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Monoclonal Antibody Therapies: Evolving into a $30 billion market

Published by: Datamonitor

Published: Apr. 15, 2005 - 360 Pages


Table of Contents


CHAPTER 1 EXECUTIVE SUMMARY

Scope of the report

Key findings




CHAPTER 2 KEY DYNAMICS IN THE MONOCLONAL ANTIBODIES MARKET

Introduction

Drivers and resistors to the growth of the monoclonal antibody market


Technology focus - evolving from murine to fully human


Development of portfolio and pipeline - fully human antibodies to take over

Conjugated antibodies - untapped potential

Class of antibody - crucial to induction of effector functions


Narrowing therapeutic focus - road to success


Infectious and niche diseases - opportunity to expand market


Development time - faster than conventional drugs

Manufacturing issues - efficiency and reliability supersede under-capacity as the primary manufacturing concern


Mammalian cell culture - disadvantages persist, but still the most widely-used system

In-house production or out-sourcing

Contract manufacturing

Novel approaches - transgenic animals and plant systems


Intellectual property - cross-licensing settlements limit legal costs and extract maximum value in the rapidly-changing IP landscape


Patent issues

Biosimilar antibodies - likely to rely on compulsory licensing


Target selection - exploiting proteomics and genomics


Antibody engineering evolution


Drug delivery - improving patient convenience


Delivery devices

Route of administration


Intracellular delivery of antibodies - expanding targets accessible

Reformulation - improving the pharmacological profile

Bispecific monoclonal antibodies - harnessing the immune system

Recombinant polyclonal antibodies - a human-like immune response


Symphogen

Therapeutic Human Polyclonals


New techniques for antibody discovery and validation


Ribosome display

Target-independent discovery

Cross-species antibodies for target validation

Hybridoma-free generation

In silico antibody modeling and analysis



Company strategy


Business model evolution - biotech moves upstream


Technology developers and providers

Early-stage antibody drug developers

Late-stage antibody drug developers

Fully integrated players

Alternative growth strategies - the impact of big pharma


Alliance networks


Key drivers of partnerships - creating synergies and lowering risk

Early-stage research and development alliances

Later-stage development alliances


Mergers & Acquisitions

Development and commercialization strategies




CHAPTER 3 MARKET ANALYSIS

Introduction to the monoclonal antibody market

Market evaluation, 2004-10


Monoclonal antibody market value, 2004


Technology focus of monoclonal antibody market, 2004

Therapeutic focus of monoclonal antibody market, 2004


Monoclonal antibody market potential to 2010


Technology focus of monoclonal antibody market, 2005-10

Therapeutic focus of monoclonal antibody market, 2005-10



Portfolio and pipeline analysis


Monoclonal antibodies marketed portfolio, 2004


Technology focus

Therapeutic focus

Launch pattern of marketed monoclonal antibodies, 1986-2004


Monoclonal antibody pipeline


Key late-stage pipeline monoclonal antibodies

Forecasted launch trajectory for monoclonal antibodies, 2005-10


Key growth drivers, 2005-10


R&D development programs


Technology focus, 2005

Therapeutic focus, 2005




CHAPTER 4 ANTIBODY ENGINEERING TECHNOLOGIES

Introduction

Murine

Chimeric

Humanized

Fully human


Transgenic mice

Phage display


Fragments

Conjugated

Technology profiles - Humanized Technologies


Protein Design Labs' SMART Humanization Technology


SMART Humanization technology

Partnerships

Product portfolio and pipeline


XOMA's Human Engineering Technology


Human Engineering

Partnerships

Product portfolio and pipeline


Aeres Biomedical's Humanization Technology


Aeres Biomedical's humanization technology

Partnerships

Product portfolio and pipeline



Technology profiles - Fully Human Technologies


Medarex's UltiMAb Technology


UltiMAb Human Antibody Development System

Partnerships

Product portfolio and pipeline


Abgenix's XenoMouse and XenoMax


XenoMouse and XenoMax

Partnerships

Product portfolio and pipeline


Cambridge Antibody Technology's Phage Display and Ribosome Display Technologies


Phage Display technology

Ribosome Display technology

Partnerships

Product portfolio and pipeline


Dyax's Phage Display Discovery Tool


Phage Display Discovery Tool

Partnerships

Product portfolio and pipeline



Technology profiles - Antibody Fragment Technologies


Enzon's Single Chain Antibody Technology


Single-Chain Antibody (SCA) technology

Partnerships

Product portfolio and pipeline


Domantis' Domain Antibodies


Domain Antibodies

Partnerships

Product portfolio and pipeline



Technology profiles - Conjugated Antibody Technologies


Immunogen's Tumor-Activated Prodrug (TAP) technology


Tumor-Activated Prodrug (TAP) Technology

Partnerships

Product portfolio and pipeline


Seattle Genetics' Antibody-drug Conjugate (ADC) and Antibody-Directed Enzyme Prodrug Therapy (ADEPT) Technologies


Antibody-drug conjugate (ADC) technology

Antibody-Directed Enzyme Prodrug Therapy (ADEPT)

Overview

Partnerships

Product portfolio and pipeline





CHAPTER 5 COMPANY ANALYSIS

Key players in mAb market, 2004


Current position


Benchmarking key players' future performance to 2010

Analysis of key players by technology focus

Analysis of key players by therapeutic focus


Oncology antibodies - current and future market leaders

AIID (arthritis, immune and inflammatory disorders) antibodies - current and future market leaders

Other therapeutic markets - niche products growing in importance


Infectious disease

Ophthalmology

CNS

Cardiovascular

Respiratory



Company profiles

Abbott Laboratories


Introduction to Abbott

Strategy


Growth strategy in the monoclonal antibody market

Financial position

SWOT analysis

Alliance network

Technology focus


Monoclonal antibody portfolio and pipeline analysis


Marketed portfolio

R&D compounds

Sales forecasts and forecast revenue growth



Alexion


Introduction to Alexion

Strategy


Growth strategy in the monoclonal antibody market

Financial position

SWOT analysis

Alliance network

Technology focus


Monoclonal antibody portfolio and pipeline analysis


Marketed portfolio

R&D compounds

Sales forecasts and forecast revenue growth



Biogen Idec


Introduction to Biogen Idec

Strategy


Growth strategy in the monoclonal antibody market

Financial position

SWOT analysis

Alliance network

Technology focus


Monoclonal antibody portfolio and pipeline analysis


Marketed portfolio

Rituxan (rituximab)

Zevalin (ibritumomab tiuxetan)

Tysabri (natalizumab)

R&D compounds

Sales forecasts and forecast revenue growth



Cambridge Antibody Technology


Introduction to Cambridge Antibody Technology

Strategy


Growth strategy in the monoclonal antibody market

Financial position

SWOT analysis

Alliance network

Technology focus


Monoclonal antibody portfolio and pipeline analysis


Marketed portfolio

R&D compounds

Sales forecasts and forecast revenue growth

Key licensed products



Genentech


Introduction to Genentech

Strategy


Growth strategy in the monoclonal antibody market

Financial position

SWOT analysis


Strengths

Weaknesses

Opportunities

Threats


Alliance network

Technology focus


Monoclonal antibody portfolio and pipeline analysis


Marketed portfolio

Rituxan (rituximab)

Herceptin (trastuzumab)

Avastin (bevacizumab)

Xolair (omalizumab)

Raptiva (efalizumab)

R&D compounds

Lucentis (ranibizumab)

Rituxan (rituximab)

Sales forecasts and forecast revenue growth



Genmab


Introduction to Genmab

Strategy


Growth strategy in the monoclonal antibody market

Financial position

SWOT analysis

Alliance network

Technology focus


Monoclonal antibody portfolio and pipeline analysis


Marketed portfolio

R&D compounds

Sales forecasts and forecast revenue growth



ImClone Systems


Introduction to ImClone Systems

Strategy


Growth strategy in the monoclonal antibody market

Financial position

SWOT analysis

Alliance network

Technology focus


Monoclonal antibody portfolio and pipeline analysis


Marketed portfolio

R&D compounds

Sales forecasts and forecast revenue growth



Medarex


Introduction to Medarex

Strategy


Growth strategy in the monoclonal antibody market

Financial position

SWOT analysis

Alliance network

Technology focus


Monoclonal antibody portfolio and pipeline analysis


Marketed portfolio

R&D compounds

Sales forecasts and forecast revenue growth



MedImmune


Introduction to MedImmune

Strategy


Growth strategy in the monoclonal antibody market

Financial position

SWOT analysis

Alliance network

Technology focus


Monoclonal antibody portfolio and pipeline analysis


Marketed portfolio

R&D compounds

Sales forecasts and forecast revenue growth



UCB


Introduction to UCB

Strategy


Growth strategy in the monoclonal antibody market

Financial position

SWOT analysis

Alliance network

Technology focus


Monoclonal antibody portfolio and pipeline analysis


Marketed portfolio

R&D compounds

Sales forecasts and forecast revenue growth





CHAPTER 6 APPENDIX : SUPPORTING DATA

Financial data


Exchange rates

Methodology for therapy area forecasting




List of Tables

Table 1: Key effector functions of antibody classes

Table 2: Sales of monoclonal antibodies by technology, 2004

Table 3: Sales of monoclonal antibodies by therapy area, 2004

Table 4: Forecast sales of the monoclonal antibodies market by technology, 2005-10

Table 5: Forecast sales of the monoclonal antibodies market by therapy area in terms of sales, 2005-10

Table 6: Marketed monoclonal antibodies, 2004

Table 7: Launch year of marketed monoclonal antibody, 1986-2004

Table 8: Top 10 late-stage pipeline monoclonal antibodies in terms of value, 2005

Table 9: Launch trajectory of monoclonal antibodies in development, 2005-10

Table 10: Products developed using PDL's SMART Humanization technology

Table 11: Products developed using Xoma's Human Engineering

Table 12: Products developed using Aeres Biomedical's antibody humanization technology

Table 13: Products developed using Medarex's UltiMAb technology

Table 14: Products developed using Abgenix's Xenomouse and Xenomax technologies

Table 15: Products developed using CAT's Phage Display technology

Table 16: Products developed using Dyax's Phage Display Discovery Tool technology

Table 17: Products developed using Enzon's SCA technology

Table 18: Products developed using Domantis's Domain Antibodies technology

Table 19: Products developed using ImmunoGen's TAP technology

Table 20: Products developed using Seattle Genetics' ADC technology

Table 21: Monoclonal antibody revenues for leading companies, 2002-04

Table 22: Forecast monoclonal antibody revenues for leading companies, 2004-10

Table 23: Leading companies' sales of monoclonal antibodies for oncology indications, 2003-10

Table 24: Leading companies' sales of monoclonal antibodies for AIID indications, 2003-10

Table 25: Leading companies' sales of monoclonal antibodies for infectious disease indications, 2003-10

Table 26: Leading companies' sales of monoclonal antibodies for ophthalmic indications, 2003-10

Table 27: Leading companies' sales of monoclonal antibodies for CNS indications, 2003-10

Table 28: Leading companies' sales of monoclonal antibodies for cardiovascular indications, 2003-10

Table 29: Leading companies' sales of monoclonal antibodies for respiratory indications, 2003-10

Table 30: Breakdown of Abbott's monoclonal antibody sales by therapy area, 2003-04

Table 31: Abbott's marketed monoclonal antibody products

Table 32: Abbott's monoclonal antibody pipeline, 2005

Table 33: Forecast sales for Abbott's monoclonal antibody portfolio, 2005-10

Table 34: Alexion's monoclonal antibody pipeline, 2005

Table 35: Forecast sales for Alexion's monoclonal antibodies, 2005-10

Table 36: Breakdown of Biogen Idec's monoclonal antibody revenues by therapy area, 2003-04

Table 37: Biogen Idec's marketed monoclonal antibody products

Table 38: Biogen Idec's monoclonal antibody pipeline, 2005

Table 39: Forecast revenues for Biogen Idec's monoclonal antibody portfolio, 2005-10

Table 40: Breakdown of CAT's monoclonal antibody sales by therapy area, 2003-04

Table 41: CAT's marketed monoclonal antibody products

Table 42: CAT's monoclonal antibody pipeline, 2005

Table 43: Forecast revenues for CAT's monoclonal antibodies, 2004-10

Table 44: Genentech's collaboration focus

Table 45: Genentech's monoclonal antibody sales by therapy area, 2003-04

Table 46: Genentech's marketed monoclonal antibody products

Table 47: Genentech's monoclonal antibody pipeline, 2005

Table 48: Forecast sales for Genentech's monoclonal antibody portfolio, 2004-10

Table 49: Genmab's monoclonal antibody pipeline, 2005

Table 50: Forecast sales for Genmab's monoclonal antibodies, 2005-10

Table 51: Breakdown of ImClone's monoclonal antibody sales by therapy area, 2003-04

Table 52: ImClone's marketed monoclonal antibody products

Table 53: BOND trial summary results

Table 54: ImClone's monoclonal antibody pipeline, 2005

Table 55: Forecast revenues for ImClone's monoclonal antibody portfolio, 2004-10

Table 56: Medarex's monoclonal antibody pipeline, 2005

Table 57: Forecast revenues for Medarex's monoclonal antibody, 2005-10

Table 58: Breakdown of MedImmune's monoclonal antibody revenue by therapy area, 2003-04

Table 59: MedImmune's marketed monoclonal antibody products

Table 60: MedImmune's monoclonal antibody pipeline, 2005

Table 61: Forecast revenues for MedImmune's monoclonal antibody portfolio, 2004-10

Table 62: UCB's monoclonal antibody pipeline, 2005

Table 63: Forecast sales for UCB's monoclonal antibody portfolio, 2004-10

Table 64: Exchange rates, 2004




List of Figures

Figure 1: Monoclonal antibody market absolute ethical sales forecast by therapy area, 2002-10

Figure 2: Technological exposure of antibody development programs, 2005

Figure 3: By 2010, the market dominance of the leading few companies will be diluted, as increasing numbers of new products and new players enter the marketplace

Figure 4: Launch trajectory of marketed monoclonal antibodies by technology, 1986-2010

Figure 5: Positioning of antibody companies by stage of development of business model

Figure 6: Technology exposure of monoclonal antibody market, 2003-04

Figure 7: Therapy area exposure of monoclonal antibody market, 2003-04

Figure 8: Evolution in technology of the monoclonal antibody market in terms of sales, 2004-10

Figure 9: Evolution in therapy area of the monoclonal antibody market, 2004-10

Figure 10: Monoclonal antibody market technology split by sales, in comparison with the number of marketed monoclonal antibodies in 2004

Figure 11: Monoclonal antibody market therapy area split by sales, in comparison with the number of marketed monoclonal antibodies in 2004

Figure 12: Growth drivers of the monoclonal antibody market, 2005-10

Figure 13: Stage of development of antibody development programs, 2005

Figure 14: Technological exposure of antibody development programs, 2005

Figure 15: Therapeutic exposure of antibody development programs, 2005

Figure 16: The structure of an antibody

Figure 17: Types of antibodies

Figure 18: Schematic illustration of antibody fragments

Figure 19: PDL's partnerships for its SMART humanization technology

Figure 20: Xoma's partnerships for its Human Engineering technology

Figure 21: Aeres Biomedical's partnerships for its antibody humanization technology

Figure 22: Medarex's partnerships for its UltiMAb technology

Figure 23: Abgenix's partnerships for its XenoMouse and XenoMax technologies

Figure 24: CAT's partnerships for its Phage Display technology

Figure 25: Dyax's partnerships for its Phage Display Discovery Tool technology

Figure 26: Enzon's partnerships for its SCA technology

Figure 27: Domantis's partnerships for its Domain Antibodies technology

Figure 28: ImmunoGen's partnerships for its TAP technology

Figure 29: Seattle Genetics' partnerships for its ADC and ADEPT technologies

Figure 30: Leading companies' global market shares of antibody product sales, 2004

Figure 31: Leading companies' forecast global market shares of antibody product sales, 2010

Figure 32: Technology exposure of key antibody companies

Figure 33: Market shares of companies involved in the oncology mAbs market, 2004-10

Figure 34: Market shares of companies involved in the AIID mAbs market, 2004-10

Figure 35: Assessment of Abbott's strategic position, 2004

Figure 36: Abbott's monoclonal antibody alliances

Figure 37: Abbott's technology exposure

Figure 38: Abbott's ethical sales breakdown, 2004

Figure 39: Abbott's therapeutic focus

Figure 40: Assessment of Alexion's strategic position, 2004

Figure 41: Alexion's monoclonal antibody alliances

Figure 42: Alexion's technology exposure

Figure 43: Alexion's therapeutic focus

Figure 44: Proportion of Biogen Idec's revenues derived from monoclonal antibodies, 2004-2010

Figure 45: Assessment of Biogen Idec's strategic position, 2004

Figure 46: Biogen Idec's monoclonal antibody alliances

Figure 47: Technology focus of Biogen Idec's antibody portfolio and pipeline

Figure 48: Therapeutic focus of Biogen Idec's antibody portfolio

Figure 49: Assessment of CAT's strategic position, 2004

Figure 50: CAT's monoclonal antibody alliances

Figure 51: CAT's technology exposure

Figure 52: CAT's business development for monoclonal antibody products by therapy area

Figure 53: Assessment of Genentech's strategic position, 2004

Figure 54: Genentech's monoclonal antibody alliances

Figure 55: Genentech's technology focus, 2004

Figure 56: Genentech's antibody sales breakdown, 2004

Figure 57: Genentech's business development for monoclonal antibody products by therapy area

Figure 58: Assessment of Genmab's strategic position, 2004

Figure 59: Genmab's monoclonal antibody alliances

Figure 60: Genmab's technology focus

Figure 61: Genmab's therapeutic focus

Figure 62: Assessment of ImClone's strategic position, 2004

Figure 63: ImClone Systems' monoclonal antibody alliances

Figure 64: ImClone's technology exposure

Figure 65: ImClone's therapeutic focus

Figure 66: Assessment of Medarex's strategic position, 2004

Figure 67: Medarex's monoclonal antibody alliances

Figure 68: Medarex's technology exposure

Figure 69: Medarex's therapeutic focus

Figure 70: Assessment of MedImmune's strategic position, 2004

Figure 71: MedImmune's monoclonal antibody alliances

Figure 72: MedImmune's technology exposure

Figure 73: MedImmune's therapeutic focus

Figure 74: UCB's monoclonal antibody exposure, 2010

Figure 75: Assessment of UCB's strategic position, 2004

Figure 76: UCB's monoclonal antibody alliances

Figure 77: UCB's technology exposure

Figure 78: UCB's therapeutic focus

Abstract

Introduction
The monoclonal antibody market is one of the fastest growing and most lucrative sectors of the pharmaceutical industry, with exceptional 48.1% growth between 2003 and 2004. It has the potential to triple in value over the next six years and reach $30.3 billion in 2010, driven by technological evolution from chimeric and humanized to fully human antibodies.

Scope
  • Global forecasts for all products launching by 2010, split by therapy area and technology type, including actual 2004 company-reported sales
  • Analysis of the portfolio and pipelines for 101 companies, covering 291 active development programs, including 10 in-depth profiles of key companies
  • Strategic evaluation of key market issues and future opportunities for companies to fully capitalize on the market
  • Evaluation of key antibody engineering technologies, including in-depth profiles of the 11 leading platforms
Highlights
The mAbs market is expected to almost triple in value over the next six years from $10.3 billion in 2004 to $30.3 billion. Oncology products will continue to dominate the market. However, sales of arthritis, immune and inflammatory disorders (AIID) products are forecast to grow strongly and account for 40.1% of the market by 2010.

The development focus of the industry is moving away from murine and chimeric antibodies, to humanized and, in particular, fully human technologies. A wave of fully human products are expected to launch from 2007 onwards, accounting for 12 of the 20 launches between 2007 and 2010.

Roche and Genentech dominate the mAbs market, with a combined market share of 44.9% in 2004, although this is forecast to slip to 35.7% in 2010. Datamonitor identified just 17 companies with direct sales of monoclonal antibodies in 2004, but this figure is expected to more than double to 36 in 2010, as new products and companies flood the market.

Reasons to Purchase
  • Validate your analysis of the market by company, therapy area and technology, with Datamonitor's sales forecasts for all antibodies launching by 2010
  • Identify key therapeutic and technological trends to capitalize on opportunities in the monoclonal antibody sector
  • Benchmark your corporate strategy and alliance networks against key competitors to optimize your future business development


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