1. Executive Summary
1.1 Monoclonal Antibody Market Review
1.2 Aims, Scope and Format of the Report
1.3 Research and Analysis Methods
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, 2010-2025
3.1 Therapeutic Monoclonal Antibodies: Market Overview
3.1.1 The Therapeutic Monoclonal Antibody Market, 2009
3.1.2 Monoclonal Antibodies: Revenue Analysis by Therapeutic Area, 2009
3.1.3 Leading Therapeutic Monoclonal Antibodies, 2009
3.1.4 Monoclonal Antibodies: Revenue Analysis by Group, 2009
3.1.5 World Monoclonal Antibody Market: Overall Forecast, 2010-2015
3.1.6 World Monoclonal Antibody Market: Overall Forecast, 2015-2025
3.2 The Market for Anti-Cancer Monoclonal Antibodies
3.2.1 The Leading Anti-Cancer Monoclonal Antibodies, 2009
3.2.2 Anti-Cancer Monoclonal Antibodies: Revenue Analysis by Type, 2009
3.2.3 Anti-Cancer Monoclonal Antibodies: Revenue Analysis by Company, 2009
3.2.4 Anti-Cancer Monoclonal Antibodies Market, 2010-2015
3.2.5 Anti-Cancer Monoclonal Antibodies Market, 2015-2025
3.3 Avastin
3.3.1 Avastin: Cancer Blockbuster Set to Reach $10bn?
3.3.2 Avastin Revenue Analysis, 2009
3.3.3 Avastin 2010-2015: 'a Pipeline-in-One'
3.3.4 The Competitive Landscape for Avastin, 2010-2015
3.3.5 Avastin Market Forecast, 2010-2015
3.3.6 Outlook for Avastin: Sales Forecast, 2015-2025
3.4 Herceptin
3.4.1 Herceptin Successfully Targets HER2-Positive Patients
3.4.2 Herceptin Revenue Analysis, 2009
3.4.3 Herceptin Market Forecast, 2010-2015
3.4.4 Increased Competition for Herceptin, 2015-2025
3.5 MabThera/Rituxan
3.5.1 MabThera/Rituxan: The First Blockbuster Monoclonal Antibody
3.5.2 MabThera/Rituxan Revenue Analysis, 2009
3.5.3 MabThera/Rituxan Market Forecast, 2010-2015
3.5.4 MabThera/Rituxan Long-Term Prospects, 2015-2025
3.5.5 New Oncology Growth Areas for MabThera/Rituxan, 2010-2015
3.5.6 Intensifying Competition: MabThera/Rituxan in Cancer Treatment, 2015-2025
3.6 Erbitux
3.6.1 Erbitux' Oncology Indications
3.6.2 Erbitux Revenue Analysis, 2009
3.6.3 Opportunities in Head and Neck Cancer and New Indications for Erbitux
3.6.4 Erbitux Sales Forecast, 2010-2025
3.7 Other Monoclonal Antibodies for Treating Cancers
3.7.1 Vectibix
3.7.2 Campath/MabCampath
3.7.3 Zevalin
3.7.4 Bexxar
3.7.5 TheraCIM (Nimotuzumab)
3.7.6 Removab
3.8 The Autoimmune Disorder Monoclonal Antibodies Market
3.8.1 Leading Autoimmune Disorder Monoclonal Antibodies: Revenue Analysis, 2009
3.8.2 Autoimmune Disorder Monoclonal Antibodies: Revenue Analysis by Type, 2009
3.8.3 Remicade, Humira and Novel Antibodies Drive Autoimmune Monoclonal Market, 2010-2015
3.8.4 Autoimmune Disorder Monoclonal Antibodies Sales Forecast, 2015-2025
3.9 Remicade
3.9.1 Remicade: The Leading Monoclonal Antibody, 2009
3.9.2 Remicade Revenue Analysis, 2009
3.9.3 Remicade's Competitors
3.9.4 Imminent Increase in Competition for Remicade
3.9.5 Remicade Market Forecast, 2010-2015
3.9.6 Remicade Market Forecast, 2015-2025
3.10 Humira
3.10.1 Humira: First Fully-Human Monoclonal Antibody on the Market
3.10.2 Humira Revenue Analysis, 2009
3.10.3 Humira's Market Potential, 2010-2015
3.10.4 Humira Sales Forecast, 2015-2025
3.11 Tysabri
3.11.1 Tysabri - A Monoclonal Antibody for the Treatment of MS
3.11.2 Tysabri Revenue Analysis, 2009
3.11.3 Tysabri Sales Forecast, 2010-2025
3.11.4 Tysabri Will Face Competition from Oral MS Drugs
3.12 Xolair
3.12.1 Genentech's Asthma Monoclonal Antibody: Xolair
3.12.2 Xolair Revenue Analysis, 2009
3.12.3 Xolair Sales Forecast, 2010-2025
3.13 MabThera/Rituxan for Rheumatoid Arthritis
3.13.1 Competitors for MabThera/Rituxan in Autoimmune Disorders, 2010-2025
3.13.2 Prospects for Revenue Growth
3.14 Other Monoclonal Antibodies for Treating Autoimmune Disorders
3.14.1 Cimzia
3.14.2 Simponi
3.14.3 Soliris
3.14.4 Simulect
3.14.5 Actemra/RoActemra
3.14.6 Stelara
3.15 Other Monoclonal Antibodies (Non-Oncology/Autoimmune Disorders)
3.15.1 Other Leading Monoclonal Antibodies: Revenue Analysis, 2009
3.15.2 Other Monoclonal Antibodies: Sales Forecast, 2010-2025
3.16 Synagis
3.16.1 Synagis: Blockbuster Respiratory Disorder Treatment
3.16.2 Synagis Revenue Analysis, 2009
3.16.3 Synagis Market Forecast, 2010-2025
3.17 Lucentis
3.17.1 Lucentis: Antibody Fragment for Ophthalmology
3.17.2 Lucentis Revenue Analysis, 2009
3.17.3 Impact of Off-Label Avastin on Lucentis, 2010-2025
3.17.4 Lucentis Sales Forecast, 2010-2015
3.17.5 Lucentis Sales Forecast, 2015-2025
3.18 ReoPro
3.18.1 ReoPro: Cardiovascular Monoclonal Antibody Fragment
3.18.2 ReoPro Revenue Analysis, 2009
4. Leading National Markets for Monoclonal Antibody Therapies, 2010-2025
4.1 Regional Overview
4.1.1 Top Seven National Markets for Therapeutic Monoclonal Antibodies
4.2 The US Monoclonal Antibody Therapeutics Market
4.2.1 US Market in 2009
4.2.2 US Monoclonal Antibody Therapeutics Market, 2010-2025
4.3 The Japanese Monoclonal Antibody Therapeutics Market, 2010-2025
4.4 Leading European Monoclonal Antibody Therapeutics Markets, 2010-2025
4.5 Prospects for Therapeutic Monoclonal Sales in Emerging Markets, 2010-2025
5. The R&D Pipeline for Therapeutic Monoclonal Antibodies
5.1 Late-Stage Oncology Pipeline: Additional and Expanded Indications
5.1.1 Avastin
5.1.2 MabThera/Rituxan
5.1.3 Erbitux
5.1.4 Tysabri
5.2 Late-Stage Oncology Pipeline: Novel Entities
5.2.1 Farletuzumab (MORAb-003)
5.2.2 Figitumumab (CP-751871)
5.2.3 Galiximab
5.2.4 Ipilimumab
5.2.5 Ramucirumab (IMC 1121B)
5.2.6 Rencarex (WX-G250)
5.2.7 Zalutumumab (HuMax-EGFr)
5.2.8 Lumiliximab
5.2.9 Pertuzumab (R1273)
5.3 Late-Stage Autoimmune Disorder Pipeline: Additional and Expanded Indications
5.3.1 MabThera/Rituximab
5.3.2 Alemtuzumab for Multiple Sclerosis
5.4 Late-Stage Autoimmune Disorder Pipeline: New Entities
5.4.1 Benlysta (Belimumab)
5.4.2 Bapineuzumab (AAB-001)
5.4.3 Briakinumab (ABT-874)
5.4.4 Mycograb (Efungumab)
5.4.5 Ocrelizumab (R1594)
5.4.6 Otelixizumab (TRX4)
5.5 Other Monoclonal Antibodies Pipeline (Non-Oncology/Autoimmune Disorders)
5.5.1 Motavizumab
5.5.2 Lucentis
5.6 Early Stage Pipeline: Antibody Fragments
5.6.1 Development and Potential of Antibody Fragments
5.6.2 Ablynx' Nanobodies
5.6.3 Domantis' Domain Fragments
5.6.4 Genmab's UniBodies
5.6.5 ESBATech
5.6.6 Affimed's TandAbs and Flexibodies
5.6.7 Micromet's BiTE Antibody Platform
5.7 Early Stage Pipeline: Antibody-Drug Conjugates
5.7.1 The Future of Conjugated Antibodies
5.7.2 Seattle Therapeutics
5.7.3 ImmunoGen's TAP Technology
5.7.4 Neuradiab
6. Issues Affecting the Therapeutic Monoclonal Antibodies Industry and Market, 2010-2025
6.1 SWOT Analysis of the Therapeutic Monoclonal Antibodies Industry and Market
6.2 Commercial Strengths
6.2.1 Monoclonal Antibodies Have a Wide Range of Specific Targets
6.2.2 Chronic and Niche Diseases Generate High Revenues
6.2.3 Strong R&D Pipeline and Technological Advances, Including Manufacturing Improvements
6.2.4 Lower Risk of Adverse Events for Monoclonal Antibodies in Cancer Treatment
6.3 Commercial Weaknesses
6.3.1 Biosimilar Monoclonal Antibodies
6.3.2 Future Prospects for Biosimilar Monoclonal Antibodies
6.3.3 High Development Cost Limits Growth
6.3.4 Injections are the Main Mode of Administration
6.3.5 The Challenge of Immunogenicity Still Present
6.3.6 Competition is Fierce for Many Targets
6.3.7 Insufficient Efficacy of Anti-Cancer Monoclonal Antibodies as Monotherapy – a Concern
6.4 Commercial Opportunities
6.4.1 Increasing Cancer Prevalence – Expanding Treatment Populations
6.4.2 Autoimmune Disorder Prevalence and Under-Treatment
6.5 Commercial Threats
6.5.1 Reimbursement for Monoclonal Antibodies
6.5.2 High Profile Safety Cases Increase Regulatory Vigilance
6.5.3 Current Financial Limitations in Research and Development
7. Interviews with Experts on the Sector
7.1 Interview 1: Dr Janice M. Reichert
7.1.1 Major Challenges and Opportunities for Monoclonal Antibody Cancer Therapeutics
7.1.2 Side-Effects of Monoclonal Antibodies for Cancer
7.1.3 Future Developments and Pipelines
7.1.4 The Effect of Biosimilars
7.2 Interview 2: Dr David Blakey
7.2.1 The Future of Humanised and Fully-Human Antibodies
7.2.2 Therapeutic Antibody Fragments versus Full-Length Antibodies
7.2.3 Major Opportunities in Monoclonal Antibody Cancer Therapeutics
7.3 Interview 3: Dr Mark Cragg
7.3.1 How Do Monoclonal Antibodies Treat Cancer?
7.3.2 The Future of Different Monoclonal Antibody Types
7.3.3 Threats and Limitations
7.3.4 Opportunities
7.3.5 Will Side Effects Limit Growth?
7.3.6 Future Developments
8. Conclusions
8.1 Monoclonal Antibodies Account for Over 30% of Biologic Drug Revenues
8.2 Prospects for the Therapeutic Monoclonal Antibody Industry and Market
8.3 The Monoclonal Antibody R&D Pipeline
8.4 Recent High Growth Rates Set to Continue to 2015
8.5 Market Forecast from 2015 Onwards
8.6 Expansion into New Markets
8.7 Concluding Thoughts
List of Tables
Table 2.1 Monoclonal Antibody Technology, 2010
Table 2.2 Modes of Action for Therapeutic Monoclonal Antibodies, 2010
Table 2.3 Monoclonal Antibody Therapies Approved by US FDA, 1986-2003
Table 2.4 Monoclonal Antibody Therapies Approved by US FDA, 2003-2010
Table 3.1 Monoclonal Antibody Sales by Therapeutic Area, 2009
Table 3.2 Sales of Leading Therapeutic Monoclonal Antibodies, 2009
Table 3.3 Monoclonal Antibody Sales by Technology Type, 2009
Table 3.4 Sales of Monoclonal Antibodies by Antibody Type, 2009
Table 3.5 Therapeutic Monoclonal Antibody Market: Commercial Drivers & Restraints, 2010-2025
Table 3.6 Total Market, Oncology, Autoimmune Disorder and Other Monoclonal Antibodies: Sales Forecasts, 2010-2015
Table 3.7 Total Market, Oncology, Autoimmune Disorder and Other Monoclonal Antibodies: Sales Forecasts, 2016-2025
Table 3.8 Sales of Leading Anti-Cancer Monoclonal Antibodies, 2009
Table 3.9 Sales by Technology Type: Monoclonal Antibodies for Cancer Treatment, 2009
Table 3.10 Sales by Antibody Type: Monoclonal Antibodies for Cancer Treatment, 2009
Table 3.11 Sales by Marketing Company: Monoclonal Antibodies for Cancer Treatment, 2009
Table 3.12 Monoclonal Antibodies for Cancer Treatment: Commercial Drivers & Restraints, 2010-2025
Table 3.13 Avastin, Herceptin, MabThera/Rituxan, Erbitux & Total Oncology Monoclonal Antibodies: Sales Forecasts, 2010-2015
Table 3.14 Avastin, Herceptin, MabThera/Rituxan, Erbitux & Total Oncology Monoclonal Antibodies: Sales Forecasts, 2016-2025
Table 3.15 Avastin: Commercial Drivers & Restraints, 2010-2025
Table 3.16 Herceptin: Commercial Drivers & Restraints, 2010-2025
Table 3.17 MabThera/Rituxan Total: Oncology and Autoimmune Disorder Sales Forecasts, 2010-2015
Table 3.18 MabThera/Rituxan Total: Oncology and Autoimmune Disorder Sales Forecasts, 2016-2025
Table 3.19 MabThera/Rituxan: Commercial Drivers & Restraints, 2010-2025
Table 3.20 Erbitux: Commercial Drivers & Restraints, 2010-2025
Table 3.21 Sales of Leading Autoimmune Disorder Monoclonal Antibodies, 2009
Table 3.22 Sales by Technology Type: Autoimmune Disorder Monoclonal Antibodies, 2009
Table 3.23 Sales by Antibody Class: Autoimmune Disorder Monoclonal Antibodies, 2009
Table 3.24 Autoimmune Disorder Monoclonal Antibodies: Commercial Drivers & Restraints, 2010-2025
Table 3.25 Remicade, Humira, Tysabri, Cimzia & Total Autoimmune Disorder Monoclonal Antibodies: Sales Forecasts, 2010-2015
Table 3.26 Remicade, Humira, Tysabri, Cimzia & Total Autoimmune Disorder Monoclonal Antibodies: Sales Forecasts, 2016-2025
Table 3.27 Remicade: Commercial Drivers & Restraints, 2010-2025
Table 3.28 Approved Indications for Humira in the US, 2010
Table 3.29 Humira, Commercial Drivers & Restraints, 2010-2025
Table 3.30 Tysabri, Commercial Drivers & Restraints, 2010-2025
Table 3.31 Sales of Other Leading Monoclonal Antibodies (Non-Oncology/Autoimmune Disorders), 2009
Table 3.32 Synagis, Lucentis and Other Non-Oncology/Autoimmune Disorder Monoclonal Antibodies: Sales Forecasts, 2010-2015
Table 3.33 Synagis, Lucentis and Other Non-Oncology/Autoimmune Disorder Monoclonal Antibodies: Sales Forecasts, 2016-2025
Table 3.34 Lucentis: Commercial Drivers & Restraints, 2010-2025
Table 4.1 Leading National Markets for Therapeutic Monoclonal Antibodies, 2009
Table 4.2 Leading National Markets for Therapeutic Monoclonal Antibodies: Sales Forecasts, 2010-2015
Table 4.3 Leading National Markets for Therapeutic Monoclonal Antibodies: Sales Forecasts, 2016-2025
Table 5.1 R&D Pipeline for mAb Cancer Treatments: Additional Indications for Avastin, 2010
Table 5.2 R&D Pipeline for mAb Cancer Treatments: Additional Indications for Approved Drugs (Other than Avastin), 2010
Table 5.3 R&D Pipeline for mAb Cancer Treatments: Selected New Entities in Phase III/Regulatory Submission, 2010
Table 5.4 Autoimmune Disorder R&D Pipeline: Selected New Entities in Phase III, 2010
Table 5.5 Antibody Fragment R&D Pipeline R&D, 2010
Table 5.6 Antibody-Cytotoxic Drug Conjugate R&D Pipeline: Part 1, 2010
Table 5.7 Antibody-Cytotoxic Drug Conjugate R&D Pipeline: Part 2, 2010
Table 6.1 SWOT Analysis of the Monoclonal Antibody Therapeutics Sector, 2010-2025
Table 6.2 Monoclonal Antibody Targets, 2010
Table 6.3 Expected Patent Expiries for Therapeutic Monoclonal Antibodies
Table 6.4 Biosimilar Monoclonal Antibodies in Development, 2010
List of Figures
Figure 2.1 Antibody Structure
Figure 3.1 Therapeutic Monoclonal Antibodies: Market Shares by Therapeutic Area, 2009
Figure 3.2 Leading Therapeutic Monoclonal Antibodies: Market Shares, 2009
Figure 3.3 Therapeutic Monoclonal Antibodies: Market Shares by Technology Type, 2009
Figure 3.4 Therapeutic Monoclonal Antibodies: Market Shares by Antibody Class, 2009
Figure 3.5 Therapeutic Monoclonal Antibodies: Overall World Sales Forecast, 2010-2025
Figure 3.6 Oncology, Autoimmune Disorder and Other Monoclonal Antibodies: Sales Forecasts, 2010-2025
Figure 3.7 Oncology, Autoimmune Disorder and Other Monoclonal Antibodies: Market Shares, 2010-2025
Figure 3.8 Monoclonal Antibodies for Cancer Treatment: Market Shares, 2009
Figure 3.9 Monoclonal Antibodies for Cancer Treatment: Market Shares by Technology Type, 2009
Figure 3.10 Monoclonal Antibodies for Cancer Treatment: Market Shares by Antibody Class, 2009
Figure 3.11 Monoclonal Antibodies for Cancer Treatment: Market Shares by Company, 2009
Figure 3.12 Monoclonal Antibodies for Cancer Treatment: Sales Forecast, 2010-2025
Figure 3.13 Monoclonal Antibodies for Cancer Treatment: Sales Breakdowns by Brand, 2009, 2015, 2020 and 2025
Figure 3.14 Avastin: Sales Forecast, 2010-2025
Figure 3.15 Herceptin: Sales Forecast, 2010-2025
Figure 3.16 MabThera/Rituxan: Total, Oncology and Autoimmune Disorder Sales Forecasts, 2010-2025
Figure 3.17 Erbitux: Sales Forecast, 2010-2025
Figure 3.18 Autoimmune Disorder Monoclonal Antibodies: Market Shares, 2009
Figure 3.19 Autoimmune Disorder Monoclonal Antibodies: Market Shares by Technology Type, 2009
Figure 3.20 Autoimmune Disorder Monoclonal Antibodies: Market Shares by Antibody Class, 2009
Figure 3.21 Autoimmune Disorder Monoclonal Antibodies: Sales Forecast, 2010-2025
Figure 3.22 Autoimmune Disorder Monoclonal Antibodies: Sales Breakdowns by Brand, 2009, 2015, 2020 and 2025
Figure 3.23 Remicade: Sales Forecast, 2010-2025
Figure 3.24 Humira: Sales Forecast, 2010-2025
Figure 3.25 Xolair: Sales Forecast, 2010-2025
Figure 3.26 Total Non-Oncology/Autoimmune Disorder Monoclonal Antibodies: Sales Forecast, 2010-2025
Figure 3.27 Synagis: Sales Forecast, 2010-2025
Figure 3.28 Lucentis: Sales Forecast, 2010-2025
Figure 4.1 Leading National Markets for Therapeutic Monoclonal Antibodies: Market Shares, 2009
Figure 4.2 Leading National Markets for Therapeutic Monoclonal Antibodies: Market Shares, 2015
Figure 4.3 Leading National Markets for Therapeutic Monoclonal Antibodies: Market Shares, 2025