Biopharmaceuticals and Biomedicine Market Key Findings with Worldwide Top Companies Amgen, F. Hoffmann-La Roche AG, Novartis AG, Johnson & Johnson, Pfizer,Sanofi S.A., Eli Lilly
In 2017, Sanofi S.A. received U.S. Food and Drug Administration (FDA) approval for Dupixent (dupilumab) injection to treat adults suffering from moderate to severe eczema (atopic dermatitis). In 2017, F. Hoffmann-La Roche AG received FDA approval for Hemlibra (emicizumab-kxwh), indicated to prevent and reduce bleeding incidents among children and adults suffering from haemophilia A with factor VIII inhibitors. In 2017, Novo Nordisk A/S received the U.S. FDA approval for REBINYN (Coagulation Factor IX (Recombinant), GlycoPEGylated) indicated for treatment and control of bleeding episodes, and perioperative management of bleeding among children and adults. In 2017, Novo Nordisk received U.S. FDA approval for Fiasp (Insulin aspart injection). Fiasp is a fast acting mealtime insulin, which is indicated to improve glycemic control among adults suffering from type 1 and type 2 diabetes.
In 2017, Serum Institute of India launched its Rabishield, a rabies monoclonal antibody, developed in partnership with the University of Massachusetts Medical School. In 2017, Mundipharma GmbH launched its Truxima (rituximab), a biosimilar monoclonal antibody for the treatment of cancer, in the UK, Germany, Italy, the Netherlands, Belgium, Republic of Ireland, and Luxembourg, following authorization by the European Medicines Agency (EMA). The launches and approvals of such novel biopharmaceutical and biomedicine technologies is expected to create a conducive environment for growth of the global biopharmaceutical and biomedicine market.
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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.
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.
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