-12
  - Figure 54: Growth drivers/resistor therapy areas of historical revenue performance ($m), 2003-06
  - Figure 55: Therapy analysis, historical and forecast sales growth ($m), 2003-12
  - Figure 56: Therapy area growth drivers and resistors ($m), 2006-12
  - Figure 57: Growth drivers/resistor technologies of historical revenue performance ($m), 2003-06
  - Figure 58: Technology analysis, historical and forecast sales growth ($m), 2003-12
  - Figure 59: Technology growth drivers and resistors ($m), 2006-12
  - Figure 60: Growth drivers/resistor targets of historical revenue performance ($m), 2003-06
  - Figure 61: Target analysis, historical and forecast sales growth ($m), 2003-12
  - Figure 62: Target growth drivers and resistors ($m), 2006-12
  - Figure 63: Count of marketed mAb players
  - Figure 64: Count of Phase III pipeline mAb players
  - Figure 65: Count of companies with more than one Phase I-II pipeline candidates
  - Figure 66: Emerging mAb players
  - Figure 67: Phase I-III pipeline count split by technology
  - Figure 68: The stepwise evolution of naked mAb technology
  - Figure 69: Overview of pipeline technology type Phase I-pre-reg
  - Figure 70: Emerging mAb technologies (% mAb candidates)
  - Figure 71: Phase I-pre-reg mAb count split by therapy area
  - Figure 72: Percentage contribution from mAb candidates, 2006
  - Figure 73: Phase III and pre-registration target count
  - Figure 74: Count of targets with more than one Phase I-II pipeline candidates
  - Figure 75: Count of the most popular targets in early-stage development

Monoclonal Antibodies Report Part I

Table of Contents