The Therapeutic Proteins Industry
Therapeutic proteins are proteins that are either extracted from human cells or engineered in the laboratory for pharmaceutical use. The majority of therapeutic proteins are recombinant human proteins manufactured using non-human mammalian cell lines that are engineered to express certain human genetic sequences to produce specific proteins. Recombinant proteins are an important class of therapeutics used to replace deficiencies in critical blood borne growth factors and to strengthen the immune system to fight cancer and infectious disease. Therapeutic proteins are also used to relieve patients' suffering from many conditions, including various cancers (treated by monoclonal antibodies and interferons), heart attacks, strokes, cystic fibrosis and Gaucher's disease (treated by Enzymes and blood factors), diabetes (treated by insulin), anemeia (treated by erythropoietins), and hemophilia (treated by blood clotting factors).
The FDA has approved 75 therapeutic proteins, also known as biopharmaceuticals, and there are more than 500 additional proteins under development. Worldwide sales of therapeutic proteins were reported to be approximately $53 billion in 2005, and are expected to increase to more than $70 billion by 2008. To date, most of the growth has been in sales of erythropoietins (used to treat anemia) and insulins (used to treat diabetes). Many of the proteins currently on the market will lose the protection of certain patent claims over the next 15 years. In addition, many marketed proteins are facing increased competition from next-generation versions or from other therapeutic proteins approved for the same disease indications.
Because proteins are broken down in the gastrointestinal system, marketed therapeutic proteins must be administered by injection. Once in the bloodstream, therapeutic proteins are broken down by enzymes and cellular activity, as well as filtered out of the blood by the body's organs. Therefore, injections must be given frequently to achieve effective therapeutic levels.