Recent approval of Zarxio (filgrastim-sndz) as first biosimilar by U.S. FDA has opened new opportunities for biosimilar manufactures. Patents for number of blockbuster bio-pharmaceuticals have either expired or are on the verge of expiration, which is majorly driving the growth of biosimilars industry. Changes in regulatory guidelines and convenient biosimilar drug approval processes have a major impact on the commercial growth of global biosimilars market. However, the high investment associated with research and development, longer development processes and requirements of economies of scale for profitability largely limit the growth of biosimilars market. The integration of developmental plan with regulatory guidelines and the adoption of optimal commercial strategies would play crucial role in commercial growth of biosimilars market.
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The market is driven by factors such rising prevalence of chronic diseases such as cancer and diabetes supplement the growing demands of pharmaceutical drugs, especially for the high priced patented drugs. However, the market growth is limited by the high cost of reference products increases the financial burden on patients as well as reimbursement service providers. The lack in economies of scale due to lower demand is a factor that results in these high costs. Furthermore, the growth of the biosimilars market is hampered due to the lack of regulatory guidelines, consumers brand preferences, reluctance of physicians to prescribed biosimilars and the high capital required for research and development. Countries from the European Union presently dominate the market owing to the favorable government regulations in this region. North America biosimilars market is currently witnessing restrictions due to the flexible and ineffective regulations.
Segment review
The product segment in the biosimilars market comprises of Human Growth Hormone, Erythropoietin, Monoclonal Antibodies, Insulin, Interferon, Colony Stimulating Factors and others. The biosimilars applications market is segmented into blood disorders, oncology diseases, chronic and autoimmune diseases and growth hormone deficiency. The application of biosimilars in blood disease treatment is the highest revenue generating segment owing to the high-priced reference biologics and frequent application.
Glycosylated proteins namely, erythropoietin and monoclonal antibodies are the leading biosimilar segments commercially available across the globe, together accounting for about one-third of the market revenue in 2021. This significant hold in the market is chiefly due to its large application in the treatment of chronic conditions such as blood related disorders, cancer, among others.
European region is the leading beneficiary of biosimilars market and is attracting investors, interested in biosimilars industry. The prospects in the European region are largely supplemented by the presence of streamlined regulatory guidelines and a high level of adoption for biosimilars among physicians. The establishment of favorable regulations such as Article 10(4) of Directive 2001/83/EC by the European Medical Association (EMA) has clarified the clinical aspect of biosimilars. This standard set by EMA has attracted investors to invest into the development of biosimilars. The Asia-Pacific region projects the fastest growth rate, supplemented by the high prevalence of chronic diseases and the growing demand for economic bio-pharmaceuticals. The commercial scenario of biosimilars in North America is bleak due to the absence of regulations for approval and commercialization. However, after the launch of the first biosimilar in United States, the investors are now focusing on this region to boost their prospects.
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