Sterile Injectable Contract Manufacturing Market Size (2024 - 2029)

Sterile Injectable Contract Manufacturing Market Analysis

The Sterile Injectable Contract Manufacturing Market size is estimated at USD 14.44 billion in 2024, and is expected to reach USD 28.5 billion by 2029, growing at a CAGR of 12% during the forecast period (2024-2029).

The increasing pipeline and approvals of injectable drugs are significant drivers of the sterile injectable contract manufacturing market. Pharmaceutical companies are developing injectable drugs due to their advantages, including faster onset of action, precise dosing, and improved patient compliance. For instance, according to the FDA report published in January 2023, CDER approved 37 novel drugs, either as new molecular entities (NMEs) under New Drug Applications (NDAs) or as new therapeutic biological products under Biologics License Applications (BLAs) in 2022. These drugs include injectables, and hence, a strong pipeline is expected to increase the demand for contract manufacturing for commercial and research purposes, thereby contributing to market growth.

The burgeoning demand for cellular and genetic treatments propels the expansion of the market. As the pipeline of these therapies expands, there is a growing need for specialized manufacturing capabilities, which contract manufacturing organizations (CMOs). For instance, according to ClinicalTrials.gov, as of March 2024, more than 581 clinical trials were investigating the potential of cell therapies and related approaches for treating various diseases in North America. Therefore, the high amount of research in clinical development for cell-based therapy is expected to boost contract manufacturing over the forecast period.

Moreover, strategic activities by the market players, such as the expansion of sterile manufacturing facilities, collaboration, and partnership, are expected to contribute to the market growth over the forecast period. For instance, in November 2023, private equity firm NorthEdge invested in a Torbay Pharmaceuticals sterile injectable contract manufacturer and license holder to support its next phase of international growth after acquiring it from Torbay and Devon NHS Foundation Trust. In March 2023, PCI Pharma Services unveiled plans for a USD 50 million expansion at its Rockford, Illinois, sterile injectables site. The project will add a 200,000-square-foot facility to boost the plant’s capacity for injectable drug-device combination products.

Hence, the growing demand for cell and gene therapy in the product pipeline and the expansion of sterile manufacturing facilities are expected to boost market growth over the forecast period. However, challenges related to quality control and high operational costs are anticipated to restrain the market’s growth.

Sterile Injectable Contract Manufacturing Industry Segmentation

As per the scope of the report, sterile injectable contract manufacturing refers to the outsourcing of the production of sterile injectable pharmaceutical products to specialized contract manufacturing organizations (CMOs). CMOs provide services for the manufacturing, filling, and packaging of sterile injectable drugs in compliance with regulatory standards, such as Good Manufacturing Practices (GMP).

The sterile injectable contract manufacturing market is segmented by molecule, therapeutic application, route of administration, end user, and geography. By molecule, the market is segmented into small molecules and large molecules. By therapeutic application, the market is segmented into cancer, diabetes, cardiovascular diseases, central nervous system diseases, infectious disorders, musculoskeletal, anti-viral, and others. By route of administration, the market is segmented into subcutaneous (SC), intravenous (IV), intramuscular (IM), and others. By end user, the market is segmented into pharmaceutical and biopharmaceutical companies and research institutes. By geography, the market is segmented into North America, Europe, Asia-Pacific, the Middle East and Africa, and South America. The report also covers the estimated market sizes and trends for 17 countries across major regions globally. The report offers the value (USD) for all the above segments.