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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 as of 2011, it has been approved for various different indications including rheumatoid arthritis. The patent for infliximab expired in Europe in Feb 2015 and will expire in the US in Sep 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. In addition to it, rising incidence and prevalence of autoimmune disease, emergence of new participants, increase in infliximab accessibility and price erosion have boosted the growth of the infliximab biosimilar market. However, stringent regulatory process for the approval of biosimilars restrains 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. 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 followed by rheumatoid arthritis segment is expected to grow at rapid pace during forecast period due to rising incidence and prevalence rate. It is estimated that 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 market is segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. Europe dominate the infliximab biosimilar market this is because of less stringent regulatory requirement, 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. In addition to it, rising incidence and prevalence of chronic diseases and increase in geriatric population have boosted the growth of the market in Europe.
North America holds second position in global infliximab biosimilar market owing to strong infliximab biosimilar 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. Some of the market players leading the global infliximab biosimilar market include, Napp Pharmaceuticals, Janssen Biotech Inc., Alvogen, Merck &Co., Celltrion Inc., Pfizer Inc. (AC. Hospira), and Nippon Kayaku.
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