The global biosimilars market contributed an overall revenue of $2.5 million in 2014 and is forecast to generate an approximate revenue of $26.3 million by 2020, growing at a CAGR of 49.1% from 2015 to 2020, according to Allied Market Research.
Allied Market Research has published a report, “World Biosimilars Market (follow-on-biologics) Opportunities, and Forecast, 2014-2020,” found the market for follow-up biologics has originated primarily due to the expiry of patent protection for many biological medicines, including many blockbuster biopharmaceuticals. These biological medicines are highly priced and coupled with rising healthcare costs globally have led to the increased demand for biosimilars.
Biosimilar may need to be approved by different regulators such as such as the EMA, the FDA and WHO to be launched in the market; developers have to prove the biosimilar to be either interchangeable with the referenced biologics in terms of efficacy or function or show them to have no meaningful clinical difference with the original biologic drug. Favorable regulatory environments across major regions such as U.S and Europe and the establishment of regulatory pathway for getting an approval for biosimilar are the factors that would persuade more developers and companies to invest in the market.
The market for biosimilars in the U.S. has gained momentum after the launch of Novartis' Zarxio (Filgrastim-sndz) in September 2015. Zarxio, the first biosimilar to be approved in the U.S., was a significant development resulting in promising emerging trends for the growth of global biosimilars market. The drug developed by its generics unit Sandoz is follow-on to Amgen’s referenced biologics Neupogen (filgrastim). Sandoz claims that the launch of biosimilar has led to the gradual erosion of the market share of Amgen’s Neupogen; as Amgen's Q1 2016 results NEUPOGEN (filgrastim) sales decreased by 13 % driven by the impact of intense market competition in the U.S.
As The U.S. region would contribute single-digit revenue share in overall biosimilar market by 2020. Recently, in March 2016, the U.S. FDA has approved its second biosimilar product Inflectra (infliximab-dyyb) as a reproduction of Janssen Biotech’s drug Remicade (infliximab). Though, Inflectra has already got its approval to market in countries such as Canada, Mexico, Australia, and various European regions, it is the first biosimilar monoclonal antibody to be approved in the U.S. Such developments would unlock new opportunities for pharmaceutical companies and drug developers in the global market.
Erythropoietin and monoclonal antibodies, types of Glycosylated proteins, form the leading segments commercially available across the globe; together they accounted for about one-third of the total market revenue in 2014. Their demand is driven by the potential application in the treatment of several chronic conditions such as blood related disorders, cancer, and others.
Emerging trends suggest that Europe is attracting major investors interested in biosimilars industry; the growth prospects are driven by streamlining of regulatory guidelines and high adoption rate for biosimilars among physicians, payers and patients.
Many governments in European countries have commissioned studies that focus on promoting the biosimilar Remsina, considered as a replacement of biological drug Remicade; these measures would considerably foster the market growth across Europe. Furthermore, the biosimilar being sold in many Nordic countries at a huge discount rate—around 75% —will further boost its adoption.
Among various application segments of biosimilar market, blood disorders and oncology combined accounted for about 61% in 2014. Interferon is fastest growing biosimilar, estimated to grow at a CAGR of 51.1% during the forecast period. Pharmaceutical companies and drug makers interested in investing into biosimilars market focus on the agreement and acquisitions to expand their presence in global market.