INTRODUCTION
OBJECTIVES AND GOALS OF STUDY
The aim of this report is to provide a range of information-from detailed
market analyses through industry trends-to quantify and qualify the emerging
market for monoclonal and polyclonal antibody drugs. Forecasts and trends are
gleaned from industry sources as well as from considered assessment of available
and emerging technologies. The report develops forecasts for the pharmaceutical
antibodies market for major disease applications from 2001 through 2007 and
examines strategies employed by biotechnology companies and pharmaceutical firms
to develop and market products in this explosive market sector.
CONTRIBUTION OF THE STUDY AND FOR WHOM
Antibody-based drugs, in particular monoclonal antibody-based products, began
to enter the market in earnest in the late 1990s. After years of struggling with
technical obstacles, products are emerging that are significantly changing the
treatment of certain diseases. In 2002, antibodies were the single largest class
of therapeutics in clinical development with the exception of vaccines. It is
estimated that some 70 monoclonal antibody products were in clinical trials in
2002 and approximately 470 were estimated to be in development worldwide by some
200 companies. Essentially every biotech and pharmaceutical company, large or
small, has a research program that centers on monoclonal antibodies.
The information and analysis presented in this report on antibody-based drugs
is an important asset in decision-making for managers involved in business
development, marketing, market research, product development, mergers and
acquisitions, licensing, business management, investment banking and deal
creation, and to consultants to the pharmaceutical and biotechnology industry.
The study provides a comprehensive analysis of the current markets for antibody
drugs and, in particular, the market potential of promising drugs and
technologies under development.
STUDY SCOPE AND FORMAT
This report analyzes and assesses therapeutic and in vivo diagnostic imaging
applications of antibodies in human medicine. Included in this report are both
monoclonal and polyclonal antibodies.
Excluded from this report are therapeutic and diagnostic imaging antibodies
for veterinary use. Also excluded are research applications of antibodies.
The scope of the study is worldwide. The Overview section provides a
description of major technical issues involved in the development of antibody
drugs, new directions in antibody research, valuation of antibody product sales,
major business issues and differences in applicability of monoclonal and
polyclonal antibody products.
The section on Technology describes antibody classes, types of products and
technical trends.
The Products section provides a synopsis of approximately 70 monoclonal and
polyclonal antibody drugs and diagnostics, including those currently marketed
and those in Phase II or later development. Comparative product and sales
analyses are provided for individual products. Tables include current and
forecasted sales by individual product as well as worldwide market size and
growth estimates for the monoclonal and polyclonal therapeutic and diagnostic
categories as a whole.
The Therapeutic and Diagnostic Applications section provides an overview of
the leading indications for available and emerging antibody-based therapeutics
and diagnostics. These include selected indications for cancer, cardiovascular
diseases, infectious diseases, organ transplant rejection, bone marrow
transplants/graft-versus-host disease, rheumatoid arthritis, Crohn's disease, Rh
isoimmunity and psoriasis.
The section on Industry Structure provides an overview of the structure of
the antibody industry as well as a discussion of the pending huge impact of
genomics and of the emergence of biotech firms into the market mainstream.
The section on Company Profiles emphasizes companies that lead the
pharmaceutical and biotechnology industry in the research and development of
antibody drugs and the innovative products they have launched or have in
development.
METHODOLOGY
The base year for this study is 2002. Figures are based on revenue figures at
the manufacturers' level and are projected at 2002-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 or which have products in development for this market.
INFORMATION SOURCES
The information and analysis 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 as to obtain expert opinion on commercial
potential and market sizes from industry professionals.