[英文調查報告書] 單株抗體

Abstract

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

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

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.

Reasons to Purchase

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

About the PharmaVitae team
Scope of the report
CHAPTER 1 EXECUTIVE SUMMARY
- Key findings
  - Total market outlook
  - Monoclonal antibody market outlook
- Summary of key changes made to mAb market forecast since 2007 report
- 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
    - Small molecules
    - Therapeutic proteins
    - Monoclonal antibodies
    - Vaccines
    - 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 to 2013
  - mAb market performance, 2007-13
  - Product analysis (size)
  - Product analysis (growth)
  - The two key commercial mAb groups: The ' Big 5' and the ' Emerging 8'
  - The ' Big 5' mAbs
  - The ' Emerging 8' mAbs
  - 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
- Scientific and market forces driving mAb success
  - 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
  - Idealized representation of ' Big 5' evolution
  - Case studies of ' Big 5' mAb commercial evolution
  - Tyrosine kinase domain provide a route to receptor targets
  - Summary - The ' mAb landscape' in 2013
    - How the mAb landscape map was created
    - Key feature 1 of the mAb landscape - the ' Big 5' mAbs
    - Key feature 2 of the mAb landscape - novel targets within the ' Emerging 8'
    - Key feature 3 of the mAb landscape - spanning multiple therapy areas
    - Key feature 4 of the mAb landscape - small molecule incursion
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, 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
    - Overview
    - Sales forecast
- CNS
  - Bapineuzumab
    - Overview
    - Sales forecast
  - Tysabri
    - Overview
    - Sales forecast
  - MabThera/Rituxan (CNS)
    - Overview
    - Sales forecast
  - Campath/MAB Campath (CNS)
    - 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
- Case studies: ' Big 5' mAb commercial evolution
  - Commercial evolution of Rituxan (CD20 market)
  - Commercial evolution of Remicade and Humira (TNF alfa market)
  - Commercial evolution of Herceptin (HER2 market)
  - Commercial evolution of Avastin (VEGF market)
  - Commercial evolution of the EGFR market
- 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 ($m) 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 8' (>$500m growth 07-13)
Table 9: Overview of a selection of marketed mAbs: technology type and immunogenicity
Table 10: Infix nomenclature for mAbs
Table 11: Manufacturing cell lines for marketed mAbs
Table 12: Historical mAb product sales ($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
Table 141: Remicade vs. Enbrel key approvals
Table 142: Remicade vs. Enbrel key approvals
Table 143: The VEGF ligand and receptor targeting therapeutics

List of Figures

Figure 1: Updated mAb market forecast ($m), 2007-13
Figure 2: The total pharmaceutical market outlook, sales ($m) and year-on-year growth rate (%), 2001-13
Figure 3: Balance of launches and expiries in the prescription pharmaceutical market ($m), 2007-12
Figure 4: Absolute growth ($m) 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 ($m), 2007
Figure 7: Sales growth drivers and resistors for mAbs, therapeutic proteins and small molecules
Figure 8: mAb market outlook, sales ($m) and year-on-year growth (%), 2007-13
Figure 9: Product analysis, historical and forecast sales growth ($m), 2001-13
Figure 10: Key mAb growth drivers & resistors ($m), 2007-13
Figure 11: Total market ($m) from the ' Big 5' , ' Emerging 8' and others, 2001-13
Figure 12: Total market growth ($m) from the ' Big 5' , ' Emerging 8' and others, 2007-13
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: Idealized mAb model
Figure 19: Protein domain structures of key receptor/ligand pairs in the mAb market
Figure 20: Conceptual map of the commercial mAb landscape in 2013
Figure 21: The structure of an antibody
Figure 22: Types of antibodies
Figure 23: Immunogenicity ranges
Figure 24: Number of marketed mAb technologies
Figure 25: Schematic illustration of antibody fragments
Figure 26: Number of marketed full length mAbs versus fragments
Figure 27: Number of marketed naked and conjugated mAbs
Figure 28: mAb timeline - technology shift
Figure 29: The monoclonal antibody market, 2001-07
Figure 30: The monoclonal antibody market, 2007-13
Figure 31: mAb product sales ($m) 2001-13
Figure 32: Growth driver/resistor products of historical revenue performance ($m), 2001-07
Figure 33: Growth driver/resistor products of forecast revenue performance ($m), 2007-13
Figure 34: mAb company sales ($m), 2001-13
Figure 35: Growth driver/resistor companies of historical revenue performance ($m), 2001-07
Figure 36: Growth driver/resistor companies of forecast revenue performance ($m), 2007-13
Figure 37: mAb therapy area sales ($m) 2001-13
Figure 38: Growth driver/resistor therapy areas of historical revenue performance ($m), 2001-07
Figure 39: Growth driver/resistor therapy areas of forecast revenue performance ($m), 2007-13
Figure 40: mAb technology sales ($m), 2001-13
Figure 41: Growth driver/resistor technologies of historical revenue performance ($m), 2001-07
Figure 42: Growth driver/resistor technologies of historical revenue performance ($m), 2007-13
Figure 43: mAb target sales ($m), 2001-13
Figure 44: Growth driver/resistor targets of historical revenue performance ($m), 2001-07
Figure 45: Growth driver/resistor targets of forecast revenue performance ($m), 2007-13
Figure 46: Count of marketed mAb players
Figure 47: Count of Phase III pipeline mAb players
Figure 48: Count of companies with multiple Phase I-II mAb candidates
Figure 49: Phase I-III pipeline count split by technology
Figure 50: The stepwise evolution of naked mAb technology
Figure 51: Overview of pipeline technology type Phase I-registration
Figure 52: Emerging mAb technologies (% mAb candidates)
Figure 53: Phase I-pre-reg mAb count split by therapy area
Figure 54: Count of the most popular targets in early-stage development
Figure 55: Commercial evolution of the CD20 market
Figure 56: Commercial evolution of the TNF alfa market
Figure 57: Commercial evolution of the HER2 market
Figure 58: Commercial evolution of the VEGF/VEGFR market
Figure 59: Commercial evolution of the EGFR market

單株抗體市場最新動向：2008年

Monoclonal Antibodies Report: 2008 Update

Abstract

Introduction

Scope

Highlights

Reasons to Purchase

Table of Contents

List of Tables

List of Figures