173 pages

Date Published:
March 2011

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Monoclonal Antibodies in the Pipeline: A Segment of Major Growth Report - Overview


Report CoverAuthor: Peter Norman, MBA, PhD 

Monoclonal antibodies are highly valuable therapeutic agents and were among the best-selling drugs in the world in 2010. Global revenues from monoclonal antibody products will have moved significantly past the $40 billion level in 2010 and are poised to continue growing steadily through to 2015.

  • Nearly 300 monoclonal antibodies currently in clinical development, organized by indication and/or target
  • Sales of currently marketed monoclonal antibodies, market share by company, and projected market growth
  • Anticipated filing dates for prospective products and their commercial prospects
  • Threats such as reimbursement constraints and the emergence of biosimilar products
  • Enabling and emerging technologies for optimization of therapeutic monoclonal antibodies
  • Corporate profiles of monoclonal antibody product-focused and technology-focused companies

As discussed in this report, approximately 286 monoclonal antibodies are in various stages of clinical development. Oncology is the area of greatest activity, with approximately 150 new monoclonal antibodies in the clinic for cancer indications. Some 70 monoclonal antibodies are in clinical development for treatment of inflammatory and autoimmune diseases. Monoclonal antibodies in clinical development for other indications include 15 products for treatment of various metabolic disorders, 16 for CNS disorders, and 25 for infectious diseases. A further 10 are in development for treatment of cardiovascular diseases or transplant rejection.

Monoclonal Antibodies in the Pipeline: A Segment of Major Growth discusses emerging technologies to improve the therapeutic characteristics of monoclonal antibodies. As injection is likely to remain the delivery route, the focus is on trying to ensure subcutaneous delivery while minimizing injection-site events and dosing frequency. PEGylation is seen as one of the simplest methods to enhance the pharmacokinetic properties of an antibody and alter its formulation properties. Therapeutic modification is being effected by efforts to improve the design of antibody conjugates and develop dual-specificity antibodies.

Discussed in this report are seven major companies that can be described as the key players in the supply and development of monoclonal antibody-based products, each with in excess of $1 billion from 2009 sales of antibody products. Also presented are major companies that currently derive only modest revenues from antibody products, several of which have made strategic acquisitions to enhance their pipelines of monoclonal antibodies and their capabilities to develop them. Smaller technology-focused companies hence remain a major source of innovation in the antibody market, both for developing new technologies and as a source of antibodies for licensing deals; 21 such companies are profiled in this report.

Recent approval rates for monoclonal antibodies suggest this momentum will continue through the period 2011–2015. Eighty percent of the antibodies that we expect to be approved during this period appear to have significant commercial potential. New antibodies for the treatment of different cancers, allied to continued growth in sales of established products, will result in steady growth in product revenues for this market segment. Commercial prospects for the anti-inflammatory segment also look good, with substantial revenue growth anticipated. Monoclonal Antibodies in the Pipeline: A Segment of Major Growth projects market values for these two major segments, as well as for the overall monoclonal antibody market, to the year 2015. The commercial prospects for monoclonal antibodies comprising additional market segments are also analyzed.

About the Author:

Peter Norman, MBA, PhD, is a pharmaceutical consultant and analyst based in Burnham Beeches, near Windsor, England. He has written and pre-sented widely on various aspects of respiratory disease, drug development, and the analysis of diverse therapeutic markets. Dr. Norman has over 20 years of experience of the pharmaceutical industry in both R&D and competitive intelligence. His publications include many reviews, 16 original scientific papers, and 11 patents, together with a number of management reports. The latter have been published by a number of companies including Insight Pharma Reports (CHI), Business Insights, FT Pharmaceuticals, Urch Publications, SMi, Decision Resources, and Informa. Dr. Norman holds science degrees from Cambridge University and Brunel University and an MBA from the Open University.