REPORT SCOPE
INTRODUCTION
STUDY GOALS AND OBJECTIVES
The aim of this report is to provide a range of information—from detailed analysis through industry trends—to quantify and qualify the rapidly growing market for therapeutic monoclonal antibody (mAb) drugs. Forecasts and trends are gleaned from industry sources, analyst reports, and company forecasts, as well as from assessment of available and emerging technologies.
The report develops forecasts for sales of the mAb market by individual antibody, by therapeutic antibody target (epidermal growth factor receptor [EGFR], cluster of differentiation [CD] 20, tumor necrosis factor [TNF] alpha, etc.), and by major disease applications from 2011 through 2016. Additionally, we examine strategies employed by biopharmaceutical firms to develop and market products in this explosive market sector.
Our main objective is to present a comprehensive analysis of the current market for therapeutic mAb disease-modifying products and to forecast this market’s future direction through 2016.
REASONS FOR DOING THE STUDY
Therapeutic mAbs represent the largest and one of the fastest-growing classes of biopharmaceutical products by sales in the U.S. and throughout the world. Of the top 20 drugs by sales throughout the world today, five are mAbs.
During our forecast period from 2011 through 2016, eight new mAbs are forecast to enter the market, and sales of therapeutic mAbs are estimated to grow from approximately $43 billion in 2010 to nearly $58 billion in 2016. Sales of humanized and fully human antibodies for autoimmune/inflammatory diseases such as rheumatoid arthritis, ulcerative colitis, and multiple sclerosis are forecast to experience the fastest sales growth.
This period of dynamic growth for humanized and fully human antibodies plus the continued rollout of antibody-drug conjugates (ADCs), also called immunoconjugates, is expected to result in stagnating sales of chimeric antibodies from 2011 through 2016.
INTENDED AUDIENCE
This study will be of interest to those working in the biotechnology and pharmaceutical industries and related life science, drug discovery, and diagnostic test manufacturing companies, as well as all those interested or actively working in drug research.
Both individuals looking for a comprehensive listing of mAbs in human clinical-stage development and individuals looking at how the mAb drug marketplace is expected to change (in terms of sales and technology) in the coming years will find this report extremely useful.
SCOPE OF REPORT
This report analyzes and assesses therapeutic applications of mAbs in human medicine. Covered in this report are mAbs exclusively, including the combination of mAbs when they are attached to a cytotoxic agent such as with ADCs.
Excluded from this report are diagnostic uses of mAbs (such as for imaging purposes) and therapeutic antibodies for veterinary use. Also excluded are research applications of mAbs.
The scope of the study is global. The “Overview” section provides a discussion of the importance and advantages of antibody-based products, valuation of antibody product sales, patent issues and differences in applicability of mAbs products versus polyclonal antibodies (pAbs), and other competing agents such as small molecule therapeutics.
The “Technology and Technical Issues” section discusses new directions in antibody research, the types of antibodies used as therapeutics, the challenges in antibody production, and other approaches—in particular transgenic sources—of antibody production.
The “Products” section provides a synopsis of more than 60 mAb drugs, including those currently marketed and those in late-stage development. Comparative product and sales analyses are provided for individual products. Tables include current and forecasted sales by individual product, sales by target and technology (for mAb-based drugs), as well as global market size and growth estimates for therapeutic mAbs.
The “Applications” section provides an overview of the leading indications for available and emerging antibody-based therapeutics. These include selected indications for autoimmune diseases (specifically rheumatoid arthritis, psoriasis, and Crohn’s disease), cancer indications (specifically the most common solid tumor types, leukemias, and lymphomas) cardiovascular diseases, infectious diseases, ophthalmic indications, and respiratory diseases.
The “Industry Structure” section provides an overview of the antibody industry as well as a discussion of the pending huge impact of genomics and the emergence of biotechnology firms into the mainstream market.
The “Company Profiles” section emphasizes 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.
INFORMATION SOURCES
The information in this report was derived from the review of more than 200 biotechnology and pharmaceutical companies developing mAbs and the review of journal articles related to mAb therapeutics. Sources of information include PubMed, ClinicalTrials.gov, the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMEA), and company presentations and annual reports.
ANALYST CREDENTIALS
Esther Bosklopper has been an analyst working in the biotechnology and pharmaceutical industry and other life sciences industries for more than six years. She holds a degree from the University of California, Davis..
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DISCLAIMER
This publication provides informative material of a professional nature. It does not constitute managerial, legal, or accounting advice, nor should it serve as a corporate policy guide or an endorsement of any given product or company. This information is intended to be as accurate as possible at the time it was written and was undertaken on a best-effort basis. The views expressed are those of the author and do not make any warranty, express or implied, for the accuracy, completeness, or usefulness of the information, or for the interpretation of data or its use by others. Projections involve risks and uncertainties that include but are not limited to technical risks associated with technology development, government regulatory approvals, and access to capital. The author assumes no responsibility for any losses or damages that may result from one’s reliance on this material.
Source: BCC Research 
