Biological products include a wide range of products such as vaccines, blood and blood components, allergenic, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Many biologics are produced using recombinant DNA technology. Biologics are the best used drugs for genetic disorders. New technologies, novel therapies are emerging for the manufacturing of new biologics which holds a prominent future for biologics market. Biologics are widely used to prevent, treat, diagnose, or cure a variety of diseases including cancer, chronic kidney disease, autoimmune disorders, and infectious diseases. Biologics are also used in treatment of rare diseases in children like for treatment of Batten disease, cerliponase alfa was approved in 2017 for the first time by U.S. Food and Drug Administration (FDA).
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The biologics market size is expected to boost owing to the increasing product pipeline from different companies like Merck and Co., Pfizer, Glaxosmithkline. Pfizer has a strong product pipeline for 2019 of biologics, biosimilars, vaccines and small molecules. 35 products are in phase 1, 28 are in phase 2 and 26 are in phase 3 and 11 products are in the process of registration. Total 100 products are in trial phase. Most recent approval by Pfizer is DAURISMO (glasdegib) in U.S. for adult patients with newly-diagnosed acute myeloid leukemia for whom intensive chemotherapy is not an option.
Furthermore, the biologics market revenue is growing because of increasing number of Food and Drug Administration (FDA) approvals for new biologic medicines for treatment of rare diseases. For instance, in 2017 US FDA approved 46 biologics and in December 2017, GlaxoSmithKline’s biologic Nucala was approved for the treatment of a rare disease called eosinophilic granulomatosis, with polyangiitis (EPGA).
North America holds dominant position in the global biologics market, owing to presence of major pharmaceutical and biopharmaceutical companies in the U.S. such as AbbVie, Amgen, Biogen Idec, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Johnson and Johnson, Merck and Co., Novartis, Pfizer, and Sanofi with a great product portfolio in biologics. In 2018, 59 novel drugs and biologics were approved in by FDA’s Center for Drug Evaluation and Research and were launched in the U.S.
Asia Pacific is anticipated to witness significant growth in biologics market size because of production and manufacturing of biosimilar products of biologics. A biosimilar is a biologic medical product that is almost an identical copy of an original product that is manufactured by a different company. For instance, Indian biopharmaceutical company Biocon Ltd., launched two biosimilars CANMAb (trastuzumab) and Krabeva (bevacizumab) in India in year 2014 and 2017 respectively for treatment of several types of cancer.
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Key players operating in the global biologics market include AbbVie, Amgen, AstraZeneca, Biogen Idec, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Johnson and Johnson, Merck and Co., Merck KGaA, Novartis, Pfizer, F. Hoffmann-La Roche Ltd, and Sanofi.
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