[英文調查報告書] 單株抗體

Abstract

Overview

Introduction

The report provides a comprehensive financial and strategic analysis of the mAb market, forecasting its commercial evolution out to 2012 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 2012
Global sales forecasts to 2012 for all 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 ethical 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 period 2006-12, the mAb market segment will achieve a sales CAGR of 14.2% versus a small molecule sales CAGR of 0.6%. The main barrier to sales growth for small molecules is exposure to material generic competition, which will have no effect on mAbs out to 2012.

mAbs currently command a two-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 2012
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 out to 2012

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

單株抗體市場動向：第I部

Monoclonal Antibodies Report Part I

Abstract

Overview

Introduction

Scope

Highlights

Reasons to Purchase

Table of Contents