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)), was valued at US$ 116.0 Bn in 2018 and
is projected to exhibit a CAGR of 10.2% during the forecast period (2018–2026).
Factors such as increasing launch
and approval of novel biopharmaceuticals and robust pipeline of
biopharmaceutical products in late phase of clinical trial is expected to
significantly drive the U.S. non-oncology biopharmaceuticals market growth. 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) for the
treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID)
in pediatric and adult patients. Furthermore, key players are involved in
development and launch of novel biopharmaceuticals for new indications. For
instance, in May 2018, Novartis announced that the U.S. FDA approved Aimovig
(erenumab) for the preventive treatment of migraine in adults. Aimovig was the
first human monoclonal antibody approved for treatment of migraine. In
September 2018, Eli Lilly and Company, and Teva Pharmaceutical Industries Ltd.
also received the U.S. FDA approval for Emgality (galcanezumab-gnlm) and AJOVY
(fremanezumab-vfrm), respectively for the preventive treatment of migraine in
adults. Launch of novel drugs for new indications is expected to support the
U.S. non-oncology biopharmaceuticals market growth over the forecast period.
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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.
Key players in the market are
involved in strategic merger, collaboration, acquisition, and partnership for
the development of novel biopharmaceuticals to expand its portfolio with
strategic acquisition of any company. 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. 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. 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
blockbuster drugs such as Humira and launch of their biosimilars at low prices
is expected to be a major factor negatively affecting the revenue generated by
blockbuster drugs, which in turn is expected to negatively affect the 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
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% during the
forecast period (2018 – 2026), owing 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
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 patents in the U.S. market
offers lucrative opportunity to other players for development of biosimilars.
Key players in the market have
lucrative opportunities to develop 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.
Major 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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