Monoclonal Antibodies Report: 2008 Update

Published by: Datamonitor

Published: Jun. 6, 2008 - 363 Pages

Table of Contents

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

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.

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