U.S. Non-oncology Biopharmaceuticals Market- Insights
Biologics can be defined as molecules derived from living cells such as microorganisms, plants 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.
Biopharmaceuticals are part of a wider category of therapeutic agents called biologics. Biopharmaceuticals are the substances developed in living systems with the help of biotechnology and are used in therapeutic and diagnostic applications. Non-oncology biopharmaceuticals are the drugs that are used in the treatment of various diseases rather than cancer such as rheumatoid arthritis, psoriatic arthritis, multiple sclerosis, hemophilia, age-related macular degeneration, osteoporosis, and others.
Increasing launches, approvals, and robust pipeline of novel biopharmaceuticals for non-oncology indications
Frequent approvals, launches, and robust pipeline of novel non-oncology biopharmaceuticals for various indications in the U.S. market is expected to significantly support the U.S. non-oncology biopharmaceuticals market growth.
For instance, in September 2018, Eli Lilly and Company received the U.S. Food and Drug Administration (FDA) approval for its Emgality (galcanezumab-gnlm) 120 mg injection, for the preventive treatment of migraine in adults.
In February 2018, Novartis announced that the U.S. Food and Drug Administration (FDA) approved a label update for its Cosentyx (secukinumab), the first interleukin-17A (IL-17A) inhibitor approved to treat moderate-to-severe plaque psoriasis.
In July 2018, Amgen Inc. and UCB Inc. resubmitted the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for EVENITY (romosozumab), an investigational monoclonal antibody for the treatment of osteoporosis in postmenopausal women at high risk of fracture.
The U.S. non-oncology biopharmaceuticals market size was valued at US$ 116.0 Bn in 2018 and is expected to witness a CAGR of 10.2% during the forecast period (2018 – 2026).
Figure 1. U.S. Non-oncology Biopharmaceuticals Market Share (%), By Product Type, 2018-2026
Source: Coherent Market Insights Analysis (2018)
Increasing mergers and collaborations among key players for development of novel non-oncology biopharmaceuticals is expected to support the market growth
Key players in the market are involved in strategic mergers and collaborations for the development of new biopharmaceutical products and to market them in the U.S. Such strategic mergers and collaborations between key players is expected to support the development of novel products, which in turn is expected to fuel the U.S. non-oncology biopharmaceuticals market growth over the forecast period.
For instance, in 2017, Sanofi S.A. and its vaccines business unit Sanofi Pasteur collaborated with MedImmune, the global biologics research and development arm of AstraZeneca Plc., for the development and commercialization of a monoclonal antibody, namely MEDI8897, for the prevention of Respiratory Syncytial Virus (RSV) associated illness in newborns and infants.
High price of branded biologic products is expected to be a major factor negatively affecting its adoption
According to the report published by the Association for Accessible Medicines in 2018, the annual treatment with Humira comes with a list price of US$ 38,000, and according to the report published by I-Mak.org, between 2012 and 2016, the average spending on Humira per person in U.S. increased from US$ 16,000 to US$ 33,000.
Table 1. Revenue of Top Non-oncology Biopharmaceutical Brands in the U.S.
Source: Coherent Market Insights Analysis (2018)
In the recent past, various blockbuster biologics such as Humira and Remicade lost patent in the U.S. market. Furthermore, various other high revenue generating biologics are expected to lose their patents in the near future.
Loss of patent in the U.S. market offers lucrative opportunity to other players for development of its biosimilars. Hence, key players in the market are focused on launch and development of biosimilars of biologic products in the market at affordable price.
For instance, in 2017, Merck & Co., Inc. launched RENFLEXIS (infliximab-abda), a biosimilar of the originator biologic medicine Remicade (infliximab) by Janssen Biotech, Inc. As per the company, RENFLEXIS is introduced in the U.S. at a list price (wholesaler acquisition cost) of US$ 753.39, representing a 35% discount to the current list price of Remicade, which is its reference product.
High R&D Investments: Developing an IV/injectable biopharmaceutical requires sophisticated infrastructure, skilled scientists, and significant resource investment. Development of a biopharmaceutical product requires extensive clinical research and multiple phases of trials, which is a lengthy and expensive process. These factors are significant barriers for the new players to enter the market.
Sales and Marketing: The U.S. non-oncology biopharmaceuticals market has established market players with strong sales and marketing team. Presence of such strong players in the country creates a big challenge for new players to enter the market and to sustain against such big players.
Physician Acceptance: Physician acceptance of substitutes for well-established products may be a challenge, particularly among indications for which numerous products are available and substitutes do not exhibit high/ better safety profile and/or lower cost.
Key players operating in the U.S. non-oncology biopharmaceuticals market include Sanofi S.A., Pfizer, Inc., Johnson & Johnson, Novartis International AG, Amgen, Inc., Eli Lilly and Company, AbbVie Inc., Bristol-Myers Squibb Company, F. Hoffmann-La Roche AG, Novo Nordisk A/S, GlaxoSmithKline plc., UCB Pharma, Teva Pharmaceutical Industries Ltd., Takeda Pharmaceutical Company Ltd, AstraZeneca Plc, Mylan N.V., LEO Pharma A/S, Boehringer Ingelheim GmbH, Alexion Pharmaceuticals Inc., Merck & Co., Inc., Elusys Therapeutics, Inc., Swedish Orphan Biovitrum AB, Samsung Bioepis NL B.V., Biogen Inc., and Theratechnologies Inc.
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.
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:
“*” marked represents similar segmentation in other categories in the respective section.
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