Protein-based therapeutics may be moving from a second-string opportunity to a first-draft prospect. The market for protein-based therapeutics is significant and growing at a rate that is well above what one would call average for the therapeutics/pharmaceuticals industry. A large product pipeline and many competitors are operating in the market and will continue to do so, presaging high growth, at least in the long term.
There are many protein-based therapeutic products currently in clinical trials and there are probably at least as many in preclinical stages. But the number of FDA-approved products has been declining over the last two years and has decreased significantly in recent years. Moreover, those products that have been approved recently have been less novel than previous entries, with less impact on economics and healthcare.
The trend has been more toward a me-too approach and the use of existing technologies (monoclonal antibodies in particular) to develop new biopharmaceutical products. More and more biopharmaceutical development projects are addressing fewer and fewer new disease targets.
At this point in time, market expansion will primarily be affected by the introduction of new products; but also through the introduction of existing products for additional indications. This is especially true for cytokines, hematopoiesis factors, and vaccines—particulary cancer vaccines. The markets for these products are expected to experience robust growth over the next ten years, and the addition of indications to the labeling will be important.
There is continual reference to protein therapeutics as if this concept were one class of therapeutics, unified by a single type of compound—a protein. Nothing can be further from the truth. Each substance or group of substances associated with protein therapeutics does have one thing in common—they are all composed primarily of a-amino acids; and these a-amino acids are linked together by a peptide bond. In this report, we consider four classes of protein-based therapeutics: peptides, proteins, enzymes, and antibodies.