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.
|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|
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.
|Restraints & Challenges:||
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.
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.
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:
“*” marked represents similar segmentation in other categories in the respective section.
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