Between 2011-2016, the FDA has approved 62 therapeutic proteins for a wide variety of therapeutic indications, including: hematology, oncology, musculoskeletal disease, endocrinology, immunology, cardiology/vascular disease, dermatology, infectious disease, ophthalmology, pulmonary/respiratory disease, gastroenterology, genetic disease, nephrology and rheumatology. These approved therapeutic proteins serve to meet unmet medical needs in a very wide spectrum of intended patient populations.
Graph 1: U.S. Food and Drug Administration-approved protein therapeutics (2011–2016)
To understand the importance of this relatively new approach to therapy, one needs to understand the wide-ranging roles and functions that proteins play in maintaining a healthy body. Table 1 shows the five basic categories of proteins and their critical roles. Whenever any of these proteins is not in its “right” condition, e.g. deficient, or non-functioning in its normal capacity, a disease will be the ensuing result.
Therefore, it should not be a surprise that the market size for therapeutic proteins is enormous. It was reported that the achieved global sales for therapeutic proteins in 2010 was over $90 B (13.8% of the total global market for pharmaceuticals, approximately $650 B, in the same year).