Protein Drugs: Manufacturing Technologies - Market Research

Protein Drugs: Manufacturing Technologies

Product Type: Market Report
Published Date: July 2000
Published By: Business Communications Co.
Order Code: R2-385
PDF Format (single user) $3968
Study Goal and Objectives
The objectives of this study are as follows:
Ascertain the commercial manufacturing methods used to produce bulk therapeutic proteins
Estimate worldwide bulk production (in grams) of drug proteins
Forecast worldwide bulk production through 2004
Place the contribution of recombinant DNA technology in context
Identify bulk drug protein producers as opposed to formulation suppliers
The goals of this study are to shed light on a partially obscure, yet important aspect of protein drugs, and to provide business-oriented technical information.
Reasons for this Study and Its Contribution
Protein drugs have emerged from the shadows to become, in the last 20 years, significant weapons in the arsenal against illness. While there are a number of conventionally made proteins, those proteins resulting from the biotechnology revolution are driving the future growth of the protein-drug industry.
The main contributions of this study are the estimation of individual bulk protein quantities and their grouping by principal manufacturing methods. While other published studies on protein drugs look at the more obvious sales aspects, this study looks specifically at how these proteins are made and how much is made. We forecast how the proteins will be made in the future, and in what quantities. Most published studies on the subject of protein drugs ignore the bulk manufacturing and quantity aspects because of the difficulties involved in finding or deriving the relevant information.
Also, this study analyzes the problems that affect protein drug manufacturing, and considers the technical and business opportunities that these problems suggest. We look at technical trends in protein drug manufacturing and examine reasons why the state of the art is where it is today.
Audience for this Report
This study is written for manufacturers of formulated protein drugs and producers of bulk drug proteins, and for those at the research and clinical stages of protein drug development and manufacture. Also expected to derive benefit are contract producers and the vendors of raw materials and equipment needed for bulk protein manufacturing.
Scope and Content of this Study
This study covers the commercial manufacture of bulk proteins serving, or intending to serve, human therapeutic drug applications. We concern ourselves with how the proteins actually are made for medical commerce ? or will be made, once approved.
This study takes up the broad categories of source extraction from human, animal and plant materials, microbial fermentation, cell culture, and chemical synthesis as bulk protein manufacturing methods. However, we do not provide detailed recipes or procedures for specific proteins. Also, we do not offer advice or counseling on the manufacture of proteins. Both regular and recombinant (including transgenic) protein manufacture are included within the scope of this study. This study also discusses the actual production of recombinant proteins, but excludes the in-lab genetic engineering aspects.
While this study provides discussion of post-bulk production operations, and data on formulation volumes and excipients for protein drugs, we do not go into detail on post-bulk production.
Excluded from consideration in this study are the methods and quantities of proteins produced for laboratory use, the methods and quantities of proteins produced for clinical trials, the methods and quantities of proteins for in vitro diagnostic use, and the methods and quantities of proteins for in vivo diagnostic use. Proteins for veterinary use, their methods of production, and quantities are also excluded, as are protein methods and quantities for other applications. This study focuses only on commercial methods of bulk manufacture for proteins of human therapeutic use or potential use.
This study does not analyze sales of formulated protein drugs to any significant degree. For detailed sales information and analysis, readers should turn to other BCC published studies, such as report C-065N in three volumes.