Sterile Injectables CDMO Market Trends
The global sterile injectables CDMO market size was estimated at USD 4.25 billion in 2024 and is projected to grow at a CAGR of 9.61% from 2025 to 2030. The market growth is primarily driven by increasing pipeline and approvals of injectable drugs. Pharmaceutical companies are proactively focusing on developing injectable medications due to their numerous benefits, such as quicker onset of action, precise dosing, and enhanced patient adherence.
For instance, as per the U.S. Food and Drug Administration (FDA) report published in January 2024, the Center for Drug Evaluation and Research (CDER) approved 55 novel drugs in 2023. These medications included injectables, indicating a robust pipeline that is anticipated to drive an increase in the demand for contract manufacturing services for both commercial and research purposes, hence contributing to overall market growth.
The increasing demand for cellular and genetic therapies is driving the market’s growth. With the expansion of therapy pipelines, there is a rising requirement for specialized manufacturing capabilities provided by contract manufacturing organizations (CMOs). For instance, according to the American Society of Gene & Cell Therapy (ASGCT), 3,866 therapies are currently in development, spanning from preclinical stages through preregistration. Within this landscape, 2,082 therapies are categorized as gene therapies, which include genetically modified cell therapies like CAR T-cell therapies, constituting 53% of gene, cell, and RNA therapies. In addition, 862 therapies are nongenetically modified cell therapies, making up 22% of the overall gene, cell, and RNA therapies in development. Thus, a strong product pipeline and growing demand for advanced therapeutics are likely to enhance overall market demand.
Strategic initiatives undertaken by market participants, such as expanding sterile manufacturing facilities and engaging in collaborations and partnerships, are anticipated to bolster market growth throughout the projected period. For instance, in March 2024, Alcami Corporation company partnered with Tanvex CDMO, enhancing its capabilities in biologics manufacturing. Alcami would leverage its expertise in sterile filling, labeling, and packaging, while Tanvex would contribute its high-throughput bulk drug substance development services. The partnership aimed to expedite the delivery of sterile injectables, addressing the increasing demand for specialty therapeutics and complex biologics.
The high demand for sterile injectables propels growth in outsourced agreements amongst contract manufacturers and biopharmaceutical companies, thereby boosting the growth of the sterile injectable CDMO industry. The growing need for faster drug action, rapid absorption, and less drug concentration are a few major aspects contributing to the adoption of sterile injectables CDMO industry. Further, pharmaceutical firms actively involved in sterile injectable development and manufacturing are gaining traction to support monoclonal antibody therapies, large-molecule injectable drugs, and infectious disease-treating drugs. Several factors, including reduced time and cost-affordable research and development cycles of generic injectables and the growing advancements in rare disease treatments, are accelerating the market growth.
Advanced manufacturing techniques are crucial for ensuring the stability and efficacy of cancer therapies. Contract manufacturers specializing in sterile injectables, particularly those experienced in handling complex formulations and biologics, are well-equipped to address the specific requirements of oncology drugs. Sterile injectables are essential for delivering complex biologics and innovative treatment methods in cancer treatment, driving the growth of the sterile injectable contract manufacturing sector. The growth in outsourcing practices is expected to drive the expansion of the segment over the forecast period. Pharmaceutical companies, particularly those specializing in oncology, are increasingly turning to outsourcing manufacturing operations to streamline processes, cut costs, and capitalize on the specialized expertise offered by contract manufacturers. This shift has notably boosted the cancer sector's sterile injectable contract development and manufacturing market.
Global Sterile Injectables CDMO Market Report Segmentation
This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the global sterile injectables CDMO market report based on molecule type, product, service, therapeutic area, route of administration, end-use, and region.
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