The modification of peptide, protein, and non-peptide with the linkage of one or more polyethylene glycol (PEG) chains is known as PEGylation. The polymer formed through PEGylation is non-immunogenic, non-antigenic, nontoxic, and highly soluble in water. PEG-drug conjugates offer several advantages over non-conjugated drugs such as elimination or reduction of protein immunogenicity, prolonged half-life, and less degradation by metabolic enzymes. PEGylation was first described by Davies and Abuchowsky in the 1970s. The process has been expanded and developed since then. A wide range of enzymatic and chemical methods for conjugation are available presently. The U.S. FDA has approved various PEGylated therapeutics for the treatment of diseases including autoimmune diseases (multiple sclerosis, gout, and Crohn's disease), hepatitis C, hepatitis B, cancer, hemophilia, anemia associated with chronic kidney disease, and neovascular age-related macular degeneration.
PEGylated protein therapeutics is projected to be a highly lucrative market in terms of revenue, with over 10 PEGylated drugs approved by the U.S FDA and 20 drugs in clinical trials. First generation PEGylated drugs were obtained through random PEGylation. Oncaspar and Adagen are two examples. Most of the drugs in clinical trials are PEGylated with larger PEGs compared to first generation therapeutics in order to increase the half-life and decrease the frequency of administration of these therapeutics. Bayer, Novo Nordisk, and Baxalta have a total of four long-acting hemophilia drugs based on PEGylated recombinant coagulation factors in phase III clinical trials. These promising ongoing clinical trials are expected to provide significant opportunities in the market during the forecast period.
The global PEGylated protein therapeutics market can be segmented based on type of PEGylation, application, distribution channel, and region. In terms of type of PEGylation, the market can be bifurcated into random PEGylation and site specific PEGylation. Based on application, the global PEGylated protein therapeutics market can be classified into cancer, autoimmune diseases, hepatitis, hemophilia, kidney disorder, and others. In terms of distribution channel, the PEGylated protein therapeutics market can be divided into hospital pharmacies, retail pharmacies, and online pharmacies. In terms of region, the global PEGylated protein therapeutics market can be segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa.
North America and Europe are anticipated to be attractive PEGylated protein therapeutics market. Well-established health care infrastructure and funding from public and private sectors for R&D are projected to propel the market in these regions. Acceptance of technologically advanced devices and novel drugs with ongoing clinical trials in PEGylated therapeutics are expected to drive the market in North America. Asia Pacific is expected to account for a significant share of the global market in terms of revenue during the forecast period. Rise in support from governing bodies and the private sector in developing effective and novel therapeutics and distribution network is anticipated to drive the PEGylated protein therapeutics market in the region. Moreover, high prevalence of chronic and rare diseases in Asia Pacific offers large opportunities to players operating in the PEGylated protein therapeutics market. Japan and Australia are well-established markets in Asia Pacific; however, emerging economies such as China and India present significant opportunities in the PEGylated protein therapeutics market in the region. Other regions such as Middle East & Africa and Latin America are anticipated to be prospective markets for PEGylated protein therapeutics in the near future due to the high adoption rate of advanced therapeutics and the rapidly developing health care industry in the regions.
Major players operating in the global PEGylated protein therapeutics market include AstraZeneca plc, Pfizer, Inc., UCB S.A., Amgen, Inc., Merck & Company, Inc., F. Hoffmann-La Roche Ltd., Shire plc, Biogen, Inc., and Horizon Pharma plc.
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