Biosimilars (Rheumatoid Arthritis) - Forecast and Market Analysis to 2023

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Date Submitted: 01/25/2016 01:29 AM

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Rheumatoid arthritis (RA) is a chronic autoimmune disease which causes inflammation and deformity of the joints . It affects over seven million individuals in the 10MM covered in this report (US, France, Germany, Italy, Spain, UK, Japan, Australia, China, and India) and the prevalence is expected to grow to just over 8.5 million individuals by 2023. The anti-TNFs have been effective in treating the signs and symptoms of RA and inhibiting progression to erosive bone disease. However, the landscape is quickly changing with the introduction of biosimilars, novel biologics, and a class of oral therapies known as JAK inhibitors, all of which will change the market dynamics between 2013 and 2023. With the anti-TNFs as extremely effective therapies for RA, the market is extremely competitive for new entrants and will undergo further pressure as biosimilars are approved and launch.

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With the cost of biologic therapies being very high, at an annual cost of at least $25,000, global healthcare systems need a reprieve from the expense. On September 9, 2013, Hospira's Inflectra and Celltrion's Remsima, which are both biosimilars of J&J's Remicade, were approved by the European Commission (EC) for marketing in the EU for multiple autoimmune diseases, including RA, Crohn's disease, ulcerative colitis, ankylosing spondylitis, and psoriatic arthritis. Remsima and Inflectra have been rolled out in selected European markets, although their launch in the 5EU is still pending due to potential intellectual property protections in these healthcare markets. The US-based generics company, Hospira, will market Inflectra in the EU, while the South Korean biotechnology company, Celltrion, the original developer of the infliximab biosimilar, will do so as well, but under the brand name Remsima, based on a collaboration forged between the two...