Biosimilar monoclonal antibodies can be defined as biological molecules derived from living cells or organisms. These are large complex molecules. Biosimilars are developed after the expiry of patent of approved recombinant drugs, and are also known as biologics. These biologics display a certain level of variability which can be attributed to the variations in the biological expression system of the recombinant and the manufacturing process. Biosimilars are regulated by the various governing bodies in different countries. In the U.S., the FDA regulates the release of these biosimilars, which are required to undergo pharmacovigilance regulations as its reference approved monoclonal antibody. In Europe, biosimilars are approved by the European Medicines Agency (EMEA). Manufacturers of biosimilars are required to submit risk management plan in addition to the marketing application.
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Increase in patent expiries of blockbuster monoclonal antibodies has led to a rise in interest among pharmaceutical companies to develop biosimilars. This is projected to drive the market during the forecast period. Focus on research and development contributing to innovative product pipeline and expanding health care infrastructure fuel the growth of the biosimilar monoclonal antibodies market. Additionally, increasing demand for cost effective treatment among patients boosts the growth of the market. Furthermore, launch of biosimilars owing to the patent expiries of Johnson & Johnson’s Remicade, Roche’s Herceptin, and Abbott’s Humira is one of the major factors propelling the market. However, stringent regulations related to product approvals and cost structure associated with the manufacturing process are likely to hamper market growth during the forecast period. Furthermore, lack of clarity related to the regulations concerning the development of biosimilar monoclonal antibodies in various emerging markets is expected to act as a restraint of the market.
The global biosimilar monoclonal antibodies market can be segmented based on indication, molecule, distribution channel, and region. In terms of indication, the market can be categorized into autoimmune diseases, oncology, hematology, gastrointestinal diseases, and others. Based on molecule, the biosimilar monoclonal antibodies market can be classified into bevacizumab, trastuzumab, infliximab, rituximab, abciximab, and adalimumab. The rituximab and infliximab segments are anticipated to dominate the market during the forecast period. Oncology was the dominant segment in 2016 and the trend is anticipated to continue in the next few years. In terms of distribution channel, the market can be divided into hospital pharmacies, retail pharmacies, specialty pharmacies, and others. The retail pharmacies and others segments, which includes online pharmacies, are anticipated to record substantial growth during the forecast period.
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Geographically, the global biosimilar monoclonal antibodies market can be segmented into five regions: North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America accounted for the highest share of the global market in terms of revenue in 2016 and the trend is anticipated to continue during the forecast period. Strong growth in the region can be attributed to increase in product approvals, well-established health care infrastructure, and favorable reimbursement scenario. Europe is expected to be the second leading market for biosimilar monoclonal antibodies. However, the sluggish economy in the region is likely to negatively impact the growth of the market. The market in Asia Pacific is anticipated to record a significantly high CAGR owing to factors such as increasing patient population, growing government focus on enhancing health care facilities, and increase in product approvals in Japan.
Leading players operating in the global biosimilar monoclonal antibodies market are Biocon Limited, Allergan plc, Accord Healthcare Ltd., Boehringer Ingelheim GmbH, 3SBio, Inc., Novartis AG, Amgen, Inc., Alvartis Pharma, Pfizer, Inc., Celltrion, Alfred E. Tiefenbacher (GmbH & Co. KG), Hospira, and Dr. Reddy's Laboratories, among others.
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