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  • Published On : Mar 2022
  • Code : CMI4961
  • Industry : Pharmaceutical
  • Pages : 154
  • Formats :

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

U.S. Sterile Injectables  | Coherent Market Insights

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.

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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  | Coherent Market Insights

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.

Sterile injectables refer to non-oral means of administration by injecting the drug directly into the body through three common routes of administration which includes intramuscular (IM), subcutaneous (SC), and intravenous (IV). Moreover, injectables are made up of small molecules and large molecule (biologics), and have immediate onset of action. Parenteral administration can be performed by injection, that is using a needle (usually hypodermic needle) and a syringe or by the insertion of an indwelling catheter.

The rise in inclination towards sterile injectables over conventional drugs owing their features such as quick therapeutic response and high absorbability inside the patient’s body and growing focus on biologics and developing advanced products in the healthcare sector are the major factors driving the sterile injectables market. The rise in number of research and development activities and increasing investment by pharmaceutical manufacturers to produce enhanced injectables products such as anti-infective, oncolytics, and cardiovascular medicines accelerate the sterile injectables market growth.

Market Dynamics

The increasing prevalence of chronic diseases, rising research and development activities, and increasing adoption of inorganic growth strategies such as mergers, acquisitions, partnerships, and collaborations by key players operating in the market are the major factors that are expected to drive growth of the U.S sterile Injectables market over the forecast period.

For instance, according to American Cancer Society estimated 104,610 new cases of colon cancer and 43,340 cases of rectal cancer diagnosed in the U.S. in 2020

Key features of the study:

  • This report provides in-depth analysis of the U.S sterile injectables market, and provides market size (US$ Bn) and compound annual growth rate (CAGR%) for the forecast period (2022–2030), considering 2021 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 approval, market trends,  regional outlook, and competitive strategies adopted by key players
  • It profiles key players in the U.S sterile injectables market based on the following parameters – company overview, financial performance, product portfolio, market presence, distribution strategies, key developments, strategies, and future plans
  • Key companies covered as a part of this study 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.
  • 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
  • Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the U.S sterile injectables market

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
  • Company Profiles
    • Baxter International Inc.
      • Company Overview
      • Material Portfolio
      • Financial Performance
      • Key Highlights
      • Market Strategies
    • AstraZeneca plc
    • Merck & Co., Inc.
    • Novartis AG
    • Johnson & Johnson Services, Inc.
    • Gilead Sciences, Inc.
    • JHP Pharmaceuticals
    • Pfizer Inc.
    • Fresenius Kabi Ag
    • CordenPharma
    • Hikma Pharmaceuticals PLC

“*” marked represents similar segmentation in other categories in the respective section.

Frequently Asked Questions

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.
Demand for oncology drugs through sterile Injectables is expected to drive the market growth over the forecast period.
Large molecule segment is expected to hold major market share, owing to increasing need of vaccines and gene therapy for the treatment of cancer.
Major factors hampering the growth of the market are product recall due to sterility failure.
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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