A biosimilar, also known as subsequent entry biologic or follow-on biologic, is a medical product (drug) that is almost a similar or identical copy of the original product which is manufactured by some other company. These products are legitimately permitted versions of the original innovator products. They are generally manufactured when the patent of original product of the parent company expires. The key factors propelling the growth of biosimilars market include the continuous increase in pressure to reduce healthcare expenditure, growing incidences of several diseases, increasing demand for biosimilars owing to their cost-effectiveness, helpful effects in the current clinical trials, growing number of off-patented drugs, and growing biosimilars demand in various therapeutic applications including blood disorders and rheumatoid arthritis. However, factors restricting the global biosimilars demand are strict regulatory requirements in different countries, high manufacturing costs and complexities and innovative strategies applied by various biosimilar drug manufacturers to limit the entry of new players.
The global biosimilar market is segmented based on product type, applications, technology, services and geography. The product segment of biosimilar market is further sub-segmented into recombinant non-glycosylated proteins, recombinant peptides and recombinant glycosylated proteins. Furthermore,the recombinant non-glycosylated proteins market is sub-segmented into granulocyte colony-stimulating factor insulin, human growth hormone and interferons. Also, recombinant glycosylated proteins are sub-segmented into monoclonal antibodies, follitropin and erythropoietin. On the basis of applications, the market is classified by blood disorders, growth hormone deficiency, oncology, chronic & autoimmune diseases and other applications. Oncology application segment in biosimilar market is leading due to introduction of new biosimilars whereas, chronic & autoimmune disorders is anticipated to grow in the coming years owing to the growing cases of autoimmune diseases such as psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis.
Further, technology segment is bifurcated into monoclonal antibodies technology, chromatography, electrophoresis, recombinant DNA technology, western blotting, nuclear magnetic resonance technology, bioassay and mass spectrometry. By services, the market is segmented into clinical trials and contract research & manufacturing services. Geographically, the market is bifurcated into North America, Asia-Pacific, Europe, Latin America, and Middle East, and Africa.
Developing economies offer substantial opportunities to the manufacturers of biosimilar products. However, the global market is anticipated to face a major challenge regarding the complex infrastructure production requirements for the biosimilars and the need to obtain approval from regulatory bodies for the rigorous clinical trials. Europe is expected to dominate the biosimilars market followed by Asia-Pacific. The growth in Europe is anticipated to grow owing to the pressure for reduction in healthcare costs, introduction of new biosimilar products, biologic products patent expiry, growing incidences of chronic diseases such as diabetes and cancer; and entry of new emerging biosimilar players in the market.
Asia-Pacific’s growth is attributed to the developing infrastructure of healthcare, rising investments in biosimilars development, huge patient population in the region and rising focus on international as well as domestic players in the Asia-Pacific region. Also, the government authorities in Asia-Pacific are focusing on promoting the use of biosimilars in order to decrease their burden towards healthcare expenses, thus providing growth opportunities to the manufacturers of biosimilars. This is backed by favorable and sound support through reimbursements related to commercialization and research; and effective regulations for biosimilar drugs. Also, the companies in developing regions are adopting alliance or collaboration strategies with key players in the developed economies in order to sustain in the market.
The key players operating in the biosimilars market include Hospira, Inc., Teva Pharmaceutical Industries Ltd., Roche Diagnostics, Sandoz International GmbH, Biocon Ltd., Amgen, Dr. Reddy's Laboratories, Mylan, Inc., Celltrion, Inc. and Merck KGAA among others.