Page - (000255) - in Biomedical Chemistry: Current Trends and Developments

Lower royalty stack Greater stability Produced potential for interaction with the immune system Better organ or tumor penetration. Peptides derived from natural source are receptor agonists, and generally, small quantities of these peptides are necessary to activate the targeted receptors 3.1.3.4.2 Market The USA and EU are the major markets for drugs of all kinds, so first approvals for peptide therapeutics have occurred primarily in one of these two regions. All 19 peptides approved in the USA during the period 2001 to 2012 were first approved in either the USA or EU. The notable expansion of peptide therapeutic development in the late 1990s and 2000s led to an unprecedented number of marketing approvals in 2012, and has provided a robust pipeline that should deliver numerous approvals during the remainder of the 2010 (Kaspar & Reichert, 2013). In the US, annual sales of peptide drugs exceed 13 billion, representing 1.5% of drug sales globally. Protein drugs such as therapeutic antibodies also represent a larger share with the combined biopharmaceutical market valued at over 70 billion. In Europe, Germany and the UK account for 63% of the peptide therapeutic market with France, Italy, Scandinavia and Spain making up the rest of the major users (Hervé, 2008). According to a review by Vlieghe, more than 60 synthetic therapeutic peptides (including those used for medical diagnostics or imaging) with a size < 50 amino acids, have reached the American, European and/or Japanese pharmaceutical markets through marketing authorization as APIs (Vlieghe, 2010). The peptides at each phase of development are undergoing evaluation for a wide variety of indications (Fig. 3.1.14). The diversity of therapeutic areas (TAs) represented is substantially higher in Phase I and II compared with Phase III, which is at least in part because of the