Monoclonal Antibody Therapies 2007: Competitive Landscape and Pipeline Insight

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

Diagrams
Figure 7.1 Modified Antibodies