A biosimilar or subsequent entry biologic is a biomedical product which is a copy of the original drug or pharmaceutical which is manufactured by a different company. Biosimilars are made of complex molecules such as monoclonal antibodies, human insulin, and erythropoietin. These are developed using animals, plants, bacteria, yeast and viruses with the help of controlled gene expression methods and recombinant DNA technology. Biosimilar market is expected to witness a lucrative growth throughout the forecast period as because biosimilar drugs are cost effective as compared to synthetic, their increasing usage in the treatment of severe conditions and diseases like heart attacks, oncology, chronic kidney failure, cancer, autoimmune diseases, growth hormone deficiency. The expected lapse of a number of biologic patents through to 2022 is also expected to boost demand in the biosimilar market.
The global biosimilar products are classified on the basis of biological drug classes and encompass recombinant peptides, recombinant non-glycosylated, and glycosylated proteins. The recombinant peptide market includes Glucagon and Calcitonin. The recombinant non-glycosylated proteins include granulocyte colony-stimulating factor, insulin, human growth hormone and interferons while monoclonal antibodies, follitropin and erythropoietin form the glycosylated proteins market. It is expected that the glycosylated proteins will witness a steady growth in market demand because of higher investment by drug producers and manufacturers in order to develop biosimilar of monoclonal antibodies, introduction of new biosimilar drugs such as Ovaleap (follitropin) and increasing demand for erythropoietin and monoclonal antibodies for the treatment of cancer. Monoclonal antibodies are expected to witness a steady growth in the demand through to 2022 owing to their increasing application in the treatment and monitoring of cancer, autoimmune diseases and molecular diagnostic techniques, and growing investments in cost effective pharmaceutical products supported by corporate and government fundings.
The global biosimilar market is segmented into North America, Europe, Asia-Pacific, Latin America and MEA. In 2014 the largest share of market was occupied by North America. The strong market position of this region can be accounted for by the presence of a well defined regulatory framework, reference pricing system, presence of large number of biosimilar drugs under research and development in product pipelines and growing acceptance of biosimilars. Asia-Pacific is expected to provide lucrative opportunities of growth in the biosimilar market owing to a semi-regulatory environment, low manufacturing costs and availability of highly skilled labours at low cost. The major participants in the biosimilar market are Biopartners, Sandoz, Hospira, Mylan, Teva, Amgen, Biocon Ltd., and Innovent Biologics, Inc.
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