Global Anti-CD20 Monoclonal Antibodies Industry

  • July 2010
  • -
  • Global Industry Analysts

This report analyzes the Global market for Anti-CD20 Monoclonal Antibodies in US$ Million. Annual estimates and forecasts are provided for the period 2006 through 2015. The report profiles 38 companies including many key and niche players such as Bayer Schering Pharma AG, Biocon, Biogen Idec, Inc., Eli Lilly and Company, F. Hoffmann-La Roche Ltd., Genentech, Inc., Genmab A/S, GlaxoSmithKline Plc, GTC Biotherapeutics, Inc., Immunomedics, Inc., InNexus Biotechnology, Inc., LFB Group, Nycomed, Pfizer, Inc., Spectrum Pharmaceuticals, Inc., Trubion Pharmaceuticals, Inc., and UCB Pharmaceutical. Market data and analytics are derived from primary and secondary research. Company profiles are mostly extracted from URL research and reported select online sources.

Table Of Contents


ANTI-CD20 MONOCLONAL ANTIBODIES MCP-6217
A GLOBAL STRATEGIC BUSINESS REPORT


CONTENTS


I. INTRODUCTION, METHODOLOGY and PRODUCT DEFINITIONS

Study Reliability and Reporting Limitations I-1
Disclaimers I-2
Data Interpretation and Reporting Level I-3
Quantitative Techniques and Analytics I-3
Product Definitions and Scope of Study I-3


II. EXECUTIVE SUMMARY

1. MARKET OVERVIEW II-1
Current and Future Analysis II-1
Monoclonal Antibody Market Garners Riches II-1
Rituxan/MabThera to Remain the Market Leader II-2
Rituxan’s Success Spurs Development of New Anti-CD20 Antibodies II-2
Clinical Trial Failures Trouble Drug Makers, Retracts Market
Growth II-3
Safety Issues Marr Penetration of Radiolabelled CD20 Antibodies II-3
Oncologists Resort to Zevalin and Bexxar As a Last Resort II-3
Novel Action Mechanisms Bode Potential for New CD20 mAbs II-4
Future of mAbs - Smaller and Inexpensive to Produce II-4
Structurally Modified Full-Size mAbs - Next Type of mAbs to
Hit the Market II-5
MAb Fragments II-5
Major Companies in the Chase for New-Generation Technologies II-5
Next Generation CD20 mABs II-6
Comparison of Marketed and Pipeline CD20 Antibodies Based on
Action Mechanism II-6
Second Generation CD20 Antibodies II-6
Ofatumumab II-6
Veltuzumab II-7
Ocrelizumab II-7
Third Generation CD20 Antibodies II-7
AME133v II-7
TRU-015 II-7
GA101/Obinutuzumab II-7
Incidence and Prevalence of Major Targeted Indications of CD20
mAbs II-8
Rheumatoid Arthritis - A Chronic, Debilitating Disease II-8
Incidence and Prevalence Higher in Urban and Developed Regions II-8
Lymphoma Incidence and Mortality Rates On the Rise II-9
Incidence of Hodgkin's Lymphoma - High in West Asia II-9
Table 1: Age-Standardized Incidence Rates for Hodgkin’s
Lymphoma in Select Countries Worldwide (2002) (includes
corresponding Graph/Chart) II-9

Table 2: Age-Standardized Mortality Rates for Hodgkin’s
Lymphoma in Select Countries Worldwide (2002) (includes
corresponding Graph/Chart) II-10

2. MARKET DYNAMICS II-11
PML Risks Clipping Label Expansions of Rituxan II-11
Rituxan and Ocrelizumab Show Promise in RRMS Treatment II-11
Ocrelizumab’s Ouster in RA Puts Development Partners in a
Quandary II-12
Zevalin and Bexxar Sales Remain in Obscurity II-13
The Road Ahead for Zevalin II-13

3. FOCUS ON SELECT ANTI-CD20 MABS AVAILABLE WORLDWIDE II-14

APPROVED ANTI-CD20 ANTIBODIES IN A NUTSHELL II-14
Select Anti-CD20 Antibodies’ Pipeline in a Nutshell II-14
Drug Details II-16
Rituxan/MabThera (Biogen, Roche and Genentech) II-16
Approved and Potential Indications for Rituxan II-17
Zevalin (Spectrumâ„¢ Pharmaceuticals) II-17
Bexxar (GlaxoSmithKline) II-18
Ofatumumab (Genmab and GlaxoSmithKline) II-18
Clinical Development of HuMax-CD20 by Indication and Stage
of Development II-19
Ocrelizumab (Biogen/Genentech) II-19
Summary of Ocrelizumab Development Status II-20
GA-101 (Roche/GlycArt) II-20
TRU-015 (Trubion) II-21
AME-133v (Eli Lilly) II-21
Veltuzumab (Immunomedics/Nycomed) II-22
Clinical Trials of Veltuzumab II-22
BVX-20 (Biocon) II-23
LFB-R603 (LFB Biotechnlogies) II-23
DXL625 (InNexus) II-23

4. PRODUCT OVERVIEW II-24
CD20 Antibody II-24
Immune System: Natural Defenders II-24
Human Antibodies II-24
Types of Monoclonal Antibodies II-24
Table 3: Worldwide mAb Market By Product Type (2008):
Percentage Share Breakdown For Chimeric, Humanized, Human And
Murine (includes corresponding Graph/Chart) II-24
Chimeric Antibodies: Show Lesser Antigenicity II-25
Murine Monoclonal Antibodies II-25
Humanized Antibodies/ CDR Grafted Antibodies (Human Antibodies) II-25
Fully Human Antibodies II-26
Bispecific Antibodies II-26

5. A PEEK INTO MONOCLOBAL ANTIBODY MARKET II-27

EVOLUTION OF MONOCLONAL ANTIBODIES - A HISTORICAL JOURNEY II-27
Market Perspective of mAbs II-28
Regional Perspective II-28
Significant Growth Awaits mAbs II-28
Shift Towards Humanized and Fully Human Antibodies II-29
Ageing Baby Boomers Spur MAbs Growth II-30
Non-Existent Generic Competition Favors MAb Market II-30
Rising Number of MAbs Under Clinical Trials II-30
High Costs Impede MAbs Penetration II-30
Opportunities in Technology Development II-31
Advancements and Challenges in Antibody Production Processes II-31
Increasing Demand for Protein A in MAb Manufacturing II-32

6. RECENT DRUG APPROVALS AND REGULATORY STATUS II-33

RITUXAN RECEIVES FDA APPROVAL FOR THE TREATMENT OF Chronic
Lymphocytic Leukemia II-33
GSK Receives Positive Opinion for Arzerraâ„¢ from EMEA II-33
LFB Obtains Orphan Drug Status for LFB-R603 in Europe II-34
FDA Grants Accelerated Approval for GSK and Genmab’s
Ofatumumab for Chronic Lymphocytic Leukemia II-34
InNexus’s DXL625 Receives Positive Opinion from FDA II-34
Spectrum Pharma Obtains FDA Approval for Zevalin’s Expanded
Label in NHL Treatment II-35
Bayer Schering Obtains EU Approval for Zevalin in First-Line
Treatment II-35

7. RECENT INDUSTRY ACTIVITY II-36
Pfizer Discontinues Development of TRU-015; Continues to
Develop SBI-087 II-36
Roche and Biogen Discontinue Ocrelizumab Development in
Rheumatoid Arthritis II-36
Roche and Biogen File Patent Suit Against GSK II-37
Ocrelizumab Meets Primary End-Point In Phase III Trial for RA II-37
Rituxan Plus FC Chemotherapy Shows Improved Survival in
Treatment-Naïve CLL Patients II-37
FDA Declines Early Use of Rituxan in RA II-38
LG Life Sciences Announces New Anti-CD20 Antibody Program II-38
Provenance Acquires Global Rights to New Anti-CD20 Antibody
from Merck II-38
Roche Takes Over Genentech II-39
Pfizer Acquires Wyeth II-39
Spectrum Pharma Acquires Lymphoma Drug Zevalin II-39
Biogen Partners with Genentech and Roche for Development of
GA-101 II-39
Roche, GlycArt and Genentech Team Up for Development of GA-101 II-40
InNexus Biotechnology Discovers New Anti-CD20 Antibody, DXLr120 II-40
MRC Completes Humanization of Biolex’s Anti-CD20 Antibody,
BLX-301 II-40
Immunomedics Inks Licensing and Collaboration Deal with Nycomed II-40
Rituxan Fails To Meet Primary End-Point in Phase II/III Trial
for SLE II-41
Rituxan Fails To Meet Primary End-Point in Phase II/III Trial
for PPMS II-41
Rituxan Meets Primary End-point in Phase III Trial for DMARD
Inadequate Responders in RA II-41
Cell Therapeutics Acquires Zevalin from Biogen Idec II-42
InNexus Develops Dxl625 Anti-Cd20 Monoclonal Antibody II-42
GTC and LFB Commence Development of Novel Anti-CD20 Antibody II-42
Favrille Purchases Anti-CD20 mAbs from Diversa II-43
Genmab and GSK Ink Global Collaboration Agreement for HuMax-CD20 II-43

8. FOCUS ON SELECT MARKET PARTICIPANTS II-44
Bayer Schering Pharma AG (Germany) II-44
Biocon (India) II-44
Biogen Idec, Inc. (US) II-45
Eli Lilly and Company (US) II-46
F. Hoffmann-La Roche Ltd. (Switzerland) II-46
Genentech, Inc. (US) II-47
Genmab A/S (Denmark) II-47
GlaxoSmithKline Plc. (UK) II-48
GTC Biotherapeutics, Inc. (US) II-49
Immunomedics, Inc. (US) II-49
InNexus Biotechnology, Inc. (Canada) II-50
LFB Group (France) II-50
Nycomed (Switzerland) II-51
Pfizer, Inc. (US) II-51
Spectrum Pharmaceuticals, Inc. (US) II-52
Trubion Pharmaceuticals, Inc. II-53
UCB Pharmaceutical (Belgium) II-53

9. GLOBAL MARKET PERSPECTIVE II-54
Table 4: World Recent Past, Current and Future Analysis for
Anti-CD20 Monoclonal Antibodies Market by Geographic Region -
US and Rest of World Markets Independently Analyzed with
Annual Sales Figures in US$ Million for Years 2006 through
2015 (includes corresponding Graph/Chart) II-54

Table 5: World 10-year Perspective for Anti-CD20 Antibodies
Market by Geographic Region - Percentage Breakdown of Value
Sales for US and Rest of World Markets for Years 2006, 2010 and
2015 II-54


III. COMPETITIVE LANDSCAPE

Total Companies Profiled: 38 (including Divisions/Subsidiaries - 44)

------------------------------------------
Region/Country Players
------------------------------------------
The United States 28
Canada 1
Japan 2
Europe 11
France 2
Germany 2
The United Kingdom 1
Rest of Europe 6
Asia-Pacific (Excluding Japan) 2
------------------------------------------

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