A biosimilar medicine possesses similar pharmacokinetic and mode of action as an original biological medicine that has already been approved for therapeutic use.
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Biosimilars are made from a living organism such as bacteria and yeast or can also be derived from small molecules such as human insulin, erythropoietin, and monoclonal antibodies via recombinant DNA and gene expression technologies. Biosimilars are developed only when original biological medicines are commercially expired and therefore are known as follow on biologics or subsequent entry biologics. Biosimilars are used for autoimmune indications such as rheumatoid arthritis (RA) and ulcerative colitis. Tumor necrosis factor is a chemical produced by the immune system that causes inflammation in the body.
Immunology biosimilar drugs are used to treat inflammatory conditions such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, juvenile arthritis, Crohn’s disease, ulcerative colitis, psoriasis, and hidradinitis suppurativa. These drugs are able to reduce inflammation and stop disease progression. The market is expected to grow during the forecast period due to rise in prevalence of chronic diseases, autoimmune diseases, lower cost of drugs compared to branded drugs, and rise in incidence of cancer. According to the World Health Organization, cancer is one of the leading causes of morbidity and mortality across the world, with approximately 14 million new cases in 2012. The number of new cases is expected to rise by about 70% over the next two decades. Developing a new biological medicine can incur cost up to US$ 1.2 Bn that is also associated with a high risk of research and development failure. However, the overall cost and research and development risk with biosimilars and biosuperiors are less than the original biologics. By some estimates, from development to approval, a biosimilar could incur cost up to US$ 75 Mn to US$ 250 Mn. On account of a requisite of lower investment, several pharmaceutical and biopharmaceutical companies are striving to enter the biosimilars and biosuperiors market.
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The global immunology biosimilars market can be segmented based on disease indication, distribution channel, and region. In terms of disease indication, the market can be categorized into plaque psoriasis, arthritis, Crohn’s disease, and others. Arthritis can be further segmented into rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, and juvenile idiopathic arthritis. Based on distribution channel, the global immunology biosimilars market can be classified into hospital pharmacies, retail pharmacies, and online pharmacies.
Geographically, the global immunology biosimilars market can be segmented into five regions: North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America dominated the global market in 2016. Usage of immunology biosimilars is high in North America primarily due to steady approval for new indications and research undertakings, and increasing geriatric population. According to the Immune Deficiency Foundation, currently around 55,000 people in the U.S. with antibody deficiency receive primary immunodeficiency diseases treatment. Expected launch of immunology biosimilars drugs that are presently in clinical trials in the U.S. during the forecast period is likely to boost market growth. Europe is expected to be the second largest market in terms of revenue and growth of the market in the region can be attributed to availability of several immunology biosimilar drugs such as Rituxan, Humira, Enbrel, and others. The market in Asia Pacific is expected to register high growth from 2017 to 2025 due to development of health care infrastructure, high disposable income, rise in health and hygiene related awareness, large untapped market base, and economic development.
Key players operating in the global immunology biosimilars market include Novartis AG, Amgen, Inc., Teva Pharmaceutical Industries Ltd., Pfizer, Inc., STADA Arzneimittel AG, Mylan N.V., and PRA Health Sciences.
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