Sterile Injectables CDMO Market Revenue to Attain USD 9.94 Bn by 2033

10 Jun 2025

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Table of Content

1. Sterile Injectables CDMO Market Revenue and Trends 2025 to 2033 2. Market Overview 3. How Is the Shift Toward Prefilled Syringes Shaping the Sterile Injectables CDMO Market?   4. Segment Analysis 5. Regional Insights 6. Sterile Injectables CDMO Market Coverage 7. Sterile Injectables CDMO Market Companies

Sterile Injectables CDMO Market Revenue and Trends 2025 to 2033

The global sterile injectables CDMO market revenue is estimated at USD 4.73 billion in 2025 and is projected to hit around USD 9.94 billion by 2033, growing at a CAGR of 9.73%.

Market Overview

The Sterile Injectables CDMO (Contract Development and Manufacturing Organization) market refers to the sector of companies that provide services for the development and production of sterile injectable drugs. The sterile injectables CDMO market is growing well with the increased demand for injectable therapies, greater biologics development, and the booming trend of outsourcing sterile manufacturing. CDMOs offer end-to-end services-from formulation development through aseptic fill-finish, packaging, and regulatory support, helping pharmaceutical companies cut costs and speed up commercialization.   

How Is the Shift Toward Prefilled Syringes Shaping the Sterile Injectables CDMO Market?  

The sterile injectables CDMO market is growing due to the rising demand for ready-to-use injectable systems such as prefilled syringes. Being more protected ways of medicating, the prefilled syringes are preferred in a hospital setting and in-home care due to security and correct dosing. Prepared, ready-to-use prefilled syringes are the best solution for managing chronic diseases, with a much lower chance of distraction by contamination or medication.

Segment Analysis

• By Service Insights, the formulation development segment dominated the market, mainly because of the need for more stable and sterilized formulations for novel injectables and vaccines in particular. The manufacturing segment is expected to grow at a significant CAGR as production is being outsourced to CDMOs to increase the capacity and lessen the load within the walls of companies supplying demand for sterile products globally.  
• By therapeutic area insights, the Oncology segment held the dominant presence in the market. Growth is attributed to the high demand for injectable cancer therapies, targeted drugs, and immunotherapies, which are fast acting and highly precise.
• By route of drug administration, the intravenous segment led the market in 2024. An IV administration guarantees fast drug delivery in oncology, critical care situations, and infectious diseases. It is a very accurate method of administration with the medicine going directly into the bloodstream and preventing the first pass effect, thus giving the desired result.
• By end-use insights, the biopharmaceuticals dominated the market in 2024 since they generally rely on CDMOs for manufacturing complex biologics. Most biopharma companies don't have sterile processing infrastructure even internally and depend on CDMOs compliant for production on scale and regulatory support. 

Regional Insights

North America held the largest market revenue in 2024. The market witnessed its peak in the North American region, propelled by mature biopharma ecosystems, leading CDMOs, and strong regulatory frameworks. Another driver has been the increased FDA-driven transparency, increased R&D spending, and clinical activity of biologics in the U.S. Demand for the outsourcing of sterile fill-finish operations, along with high-potency and biosimilar injectables, merely strengthens this leadership position. Further impetus to pursue alliances between pharmaceutical companies and CDMOs comes from the effort to shorten time-to-market.

Sterile Injectables CDMO Market Coverage

Recent Developments of Sterile Injectables CDMO Market

• In January 2025, Vetter, a pioneer CDMO, announced the development and upcoming launch of the latest version of its proprietary V-OVS syringe closure system. 
  (Source: https://pharmaceuticalmanufacturer.media) 

Sterile Injectables CDMO Market Companies

• Aenova Group
• Ajinomoto Bio-Pharma
• Alcami Corporation
• Baxter (Simtra BioPharma Solutions)
• Boehringer Ingelheim International GmbH
• Eurofins Scientific
• FAMAR Health Care Services
• Fareva Group
• Fresenius Kabi Contract Manufacturing (Fresenius Kabi AG)
• IDT Biologika GmbH
• PCI Pharma Services
• Pfizer CentreOne (Pfizer Inc)
• Recipharm AB
• Siegfried AG
• Torbay Pharmaceuticals
• Unither Pharmaceuticals
• Vetter Pharma International GmbH 

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