Press release
Biological Product Manufacturing Market to Reap Excessive Revenues by 2025
The biological product manufacturing is governed by many various regulatory authorities which make it harder for products approvals, because of overlapping opinions and other redundancies. Therefore to bring all regulatory authorities under one roof, the international conference on harmonization of technical requirements was formed in 1990 for the registration of pharmaceuticals for human use. The ICH has helped biological product manufacturers to register and develop a better quality product which is safe and more efficient.
The biological products are produced in three ways: by developing ways to achieve commercial production of the substance to be used, by gene alteration of the molecule and finally by developing an entirely new substance. Some of the tools used by modern day researcher in the manufacturing of biological products are recombinant DNA and monoclonal antibodies.
Recombinant DNA involves altering of the DNA chain of one organism with desired DNA molecule to produce a novel biological product. Monoclonal antibodies were developed from single cell cultures using cloning techniques; these were designed to fight against toxins, viruses, and cancer cells. The first genetically engineered biological product approved for use in the U.S. was a vaccine for hepatitis-B which was approved in 1986, in the same year, other biological products like therapeutic monoclonal antibodies (MAB’s) and alpha interferon’s were approved.
The biological product manufacturing strictly follows GMP (Good manufacturing practices) rules for all production process from beginning to the last step for biological product manufacturing. These guidelines imply to the change in facility, manufacturing processes and other guidelines regarding clinical trials of the biological product related to its safety and purity. The major drivers for biological product manufacturing market increase in population, increasing the incidence of chronic diseases and increased government initiatives.
By regional presence, global biological product manufacturing market is segmented into five key regions viz. North America, Latin America, Europe, Asia-Pacific-Pacific, and the Middle East & Africa. The region of North America is a forerunner in biological product manufacturing market globally mainly because of strong product development, technological advancements and increasing the population.
The North America market is closely followed by Europe and Asia-Pacific. The region of Asia Pacific is an emerging market for referral management system mainly because of increasing proficiency in IT skills and growing healthcare expenditure in the region.
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The leading players in the referral management market are Novartis AG, F.Hoffmann-La Roche Ltd., Merck & Co., Inc., Bayer AG, Lonza, China Biologic Products, Inc., Pfizer Inc., Sanofi, GOLDEN WEST BIOLOGICALS, Inc., Teva Pharmaceutical Industries Ltd., Amgen Inc.
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