Market Report Source

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

Table of Contents

TABLE OF CONTENTS

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

Prescription pharmaceutical sales by molecule type, 2006–12

Change in annual sales by molecule type

Sales growth rate by molecule type, 2006–12

The lack of a biosimilar/generic protein product threat for mAbs

Monoclonal antibodies are the most attractive product segment in the prescription pharmaceutical market out to 2012

mAb market performance, 2006–12

mAb market 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’

CHAPTER 2 MAB TECHNOLOGY OVERVIEW

Key findings

Introduction

The immune system

Antibody structure

Hybridoma technique – the production of mAbs

Targets

Mode of action

Evolution of mAbs

Murine

Chimeric and humanized antibodies

Fully human

Fragments

Conjugated

Naked mAbs still dominate

Systematic naming of monoclonal antibodies

The mAb timeline – technology evolution

Manufacturing

CHAPTER 3 MARKET ANALYSIS

Key findings

Introduction

mAb market: historical performance, 2003–06

mAb market: forecast performance, 2006–12

Historical product analysis, 2003–06

Forecast product analysis, 2006–12

Growth drivers

Growth resistors

Historical company analysis, 2003–06

Forecast company analysis, 2006–12

Growth drivers

Historical therapy area analysis, 2003–06

Forecast therapy area analysis, 2006–12

Growth drivers

Historical technology analysis, 2003–06

Humanized

Chimeric

Human

Others

Forecast technology analysis, 2006–12

Growth drivers

Historical target analysis, 2003–06

Forecast target analysis, 2006–12

Growth drivers

CHAPTER 4 PIPELINE ANALYSIS

Key findings

Introduction

mAb pipeline overview

Company pipeline analysis

Technology pipeline analysis

Therapy area pipeline analysis

Target pipeline analysis

CHAPTER 5 PRODUCT OVERVIEW

Key findings

Oncology

Avastin

Rituxan/MabThera

Herceptin

Erbitux

Vectibix

Pertuzumab

Ticilimumab

Ipilimumab

Humax CD20

Lumiliximab

Rencarex

Mylotarg

Campath/MAB Campath

Zevalin

Bexxar

Zalutumumab

Zanolimumab

Proxinium/Vicinium

Catumaxomab

AIID

Humira

Remicade

Cimzia

Rituxan/MabThera RA

Actemra

Golimumab

Raptiva

CNTO-1275

Mepolizumab

Simulect

Lymphocide

Zenapax

Nuvion

Leukotac

CNS

Tysabri

Cardiovascular

ReoPro

Respiratory

Xolair

Ophthalmology

Lucentis

Hematology

Soliris

AMG-531

Women’s health

Denosumab

Infectious disease

Numax

Mycograb

Aurograb

Synagis

CHAPTER 6 APPENDIX

References

Datamonitor reports

TABLE 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