Biopharmaceuticals are drugs that are partially or fully manufactured, or extracted from biological sources. Biopharmaceuticals contain variety of products such as monoclonal antibodies, vaccines, recombinant human insulin, human growth hormone, erythropoietin, interferon, colony stimulating factor, and blood factors. Currently, biopharmaceuticals accounts for over one-fifth of pharmaceutical market, and this percentage share of biopharmaceutical is expected to increase, owing to its advantage compared to totally synthesize pharmaceutical drugs. Fewer side effects, high effectiveness and potent action, and ability to cure the disease rather than treat are some of the major advantages of these drugs.
Continuous launch, approvals, and robust pipeline of biopharmaceutical products is expected to drive growth of the market
In the recent past, regulatory bodies in key regions such as U.S. and Europe have approved a number of biopharmaceutical products, which have been subsequently launched in the market. For instance in 2017, Johnson & Johnson received U.S. FDA approval for its new immunology product—Tremfya (Guselkumab)—used for the treatment of moderate to severe plaque psoriasis. In 2017, Sanofi S.A. received U.S. FDA approval for its new Admelog, a rapid-acting insulin, indicated for the management of blood sugar levels at mealtime. In 2017, U.S. FDA approved GlaxoSmithKline Plc.’s New Shingrix, a shingles vaccine. FDA approved this vaccine to be used by people aged 50 years and above as an immunization against the painful condition caused by latent varicella infection. In 2017, Spark Therapeutics, Inc. received FDA approval for its LUXTURNA (voretigene neparvovec-rzyl). LUXTURNA is first gene therapy and pharmacologic treatment for an inherited retinal disease (IRD), and the first approved adeno-associated virus (AAV) vector gene therapy in the U.S. In 2017, HumanZyme Inc. launched its new HumanKine Interferon beta (IFN beta) expressed from HEK293 cells. IFN beta is an interferon of type I family, which activates Th1-type innate immune responses against viral and bacterial infection. In 2016, Novo Nordisk A/S launched its new next-generation once-daily basal insulin Tresiba (insulin degludec) in the U.S. market and in 2017, Nordisk A/S received China Food and Drug Administration (CFDA) approval to market its Tresiba (insulin degludec) in China. Such frequent launches and approvals of novel products is expected to drive growth of the market in the near future.
The global biopharmaceutical and biomedicine market was valued at US$ 358.4 Bn in 2016 and is expected to witness a CAGR of 9.4% over the forecast period (2017–2025).
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Players in the market are focusing on strategic collaborations, in order to increase their product offerings. In February 2018, LGC Limited— U.K.-based Company acquired Lucigen Corporation, a U.S.-based developer, and manufacturer of molecular biology enzymes, reagents and kits. Through this strategic acquisition, LGC Limited expanded its portfolio with the Lucigen’s extensive portfolio of NGS kits, enzymes, competent cells, and cloning systems. In February 2018, Servier Laboratories and ImmunoQure AG entered into a strategic collaboration for development of a therapeutic autoantibody neutralizing interferon- a. In March 2018, Wuxi Biologics Co. Ltd. collaborated with Adagene Inc., for the discovery and development of novel antibody therapeutics. In 2017, Omicia, Inc., acquired a bioinformatics startup Spiral Genetics at an undisclosed amount. Through this acquisition of Spiral’s advanced tools, Omicia, Inc., expanded its bioinformatics tools portfolio and strengthened its position in the global market.
Moreover, increasing funding and investments to support the development and research of new biopharmaceutical is also expected to drive the market growth. For instance in 2017, Indian government launched a National Biopharmaceutical Mission. As per the program, the government has invested US $250 Mn that includes a US$ 125 Mn loan from the World Bank to promote development of biological drugs in India. In 2017, The University of Liverpool and the Johns Hopkins University School of Medicine (JHUSM) collaborated for the development of new nanomedicine approaches for HIV therapy, and received an award of US$ 3 million from National Institutes of Health (NIH) to generate new technologies and continue research and development.
Cost of biopharmaceutical and biomedicine products are quite high as these need research and development process, and its manufacturing is very complex process, which needs highly skilled scientists. Such expensive biopharmaceutical products are not affordable to organizations in emerging economies such as India, China, and Africa. High cost of biopharmaceutical and biomedicine is a major factor hindering its adoption. For instance, in India a vial of Avastin, a monoclonal antibody, costs between US$ 372.65 to US$ 402.46. High cost medicine is not affordable to everyone, hence, it is a major restraining factor for the market growth. Cost of gene therapy such as Kymriah is very high. Kymriah is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia. The cost of Novartis AG’s cancer therapy Kymriah is about US$ 475,000.
Key players operating in the global biopharmaceutical and biomedicine market include Amgen Inc., F. Hoffmann-La Roche AG, Novartis AG, Johnson & Johnson, Pfizer, Inc., Sanofi S.A., Eli Lilly and Company, AbbVie Inc., Novo Nordisk A/S, Bristol – Myers Squibb, NanoString Technologies, Inc., Qiagen N.V., Celgene Corporation, and Affimed N.V.
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