1. Executive Summary
1.1 Therapeutic Monoclonal Antibodies: World Market Outlook
1.2 Research and Analysis Methods
1.3 Chapter Outlines
2. Introduction to Monoclonal Antibodies
2.1 Antibodies
2.1.1 Function of Antibodies
2.1.2 Structure of Antibodies
2.2 Therapeutic Monoclonal Antibodies
2.2.1 Polyclonal and Monoclonal Antibodies
2.2.2 Murine Monoclonal Antibodies
2.2.3 Chimeric and Humanised Monoclonal Antibodies
2.2.4 Fully-Human Monoclonal Antibodies
2.2.5 Currently-Approved Monoclonal Antibody Therapies
3. World Therapeutic Monoclonal Antibodies Market, 2011-2021
3.1 Therapeutic Monoclonal Antibodies: Market Overview
3.1.1 The Therapeutic Monoclonal Antibody Market, 2010
3.1.2 Monoclonal Antibodies: Revenue Analysis by Therapeutic Area, 2010
3.1.3 Leading Therapeutic Monoclonal Antibodies, 2010
3.1.4 Leading Monoclonal Antibodies: Revenue Analysis by Group, 2010
3.1.5 World Monoclonal Antibody Market: Overall Forecast, 2010-2015
3.1.6 World Monoclonal Antibody Market: Overall Forecast, 2015-2021
3.2 The Market for Anti-Cancer Monoclonal Antibodies
3.2.1 The Leading Anti-Cancer Monoclonal Antibodies, 2010
3.2.2 Anti-Cancer Monoclonal Antibodies: Revenue Analysis by Type, 2010
3.2.3 Anti-Cancer Monoclonal Antibodies Market, 2010-2015
3.2.4 Anti-Cancer Monoclonal Antibodies Market, 2015-2021
3.3 The Monoclonal Antibodies for Treating Autoimmune Disorders Market
3.3.1 Leading Monoclonal Antibodies for Autoimmune Disorders: Revenue Analysis, 2010
3.3.2 Monoclonal Antibodies for Autoimmune Disorders: Types of Antibody Contributing to the Market
3.3.3 Remicade and Humira Drive the Autoimmune Disorders Treatment Market, 2010-2015
3.3.4 Monoclonal Antibodies for Autoimmune Disorders: Sales Forecast, 2015-2021
3.4 Monoclonal Antibodies for Other Therapeutic Uses
3.4.1 Other Leading Monoclonal Antibodies: Revenue Analysis, 2010
3.4.2 Other Monoclonal Antibodies: Sales Forecast, 2010-2021
3.5 Monoclonal Antibodies: Revenue Analysis by Company, 2010
3.6 Drivers and Restraints in the Market for Cancer and Autoimmune Disorders Monoclonal Antibodies
4. Leading Products in the Therapeutic Monoclonal Antibody Therapies Market, 2011-2021
4.1 Leading Anti-Cancer Monoclonal Antibodies in 2010
4.2 Avastin
4.2.1 Avastin: Cancer Blockbuster Set to Reach $10bn?
4.2.2 Avastin Revenue Analysis, 2010
4.2.3 Avastin 2010-2015: 'Pipeline-in-One'
4.2.4 The Competitive Landscape for Avastin, 2010-2015
4.2.5 Avastin Revenue Forecast, 2010-2015
4.2.6 Avastin Revenue Forecast, 2015-2021
4.3 Herceptin
4.3.1 Herceptin for HER2-Positive Patients
4.3.2 Herceptin Revenue Analysis, 2010
4.3.3 Herceptin Revenue Forecast, 2010-2015
4.3.4 Increased Competition for Herceptin, 2015-2021
4.4 MabThera/Rituxan
4.4.1 MabThera/Rituxan: The First Blockbuster Monoclonal Antibody
4.4.2 MabThera/Rituxan Revenue Analysis, 2010
4.4.3 MabThera/Rituxan Revenue Forecast, 2010-2015
4.4.4 MabThera/Rituxan Revenue Forecast, 2015-2021
4.4.5 New Uses for MabThera/Rituxan Will Benefit Revenues
4.4.6 Intensifying Competition: MabThera/Rituxan in Cancer Treatment, 2015-2021
4.5 Erbitux
4.5.1 Erbitux' Cancer Indications
4.5.2 Erbitux Revenue Analysis, 2010
4.5.3 Opportunities from New Indications for Erbitux
4.5.4 Erbitux Revenue Forecast, 2010-2021
4.6 Other Monoclonal Antibodies for Treating Cancers
4.6.1 Vectibix
4.6.2 Campath/MabCampath
4.6.3 Zevalin
4.6.4 Bexxar
4.6.5 TheraCIM (Nimotuzumab)
4.6.6 Removab
4.7 Leading Monoclonal Antibodies for Autoimmune Disorders in 2010
4.8 Remicade
4.8.1 Remicade: Leading Monoclonal Antibody, 2010
4.8.2 Remicade Revenue Analysis, 2010
4.8.3 Remicade's Competitors
4.8.4 Imminent Increase in Competition for Remicade
4.8.5 Remicade Revenue Forecast, 2011-2015
4.8.6 Remicade Revenue Forecast, 2015-2021
4.9 Humira
4.9.1 Humira: First Fully-Human Monoclonal Antibody on the Market
4.9.2 Humira Revenue Analysis, 2010
4.9.3 Humira's Market Potential, 2011-2015
4.9.4 Humira Revenue Forecast, 2015-2021
4.10 Tysabri
4.10.1 Tysabri - Monoclonal Antibody for the Treatment of MS
4.10.2 Tysabri Revenue Analysis, 2010
4.10.3 Tysabri Revenue Forecast, 2010-2021
4.10.4 Tysabri Will Face Competition from Oral MS Drugs
4.11 Xolair
4.11.1 Genentech's Asthma Monoclonal Antibody
4.11.2 Xolair Revenue Analysis, 2010
4.11.3 Xolair Revenue Forecast, 2011-2021
4.12 MabThera/Rituxan
4.12.1 MabThera for Rheumatoid Arthritis
4.12.2 Competitors for MabThera/Rituxan in Autoimmune Disorders, 2011-2015
4.12.3 Prospects for Revenue Growth
4.13 Actemra
4.13.1 Actemra for Rheumatoid Arthritis
4.13.2 Actemra Revenue Forecast, 2011-2021
4.14 Cimzia
4.14.1 Cimzia for Crohn's Disease
4.14.2 Cimzia Revenue Forecast, 2011-2021
4.15 Other Monoclonal Antibodies for Autoimmune Diseases
4.15.1 Simponi
4.15.2 Soliris
4.15.3 Simulect
4.15.4 Stelara
4.16 Other Monoclonal Antibodies
4.16.1 Other Leading Monoclonal Antibodies: Revenue Analysis, 2010
4.17 Synagis
4.17.1 Synagis: Blockbuster Respiratory Disorder Treatment
4.17.2 Synagis Revenue Analysis, 2010
4.17.3 Synagis Revenue Forecast, 2011-2021
4.18 Lucentis
4.18.1 Lucentis: Important Ophthalmological Drug
4.18.2 Lucentis Revenue Analysis, 2010
4.18.3 Impact of Off-Label Avastin on Lucentis, 2010-2021
4.18.4 Lucentis Revenue Forecast, 2011-2015
4.18.5 Lucentis Revenue Forecast, 2015-2021
4.19 ReoPro
4.19.1 ReoPro: Cardiovascular Monoclonal Antibody Fragment
5. Leading National Markets for Monoclonal Antibody Therapies, 2011-2021
5.1 Overview of Leading National Markets
5.1.1 Top Nine National Markets for Therapeutic Monoclonal Antibodies
5.2 The US Monoclonal Antibody Therapies Market, 2010-2021
5.2.1 US Market in 2010
5.2.2 US Monoclonal Antibody Therapies Market, 2011-2021
5.3 Japanese Monoclonal Antibody Therapies Market, 2010-2021
5.4 Leading European Monoclonal Antibody Therapies Markets, 2010-2021
5.5 Prospects for Therapeutic Monoclonal Antibody Sales in China and India, 2010-2021
6. R&D Pipeline for Therapeutic Monoclonal Antibodies, 2011
6.1 Late-Stage Oncology Pipeline: Additional and Expanded Indications
6.1.1 Avastin
6.1.2 MabThera/Rituxan
6.1.3 Erbitux
6.1.4 Tysabri
6.2 Late-Stage Oncology Pipeline: Novel Entities
6.2.1 Farletuzumab (MORAb-003)
6.2.2 Figitumumab (CP-751871)
6.2.3 Galiximab
6.2.4 Ipilimumab
6.2.5 Ramucirumab (IMC 1121B)
6.2.6 Rencarex (WX-G250)
6.2.7 Zalutumumab (HuMax-EGFr)
6.2.8 Lumiliximab
6.2.9 Pertuzumab (R1273)
6.3 Late-Stage Autoimmune Disorders Pipeline: Additional and Expanded Indications
6.3.1 MabThera/Rituximab
6.3.2 Alemtuzumab for Multiple Sclerosis
6.4 Late-Stage Autoimmune Disorders Pipeline: New Entities
6.4.1 Benlysta (Belimumab)
6.4.2 Bapineuzumab (AAB-001)
6.4.3 Briakinumab (ABT-874)
6.4.4 Mycograb (Efungumab)
6.4.5 Ocrelizumab (R1594)
6.4.6 Otelixizumab (TRX4)
6.5 Pipeline for Other Monoclonal Antibodies
6.5.1 Motavizumab
6.5.2 Lucentis
6.6 R&D Pipeline: Antibody Fragments
6.6.1 Development and Potential of Antibody Fragments
6.6.2 Ablynx' Nanobodies
6.6.3 Domantis' Domain Fragments
6.6.4 Genmab's UniBody
6.6.5 ESBATech
6.6.6 Affimed's TandAbs and Flexibodies
6.6.7 Micromet's BiTE Antibody Platform
6.7 R&D Pipeline: Antibody-Drug Conjugates
6.7.1 The Future of Conjugated Antibodies
6.7.2 Seattle Therapeutics
6.7.3 ImmunoGen
6.7.4 Neuradiab
7. Drivers and Restraints in the Therapeutic Monoclonal Antibody Industry and Market, 2011-2021
7.1 SWOT Analysis of the Therapeutic Monoclonal Antibody Industry and Market, 2011-2021
7.2 Commercial Strengths
7.2.1 Monoclonal Antibodies Have a Wide Range of Specific Targets
7.2.2 Chronic and Niche Diseases Can Generate High Revenues
7.2.3 Strong R&D Pipeline and Technological Advances, Including Manufacturing Improvements
7.2.4 Lower Risk of Adverse Events for Monoclonal Antibodies in Cancer Treatment
7.3 Commercial Weaknesses
7.3.1 Biosimilars/Follow-on Biologics - Threat to Original-Branded Antibodies?
7.3.2 Future Prospects for Biosimilar Monoclonal Antibodies
7.3.3 High Development Cost Limits Growth
7.3.4 Injections are the Main Mode of Administration
7.3.5 The Challenge of Immunogenicity
7.3.6 Competition is Fierce for Many Targets
7.3.7 Insufficient Efficacy of Anti-Cancer Monoclonal Antibodies as Monotherapy is a Concern
7.4 Commercial Opportunities
7.4.1 Increasing Cancer Prevalence - Expanding Treatment Populations
7.4.2 Autoimmune Disorder Prevalence and Under-Treatment
7.5 Commercial Threats
7.5.1 Reimbursement for Monoclonal Antibodies
7.5.2 High Profile Safety Cases Increase Regulatory Vigilance
7.5.3 Current Financial Limitations in Research and Development
8. Research Interviews
8.1 Dr David Blakey, Chief Scientist, Cancer & Infection Research Area, AstraZeneca
8.1.1 The Future of Humanised and Fully-Human Antibodies
8.1.2 Therapeutic Antibody Fragments vs Full-Length Antibodies
8.1.3 Opportunities in Monoclonal Antibody Cancer Therapeutics
8.2 Professor Mark Cragg, Cancer Sciences Division, Southampton General Hospital, Southampton, UK
8.2.1 How Do Monoclonal Antibodies Treat Cancer?
8.2.2 The Future of Different Monoclonal Antibody Types
8.2.3 Threats and Limitations
8.2.4 Opportunities
8.2.5 Will Side Effects Limit Potential?
8.2.6 Future Developments
8.3 Dr Janice Reichert, Tufts Center for the Study of Drug Development, and Editor-in-Chief, mAbs
8.3.1 On the Reasons for the Ascendancy of MAbs
8.3.2 On the Current Indications for MAbs
8.3.3 On Antibody-Drug Conjugates and Biospecifics
8.3.4 On Non-Human Antibodies and Alternative Scaffolds
8.3.5 On the Prospects for Biosimilar Antibodies
9. Conclusions
9.1 Monoclonal Antibodies Are Important Contributors to Biologic Drug Revenues
9.2 Prospects for the Therapeutic Monoclonal Antibody Industry and Market
9.3 The Monoclonal Antibody R&D Pipeline
9.4 Monoclonal Antibodies Therapies Market from 2010 to 2015
9.5 Monoclonal Antibodies Therapies Market from 2015 to 2021
9.6 Expansion into New Markets
9.7 Concluding Thoughts
List of Tables
Table 2.1 Types of Monoclonal Antibody, 2011
Table 2.2 Monoclonal Antibody Therapies Approved in the US, 2011
Table 2.3 Monoclonal Antibody Therapies Approved in the US (continued), 2011
Table 2.4 Monoclonal Antibody Therapies Approved in Other Countries, 2011
Table 3.1 Therapeutic Monoclonal Antibodies: Therapeutic Areas ($bn), 2010, 2015 & 2021
Table 3.2 Top 10 Monoclonal Antibodies: Revenues ($bn) and Market Shares (%), 2010
Table 3.3 World Therapeutic Monoclonal Antibody Revenue ($bn) Forecast, 2010-2021
Table 3.4 Leading Monoclonal Antibodies for Cancer: Revenues ($bn) and Market Shares (%), 2010
Table 3.5 World Cancer Monoclonal Antibody Revenue ($bn) Forecast, 2010-2021
Table 3.6 Leading Monoclonal Antibodies for Autoimmune Disorders: Revenues ($bn) and Market Shares (%), 2010
Table 3.7 World Autoimmune Disorder Monoclonal Antibody Revenue ($bn) Forecast, 2010-2021
Table 3.8 Leading Monoclonal Antibodies for Other Disorders: Revenues ($bn) and Market Shares (%), 2010
Table 3.9 World Non-Oncology/Autoimmune Disorder Monoclonal Antibody Revenue ($bn) Forecast, 2010-2021
Table 3.10 World Monoclonal Antibody Therapies Market by Company: Revenues ($bn) and Market Shares (%), 2010
Table 3.11 Drivers and Restraints in the Cancer Monoclonal Antibodies Market, 2011
Table 3.12 Drivers and Restraints in the Autoimmune Disorders Monoclonal Antibodies Market, 2011
Table 4.1 World Avastin Revenue ($bn) Forecast, 2010-2021
Table 4.2 World Herceptin Revenue ($bn) Forecast, 2010-2021
Table 4.3 World MabThera Revenue ($bn) Forecasts, 2010-2021
Table 4.4 World Erbitux Revenue ($bn) Forecast, 2010-2021
Table 4.5 World Cancer Monoclonal Antibody Revenue ($bn) Forecasts Grouped, 2010-2021
Table 4.6 World Remicade Revenue ($bn) Forecast, 2010-2021
Table 4.7 World Humira Revenue ($bn) Forecast, 2010-2021
Table 4.8 World Tysabri Revenue ($bn) Forecast, 2010-2021
Table 4.9 World Xolair Revenue ($bn) Forecast, 2010-2021
Table 4.10 World MabThera Revenue ($bn) Forecast for Autoimmune Diseases, 2010-2021
Table 4.11 World Actemra Revenue ($bn) Forecast, 2010-2021
Table 4.12 World Cimzia Revenue ($bn) Forecast, 2010-2021
Table 4.13 World Autoimmune Disorder Monoclonal Antibody Revenue ($bn) Forecasts Grouped, 2010-2021
Table 4.14 World Synagis Revenue ($bn) Forecast, 2010-2021
Table 4.15 World Lucentis Revenue ($bn) Forecast, 2010-2021
Table 4.16 World Other Monoclonal Antibody Revenue ($bn) Forecasts Grouped, 2010-2021
Table 5.1 Leading National Market Revenues ($bn) and Market Shares (%) for Monoclonal Antibody Therapies, 2010-2021
Table 5.2 US Monoclonal Antibody Therapies Market Forecast ($bn), 2010-2021
Table 5.3 Japanese Monoclonal Antibody Therapies Market Forecast ($bn), 2010-2021
Table 5.4 Leading European Markets for Monoclonal Antibody Therapies: Market Forecasts ($bn), 2010-2021
Table 5.5 Monoclonal Antibody Therapy Markets in China and India: Forecasts ($bn), 2010-2021
Table 5.6 Leading National Market Forecasts ($bn) Grouped, 2010-2021
Table 6.1 Late-Stage Oncology Pipeline: Additional and Expanded Indications, 2011
Table 6.2 Late-Stage Oncology Pipeline: Additional and Expanded Indications (continued), 2011
Table 6.3 Late-Stage Oncology Pipeline: Novel Entities, 2011
Table 6.4 Late-Stage Autoimmune Disorders Pipeline: New Entities, 2011
Table 6.5 Antibody Fragments Pipeline, 2011
Table 6.6 Antibody-Drug Conjugates Pipeline, 2011
Table 6.7 Antibody-Drug Conjugates Pipeline (continued), 2011
Table 7.1 SWOT Analysis of the Therapeutic Monoclonal Antibodies Industry and Market, 2011-2021
Table 7.2 Expected Biosimilar Products in the R&D Pipeline, 2011
Table 7.3 Expected Patent Expiries for Leading Therapeutic Monoclonal Antibodies, 2011-2020
List of Figures
Figure 2.1 Structure of an Antibody
Figure 3.1 Market Shares (%) for Monoclonal Antibodies by Therapy Sector, 2010
Figure 3.2 Market Shares (%) for Monoclonal Antibodies by Therapy Sector, 2015
Figure 3.3 Market Shares (%) for Monoclonal Antibodies by Therapy Sector, 2021
Figure 3.4 World Therapeutic Monoclonal Antibody Revenue ($bn) Forecast, 2010-2021
Figure 3.5 Leading Cancer Monoclonal Antibodies: Market Shares (%), 2010
Figure 3.6 World Cancer Monoclonal Antibody Revenue ($bn) Forecast, 2010-2021
Figure 3.7 Leading Autoimmune Disorder Monoclonal Antibodies: Revenues ($bn) and Market Shares (%), 2010
Figure 3.8 World Autoimmune Disorder Monoclonal Antibody Revenue ($bn) Forecast, 2010-2021
Figure 3.9 Leading Monoclonal Antibodies for Other Disorders: Market Shares (%), 2010
Figure 3.10 World Non-Oncology/Autoimmune Disorder Monoclonal Antibody Revenue ($bn) Forecast, 2010-2021
Figure 3.11 World Monoclonal Antibody Therapies Market by Company: Market Shares (%), 2010
Figure 4.1 World Avastin Revenue ($bn) Forecast, 2010-2021
Figure 4.2 World Herceptin Revenue ($bn) Forecast, 2010-2021
Figure 4.3 World MabThera Revenue ($bn) Forecast for Cancer Treatment, 2010-2021
Figure 4.4 World Erbitux Revenue ($bn) Forecast, 2010-2021
Figure 4.5 World Remicade Revenue ($bn) Forecast, 2010-2021
Figure 4.6 World Humira Revenue ($bn) Forecast, 2010-2021
Figure 4.7 World Tysabri Revenue ($bn) Forecast, 2010-2021
Figure 4.8 World Xolair Revenue ($bn) Forecast, 2010-2021
Figure 4.9 World MabThera Revenue ($bn) Forecast for Autoimmune Diseases, 2010-2021
Figure 4.10 World Actemra Revenue ($bn) Forecast, 2010-2021
Figure 4.11 World Cimzia Revenue ($bn) Forecast, 2010-2021
Figure 4.12 World Synagis Revenue ($bn) Forecast, 2010-2021
Figure 4.13 World Lucentis Revenue ($bn) Forecast, 2010-2021
Figure 5.1 Leading National Market Shares (%), 2010
Figure 5.2 Leading National Market Shares (%), 2015
Figure 5.3 Leading National Market Shares (%), 2021
Figure 5.4 US Monoclonal Antibody Therapies Market Forecast ($bn), 2010-2021
Figure 5.5 Japanese Monoclonal Antibody Therapies Market Forecast ($bn), 2010-2021
Figure 5.6 US and Japanese Monoclonal Antibody Therapies Market Forecasts ($bn), 2010-2021
Figure 5.7 Leading European Markets for Monoclonal Antibody Therapies: Market Forecasts ($bn), 2010-2021
Figure 5.8 Monoclonal Antibody Therapy Markets in China and India: Forecasts ($bn), 2010-2021