New Market Study Published: Biosimilars Market - Global Forecast to 2018

Biosimilars Market by Product [Recombinant Non-Glycosylated Proteins (Insulin, Filgrastim, Somatropin), Glycosylated (Monoclonal Antibodies, Erythropoietin), Peptides (Glucagon, Calcitonin)] & Application (Oncology, Blood Disorders) - Global Forecast to 2018

The biosimilar products market is segmented into recombinant non-glycosylated proteins, recombinant glycosylated proteins, and recombinant peptides. The recombinant non-glycosylated proteins market is further segmented as insulin, granulocyte colony-stimulating factor (G-CSF), interferons, and human growth hormone; whereas the recombinant glycosylated proteins market is further broken down into erythropoietin, monoclonal antibodies, and follitropin. Calcitonin and glucagon are considered in the recombinant peptides market. The recombinant glycosylated proteins segment is expected to witness the highest growth due to the increased demand for monoclonal antibodies in the treatment for cancer (oncology), autoimmune disorders, blood disorders, and infectious diseases. Oncology will be the fastest-growing segment and currently accounts for a 25% market share in the global market in 2013. Following monoclonal antibodies, biosimilars of insulin will be the fastest-growing products and are estimated to grow at a CAGR of 35.6% from 2013 to 2018. The growth is attributed to the rise in incidences of diabetes; ongoing patent expirations of biologic drugs such as Lantus, Humalog, and Novorapid; and the cost effectiveness of the biosimilars of insulin.

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Other notable driving factors for the global market include increasing number of off-patented drugs, positive outcome in the ongoing clinical trials, and rising demand for biosimilars in different therapeutic applications such as rheumatoid arthritis and blood disorders.

Market dynamics analysis has identified that rising budgetary pressures to reduce healthcare expenditures, increasing aging population, growing demand for cost-effective alternatives, rising incidences of various diseases, and conducive government initiatives are significant factors propelling the market in the forecast period (2013 to 2018). On the other hand, stringent regulatory environment, high manufacturing complexities and costs, and high-entry barriers are considered to hinder the market growth. Additionally, the different terminology and guidelines for biosimilars across regions will further burden the biosimilars industry. Generic versions of biologic drugs approved under the European Medical Agency (EMA) regulatory pathway and section 351K of the U.S. FDA are considered as biosimilars. In the U.S., biosimilars are also known as follow-on-proteins and have been approved under section 501(b), whereas in Canada, biosimilars are called Substituent Entry Biologics (SEB).

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