U.S. Specialty Injectable Generics Market Size, Share & Trends Analysis Report By Type (Drugs, Biologics), By Application (Oncology, CNS, Cardiovascular), By Distribution Channel (Hospitals, Retail Pharmacy), And Segment Forecasts, 2023 - 2030

The U.S. specialty injectable generics market is expected to reach USD 36.16 million by 2030, expanding at a CAGR of 8.33% from 2023 to 2030. High presence of key pharmaceutical players in the U.S. and the rising prevalence of chronic diseases are among the key drivers for the growth. Furthermore, the growing number of FDA approvals for specialty injectable generics, emerging research & development activities, and well-established healthcare infrastructure contribute to U.S. space growth.

In the U.S., the increasing cancer diagnosis and treatment demand has created immense demand for specialty injectable generics. According to the American Cancer Society, in 2022, it is expected that 1.9 million new oncology cases are anticipated to diagnose and 609, 360 cancer deaths in the U.S. This factor has led companies to increase their focus on the development of innovative and effective treatments for oncology cases. For instance, in November 2022, Amneal Pharmaceuticals, Inc. received abbreviated new drug application approval from the U.S. FDA for leuprolide acetate. The injection is used for advanced prostatic cancer treatment.

Furthermore, pharmaceutical drug products have become increasingly important as they provide consumers with an array of treatments and life expectancy-enhancing patient lives. Thereby, continued specialty injectable generics innovation has benefited the U.S. space. For instance, in June 2022, Dr. Reddy’s Laboratories Ltd. acquired branded & generic injectable products portfolio from Eton Pharmaceuticals, Inc. The acquisition will support Dr. Reddy's company to expand & accelerate affordable medications for patients. The acquisition will add Dr. Reddy’s U.S. institutional business with limited competition injectable products.

Likewise, the COVID-19 pandemic has moderately impacted the specialty injectable generics market. During the pandemic, there was a rapid demand for specialty injections. However, shortage of production and products, and supply chain disruptions in hospitals, retail pharmacy had hampered the supply chain to some extent. One of the key issues faced by companies was production demand and delivery of products to end users. However, post-pandemic the market has witnessed rapid growth with increased production and supply chain.

Furthermore, the key participants are engaged in strategies such as partnerships, agreements, mergers & acquisitions, collaborations, and launches, among others, to expand their global footprints and portfolios. For instance, in January 2023, Glenmark Pharmaceuticals Inc., USA launched Bumetanide Injection USP, 1 mg/4 mL Single-Dose Vials & 2.5 mg/10 Multi-Dose Vials which is Validus Pharmaceuticals, Inc’s generic version of Bumex1 Injection, 0.25 mg/mL. Similarly, in October 2022, Akorn Operating Company LLC launched the generic Cetrorelix Acetate for Injection 0.25 mg (Cetrorelix) at the 2022 American Society for Reproductive Medicine Conference, California.

U.S. Specialty Injectable Generics Market Report Highlights

• Based on type, the Biologics segment held the largest revenue share in 2022 and is anticipated to grow at the fastest growth rate over the forecast period owing to the wide adoption of the biologics in the treatment of chronic diseases
• The oncology segment dominated the U.S. market with a revenue share of 48.9% in 2022. The growth is attributed to the growing burden of cancer cases and strong demand for breast and lung cancer therapies, among other types.
• On the basis of distribution channels, the hospital pharmacy segment dominated the U.S. market in 2022 due to the presence of hospital pharmacies and increased injectable demand among critical patients.
• Key players operating in the space are constantly focusing on product launches and geographical expansion to maintain their presence.
• A few of the key players include Pfizer, Inc., Teva Pharmaceutical Industries Ltd., Baxter International, Novartis AG, Fresenius SE & Co. KGaA, Par Pharmaceutical, Hikma Pharmaceuticals PLC, Dr. Reddy's Laboratories, Sagent Pharmaceuticals, Inc., Mylan N.V.