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Dynamic Antibody Industry

Published by: BCC Research

Published: Aug. 1, 2005 - 251 Pages


Table of Contents


INTRODUCTION


STUDY GOAL AND OBJECTIVES


CONTRIBUTION OF THE STUDY AND FOR WHOM


STUDY SCOPE AND FORMAT


METHODOLOGY


INFORMATION SOURCES


ANALYST'S CREDENTIALS


RELATED BCC WORK CREDENTIALS INCLUDING WORK DONE BY OTHER AUTHORS


BCC ONLINE SERVICES


DISCLAIMER


SUMMARY


Summary Table:


WORLDWIDE SALES OF THERAPEUTIC AND DIAGNOSTIC IMAGING ANTIBODIES, THROUGH 2010 ($ MILLIONS)


Summary Figure:


WORLDWIDE SALES OF THERAPEUTIC AND DIAGNOSTIC IMAGING ANTIBODIES, 2002-2010 ($ MILLIONS)


OVERVIEW


DEFINITIONS


THE IMPORTANCE OF ANTIBODY DRUGS AND DIAGNOSTICS


INTELLECTUAL PROPERTY ISSUES/PATENT LICENSING


THE TIMELINE TO COMMERCIALIZATION OF MONOCLONAL ANTIBODY PRODUCTS


Table 1 TIMELINE TO COMMERCIALIZATION OF MONOCLONAL ANTIBODY PRODUCTS


ADVANTAGES OF MONOCLONAL ANTIBODY DRUGS


WHY DO MONOCLONAL ANTIBODY PRODUCTS HAVE SO MANY APPLICATIONS AND POLYCLONAL ANTIBODY PRODUCTS DO NOT?


VALUATION OF ANTIBODY PRODUCT SALES


TECHNOLOGY


OVERVIEW


THE HAMA PROBLEM AND ITS RESOLUTION


PHAGE DISPLAY AND POLYSOME DISPLAY


DIRECTED EVOLUTION


ANTIBODY CLASSES


ANTIBODY FORMS IN PRODUCTS


ABTIDES


ANTIBODY CONJUGATES


ANTISERUMS


BISPECIFIC ANTIBODIES


CAMOUFLAGED ANTIBODIES


CHIMERIC ANTIBODIES


FULLY HUMAN ANTIBODIES


HUMANIZED ANTIBODIES


PROGENITOR STEM CELLS


SINGLE-CHAIN ANTIBODIES


SYNTHETIC ANTIBODIES


SOURCES OF MONCLONAL ANTIBODIES ON THE MARKET


Table 2 MARKETED MONOCLONAL ANTIBODY PRODUCTS AND THEIR SOURCES


THE SPECIAL CASE OF ENBREL


ANTIBODY TECHNOLOGIES IN DEVELOPMENT


AFFIBODIES


DOMAIN ANTIBODIES


NANOBODIES


NEW DIRECTIONS IN ANTIBODY RESEARCH


THE MARKET OPPORTUNITY FOR TRANSGENIC PRODUCTION OF ANTIBODY PRODUCTS


THE HIGH COST OF PRODUCING ANTIBODIES AND OTHER PROTEIN DRUGS


THE GROWING CRISIS IN MEETING PRODUCTION DEMANDS FOR PROTEIN DRUGS


Table 3 U.S. DEMAND FOR BIOLOGICS, THROUGH 2010 ($ MILLIONS)


Table 4 MONOCLONAL ANTIBODY BIOPROCESSING MARKET: U.S., THROUGH 2010 ($ MILLIONS)


THE TRANSGENIC ADVANTAGE


TRADITIONAL PRODUCTION METHODS


MICROBIAL FERMENTATION


MAMMALIAN CELL CULTURE


Table 5 SELECTED PROTEIN DRUGS AND THEIR SOURCE CELLS


Table 6 ESTIMATED CAPACITY REQUIREMENTS FOR SELECTED CURRENTLY MARKETED PROTEIN PRODUCTS


Table 7 ESTIMATED MAMMALIAN CELL CULTURE MANUFACTURING CAPACITIES FOR SELECTED COMPANIES


THE ENBREL SHORTAGE


THE CRUNCH IN CAPACITY


REASONS FOR THE NEED TO INCREASE PROTEIN DRUG PRODUCTION


GENOMICS AND GENE DISCOVERY DRIVE THE EXPANDING DEVELOPMENT OF PROTEIN DRUGS


PRODUCTION OF ANTIBODIES IN ANIMALS


GOATS AS MONOCLONAL ANTIBODIES FACTORIES


CHICKENS AS MONOCLONAL ANTIBODIES FACTORIES


PRODUCTION OF ANTIBODIES IN PLANTS


PLASTIDS


TARGETING AND COMPARTMENTALIZING


TRANSGENIC SEEDS FOR ANTIBODY STORAGE


THE MARKET FOR TRANSGENICALLY PRODUCED ANTIBODY PRODUCTS


Table 8 TRANGENICALLY PRODUCED THERAPEUTIC PROTEIN MARKET: ESTIMATED WORLDWIDE SALES OF SELECTED MONOCLONAL ANTIBODIES, 2008-2013 ($ MILLIONS)


Figure 1 TRANGENICALLY PRODUCED THERAPEUTIC PROTEIN MARKET: ESTIMATED WORLDWIDE SALES OF SELECTED MONOCLONAL ANTIBODIES, 2008-2013 ($ MILLIONS)


PLANTIBODIES IN DEVELOPMENT


Table 9 THERAPEUTIC PLANTIBODIES: APPLICATION AND SPECIFICITY, SIGNAL SEQUENCES AND PLANT SOURCE


ANTI-RABIES ANTIBODIES


CARORX


CLOSTRIDIUM DIFFICILE TOXIN A AND TOXIN B


OTHER THERAPEUTIC PLANTIBODIES IN DEVELOPMENT


TECHNOLOGY ISSUES WITH PLANT-BASED HUMAN ANTIBODIES


USING MONOCLONAL ANTIBODIES AS CARRIERS FOR CYTOTOXIC DRUGS


CONTRACT MANUFACTURING MARKET FOR BIOPHARMACEUTICALS GROWING


Table 10 U.S. BIOPHARMACEUTICALS CONTRACT MANUFACTURING MARKET, THROUGH 2010 ($ MILLIONS)


PRODUCTS


THE MARKET FOR POLYCLONAL AND MONOCLONAL ANTIBODY DRUGS


Table 11 WORLDWIDE SALES OF MONOCLONAL AND POLYCLONAL ANTIBODIES AS DRUGS, THROUGH 2010 ($ MILLIONS)


Figure 2 WORLDWIDE SALES OF MONOCLONAL AND POLYCLONAL ANTIBODIES AS DRUGS, 2002-2010 ($ MILLIONS)


THERAPEUTIC MONOCLONAL ANTIBODY PRODUCTS


THE MARKET FOR THERAPEUTIC MONOCLONAL ANTIBODIES


Table 12 THERAPEUTIC MONOCLONAL ANTIBODY PRODUCTS: WORLDWIDE SALES, THROUGH 2010 ($ MILLIONS)


Sales by Technology


Table 13 MARKET FOR THERAPEUTIC MONOCLONAL ANTIBODY PRODUCTS BY TECHNOLOGY: WORLDWIDE, THROUGH 2010 ($ MILLIONS)


Figure 3 MARKET FOR THERAPEUTIC MONOCLONAL ANTIBODY PRODUCTS BY TECHNOLOGY: WORLDWIDE, 2002-2010 ($ MILLIONS)


Sales by Target


Table 14 MARKET FOR THERAPEUTIC MONOCLONAL ANTIBODY PRODUCTS BY TARGET: WORLDWIDE, THROUGH 2010 ($ MILLIONS)


THE U.S. MARKET FOR THERAPEUTIC MONOCLONAL ANTIBODIES


Table 15 THERAPEUTIC MONOCLONAL ANTIBODY PRODUCTS: U.S., THROUGH 2010 ($ MILLIONS)


Marketed Products


Table 16 MONOCLONAL ANTIBODY PRODUCTS ON THE U.S. MARKET


THE EUROPEAN MARKET FOR THERAPEUTIC MONOCLONAL ANTIBODIES


Table 17 THERAPEUTIC MONOCLONAL ANTIBODY PRODUCTS: EUROPE, THROUGH 2010 ($ MILLIONS)


Marketed Products


Table 18 MONOCLONAL ANTIBODY PRODUCTS ON THE EUROPEAN MARKET


Avastin


The Avastin Advantage


New Medicare Reimbursement Law Supports Use of Avastin


Bexxar


Campath/MabCampath


Erbitux


Table 19 RANGE OF EGFR EXPRESSION IN SOLID TUMORS


Table 20 EGFR IN PROGNOSIS FOR SELECTED TUMOR TYPES


Herceptin


Humira


Mylotarg


Orthoclone OKT3


Panorex


Raptiva


Remicade


ReoPro


Rituxan/MabThera


Simulect


Synagis


Tysabri (formerly Antegren)


Xolair


Zenapax


Zevalin


First Radioimmunotherapeutic Drug


Results of Trials


Sales of Zevalin


THERAPEUTIC MONOCLONAL ANTIBODY PRODUCTS IN DEVELOPMENT


Table 21 MONOCLONAL ANTIBODY PRODUCTS IN PHASE II OR LATER DEVELOPMENT


ABT-874


AMG 108


AMG 162


AMG 714


Anti-CD20 Humanized Anticlonal Antibody


Anti-Tac(Fv)-PE38 Immunotoxin


Anti-TGF Beta


Avastin


CAL


Campath


Cantuzumab Mertansine


CAT-192


Cimzia (formerly CDP-870)


Cotara


Eculizumab


Erbitux


Felvizumab


Herceptin


HuMax-CD4


HuMax-CD20


HuMax-EGFr


HuMax-Inflam


Humira


HuN901-DM1


HuZAF


IMMU-102 and IMMU-103


Lucentis


LymphoStat-B


M200


MDX-010


MDX-018


MDX-060


MDX-070


Mepolizumab


MLN 02


MLN 1202


MLN 2704


Numax


Nuvion


Omnitarg


Osidem


OvaRex


Panitumumab


Pemtumomab


Pexelizumab


Pro70769


R1569


Remicade


Rituxan/MabThera


SGN-15


SGN-30


Synagis


TheraCIM hR3


Trabio


Tysabri


Vitaxin


Xolair


Zenapax


THERAPEUTIC POLYCLONAL ANTIBODY PRODUCTS


IMMUNOGLOBULINS


Intramuscular Products


Intravenous Products


NEW APPROACHES TO THE PRODUCTION OF HUMAN POLYCLONAL ANTIBODIES


THE MARKET FOR THERAPEUTIC POLYCLONAL ANTIBODY PRODUCTS


Table 22 POLYCLONAL ANTIBODY PRODUCTS: WORLDWIDE SALES, THROUGH 2010 ($ MILLIONS)


MARKETED PRODUCTS


ATG-Fresenius S


BabyBIG


CytoGam


Flebogamma


Gamimune


Gamunex


Nabi-HB


Octagam


Rabies Immune Globulin


RespiGam


Tetanus Immune Globulin


Vaccinia Immune Globulin


Varicella-Zoster Immune Globulin


WinRho SDF Rho(D) Immune Globulin


Anti-Thymocyte Globulin


Atgam


Thymoglobulin


Antitoxins and Antivenins


CroFab


DigiFab


Diphtheria Antitoxin


ViperTAb


PRODUCTS IN DEVELOPMENT


Table 23 POLYCLONAL ANTIBODY PRODUCTS IN PHASE II OR LATER DEVELOPMENT


Altastaph


ATG-Fresenius S


CytoFab


Nabi-HB Intravenous


Thymoglobulin


WinRho SDF


Early-Stage Products in Development


IN VIVO DIAGNOSTIC ANTIBODY PRODUCTS


Table 24 DIAGNOSTIC IMAGING ANTIBODIES: WORLDWIDE SALES, THROUGH 2010 ($ MILLIONS)


Figure 4 DIAGNOSTIC IMAGING ANTIBODIES: WORLDWIDE SALES, 2002-2010 ($ MILLIONS)


MARKETED PRODUCTS


CEA-Scan


Humaspect


LeukoScan


MIBG


MyoScint


NeutroSpec


OctreoScan


ProstaScint


Verluma


PRODUCTS IN DEVELOPMENT


Table 25 DIAGNOSTIC ANTIBODY PRODUCTS IN PHASE II OR LATER DEVELOPMENT


AFP-Scan


Blood Tumor Antibody Diagnostics


CEA-Scan


LeukoScan


LymphoScan


NeutroSpec


ProstaScint


Tru-Scint AD


Tru-Scint AG


APPLICATIONS


LEADING THERAPEUTIC INDICATIONS OF APPROVED MONOCLONAL THERAPEUTIC ANTIBODY PRODUCTS


Table 26 APPLICATIONS OF THERAPEUTIC MONOCLONAL ANTIBODIES: WORLDWIDE SALES, THROUGH 2010 ($ MILLIONS)


Figure 5 WORLDIWDE THERAPEUTIC MONOCLONAL ANTIBODIES, PERCENTAGE OF MARKET BY APPLICATION, 2004 AND 2010 (%)


AUTOIMMUNE DISEASES


Crohn's Disease


Psoriasis


Rheumatoid Arthritis


Antibody Products on the Market for the Treatment of Autoimmune Diseases


Table 27 MARKETED MONOCLONAL ANTIBODY PRODUCTS FOR THE TREATMENT OF AUTOIMMUNE DISEASES


Antibodies in Development for the Treatment of Autoimmune Diseases


Table 28 THERAPEUTIC ANTIBODY PRODUCTS IN PHASE II OR LATER DEVELOPMENT FOR THE TREATMENT OF AUTOIMMUNE DISEASES


CANCER


U.S. Cancer Statistics


Table 29 INCIDENCE, MORTALITY, AND SURVIVAL RATES FOR COMMON CANCERS: U.S., 2004 (ESTIMATED)


Table 30 CANCER PREVALENCE RATES: U.S., 2000


Breast Cancer


Colorectal Cancer


Head and Neck Cancer


Kidney Cancer


Leukemias


Liver Cancer


Lung Cancer


Malignant Melanoma


NonHodgkin's Lymphoma


Osteosarcoma


Ovarian Cancer


Pancreatic Cancer


Prostate Cancer


Stomach Cancer


Antibody Products on the Market for the Treatment of Cancer


Table 31 MARKETED MONOCLONAL ANTIBODY PRODUCTS FOR THE TREATMENT OF CANCER


Antibodies in Development for the Treatment of Cancer


Table 32 THERAPEUTIC ANTIBODY PRODUCTS IN PHASE II OR LATER DEVELOPMENT FOR THE TREATMENT OF SPECIFIC CANCERS


CARDIOVASCULAR DISEASES


Table 33 ESTIMATED INPATIENT CARDIOVASCULAR PROCEDURES, U.S., 2002


Percutaneous Transluminal Coronary Angioplasty


Antibody Products on the Market for the Treatment of Cardiovascular Disease


Antibodies in Development for the Treatment of Cardiovascular Diseases


Table 34 THERAPEUTIC ANTIBODY PRODUCTS IN PHASE II OR LATER DEVELOPMENT FOR THE TREATMENT OF CARDIOVASCULAR DISEASES


INFECTIOUS DISEASES


Cytomegalovirus Infection


Hepatitis


Respiratory Syncytial Virus Infection


Antibodies on the Market for the Treatment of Infectious Diseases


Antibodies in Development for the Treatment of Infectious Diseases


Table 35 THERAPEUTIC ANTIBODY PRODUCTS IN PHASE II OR LATER DEVELOPMENT FOR THE TREATMENT OF INFECTIOUS DISEASES


OPHTHALMIC DISEASES


Macular Degeneration


ORGAN TRANSPLANT REJECTION AND GRAFT-VERSUS-HOST DISEASE


Organ Transplant Market Size


Table 36 U.S. ORGAN TRANSPLANTS BY TYPE, 1997 TO 2004


Antibody Products on the Market for the Treatment of Organ Transplant Rejection


Table 37 MARKETED MONOCLONAL ANTIBODY PRODUCTS FOR THE TREATMENT OF ORGAN TRANSPLANT REJECTION


Antibodies in Development for Organ Transplant Rejection


Table 38 THERAPEUTIC ANTIBODY PRODUCTS IN PHASE II OR LATER DEVELOPMENT FOR THE PREVENTION OF ORGAN TRANSPLANT REJECTION


Bone Marrow and Stem Cell Transplantation/Graft-Versus-Host Disease


Table 39 GRAFT-VERSUS-HOST DISEASE: WORLDWIDE INCIDENCE, 1998-2004


RESPIRATORY DISEASES


Allergic Rhinitis and Asthma


Antibody Products on the Market for the Treatment of Allergic Rhinitis and Asthma


Antibodies in Development for the Treatment of Allergic Rhinitis and Asthma


Table 40 THERAPEUTIC ANTIBODY PRODUCTS IN PHASE II OR LATER DEVELOPMENT FOR THE TREATMENT OF ALLERGIC RHINITIS AND/OR ASTHMA


OTHER THERAPEUTIC APPLICATIONS


Table 41 THERAPEUTIC ANTIBODY PRODUCTS IN PHASE II OR LATER DEVELOPMENT FOR THE TREATMENT OF SELECTED OTHER DISEASES


DIAGNOSTIC IMAGING APPLICATIONS


IN VIVO DIAGNOSTIC IMAGING ANTIBODY PRODUCTS IN DEVELOPMENT FOR SELECTED INDICATIONS


Table 42 IN VIVO DIAGNOSTIC IMAGING ANTIBODY PRODUCTS IN PHASE II OR LATER DEVELOPMENT FOR SELECTED INDICATIONS


INDUSTRY STRUCTURE


ORIGINATORS


COMMERCIAL DEVELOPERS


VENDORS


MANUFACTURERS


TECHNOLOGY INNOVATORS


PRICING FORECASTS


PARTNERSHIPS ABOUND


Table 43 SELECTED ANTIBODY PRODUCT DEVELOPMENT PARTNERSHIPS FORMED IN 2003 AND 2004


THE REGULATORY ENVIRONMENT


MARKET SHARE OF MONOCLONAL ANTIBODY PRODUCT MANUFACTURERS


Figure 6 MARKET SHARE OF THERAPEUTIC MONOCLONAL ANTIBODY PRODUCTS BY MANUFACTURER, 2004 (%)


GENOMICS AND MONOCLONAL ANTIBODIES: A MATCH FOR SUCCESS


COMPANY PROFILES


ABGENIX, INC.


BUSINESS OVERVIEW


FINANCIAL INFORMATION


PRODUCTS


XenoMouse and XenoMax Technologies


Technology Advantages


CORPORATE STRATEGY


AMGEN, INC.


BUSINESS OVERVIEW


FINANCIAL INFORMATION


PRODUCTS


Table 44 AMGEN'S MONOCLONAL ANTIBODY PRODUCT PIPELINE


CORPORATE STRATEGY


BIOGEN IDEC, INC.


BUSINESS OVERVIEW


FINANCIAL INFORMATION


PRODUCTS


CORPORATE STRATEGY


CAMBRIDGE ANTIBODY TECHNOLOGY GROUP PLC


BUSINESS OVERVIEW


PRODUCTS


CORPORATE STRATEGY


CORIXA CORP.


BUSINESS OVERVIEW


FINANCIAL INFORMATION


PRODUCTS


CORPORATE STRATEGY


CYTOGEN CORPORATION


BUSINESS OVERVIEW


FINANCIAL INFORMATION


PRODUCTS


CORPORATE STRATEGY


GENENTECH, INC.


BUSINESS OVERVIEW


FINANCIAL INFORMATION


PRODUCTS


CORPORATE STRATEGY


Table 45 SELECTED PRODUCTS FROM WHICH GENENTECH RECEIVES ROYALTIES


Table 46 SELECTED PRODUCTS FROM WHICH GENENTECH RECEIVES ROYALTIES


GENMAB A/S


BUSINESS OVERVIEW


PRODUCTS


CORPORATE STRATEGY


GENZYME CORPORATION


BUSINESS OVERVIEW


FINANCIAL INFORMATION


PRODUCTS


Table 47 GENZYME'S MONOCLONAL ANTIBODY PRODUCT PIPELINE


CORPORATE STRATEGY


GTC BIOTHERAPEUTICS


BUSINESS OVERVIEW


FINANCIAL INFORMATION


PRODUCTS AND TECHNOLOGIES


Monoclonal Antibodies (MAB) and Immunoglobulin (Ig) Fusion Proteins


CORPORATE STRATEGY


IMMUNOMEDICS, INC.


BUSINESS OVERVIEW


FINANCIAL INFORMATION


PRODUCTS


Table 48 IMMUNOMEDICS' PRODUCT PIPELINE


CORPORATE STRATEGY


MEDAREX, INC.


BUSINESS OVERVIEW


FINANCIAL INFORMATION


PRODUCTS


Table 49 MEDAREX'S PRODUCT PIPELINE


CORPORATE STRATEGY


MEDIMMUNE, INC.


BUSINESS OVERVIEW


FINANCIAL INFORMATION


LEADING PRODUCTS


Table 50 MEDIMMUNE'S MONOCLONAL ANTIBODY PRODUCT PIPELINE


CORPORATE STRATEGY


MILLENNIUM PHARMACEUTICALS, INC.


BUSINESS OVERVIEW


FINANCIAL INFORMATION


PRODUCTS


Table 51 MILLENNIUM'S MONOCLONAL ANTIBODY PRODUCT PIPELINE


CORPORATE STRATEGY


NABI BIOPHARMACEUTICALS


BUSINESS OVERVIEW


FINANCIAL INFORMATION


PRODUCTS


Table 52 NABI BIOPHARMACEUTICALS' PRODUCT PIPELINE


CORPORATE STRATEGY


PLANET BIOTECHNOLOGY, INC.


BUSINESS OVERVIEW


PRODUCTS AND TECHNOLOGY


CaroRx


RhinoRx


DoxoRx


PROTEIN DESIGN LABS


BUSINESS OVERVIEW


FINANCIAL INFORMATION


PRODUCTS


Table 53 PROTEIN DESIGN LABS' MONOCLONAL ANTIBODY PRODUCT PIPELINE


CORPORATE STRATEGY


PROTHERICS PLC


BUSINESS OVERVIEW


FINANCIAL INFORMATION


PRODUCTS


CORPORATE STRATEGY


SYMPHOGEN A/S


BUSINESS OVERVIEW


PRODUCTS


Table 54 COMPARISON OF SYMPHOBODIES, OLIGOCLONAL ANTIBODIES AND MONOCLONAL ANTIBODIES


CORPORATE STRATEGY


TRANXENOGEN, INC.


BUSINESS OVERVIEW


FINANCIAL INFORMATION


PRODUCTS AND TECHNOLOGY


CORPORATE STRATEGY


VIREXX MEDICAL CORPORATION


BUSINESS OVERVIEW


FINANCIAL INFORMATION


PRODUCTS


CORPORATE STRATEGY


XOMA LTD.


BUSINESS OVERVIEW


FINANCIAL INFORMATION


PRODUCTS


CORPORATE STRATEGY


YM BIOSCIENCES INC.


BUSINESS OVERVIEW


FINANCIAL INFORMATION


PRODUCTS


Table 55 YM BIOSCIENCE'S PRODUCT PIPELINE


CORPORATE STRATEGY



LIST OF TABLES


Summary Table:


WORLDWIDE SALES OF THERAPEUTIC AND DIAGNOSTIC IMAGING ANTIBODIES, THROUGH 2010 ($ MILLIONS)


Table 1 TIMELINE TO COMMERCIALIZATION OF MONOCLONAL ANTIBODY PRODUCTS


Table 2 MARKETED MONOCLONAL ANTIBODY PRODUCTS AND THEIR SOURCES


Table 3 U.S. DEMAND FOR BIOLOGICS, THROUGH 2010 ($ MILLIONS)


Table 4 MONOCLONAL ANTIBODY BIOPROCESSING MARKET: U.S., THROUGH 2010 ($ MILLIONS)


Table 5 SELECTED PROTEIN DRUGS AND THEIR SOURCE CELLS


Table 6 ESTIMATED CAPACITY REQUIREMENTS FOR SELECTED CURRENTLY MARKETED PROTEIN PRODUCTS


Table 7 ESTIMATED MAMMALIAN CELL CULTURE MANUFACTURING CAPACITIES FOR SELECTED COMPANIES


Table 8 TRANGENICALLY PRODUCED THERAPEUTIC PROTEIN MARKET: ESTIMATED WORLDWIDE SALES OF SELECTED MONOCLONAL ANTIBODIES, 2008-2013 ($ MILLIONS)


Table 9 THERAPEUTIC PLANTIBODIES: APPLICATION AND SPECIFICITY, SIGNAL SEQUENCES AND PLANT SOURCE


Table 10 U.S. BIOPHARMACEUTICALS CONTRACT MANUFACTURING MARKET, THROUGH 2010 ($ MILLIONS)


Table 11 WORLDWIDE SALES OF MONOCLONAL AND POLYCLONAL ANTIBODIES AS DRUGS, THROUGH 2010 ($ MILLIONS)


Table 12 THERAPEUTIC MONOCLONAL ANTIBODY PRODUCTS: WORLDWIDE SALES, THROUGH 2010 ($ MILLIONS)


Table 13 MARKET FOR THERAPEUTIC MONOCLONAL ANTIBODY PRODUCTS BY TECHNOLOGY: WORLDWIDE, THROUGH 2010 ($ MILLIONS)


Table 14 MARKET FOR THERAPEUTIC MONOCLONAL ANTIBODY PRODUCTS BY TARGET: WORLDWIDE, THROUGH 2010 ($ MILLIONS)


Table 15 THERAPEUTIC MONOCLONAL ANTIBODY PRODUCTS: U.S., THROUGH 2010 ($ MILLIONS)


Table 16 MONOCLONAL ANTIBODY PRODUCTS ON THE U.S. MARKET


Table 17 THERAPEUTIC MONOCLONAL ANTIBODY PRODUCTS: EUROPE, THROUGH 2010 ($ MILLIONS)


Table 18 MONOCLONAL ANTIBODY PRODUCTS ON THE EUROPEAN MARKET


Table 19 RANGE OF EGFR EXPRESSION IN SOLID TUMORS


Table 20 EGFR IN PROGNOSIS FOR SELECTED TUMOR TYPES


Table 21 MONOCLONAL ANTIBODY PRODUCTS IN PHASE II OR LATER DEVELOPMENT


Table 22 POLYCLONAL ANTIBODY PRODUCTS: WORLDWIDE SALES, THROUGH 2010 ($ MILLIONS)


Table 23 POLYCLONAL ANTIBODY PRODUCTS IN PHASE II OR LATER DEVELOPMENT


Table 24 DIAGNOSTIC IMAGING ANTIBODIES: WORLDWIDE SALES, THROUGH 2010 ($ MILLIONS)


Table 25 DIAGNOSTIC ANTIBODY PRODUCTS IN PHASE II OR LATER DEVELOPMENT


Table 26 APPLICATIONS OF THERAPEUTIC MONOCLONAL ANTIBODIES: WORLDWIDE SALES, THROUGH 2010 ($ MILLIONS)


Table 27 MARKETED MONOCLONAL ANTIBODY PRODUCTS FOR THE TREATMENT OF AUTOIMMUNE DISEASES


Table 28 THERAPEUTIC ANTIBODY PRODUCTS IN PHASE II OR LATER DEVELOPMENT FOR THE TREATMENT OF AUTOIMMUNE DISEASES


Table 29 INCIDENCE, MORTALITY, AND SURVIVAL RATES FOR COMMON CANCERS: U.S., 2004 (ESTIMATED)


Table 30 CANCER PREVALENCE RATES: U.S., 2000


Table 31 MARKETED MONOCLONAL ANTIBODY PRODUCTS FOR THE TREATMENT OF CANCER


Table 32 THERAPEUTIC ANTIBODY PRODUCTS IN PHASE II OR LATER DEVELOPMENT FOR THE TREATMENT OF SPECIFIC CANCERS


Table 33 ESTIMATED INPATIENT CARDIOVASCULAR PROCEDURES, U.S., 2002


Table 34 THERAPEUTIC ANTIBODY PRODUCTS IN PHASE II OR LATER DEVELOPMENT FOR THE TREATMENT OF CARDIOVASCULAR DISEASES


Table 35 THERAPEUTIC ANTIBODY PRODUCTS IN PHASE II OR LATER DEVELOPMENT FOR THE TREATMENT OF INFECTIOUS DISEASES


Table 36 U.S. ORGAN TRANSPLANTS BY TYPE, 1997 TO 2004


Table 37 MARKETED MONOCLONAL ANTIBODY PRODUCTS FOR THE TREATMENT OF ORGAN TRANSPLANT REJECTION


Table 38 THERAPEUTIC ANTIBODY PRODUCTS IN PHASE II OR LATER DEVELOPMENT FOR THE PREVENTION OF ORGAN TRANSPLANT REJECTION


Table 39 GRAFT-VERSUS-HOST DISEASE: WORLDWIDE INCIDENCE, 1998-2004


Table 40 THERAPEUTIC ANTIBODY PRODUCTS IN PHASE II OR LATER DEVELOPMENT FOR THE TREATMENT OF ALLERGIC RHINITIS AND/OR ASTHMA


Table 41 THERAPEUTIC ANTIBODY PRODUCTS IN PHASE II OR LATER DEVELOPMENT FOR THE TREATMENT OF SELECTED OTHER DISEASES


Table 42 IN VIVO DIAGNOSTIC IMAGING ANTIBODY PRODUCTS IN PHASE II OR LATER DEVELOPMENT FOR SELECTED INDICATIONS


Table 43 SELECTED ANTIBODY PRODUCT DEVELOPMENT PARTNERSHIPS FORMED IN 2003 AND 2004


Table 44 AMGEN'S MONOCLONAL ANTIBODY PRODUCT PIPELINE


Table 45 SELECTED PRODUCTS FROM WHICH GENENTECH RECEIVES ROYALTIES


Table 46 SELECTED PRODUCTS FROM WHICH GENENTECH RECEIVES ROYALTIES


Table 47 GENZYME'S MONOCLONAL ANTIBODY PRODUCT PIPELINE


Table 48 IMMUNOMEDICS' PRODUCT PIPELINE


Table 49 MEDAREX'S PRODUCT PIPELINE


Table 50 MEDIMMUNE'S MONOCLONAL ANTIBODY PRODUCT PIPELINE


Table 51 MILLENNIUM'S MONOCLONAL ANTIBODY PRODUCT PIPELINE


Table 52 NABI BIOPHARMACEUTICALS' PRODUCT PIPELINE


Table 53 PROTEIN DESIGN LABS' MONOCLONAL ANTIBODY PRODUCT PIPELINE


Table 54 COMPARISON OF SYMPHOBODIES, OLIGOCLONAL ANTIBODIES AND MONOCLONAL ANTIBODIES


Table 55 YM BIOSCIENCE'S PRODUCT PIPELINE



LIST OF FIGURES


Summary Figure:


WORLDWIDE SALES OF THERAPEUTIC AND DIAGNOSTIC IMAGING ANTIBODIES, 2002-2010 ($ MILLIONS)


XXV


Figure 1 TRANGENICALLY PRODUCED THERAPEUTIC PROTEIN MARKET: ESTIMATED WORLDWIDE SALES OF SELECTED MONOCLONAL ANTIBODIES, 2008-2013 ($ MILLIONS)


Figure 2 WORLDWIDE SALES OF MONOCLONAL AND POLYCLONAL ANTIBODIES AS DRUGS, 2002-2010 ($ MILLIONS)


Figure 3 MARKET FOR THERAPEUTIC MONOCLONAL ANTIBODY PRODUCTS BY TECHNOLOGY: WORLDWIDE, 2002-2010 ($ MILLIONS)


Figure 4 DIAGNOSTIC IMAGING ANTIBODIES: WORLDWIDE SALES, 2002-2010 ($ MILLIONS)


Figure 5 WORLDIWDE THERAPEUTIC MONOCLONAL ANTIBODIES, PERCENTAGE OF MARKET BY APPLICATION, 2004 AND 2010 (%)


Figure 6 MARKET SHARE OF THERAPEUTIC MONOCLONAL ANTIBODY PRODUCTS BY MANUFACTURER, 2004 (%)

Abstract

INTRODUCTION

Monoclonal antibody drugs offer several advantages over other types of drugs. Technologically, antibodies exhibit amazing specificity that allows for a safe and targeted attack on disease-causing cells or compounds. The antibody itself may be used as a weapon or the antibody may serve as the vehicle to deliver a drug. Along with high specificity, monoclonal antibodies are effective in a broad range of diseases including autoimmune, cardiovascular and infectious diseases, cancer and inflammation. Also of great importance is that antibodies are virtually never toxic.

As of May 2005, there were 18 therapeutic monoclonal antibody products on the U.S. market. Worldwide, there were an estimated 500 monoclonal antibody products in development by more than 200 companies for the treatment of virtually every debilitating disease. Approximately 80 of these were in clinical trials.

This BCC report provides detailed market analyses and industry trends. It quantifies and qualifies the emerging market for monoclonal and polyclonal antibody drugs and imaging products. Forecasts and trends are gleaned from industry sources as well as from considered assessments of available and emerging technologies. The study also examines strategies used by biotechnology companies and pharmaceutical firms to develop and market products in this explosive market sector.

SCOPE OF STUDY

The report contains:
  • A discussion of the importance and advantages of antibody-based products, patent issues and applicability
  • Analysis of antibody technology, research and production, and the types of antibodies used as therapeutics or diagnostics
  • A synopsis of more than 100 monoclonal and polyclonal antibody drugs and diagnostic imaging products currently marketed and those in Phase II or later development
  • Comparative product and sales analyses, including current and forecasted sales through 2010 by individual product, target and technology, as well as worldwide market size and growth estimates
  • An overview of the leading indications for available and emerging antibody-based therapeutics and diagnostics
  • Profiles of leading companies and those with emerging products or technologies.

METHODOLOGY

The base year for this study is 2005. Figures are based on revenue figures at the manufacturers' level and are projected at 2005-dollar value; that is, inflation is not computed into the projection figures.

Information to prepare this study was derived from information obtained from product managers, marketing strategists, research executives and others at leading pharmaceutical and biotechnology companies that compete in the market for antibody drugs and imaging diagnostics or which have products in development for this market.

INFORMATION SOURCES

The information and analyses presented in this report are based on an extensive survey of the biotechnology and pharmaceutical industries as well as a detailed examination of published literature and reports obtained from regulatory authorities, medical research institutions, pharmaceutical trade associations and national and world health organizations. Key information from the business literature was used to obtain expert opinion on commercial potential and market sizes from industry professionals.

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