Anti-CD20 Monoclonal Antibodies: Market Research Report
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.
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.
I.INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS
Study Reliability and Reporting Limitations
Disclaimers
Data Interpretation & Reporting Level
Quantitative Techniques & Analytics
Product Definitions and Scope of Study
II. EXECUTIVE SUMMARY
1.MARKET OVERVIEW
Current and Future Analysis
Monoclonal Antibody Market Garners Riches
Rituxan/MabThera to Remain the Market Leader
Rituxan’s Success Spurs Development of New Anti-CD20 Antibodies
Clinical Trial Failures Trouble Drug Makers, Retracts Market Growth
Safety Issues Marr Penetration of Radiolabelled CD20 Antibodies
Oncologists Resort to Zevalin and Bexxar As a Last Resort
Novel Action Mechanisms Bode Potential for New CD20 mAbs
Future of mAbs – Smaller and Inexpensive to Produce
Structurally Modified Full-Size mAbs – Next Type of mAbs to Hit the Market
MAb Fragments
Major Companies in the Chase for New-Generation Technologies
Next Generation CD20 mABs
Comparison of Marketed and Pipeline CD20 Antibodies Based on Action Mechanism
Second Generation CD20 Antibodies
Ofatumumab
Veltuzumab
Ocrelizumab
Third Generation CD20 Antibodies
AME133v
TRU-015
GA101/Obinutuzumab
Incidence and Prevalence of Major Targeted Indications of CD20 mAbs
Rheumatoid Arthritis – A Chronic, Debilitating Disease
Incidence and Prevalence Higher in Urban and Developed Regions
Lymphoma Incidence and Mortality Rates On the Rise
Incidence of Hodgkin's Lymphoma - High in West Asia
2.MARKET DYNAMICS
PML Risks Clipping Label Expansions of Rituxan
Rituxan and Ocrelizumab Show Promise in RRMS Treatment
Ocrelizumab’s Ouster in RA Puts Development Partners in a Quandary
Zevalin and Bexxar Sales Remain in Obscurity
The Road Ahead for Zevalin
3.FOCUS ON SELECT ANTI-CD20 MABS AVAILABLE WORLDWIDE
Approved Anti-CD20 Antibodies in a Nutshell
Select Anti-CD20 Antibodies’ Pipeline in a Nutshell
Drug Details
Rituxan/MabThera (Biogen, Roche and Genentech)
Approved and Potential Indications for Rituxan
Zevalin (Spectrum™ Pharmaceuticals)
Bexxar (GlaxoSmithKline)
Ofatumumab (Genmab and GlaxoSmithKline)
Clinical Development of HuMax-CD20 by Indication and Stage of Development
Ocrelizumab (Biogen/Genentech)
Summary of Ocrelizumab Development Status
GA-101 (Roche/GlycArt)
TRU-015 (Trubion)
AME-133v (Eli Lilly)
Veltuzumab (Immunomedics/Nycomed)
Clinical Trials of Veltuzumab
BVX-20 (Biocon)
LFB-R603 (LFB Biotechnlogies)
DXL625 (InNexus)
4.PRODUCT OVERVIEW
CD20 Antibody
Immune System: Natural Defenders
Human Antibodies
Types of Monoclonal Antibodies
Chimeric Antibodies: Show Lesser Antigenicity
Murine Monoclonal Antibodies
Humanized Antibodies/ CDR Grafted Antibodies (Human Antibodies)
Fully Human Antibodies
Bispecific Antibodies
5.A PEEK INTO MONOCLOBAL ANTIBODY MARKET
Evolution of Monoclonal Antibodies – A Historical Journey
Market Perspective of mAbs
Regional Perspective
Significant Growth Awaits mAbs
Shift Towards Humanized and Fully Human Antibodies
Ageing Baby Boomers Spur MAbs Growth
Non-Existent Generic Competition Favors MAb Market
Rising Number of MAbs Under Clinical Trials
High Costs Impede MAbs Penetration
Opportunities in Technology Development
Advancements & Challenges in Antibody Production Processes
Increasing Demand for Protein A in MAb Manufacturing
6.RECENT DRUG APPROVALS AND REGULATORY STATUS
Rituxan Receives FDA Approval for the Treatment of Chronic Lymphocytic Leukemia
GSK Receives Positive Opinion for Arzerra™ from EMEA
LFB Obtains Orphan Drug Status for LFB-R603 in Europe
FDA Grants Accelerated Approval for GSK and Genmab’s Ofatumumab for Chronic Lymphocytic Leukemia
InNexus’s DXL625 Receives Positive Opinion from FDA
Spectrum Pharma Obtains FDA Approval for Zevalin’s Expanded Label in NHL Treatment
Bayer Schering Obtains EU Approval for Zevalin in First-Line Treatment
7.RECENT INDUSTRY ACTIVITY
Pfizer Discontinues Development of TRU-015; Continues to Develop SBI-087
Roche and Biogen Discontinue Ocrelizumab Development in Rheumatoid Arthritis
Roche and Biogen File Patent Suit Against GSK
Ocrelizumab Meets Primary End-Point In Phase III Trial for RA
Rituxan Plus FC Chemotherapy Shows Improved Survival in Treatment-Naïve CLL Patients
FDA Declines Early Use of Rituxan in RA
LG Life Sciences Announces New Anti-CD20 Antibody Program
Provenance Acquires Global Rights to New Anti-CD20 Antibody from Merck
Roche Takes Over Genentech
Pfizer Acquires Wyeth
Spectrum Pharma Acquires Lymphoma Drug Zevalin
Biogen Partners with Genentech and Roche for Development of GA-101
Roche, GlycArt and Genentech Team Up for Development of GA-101
InNexus Biotechnology Discovers New Anti-CD20 Antibody, DXLr120
MRC Completes Humanization of Biolex’s Anti-CD20 Antibody, BLX-301
Immunomedics Inks Licensing and Collaboration Deal with Nycomed
Rituxan Fails To Meet Primary End-Point in Phase II/III Trial for SLE
Rituxan Fails To Meet Primary End-Point in Phase II/III Trial for PPMS
Rituxan Meets Primary End-point in Phase III Trial for DMARD Inadequate Responders in RA
Cell Therapeutics Acquires Zevalin from Biogen Idec
InNexus Develops Dxl625 Anti-Cd20 Monoclonal Antibody
GTC and LFB Commence Development of Novel Anti-CD20 Antibody
Favrille Purchases Anti-CD20 mAbs from Diversa
Genmab and GSK Ink Global Collaboration Agreement for HuMax-CD20
8.FOCUS ON SELECT MARKET PARTICIPANTS
Bayer Schering Pharma AG (Germany)
Biocon (India)
Biogen Idec, Inc. (US)
Eli Lilly and Company (US)
F. Hoffmann-La Roche Ltd. (Switzerland)
Genentech, Inc. (US)
Genmab A/S (Denmark)
GlaxoSmithKline Plc. (UK)
GTC Biotherapeutics, Inc. (US)
Immunomedics, Inc. (US)
InNexus Biotechnology, Inc. (Canada)
LFB Group (France)
Nycomed (Switzerland)
Pfizer, Inc. (US)
Spectrum Pharmaceuticals, Inc. (US)
Trubion Pharmaceuticals, Inc.
UCB Pharmaceutical (Belgium)
9.GLOBAL MARKET PERSPECTIVE
III. COMPETITIVE LANDSCAPE
Total Companies Profiled: 38 (including Divisions/Subsidiaries - 44)
Region/CountryPlayers
The United States
Canada
Japan
Europe
France
Germany
The United Kingdom
Rest of Europe
Asia-Pacific (Excluding Japan)
Study Reliability and Reporting Limitations
Disclaimers
Data Interpretation & Reporting Level
Quantitative Techniques & Analytics
Product Definitions and Scope of Study
II. EXECUTIVE SUMMARY
1.MARKET OVERVIEW
Current and Future Analysis
Monoclonal Antibody Market Garners Riches
Rituxan/MabThera to Remain the Market Leader
Rituxan’s Success Spurs Development of New Anti-CD20 Antibodies
Clinical Trial Failures Trouble Drug Makers, Retracts Market Growth
Safety Issues Marr Penetration of Radiolabelled CD20 Antibodies
Oncologists Resort to Zevalin and Bexxar As a Last Resort
Novel Action Mechanisms Bode Potential for New CD20 mAbs
Future of mAbs – Smaller and Inexpensive to Produce
Structurally Modified Full-Size mAbs – Next Type of mAbs to Hit the Market
MAb Fragments
Major Companies in the Chase for New-Generation Technologies
Next Generation CD20 mABs
Comparison of Marketed and Pipeline CD20 Antibodies Based on Action Mechanism
Second Generation CD20 Antibodies
Ofatumumab
Veltuzumab
Ocrelizumab
Third Generation CD20 Antibodies
AME133v
TRU-015
GA101/Obinutuzumab
Incidence and Prevalence of Major Targeted Indications of CD20 mAbs
Rheumatoid Arthritis – A Chronic, Debilitating Disease
Incidence and Prevalence Higher in Urban and Developed Regions
Lymphoma Incidence and Mortality Rates On the Rise
Incidence of Hodgkin's Lymphoma - High in West Asia
Table 1. Age-Standardized Incidence Rates for Hodgkin’s Lymphoma in Select Countries Worldwide (2002) (includes corresponding Graph/Chart)
Table 2. Age-Standardized Mortality Rates for Hodgkin’s Lymphoma in Select Countries Worldwide (2002) (includes corresponding Graph/Chart)
2.MARKET DYNAMICS
PML Risks Clipping Label Expansions of Rituxan
Rituxan and Ocrelizumab Show Promise in RRMS Treatment
Ocrelizumab’s Ouster in RA Puts Development Partners in a Quandary
Zevalin and Bexxar Sales Remain in Obscurity
The Road Ahead for Zevalin
3.FOCUS ON SELECT ANTI-CD20 MABS AVAILABLE WORLDWIDE
Approved Anti-CD20 Antibodies in a Nutshell
Select Anti-CD20 Antibodies’ Pipeline in a Nutshell
Drug Details
Rituxan/MabThera (Biogen, Roche and Genentech)
Approved and Potential Indications for Rituxan
Zevalin (Spectrum™ Pharmaceuticals)
Bexxar (GlaxoSmithKline)
Ofatumumab (Genmab and GlaxoSmithKline)
Clinical Development of HuMax-CD20 by Indication and Stage of Development
Ocrelizumab (Biogen/Genentech)
Summary of Ocrelizumab Development Status
GA-101 (Roche/GlycArt)
TRU-015 (Trubion)
AME-133v (Eli Lilly)
Veltuzumab (Immunomedics/Nycomed)
Clinical Trials of Veltuzumab
BVX-20 (Biocon)
LFB-R603 (LFB Biotechnlogies)
DXL625 (InNexus)
4.PRODUCT OVERVIEW
CD20 Antibody
Immune System: Natural Defenders
Human Antibodies
Types of Monoclonal Antibodies
Table 3. Worldwide mAb Market By Product Type (2008): Percentage Share Breakdown For Chimeric, Humanized, Human And Murine (includes corresponding Graph/Chart)
Chimeric Antibodies: Show Lesser Antigenicity
Murine Monoclonal Antibodies
Humanized Antibodies/ CDR Grafted Antibodies (Human Antibodies)
Fully Human Antibodies
Bispecific Antibodies
5.A PEEK INTO MONOCLOBAL ANTIBODY MARKET
Evolution of Monoclonal Antibodies – A Historical Journey
Market Perspective of mAbs
Regional Perspective
Significant Growth Awaits mAbs
Shift Towards Humanized and Fully Human Antibodies
Ageing Baby Boomers Spur MAbs Growth
Non-Existent Generic Competition Favors MAb Market
Rising Number of MAbs Under Clinical Trials
High Costs Impede MAbs Penetration
Opportunities in Technology Development
Advancements & Challenges in Antibody Production Processes
Increasing Demand for Protein A in MAb Manufacturing
6.RECENT DRUG APPROVALS AND REGULATORY STATUS
Rituxan Receives FDA Approval for the Treatment of Chronic Lymphocytic Leukemia
GSK Receives Positive Opinion for Arzerra™ from EMEA
LFB Obtains Orphan Drug Status for LFB-R603 in Europe
FDA Grants Accelerated Approval for GSK and Genmab’s Ofatumumab for Chronic Lymphocytic Leukemia
InNexus’s DXL625 Receives Positive Opinion from FDA
Spectrum Pharma Obtains FDA Approval for Zevalin’s Expanded Label in NHL Treatment
Bayer Schering Obtains EU Approval for Zevalin in First-Line Treatment
7.RECENT INDUSTRY ACTIVITY
Pfizer Discontinues Development of TRU-015; Continues to Develop SBI-087
Roche and Biogen Discontinue Ocrelizumab Development in Rheumatoid Arthritis
Roche and Biogen File Patent Suit Against GSK
Ocrelizumab Meets Primary End-Point In Phase III Trial for RA
Rituxan Plus FC Chemotherapy Shows Improved Survival in Treatment-Naïve CLL Patients
FDA Declines Early Use of Rituxan in RA
LG Life Sciences Announces New Anti-CD20 Antibody Program
Provenance Acquires Global Rights to New Anti-CD20 Antibody from Merck
Roche Takes Over Genentech
Pfizer Acquires Wyeth
Spectrum Pharma Acquires Lymphoma Drug Zevalin
Biogen Partners with Genentech and Roche for Development of GA-101
Roche, GlycArt and Genentech Team Up for Development of GA-101
InNexus Biotechnology Discovers New Anti-CD20 Antibody, DXLr120
MRC Completes Humanization of Biolex’s Anti-CD20 Antibody, BLX-301
Immunomedics Inks Licensing and Collaboration Deal with Nycomed
Rituxan Fails To Meet Primary End-Point in Phase II/III Trial for SLE
Rituxan Fails To Meet Primary End-Point in Phase II/III Trial for PPMS
Rituxan Meets Primary End-point in Phase III Trial for DMARD Inadequate Responders in RA
Cell Therapeutics Acquires Zevalin from Biogen Idec
InNexus Develops Dxl625 Anti-Cd20 Monoclonal Antibody
GTC and LFB Commence Development of Novel Anti-CD20 Antibody
Favrille Purchases Anti-CD20 mAbs from Diversa
Genmab and GSK Ink Global Collaboration Agreement for HuMax-CD20
8.FOCUS ON SELECT MARKET PARTICIPANTS
Bayer Schering Pharma AG (Germany)
Biocon (India)
Biogen Idec, Inc. (US)
Eli Lilly and Company (US)
F. Hoffmann-La Roche Ltd. (Switzerland)
Genentech, Inc. (US)
Genmab A/S (Denmark)
GlaxoSmithKline Plc. (UK)
GTC Biotherapeutics, Inc. (US)
Immunomedics, Inc. (US)
InNexus Biotechnology, Inc. (Canada)
LFB Group (France)
Nycomed (Switzerland)
Pfizer, Inc. (US)
Spectrum Pharmaceuticals, Inc. (US)
Trubion Pharmaceuticals, Inc.
UCB Pharmaceutical (Belgium)
9.GLOBAL MARKET PERSPECTIVE
Table 4. World Recent Past, Current & 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)
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 & 2015
III. COMPETITIVE LANDSCAPE
Total Companies Profiled: 38 (including Divisions/Subsidiaries - 44)
Region/CountryPlayers
The United States
Canada
Japan
Europe
France
Germany
The United Kingdom
Rest of Europe
Asia-Pacific (Excluding Japan)
