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 manufacturing of new biologics, which hold a prominent future for the global 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 to treat children with CLN2 disease, which is a form of Batten disease. In 2017, BioMarin Pharmaceutical Inc. received the U.S. FDA approval for its Brineura (cerliponase alfa), which is indicated for the treatment CLN2 disease.
Global Biologics Market: Drivers
The global biologics market size is expected to increasing, owing to increasing product pipeline from different companies such as Merck and Co., Pfizer, and GlaxoSmithKline. Pfizer has a strong product pipeline for 2019 of biologics, biosimilars, vaccines, and small molecules. Its 35 products are in phase 1, 28 are in phase 2, 26 are in phase 3, and 11 products are in the process of registration. In 2018, the U.S. FDA approved Pfizer’s DAURISMO (glasdegib) in the U.S. for adult patients with newly-diagnosed acute myeloid leukemia for whom intensive chemotherapy is not an option.
Furthermore, the global biologics market revenue is growing due to of increasing regulatory approvals for new biologic medicines for treatment of rare diseases. For instance, in 2017, the U.S. 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).
Global Biologics Market Regional Analysis
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. In 2018, 59 novel drugs and biologics were approved in by the U.S. FDA’s Center for Drug Evaluation and Research and were launched in the U.S.
Asia Pacific is expected to witness significant growth in the global biologics market, owing to increasing 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.
Global Biologics Market: Competitive Landscape
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.
Global Biologics Market: Taxonomy
The global biologics market is segmented on the basis of product type, application, end user, and region.
By Product Type
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