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Biotechnology

Monoclonal Antibody Therapies

Evolving into a $30 billion market

Publication Date   April 2005
Publisher   Datamonitor
Product Type   Report
Pages   360
ISBN Number   not applicable
Product Code   DAT291
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approximately: $14,126 | €10,144

Summary


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.

  • 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

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.

  • Validate your analysis of the market by company, therapy area and technology, with sales forecasts for all antibodies launching by 2010h3>
  • 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

Content


  • Chapter 1 Executive Summary
    • Scope of the report
    • Key findings
    • The monoclonal antibodies market is expected to almost triple in value over the next six years from $10.3 billion in 2004 to $30.3 billion, growing at a CAGR of 19.8%. Oncology products will continue to dominate the market in terms of commercial value and pipeline development. However, sales of arthritis, immune and inflammatory disorders (AIID) products are forecast to grow strongly and account for 40.1% of the market value in 2010.
    • The development focus of the industry is moving away from murine and chimeric antibodies, to humanized and, in particular, fully human technologies. The market is expected to continue to evolve as antibody engineering capabilities advance further, including more efficient manufacturing and alternative delivery methods, broadening the commercial viability of antibodies treatments in a wider range of diseases.
    • Roche and Genentech dominate the monoclonal 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
    • The intellectual property (IP) situation surrounding monoclonal antibodies remains complex, although resolution of patent disputes and cross-licensing agreements are starting to simplify the IP landscape. In stark contrast to small molecule drugs, antibodies currently face no prospect of generic competition. Datamonitor expects this to extend the lifecycle of antibody therapies, thereby massively increasing their profitability.
  • 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
    • Narrowing therapeutic focus - road to success
    • Development time - faster than conventional drugs
    • Manufacturing issues - efficiency and reliability supersede under-capacity as the primary manufacturing concern
    • Intellectual property - cross-licensing settlements limit legal costs and extract maximum value in the rapidly-changing IP landscape
    • Target selection - exploiting proteomics and genomics
    • Antibody engineering evolution
    • Drug delivery - improving patient convenience
    • 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
    • New techniques for antibody discovery and validation
    • Company strategy
    • Business model evolution - biotech moves upstream
    • Alliance networks
    • 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
    • Monoclonal antibody market potential to 2010
    • Portfolio and pipeline analysis
    • Monoclonal antibodies marketed portfolio, 2004
    • Monoclonal antibody pipeline
    • Key growth drivers, 2005-10
    • R&D development programs
    • Technology focus, 2005
    • Therapeutic focus, 2005
  • Chapter 4 Antibody Engineering Technologies
    • Introduction
    • Murine
    • Chimerc
    • Humanized
    • Fully human
    • Transgenic mice
    • Phage display
    • Fragments
    • Conjugated
    • Technology profiles - Humanized Technologies
    • Protein Design Labs' SMART Humanization Technology
    • XOMA's Human Engineering Technology
    • Aeres Biomedical's Humanization Technology
    • Technology profiles - Fully Human Technologies
    • Medarex's UltiMAb Technology
    • Abgenix's XenoMouse and XenoMax
    • Cambridge Antibody Technology's Phage Display and Ribosome Display Technologies
    • Dyax's Phage Display Discovery Tool
    • Technology profiles - Antibody Fragment Technologies
    • Enzon's Single Chain Antibody Technology
    • Domantis' Domain Antibodies
    • Technology profiles - Conjugated Antibody Technologies
    • Immunogen's Tumor-Activated Prodrug (TAP) technology
    • Seattle Genetics' Antibody-drug Conjugate (ADC) and Antibody-Directed Enzyme Prodrug Therapy (ADEPT) Technologies
  • 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
    • Company profiles
    • Abbott Laboratories
    • Introduction to Abbott
    • Strategy
    • Monoclonal antibody portfolio and pipeline analysis
    • Alexion
    • Introduction to Alexion
    • Strategy
    • Monoclonal antibody portfolio and pipeline analysis
    • Biogen Idec
    • Introduction to Biogen Idec
    • Strategy
    • Monoclonal antibody portfolio and pipeline analysis
    • Key marketed products
    • Cambridge Antibody Technology
    • Introduction to Cambridge Antibody Technology
    • Strategy
    • Monoclonal antibody portfolio and pipeline analysis
    • Genentech
    • Introduction to Genentech
    • Strategy
    • Strengths
    • Weaknesses
    • Opportunities
    • Threats
    • Monoclonal antibody portfolio and pipeline analysis
    • Genmab
    • Introduction to Genmab
    • Strategy
    • Monoclonal antibody portfolio and pipeline analysis
    • ImClone Systems
    • Introduction to ImClone Systems
    • Strategy
    • Monoclonal antibody portfolio and pipeline analysis
    • Medarex
    • Introduction to Medarex
    • Strategy
    • Monoclonal antibody portfolio and pipeline analysis
    • MedImmune
    • Introduction to MedImmune
    • Strategy
    • Monoclonal antibody portfolio and pipeline analysis
    • UCB
    • Introduction to UCB
    • Strategy
    • Monoclonal antibody portfolio and pipeline analysis
  • 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 alliance
    • 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