Adalimumab is a first humanized monoclonal antibody indicated for the treatment of various autoimmune diseases. Adalimumab is an anti-TNF (tumour necrosis factor) drug that block the action of TNF (tumour necrosis factor) to reduce the inflammation. It is prescribed for the treatment of diseases such as rheumatoid arthritis, ankylosing spondylitis, juvenile idiopathic arthritis, psoriatic arthritis, Crohn’s disease, ulcerative colitis, and psoriasis. It was first discovered by “phage display” technique which was named ‘D2E7’. Furthermore, it experienced the various manufacturing process at BASF Bioresearch Corporation and developed by BASF Knoll. In December 2000, Abbott announced the acquisition of BASF Bioresearch Corporation. In January 2013, Abbott Laboratories separated its pharma business named as AbbVie Inc. which was further involved in development and commercializing activities. AbbVie marketed Adalimumab product under the trade name of Humira. It was approved by U.S. Food Drug and Administration (FDA) in 2008 and by European Medicines Agency in 2003. However, the patent on Humira has expired in Europe in June 2017 and in the U.S. in November 2017. It is world’s best-selling drug thus several pharmaceutical companies are focusing on the development of biosimilar adalimumab products. Some of the market players leading the global adalimumab biosimilar market include Amgen, Pfizer, Sandoz International GmbH, Celltrion Healthcare Co., Ltd., Fresenius Kabi, Kyowa Hakko Kirin, LG Life Sciences, Mochida Pharmaceutical, and Momenta Pharmaceuticals.
The adalimumab biosimilar market is expected to grow at rapid pace during forecast period. Adalimumab is world’s one of the top best-selling drug. Moreover, entry of adalimumab biosimilar players into market is expected to boost the growth of global adalimumab biosimilar market. For instance, in 2017, U.S. FDA approved Boehringer Ingelheim’s ‘Cyltezo’ adalimumab biosimilar drug for multiple indications. In addition, the factors s presence of such as presence of strong pipeline molecules such as FKB-327, GP-2017, Amgevita, and many more along with rising incidence of autoimmune disorders (such rheumatoid arthritis) is expected to compel the demand for adalimumab biosimilar market. Growing demand for biosimilar drugs and increase in demand for cost effective treatment in low and medium income countries further drives the growth of the adalimumab biosimilar market during the forecast period. However, stringent regulatory process for the approval of biosimilar is major restraining factor that hampers the growth of the adalimumab biosimilar market. Also, strategies used by the patent holder companies to fight against the biosimilar competition hampers the growth of the adalimumab biosimilar market. For instance, Abbvie filed a complaint against Boehringer Ingelheim for a biosimilar version Humira.
Based on application, the global adalimumab biosimilar market is segmented in rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, Crohn’s disease, ankylosing spondylitis, ulcerative colitis, and psoriasis. Rheumatoid arthritis application segment is expected to grow at higher pace during the forecast period owing to increasing incidence and prevalence rate of disease across the globe. Based on distribution channel the global adalimumab biosimilar market is segmented as hospital pharmacy, online pharmacy and other direct distribution channels. Online pharmacy segment is expected to grow during forecast period due to rapidly increasing adoption of online pharmacy portals to buy the drugs.
At regional level, the global adalimumab biosimilar market has been segmented into Asia Pacific, Europe, North America, Latin America and Middle East & Africa. In terms of revenue, Europe is major contributor for the global adalimumab biosimilar market. This is attributed owing to the factor such as less stringent regulatory product approval process compared to US FDA and high demand for biosimilar drugs. Europe is followed by North America which is second major revenue generator owing to factors such as strong pipeline product portfolio, rising focus on research and drug development activities. Asia Pacific is third promising region in terms of revenue contribution which is expected to grow at rapid pace in upcoming forecast period. Asian countries such as Japan, India and China are major contributors for Asia Pacific adalimumab biosimilar market. Presence emerging economies with rising healthcare expenditure and huge population base countries such as China and India offer tremendous opportunities
