 By 2004, human therapeutic protein sales will reach $20 billion in the global market, about 5% of the total drug market. The current therapeutic proteins, used for the treatment of various human diseases with $300 million to 2 billion US sales, are produced mostly by recombinant DNA technology in mammalian cell culture. This therapeutic protein market has an annual growth rate of 25-30%. However, therapeutic proteins are fast becoming victims of their own success, and a looming deficit in biomanufacturing capacity, along with the very high manufacturing expense, threatens to restrict the commercial expansion of this group of products.
The current cost of 1 kg of cGMP standard therapeutic protein ranges from a few million to $10 million US (including manufacturing plant and capital expenses). The expense of treatment using therapeutic proteins runs from thousands to tens of thousands of US dollars per person per year. Many therapeutic protein therapies require a high dose to function properly, especially monoclonal antibody (mAb) therapy, which might require 1-10 mg for each dose (about 10-100 times more than other protein drugs). Therefore, a mAb drug will require a production of a few hundred kg per year, assuming 40-100 thousand patients per year.
Consequently, BioAgri’s technology has a major opportunity to produce large quantities of low cost proteins from transgenic chickens’ egg whites and transgenic cows’ or goats’ milk.
|
