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More than 165 recombinant drugs are currently approved for use in humans. An additional 500 protein candidates are in preclinical and clinical development, of which approximately 70% are glycosylated proteins. Protein therapeutics are the largest class of new products being developed by the biopharmaceutical industry. To meet the increasing demand for the production of protein therapeutics, efforts are being applied to expression systems to increase productivity and protein quality. The expression systems of biotherapeutic glycoproteins mainly include the yeast system, mammalian system, insect cells, and plant expression system.
The complex biotherapeutic glycoproteins are typically from mammalian systems. Insect cells are alternative systems for expressing recombinant bio-therapeutic proteins. Yeast and humans have the same N-glycan linkage. Of all the systems, mammalian systems have been well established in the pharmaceutical field.
Fig.1 N-linked glycans on glycoproteins produced in different expression systems. (Ma, 2020)
North America dominates the global bio-therapeutic glycoprotein market, in which the United States is a major stakeholder because of the high acceptance of bioactive peptides. Due to the increase of research, Europe and the Asia Pacific have become the fastest-growing markets in the bio-therapeutic glycoprotein market. The Middle East and Africa region and Latin America also saw significant growth.
Due to the potential health benefits, the global market for bio-therapeutic glycoproteins is growing rapidly. Because of the high efficiency of alternative production systems such as yeast systems, insect systems, and plant systems, manufacturers are focusing more on alternative production systems. The wider market for bio-therapeutic glycoproteins has also witnessed an increase in regulatory support and government funding. The bio-therapeutic glycoprotein market is expected to grow at a CAGR of two times over the forecast period.
Advances in the production of biopharmaceuticals have evolved from cell engineering and bioprocess development of efficient expression systems that produce glycoproteins with appropriate structures for efficacious clinical application. Future developments in the expression systems will focus on the enhancement of productivity to meet the growing demand for these products and the refinement of their function so that the dosage requirements are minimized.
Bio-therapeutic glycoproteins have a wide range of applicability and are the fastest developing fields in the pharmaceutical industry. They represent a combination of treatments for most autoimmune diseases, cancers, and alternative therapies such as hormones and enzymes. All of these benefits are driving strong growth in the biotherapeutic glycoprotein market.
Manufacturers' manufacturing capacity limits the use of glycoprotein, its high cost, and limited control, all of which have inhibited the growth of the biotherapeutic glycoprotein market.
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