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Antibody Drugs: Technologies and Global Markets

Antibody Drugs: Technologies and Global Markets

The global market for antibody drugs was worth nearly $63.4 billion in 2013. This market is expected to grow at a compound annual growth rate (CAGR) of 12.2% between 2014 and 2019 resulting in totals nearly $68.9 billion in 2014 and $122.6 billion globally in 2019.

This report provides:

An overview of the global market for therapeutic monoclonal antibody (mAb) drugs and related applications and technologies.

Analyses of global market trends, with data from 2012 to 2014, and projections of CAGRs through 2019.

Analysis and assessment of the therapeutic applications of mAbs in human medicine.

A look at the antibody industry as a whole as well as a discussion of the pending huge impact of genomics and the emergence of biotechnology firms into the mainstream market.

Comprehensive profiles of companies that lead the biotechnology and pharmaceutical industry in the research and development of antibody drugs and the innovative products that those companies have launched or have in development.


SCOPE OF THE STUDY

The scope of this report embraces the key market analysis, market drivers, market constraints, and also competitive developments and trends in this market. BCC Research analyzes each market and its applications, regulatory environment, technology, market projections and market shares.

The study involves the antibody drugs used in the pharmaceutical and the biopharmaceutical markets. This report analyzes and assesses therapeutic applications of mAbs in human medicine, including the combination of mAbs when they are attached to cytotoxic agent such as with antibody-drug conjugates (ADCs).

Excluded from this report is information regarding polyclonal antibodies, as well as screening equipment and diagnostic uses (such as for imaging purposes) of mAbs. Also excluded is discussion relating to the research applications of mAbs and therapeutic antibodies for veterinary use.

Complete geographical analysis of market is also studied in report. The emerging market for mAbs includes countries such as India, China, Japan, South Korea, Taiwan, Canada, Africa, Australia, New Zealand and so forth. Profiles of key market players are also covered for this report. The U.S. and Europe markets are also covered.

The technological issues include all the latest trends, for example, the human antimouse antibody (HAMA) problem because of murine antibodies and its resolution by using chimeric, human and humanized antibodies instead of murine antibodies for therapy, pipeline products and developments. Also included in the report are comprehensive profiles of companies that lead the biotechnology and pharmaceutical industry in the research and development (R&D) of antibody drugs.

CHAPTER 1 INTRODUCTION
STUDY OBJECTIVES
REASONS FOR DOING THIS STUDY
CONTRIBUTIONS OF THE STUDY AND FOR WHOM
SCOPE OF THE STUDY
METHODOLOGY
INFORMATION SOURCES
ANALYST'S CREDENTIALS
RELATED BCC RESEARCH REPORTS
BCC RESEARCH WEBSITE
DISCLAIMER
CHAPTER 2 SUMMARY
SUMMARY TABLE GLOBAL MARKET FOR ANTIBODY DRUGS BY REGION, THROUGH 2019 ($ MILLIONS)
SUMMARY FIGURE GLOBAL MARKET FOR ANTIBODY DRUGS BY REGION, 2012-2019 ($ MILLIONS)
CHAPTER 3 OVERVIEW
DEFINITIONS
MONOCLONAL ANTIBODIES
HISTORY OF MONOCLONAL ANTIBODIES
TABLE 1 EVOLUTION OF MONOCLONAL ANTIBODIES
TABLE 2 ADVANTAGES AND DISADVANTAGES OF MONOCLONAL
ANTIBODIES
TABLE 3 DIFFERENCES BETWEEN MONOCLONAL ANTIBODY DRUGS VS. CHEMICALLY SYNTHESIZED DRUGS
TYPES OF MONOCLONAL ANTIBODIES
Murine Monoclonal Antibodies
TABLE 4 MURINE MONOCLONAL ANTIBODIES
Chimeric Monoclonal Antibodies
TABLE 5 CHIMERIC MONOCLONAL ANTIBODIES
Humanized Monoclonal Antibodies
TABLE 6 HUMANIZED MONOCLONAL ANTIBODIES
Human Monoclonal Antibodies
TABLE 7 HUMAN MONOCLONAL ANTIBODIES
MANUFACTURING TECHNOLOGIES OF MONOCLONAL ANTIBODIES
Hybridoma Technology
Production of Recombinant Antibodies by Display Technology
TABLE 8 DIFFERENCES BETWEEN HYBRIDOMA TECHNOLOGY AND RECOMBINANT TECHNOLOGY
Production of Antibodies in Plants
Recombinant Antibody Expression in Transgenic Plants
Recombinant Antibody Expression in Transgenic Animals
Mammalian Cell Culture
Microbial Cell Fermentation
TABLE 9 COMPARISON OF VARIOUS EXPRESSION SYSTEMS FOR RECOMBINANT PHARMACEUTICAL PROTEINS
APPLICATIONS OF MONOCLONAL ANTIBODIES
Diagnostic Tests
Human Therapy
TABLE 10 MURINE MONOCLONAL ANTIBODIES AND THEIR APPLICATIONS
TABLE 11 CHIMERIC MONOCLONAL ANTIBODIES AND THEIR APPLICATIONS
TABLE 12 HUMAN MONOCLONAL ANTIBODIES AND THEIR APPLICATIONS
TABLE 13 HUMANIZED MONOCLONAL ANTIBODIES AND THEIR APPLICATIONS
CHAPTER 4 REGULATORY ASPECTS
TABLE 14 NEW APPROVALS OF MONOCLONAL ANTIBODIES FROM JANUARY 2009 TO MAY 2014
RECALLS
TABLE 15 RECALLS FROM JANUARY 2009 TO JUNE 2014
NEW DRUG APPLICATIONS/BIOLOGICAL LICENSE APPLICATIONS
TABLE 16 NEW DRUG APPLICATIONS/BIOLOGICAL LICENSE APPLICATIONS
FROM JANUARY 2009 TO JANUARY 2014
SAFETY ALERTS
TABLE 17 SAFETY ALERTS FROM 2010 TO MAY 2014
CHAPTER 5 NEW DEVELOPMENTS
PHASE I CLINICAL TRIALS
TABLE 18 MONOCLONAL ANTIBODIES IN PHASE I CLINICAL TRIALS
PHASE II CLINICAL TRIALS
TABLE 19 MONOCLONAL ANTIBODIES IN PHASE II CLINICAL TRIALS
PHASE III CLINICAL TRIALS
TABLE 20 MONOCLONAL ANTIBODIES IN PHASE III CLINICAL TRIALS
PHASE IV CLINICAL TRIALS
TABLE 21 MONOCLONAL ANTIBODIES IN PHASE IV CLINICAL TRIALS
MERGERS AND ACQUISITIONS
TABLE 22 MERGERS AND ACQUISITIONS OF TOP PHARMACEUTICAL COMPANIES FROM 2009 TO JUNE 2014
CHAPTER 6 MARKET ANALYSIS OF ANTIBODY DRUGS
MARKET BY TYPE
MARKET OVERVIEW
MARKET REVENUE
TABLE 23 GLOBAL REVENUE OF ANTIBODY DRUGS BY TYPE, THROUGH 2019 ($ MILLIONS)
FIGURE 1 GLOBAL REVENUE OF ANTIBODY DRUGS BY TYPE, 2012-2019 ($ MILLIONS)
MARKET SHARE
TABLE 24 MARKET SHARE OF ANTIBODY DRUGS BY TYPE, 2013 (%)
FIGURE 2 MARKET SHARE OF ANTIBODY DRUGS BY TYPE, 2013 (%)
MARKET BY REGION
MARKET OVERVIEW
MARKET REVENUE
TABLE 25 GLOBAL REVENUE OF ANTIBODY DRUGS BY REGION, THROUGH 2019 ($ MILLIONS)
FIGURE 3 GLOBAL REVENUE OF ANTIBODY DRUGS BY REGION, 2012-2019 ($ MILLIONS)
MARKET SHARE
TABLE 26 MARKET SHARE OF ANTIBODY DRUGS BY REGION, 2013 (%)
FIGURE 4 MARKET SHARE OF ANTIBODY DRUGS BY REGION, 2013 (%)
Murine Monoclonal Antibodies
Market Overview
Market Revenue
TABLE 27 GLOBAL REVENUE OF MURINE MONOCLONAL ANTIBODIES BY REGION, THROUGH 2019 ($ MILLIONS)
FIGURE 5 GLOBAL REVENUE OF MURINE MONOCLONAL ANTIBODIES BY REGION, 2012-2019 ($ MILLIONS)
Chimeric Monoclonal Antibodies
Market Overview
Market Revenue
TABLE 28 GLOBAL REVENUE OF CHIMERIC MONOCLONAL ANTIBODIES BY REGION, THROUGH 2019 ($ MILLIONS)
FIGURE 6 GLOBAL REVENUE OF CHIMERIC MONOCLONAL ANTIBODIES BY REGION, 2012-2019 ($ MILLIONS)
Human Monoclonal Antibodies
Market Overview
Market Revenue
TABLE 29 GLOBAL REVENUE OF HUMAN MONOCLONAL ANTIBODIES BY REGION, THROUGH 2019 ($ MILLIONS)
FIGURE 7 GLOBAL REVENUE OF HUMAN MONOCLONAL ANTIBODIES BY REGION, 2012-2019 ($ MILLIONS)
Humanized Monoclonal Antibodies
Market Overview
Market Revenue
TABLE 30 GLOBAL REVENUE OF HUMANIZED MONOCLONAL ANTIBODIES BY REGION, THROUGH 2019 ($ MILLIONS)
FIGURE 8 GLOBAL REVENUE OF HUMANIZED MONOCLONAL ANTIBODIES BY REGION, 2012-2019 ($ MILLIONS)
MARKET BY MANUFACTURING PROCESS
TABLE 31 GLOBAL REVENUE OF MANUFACTURING PROCESSES BY TYPE OF MONOCLONAL ANTIBODIES, THROUGH 2019 ($ MILLIONS)
FIGURE 9 GLOBAL REVENUE OF MANUFACTURING PROCESSES BY TYPE OF MONOCLONAL ANTIBODIES, 2012-2019 ($ MILLIONS)
MARKET SHARE
TABLE 32 MARKET SHARE OF ANTIBODY DRUGS BY MANUFACTURING PROCESS, 2013 (%)
FIGURE 10 MARKET SHARE OF ANTIBODY DRUGS BY MANUFACTURING PROCESS, 2013 (%)
Murine Monoclonal Antibodies
Market Overview
Market Revenue
TABLE 33 GLOBAL REVENUE OF MURINE ANTIBODY DRUGS BY MANUFACTURING PROCESS, THROUGH 2019 ($ MILLIONS)
FIGURE 11 GLOBAL REVENUE OF MURINE ANTIBODY DRUGS BY MANUFACTURING PROCESS, 2012-2019 ($ MILLIONS)
Chimeric Monoclonal Antibodies
Market Overview
Market Revenue
TABLE 34 GLOBAL REVENUE OF CHIMERIC MONOCLONAL ANTIBODIES BY MANUFACTURING PROCESS, THROUGH 2019 ($ MILLIONS)
FIGURE 12 GLOBAL REVENUE OF CHIMERIC MONOCLONAL ANTIBODIES BY MANUFACTURING PROCESS, 2012-2019 ($ MILLIONS)
Human Monoclonal Antibodies
Market Overview
Market Revenue
TABLE 35 GLOBAL REVENUE OF HUMAN MONOCLONAL ANTIBODIES BY MANUFACTURING PROCESS, THROUGH 2019 ($ MILLIONS)
FIGURE 13 GLOBAL REVENUE OF HUMAN MONOCLONAL
ANTIBODIES BY MANUFACTURING PROCESS, 2012-2019 ($ MILLIONS)
Humanized Monoclonal Antibodies
Market Overview
Market Revenue
TABLE 36 GLOBAL REVENUE OF HUMANIZED MONOCLONAL ANTIBODIES BY MANUFACTURING PROCESS, THROUGH 2019 ($ MILLIONS)
FIGURE 14 GLOBAL REVENUE OF HUMANIZED MONOCLONAL ANTIBODIES BY MANUFACTURING PROCESS, 2012-2019 ($MILLIONS)
CHAPTER 7 MARKET APPLICATIONS OF ANTIBODY DRUGS
MARKET BY DISEASES
GLOBAL ANTIBODY DRUG MARKET BY DISEASES
TABLE 37 GLOBAL REVENUE FOR ANTIBODY DRUGS BY DISEASES, THROUGH 2019 ($ MILLIONS)
FIGURE 15 GLOBAL REVENUE FOR ANTIBODY DRUGS BY DISEASES, 2012-2019 ($ MILLIONS)
MARKET SHARE
TABLE 38 MARKET SHARES FOR ANTIBODY DRUGS BY DISEASES, 2013 (%)
FIGURE 16 MARKET SHARE FOR ANTIBODY DRUGS BY DISEASES, 2013 (%)
AUTOIMMUNE DISEASE
TABLE 39 VARIOUS TYPES OF AUTOIMMUNE DISEASES
Autoimmune Diseases by Type of Antibody Used
Market Overview
Market Revenue
TABLE 40 GLOBAL REVENUE OF ANTIBODY DRUGS IN AUTOIMMUNE DISEASES BY TYPE, THROUGH 2019 ($ MILLIONS)
FIGURE 17 GLOBAL REVENUE OF ANTIBODY DRUGS IN AUTOIMMUNE DISEASES BY TYPE, 2012-2019 ($MILLIONS)
Market Analysis of Autoimmune Diseases by Region
Market Overview
Market Revenue
TABLE 41 GLOBAL REVENUE OF ANTIBODY DRUGS IN AUTOIMMUNE DISEASES BY REGION, THROUGH 2019 ($ MILLIONS)
FIGURE 18 GLOBAL MARKET FOR ANTIBODY DRUGS IN AUTOIMMUNE DISEASES BY REGION, 2012-2019 ($
MILLIONS)
SOLID TUMORS
TABLE 42 VARIOUS CANCER TYPES DEPENDING ON THE TISSUE OF ORIGIN
Market Analysis of Solid Tumors by Type of Antibody Used in Treatment
Market Overview
Market Revenue
TABLE 43 GLOBAL REVENUE OF ANTIBODY DRUGS IN SOLID TUMOR BY TYPE, THROUGH 2019 ($ MILLIONS)
FIGURE 19 GLOBAL REVENUE OF ANTIBODY DRUGS IN SOLID TUMOR BY TYPE, 2012-2019 ($ MILLIONS)
Market Analysis of Solid Tumors by Region
Market Overview
Market Revenue
TABLE 44 GLOBAL REVENUE OF ANTIBODY DRUGS IN SOLID TUMOR BY REGION, THROUGH 2019 ($ MILLIONS)
FIGURE 20 GLOBAL REVENUE OF ANTIBODY DRUGS IN SOLID TUMOR BY REGION, 2012-2019 ($ MILLIONS)
LYMPHOMAS AND LEUKEMIA
Lymphoma
TABLE 45 TYPES OF LYMPHOMAS
Leukemia
TABLE 46 TYPES OF LEUKEMIA
Market Analysis of Lymphomas and Leukemia by Type of Antibody Used
in Treatment
Market Overview
Market Revenue
TABLE 47 GLOBAL REVENUE OF ANTIBODY DRUGS IN LYMPHOMA AND LEUKEMIA BY TYPE, THROUGH 2019 ($ MILLIONS)
FIGURE 21 GLOBAL REVENUE OF ANTIBODY DRUGS IN LYMPHOMA AND LEUKEMIA BY TYPE, 2012-2019 ($ MILLIONS)
Market Analysis of Lymphomas and Leukemia by Region
Market Overview
Market Revenue
TABLE 48 GLOBAL REVENUE OF ANTIBODY DRUGS IN LYMPHOMA AND LEUKEMIA BY REGION, THROUGH 2019 ($ MILLIONS)
FIGURE 22 GLOBAL REVENUE OF ANTIBODY DRUGS IN LYMPHOMA AND LEUKEMIA BY REGION, 2012-2019 ($ MILLIONS)
OTHERS
Osteoporosis
Asthma
Age-related Macular Degeneration
Paroxysmal Nocturnal Hemoglobinuria
Cardiovascular Diseases
Respiratory Syncytial Virus Infection
Market Analysis of Other Diseases by Type of Antibody Used in Treatment
Market Overview
Market Revenue
TABLE 49 GLOBAL REVENUE OF ANTIBODY DRUGS IN OTHER DISEASES BY TYPE, THROUGH 2019 ($ MILLIONS)
FIGURE 23 GLOBAL REVENUE OF ANTIBODY DRUGS BY APPLICATION IN OTHER DISEASES BY TYPE, 2012-2019
($ MILLIONS)
Market Analysis of Other Diseases by Region
Market Overview
Market Revenue
TABLE 50 GLOBAL REVENUE OF ANTIBODY DRUGS IN OTHER DISEASES BY REGION, THROUGH 2019 ($ MILLIONS)
FIGURE 24 GLOBAL REVENUE OF ANTIBODY DRUGS IN OTHER DISEASES BY REGION, 2012-2019 ($ MILLIONS)
CHAPTER 8 INDUSTRY STRUCTURE
MURINE MONOCLONAL ANTIBODIES
MARKET LEADERS
TABLE 51 LEADING MANUFACTURERS/SUPPLIERS OF MURINE MONOCLONAL ANTIBODIES, 2013
MARKET SHARE
TABLE 52 MARKET SHARE OF THE MANUFACTURERS/SUPPLIERS FOR MURINE MONOCLONAL ANTIBODIES, 2013 (%)
FIGURE 25 MARKET SHARE OF THE MANUFACTURERS/SUPPLIERS FOR MURINE MONOCLONAL ANTIBODIES, 2013 (%)
CHIMERIC MONOCLONAL ANTIBODIES
MARKET LEADERS
TABLE 53 LEADING MANUFACTURERS/SUPPLIERS OF CHIMERIC MONOCLONAL ANTIBODIES, 2013
MARKET SHARE
TABLE 54 MARKET SHARE OF THE MANUFACTURERS/SUPPLIERS FOR CHIMERIC MONOCLONAL ANTIBODIES, 2013 (%)
FIGURE 26 MARKET SHARE OF THE MANUFACTURERS/SUPPLIERS FOR CHIMERIC MONOCLONAL ANTIBODIES, 2013 (%)
HUMANIZED MONOCLONAL ANTIBODIES
MARKET LEADERS
TABLE 55 LEADING MANUFACTURERS/SUPPLIERS OF HUMANIZED MONOCLONAL ANTIBODIES, 2013
MARKET SHARE
TABLE 56 MARKET SHARE OF THE MANUFACTURERS/SUPPLIERS FOR HUMANIZED MONOCLONAL ANTIBODIES, 2013 (%)
FIGURE 27 MARKET SHARE OF THE MANUFACTURERS/SUPPLIERS FOR HUMANIZED MONOCLONAL ANTIBODIES, 2013 (%)
HUMAN MONOCLONAL ANTIBODIES
MARKET LEADERS
TABLE 57 LEADING MANUFACTURERS/SUPPLIERS OF HUMAN MONOCLONAL ANTIBODIES, 2013
MARKET SHARE
TABLE 58 MARKET SHARE OF THE MANUFACTURERS/SUPPLIERS FOR HUMAN MONOCLONAL ANTIBODIES, 2013 (%)
FIGURE 28 MARKET SHARE OF THE MANUFACTURERS/SUPPLIERS FOR HUMAN MONOCLONAL ANTIBODIES, 2013 (%)
CHAPTER 9 PATENT ANALYSIS
PATENTS BY YEAR
TABLE 59 NUMBER OF PATENTS BY YEAR, 2009-JUNE 2014
FIGURE 29 NUMBER OF PATENTS BY YEAR, 2009-JUNE 2014
PATENTS BY TYPE/CATEGORY
TABLE 60 NUMBER OF PATENTS BY CATEGORY, 2009-JUNE 2014
FIGURE 30 NUMBER OF PATENTS BY CATEGORY, 2009-JUNE 2014
PATENTS BY COMPANY
TABLE 61 NUMBER OF PATENTS BY COMPANY, 2009-JUNE 2014
PATENTS BY COUNTRY
TABLE 62 NUMBER OF PATENTS BY COUNTRY, 2009-JUNE 2014
TABLE 63 PATENT SHARES BY COUNTRY, 2009-JUNE 2014
FIGURE 31 NUMBER OF PATENTS BY COUNTRY, 2009-JUNE 2014 (%) (%)
PATENTS BY ASSIGNEE
TABLE 64 NUMBER OF PATENTS BY ASSIGNEE, 2009-JUNE 2014
FIGURE 32 NUMBER OF PATENTS BY ASSIGNEE, 2009-JUNE 2014
CHAPTER 10 CURRENT SITUATION
TECHNICAL ISSUES
THE HUMAN ANTIMOUSE ANTIBODY PROBLEM
Effects of the HAMA Response
Resolution of the HAMA Problem
ADVANTAGES OF HUMANIZED OR CHIMERIC OR TRANSGENIC ANTIBODIES
NEW TECHNOLOGIES IN ANTIBODY DEVELOPMENT
FUSION PROTEINS
AFFIBODIES
NANOBODIES
TABLE 65 NANOBODIES IN DEVELOPMENT
OTHER ADVANCES IN ANTIBODIES DEPENDING ON THE TREATMENT
FACTORS AFFECTING THE MONOCLONAL ANTIBODY DRUG MARKET
INCREASING PREVALENCE OF CHRONIC DISEASES
GROWING AGING POPULATION
LIFESTYLE CHANGES
NEW PRODUCT LAUNCHES
ADVANCEMENTS IN MANUFACTURING TECHNOLOGIES
PRICE CONTROLS
REGULATORY PRESSURES
ENTRY OF BIOLOGICS/BIOSIMILARS
LICENSING AGREEMENTS
MERGERS AND ACQUISITIONS
CHAPTER 11 COMPANY PROFILES
ABBOTT LABORATORIES
ALEXION PHARMACEUTICALS
AMGEN
BIOGEN IDEC
BRISTOL-MYERS SQUIBB
ELI LILLY AND CO.
GLAXOSMITHKLINE
HOFFMAN-LA ROCHE
JOHNSON & JOHNSON
MERCK & CO.
MERCK KGAA
NOVARTIS
SEATTLE GENETICS INC.
SPECTRUM PHARMACEUTICALS
TAKEDA PHARMACEUTICAL U.S.A. INC.
UCB COMPANY
CHAPTER 12 APPENDIX ABBREVIATIONS

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