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).

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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.

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Market Challenges

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

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