U.S. Non-oncology Biopharmaceuticals Market Size to Score past US$ 253.0 Bn Threshold by 2027 at a 10.2% CAGR | Generated Opportunities for Growth In Non-oncology Biopharmaceuticals Industry

Biologics are substances that are derived from living cells such as microbes, plants, or animal cells and are used to treat, diagnose, or prevent diseases. The majority of biologic molecules are huge, complex compounds or combinations of molecules.

Biopharmaceuticals are part of the biologics group of medicinal drugs. Biopharmaceuticals are compounds that are created in biological systems using biotechnology and are utilized for medicinal and diagnostic purposes. Multiple sclerosis, osteoporosis, rheumatoid arthritis, hemophilia, psoriatic arthritis, age-related macular degeneration, and other disorders are treated with non-oncology biopharmaceuticals.

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Launches, approvals, and a strong pipeline of innovative biopharmaceuticals for non-oncology indications are all on the rise:

The U.S. non-oncology biopharmaceuticals market is predicted to increase rapidly due to frequent approvals, launches, and a rich pipeline of innovative non-oncology biopharmaceuticals for various purposes.

For example, the U.S. Food and Drug Administration (FDA) approved Eli Lilly and Company's Emgality (galcanezumab-gnlm) 120 mg injectable for the prevention of migraine in adults in September 2018.

The Food and Drug Administration (FDA) authorized a label update for Novartis' Cosentyx (secukinumab), the first interleukin-17A (IL-17A) inhibitor licensed to treat moderate-to-severe plaque psoriasis, in February 2018.

In July 2018, Amgen Inc. and UCB Inc. resubmitted the Biologics License Application (BLA) for EVENITY (romosozumab), an experimental monoclonal antibody for the treatment of osteoporosis in postmenopausal women at high risk of fracture, to the US Food and Drug Administration (FDA).

The market is predicted to rise due to an increase in mergers and partnerships among key companies for the development of novel non-oncology biopharmaceuticals:

Strategic mergers and collaborations are taking place among the market's major competitors in order to develop and commercialize novel biopharmaceutical products in the United States. The development of novel medicines is projected to be aided by strategic mergers and partnerships between key competitors, which is projected to boost the non-oncology biopharmaceuticals market expansion in the United States throughout the forecast period.

For example, in 2017, Sanofi S.A. and its vaccines business unit Sanofi Pasteur teamed up with MedImmune, AstraZeneca Plcglobal .'s biologics research and development arm, to develop and commercialize MEDI8897, a monoclonal antibody for the prevention of Respiratory Syncytial Virus (RSV)-related illness in newborns and infants.

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The high cost of branded biologics is projected to be a key factor hampering adoption rate:

According to a report published by the Association for Accessible Medicines in 2018, Humira has a list price of US$ 38,000 per year, and according to a report published by I-Mak.org, the average spending on Humira per person in the United States increased from US$ 16,000 to US$ 33,000 between 2012 and 2016.

Market Opportunity:

Several biologics, including Humira and Remicade, have recently lost their patent protection in the United States. In addition, several more high-profit biologics are projected to lose their patents in the near future.

The loss of a patent in the US market presents a profitable opportunity for other companies to create biosimilars. As a result, prominent market participants are focusing on the launch and development of biosimilars of biologic drugs in the market at a reasonable cost.

For example, in 2017, Merck & Co., Inc. developed RENFLEXIS (infliximab-abda), a biosimilar of Janssen Biotech, Inc.'s original biologic medication Remicade (infliximab). RENFLEXIS is being launched in the United States at a list price (wholesaler acquisition cost) of US$ 753.39, which represents a 35 percent decrease over Remicade, the company's reference product.

Market Challenges:

High R&D Investments:  Developing an IV/injectable biopharmaceutical necessitates a complex infrastructure, a substantial financial investment and a highly trained scientists. A biopharmaceutical product's development necessitates substantial clinical research and numerous phases of trials, which is a time-consuming and costly procedure. These variables operate as significant roadblocks for new entrants into the industry.

Sales and Marketing: The non-oncology biopharmaceuticals industry in the United States is dominated by established competitors with strong sales and marketing teams. The presence of such powerful firms in the country makes it difficult for new players to enter the market and compete against them.

Physician Acceptance: Physician acceptance of alternatives for well-established medicines can be difficult, especially in indications where there are multiple medicines available and substitutes do not have a high/better safety profile or are less expensive.

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