The global sterile injectables CDMO market size is anticipated to reach USD 7,291.1 million by 2030 and is expected to expand at a CAGR of 9.6% during the forecast period, according to a new report by Grand View Research, Inc. The market growth is driven by increasing demand for injectable drugs, particularly in oncology, infectious diseases, and chronic conditions, where rapid drug delivery is critical.

Pharmaceutical companies are increasingly outsourcing sterile manufacturing to CDMOs to reduce costs, accelerate time-to-market, and access specialized expertise. The rise of biologics, biosimilars, and personalized medicine is also fueling the need for advanced sterile injectable capabilities.

The increasing prevalence of chronic and infectious diseases has intensified demand for injectable therapies, which offer rapid and targeted delivery. Pharmaceutical companies are increasingly outsourcing these complex processes to CDMOs to reduce operational costs, accelerate product development timelines, and access advanced technologies without the burden of in-house investment. Regulatory agencies have also played a pivotal role by streamlining approval pathways for novel injectables, encouraging innovation, and expanding the pipeline of injectable drugs.

The emergence of gene and cell therapies has introduced new manufacturing challenges that CDMOs are uniquely positioned to address. These therapies demand rigorous aseptic conditions and precise handling, prompting CDMOs to invest in high-containment facilities and cutting-edge fill-finish capabilities. Additionally, expanding healthcare infrastructure in emerging economies has created opportunities for sterile manufacturing to experience significant growth due to favorable regulatory frameworks and increased pharmaceutical investment.

Further key findings from the report suggest:

  • By molecular type, the large molecule segment led the market with the largest revenue share of 66.00% in 2024.
  • By product, the pre-filled syringes segment led the market with the largest revenue share of 41.26% in 2024 and is anticipated to grow at the fastest CAGR over the forecast period.
  • Based on service, the formulation development segment led the market with the largest revenue share with 39.04% in 2024.
  • Based on therapeutic area, the oncology segment led the market with the largest revenue share of 29.67% in 2024.
  • Based on route of administration, the intravenous (IV) segment led the market with the largest revenue share of 29.56% in 2024. 
  • Based on end use, the biopharmaceutical companies segment led the market with the largest revenue share of 42.89% in 2024 and is anticipated to grow at the fastest CAGR over the forecast period. 
  • North America dominated the sterile injectables CDMO market with the largest revenue share of 40.64% in 2024.
  • The sterile injectables CDMO market in Asia Pacific is anticipated to grow at the fastest CAGR of 10.91% during the forecast period. 

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