モノクローナル抗体療法：300億米ドル市場への進化

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 of this report

• 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

Research and analysis 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.

Key reasons to read this report

• Validate your analysis of the market by company, therapy area and technology, with Datamonitors 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

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

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

XOMAs Human Engineering Technology

Human Engineering

Partnerships

Product portfolio and pipeline

Aeres Biomedicals Humanization Technology

Aeres Biomedicals humanization technology

Partnerships

Product portfolio and pipeline

Technology profiles - Fully Human Technologies

Medarexs UltiMAb Technology

UltiMAb Human Antibody Development System

Partnerships

Product portfolio and pipeline

Abgenixs XenoMouse and XenoMax

XenoMouse and XenoMax

Partnerships

Product portfolio and pipeline

Cambridge Antibody Technologys Phage Display and Ribosome Display Technologies

Phage Display technology

Ribosome Display technology

Partnerships

Product portfolio and pipeline

Dyaxs Phage Display Discovery Tool

Phage Display Discovery Tool

Partnerships

Product portfolio and pipeline

Technology profiles - Antibody Fragment Technologies

Enzons 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

Immunogens 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 PDLs SMART Humanization technology

Table 11: Products developed using Xomas Human Engineering

Table 12: Products developed using Aeres Biomedicals antibody humanization technology

Table 13: Products developed using Medarexs UltiMAb technology

Table 14: Products developed using Abgenixs Xenomouse and Xenomax technologies

Table 15: Products developed using CATs Phage Display technology

Table 16: Products developed using Dyaxs Phage Display Discovery Tool technology

Table 17: Products developed using Enzons SCA technology

Table 18: Products developed using Domantiss Domain Antibodies technology

Table 19: Products developed using ImmunoGens 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 Abbotts monoclonal antibody sales by therapy area, 2003-04

Table 31: Abbotts marketed monoclonal antibody products

Table 32: Abbotts monoclonal antibody pipeline, 2005

Table 33: Forecast sales for Abbotts monoclonal antibody portfolio, 2005-10

Table 34: Alexions monoclonal antibody pipeline, 2005

Table 35: Forecast sales for Alexions monoclonal antibodies, 2005-10

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

Table 37: Biogen Idecs marketed monoclonal antibody products

Table 38: Biogen Idecs monoclonal antibody pipeline, 2005

Table 39: Forecast revenues for Biogen Idecs monoclonal antibody portfolio, 2005-10

Table 40: Breakdown of CATs monoclonal antibody sales by therapy area, 2003-04

Table 41: CATs marketed monoclonal antibody products

Table 42: CATs monoclonal antibody pipeline, 2005

Table 43: Forecast revenues for CATs monoclonal antibodies, 2004-10

Table 44: Genentechs collaboration focus

Table 45: Genentechs monoclonal antibody sales by therapy area, 2003-04

Table 46: Genentechs marketed monoclonal antibody products

Table 47: Genentechs monoclonal antibody pipeline, 2005

Table 48: Forecast sales for Genentechs monoclonal antibody portfolio, 2004-10

Table 49: Genmabs monoclonal antibody pipeline, 2005

Table 50: Forecast sales for Genmabs monoclonal antibodies, 2005-10

Table 51: Breakdown of ImClones monoclonal antibody sales by therapy area, 2003-04

Table 52: ImClones marketed monoclonal antibody products

Table 53: BOND trial summary results

Table 54: ImClones monoclonal antibody pipeline, 2005

Table 55: Forecast revenues for ImClones monoclonal antibody portfolio, 2004-10

Table 56: Medarexs monoclonal antibody pipeline, 2005

Table 57: Forecast revenues for Medarexs monoclonal antibody, 2005-10

Table 58: Breakdown of MedImmunes monoclonal antibody revenue by therapy area, 2003-04

Table 59: MedImmunes marketed monoclonal antibody products

Table 60: MedImmunes monoclonal antibody pipeline, 2005

Table 61: Forecast revenues for MedImmunes monoclonal antibody portfolio, 2004-10

Table 62: UCBs monoclonal antibody pipeline, 2005

Table 63: Forecast sales for UCBs 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: PDLs partnerships for its SMART humanization technology

Figure 20: Xomas partnerships for its Human Engineering technology

Figure 21: Aeres Biomedicals partnerships for its antibody humanization technology

Figure 22: Medarexs partnerships for its UltiMAb technology

Figure 23: Abgenixs partnerships for its XenoMouse and XenoMax technologies

Figure 24: CATs partnerships for its Phage Display technology

Figure 25: Dyaxs partnerships for its Phage Display Discovery Tool technology

Figure 26: Enzons partnerships for its SCA technology

Figure 27: Domantiss partnerships for its Domain Antibodies technology

Figure 28: ImmunoGens 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 Abbotts strategic position, 2004

Figure 36: Abbotts monoclonal antibody alliances

Figure 37: Abbotts technology exposure

Figure 38: Abbotts ethical sales breakdown, 2004

Figure 39: Abbotts therapeutic focus

Figure 40: Assessment of Alexions strategic position, 2004

Figure 41: Alexions monoclonal antibody alliances

Figure 42: Alexions technology exposure

Figure 43: Alexions therapeutic focus

Figure 44: Proportion of Biogen Idecs revenues derived from monoclonal antibodies, 2004-2010

Figure 45: Assessment of Biogen Idecs strategic position, 2004

Figure 46: Biogen Idecs monoclonal antibody alliances

Figure 47: Technology focus of Biogen Idecs antibody portfolio and pipeline

Figure 48: Therapeutic focus of Biogen Idecs antibody portfolio

Figure 49: Assessment of CATs strategic position, 2004

Figure 50: CATs monoclonal antibody alliances

Figure 51: CATs technology exposure

Figure 52: CATs business development for monoclonal antibody products by therapy area

Figure 53: Assessment of Genentechs strategic position, 2004

Figure 54: Genentechs monoclonal antibody alliances

Figure 55: Genentechs technology focus, 2004

Figure 56: Genentechs antibody sales breakdown, 2004

Figure 57: Genentechs business development for monoclonal antibody products by therapy area

Figure 58: Assessment of Genmabs strategic position, 2004

Figure 59: Genmabs monoclonal antibody alliances

Figure 60: Genmabs technology focus

Figure 61: Genmabs therapeutic focus

Figure 62: Assessment of ImClones strategic position, 2004

Figure 63: ImClone Systems monoclonal antibody alliances

Figure 64: ImClones technology exposure

Figure 65: ImClones therapeutic focus

Figure 66: Assessment of Medarexs strategic position, 2004

Figure 67: Medarexs monoclonal antibody alliances

Figure 68: Medarexs technology exposure

Figure 69: Medarexs therapeutic focus

Figure 70: Assessment of MedImmunes strategic position, 2004

Figure 71: MedImmunes monoclonal antibody alliances

Figure 72: MedImmunes technology exposure

Figure 73: MedImmunes therapeutic focus

Figure 74: UCBs monoclonal antibody exposure, 2010

Figure 75: Assessment of UCBs strategic position, 2004

Figure 76: UCBs monoclonal antibody alliances

Figure 77: UCBs technology exposure

Figure 78: UCBs therapeutic focus