Us sterile injectables market

U.S. Sterile Injectables Market, by Molecule Type (Large Molecule and Small Molecule), by Drug Type (Monoclonal Antibody (mAbs), Cytokines, Insulin, Peptide Hormones, Vaccines, Immunoglobulin’s, Blood Factors, Peptide Antibiotics, and Others), by Therapeutic Application (Cancer, Metabolic Diseases, Cardiovascular Diseases, Central Nervous System Disorder, Infectious Diseases, Musculoskeletal Disorders, and Others), by Route of Administration (Subcutaneous (SC), Intravenous (IV), Intramuscular (IM), and Others), and by Distribution Channel (Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies) - Size, Share, Outlook, and Opportunity Analysis, 2022 - 2030

  • Mar 2022
  • CMI4961
  • 154 Pages
  • Excel & Pdf
  • Pharmaceutical

Injectables are preparations administered through the skin or other external boundary tissue, rather than through the alimentary canal, so that the active substance they contain are administered, using gravity or force, directly into a blood vessel, organ, tissue, or lesion. The injectable preparation are administered through subcutaneous, intravenous, and intramuscular route of administration.

The containers, including the closures, for preparation for injectables do not interact physically or chemically with the preparations in any manner to alter the strength, quality, or purity beyond the official requirements.

The U.S sterile injectables market is estimated to be valued at US$ 131.8 billion in 2022 and expected to exhibit a CAGR of 9.3% over the forecast period (2022-2030).

Figure 1. U.S Sterile Injectables Market Share (%), by Molecule Type, 2022

Increasing prevalence of type 1 and type 2 diabetes and cancers is expected to drive the growth of the U.S sterile injectables market over the forecast period.

For instance, according to American Diabetes Association, in 2018, 34.2 million Americans or 10.15% of the population, had diabetes. Moreover, nearly 1.6 million Americans have type 1 diabetes, including about 187,000 children and adolescents.

Increasing research and development activities for the treatment of chronic diseases such as HIV is expected to drive the market over the forecast period.

For instance, in January 2022, Moderna, Inc. American pharmaceutical and biotechnology company based in Cambridge Massachusetts that focuses on RNA technology has started clinical trial for HIV vaccine, the first vaccination was given at George Washington University School of Medicine and Health Sciences in Washington DC.

U.S Sterile Injectables Market Report Coverage

Report Coverage Details
Base Year: 2021 Market Size in 2022: US$ 131.8 Bn
Historical Data for: 2017 to 2020 Forecast Period: 2022 to 2030
Forecast Period 2022 to 2030 CAGR: 9.3% 2030 Value Projection: US$ 268.6 Bn
Geographies covered:
  • U.S.
Segments covered:
  • By Molecule Type: Large Molecule, Small Molecule
  • By Drug Type: Monoclonal Antibody (mAbs), Cytokines, Insulin, Peptide Hormones, Vaccines, Immunoglobulins, Blood Factors, Peptide Antibiotics, Others
  • By Therapeutic Application: Cancer, Metabolic Diseases, Cardiovascular Diseases, Central Nervous System Disorder, Infectious Diseases, Musculoskeletal Disorders, Others
  • By Route of Administration: Subcutaneous (SC), Intravenous (IV), Intramuscular (IM), Others
  • By Distribution Channel: Hospital Pharmacies, Retail Pharmacies, Online Pharmacies
Companies covered:

Baxter International Inc., AstraZeneca plc, Merck & Co., Inc., Novartis AG, Johnson & Johnson Services, Inc., Gilead Sciences, Inc., JHP Pharmaceuticals, Pfizer Inc., Fresenius Kabi Ag, CordenPharma, and Hikma Pharmaceuticals PLC.

Growth Drivers:
  • Demand for oncology drugs through sterile Injectables
  • Increasing demand for COVID-19 vaccine
  • Increasing demand for insulin
Restraints & Challenges:
  • Product recall due to sterility failure

Increasing product launches and approval is expected to drive the market growth over the forecast period.

For instance, in July 2021, AstraZeneca’s BYDUREON BCise (exenatide extended release), once weekly injectable suspension has been approved in the U.S for the treatment of type 2 diabetes (T2D) to improve glycemic control in pediatric patients (10 to 17 years) as an adjunct to diet and exercise. 

Figure 2. U.S Sterile Injectables Market Share (%), by Distribution Channel, 2022

U.S Sterile Injectables Market – Impact of Coronavirus (COVID-19) Pandemic

Coronavirus (COVID-19) outbreak was first reported on December 31, 2019, in Wuhan, China. The World Health Organization declared COVID-19, as pandemic on March 11, 2020. According to the Coronavirus (COVID-19) Weekly Epidemiological Update by the World Health Organization, over 63,397,935 cases due to coronavirus (COVID-19) were reported till January 12, 2022, in the U.S.

COVID-19 has had a positive impact on the sterile injectables market as lot of people got infected with COVID-19 infection and severely infected people have to get admitted to the hospitals, while on the other hand most of the U.S population have got vaccinated to stop the spread of virus.

For instance, the U.S vaccination program began on December 14, 2020. As of January 27, 2022, 536.4 million vaccine doses have been administered in the U.S. Overall, about 249.3 million people or 75.1% of the total U.S population, have received at least one dose of vaccine.

U.S Sterile Injectables Market - Restraint

Factors restraining the U.S sterile injectables market growth include product recall due to sterility failure in injectables. For instance, in January 2022, AuroMedics Pharma LLC, is located in east Windsor, NJ, U.S, issued voluntary nationwide recall of Polymyxin B for injection USP, 500,000 unit per vial, due to the presence of particular matter. 

Key Players

Major players operating in the U.S sterile injectables market include Baxter International Inc., AstraZeneca plc, Merck & Co., Inc., Novartis AG, Johnson & Johnson Services, Inc., Gilead Sciences, Inc., JHP Pharmaceuticals, Pfizer Inc., Fresenius Kabi Ag, CordenPharma, and Hikma Pharmaceuticals PLC.

Table of Contents

  1. Research Objectives and Assumptions
    • Research Objectives
    • Assumptions
    • Abbreviations
  2. Market Purview
    • Report Description
      • Market Definition and Scope
    • Executive Summary
      • Market Snippet, By Molecule Type
      • Market Snippet, By Drug Type
      • Market Snippet, By Therapeutic Application
      • Market Snippet, By Route of Administration
      • Market Snippet, By Distribution Channel
    • Coherent Opportunity Map (COM)
  3. Market Dynamics, Regulations, and Trends Analysis
    • Market Dynamics
      • Drivers
      • Restraints
      • Market Opportunities
    • Impact Analysis
    • Pipeline Analysis
    • PEST Analysis
    • Regulatory Scenario
    • Market Trends
    • Key Highlights
    • Reimbursement Scenario
    • Mergers & Acquisitions
  4. U.S. Sterile Injectables Market – Impact of Coronavirus (COVID-19) Pandemic
    • Economic Impact
    • Impact on Clinical Trials and Drug Development
    • Government Initiatives
  5. U.S. Sterile Injectables Market, By Molecule Type, 2017 – 2030, (US$ Bn)
    • Introduction
      • Market Share Analysis, 2022 and 2030 (%)
      • Y-o-Y Growth Analysis, 2018 – 2030
      • Segment Trends
    • Large Molecule
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Bn)
    • Small Molecule
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Bn)
  6. U.S. Sterile Injectables Market, By Drug Type, 2017 – 2030, (US$ Bn)
    • Introduction
      • Market Share Analysis, 2022 and 2030 (%)
      • Y-o-Y Growth Analysis, 2018 – 2030
      • Segment Trends
    • Monoclonal Antibody (mAbs)
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Bn)
    • Cytokines
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Bn)
    • Insulin
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Bn)
    • Peptide Hormones
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Bn)
    • Vaccines
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Bn)
    • Immunoglobulin’s
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Bn)
    • Blood Factors
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Bn)
    • Peptide Antibiotics
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Bn)
    • Others
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Bn)
  7. U.S. Sterile Injectables Market, By Therapeutics Application, 2017 – 2030, (US$ Bn)
    • Introduction
      • Market Share Analysis, 2022 and 2030 (%)
      • Y-o-Y Growth Analysis, 2018 – 2030
      • Segment Trends
    • Cancer
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Bn)
    • Metabolic Diseases
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Bn)
    • Cardiovascular Diseases
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Bn)
    • Central Nervous System Disorder
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Bn)
    • Infectious Diseases
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Bn)
    • Musculoskeletal Disorders
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Bn)
    • Others
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Bn)
  8. U.S. Sterile Injectables Market, By Route of Administration, 2017 – 2030, (US$ Bn)
    • Introduction
      • Market Share Analysis, 2022 and 2030 (%)
      • Y-o-Y Growth Analysis, 2018 – 2030
      • Segment Trends
    • Subcutaneous (SC)
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Bn)
    • Intravenous (IV)
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Bn)
    • Intramuscular (IM)
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Bn)
    • Others
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Bn)
  9. U.S. Sterile Injectables Market, By Distribution Channel, 2017 – 2030, (US$ Bn)
    • Introduction
      • Market Share Analysis, 2022 and 2030 (%)
      • Y-o-Y Growth Analysis, 2018 – 2030
      • Segment Trends
    • Hospital Pharmacies
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Bn)
    • Retail Pharmacies
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Bn)
    • Online Pharmacies
      • Introduction
      • Market Size and Forecast, and Y-o-Y Growth, 2017 – 2030, (US$ Bn)
  10. Competitive Landscape
    • Heat Map Analysis
    • Market Share Analysis
      • Baxter International Inc.
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • AstraZeneca plc
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Merck & Co., Inc.
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Novartis AG
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Johnson & Johnson Services, Inc.
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Gilead Sciences, Inc.
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • JHP Pharmaceuticals
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Pfizer Inc.
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Fresenius Kabi Ag
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • CordenPharma
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
      • Hikma Pharmaceuticals PLC
        • Company Overview
        • Product Portfolio
        • Financial Overview
        • Key Highlights
        • Market Strategies
    • Analyst Views
  11. Section
    • References
    • Research Methodology
    • About Us and Sales Contact

*Browse 16 market data tables and 36 figures on “Sterile Injectables Market” – U.S. forecast to 2030

Detailed Segmentation:

  • U.S. Sterile Injectables Market, By Molecule Type:
    • Large Molecule
    • Small Molecule
  • U.S. Sterile Injectables Market, By Drug Type:
    • Monoclonal Antibody (mAbs)
    • Cytokines
    • Insulin
    • Peptide Hormones
    • Vaccines
    • Immunoglobulin’s
    • Blood Factor
    • Peptide Antibiotics
    • Others
  • U.S. Sterile Injectables Market, By Therapeutic Application:
    • Cancer
    • Metabolic Diseases
    • Cardiovascular Diseases
    • Central Nervous System Disorder
    • Infectious Diseases
    • Musculoskeletal Disorders
    • Others
  • U.S. Sterile Injectables Market, By Route of Administration:
    • Subcutaneous (SC)
    • Intravenous (IV)
    • Intramuscular (IM)
    • Others
  • U.S. Sterile Injectables Market, By Distribution Channel:
    • Hospital Pharmacies
    • Retail Pharmacies
    • Online Pharmacies
- Frequently Asked Questions -

What is the current market size and compound annual growth rate (CAGR) of the U.S sterile Injectables market during the forecast period (2022-2030)?

The U.S sterile Injectables market size is estimated to be valued at US$ 131.8  billion in 2022 and is expected to exhibit a CAGR of 9.3% between 2022 and 2030.

What are the major factors driving the market growth?

Demand for oncology drugs through sterile Injectables is expected to drive the market growth over the forecast period.

Which is the leading product type segment in the market?

Large molecule segment is expected to hold major market share, owing to increasing need of vaccines and gene therapy for the treatment of cancer.

What are the key factors hampering growth of the market?

Major factors hampering the growth of the market are product recall due to sterility failure.

Which are the major players operating in the market?

Major players operating in the market include Baxter International Inc., AstraZeneca plc, Merck & Co., Inc., Novartis AG, Johnson & Johnson Services, Inc., Gilead Sciences, Inc., JHP Pharmaceuticals, Pfizer Inc., Fresenius Kabi Ag, CordenPharma, and Hikma Pharmaceuticals PLC.
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