Biological drugs constitutes complex mixtures which cannot be easily characterized. According to the standard definition provided by the U.S. Food and Drug Administration (FDA) biologics represent an umbrella term which encompasses several products such as blood and blood components, recombinant therapeutic proteins, vaccines and others. Adalimumab (Trade Names: Humira and Exemptia) constitute the tumor necrosis factor (TNF) inhibiting anti-inflammatory medication which has been approved in the U.S for the treatment of several medical conditions such as rheumatoid arthritis, psoriasis, ulcerative colitis, Crohn’s disease and others.
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The market for adalimumab is majorly impacted by the factors such as the U.S. and Europe patent expirations in 2016 and 2018 respectively followed by the upcoming adalimumab biosimilars in development. For instance, the recent approval of Exemptia for the Zydus Cadila in India and the company is in talks with the U.S. and Europe regulatory authorities for the respective approval in these markets. However, the patent holder of the originator drug, AbbVie claims that this product will not face any substantial competition until 2020 as it is a biologic drug unlike any other small-molecule drugs. High cost of the therapy is one of the major restraints thereby making this drug inaccessible in majority of the emerging nations. Emerging markets such as Asia Pacific and Latin America provides lucrative growth opportunities for the upcoming adalimumab biosimilars due to their large target patient population and expected decreased cost of biosimilars as compared to originator drugs. In addition, low cost of the research along with the easy availability of trained research professionals will further favor the growth of adalimumab market in these regions.
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The LATAM Adalimumab market was valued at US$ 994.8 million in 2014 and is projected to reach US$ 1,186.4 million by 2023, expanding at a CAGR of 0.4% during the forecast period from 2015 to 2023. Increasing preference for effective medications, possession of medical expertise in biosimilar research followed by low cost of production and marketing for the market players in Latin America will support the adalimumab market growth in this region.
Adalimumab is approved for the treatment of several medical conditions such as rheumatoid arthritis, psoriasis, Crohn’s disease among others. Several research studies support the efficiency of adalimumab to treat aforementioned medical conditions and moreover, the market players are conducting the clinical research trials to prove the efficacy and performance of adalimumab biosimilars for majorly the treatment of rheumatoid arthritis and psoriasis. For instance, Pfizer, Inc., Amgen, Inc., and Novartis AG represent some of the companies conducting the clinical trials for the adalimumab biosimilars of which recently in 2015, Amgen, Inc. has announced the positive results of Phase III trials of their adalimumab pipeline molecule ABP501.
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Brazil comprises the major markets in Latin America, followed by Mexico with established regulatory policies in place followed by increasing patient preference for effective biologic drugs and presence of local production facilities resulting in low cost of the drugs. While other countries such as Argentina, Colombia, Chile, Peru and Venezuela among others represent the middle or low income LATAM nations and they lack the presence of established biosimilar regulatory policies and lack of native production facilities and the government support for acceptance of biologic drugs. However, TMR analysts anticipate that the market for the adalimumab in Latin American countries will grow with a slow and steady pace assuming the positive entry of the adalimumab biosimilars in this region post the patent expirations.
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