Abstract
STUDY GOALS AND OBJECTIVES
Protein drugs have received enormous attention from pharmaceutical companies
due to a combination of their bioreactivity, specificity, safety and overall
success rate. Yet there are still improvements to be made, especially with
respect to their formulation and delivery method. Advances in protein drug
delivery are certain to increase patient compliance and expand many drug
markets.
REASONS FOR DOING THE STUDY
Although the drug development industry still focuses primarily on small
molecules, in recent years protein and peptide therapeutics comprise a
significant percent of the product line and pipeline for most major
pharmaceutical companies. Peptide and protein therapeutics, especially
antibody drugs, are attractive due to their high specificity and potency and
low incidence of toxicity. Developments in manufacturing, including
transgenic, recombinant and synthetic methods, have been key as protein drugs
have moved into the mainstream. A previous report by BCC, Protein Drugs in
2003, discussed the early days of these manufacturing improvements and focused
on emerging recombinant methods of protein production.
Recombinant protein technologies are now standard and the current focus has
shifted from the method of bulk production to post-production techniques that
promise to enhance stability and delivery. In the effort to produce orally
available therapeutics, formulation issues have become critical.
SCOPE OF REPORT
In this report, we analyze the markets for each major class of protein
therapeutic monoclonal antibodies, cytokines, peptide hormones, vaccines and
blood products. We examine the current successes, including the size of the
global market and the sales forecast for each class through 2013. Where
appropriate, we break down the markets further to examine the major individual
protein drugs in the class. We discuss challenges such as delivery methods,
and side effects and consider issues of add-on products and patent protection.
INTENDED AUDIENCE
This study will be of interest to individuals involved in the design,
manufacture, and marketing of next-generation pharmaceuticals. Venture
capitalists, entrepreneurs, medical analysts, and research directors with an
interest in the protein and peptide drug industry will find this research
valuable. Those involved in the development of novel formulations and chemical
modifications will also find a comprehensive discussion of the challenges and
advances in the field.
INFORMATION SOURCES
This report has been assembled following an in-depth analysis of primary and
secondary data. Primary research was conducted via telephone interviews with
industry professionals, research scientists, physician-researchers, and
laboratory heads to discover the most recent developments in their fields of
interest. Secondary data was collected via a comprehensive search of the
scientific, peer-reviewed literature, clinical trial reports and databases,
industry trade media, company websites, annual reports, and industry press
releases.
The market assessments provided have been assembled based on publicly
available information up to and including August 2008. The base year for this
report is 2008 and forecast data are provided through 2013. In many cases,
figures for 2008 were not yet released and in these cases figures were
extrapolated from 2007 statistics, half-year projections for 2008, and
historical trends. Market figures are based on current dollars and inflation
is not computed into the projection figures.
ANALYST CREDENTIALS
Amy Brock has over 12 years of research experience working at the interface of
the biological sciences, bioengineering, and biophysics. Trained at the
Massachusetts Institute of Technology and Harvard University, she holds a B.S.
and Ph.D. in biomedical science. She is the author of Pharmacogenomics: New
Technologies in the Development of Personalized Therapies; Kinase Inhibitors
in Clinical Use; and Genetic Diseases and Medical Imaging.
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