The U.S sterile injectables market is driven by factors such as the increasing incidence of chronic diseases, rising demand for biologics, technological advancements in drug delivery systems, and the growing geriatric population. Sterile injectables are commonly used in the treatment of cancer, autoimmune disorders, infectious diseases, and other medical conditions. The COVID-19 pandemic has also had a significant impact on the market, with an increased demand for sterile injectables to treat critically ill patients. However, factors such as the high cost of development and production, stringent regulatory requirements, and the risk of contamination and infection associated with injectable drug delivery systems may impede market growth. The trend towards outsourcing of manufacturing and supply chain activities, as well as the development of innovative drug delivery technologies, are expected to provide growth opportunities for the market in the coming years.
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).
Market Players in the U.S sterile injectables Industry:
1. Baxter International Inc.
Baxter International Inc. was founded in 1931 and is headquartered in Deerfield, Illinois, USA. The company operates in over 100 countries and specializes in products and services related to renal care, acute therapies, nutritional therapies, and medication delivery. . In February, 2023 Miromatrix Medical Inc. and Baxter International Inc. announced a collaborative research agreement to help support additional treatment options for patients with acute liver failure (ALF) in need of organ support therapies.
2. AstraZeneca plc
AstraZeneca plc was founded in 1999 and is headquartered in Cambridge, England. The company operates in over 100 countries and focuses on the discovery, development, and commercialization of prescription drugs across several therapeutic areas, including oncology, cardiovascular, respiratory, and immunology. In December, 2022 AstraZeneca’s Calquence (acalabrutinib), a selective Bruton’s tyrosine kinase (BTK) inhibitor, has been approved in Japan for the treatment of adult patients with treatment-naïve chronic lymphocytic leukaemia (CLL)
3. Merck & Co., Inc.
Merck & Co., Inc., also known as MSD outside of the US and Canada, was founded in 1891 and is headquartered in Kenilworth, New Jersey, USA. The company operates in more than 140 countries and specializes in the development, manufacture, and marketing of pharmaceuticals, vaccines, and animal health products. In November, 2021 Merck & Co. Inc. announced that the US Food and Drug Administration (FDA) had granted the company's investigational HIV-1 capsid inhibitor, MK-8718, Breakthrough Therapy designation for the treatment of people living with HIV-1 who have highly resistant strains of the virus.
4. Novartis AG
Novartis AG was founded in 1996 and is headquartered in Basel, Switzerland. The company operates in over 150 countries and focuses on the research, development, and manufacturing of pharmaceuticals, generics, biosimilars, and eye care products. In March, 2023 Sandoz, the global leader in off-patent medicines, has signed an agreement to acquire worldwide product rights for leading systemic antifungal agent Mycamine® (micafungin sodium, Funguard® in Japan) from Astellas.
5. Johnson & Johnson Services, Inc.
Johnson & Johnson Services, Inc. is a subsidiary of Johnson & Johnson and was founded in 1886. The company is headquartered in New Brunswick, New Jersey, USA, and operates in over 60 countries. It is a diversified healthcare company that specializes in pharmaceuticals, medical devices, and consumer health products.
6. Gilead Sciences, Inc.
Gilead Sciences, Inc. was founded in 1987 and is headquartered in Foster City, California, USA. The company operates in over 35 countries and specializes in the research, development, and commercialization of therapies for infectious diseases, oncology, and inflammatory disorders.
7. JHP Pharmaceuticals
JHP Pharmaceuticals is a subsidiary of PAR Pharmaceutical and was founded in 2007. The company is headquartered in Rochester, Michigan, USA, and operates in the US market. It specializes in the development and manufacturing of sterile injectable pharmaceutical products.
8. Pfizer Inc.
Pfizer Inc. was founded in 1849 and is headquartered in New York City, New York, USA. The company operates in over 150 countries and specializes in the research, development, and manufacturing of pharmaceuticals, vaccines, and consumer health products.
9. Fresenius Kabi Ag
Fresenius Kabi Ag is a subsidiary of Fresenius SE & Co. KGaA and was founded in 1912. The company is headquartered in Bad Homburg, Germany, and operates in over 60 countries. It specializes in the development, manufacturing, and marketing of sterile injectable drugs, infusion therapies, and clinical nutrition products.
10. CordenPharma
CordenPharma is a subsidiary of International Chemical Investors Group (ICIG) and was founded in 2006. The company is headquartered in Plankstadt, Germany, and operates in several countries, including the US, Germany, Switzerland, and France. It specializes in the development, manufacturing, and supply of APIs, drug products, and other pharmaceutical services.
11. Hikma Pharmaceuticals PLC
Hikma Pharmaceuticals PLC was founded in 1978 and is headquartered in London, UK. The company operates in over 50 countries and specializes in the development, manufacturing, and marketing of generic and branded pharmaceutical products across several therapeutic areas, including oncology, cardiovascular, and respiratory. In January, 2023 Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, announces a new exclusive licensing agreement with Celltrion Healthcare Co., Ltd, a global biopharmaceutical company.
*Definition- Sterile injectables are pharmaceutical drugs that are prepared and packaged in a sterile environment and delivered via injection to ensure the safety and efficacy of the drug. They are used for a wide range of medical treatments, including chemotherapy, anesthesia, and emergency care.
