Impact Analysis of Covid-19
The complete version of the Report will include the impact of the COVID-19, and anticipated change on the future outlook of the industry, by taking into the account the political, economic, social, and technological parameters.
The U.S. Non-oncology Biopharmaceuticals Market, by Product Type (Biologics and Biosimilars), By Drug Class (Monoclonal Antibody, Enzyme Replacement Therapy, Erythropoietin, Interferon, Colony-stimulating Factor, Botulinum Toxin, Fusion Protein, Vaccines, Human Recombinant Insulin, Blood Factors, Human Growth Hormone, and Others), and by Disease Indication (Diabetes, Rheumatoid Arthritis, Psoriatic Arthritis, Multiple Sclerosis, Hemophilia, Anemia, Age-related Macular Degeneration, Hepatitis B, Cystic Fibrosis, Osteoporosis, Crohn’s Disease, Ulcerative Colitis, Psoriasis, Ankylosing Spondylitis, and Others (Cardiac Diseases and Others)), is estimated to be valued at US$ 116.0 Bn in 2018 and is estimated to exhibit a CAGR of 10.2% over the forecast period (2018-2026).
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The increasing launches and regulatory approvals of novel biopharmaceuticals, coupled with robust pipeline of biopharmaceutical products in late phase of clinical trial are the factors that are expected to augment the U.S. non-oncology biopharmaceuticals market growth over the forecast period. For instance, in October 2018, Leadiant Biosciences, Inc. received the U.S. Food and Drug Administration (FDA) approval for its Revcov (elapegademase-lvlr) injection in the U.S. Revcovi is a new enzyme replacement therapy (ERT) indicated for the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID) in pediatric and adult patients. Furthermore, in May 2018, Novartis received the U.S. FDA approval for its Aimovig (erenumab) for the preventive treatment of migraine in adults. Aimovig was the first human monoclonal antibody approved for treatment of migraine. Similarly, Eli Lilly and Company, and Teva Pharmaceutical Industries Ltd. also received the U.S. FDA approval for their Emgality (galcanezumab-gnlm) and AJOVY (fremanezumab-vfrm), respectively, in September 2018, indicated for the preventive treatment of migraine in adults.
Browse 35 Market Data Tables and 38 Figures spread through 224 Pages and in-depth TOC on U.S. Non-oncology Biopharmaceuticals Market, by Product Type (Biologics and Biosimilars), by Drug Class (Monoclonal Antibody, Enzyme Replacement Therapy, Erythropoietin, Interferon, Colony-stimulating Factor, Botulinum Toxin, Fusion Protein, Vaccines, Human Recombinant Insulin, Blood Factors, Human Growth Hormone, and Others), and by Disease Indication (Diabetes, Rheumatoid Arthritis, Psoriatic Arthritis, Multiple Sclerosis, Hemophilia, Anemia, Age-related Macular Degeneration, Hepatitis B, Cystic Fibrosis, Osteoporosis, Crohn’s Disease, Ulcerative Colitis, Psoriasis, Ankylosing Spondylitis, and Others (Cardiac Diseases and Others)) – U.S. Forecast to 2026.
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Additionally, major players in the market are focusing on strategic mergers, collaborations, acquisition, and partnerships for the development of novel biopharmaceuticals to expand their product portfolio and to strengthen their position in the global market. For instance, in October 2018, 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. Similarly, in 2016, AbbVie Inc. acquired all rights from Boehringer Ingelheim (BI) for Risankizumab (BI 655066). Risankizumab is an anti-IL-23 monoclonal biologic antibody for psoriasis. The company is also evaluating the product for other indications such as Crohn’s disease, asthma, and psoriatic arthritis. Currently, it is in clinical phase 3.
Furthermore, patent loss of bestseller drugs such as Humira and launch of their biosimilars at low prices are expected to be major factors that are expected to hamper overall U.S non-oncology biopharmaceutical market size and growth over the forecast period. For instance, in the recent past, various players such as Sandoz Inc., Boehringer Ingelheim GmbH, and Amgen Inc., received the U.S. FDA approval for their biosimilar versions of AbbVie Inc.’s blockbuster drug, Humira (adalimumab) in the U.S. However, most of these companies have reached a settlement agreement with AbbVie Inc. to delay launch of Humira biosimilar up to 2023.
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Key Takeaways of the U.S. Non-oncology Biopharmaceuticals Market:
- The U.S. non-oncology biopharmaceuticals market is expected to exhibit a CAGR of 10.2% over the forecast period (2018-2026), attributed to increasing product launches and approvals, and robust pipeline of novel U.S. non-oncology biopharmaceuticals
- The U.S. is the most lucrative economy for monoclonal antibodies, as most of the key players such as AbbVie Inc., Roche Holding AG, and Merck & Co. generate major revenue of their biological drugs from the U.S.
- In the recent past, various bestseller biologics such as Humira and Remicade lost patent in the U.S. market. Furthermore, several other high revenue generating biologics are expected to lose their patents in the near future. Thus, loss of patents in the U.S. market offers lucrative opportunity to other players for development of biosimilars.
- Key players in the market are focusing on developing novel and innovative therapies for various rare diseases and target the underserved patients. Acts such as the Orphan Drug Act also supports in creating financial incentives for companies to develop new drugs for rare diseases.
- 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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