Biosimilars are complex biological products made from living organism that include microorganisms such as bacteria and yeast, humans, and animals. These biological products are similar biological product also known as biological reference product, that have been approved by the U.S. Food Drug and Administration (USFDA). Biosimilars are compared with the biological reference products and licensed by the USFDA. Patent expiration of biological reference product is the key factor leading to development of biosimilars. These are composed of complex molecules such as monoclonal antibodies and human insulin. Advanced technologies are involved in the development and manufacturing of biosimilars that include monoclonal antibody (MAb) technology, nuclear magnetic resonance (NMR)technology, recombinant DNA (r-DNA) technology, electrophoresis and bioassays. Monoclonal antibody technology and bioassay are most significant technologies for the development and validation of biosimilars. Most of the biologics, such as monoclonal antibodies, anticoagulants, and vaccines are large molecules which need to be administered parenterally to achieve the desired therapeutic effects. These complex biosimilars are used in prevention and treatment of diabetes, multiple sclerosis, cancer, rheumatoid arthritis, inflammatory bowel diseases, low white blood cell count, anemia, infectious diseases, chronic kidney failure and other health conditions and offers cost effective treatment than other synthetic and biological drugs.
Various regulatory authorities such as the USFDA and The European Medicine Agency (EMA) has established some regulatory guidelines for the safety, efficacy and quality standards of biosimilars and regulates the development and commercialization of biosimilars. The new developments in antibody drug conjugates, immunotherapies and gene and cell therapies, drives the growth of biosimilars market. The rapidly increasing burden of cancers, diabetes, anaphylaxis, multiple sclerosis, rheumatoid arthritis and other diseases further compels government organizations and healthcare providers to provide improved facilities for effective disease treatment, leading to rising number of launches of technologically advanced products, globally.
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Global Biosimilars market has been witnessing growth driven by increasing prevalence of chronic and autoimmune diseases, growing demand of cost-effective medicinal products and growing aging population. According to World Cancer Research Fund International, 14.1 million cancer cases were estimated in 2012 and is expected to increase to 24 million by 2035. Elderly people are more prone to chronic disease such as diabetes, rheumatoid arthritis chronic pain and other health conditions. As per United Nations Department of Economic and Social Affairs (UNDESA) report on the global aging population, the population of people aged 60 years or above is growing at a high rate. The number of people aged 60 years or over is projected to grow by 56.0 % globally, i.e. from 901 million in 2015 to 1.4 billion by 2030, and it is projected to more than double its size from 2015, to reach 2.1 billion by 2050. In addition, increasing research and development investments, healthcare expenditures and technological advancement also drive the growth of biosimilars market. However, Stringent regulations and complex manufacturing process restricts the growth of biosimilars market. FDA and EMA along with World Health Organisation are actively regulating the development and validation of biosimilars. Countries such as Japan, South Africa, Australia, Canada, Korea have crafted their own regulatory guidelines for the development and validation of biosimilars.
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Geographically, Europe is the largest market for biosimilars The European market for biosimilars is driven by increasing prevalence of chronic diseases, and various initiatives taken by the EMA and government to increase the awareness regarding new approaches and use of biosimilars. North America is the second largest market for biosimilars market, with the U.S. accounting for the largest revenue contribution to the North American market. Some of the key factors driving the revenue growth of the biosimilars market in North America include rise in the number of chronic and lifestyle diseases, increasing research and development investments and increasing healthcare expenditures. Private health insurance plays an important role in U.S. healthcare system, provides primary healthcare coverage to large population group leading to affordability of better healthcare facilities. Asia-Pacific is expected to be the fastest growing market for biosimilars due to a rise in the population, increased government initiatives, availability of skilled labour, low manufacturing cost and growing medical tourism in Singapore, Thailand, India and Malaysia.
Some of the key players in the global biosimilars market include Sandoz International GmbH, Pfizer Inc., Merck Serono (Merck Group) Teva Pharmaceuticals Industries Ltd., Biocon Ltd, Biogen Idec, Inc. Dr. Reddy’s Laboratories, Amgen Inc., Celltrion, Inc, F.Hoffmann-La Roche Ltd, Samsung Bioepis and Synthon Pharmaceuticals, Inc.
In February 2016, Sandoz, a Novartis company announced acquisition of rights for the development and commercialization of PF06438179(biosimilar infliximab) in the European Economic Area (EEA) from Pfizer. Infliximab is used in the treatment of rheumatoid arthritis.
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