Infliximab is chimeric anti-TNF monoclonal antibody approved for the treatment of Chron’s Disease. It is also approved for the treatment of other autoimmune diseases such as Psoriasis, rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and others. It is marketed under the trade name of Remicade. It is developed by Jansen Biotech (Johnson & Johnson) operated as Centocor and was approved by U.S Food Drug Administration (FDA) in 1998 and by European Medicines Agency in 1999. It was originally approved for the treatment of Crohn’s Diseases however in 2011, it has been approved for various indications including rheumatoid arthritis. The patent for infliximab has been expired in Europe in February 2015 and it will expire in the US during the end of year 2018. Biosimilars are defined as biotherapeutic product that have similar safety and efficacy as an approved biologic product. Pfizer’s Hospira subsidiary in partnership with Celltrion launched first biosimilar of infliximab i.e. Inflectra in the U.S. on April 2016 and in Europe in June 2013, thus entry of biosimilar into the market have boosted the growth of infliximab biosimilar market. Also, rising incidence and prevalence of autoimmune disease, emergence of new market players, increase in infliximab accessibility and price erosion have boosted the growth of the infliximab biosimilar market. However, stringent regulatory process for the product approval of biosimilars restrain the growth of the market. Furthermore, complex nature of the molecule, patent term extension, unavailability FDA certified manufacturing facilities and low switching tendency from brand to biosimilar hampers the growth of infliximab biosimilar market. Some of the market players leading the global infliximab biosimilar market include, Napp Pharmaceuticals Group Ltd, Janssen Biotech Inc., Alvogen, Merck &Co. Inc., Celltrion Inc., Pfizer Inc. (AC. Hospira), and Nippon Kayaku.
Based on the application the infliximab biosimilar market is segmented into crohn’s disease, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, ankylosing spondylitis, plaque psoriasis and others. Crohn’s disease and rheumatoid arthritis segment are expected to grow at rapid pace during forecast period due to rising incidence and prevalence rate. It is estimated that around 1-10 cases per 100,000 persons is suffering from crohn’s disease. In terms of end user, the global infliximab market is segmented into hospital pharmacy, retail pharmacy and online pharmacy. Online pharmacy segment is expected to grow at higher pace owing to increase in number of internet use, availability of various options for the buyer with attractive offers, and ease of use.
At regional level, the global infliximab biosimilar market is segmented into Asia Pacific, Europe, North America, Latin America, and Middle East & Africa. Europe dominate the infliximab biosimilar market owing to factors such as less stringent regulatory requirement compared to US FDA, early entry of infliximab biosimilar in European market (infliximab biosimilar is available in Europe since 2013), early loss of patent exclusivity and entry of new participants. Also, rising incidence and prevalence of chronic diseases and increase in geriatric population have boosted the growth of the infliximab biosimilar market in Europe. North America hold second position in global infliximab biosimilar market owing to strong infliximab biosimilar product pipeline, increased research and development expenditure and rising government initiatives. Asia Pacific is third promising revenue contributor which is expected to grow at rapid pace during forecast period. Countries such as Japan, India, and China are major contributor to the infliximab biosimilar market. Emerging and huge population base countries such as China and India offer tremendous market opportunities.