Biosimilars are biological products that are similar to FDA-approved drug known as branded drug. Biosimilars are drugs licensed by the European Medicines Agency (EMA) and the U.S. FDA. These do not have significant differences from the reference products in terms of purity, effectiveness, and safety. Biosimilar drugs can only be permitted for conditions and indications that have been formerly accepted for the reference product by government regulatory agencies and organizations, when the original products patents expires. Compared to generic drugs, biosimilars show more molecular complexity. These are also quite sensitive to modifications in the manufacturing process.
Infliximab (Remicade) is a monoclonal antibody first manufactured by Janssen Biotech, Inc. in collaboration with Merck & Co. The U.S. Food and Drug Administration (FDA) first approved it in 1998. It is used in the treatment of active ulcerative colitis, rheumatoid arthritis, active and spinal psoriatic arthritis, Crohn’s disease (inflammatory bowel disease) in both pediatric and adult patients, and plaque psoriasis. Infliximab binds to chemical messenger tumor necrosis factor (TNF-α). It is one of the important part of autoimmune reaction. TNF-α stimulates the overall messenger cascade. Infliximab seems to act by binding to the receptor in the cell.
The global infliximab market is projected to grow at a rapid pace in the next few years. Increase in incidence of hereditary and autoimmune diseases such as plaque psoriasis and rheumatoid arthritis drive the global market. The number of people suffering from Crohn’s disease and ulcerative colitis (UC) has increased in various regions in the past few years. All the inflammatory bowel diseases (IBD) are associated with considerable morbidity cases with substantial use of health care resources. Early patent expiry, discounted pricing on branded drugs, and quick response time due to intravenous mode of administration propel the market.
Additionally, entry of biosimilars into the market has the ability to provide significant financial relief to the current health care systems. However, side effects of the drug treatment such as histoplasmosis (fungal infection), tuberculosis (TB), bacterial sepsis, and others restrain the global infliximab market. Hence, manufacturers of the drug have been mandated to include warnings to alert both patients and health care professionals. Additionally, lack of FDA-approved facilities, especially in developing countries, to manufacture the drug are the factors expected to restrain the market.
The global infliximab market can be segmented based on product and application. In terms of product, the global infliximab market can be bifurcated into biologics and biosimilars. Based on application, the global infliximab market can be divided into rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.
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Geographically, the global infliximab market can be segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America and Europe are projected to dominate the market, followed by Asia Pacific and Latin America. Dominance of North America and Europe is attributed to launch of biosimilars after patent expiry. The market in Asia Pacific is anticipated to grow at a rapid pace in the next few years.
This is due to presence of rapidly developing economies such as China and India, increase in awareness about health and hygiene, enhanced health care infrastructure, and unexploited market as increase in geriatric population that lacks adequate diagnostic & treatment solutions. Additionally, rise in government support for the manufacture of biosimilars drugs and increase in awareness and adoption of biosimilars is anticipated to drive the global infliximab market.
Key players in the global infliximab market are Merck & Co., Celltrion, Inc., Alvogen, Janssen Biotech, Inc., NAPP Pharmaceuticals, Nippon Kayaku, and Pfizer, Inc. (AC. Hospira), among others.