Active biopharmaceutical ingredients (Bio APIs) such as proteins and peptides are gaining significance across the world. A number of peptide-based products have been developed beyond the discovery and pre-clinical stages. Several of these peptides have gone through the stringent clinical trials and are now in the market.
With recent development in synthesis and chemistry techniques, progress has been made to make peptides more stable and application oriented. In future, peptides will serve not only as research tools but also as a preferred choice for therapeutics, according to experts.
Peptides are short length proteins (approximately 1-50 amino acids) or stretches of amino acids that either occur naturally or can be made synthetically. Growth factors, hormones, and chemokines are small polypeptide molecules that act on cellular proteins to exert their function.
With the developments in proteomics, peptides are becoming important molecules for cancer therapeutics. Additionally, with the development and advancements in the areas of phage display technologies, a number of new tissue, disease, and cell specific peptides have been identified. Such peptides have shown potential in preliminary cell culture and animal studies.
It is estimated that there are over 30,000 genes and approximately 10,000 potential disease related drug targets. As these targets are cloned, characterized, sequenced, and produced in purified protein forms, phage display technologies will result in the identification of new peptide candidates for potential diagnostics and therapeutic applications.
In India, companies like Hyderabad-based Jupiter Biosciences are aiming at establishing a Global Peptide Solutions Group having a broad canvas of Peptide Chemistry products including - bulk actives, formulations, peptide reagents, coupling additives, Protecting Agents and supplier of key ingredients used in peptide based pharmaceuticals.
Jupiter plans to move up the value chain into manufacturing generic peptide APIs and finished formulations, which it would supply to generic drug marketers as well as original patent holders, for the highly regulated markets. With this objective Jupiter's US arm seeks to expand its presence in the US, which is the key target market for its products and is in the process of acquiring a company, which will engage in final stage API production as well as finished formulations.
The rising need for new therapeutic approaches, combined with the potential of peptides as Active Pharmaceutical Ingredients (API's), for effective drug formulations is contributing to rapid market development in this area. Therapeutic peptides are now viable alternatives to other biopharmaceuticals, such as antibodies, especially in the case of cancer treatment, due to their ability to penetrate tumors.
Globally, the manufacturing community is distinctly segregated as component manufacturers, manufacturers of custom and catalog peptides and bulk peptide manufacturers. Worldwide, there are approximately 10 to 12 manufacturers of bulk peptides, who include Mallinckrodt, Akzo Nobel's Diosynth, Abbott, UCB,
Zeneca LifeScience Molecules, Polypeptide Laboratories, Peninsula and an emerging player, NPE Neosystems.
Besides independent manufacturers, there are other producers that make peptides captively for internal drug development, like Genzyme Pharmaceuticals, ICN Pharma, Abbott and Zeneca. There are also around 40 manufacturers of custom and catalog peptides, including companies like Sigma-Aldrich and Merck (catalogs business). Most of these are concentrated in the US, especially the West Coast (San Diego).
There are few companies, which are present in all categories. Bachem AG is the largest among such companies and is an independent manufacturer of peptide Raw Materials, custom peptides and bulk actives. Other companies, which fall into this category, include UCB, SNPE Neosystems, Diosynth and Mallinckrodt Inc.