U.S. Generic Injectables Pharmaceutical Contract Manufacturing Market Summary

The U.S. generic injectables pharmaceutical contract manufacturing market size was estimated at USD 3.0 billion in 2024 and is projected to grow at a CAGR of 10.8% from 2025 to 2030. Growth in the market can be attributed to the rising frequency of patent expirations for blockbuster drugs, streamlined regulatory pathways and low cost of generics, and the increasing number of market players entering generic injectables CDMOs. Currently, one of the major factors fueling the market growth is the rising frequency at which injectable medications are losing their patent protection. For instance, in July 2023, the patent for Sanofi's highly successful medication Mozobil expired, leading to the introduction of generic versions of Plerixafor.

Moreover, growing outsourcing by pharmaceutical companies, growing drug shortage, rising prevalence of cancer and age-related disorders, and increasing investment & expansion of new facilities in the U.S. are among the key factors driving market growth. In addition, smaller to mid-sized pharmaceutical companies increasingly rely on external service providers for their research, development, and manufacturing needs, fueling the trend towards increased outsourcing and creating opportunities for expansion in generic injectables pharmaceutical contract manufacturing.

Key Market Trends & Insights

• On the basis of molecule segment, the market is segregated into small molecule, and large molecule. In 2024, the large molecule segment dominated the market, accounting for a revenue share of 58.02%. This growth can be attributed to the growing emphasis on tailored treatments and precision medicine is one of the major factors augmenting the growth of the large molecule generic injectable drugs segment in the U.S.
• On the basis of application segment, the market is segregated into oncology, immunology, antidiabetic, neurology, cardiovascular, respiratory, and others. In 2024, the oncology segment dominated the market, accounting for a revenue share of 29.42%.
• The neurology segment is anticipated to register the fastest CAGR of 11.64% during the forecast period. This is mainly due to the rise in demand for biosimilars to treat several neurological conditions. Moreover, large scale contract manufacturers are focusing on the development of neurology based biosimilars, thereby supporting the segment’s growth.

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Market Size & Forecast

• 2024 Market Size: USD 3.0 billion
• 2030 Projected Market Size: USD 5.59 billion
• CAGR (2025 - 2030): 10.8%

Key Companies & Market Share Insights

The key players operating across the U.S. market are adopting in-organic strategic initiatives such as partnerships, mergers, and acquisitions, etc. The strategies adopted by companies are mergers & acquisitions/joint ventures merger, service launches, partnership & agreements, expansions, and others to increase market presence & revenue and gain a competitive edge drives the market growth. Hence, increasing adoption of in-organic strategic initiatives is highly anticipated to boost market share of prominent players operating across the market. For instance, in March 2023, PCI Pharma Services, a biopharmaceutical-based contract manufacturer, announced its intention to invest USD 50 million in expanding its sterile injectables facility located in Rockford, Illinois U.S. Moreover, in January 2024, Fresenius Kabi launched the Posaconazole Injection. These injections are a generic substitute for Noxafil and can be used to treat and prevent fungal infections in children and adults. Posaconazole injection is a new addition to the company’s product portfolio of 30+ anti-infective molecules and is available in the U.S. market.

Key Players

• Hikma Pharmaceuticals PLC
• Pfizer Inc.
• Fresenius Kabi
• Sandoz AG
• Jubilant Pharma Limited
• Baxter
• PCI Pharma Services
• Gland Pharma Limited (USA)
• Dr.Reddy’s Laboratories Ltd.
• Grand River Aseptic Manufacturing

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Conclusion

The U.S. generic injectables pharmaceutical contract manufacturing market is expected to witness strong growth over the coming years, driven by patent expirations, the rising prevalence of chronic diseases, and increasing reliance on outsourcing by pharmaceutical companies. Expansion of sterile injectable facilities, continuous product launches, and strategic collaborations are strengthening the market landscape. With oncology and neurology emerging as high-potential segments, and large molecules gaining significant traction, the industry is well-positioned for sustained growth. Moreover, the active participation of major players in introducing innovative, cost-effective solutions ensures that the market will continue to expand and evolve.