Biopharmaceuticals are complex, high molecular weight proteins and peptides that are produced or synthesized from living biological source. Biopharmaceuticals are further divided into biologics and biosimilars.
Biologics can be defined as molecules derived from the living cells such as microorganisms, or plant or animal cells and used in the treatment, diagnosis, or prevention of diseases. Most of the biologic molecules are very large, complex molecules, or mixture of molecules. The U.S. Food and Drug Administration (FDA) defines biosimilar as a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product.
Non-oncology biopharmaceuticals are drugs which are indicated for treatment of a number of diseases except cancer such as rheumatoid arthritis, psoriatic arthritis, multiple sclerosis, hemophilia, age-related macular degeneration, osteoporosis, and others.
Market Dynamics
Frequent launch, approval, and presence of robust pipeline of novel biopharmaceutical products indicated for treatment of number of non-oncology indication is expected to drive the U.S. non-oncology biopharmaceuticals market growth over the forecast period. For instance, in November 2018, Swedish Orphan Biovitrum AB and Novimmune SA received the U.S. Food and Drug Administration (FDA) approval for Gamifant (emapalumab-lzsg), an interferon gamma (IFNγ) blocking antibody for the treatment of pediatric (new born and older) and adult patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent, or progressive disease or intolerance to conventional HLH therapy.
In March 2018, Theratechnologies Inc. and its partner TaiMed Biologics Inc. received the U.S. Food and Drug Administration (FDA) approval for its Trogarzo (ibalizumab-uiyk) Injection. In combination with other ARTs, Trogarzo is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection, who are failing their current antiretroviral regimen.
Key players in the market are adopting inorganic growth strategies such as mergers and partnerships for the development of novel products or to expand their product portfolio by acquisition. Such frequent activities by key players is expected to significantly support the U.S. non-oncology biopharmaceuticals market growth over the forecast period.
For instance, in 2016, Teva Pharmaceutical Industries Ltd. and Celltrion Inc. entered into an exclusive partnership to commercialize two of Celltrion’s mAb biosimilar candidates in the U.S. and Canada.
In 2016, Shire plc. and Baxalta Incorporated entered into an agreement, under which Shire will combine with Baxalta. Baxalta has a well-established hematology portfolio based on its heritage and legacy of leadership in hemophilia. With this merger, the established company (Shire plc.) will strengthen its position in the market.
Furthermore, high prevalence of various chronic disorders such as diabetes, asthma, cardiovascular diseases, and arthritis in the U.S. is expected to increase demand for biopharmaceutical products and in turn support the non-oncology biopharmaceuticals market growth. For instance, according to the data published by Centers for Disease Control and Prevention (CDC), in 2017, over 100 million U.S. adults were suffering from diabetes or pre-diabetes.
Key features of the study:
Detailed Segmentation:
“*” marked represents similar segmentation in other categories in the respective section.
Detailed Segmentation:
Joining thousands of companies around the world committed to making the Excellent Business Solutions.
View All Our Clients