Monoclonal Antibody Based Products

SUMMARY

FACTS AT A GLANCE

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• Covering Key Niche Players worldwide
• Market Data, Tables, Shares, Analyses, Trends, etc.
• 2,050+ employee hours of research and analyses
• Research assisted and subscribed by many key players worldwide!

TABLE OF CONTENTS

I. RESEARCH METHODOLOGY

II. EXECUTIVE SUMMERY

1. Industry Overview II-1

• World MAb-Based Products Market: A Profile II-1
• Genomics Research Leads Way to New Monoclonal Antibodies II-1
• Current and Future Analysis II-1
• Regional Perspective II-1
• Product Segment Perspective II-2
• Competitive Scenario II-2
• Top Monoclonal Antibody Based Therapeutics in 2002 by Sales II-2
• Therapeutic Antibodies in the Market: 2003 II-3
• A Revolution Not too Far II-3
• Mile Stones in Development of MAb II-3
• Focus on Unmet Medical Needs in the Emerging Market II-3

2. Industry Analysis II-4

• Trends and Issues II-4
• Booming Period for Therapeutic Antibodies II-4
• Future Prospects of Therapeutic Mabs II-4
• Partnerships and Collaborations Spark Increase in Profit Margins II-4
• Opportunities in Technology Development II-5
• Worldwide Selected Antibody Technology Companies II-5

3. Product Overview II-5

• Immune System: Natural Defenders II-5
• Human Antibodies II-5
• Antibodies Offer Natural Immunity II-6
• Induction of The Immune Process II-6
• Mechanism of Action II-6
• Polyclonal and Monoclonal Antibodies II-6
• Production of Monoclonal Antibodies II-6
• Traditional Methods II-6
• The Hybridoma Technology II-7
• Separation and Purification of MAB II-7
• Types of Monoclonal Antibodies II-7
• Murine Monoclonal Antibodies II-7
• Humanized Antibodies/ CDR Grafted Antibodies II-8
• Murine Vs Human Monoclonal Antibodies II-8
• Chimeric Antibodies: Show Lesser Antigenicity II-9
• Fully Human Antibodies II-9
• Bispecific Antibodies II-9
• Certain Limitations Do Exist II-9
• Advantages and Limitations of MAb Technologies II-10

4. Diagnostic Applications of Monoclonal Antibodies II-10

• Monoclonal Antibody Based Diagnostics II-10
• Immunodiagnostics II-10
• Monoclonals Used as Targeting Agents II-10
• Radio labeled Monoclonal Antibodies for Diagnostic Imaging II-11
• The Pros and Cons of MAb-Based Immunoconjugates II-11
• Cytogen: The First to Introduce A Monoclonal Antibody-based Cancer Agent II-11
• NeoProbe's Radioimmunogzuided Surgery II-12
• Mechanism of Working II-12
• The Avicidin Cancer Therapy - Pathbreaking Pretargeting Technology II-12
• Cancer II-13
• A Historical Overview II-13
• Initial Hiccups II-14
• New Cancer Diagnostic Products II-14
• Tumor Markers II-14
• Pregnancy/Fertility Testing II-14

5. Monoclonal Antibody-Based Therapeutics For

• Cancer II-15
• Evolution of Therapeutic Antibody Products II-15
• Advantages of Therapeutic Monoclonal Antibodies II-15
• Cancer Therapeutics II-15
• Monoclonal Antibodies Offer Hope Against Cancer II-15
• Antibody Therapies for Cancer II-16
• Cancer: A Serious Issue and Plaguing Illness Worldwide II-16
• Therapeutic Monoclonal Antibody Drugs and Applications for Cancer II-16
• Companies and Technologies Platforms Focusing on Cancer Monoclonal Antibody Production II-17
• Status of MAbs for Cancer in 2003 II-18
• Breast Cancer: The Most Common Form of Cancer in American Women II-18
• Breast Cancer - Treatment Options II-19
• Monoclonal Antibodies Against NHL II-19
• Monoclonal Antibodies Against Ovarian Cancer II-19
• Melanoma II-20
• MAbs Linked With Toxins Found Effective II-20
• Immunologic Effector Functions II-21
• Colorectal Cancer: Rising Incidence II-21
• Panorex: The First Cancer Therapeutic in the Market II-21
• Mode of Action II-21
• Myeloid Leukemia II-22
• Prostrate Cancer II-22
• Cancers Of The Immune System II-23
• Monoclonal Antibodies Attack Residual Cancer II-23
• What the Future Holds II-23

6. Other Therapeutic Monoclonal Antibodies II-23

• Therapeutic Monoclonal Antibody Drugs and Applications II-24
• MAbs used in Clinical Field II-24
• Inflammation Therapeutics II-24
• Inflammation II-24
• Asthma: A Chronic Affliction II-25
• CGP 51 901 To Treat Asthma II-25
• Autoimmune Diseases II-25
• What Goes Wrong II-25
• Intervention Better Than Prevention II-26
• Some Autoimmune Diseases II-26
• Multiple Sclerosis II-26
• Crohn's Disease II-27
• Rheumatoid Arthritis II-27
• CenTNF: A Trailblazing Drug II-27
• Organ Transplantation II-28
• The Biology of Transplantation II-28
• Types of Transplants II-28
• Autografts II-28
• Syngeneic transplants II-28
• Allografts II-28
• Xenografts II-29
• Follow-up Treatment II-29
• Products to Counter Rejection II-29
• OKT3: A Monoclonal Already in the Market II-29
• Infectious Diseases II-30
• Sepsis II-30
• A Rapid Process II-30
• Gram Negative Bacteria are the Causative Agents II-30
• A Retrospect II-31
• Monoclonal Antibodies and Septic Shock II-31
• What is HIV/AIDS II-31
• HIV/AIDS Testing II-32
• Current Therapy II-32
• Monoclonal Antibodies and HIV II-32
• CenTNF Role in HIV Treatment II-32
• Cardiovascular II-33
• Cardiovascular Diseases are Fatal II-33
• Treatment Options II-33
• Causes of Cardiovascular Diseases II-33
• ReoPro: The Solution to the Problem II-33

7. Regulation Impacting The Industry II-34

• Regulations in the U.S II-34
• Approval: A Laborious Process II-34
• Clinical Trials II-34
• Orphan Drug Status II-35

8. Contract Manufacturing II-35

• Outlook II-36

9. Research and Development Activities II-36

• Rituxan and Herceptin from Genentech II-36
• FuCell hybridomas II-36
• Test-tube MAbs/ Phase Display Library II-37
• Raituxanis for Cancer Treatment II-37
• GenMAb Develops Fully Human Antibodies II-37
• Protein Design Labs Licenses Trioma II-37
• Protein Design Labs' Innovative Technology II-37
• Other Developments: 2001 II-38

10. Product Launches II-39

• Genetix Launches ClonePix II-39
• IGEN Launches Monoclonal Antibody Therapies II-39
• MAb Developed MAb Against Pseudomonas Aeruginosa II-39
• Generics Ltd Launches Herceptin II-39

11. Recent Industry Activity II-39

• CAT Signs Licensing Agreement with Micromet II-39
• CAT Enters into Agreement with Genzyme II-40
• Medarex and Avlon Enters into Agreement II-40
• Micromet, Enzon and CAT Signs Cross-License Agreement II-40
• Xerion and CAT Enters into Agreement II-40
• Genetastix and Nissho Enter into Agreement II-40
• InNexus and Corixa Enters into Agreement II-40
• Abbott Collaborates with LigoCyte II-41
• CAT Acquires Drug Royalty Corporation II-41
• CAT and Amrad Joins Hands for Research II-41
• IDEC's receives FDA Approval for Zevalin II-41
• Medarex Enters into Research Alliance with Seattle Genetics II-41
• Dow, Epicyte and Centocor Join Forces to Develop Monoclonal Antibody II-41
• Eos, Medarex and Biosite in Alliance for Cancer Treatment II-42
• Imgenex Forms Alliance with GMO II-42
• CAT and Elan Enter into Strategic Alliance II-42
• Bioinvent International Enters Into Agreement With Novo
• Nordisk For Drug Discovery Research II-42
• Epicyte and Dow Chemical Enter into Agreement II-42
• Rockland Announces the Completion of Laboratory Expansion II-43
• Roche's MAbThera Receives Approval in Japan II-43
• Aviva Launches Manufacturing and Marketing Operations II-43
• Parker Hannifin to Acquire Whatman's Industrial Business Segment II-43
• ICOS and Seattle Enters into Joint Development and Manufacturing Agreement II-43
• Medarex and Corixa Team-up to Develop Human Monoclonal Antibodies II-43
• Taisho Enters into Research Alliance with IDEC II-43
• PDL Signs Agreement with InterMune II-44
• ProMetic Agreements with Integrated Protein Technologies II-44
• Medarex Sign Agreement with ZynloGenetics II-44
• CAT Joins Hands with GD. Searle II-44
• Medarex and MedImmune Enters into Antibody Research Agreement II-44
• Lonza Signs Agreement with ImClone Systems II-44
• MedImmune and Alkermes Enter into Agreement II-45
• GTC and Abgenix Enter into Production Agreement II-45
• Genzyme Transgenics Expands Agreement with Centocor II-45
• PDL and InterMune Enter into an Agreement II-45

12. Focus on Select Global Players II-45

• Abgenix (US) II-45
• Amgen (US) II-45
• BD Biosciences (US) II-46
• Biogen Inc. (US) II-46
• Biotest AG (Germany) II-47
• Cambridge Antibody Technology (CAT) (UK) II-47
• Celltech (Europe) II-47
• Centocor (US) II-48
• Corvas International Inc (US) II-48
• Dendreon Corporation (US) II-48
• Elan Corporations Plc (Ireland) II-49
• Eli Lilly (US) II-49
• Genentech, Inc. (USA) II-50
• Guildhay (UK) II-51
• Human Genome Sciences (US) II-52
• ICOS (US) II-52
• Immunomedics (US) II-52
• Oxford GlycoSciences Plc (UK) II-53
• Protein Design Labs, Inc (US) II-53
• Strategic BioSolutions (US) II-53
• Wyeth-Ayerst Laboratories (US) II-54

13. Global Market Perspective II-54

• World Market for Monoclonal Antibody Based Products - A Current & Future Analysis: Annual Sales for the Years  2000 through 2010 in US$ Million. Geographic Regions Independently Analyzed II-54
• US
• Canada
• Japan
• Europe
• Asia-Pacific
• Rest of World
• World Market for Therapeutic Monoclonal Antibody Based Products - A Current & Future Analysis: Annual Sales for the Years 2000 through 2010 in US$ Million. Geographic Regions Independently Analyzed II-56
• US
• Canada
• Japan
• Europe
• Asia-Pacific
• Rest of World
• World Market for Therapeutics Monoclonal Antibody Based products - A Current & Future Analysis: Annual Sales  for the Years 2000 through 2010 in US$ Million. Segments Independently Analyzed II-56
• Cancer
• Other
• World Market for Cancer Therapeutic Monoclonal Antibody Based Products - A Current & Future Analysis: Annual  Sales for the Years 2000 through 2010 in US$ Million. Geographic Regions Independently Analyzed II-58
• US
• Canada
• Japan
• Europe
• Asia-Pacific
• Rest of World
• World Market for Other Therapeutic Monoclonal Antibody Based Products - A Current & Future Analysis: Annual  Sales for the Years 2000 through 2010 in US$ Million. Geographic Regions Independently Analyzed II-59
• US
• Canada
• Japan
• Europe
• Asia-Pacific
• Rest of World
• World Market for Monoclonal Antibody Based Products (Diagnostics) - A Current & Future Analysis: Annual Sales  for the Years 2000 through 2010 in US$ Million. Geographic Regions Independently Analyzed II-60
• US
• Canada
• Japan
• Europe
• Asia-Pacific
• Rest of World
• World Market for Monoclonal Antibody Based products (Diagnostics) - A Current & Future Analysis: Annual Sales  for the Years 2000 through 2010 in US$ Million. Segments Independently Analyzed II-60
• Cancer
• Other
• World Market for Diagnostic Monoclonal Antibody Based Products (Cancer) - A Current & Future Analysis: Annual  Sales for the Years 2000 through 2010 in US$ Million. Geographic Regions Independently Analyzed II-62
• US
• Canada
• Japan
• Europe
• Asia-Pacific
• Rest of World
• World Market for Diagnostic Monoclonal Antibody Based Products (Others) - A Current & Future Analysis: Annual  Sales for the Years 2000 through 2010 in US$ Million. Geographic Regions Independently Analyzed II-63
• US
• Canada
• Japan
• Europe
• Asia-Pacific
• Rest of World

III. GEOGRAPHIC MARKET ANALYSES

1. The Untied States III-1

• A. Market Analysis III-1
• Trends III-1
• New Heights of US Cancer Therapeutics III-1
• Product launches III-1
• Strategic Corporate Developments III-2
• Historic Developments III-5
• Focus on Key Players III-6
• Abgenix III-6
• Amgen III-6
• BD Biosciences III-6
• Beckman Coulter, Inc III-7
• Biogen Inc. III-7
• Centocor III-8
• Corvas International Inc III-8
• Dendreon Corporation III-8
• Eli Lilly III-9
• Genentech, Inc. III-9
• Human Genome Sciences III-11
• ICOS III-11
• Immunomedics III-11
• Medarex, Inc. III-12
• MedImmune, Inc III-12
• Protein Design Labs, Inc III-12
• Strategic BioSolutions III-12
• Wyeth-Ayerst Laboratories III-13
• B. Market Analytics III-14
• US Market for Monoclonal Antibody Based Products- A Current & Future Analysis: Annual Sales for the Years 2000 through 2010 in US$ Million. Segments Independently Analyzed III-14
• A. Therapeutics
• Cancer
• Other
• B. Diagnostics
• Cancer
• Other

2. Canada III-15

• A. Market Analysis III-15
• Strategic Corporate Developments III-15
• B. Market Analytics III-16
• Canadian Market for Monoclonal Antibody Based Products- A Current & Future Analysis: Annual Sales for the  Years 2000 through 2010 in US$ Million. Segments Independently Analyzed III-16
• A. Therapeutics
• Cancer
• Other
• B. Diagnostics
• Cancer
• Other

3. Japan III-17

• A. Market Analysis III-17
• Strategic Corporate Developments III-17
• B. Market Analytics III-17
• Japanese Market for Monoclonal Antibody Based Products- A Current & Future Analysis: Annual Sales for the  Years 2000 through 2010 in US$ Million. Segments Independently Analyzed III-17
• A. Therapeutics
• Cancer
• Other
• B. Diagnostics
• Cancer
• Other

4. Europe III-19

• A. Market Analysis III-19
• Biotechnology and Pharmacy Research III-19
• Monoclonal Antibody Based Products Market in Europe III-19
• Trends in Select European Countries III-19
• Historic Developments III-19
• Focus on Key Players III-20
• Celltech III-20
• Elan Corporations Plc (Ireland) III-20
• B. Market Analytics III-21
• European Market for Monoclonal Antibody Based Products - A Current & Future Analysis: Annual Sales for the  Years 2000 through 2010 in US$ Million. Geographic Regions Independently Analyzed III-21
• France
• Germany
• Italy
• UK
• Rest of Europe
• European Market for Monoclonal Antibody Based products - A Current & Future Analysis: Annual Sales for the  Years 2000 through 2010 in US$ Million. Segments Independently Analyzed III-21
• A. Therapeutics
• Cancer
• Other
• B. Diagnostics
• Cancer
• Other

4a. France III-23

• A. Market Analysis III-23
• B. Market Analytics III-23
• French Market for Monoclonal Antibody Based Products- A Current & Future Analysis: Annual Sales for the  Years 2000 through 2010 in US$ Million. Segments Independently Analyzed III-23
• A. Therapeutics
• Cancer
• Other
• B. Diagnostics
• Cancer
• Other

4b. Germany III-24

• A. Market Analysis III-24
• Strategic Corporate Developments III-24
• Focus on Key Players III-25
• Biotest AG III-25
• B. Market Analytics III-25
• German Market for Monoclonal Antibody Based Products- A Current & Future Analysis: Annual Sales for the  Years 2000 through 2010 in US$ Million. Segments Independently Analyzed III-25
• A. Therapeutics
• Cancer
• Other
• B. Diagnostics
• Cancer
• Other

4c. Italy III-26

• A. Market Analysis III-26
• B. Market Analytics III-27
• Italian Market for Monoclonal Antibody Based Products-  A Current & Future Analysis: Annual Sales for the  Years 2000 through 2010 in US$ Million. Segments Independently Analyzed III-27
• A. Therapeutics
• Cancer
• Other
• B. Diagnostics
• Cancer
• Other

4d. United Kingdom III-28

• A. Market Analysis III-28
• Product launches III-28
• Strategic Corporate Developments III-28
• Focus on Key Players III-29
• Cambridge Antibody Technology (CAT) III-29
• Guildhay III-30
• Oxford GlycoSciences Plc III-30
• B. Market Analytics III-30
• The UK Market for Monoclonal Antibody Based Products- A Current & Future Analysis: Annual Sales for the  Years 2000 through 2010 in US$ Million. Segments Independently Analyzed III-30
• A. Therapeutics
• Cancer
• Other
• B. Diagnostics
• Cancer
• Other

4e. Rest of Europe III-31

• A. Market Analysis III-31
• Strategic Corporate Developments III-31
• B. Market Analytics III-32
• Market for Monoclonal Antibody Based Products in Rest  of Europe- A Current & Future Analysis: Annual Sales  for the Years 2000 through 2010 in US$ Million. Segments Independently Analyzed III-32
• A. Therapeutics
• Cancer
• Other
• B. Diagnostics
• Cancer
• Other

5. Asia-Pacific III-33

• A. Market Analysis III-33
• Indian Market III-33
• Strategic Corporate Developments III-33
• B. Market Analytics III-34
• Market for Monoclonal Antibody Based Products in Asia-Pacific- A Current & Future Analysis: Annual Sales for  the Years 2000 through 2010 in US$ Million. Segments Independently Analyzed III-34
• A. Therapeutics
• Cancer
• Other
• B. Diagnostics
• Cancer
• Other

6. Rest of World III-35

• A. Market Analysis III-35
• B. Market Analytics III-35
• Market for Monoclonal Antibody Based Products in Rest of World- A Current & Future Analysis: Annual Sales  for the Years 2000 through 2010 in US$ Million. Segments Independently Analyzed III-35
• A. Therapeutics
• Cancer
• Other
• B. Diagnostics
• Cancer
• Other

IV. KEY PLAYERS

• 1. Abgenix, Inc. (USA) IV-1
• 2. Altarex Corporation (Canada) IV-4
• 3. American Diagnostic Corporation (USA) IV-5
• 4. American Diagnostica, Inc. (USA) IV-6
• 5. American Qualex (USA) IV-7
• 6. Amgen, Inc. (USA) IV-8
• 7. Antibodies, Inc. (USA) IV-12
• 8. Beckman Coulter, Inc. (USA) IV-15
• 9. Becton, Dickinson And Company (USA) IV-26
• BD Asia (India) IV-33
• BD Biosciences (USA) IV-35
• 10. Binding Site Ltd., The (UK) IV-37
• 11. Bioclone Australia Pty., Ltd. (Australia) IV-39
• 12. Biogen Idec, Inc. (USA) IV-40
• 13. BioGenex Laboratories, Inc. (USA) IV-44
• 14. Bioinvent International AB (Sweden) IV-49
• 15. BioMerieux SA (France) IV-51
• Biomerieux, Inc. (USA) IV-58
• 16. Biomira, Inc. (Canada) IV-60
• Biomira USA, Inc. (USA) IV-61
• 17. Biosource International, Inc. (USA) IV-62
• 18. Biotest AG (Germany) IV-66
• 19. Calbiochem (USA) IV-71
• 20. Cambrex Corp. (USA) IV-75
• 21. Cambridge Antibody Technology (UK) IV-82
• 22. Canag Diagnostics AB (Sweden) IV-87
• 23. Capricorn Products, Inc. (USA) IV-89
• 24. Celgene Corporation (USA) IV-91
• 25. Celltech Group Plc (UK) IV-94
• 26. Centocor, Inc. (USA) IV-103
• 27. Chemicon International, Inc. (USA) IV-106
• 28. Cytogen Corporation (USA) IV-111
• 29. Dako Cytomation Denmark A/S (Denmark) IV-114
• Dakocytomation California, Inc. (USA) IV-117
• Dakocytomation Diagnosticos SA (Spain) IV-122
• 30. Dendreon Corporation (USA) IV-123
• 31. Diagnostic Systems Laboratories, Inc. (USA) IV-127
• 32. DiaSorin SpA (Italy) IV-130
• Diasorin, Inc. (USA) IV-131
• 33. DRG International, Inc. (USA) IV-133
• DRG Instruments GmbH (Germany) IV-135
• DRG Medtek Sp Z O O (Poland) IV-136
• 34. Elan Corporation Plc (Ireland) IV-137
• 35. Eli Lilly and Company (USA) IV-140
• 36. EMD Biosciences, Inc. (USA) IV-148
• 37. Enzo Diagnostics, Inc. (USA) IV-156
• 38. Exocell, Inc. (USA) IV-158
• 39. Genentech, Inc. (USA) IV-163
• 40. Genzyme Corp. (USA) IV-169
• Genzyme Diagnostics (USA) IV-178
• Genzyme Virotech GmbH (Germany) IV-178
• 41. GlaxoSmithKline (UK) IV-179
• 42. Goodwin Biotechnology, Inc. (USA) IV-187
• 43. Guildhay Ltd. (UK) IV-188
• 44. Human Genome Sciences, Inc. (USA) IV-189
• 45. ICOS Corporation (USA) IV-198
• 46. IGEN International, Inc. (USA) IV-201
• 47. ImmunoDiagnostics, Inc. (USA) IV-205
• 48. Immunomedics, Inc. (USA) IV-206
• 49. Immunovision, Inc. (USA) IV-209
• 50. Intersciences, Inc. (Canada) IV-215
• 51. Kamada Ltd. (Israel) IV-219
• 52. Lampire Biological Laboratories, Inc. (USA) IV-220
• 53. Medarex, Inc. (USA) IV-225
• 54. Mediagnost GmbH (Germany) IV-232
• 55. Medicorp, Inc. (Canada) IV-234
• 56. MedImmune, Inc. (USA) IV-240
• 57. New Horizons Diagnostics Corp. (USA) IV-243
• 58. Olympus America, Inc. (USA) IV-246
• 59. One Lambda, Inc. (USA) IV-252
• 60. Ortho-Clinical Diagnostics, Inc. (USA) IV-259
• Ortho-Clinical Diagnostics (UK) IV-262
• 61. Oxoid, Inc. (USA) IV-263
• 62. Parks Medical Electronics, Inc. (USA) IV-264
• 63. Peptech Technology Ltd. (Australia) IV-266
• 64. Perstorp AB (Sweden) IV-269
• 65. Protein Design Labs, Inc. (USA) IV-272
• 66. Scimedx Corporation (USA) IV-276
• 67. Seikagaku America, Inc. (USA) IV-279
• 68. SIFIN Institut f...r Immunpräparate und Nährmedien GmbH (Berlin) IV-280
• 69. Signet Laboratories, Inc. (USA) IV-281
• 70. Spectral Diagnostics, Inc. (Canada) IV-283
• 71. Steraloids, Inc. (USA) IV-285
• 72. STI-Signal Transduction Products (USA) IV-286
• 73. Strategic Biosolutions (USA) IV-287
• 74. Synbiotics Corp. (USA) IV-290
• 75. Tanox, Inc. (USA) IV-292
• 76. Trinity Biotech Plc (Ireland) IV-294
• 77. Valeant Pharmaceuticals International (USA) IV-297
• 78. Virostat, Inc. (USA) IV-302
• 79. Wyeth (USA) IV-303