U.S. Sterile Injectables Market, By Molecule Type, By Drug Type (Monoclonal Antibody, Cytokines, Insulin, Peptide Hormones, Vaccines, and Others), By Therapeutic Application, By Route of Administration, By Distribution Channel

Description

The U.S. sterile injectables market is estimated to be valued at USD 155.46 Bn in 2024 and is expected to reach USD 295.22 Bn by 2031, exhibiting a compound annual growth rate (CAGR) of 9.6% from 2024 to 2031.

Report Coverage		Report Details
Base Year:	2023	Market Size in 2024:	155.46 Bn
Historical Data for:	2019 to 2023	Forecast Period:	2024 to 2031
Forecast Period 2024 to 2031 CAGR:	9.60%	2031 Value Projection:	295.22 Bn

Figure. U.S. Sterile Injectables Market Share (%), By Molecule Type, 2024

Sterile injectables refer to parenteral drugs that are administered via various injection routes such as intravenous, intramuscular, subcutaneous, and others in their final sterile form for healing or preventing medical conditions. The rising prevalence of chronic diseases like cancer, diabetes, autoimmune disorders, and others and the increasing complexity of therapies have augmented the demand for sterile injectable drugs in the country. Moreover, the growing geriatric population who are more susceptible to such conditions also contributes to market expansion. Several pharmaceutical companies have been actively developing generic sterile injectable drugs to cater to this growing therapeutic segment in a cost-effective manner.

Market Dynamics:

The U.S. sterile injectables market is driven by factors such as the rising burden of chronic diseases, increasing adoption of biologics and biosimilars, growing healthcare spending, and expansion of drug manufacturing capabilities. However, the market growth can be hindered by stringent regulatory frameworks and the complex nature of sterile product development. Pharmaceutical firms now have significant opportunities to reduce production costs, improve process efficiencies, and ensure drug quality through advanced manufacturing technologies like continuous manufacturing and real-time release. Outsourcing sterile injectable production to well-established contract development and manufacturing organizations is also gaining traction.

Key Features of the Study:

This report provides in-depth analysis of the U.S. sterile injectables market, and provides market size (USD Bn) and compound annual growth rate (CAGR%) for the forecast period (2024-2031), considering 2023 as the base year

It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrices for this market

This study also provides key insights about market drivers, restraints, opportunities, new product launches or approvals, market trends, regional outlook, and competitive strategies adopted by key players

Key companies covered as a part of this study include Baxter, AstraZeneca, Merck & Co., Inc., Novartis AG, Gilead Sciences, Inc., JHP Pharmaceuticals, Pfizer Inc., Fresenius Kabi Ag, CordenPharma, Recipharm AB, Hikma Pharmaceuticals PLC, and Eli Lilly and Company

Insights from this report would allow marketers and the management authorities of the companies to make informed decisions regarding their future product launches, type up-gradation, market expansion, and marketing tactics

The U.S. sterile injectables market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts

Market Segmentation:

By Molecule Type Insights (Revenue, USD Bn, 2019 - 2031)
- Large Molecule
- Small Molecule
By Drug Type Insights (Revenue, USD Bn, 2019 - 2031)
- Monoclonal Antibody (mAbs)
- Cytokines
- Insulin
- Peptide Hormones
- Vaccines
- Others
By Therapeutic Application Insights (Revenue, USD Bn, 2019 - 2031)
- Cancer
- Metabolic Disorder
- Cardiovascular Diseases
- Infectious Diseases
- Musculoskeletal Disorders
- Others
By Route of Administration Insights (Revenue, USD Bn, 2019 - 2031)
- Subcutaneous
- Intravenous
- Intramuscular
- Others
By Distribution Channel Insights (Revenue, USD Bn, 2019 - 2031)
- Hospital Pharmacies
- Retail Pharmacies
- Online Pharmacies
Key Players Insights
- Baxter
- AstraZeneca
- Merck & Co., Inc.
- Novartis AG
- Gilead Sciences, Inc.
- JHP Pharmaceuticals
- Pfizer Inc.
- Fresenius Kabi Ag
- CordenPharma
- Recipharm AB
- Hikma Pharmaceuticals PLC
- Eli Lilly and Company

Product Code: CMI4961

1. Research Objectives and Assumptions

Research Objectives
Assumptions
Abbreviations

2. Market Purview

Report Description
- Market Definition and Scope
Executive Summary
- U.S. Sterile Injectables Market, By Molecule Type
- U.S. Sterile Injectables Market, By Drug Type
- U.S. Sterile Injectables Market, By Therapeutic Application
- U.S. Sterile Injectables Market, By Route of Administration
- U.S. Sterile Injectables Market, By Distribution Channel

3. Market Dynamics, Regulations, and Trends Analysis

Market Dynamics
Impact Analysis
Key Highlights
Regulatory Scenario
Product Launches/Approvals
PEST Analysis
PORTER's Analysis
Merger and Acquisition Scenario
Epidemiology

4. U.S. Sterile Injectables Market, By Molecule Type, 2019-2031, (USD Bn)

Introduction
- Market Share Analysis, 2024 and 2031 (%)
- Y-o-Y Growth Analysis, 2020 - 2031
- Segment Trends
Large Molecule
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
Small Molecule
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)

5. U.S. Sterile Injectables Market, By Drug Type, 2019-2031, (USD Bn)

Introduction
- Market Share Analysis, 2024 and 2031 (%)
- Y-o-Y Growth Analysis, 2020 - 2031
- Segment Trends
Monoclonal Antibody (mAbs)
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
Cytokines
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
Insulin
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
Peptide Hormones
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
Vaccines
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
Others
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)

6. U.S. Sterile Injectables Market, By Therapeutic Application, 2019-2031, (USD Bn)

Introduction
- Market Share Analysis, 2024 and 2031 (%)
- Y-o-Y Growth Analysis, 2020 - 2031
- Segment Trends
Cancer
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
Metabolic Disorder
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
Cardiovascular Diseases
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
Infectious Diseases
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
Musculoskeletal Disorders
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
Others
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)

7. U.S. Sterile Injectables Market, By Route of Administration, 2019-2031, (USD Bn)

Introduction
- Market Share Analysis, 2024 and 2031 (%)
- Y-o-Y Growth Analysis, 2020 - 2031
- Segment Trends
Subcutaneous
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
Intravenous
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
Intramuscular
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
Others
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)

8. U.S. Sterile Injectables Market, By Distribution Channel, 2019-2031, (USD Bn)

Introduction
- Market Share Analysis, 2024 and 2031 (%)
- Y-o-Y Growth Analysis, 2020 - 2031
- Segment Trends
Hospital Pharmacies
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
Retail Pharmacies
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)
Online Pharmacies
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2019-2031, (USD Bn)

9. Competitive Landscape

Baxter
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
AstraZeneca
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
Merck & Co., Inc.
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
Novartis AG
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
Gilead Sciences, Inc.
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
JHP Pharmaceuticals
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
Pfizer Inc.
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
Fresenius Kabi Ag
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
CordenPharma
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
Recipharm AB
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
Hikma Pharmaceuticals PLC
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies
Eli Lilly and Company
- Company Highlights
- Product Portfolio
- Key Developments
- Financial Performance
- Strategies

10. Analyst Recommendations

Wheel of Fortune
Analyst View
Coherent Opportunity Map

11. References and Research Methodology

References
Research Methodology
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