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Monoclonal Antibody Based Products - Global Strategic Business Report
Global Industry Analysts, Inc, October 2008, Pages: 527
This report analyzes the worldwide markets for Monoclonal Antibody Based Products in Millions of US$. The major product segments and application areas analyzed are Therapeutics, and Diagnostics, especially for cancer. The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, and Rest of world. Annual forecasts are provided for each region for the period of 2003 through 2015. The report profiles 123 companies including many key and niche players worldwide such as Amgen, Inc., BD Biosciences, Biogen Idec, CMC ICOS Biologics, Inc., Dendreon Corporation, Eli Lilly and Company, Genentech, Inc., Human Genome Sciences, Inc., Immunomedics, Johnson & Johnson, Centocor, Ortho Biotech Products, L.P., Medarex Inc, Medlmmune Inc, PDL BioPharma, Schering-Plough Corporation, Strategic Diagnostics Inc., and Wyeth Pharmaceuticals. Market data and analytics are derived from primary and secondary research. Company profiles are mostly extracted from URL research and reported select online sources.
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MONOCLONAL ANTIBODY BASED PRODUCTS
A GLOBAL STRATEGIC BUSINESS REPORT
CONTENTS
I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS
Study Reliability and Reporting Limitations I-1
Disclaimers I-2
Data Interpretation & Reporting Level I-2
Quantitative Techniques & Analytics I-3
Product Definitions and Scope of Study I-3
Therapeutics I-3
Cancer I-4
Other Therapeutic Mabs I-4
Diagnostics I-4
II. EXECUTIVE SUMMERY
1. Industry Overview II-1
World MAb-Based Products Market: A Profile II-1
MAb Market – Set for Significant Growth II-1
Therapeutic mAb Market – Principal Driving Force II-2
Development of New MAbs on a Fast Track II-2
Genomics Research Leads Way to New Monoclonal Antibodies II-3
Bright Outlook for MAbs II-3
Current and Future Analysis II-3
Regional Perspective II-3
Product Segment Perspective II-4
Competitive Scenario II-4
Intensifying Consolidation Activity II-4
Table 1: Major Acquisitions of Antibody-Focused Companies (
2005-2007) II-5
Table 2: Leading Players in the Worldwide Monoclonal
Antibody Therapy Market (2005): Percentage Breakdown of
Sales for Genentech/Roche, J & J/Schering Plough, Abbott
Laboratories, MedImmune, ImClone/BMS, and Eli Lilly
(includes corresponding Graph/Chart) II-5
Table 3: Leading Drugs in the Global Therapeutic Monoclonal
Antibodies Market (2006): Percentage Breakdown of Dollar
Sales for Remicade, Rituxan, Herceptin, Avastin, Humira,
Erbitux, Synagis, Xolair and Others (includes corresponding
Graph/Chart) II-6
Table 4: Monoclonal Antibody Based Products Market (2004):
Percentage Breakdown of Leading Manufacturers by Sales for
Genentech, Johnson & Johnson, Roche, Abbott, MedImmune,
Schering Plough, Eli Lilly, and Others (includes
corresponding Graph/Chart) II-6
Table 5: Monoclonal Antibody Based Products Market (2004):
Percentage Breakdown of Leading Drugs by Sales for Remicade,
Rituxan, Herceptin, Synagis, Humira, Avastin, ReoPro,
Erbitux, Xolair, and Others (includes corresponding
Graph/Chart) II-6
Table 6: Leading Products in the Global Oncology Monoclonal
Antibodies Market (2008E): Percentage Share Breakdown of
Sales for Avastin, Herceptin, Rituxan, Erbitux, and Others
(includes corresponding Graph/Chart) II-7
Table 7: Leading Products in the Global Antibody-Based
Anti-Inflammatory Market (2006): Percentage Share Breakdown
of Revenues for Enbrel, Remicade, Humira, and Others
(includes corresponding Graph/Chart) II-7
Therapeutic Antibodies in the Market II-7
Drug Developers Trying to Break the Shackles II-8
Rituximab Vs. Epratuzumab II-8
A Revolution Not too Far II-9
Milestones in Development of MAbs II-9
Focus on Unmet Medical Needs in the Emerging Markets II-9
2. Industry Analysis II-10
Evolution of Monoclonal Antibodies – A Historical Journey II-10
Trends and Issues II-11
Shift Towards Humanized and Fully Human Antibodies II-11
Ageing Baby Boomers Spur MAbs Growth II-11
Non-Existent Generic Competition Favors MAb Market II-11
Partnerships and Collaborations Spark Increase in Profit Margins II-12
Pharma Majors & CMOs Augment Investment in Mab Production II-12
Rising Number of MAbs Under Clinical Trials II-12
Select Clinical Trials for Monoclonal Antibodies II-13
Major Monoclonal Antibodies in Phase III Trials Across the
World II-14
High Costs Impede MAbs Penetration II-14
Opportunities in Technology Development II-15
Advancements & Challenges in Antibody Production Processes II-15
Increasing Demand for Protein A in Mab Manufacturing II-15
FCA- A Major Cause for Discomfort in Mice II-16
Innovations to Drive Growth in Anti-Ovarian Cancer Drugs Market II-16
Rising Incidence of NHL to Drive Monoclonal Antibody Drug Market II-16
3. Product Overview II-17
Immune System: Natural Defenders II-17
Human Antibodies II-17
Antibodies Offer Natural Immunity II-17
Induction of The Immune Process II-17
Mechanism of Action II-17
Polyclonal and Monoclonal Antibodies II-18
Production of Monoclonal Antibodies II-18
Traditional Methods II-18
The Hybridoma Technology II-18
Separation and Purification of Monoclonals II-18
Factors Impacting Production of MAbs II-19
Types of Monoclonal Antibodies II-19
Table 8: Worldwide MAb Market by Product Type (2008):
Percentage Share Breakdown for Chimeric, Humanized, Human and
Murine (includes corresponding Graph/Chart) II-19
Murine Monoclonal Antibodies II-19
Humanized Antibodies/ CDR Grafted Antibodies II-20
Murine Vs Human Monoclonal Antibodies II-20
Chimeric Antibodies: Show Lesser Antigenicity II-21
Fully Human Antibodies II-21
Bispecific Antibodies II-21
Certain Limitations Do Exist II-21
Advantages of MAbs II-22
Advantages and Limitations of MAb Technologies II-22
4. Diagnostic Applications of Monoclonal Antibodies II-23
Monoclonal Antibody Based Diagnostics II-23
Immunodiagnostics II-23
Monoclonals Used as Targeting Agents II-23
Radio labeled Monoclonal Antibodies for Diagnostic Imaging II-23
The Pros and Cons of MAb-Based Immunoconjugates II-24
Cytogen: The First to Introduce A Monoclonal Antibody-based
Cancer Agent II-24
NeoProbe’s Radioimmunogzuided Surgery II-24
Cancer II-25
A Historical Overview II-25
Initial Hiccups II-25
Tumor Markers II-25
5. Monoclonal Antibody-Based Therapeutics II-26
Evolution of Therapeutic Antibody Products II-26
Advantages of Therapeutic Monoclonal Antibodies II-26
Current Scenario in Monoclonal Antibody Therapeutics Market II-27
Table 9: Monoclonal Antibody Market by Therapy Area (2004 &
2010): Percentage Breakdown by Sales for Oncology, Arthritis,
Immune & Inflammatory Disorders, Infectious Diseases,
Cardiovascular, Respiratory, Ophthalmology, and CNS (includes
corresponding Graph/Chart) II-27
Cancer Therapeutics II-28
Monoclonal Antibodies Offer Hope Against Cancer II-28
Monoclonal Antibodies Approved For Cancer Treatment in the
World II-28
Monoclonal Antibody Cancer Therapies Under Development II-29
Antibody Therapies for Cancer II-29
Cancer: A Serious Issue and Plaguing Illness Worldwide II-30
Breast Cancer: The Most Common Form of Cancer in American Women II-30
Breast Cancer - Treatment Options II-30
Monoclonal Antibodies Against NHL II-31
Monoclonal Antibodies Against Ovarian Cancer II-31
MAb Immunotherapy – Effective for Residual Ovarian Cancer II-31
Melanoma II-31
Immunologic Effector Functions II-32
Colorectal Cancer: Rising Incidence II-32
Panorex: The First Cancer Therapeutic in the Market II-32
Myeloid Leukemia II-32
6. Other Therapeutic Monoclonal Antibodies II-34
Therapeutic Monoclonal Antibody Drugs and Applications II-34
MAbs used in Clinical Field II-34
Inflammation Therapeutics II-34
Inflammation II-34
Asthma: A Chronic Affliction II-35
Autoimmune Diseases II-35
What Goes Wrong II-35
Intervention Better Than Prevention II-36
Some Autoimmune Diseases II-36
Multiple Sclerosis II-36
Crohn’s Disease II-37
Rheumatoid Arthritis II-37
Organ Transplantation II-37
Biology of Transplantation II-37
Types of Transplants II-37
Autografts II-37
Syngeneic Transplants II-38
Allografts II-38
Xenografts II-38
Follow-up Treatment II-38
Products to Counter Rejection II-38
OKT3: A Monoclonal Already in the Market II-38
Infectious Diseases II-39
Sepsis II-39
A Rapid Process II-39
Gram Negative Bacteria are the Causative Agents II-39
A Retrospect II-40
Monoclonal Antibodies and Septic Shock II-40
HIV/AIDS II-40
What is AIDS? II-40
Global Statistics II-41
HIV/AIDS Testing II-41
Monoclonal Antibodies and HIV II-41
Cardiovascular II-41
Cardiovascular Diseases are Fatal II-41
Treatment Options II-42
Causes of Cardiovascular Diseases II-42
ReoPro II-42
7. Regulation Impacting The Industry II-43
Regulations in the U.S II-43
Approval: A Laborious Process II-43
Clinical Trials II-43
Orphan Drug Status II-44
8. Research and Development Activities II-45
Rituxan and Herceptin from Genentech II-45
FuCell hybridomas II-45
Test-tube MAbs/ Phase Display Library II-45
Rituxan for Cancer Treatment II-45
GenMAb Develops Fully Human Antibodies II-46
Protein Design Labs Licenses Trioma II-46
Protein Design Labs’ Innovative Technology II-46
9. Product Launches and Developments II-47
Amgen Introduces Vectibix II-47
Trevigen Introduces Mouse Monoclonal Antibody II-47
UCB Receives FDA Approval for Cimzia® II-47
GSK’s Tykerb Receives FDA Approval II-47
Dr. Reddy’s Introduces Reditux™ II-48
Morphotek Receives Orphan Drug Status for MORAb - 009 mAb II-48
Biocon Introduces BIOMab Monoclonal Antibody II-48
Biotest AG and AERES Biomedical Develop BT- 062 II-48
Genentech Launches Avastin II-48
Biotest Unveils Intratect® II-48
Genentech Introduces Xolair II-49
Genentech Unveils Raptiva II-49
Corixa Presents BEXXAR II-49
IGEN Launches Monoclonal Antibody Therapies II-49
MAb Against Pseudomonas Aeruginosa II-49
Wyeth Introduces Mylotarg II-49
10. Recent Industry Activity II-50
EUSA Pharma to Take Over Cytogen II-50
AVANIR Inks a Definitive Agreement to Divest Anthrax Antibodies II-50
Access Pharmaceuticals Acquires Somanta Pharmaceuticals II-51
Daiichi Sankyo to Take Over U3 Pharma II-51
IMUC Completes Molecular Antibody Technology Acquisition II-51
Callisto Merger Corporation Merges with Celldex Therapeutics II-51
Genmab Enters into Antibody Research Collaboration with Pepscan II-52
BTI Enters into an Agreement with Raven II-52
Arana and Kyowa Hakko Sign Agreement to Jointly Develop ART 104 II-52
Eusa Sells Antibody Research Business II-53
CG Therapeutics and UoW Agree for Joint Monoclonal Antibody
Program II-53
Raven and CMC ICOS Collaborate to Advance RAV18 II-53
SDI to Develop mAbs for SAIC-F and NCI II-53
HGS Reacquires Rights for TRAIL Receptor Antibodies II-54
CAT Grants Exclusive Worldwide License of CAT-213 to iCo II-54
Morphotek and HMI in Licensing Agreement II-54
Amgen Enters into Licensing Agreement with Kyowa Hakko II-54
Dyax and Sanofi-Aventis Sign Agreements II-55
HGS Enters into Antibody Collaboration Agreement with Xencor II-55
CSL Limited Inks a Collaboration Agreement with Celltrion II-56
Eisai Acquires Morphotek II-56
Astellas US Holding Takes Over Agensys II-57
Astrazeneca Creates New Integrated Business Unit – Medimmune II-57
Genentech Acquires Tanox II-58
Biotest Acquires Assets of Nabi Biologics II-58
CMC Acquires ICOS Biologics Operation II-58
Roche Takes Over THP II-58
GTC and LFB Commence CD20 Monoclonal Antibody Development II-59
Regeneron Grants a Non-Exclusive License to AstraZeneca II-59
OncoMed Enters into Monoclonal Antibody Deal with GSK II-59
BioArctic and Eisai Announce Licensing Agreement II-60
MediGene Collaborates with Celltrion II-60
Amgen Inks Collaboration and License Pact with Daiichi Sankyo II-60
CMC Biopharmaceuticals Inks Agreement with Morphotek II-60
CMC Biopharmaceuticals Inks Agreement with Biotest II-61
Eli Lilly Collaborates with MacroGenics II-61
Genentech Inks Global Licensing Agreement with Seattle Genetics II-61
VaxGen to Merge with Raven Biotechnologies II-61
Abeome Enters into Distribution Agreement with Millipore II-62
Compugen Forays into Monoclonal Antibody Business II-62
MilleGen and LFB Enter into Partnership Agreement II-62
Favrille Acquires Diversa’s Anti-CD20 Monoclonal Antibodies II-63
Kirin Inks Licensing Agreement with Astellas Pharma II-63
Viropro in Partnership with NRC-BRI II-63
Merck Acquires Abmaxis II-64
Micromet Merges with CancerVax II-64
Tanabe & Janssen Team Up to Develop Anti-TNF Alpha Monoclonal
Antibody II-64
Intercell Enters into Strategic Alliance with Kirin II-64
Xencor Extends R&D Collaboration with Roche II-65
MedImmune Inks Licensing Agreement with Japan Tobacco II-65
Immunomedics Enters into an Agreement with UCB for Epratuzumab II-65
Akorn and Serum Institute Enter into Development and
Distribution Agreement II-66
FDA Clears IND for CYT-500 Monoclonal Antibody from Cytogen II-66
LSP Acquires Global License for Monoclonal Antibodies from
Ludwig Institute II-66
Seattle Genetics in Agreement with Laureate to Manufacture
Monoclonal Antibody Drug Candidates II-67
EU Grants Orphan Drug Designation to GPC’s Anticancer
Monoclonal Antibody II-67
Laureate Collaborates with Bradmer on Neuradiab Monoclonal
Antibody for Cancer Treatment II-68
Amgen Takes Over Abgenix II-68
Celera and Medarex in Strategic Alliance for Developing Human
Monoclonal Antibody Therapeutics II-68
UCB Collaborates with Immunomedics II-68
Crucell Collaborates with DSM for Monoclonal Antibody
Licensing Business II-69
Roche Licenses Rabbit Monoclonal Antibody Technology from
Epitomics II-69
BioGenex Receives FDA Pre-Market Approval for InSite™
Monoclonal Antibody II-69
Upstate Bags Marketing Rights for Anti-ZAP-70 Monoclonal Antibody II-69
XOMA Bags NIAID Contract to Develop Anti-Botulinum Neurotoxin
Monoclonal Antibodies II-70
HGS Bags Two-Phase Contract for ABthrax™ Mab from the US
Government II-70
Medarex and PharmAthene Receive Funding for Development of
Valortim™ II-70
UCB Collaborates with Millenium II-71
MorphoSys Acquires Two Antibody Technology Companies II-71
Tanabe Seiyaku and Remicade Sign Addendum II-71
Abgenix Receives Royalty from Human Genome II-71
Amgen Acquires Tularik II-71
Sunesis Pharmaceuticals Collaborates with Biogen Idec II-71
H3 Pharma Inc. Enters into a Manufacturing Agreement with DSM
Biologics II-72
EMBL and Abnova Inks Collaboration Agreement II-72
AstraZeneca and CAT in Five-Year Strategic Alliance for
Monoclonal Antibody Research II-72
UCB Acquires Celltech II-72
ImmunoGen Signs Licensing Agreement with Biogen II-73
Lonza Inks MAbs Manufacturing and Supply Agreement with NovImmune II-73
Avanir and Peregrine Sign License Agreement II-73
BioVest Concludes Agreement with Bioventix II-73
Roche to Set Up Two Manufacturing Facilities in Switzerland II-73
XTL Biopharm Bags European patent for Human Monoclonal Anti Body II-73
MBL and Medarex Bags FDA approval for CDA-1 Phase I Trials II-74
Health Canada Approves HUMIRA II-74
11. Industry Activity in the Recent Past (2000-2003) II-75
CAT Signs Licensing Agreement with Micromet II-75
CAT Enters into Agreement with Genzyme II-75
Medarex and Avlon Enter into Agreement II-75
Micromet, Enzon and CAT Sign Cross-License Agreement II-75
Xerion and CAT Enter into Agreement II-75
Genetastix and Nissho Enter into Agreement II-75
InNexus and Corixa Enter into Agreement II-76
Abbott Collaborates with LigoCyte II-76
CAT Acquires Drug Royalty Corporation II-76
CAT and Amrad Join Hands for Research II-76
IDECs Receives FDA Approval for Zevalin II-76
Medarex Enters into Research Alliance with Seattle Genetics II-76
Dow, Epicyte and Centocor Join Forces to Develop Monoclonal
Antibody II-77
Eos, Medarex and Biosite in Alliance for Cancer Treatment II-77
Imgenex forms Alliance with GMO II-77
CAT and Elan Enter into Strategic Alliance II-77
Bioinvent International Enters into Agreement with Novo
Nordisk for Drug Discovery Research II-77
Epicyte and Dow Chemical Enter into Agreement II-78
Rockland Announces the Completion of Laboratory Expansion II-78
Roche’s MAbThera Receives Approval in Japan II-78
Aviva Launches Manufacturing and Marketing Operations II-78
ICOS and Seattle Enters into Joint Development and
Manufacturing Agreement II-78
Medarex and Corixa Team-up to Develop Human Monoclonal Antibodies II-78
Taisho Enters into Research Alliance with IDEC II-78
PDL Signs Agreement with InterMune II-79
ProMetic Signs Agreement with Integrated Protein II-79
Medarex Signs Agreement with ZynloGenetics II-79
CAT Joins Hands with GD. Searle II-79
Medarex and MedImmune Enter into Antibody Research Agreement II-79
Lonza Signs Agreement with ImClone Systems II-79
MedImmune and Alkermes Enter into Agreement II-80
GTC and Abgenix Enter into Production Agreement II-80
Genzyme Transgenics Expands Agreement with Centocor II-80
PDL and InterMune Enter into an Agreement II-80
12. Focus on Select Global Players II-81
Amgen, Inc. (US) II-81
BD Biosciences (US) II-81
Biogen Idec Inc (US) II-82
Biotest AG (Germany) II-82
CMC ICOS Biologics, Inc. II-83
Dendreon Corporation (US) II-83
Elan Corporations Plc (Ireland) II-83
Eli Lilly and Company (US) II-84
Genentech, Inc. (USA) II-84
Human Genome Sciences, Inc. (US) II-85
Immunomedics (US) II-85
Johnson & Johnson (US) II-86
Centocor (US) II-86
Ortho Biotech Products, L.P. (US) II-87
Medarex, Inc. (US) II-87
MedImmune, Inc. (US) II-87
PDL BioPharma (US) II-88
Schering-Plough Corporation (US) II-88
Strategic Diagnostics Inc (US) II-89
UCB Group (Belgium) II-89
Wyeth Pharmaceuticals (US) II-89
13. Global Market Perspective II-91
Table 10: World Recent Past, Current & Future Market Analysis
for Monoclonal Antibody Based Products by Geographic Region –
US, Canada, Japan, Europe, and Rest of World Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2003 through 2010 (includes corresponding Graph/Chart) II-91
Table 11: World Long-term Projections for Monoclonal Antibody
Based Products by Geographic Region – US, Canada, Japan,
Europe, and Rest of World Independently Analyzed with Annual
Sales Figures in US$ Million for Years 2011 through 2015
(includes corresponding Graph/Chart) II-92
Table 12: World 10-Year Perspective for Monoclonal Antibody
Based Products by Geographic Region – Percentage Breakdown of
Dollar Sales for US, Canada, Japan, Europe, and Rest of World
Markets for Years 2003, 2008 & 2012 (includes corresponding
Graph/Chart) II-93
Table 13: World Recent Past, Current & Future Market Analysis
for Therapeutic Monoclonal Antibody Based Products by
Geographic Region – US, Canada, Japan, Europe, and Rest of
World Independently Analyzed with Annual Sales Figures in US$
Million for Years 2003 through 2010 (includes corresponding
Graph/Chart) II-94
Table 14: World Long-term Projections for Therapeutic
Monoclonal Antibody Based Products by Geographic Region – US,
Canada, Japan, Europe, and Rest of World Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2011 through 2015 (includes corresponding Graph/Chart) II-95
Table 15: World 10-Year Perspective for Monoclonal Antibody
Based Products by Geographic Region – Percentage Breakdown of
Dollar Sales for US, Canada, Japan, Europe, and Rest of World
Markets for Years 2003, 2008 & 2012 (includes corresponding
Graph/Chart) II-96
Table 16: World Long-term Projections for Therapeutic
Monoclonal Antibody Based Products by Segment – Cancer and
Other Therapeutics Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2003 through 2010 (includes
corresponding Graph/Chart) II-97
Table 17: World Long-term Projections for Therapeutic
Monoclonal Antibody Based Products by Segment – Cancer and
Other Therapeutics Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2011 through 2015 (includes
corresponding Graph/Chart) II-97
Table 18: World 10-Year Perspective for Therapeutic Monoclonal
Antibody Based Products by Segments – Percentage Breakdown of
Dollar Sales for Cancer and Other Therapeutics Markets for
Years 2003, 2008 & 2012 II-98
Table 19: World Recent Past, Current & Future Market Analysis
for Cancer Therapeutic Monoclonal Antibody Based Products by
Geographic Region – US, Canada, Japan, Europe, and Rest of
World Independently Analyzed with Annual Sales Figures in US$
Million for Years 2003 through 2010 (includes corresponding
Graph/Chart) II-99
Table 20: World Long-term Projections for Cancer Therapeutic
Monoclonal Antibody Based Products by Geographic Region – US,
Canada, Japan, Europe, and Rest of World Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2011 through 2015 (includes corresponding Graph/Chart) II-100
Table 21: World 10-Year Perspective for Cancer Therapeutic
Monoclonal Antibody Based Products by Geographic Region –
Percentage Breakdown of Dollar Sales for US, Canada, Japan,
Europe, and Rest of World Markets for Years 2003, 2008 & 2012
(includes corresponding Graph/Chart) II-101
Table 22: World Recent Past, Current & Future Market Analysis
for Other Therapeutic Monoclonal Antibody Based Products by
Geographic Region – US, Canada, Japan, Europe, and Rest of
World Independently Analyzed with Annual Sales Figures in US$
Million for Years 2003 through 2010 (includes corresponding
Graph/Chart) II-102
Table 23: World Long-term Projections for Other (*)
Therapeutic Monoclonal Antibody Based Products by Geographic
Region – US, Canada, Japan, Europe, and Rest of World
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2011 through 2015 (includes corresponding
Graph/Chart) II-103
Table 24: World 10-Year Perspective for Other Therapeutic
Monoclonal Antibody Based Products by Geographic Region –
Percentage Breakdown of Dollar Sales for US, Canada, Japan,
Europe and Rest of World Markets for Years 2003, 2008 & 2012
(includes corresponding Graph/Chart) II-104
Table 25: World Recent Past, Current & Future Market Analysis
for Diagnostic Monoclonal Antibody Based Products by
Geographic Region – US, Canada, Japan, Europe, and Rest of
World Independently Analyzed with Annual Sales Figures in US$
Million for Years 2003 through 2010 (includes corresponding
Graph/Chart) II-105
Table 26: World Long-term Projections for Diagnostic
Monoclonal Antibody Based Products by Geographic Region – US,
Canada, Japan, Europe, and Rest of World Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2011 through 2015 (includes corresponding Graph/Chart) II-106
Table 27: World 10-Year Perspective for Diagnostic Monoclonal
Antibody Based Products by Geographic Region – Percentage
Breakdown of Dollar Sales for US, Canada, Japan, Europe and
Rest of World Markets for Years 2003, 2008 & 2012 (includes
corresponding Graph/Chart) II-107
III. MARKET
1. The Untied States III-1
A.Market Analysis III-1
Global Hub of MAbs III-1
Approved Therapeutic Antibodies in the US (As of 2007) III-1
Therapeutic Monoclonal Antibodies Market – An Overview III-2
New Heights f or US Cancer Therapeutics III-2
Competitive Landscape III-2
Leading Products III-3
Table 28: Leading Products in the US Therapeutic
Monoclonal Antibodies Market (2007): Percentage Breakdown
of Revenues for Remicade, Avastin, Rituxan, Herceptin,
Synagis, Lucentis, Erbitux, and Others (includes
corresponding Graph/Chart) III-3
Table 29: Leading Players in the US Therapeutic Monoclonal
Antibodies Market (2007): Percentage Share Breakdown of
Revenues for Genentech Inc, Centocor, MedImmune, Bristol
Meyers Squibb, Amgen, Hoffman-La Roche, and Others
(includes corresponding Graph/Chart) III-4
Focus on Key Players III-4
Amgen, Inc. III-4
BD Biosciences III-5
Biogen Idec. III-5
CMC ICOS Biologics, Inc. III-6
Dendreon Corporation III-6
Eli Lilly and Company III-7
Genentech, Inc. III-7
Human Genome Sciences III-7
Immunomedics III-8
Johnson & Johnson III-9
Centocor III-9
Ortho Biotech Products, L.P. III-9
Medarex, Inc. III-9
MedImmune, Inc III-10
PDL BioPharma III-11
Schering-Plough Corporation III-11
Strategic Diagnostics Inc III-11
Wyeth Pharmaceuticals III-12
Product launches III-12
Strategic Developments III-14
B.Market Analytics III-33
Table 30: US Recent Past, Current & Future Analysis for
Monoclonal Antibody Based Products by Segment – Therapeutics
(Cancer and Others), and Diagnostics Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2003 through 2010 (includes corresponding Graph/Chart) III-33
Table 31: US Long-term Projections for Monoclonal Antibody
Based Products by Segment – Therapeutics (Cancer and
Others), and Diagnostics Markets Independently Analyzed with
Annual Sales Figures in US$ Million for Years 2011 through
2015 (includes corresponding Graph/Chart) III-33
Table 32: US 10-Year Perspective for Monoclonal Antibody
Based Products by Segment – Percentage Breakdown of Dollar
Sales for Therapeutics (Cancer and Others),and Diagnostics
Markets for 2003, 2008 & 2012 (includes corresponding
Graph/Chart) III-34
2. Canada III-35
A.Market Analysis III-35
Strategic Developments III-35
B.Market Analytics III-36
Table 33: Canadian Recent Past, Current & Future Analysis
for Monoclonal Antibody Based Products by Segment
–Therapeutics (Cancer and Others), and Diagnostics Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2003 through 2010 (includes corresponding
Graph/Chart) III-36
Table 34: Canadian Long-term Projections for Monoclonal
Antibody Based Products by Segment – Therapeutics (Cancer
and Others), and Diagnostics Markets Independently Analyzed
with Annual Sales Figures in US$ Million for Years 2011
through 2015 (includes corresponding Graph/Chart) III-36
Table 35: Canadian 10-Year Perspective for Monoclonal
Antibody Based Products by Segment – Percentage Breakdown of
Dollar Sales for Therapeutics (Cancer and Others),and
Diagnostics Markets for 2003, 2008 & 2012 (includes
corresponding Graph/Chart) III-37
3. Japan III-38
A.Market Analysis III-38
Strategic Developments III-38
B.Market Analytics III-41
Table 36: Japanese Recent Past, Current & Future Analysis
for Monoclonal Antibody Based Products by Segment
–Therapeutics (Cancer and Others), and Diagnostics Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2003 through 2010, (includes corresponding
Graph/Chart) III-41
Table 37: Japanese Long-term Projections for Monoclonal
Antibody Based Products by Segment – Therapeutics (Cancer
and Others), and Diagnostics Markets Independently Analyzed
with Annual Sales Figures in US$ Million for Years 2011
through 2015 (includes corresponding Graph/Chart) III-41
Table 38: Japanese 10-Year Perspective for Monoclonal
Antibody Based Products by Segment – Percentage Breakdown of
Dollar Sales for Therapeutics (Cancer and Others),and
Diagnostics Markets for 2003, 2008 & 2012 (includes
corresponding Graph/Chart) III-42
4. Europe III-43
A.Market Analysis III-43
Biotechnology and Pharmacy Research III-43
Monoclonal Antibody Based Products Market in Europe III-43
European Therapeutic MAbs Market – An Overview III-43
Approved Therapeutic Antibodies in Europe as of 2004 III-43
Need to Reduce Complexities, Time & Cost of mAb Development III-44
Information Dissemination – Critical for Enhancing mAb Sales III-44
Monoclonal Antibody Immunotherapy for NHL III-44
MabThera – A Dominant MAb Drug in Europe III-44
Emerging Radioimmunotherapy Products III-45
Challenges for New Drug Development III-45
B.Market Analytics III-46
Table 39: European Recent Past, Current & Future Analysis
for Monoclonal Antibody Based Products by Geographic Region
– France, Germany, Italy, UK & Rest of Europe Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2003 through 2010 (includes corresponding
Graph/Chart) III-46
Table 40: European Long-term Projections for Monoclonal
Antibody Based Products by Geographic Region – France,
Germany, Italy, UK & Rest of Europe Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2011 through 2015 (includes corresponding Graph/Chart) III-46
Table 41: European Recent Past, Current & Future Analysis
for Monoclonal Antibody Based Products by Segment –
Therapeutics (Cancer and Others), and Diagnostics Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2003 through 2010 (includes corresponding
Graph/Chart) III-47
Table 42: European Long-term Projections for Monoclonal
Antibody Based Products by Segment – Therapeutics (Cancer
and Others), and Diagnostics Markets Independently Analyzed
with Annual Sales Figures in US$ Million for Years 2011
through 2015 (includes corresponding Graph/Chart) III-47
Table 43: European 10-Year Perspective for Monoclonal
Antibody Based Products by Geographic Region –Percentage
Breakdown of Dollar Sales for France, Germany, Italy, The
UK, and Rest of Europe for Years 2003, 2008 & 2012 (includes
corresponding Graph/Chart) III-48
Table 44: European 10-Year Perspective for Monoclonal
Antibody Based Products by Segment – Percentage Breakdown of
Dollar Sales for Therapeutics (Cancer and Others),and
Diagnostics Markets for 2003, 2008 & 2012 (includes
corresponding Graph/Chart) III-49
4a. France III-50
A.Market Analysis III-50
Strategic Developments III-50
B.Market Analytics III-52
Table 45: French Recent Past, Current & Future Analysis for
Monoclonal Antibody Based Products by Segment –Therapeutics
(Cancer and Others), and Diagnostics Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2003 through 2010 (includes corresponding Graph/Chart) III-52
Table 46: French Long-term Projections for Monoclonal
Antibody Based Products by Segment – Therapeutics (Cancer
and Others), and Diagnostics (Cancer and Others) Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2011 through 2015 (includes corresponding
Graph/Chart) III-52
Table 47: French 10-Year Perspective for Monoclonal Antibody
Based Products by Segment – Percentage Breakdown of Dollar
Sales for Therapeutics (Cancer and Others), and Diagnostics
Markets for 2003, 2008 & 2012 (includes corresponding
Graph/Chart) III-53
4b. Germany III-54
A.Market Analysis III-54
Biotest AG- A Key Player III-54
Product Launches III-54
Strategic Developments III-55
B.Market Analytics III-57
Table 48: German Recent Past, Current & Future Analysis for
Monoclonal Antibody Based Products by Segment –Therapeutics
(Cancer and Others), and Diagnostics Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2003 through 2010 (includes corresponding Graph/Chart) III-57
Table 49: German Long-term Projections for Monoclonal
Antibody Based Products by Segment – Therapeutics (Cancer
and Others), and Diagnostics Markets Independently Analyzed
with Annual Sales Figures in US$ Million for Years 2011
through 2015 (includes corresponding Graph/Chart) III-57
Table 50: German 10-Year Perspective for Monoclonal Antibody
Based Products by Segment – Percentage Breakdown of Dollar
Sales for Therapeutics (Cancer and Others),and Diagnostics
Markets for 2003, 2008 & 2012 (includes corresponding
Graph/Chart) III-58
4c. Italy III-59
Market Analysis III-59
Table 51: Italian Recent Past, Current & Future Analysis for
Monoclonal Antibody Based Products by Segment –Therapeutics
(Cancer and Others), and Diagnostics Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2003 through 2010 (includes corresponding Graph/Chart) III-59
Table 52: Italian Long-term Projections for Monoclonal
Antibody Based Products by Segment – Therapeutics (Cancer
and Others), and Diagnostics Markets Independently Analyzed
with Annual Sales Figures in US$ Million for Years 2011
through 2015 (includes corresponding Graph/Chart) III-60
Table 53: Italian 10-Year Perspective for Monoclonal
Antibody Based Products by Segment – Percentage Breakdown of
Dollar Sales for Therapeutics (Cancer and Others),and
Diagnostics Markets for 2003, 2008 & 2012 (includes
corresponding Graph/Chart) III-61
4d. The United Kingdom III-62
A.Market Analysis III-62
Monoclonal Antibodies Market – An Overview III-62
Strategic Developments III-62
Product Launches III-64
B.Market Analytics III-65
Table 54: UK Recent Past, Current & Future Analysis for
Monoclonal Antibody Based Products by Segment –Therapeutics
(Cancer and Others), and Diagnostics Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2003 through 2010 (includes corresponding Graph/Chart) III-65
Table 55: UK Long-term Projections for Monoclonal Antibody
Based Products by Segment – Therapeutics (Cancer and
Others), and Diagnostics Markets Independently Analyzed with
Annual Sales Figures in US$ Million for Years 2011 through
2015 (includes corresponding Graph/Chart) III-65
Table 56: UK 10-Year Perspective for Monoclonal Antibody
Based Products by Segment – Percentage Breakdown of Dollar
Sales for Therapeutics (Cancer and Others), and Diagnostics
Markets for 2003, 2008 & 2012 (includes corresponding
Graph/Chart) III-66
4e. Rest of Europe III-67
A.Market Analysis III-67
Key Players III-67
Elan Corporations Plc (Ireland) III-67
UCB Group (Belgium) III-67
Strategic Developments III-68
B.Market Analytics III-71
Table 57: Rest of Europe Market for Monoclonal Antibody
Based Products – Recent Past, Current & Future Analysis by
Product Segment for Therapeutics (Cancer and Others), and
Diagnostics Markets Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2003 through 2010 (includes
corresponding Graph/Chart) III-71
Table 58: Rest of Europe Long-term Projections for
Monoclonal Antibody Based Products by Segment – Therapeutics
(Cancer and Others), and Diagnostics Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2011 through 2015 (includes corresponding Graph/Chart) III-72
Table 59: Rest of Europe 10-Year Perspective for Monoclonal
Antibody Based Products by Segment – Percentage Breakdown of
Dollar Sales for Therapeutics (Cancer and Others),and
Diagnostics Markets for 2003, 2008 & 2012 (includes
corresponding Graph/Chart) III-73
5. Rest of World III-74
A.Market Analysis III-74
Australia III-74
India III-74
Strategic Developments III-74
B.Market Analytics III-76
Table 60: Rest of World Market for Monoclonal Antibody Based
Products - Recent Past, Current & Future Analysis by Product
Segment for Therapeutics (Cancer and Others), and
Diagnostics Markets Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2003 through 2010 (includes
corresponding Graph/Chart) III-76
Table 61: Rest of World (*) Market for Monoclonal Antibody
Based Products - Long-term Projections by Product Segment
for Therapeutics (Cancer and Others), and Diagnostics
Markets Independently Analyzed with Annual Sales Figures in
US$ Million for Years 2011 through 2015 (includes
corresponding Graph/Chart) III-76
Table 62: Rest of World 10-Year Perspective for Monoclonal
Antibody Based Products by Segment - Percentage Breakdown of
Dollar Sales for Therapeutics (Cancer and Others),and
Diagnostics Markets for 2003, 2008 & 2012 (includes
corresponding Graph/Chart) III-77
IV. COMPETITIVE LANDSCAPE
The Companies Mentioned inside this report include:
Abgenix, Inc (USA)
Altarex Corporation (Canada)
American Diagnostic Corporation (USA)
American Diagnostica, Inc (USA)
American Qualex (USA)
Amgen, Inc (USA)
Antibodies, Inc (USA)
Beckman Coulter, Inc (USA)
Becton, Dickinson & Company (USA)
BD Biosciences (USA)
Bellco Glass, Inc (USA)
Berna Biotech AG (Switzerland)
Binding Site Ltd, The (UK)
Bioclone Australia Pty, Ltd (Australia)
Biogen Idec, Inc (USA)
BioGenex Laboratories, Inc (USA)
Bioinvent International AB (Sweden)
BioMerieux SA (France)
Biomerieux, Inc (USA)
Biomira, Inc (Canada)
Biomira USA, Inc (USA)
Biosource International, Inc (USA)
Biotest AG (Germany)
Calbiochem (USA)
Cambrex Corporation (USA)
Cambridge Antibody Technology (UK)
Canag Diagnostics AB (Sweden)
Capricorn Products, Inc (USA)
Celgene Corporation (USA)
Celltech Group Plc (UK)
Centocor, Inc (USA)
Chemicon International, Inc (USA)
Cytogen Corporation (USA)
DakoCytomation A/S (Denmark)
Dakocytomation California, Inc (USA)
Dakocytomation Diagnosticos SA (Spain)
Dendreon Corporation (USA)
Diagnostic Systems Laboratories, Inc (USA)
DiaSorin SPA (Italy)
Diasorin, Inc (USA)
DRG International, Inc (USA)
DRG Instruments GmbH (Germany)
DRG Medtek SP Z O O (Poland)
Elan Corporation Plc (Ireland)
Eli Lilly and Company (USA)
EMD Biosciences, Inc (USA)
Enzo Diagnostics, Inc (USA)
Exocell, Inc (USA)
Genentech, Inc (USA)
Genzyme Corporation (USA)
Genzyme Diagnostics (USA)
Genzyme Virotech GmbH (Germany)
GlaxoSmithKline PLC (UK)
Goodwin Biotechnology, Inc (USA)
Guildhay Ltd (UK)
Human Genome Sciences, Inc (USA)
ICOS Corporation (USA)
IGEN International, Inc (USA)
ImmunoDiagnostics, Inc (USA)
Immunomedics, Inc (USA)
Immunovision, Inc (USA)
Intersciences, Inc (Canada)
Johnson & Johnson (USA)
Ortho-Clinical Diagnostics (USA)
Ortho-Clinical Diagnostics (UK)
Kamada Ltd (Israel)
LabFrontier Co, Ltd (Korea)
Lampire Biological Laboratories, Inc (USA)
Lonza Group (Switzerland)
Medarex, Inc (USA)
Mediagnost GmbH (Germany)
Medicorp, Inc (Canada)
MedImmune, Inc (USA)
New Horizons Diagnostics Corporation (USA)
Olympus America, Inc (USA)
One Lambda, Inc (USA)
Oxoid, Inc (USA)
Parks Medical Electronics, Inc (USA)
Peptech Technology Ltd (Australia)
Perstorp AB (Sweden)
Protein Design Labs, Inc (USA)
Roche Diagnostics (Schweiz) AG (Switzerland)
Scimedx Corporation (USA)
SIFIN Institut für Immunpräparate und Nährmedien GmbH
(Berlin)
Signet Laboratories, Inc (USA)
Spectral Diagnostics, Inc (Canada)
Steraloids, Inc (USA)
STI-Signal Transduction Products (USA)
Strategic Biosolutions (USA)
Synbiotics Corporation (USA)
Tanabe Seiyaku Co, Ltd (Japan)
Tanox, Inc (USA)
Trinity Biotech Plc (Ireland)
Valeant Pharmaceuticals International (USA)
Virostat, Inc (USA)
Wyeth (USA)
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