Dynamic Antibody Industry, Including Polyclonals and Monoclonals

Report Highlights

• As of May 2002, there were 11 therapeutic monoclonal antibody products on the U.S. market. Worldwide, there were an estimated 470 monoclonal antibody products in development by more than 200 companies for the treatment of virtually every debilitating disease. Approximately 70 of these monoclonal antibody products were in clinical trials. According to the Pharmaceutical Research and Manufacturers of America (PhRMA), monoclonal antibody products represented approximately 20% of all products in development and 33% of all biotech products in development by its members.
• The therapeutic monoclonal antibody market is projected to have an average annual growth rate (AAGR) of approximately 25% throughout the forecast period. The therapeutic polyclonal antibody market, which is driven more by volume and demand than innovation, is projected to see an AAGR of just less than 11%. The diagnostic imaging market, though small, will see average annual growth exceeding 28% throughout the forecast period.

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 development, marketing, market research, product development, mergers and acquisitions, licensing, 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 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 literature was used as to obtain expert opinion on commercial potential and market sizes from industry professionals.