U.S. NON ONCOLOGY BIOPHARMACEUTICALS MARKET SIZE AND SHARE ANALYSIS - GROWTH TRENDS AND FORECASTS (2026 - 2033)

Biopharmaceuticals are complex, high molecular weight proteins and peptides that are produced or synthesized from living biological source. Biopharmaceuticals are further divided into biologics and biosimilars.

Biologics can be defined as molecules derived from the living cells such as microorganisms, or plant 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. The U.S. Food and Drug Administration (FDA) defines biosimilar as a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product.

Non-oncology biopharmaceuticals are drugs which are indicated for treatment of a number of diseases except cancer such as rheumatoid arthritis, psoriatic arthritis, multiple sclerosis, hemophilia, age-related macular degeneration, osteoporosis, and others.

Market Dynamics

Frequent launch, approval, and presence of robust pipeline of novel biopharmaceutical products indicated for treatment of number of non-oncology indication is expected to drive the U.S. non-oncology biopharmaceuticals market growth over the forecast period. For instance, in November 2018, Swedish Orphan Biovitrum AB and Novimmune SA received the U.S. Food and Drug Administration (FDA) approval for Gamifant (emapalumab-lzsg), an interferon gamma (IFNγ) blocking antibody for the treatment of pediatric (new born and older) and adult patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent, or progressive disease or intolerance to conventional HLH therapy.

In March 2018, Theratechnologies Inc. and its partner TaiMed Biologics Inc. received the U.S. Food and Drug Administration (FDA) approval for its Trogarzo (ibalizumab-uiyk) Injection. In combination with other ARTs, Trogarzo is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection, who are failing their current antiretroviral regimen.

Key players in the market are adopting inorganic growth strategies such as mergers and partnerships for the development of novel products or to expand their product portfolio by acquisition. Such frequent activities by key players is expected to significantly support the U.S. non-oncology biopharmaceuticals market growth over the forecast period.

For instance, in 2016, 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, Shire plc. and Baxalta Incorporated entered into an agreement, under which Shire will combine with Baxalta. Baxalta has a well-established hematology portfolio based on its heritage and legacy of leadership in hemophilia. With this merger, the established company (Shire plc.) will strengthen its position in the market.

Furthermore, high prevalence of various chronic disorders such as diabetes, asthma, cardiovascular diseases, and arthritis in the U.S. is expected to increase demand for biopharmaceutical products and in turn support the non-oncology biopharmaceuticals market growth. For instance, according to the data published by Centers for Disease Control and Prevention (CDC), in 2017, over 100 million U.S. adults were suffering from diabetes or pre-diabetes.

Key features of the study

• This report provides in-depth analysis of U.S. non-oncology biopharmaceuticals market and provides market size (USD Bn) and Compound Annual Growth Rate (CAGR %) for the forecast period (2026 – 2033), considering 2025, as the base year
• It elucidates potential revenue opportunity across different segments and explains attractive investment proposition matrices for this market
• This study also provides key insights into market drivers, restraints, opportunities, new product launches or approval, regional outlook, and competitive strategy adopted by key players
• It profiles key players in the U.S. Non-oncology biopharmaceuticals market based on the following parameters – company overview, financial performance, product portfolio, geographical presence, distribution strategies, key developments, and strategies, and future plans
• Key companies covered as a part of this study 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.
• Insights from this report would allow marketers and the management authorities of the companies to make informed decision regarding their future product launches, technology up-gradation, market expansion, and marketing tactics
• The U.S. non-oncology biopharmaceuticals market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts
• Stakeholders would have ease in decision-making through the various strategy matrices used in analyzing the U.S. non-oncology biopharmaceuticals market

Market Segmentation

• Product Type Insights (Revenue, USD Bn, 2026 - 2033)
  • Biologics
  • Biosimilars
• Drug Class Insights (Revenue, USD Bn, 2026 - 2033)
  • Monoclonal Antibody
  • Enzyme Replacement Therapy
  • Erythropoietin
  • Interferon
  • Colony-stimulating Factor
  • Botulinum Toxin
  • Fusion Protein
  • Vaccines
  • Human Recombinant Insulin
  • Blood Factors
  • Human Growth Hormone
  • Others
• Disease Indication Insights (Revenue, USD Bn, 2026 - 2033)
  • 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
  • Others (Cardiac diseases and others)
• Key Players Insights
  • Sanofi S.A., Pfizer, Inc.
  • Johnson & Johnson
  • Novartis International AG
  • Amgen, Inc.
  • Eli Lilly and Company
  • AbbVie Inc.
  • Bristol-Myers Squibb Company
  • 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.
  • Theratechnologies Inc