Etanercept is a tumor necrosis factor alpha (TNF-α) inhibitor, an important inflammatory disease mediator in various articular diseases. Etanercept was the first tumour necrosis factor-alpha (TNF-α) inhibitor approved for the treatment of rheumatoid arthritis. It is also approved for the treatment of juvenile rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, and ankylosing spondylitis. Etanercept competitively inhibits the binding of TNF to cell surface receptors and thus makes TNF biologically inactive. By doing so, the drug inhibits the pro-inflammatory effects of TNF and thereby leads in a reduction of joint inflammation. Etanercept was developed and marketed by Amgen and Pfizer. The drug was approved by the U.S. Food Drug and Administration in November 1998. It was approved in Europe by European Medicines Agency in February 2000. It is marketed under the trade name of ‘Enbrel’.
Expiration of patent and near-term expiration of patent has led to the entry of biosimilar into the market. The patent of Enbrel is expired in Europe in August 2015 and will expire in the U.S. in November 2028. Biosimilar is defined as a type of biological product that is approved by respective regulatory bodies because of its clinical similarity to already approved biological products. Reducing treatment cost is the principal attraction factor for the growth of etanercept biosimilars market. Thus many of biosimilar of etanercept are currently approved and some are in development phase which are expected to come into the market during forecast period. Introduction to biosimilars, increase in incidence and prevalence rate of various articular diseases, and rising demand for cost effective alternatives are the factors boosted the growth of etanercept biosimilar market. However, stringent regulatory process for the approval of etanercept biosimilar and complicated manufacturing process are the major restrain factors for the growth of the etanercept biosimilar market.
The global etanercept biosimilar market is segmented on the basis of application, distribution channel and geography. Based on the application global etanercept biosimilar market is segmented into rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, and ankylosing spondylitis. Rheumatoid arthritis segment is expected to grow at higher pace during the forecast period owing to increasing incidence and prevalence rate. Based on distribution channel the global etanercept biosimilar market is segmented as hospital pharmacy, online pharmacy and others. Online pharmacy segment is expected to grow during forecast period due to increase in number of internet users and ease of use.
Geographically, the global etanercept biosimilar market has been segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa. In terms of revenue, Europe followed by Asia Pacific is major contributor for the global etanercept biosimilar market. This is because early patent expiry, entry of etanercept biosimilars, strong clinical pipeline, increasing research and drug development activities, presence of major players, and developing healthcare infrastructure propels the growth of the market in the region. Asia Pacific is promising revenue contributor which is expected to grow at rapid pace in upcoming year. Countries such as Japan, India and China are major contributors for this market. Huge population base in countries such as China and India offers tremendous market opportunities for the etanercept biosimilar market. North America is third major contributor for the market in forecast period and is expected to grow at rapid pace, due to presence of strong clinical pipeline.
Some of the market players leading the global etanercept biosimilar market include Avesthagen, Cipla, LG Life Sciences, Protalix Biotherapeutics, BioXpress Therapeutics, Sandoz, Celltrion, Teva Pharmaceutical Industries, Pfizer, Samsung Bioepis, mAbxience, and among others.
