Number of pages: 100-120 | Report Format: PDF | Published date: 15 May, 2020
Historical Years – 2018 & 2019 | Base Year – 2020 | Forecasted Years – 2021 to 2031
Biosimilars are biological agents approved by the U.S Food and Drug Administration. These products are biologically identical to a known biological reference product in terms of potency, purity, and safety. The minor difference between the reference product and biosimilar is the clinically inactive compounds used in the making of biosimilars whereas the active compound remains the same.
In the U.S, Filgrastim-sndz (Zarxio) was the first biosimilar product approved by the Food and Drug Administration in 2015. Zarxio was developed by Sandoz, a Novartis company for the treatment of five indications. The five indications included patients with cancer receiving myelosuppressive chemotherapy, patients with acute myeloid leukemia receiving induction/consolidation chemotherapy, patients with cancer undergoing bone marrow transplantation, patients undergoing autologous peripheral blood progenitor cell collection and therapy, and patients with severe chronic neutropenia. Since then several other companies have launched their biosimilars in the market. According to the FDA, by the end of 2020, there were a total of 29 approved biosimilars in the market.
The global biosimilars market is mainly driven by their cost-effectiveness. Rising incidence of infectious diseases, an increasing number of pipeline products, and product launches are playing a pivotal role in contributing to the market growth globally. However, the longer time required for development, higher cost associated with the development of biosimilars, and stringent government regulations for the development and production of these products are some of the factors hindering the market growth to a certain extent.
The global biosimilars market has been analyzed from four perspectives: Products, Disease Indication, Manufacturing Type, and Region.
Biosimilars Market by Product
Based on product, the biosimilars market has been segmented into recombinant glycosylated proteins, recombinant peptides, and recombinant non-glycosylated proteins. Recombinant glycosylated proteins segment is further categorized into monoclonal antibodies, follitropin, and erythropoietin. Similarly, a recombinant peptide is categorized into calcitonin and glucagon. The recombinant non-glycosylated proteins segment is segmented into human growth hormone, insulin, interferons, and granulocyte colony-stimulating factor. The recombinant non-glycosylated proteins segment is anticipated to hold the largest market share owing to increasing product launches and product approvals.
Biosimilars Market by Disease Indication
Based on disease indication, the market has been segmented into infectious diseases, oncology, autoimmune diseases, growth hormone deficiency, blood disorders, and others. The oncology segment held the largest market share due to the rising incidence of cancers that have led to increasing R&D activities for developing cancer drugs/medicines.
Biosimilars Market by Manufacturing Type
Based on manufacturing type, the market has been segmented into In-house manufacturing and contract manufacturing. The in-house manufacturing segment held the largest market share owing to factors such as involvement of lower manufacturing costs and increasing preference for in-house production to ensure product quality and confidentiality of the manufacturing process.
Biosimilars Market by Region
Based on the region, the global biosimilars market has been segmented into North America, Europe, Asia Pacific, and the Rest of the World (RoW). Europe dominated the biosimilars market followed by Asia-Pacific. The large share of Europe in the global market can be attributed to several factors such as rising incidence of infectious diseases, rising geriatric population, and the presence of prominent players in this region. Moreover, biosimilars were approved in Europe since 2006 long before the FDA gave a nod for biosimilars in the U.S. According to a report published by the European Medicine Agency, over the past 10 years, the EU has approved the highest number of biosimilars worldwide, amassing considerable experience of their use and safety. Higher count of approved products and stronger biosimilar product pipeline by the regional players are anticipated to fuel the market during the forecasted period.
Some of the prominent players operating in the global biosimilars market include:-