U.S. Non-oncology Biopharmaceuticals Market, By Product Type, By Drug Class, By Disease Indication

Description

U.S. Non-oncology Biopharmaceuticals Market is estimated to be valued at USD 252 Bn in 2026 and is expected to reach USD 497 Bn by 2033, growing at a compound annual growth rate (CAGR) of 10.2% from 2026 to 2033.

Report Coverage		Report Details
Base Year:	2025	Market Size in 2026:	USD 252 Bn
Historical Data for:	2020 To 2024	Forecast Period:	2026 To 2033
Forecast Period 2026 to 2033 CAGR:	10.20%	2033 Value Projection:	USD 497 Bn

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 (IFNY) 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

Product Code: CMI2575

1. Research Objectives and Assumptions

Research Objectives
Assumptions
Abbreviations

2. 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)

3. 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

4. U.S. Non-oncology Biopharmaceuticals Market, By Product Type, 2026-2033(USD Bn)

Introduction
- Market Share Analysis, 2025, 2028, and 2033 (%)
- Y-o-Y Growth Analysis, 2021 - 2033
- Segment Trends
Biologics
- Market Share Analysis, 2025, 2028, and 2033 (%)
- Y-o-Y Growth Analysis, 2021 - 2033
- Segment Trends
Biosimilars
- Market Share Analysis, 2025, 2028, and 2033 (%)
- Y-o-Y Growth Analysis, 2021 - 2033
- Segment Trends

5. U.S. Non-oncology Biopharmaceuticals Market, By Drug Class, 2026-2033(USD Bn)

Introduction
- Market Share Analysis, 2025, 2028, and 2033 (%)
- Y-o-Y Growth Analysis, 2021 - 2033
- Segment Trends
Blood Factors
- Market Share Analysis, 2025, 2028, and 2033 (%)
- Y-o-Y Growth Analysis, 2021 - 2033
- Segment Trends
Botulinum Toxin
- Market Share Analysis, 2025, 2028, and 2033 (%)
- Y-o-Y Growth Analysis, 2021 - 2033
- Segment Trends
Colony-stimulating Factor
- Market Share Analysis, 2025, 2028, and 2033 (%)
- Y-o-Y Growth Analysis, 2021 - 2033
- Segment Trends
Enzyme Replacement Therapy
- Market Share Analysis, 2025, 2028, and 2033 (%)
- Y-o-Y Growth Analysis, 2021 - 2033
- Segment Trends
Erythropoietin
- Market Share Analysis, 2025, 2028, and 2033 (%)
- Y-o-Y Growth Analysis, 2021 - 2033
- Segment Trends
Fusion Protein
- Market Share Analysis, 2025, 2028, and 2033 (%)
- Y-o-Y Growth Analysis, 2021 - 2033
- Segment Trends
Human Growth Hormone
- Market Share Analysis, 2025, 2028, and 2033 (%)
- Y-o-Y Growth Analysis, 2021 - 2033
- Segment Trends
Interferon
- Market Share Analysis, 2025, 2028, and 2033 (%)
- Y-o-Y Growth Analysis, 2021 - 2033
- Segment Trends
Monoclonal Antibody
- Market Share Analysis, 2025, 2028, and 2033 (%)
- Y-o-Y Growth Analysis, 2021 - 2033
- Segment Trends
Recombinant Human Insulin
- Market Share Analysis, 2025, 2028, and 2033 (%)
- Y-o-Y Growth Analysis, 2021 - 2033
- Segment Trends
Vaccines
- Market Share Analysis, 2025, 2028, and 2033 (%)
- Y-o-Y Growth Analysis, 2021 - 2033
- Segment Trends
Others
- Market Share Analysis, 2025, 2028, and 2033 (%)
- Y-o-Y Growth Analysis, 2021 - 2033
- Segment Trends

6. U.S. Non-oncology Biopharmaceuticals Market, By Disease Indication, 2026-2033 (USD Bn)

Introduction
- Market Share Analysis, 2025, 2028, and 2033 (%)
- Y-o-Y Growth Analysis, 2021 - 2033
- Segment Trends
Age-related Macular Degeneration
- Market Share Analysis, 2025, 2028, and 2033 (%)
- Y-o-Y Growth Analysis, 2021 - 2033
- Segment Trends
Anemia
- Market Share Analysis, 2025, 2028, and 2033 (%)
- Y-o-Y Growth Analysis, 2021 - 2033
- Segment Trends
Ankylosing Spondylitis
- Market Share Analysis, 2025, 2028, and 2033 (%)
- Y-o-Y Growth Analysis, 2021 - 2033
- Segment Trends
Crohn's Disease
- Market Share Analysis, 2025, 2028, and 2033 (%)
- Y-o-Y Growth Analysis, 2021 - 2033
- Segment Trends
Cystic Fibrosis
- Market Share Analysis, 2025, 2028, and 2033 (%)
- Y-o-Y Growth Analysis, 2021 - 2033
- Segment Trends
Diabetes
- Market Share Analysis, 2025, 2028, and 2033 (%)
- Y-o-Y Growth Analysis, 2021 - 2033
- Segment Trends
Hemophilia
- Market Share Analysis, 2025, 2028, and 2033 (%)
- Y-o-Y Growth Analysis, 2021 - 2033
- Segment Trends
Hepatitis B
- Market Share Analysis, 2025, 2028, and 2033 (%)
- Y-o-Y Growth Analysis, 2021 - 2033
- Segment Trends
Multiple Sclerosis
- Market Share Analysis, 2025, 2028, and 2033 (%)
- Y-o-Y Growth Analysis, 2021 - 2033
- Segment Trends
Osteoporosis
- Market Share Analysis, 2025, 2028, and 2033 (%)
- Y-o-Y Growth Analysis, 2021 - 2033
- Segment Trends
Psoriasis
- Market Share Analysis, 2025, 2028, and 2033 (%)
- Y-o-Y Growth Analysis, 2021 - 2033
- Segment Trends
Psoriatic Arthritis
- Market Share Analysis, 2025, 2028, and 2033 (%)
- Y-o-Y Growth Analysis, 2021 - 2033
- Segment Trends
Rheumatoid Arthritis
- Market Share Analysis, 2025, 2028, and 2033 (%)
- Y-o-Y Growth Analysis, 2021 - 2033
- Segment Trends
Ulcerative Colitis
- Market Share Analysis, 2025, 2028, and 2033 (%)
- Y-o-Y Growth Analysis, 2021 - 2033
- Segment Trends
Others
- Market Share Analysis, 2025, 2028, and 2033 (%)
- Y-o-Y Growth Analysis, 2021 - 2033
- Segment Trends

7. Competitive Landscape

Heat Map Analysis
Company Profiles
- Sanofi S.A.
  - Company Overview
  - Product Portfolio
  - Key Developments
  - Financial Performance
  - Strategies
- Pfizer, Inc.
  - Company Overview
  - Product Portfolio
  - Key Developments
  - Financial Performance
  - Strategies
- Johnson & Johnson
  - Company Overview
  - Product Portfolio
  - Key Developments
  - Financial Performance
  - Strategies
- Novartis International AG
  - Company Overview
  - Product Portfolio
  - Key Developments
  - Financial Performance
  - Strategies
- Amgen, Inc.
  - Company Overview
  - Product Portfolio
  - Key Developments
  - Financial Performance
  - Strategies
- Eli Lilly and Company
  - Company Overview
  - Product Portfolio
  - Key Developments
  - Financial Performance
  - Strategies
- AbbVie Inc.
  - Company Overview
  - Product Portfolio
  - Key Developments
  - Financial Performance
  - Strategies
- Bristol - Myers Squibb Company
  - Company Overview
  - Product Portfolio
  - Key Developments
  - Financial Performance
  - Strategies
- F. Hoffmann-La Roche AG
  - Company Overview
  - Product Portfolio
  - Key Developments
  - Financial Performance
  - Strategies
- Novo Nordisk A/S
  - Company Overview
  - Product Portfolio
  - Key Developments
  - Financial Performance
  - Strategies
- GlaxoSmithKline plc.
  - Company Overview
  - Product Portfolio
  - Key Developments
  - Financial Performance
  - Strategies
- UCB Pharma
  - Company Overview
  - Product Portfolio
  - Key Developments
  - Financial Performance
  - Strategies
- Teva Pharmaceutical Industries Ltd.
  - Company Overview
  - Product Portfolio
  - Key Developments
  - Financial Performance
  - Strategies
- Takeda Pharmaceutical Company Ltd
  - Company Overview
  - Product Portfolio
  - Key Developments
  - Financial Performance
  - Strategies
- AstraZeneca Plc
  - Company Overview
  - Product Portfolio
  - Key Developments
  - Financial Performance
  - Strategies
- Mylan N.V.
  - Company Overview
  - Product Portfolio
  - Key Developments
  - Financial Performance
  - Strategies
- LEO Pharma A/S
  - Company Overview
  - Product Portfolio
  - Key Developments
  - Financial Performance
  - Strategies
- Boehringer Ingelheim GmbH
  - Company Overview
  - Product Portfolio
  - Key Developments
  - Financial Performance
  - Strategies
- Alexion Pharmaceuticals Inc.
  - Company Overview
  - Product Portfolio
  - Key Developments
  - Financial Performance
  - Strategies
- Merck & Co., Inc.
  - Company Overview
  - Product Portfolio
  - Key Developments
  - Financial Performance
  - Strategies
- Elusys Therapeutics, Inc.
  - Company Overview
  - Product Portfolio
  - Key Developments
  - Financial Performance
  - Strategies
- Swedish Orphan Biovitrum AB
  - Company Overview
  - Product Portfolio
  - Key Developments
  - Financial Performance
  - Strategies
- Samsung Bioepis NL B.V.
  - Company Overview
  - Product Portfolio
  - Key Developments
  - Financial Performance
  - Strategies
- Biogen Inc.
  - Company Overview
  - Product Portfolio
  - Key Developments
  - Financial Performance
  - Strategies
- Theratechnologies Inc.
  - Company Overview
  - Product Portfolio
  - Key Developments
  - Financial Performance
  - Strategies

8. Section

References
Research Methodology
About us and Sales Contact