The U.S. Non-oncology Biopharmaceuticals Market, by Product Type (Biosimilars and Biologics), by Drug Class (Human Recombinant Insulin, Monoclonal Antibody, Botulinum Toxin, Human Growth Hormone, Interferon, Enzyme Replacement Therapy, Fusion Protein, Erythropoietin, Vaccines and Others), and by Disease Indication (Age-related Macular Degeneration, Ankylosing Spondylitis, Psoriatic Arthritis, Hepatitis B, Ulcerative Colitis, Cystic Fibrosis, Rheumatoid Arthritis, Anemia, Diabetes, and Others (Cardiac Diseases and Others)), was worth US$ 116.0 billion in 2018 and is expected to grow at a CAGR of 10.2% over the forecast period (2018–2026).
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Increased launch and approval of novel biopharmaceuticals, as well as a solid pipeline of biopharmaceutical products in late-stage clinical trials, are likely to propel the non-oncology biopharmaceuticals market in the United States. For example, Leadiant Biosciences, Inc. got FDA approval for its Revcov (elapegademase-lvlr) injection in the United States in October 2018. Revcovi is a new enzyme replacement therapy (ERT) for pediatric and adult patients with adenosine deaminize severe combination immune deficiency (ADA-SCID). In addition, significant businesses participate in the development and launch of innovative biopharmaceuticals for new indications. In May 2018, Novartis announced that the US Food and Drug Administration had approved Aimovig (erenumab) for the prevention of migraine in adults. The human monoclonal antibody Aimovig was the first to be approved for the treatment of migraines. In September 2018, the FDA approved Emgality (galcanezumab-gnlm) and AJOVY (fremanezumab-vfrm) for the prevention of migraine in adults, respectively, from Eli Lilly and Company and Teva Pharmaceutical Industries Ltd. The launch of novel medications for new indications is likely to support the growth of the non-oncology biopharmaceuticals market in the United States.
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Strategic mergers, collaborations, acquisitions, and partnerships are being pursued by key market participants in order to develop novel biopharmaceuticals and extend their portfolios through strategic acquisitions of any company. Teva Pharmaceutical Industries Ltd. and Celltrion, Inc., for example, formed an exclusive agreement in October 2018 to commercialize two of Celltrion’s mAb biosimilar candidates in the U.S. and Canada. Risankizumab was bought by AbbVie Inc. from Boehringer Ingelheim (BI) in 2016. (BI 655066). Risankizumab is a psoriasis drug that is an anti-IL-23 monoclonal biologic antibody. The medicine is also being tested for other indications such as Crohn’s disease, asthma, and psoriatic arthritis, according to the company. It is currently in the third round of clinical trials. Furthermore, the loss of patents for major drugs like Humira and the launch of low-cost biosimilars is expected to be a major factor reducing the revenue generated by major drugs, which is expected to have a negative impact on the overall size and growth of the non-oncology biopharmaceutical market in the United States over the forecast period. For example, in the recent past, Sandoz Inc., Boehringer Ingelheim GmbH, and Amgen Inc. won FDA approval in the United States for biosimilar copies of AbbVie Inc.’s blockbuster medication, Humira (adalimumab). Most of these businesses, however, have negotiated an agreement with AbbVie Inc. to postpone the launch of a Humira copycat until 2023.
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Key Takeaways:
Due to increased product releases and approvals, as well as a healthy pipeline of innovative non-oncology biopharmaceuticals in the United States, the non-oncology biopharmaceuticals market in the United States is predicted to grow at a CAGR of 10.2 percent from 2018 to 2026.
The United States is the most profitable economy for monoclonal antibodies, as most significant firms such as AbbVie Inc., Roche Holding AG, and Merck & Co. get the majority of their revenue from biological products sold in the United States.
Several key biologics, including Remicade and Humira, 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 patents in the United States presents a profitable opportunity for other companies to create biosimilars.
Key market participants have attractive prospects to create novel and creative therapeutics for a variety of rare diseases, with a focus on underserved people. Acts like the Orphan Drug Act help companies explore new treatments for uncommon diseases by providing financial incentives.
Table of Contents
- Research Objectives and Assumptions
- Research Objectives
- Assumptions
- Abbreviations
- Market Purview
- Report Description
- Market Definition and Scope
- Executive Summary
- Market Snippet, By Product Type
- Market Snippet, By Drug Class
- Market Snippet, By Disease Indication
- Coherent Opportunity Map (COM)
- Report Description
- Market Dynamics, Regulations, and Trends Analysis
- Market Dynamics
- Drivers
- Restraints
- Market Opportunities
- Impact Analysis
- Recent Product Approval/Launch
- Merger-Acquisition Scenario
- Regulatory Scenario
- Reimbursement Scenario
- Pest Analysis
- Market Challenges
- Top 10 Non-oncology Biologics Brand Share
- Major Biopharmaceuticals Administration Method
- Analysis Of Mode Of Administration
- Epidemiology
- Pest Analysis
- Porter’s Five Forces Analysis
- Market Dynamics
- U.S. Non-oncology Biopharmaceuticals Market, By Product Type, 2016 – 2026 (US$ Bn)
- Introduction
- Market Share Analysis, 2018 and 2026 (%)
- Y-o-Y Growth Analysis, 2017–2026
- Segment Trends
- Biologics
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Bn)
- Biosimilars
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Bn)
- Introduction
- U.S. Non-oncology Biopharmaceuticals Market, By Drug Class, 2016 – 2026 (US$ Bn)
- Introduction
- Market Share Analysis, 2018 and 2026 (%)
- Y-o-Y Growth Analysis, 2017–2026
- Segment Trends
- Blood Factors
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Bn)
- Botulinum Toxin
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Bn)
- Colony-stimulating Factor
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Bn)
- Enzyme Replacement Therapy
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Bn)
- Erythropoietin
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Bn)
- Fusion Protein
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Bn)
- Human Growth Hormone
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Bn)
- Interferon
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Bn)
- Monoclonal Antibody
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Bn)
- Recombinant Human Insulin
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Bn)
- Vaccines
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Bn)
- Others
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Bn)
- Introduction
- U.S. Non-oncology Biopharmaceuticals Market, By Disease Indication, 2016 – 2026 (US$ Bn)
- Introduction
- Market Share Analysis, 2018 and 2026 (%)
- Y-o-Y Growth Analysis, 2017–2026
- Segment Trends
- Age-related Macular Degeneration
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Bn)
- Anemia
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Bn)
- Ankylosing Spondylitis
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Bn)
- Crohn’s Disease
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Bn)
- Cystic Fibrosis
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Bn)
- Diabetes
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Bn)
- Hemophilia
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Bn)
- Hepatitis B
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Bn)
- Multiple Sclerosis
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Bn)
- Osteoporosis
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Bn)
- Psoriasis
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Bn)
- Psoriatic Arthritis
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Bn)
- Rheumatoid Arthritis
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Bn)
- Ulcerative Colitis
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Bn)
- Others
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2016 – 2026, (US$ Bn)
- Introduction
- Competitive Landscape
- Heat Map Analysis
- Company Profiles
- Section
- References
- Research Methodology
- About us and Sales Contact
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