Overview

In 2005, the antibodies market was valued at an estimated US$14 billion, accounting for over 24 percent of the total protein therapeutics market. This share increased substantially since 2001, when it barely surpassed 13 percent. Monoclonal antibody (MAbs) therapies have been posting the fastest growth within the protein therapeutics market. According to Arrowhead Publishers’ report Monoclonal Antibody Therapies 2007: Competitive Landscape and Pipeline Insight the value of this market is set to reach more than $16 billion in 2006This growth will continue in the coming years, boosted by a number of new MAbs on the market, new indications for successful medications, and their ability to treat conditions and diseases for which there is great unmet need.

Monoclonal Antibody Therapies 2007 provides an analytically-based overview of the growing market for therapeutic monoclonal antibodies, which represent the largest segment of protein-based therapeutics. An increasing number of biotech companies are investing in the MAbs field, mostly in collaboration with major pharmaceutical companies, to take advantage of this dynamic and growing field.

This report assesses the overall monoclonal antibody market, as part of the wider protein therapeutics industry. Factors influencing their historical and future performance - including manufacturing problems and the impact of future generic competition - are assessed to provide a balanced overview of the market and key products by major therapeutic categories. Finally, the report forecasts likely revenue performance of the most successful products in the next five years, identifying key areas of growth.

Key Features of this report:

• Thorough market analysis of global monoclonal antibody sales, segmented by product, company, and geographic region

• Financial forecasts for key MAbs on the market as well as promising new MAbs entering the market

• Analysis of MAb manufacturing issues and their effect on the financial potential of the therapeutic MAb market

• Profiles of key companies involved in the development and marketing of therapeutic MAbs

• A review of important happenings in R&D and an evaluation of the upcoming crop of new MAbs

Table of Contents

1 Methodology, Objectives and Executive Summary
1.1 Report Objectives
1.2 Research Methodology
1.3 Executive Summary

2 Challenges and Issues In the Protein Therapeutics Market
2.1 Pricing
2.2 Drug Delivery
2.3 Manufacturing Capacity
2.4 The Biogeneric Threat
2.4.1 Loss of Patent Protection
2.4.2 High Manufacturing Costs
2.4.3 Lack of Adequate Legislation
2.4.4 Restrictive Cost of Biotech Generics
2.4.5 Biogeneric Landscape

3 Overview of the Monoclonal Antibody Class
3.1 History of MAbs
3.2 The Production of MAbs
3.3 How do Monoclonal Antibodies Work?
3.4 Types of Monoclonal Antibodies
3.4.1 Human Antibodies
3.4.2 Humanized Antibodies (CDR-Grafted)
3.4.3 Chimeric Antibodies
3.4.4 Murine Antibodies

4 Barriers to Successful Treatment with Monoclonal Antibodies
4.1 Human Anti-Mouse Response
4.2 Side Effects
4.3 Nature of Disease
4.4 Manufacturing Capacity Limitations
4.4.1 Manufacturing Costs
4.4.2 Contract Manufacturing as an Alternative
4.4.3 Potential of Transgenic Protein Production

5 Therapeutic Applications for Monoclonal Antibodies
5.1 Cancer
5.1.1 Rituxan (rituxumab)
5.1.2 Herceptin (trastuzumab)
5.1.3 Campath (alemtuzumab)
5.1.4 Mylotarg (gemtuzumab ozogamicin)
5.1.5 Zevalin (ibritumomab tiuxetan)
5.1.6 Erbitux (cetuximab)
5.1.7 Bexxar (tositumomab)
5.1.1.8 Avastin (bevacizumab)
5.2 Autoimmune/Inflammatory Diseases
5.2.1 Rheumatoid Arthritis
5.2.1.1 Remicade (infliximab)
5.2.1.2 Humira (adalimumab)
5.2.2 Inflammatory Bowel Disease
5.2.2.1 Remicade (infliximab)
5.2.3 Multiple Sclerosis
5.2.3.1 Tysabri (natalizumab)
5.2.4 Psoriasis
5.2.4.1 Raptiva (efalizumab)
5.2.5 Asthma
5.2.5.1 Xolair
5.2.6 Age-Related Macular Degeneration (AMD)
5.2.6.1 Lucentis (ranibizumab)
5.2.7 Transplant Rejection
5.2.7.1 Simulect (basiliximab)
5.2.7.2 Zenapax (daclizumab)
5.2.7.3 Orthoclone OKT-3 (muromonab CD3)
5.2.8 Other Conditions
5.2.8.1 Percutaneous coronary intervention (PCI)
5.2.8.1.1 ReoPro (abciximab)
5.2.8.2 Lower Respiratory Tract Disease
5.2.8.2.1 Synagis (palivizumab)

6 Market Analysis
6.1 Commercial Market Size
6.2 Segmentation by Therapeutic Category
6.2.1 Cancer
6.2.2 Autoimmune/Inflammatory
6.3 Market Share by Country/Region
6.4 Key Product Sales
6.5 Market Share by Company
6.6 Market Outlook
6.6.1 Drivers
6.6.2 Restraints
6.6.3 Financial Forecast

7 MAbs Innovation
7.1 MAb Structure Innovation
7.1.1 Immunogenicity
7.1.2 Effector Function
7.1.3 Antibody Size and Structure
7.1.4 Affinity
7.2 MAbs Drug Delivery Innovation
7.2.1 Inhaled MAb Delivery
7.2.2 Oral MAb Delivery
7.3 MAbs Technology Innovation

8 Emerging Monoclonal Antibody Therapies
8.1 Cancer
8.1.1 ABX-EGF (panitumumab)
8.1.2 Cotara (TNT-1)
8.1.3 Rencarex (WX-G250)
8.1.4 OvaRex
8.1.5 MDX-010
8.1.6 HuMax-CD4
8.1.7 Avastin
8.1.8 HuMax-CD20
823 Autoimmune/Inflammatory
8.2.1 Humira
8.2.2 Rituxan
8.2.3 Actemra (tocilizumab)
8.2.4 HuMax-CD20
8.2.5 Campath
8.2.6 CDP 870 (certolizumab pegol)
8.2.7 Remicade
8.2.8 Tysabri
8.2.9 AMG 412
8.2.10 LymphoCyde
8.2.11 SB 240563
8.2.12 MLN 1202
8.2.13 ABT 875
8.2.14 CNTO 148
8.3 Other Conditions
8.3.1 Segard
8.3.2 Anti-C5 Antibody
8.3.3 5G1.1
8.3.4 Aurograb
8.3.5 AMG 162

9 Key Companies in the MAbs Market
9.1 Abbott Laboratories
9.2 Biogen Idec
9.3 Cambridge Antibody Technology
9.4 Chugai Pharmaceutical
9.5 Dyax
9.6 Elan Corporation
9.7 Genentech
9.8 Genmab
9.9 Genzyme
9.10 Human Genome Sciences
9.11 ImClone
9.12 Immunomedics
9.13 InNexus Biotechology
9.14 Johnson & Johnson
9.15 Medarex
9.16 MedImmune
9.17 PDL Biopharma
9.18 Raven Biotechnologies
9.19 Regeneron Pharmaceuticals
9.20 Roche
9.21 Seattle Genetics
9.22 Xencor
9.23 Xoma

Appendix

Tables
Table 3.1 Mammalian Antibody Types
Table 4.1 Principal Methods of Creating Transgenic Animals
Table 4.2 Pros and Cons of Transgenic Plants
Table 4.3 Companies Involved in the Field of Transgenic Protein Technology
Table 5.1 Monoclonal Antibody Therapies on the Market 2006
Table 5.2 Monoclonal Antibodies on the Market for the Treatment of Cancer
Table 5.3 Monoclonal Antibodies on the Market for the Treatment of Autoimmune/Inflammatory Conditions
Table 5.4 Description of IBD
Table 5.5 Types of MS
Table 5.6 Types of Transplant Rejection
Table 5.7 Antibodies Used to Prevent Transplant Rejection
Table 6.1 Leading Monoclonal Antibody Products, by Sales 2000-2006 (US$mn)
Table 6.2 US Sales of Monoclonal Antibodies, Cancer Indications 2000-2006 (US$mn)
Table 6.3 Monoclonal Antibody Sales, Autoimmune/Inflammatory Indications, 1999-2006 (US$mn)
Table 6.4 Monoclonal Antibody Market Share (2005), by Country/Region
Table 6.5 Global Sales of Herceptin 2000-2006 (US$mn)
Table 6.6 Global Sales of Avastin 2004-2006 (US$mn)
Table 6.7 Global Sales of Rituxan 2003-2006 (US$mn)
Table 6.8 Global Sales of Humira 2003-2006 (US$mn)
Table 6.9 Global Sales of Remicade 2000-2006 (US$mn)
Table 6.10 Global Sales of Raptiva 2003-2006 (US$mn)
Table 6.11 Global Sales of Xolair 2003-2006 (US$mn)
Table 6.12 Financial Forecast for the Monoclonal Antibody Market 2005-2010 (US$bn)
Table 6.13 Forecast Sales of Leading Monoclonal Antibody Products 2005-2010 (US$mn)
Table 7.1 Key Areas of MAb R&D Efforts
Table 7.2 Targeted Therapy Approaches
Table 8.1 Avastin Status in Clinical Trials
Table 8.2 Types of ACR Response Criteria
Table 9.1 Biogen Idec’s Mab Pipeline
Table 9.2 CAT’s Clinical Pipeline
Table 9.3 Immunomedics’ Key Product Pipeline
Table 9.4 Medarex’s MAb Pipeline
Table 9.5 Roche’s Mab Products

Graphs
Graph 6.1 Leading Monoclonal Antibody Products by 2005 Sales (US$mn)
Graph 6.2 Monoclonal Antibody Market Share by Therapeutic Category (2005)
Graph 6.3 Annual Percentage Growth of US Sales of Monoclonal Antibodies, Cancer Indications 2000-2005
Graph 6.4 Annual Growth of Monoclonal Antibody Sales, Autoimmune/Inflammatory Indications, 2001-2005
Graph 6.5 Monoclonal Antibody Market Share, US vs Rest of World
Graph 6.6 Monoclonal Antibody Market Share, by Top Five Products 2005
Graph 6.7 Leaders in the Monoclonal Antibody Therapy Market, 2005 Market Share
Graph 6.9 Forecast of Annual Percentage Sales Growth of Leading Monoclonal Antibody Products 2005-2010
Graph 6.8 Total Forecast Sales of Leading Monoclonal Antibody Products 2005-2010 (US$mn)

Diagrams
Figure 7.1 Modified Antibodies

Sample Pages

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• Monoclonal Antibodies 2007 sample pages