Protein Drugs: Global Markets and Manufacturing Technologies

 

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. 

 

 

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. 

 

 

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. 

  

 

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.

 

 

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 2008-08-15. 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. 

 

 

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.