Biologics or biosimilars are biological drugs designed to have similar active ingredients as that of patented drugs and are approved by regional drug regulatory agencies like US Food and Drug Administration (USFDA) and European Medicine Agency (EMA). Factors like expiry of patent protection for blockbuster biopharmaceutical drugs and escalation in healthcare costs are major reasons contributing to the demand of biosimilars.
Global biosimilar market is classified on the basis of products and applications. The product segment comprises erythropoietin, insulin, human growth hormone, monoclonal antibodies (MAbs), colony stimulating factors, interferon and others. Out of these, erythropoietin contributes the maximum to the market revenue due to high approval rate for commercialization. Whereas interferon is witnessing higher growth due to wider applicability across diseases. Additionally, by applications, biosimilar market is segmented into oncology, blood disorders, autoimmune and growth deficiency disorder, wherein blood disorders contributed the highest sales due to highly priced biosimilar and their frequent applications. However, biosimilar pertaining to autoimmune and chronic diseases are expected to show the most promising growth in near future.
Factors such as patent-cliff, growing demand of biosimilar drugs, escalating pressure to control healthcare costs by governments and increasing prevalence of chronic diseases are propelling growth of global biosimilar market. The market is witnessing rising collaboration between larger biopharmaceutical companies and regional players to seek opportunities globally. In addition, monoclonal antibodies and colony stimulating factors are emerging as promising areas for new companies looking to enter the market.
Global biopharmaceutical companies face greater complications pertaining to biosimilar approvals as each product has regulations specific to its formulation, implying higher complexity to authorization of new biosimilar product. USFDA has also shown concerns over interchangeability of biosimilars over health safety grounds, which raises demand for stringent standards.
ASDReport.com has an extensive collection of reports on biosimilars market. The reports cover emerging biosimilar drugs and other related topics like, biosimilar monoclonal antibodies, oncology biosimilars and much more.