PUBLISHER: The Business Research Company | PRODUCT CODE: 1811037
PUBLISHER: The Business Research Company | PRODUCT CODE: 1811037
Sterile injectables CDMO refers to a contract development and manufacturing organization that focuses on producing injectable pharmaceutical products in sterile environments. These organizations adhere to strict regulatory requirements to guarantee the safety, effectiveness, and quality of the products. They serve a vital role in the pharmaceutical supply chain by offering the facilities, specialized knowledge, and aseptic processing conditions necessary for sterile manufacturing.
The primary categories of sterile injectable CDMO include small molecule and large molecule products. Small molecules are low molecular weight compounds that can readily penetrate cells due to their simple chemical makeup. These CDMOs provide a range of services such as formulation development, analytical and testing support, manufacturing, packaging, storage, and more. Administration routes include subcutaneous (SC), intravenous (IV), intramuscular (IM), and others. These services are utilized across various therapeutic areas, including oncology, cardiovascular diseases, central nervous system disorders, infectious diseases, musculoskeletal conditions, hormonal disorders, and more, catering to a range of end-users such as pharmaceutical companies, biopharmaceutical firms, research institutions, and others.
Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report's Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.
The sudden escalation of U.S. tariffs and the consequent trade frictions in spring 2025 are severely impacting the pharmaceutical companies contend with tariffs on APIs, glass vials, and lab equipment inputs with few alternative sources. Generic drug makers, operating on razor-thin margins, are especially vulnerable, with some reducing production of low-profit medicines. Biotech firms face delays in clinical trials due to tariff-related shortages of specialized reagents. In response, the industry is expanding API production in India and Europe, increasing inventory stockpiles, and pushing for trade exemptions for essential medicines.
The sterile injectables CDMO market research report is one of a series of new reports from The Business Research Company that provides sterile injectables CDMO market statistics, including sterile injectables CDMO industry global market size, regional shares, competitors with a sterile injectables CDMO market share, detailed sterile injectables CDMO market segments, market trends and opportunities, and any further data you may need to thrive in the sterile injectables CDMO industry. This sterile injectables CDMO market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.
The sterile injectables CDMO market size has grown rapidly in recent years. It will grow from $6.01 billion in 2024 to $6.65 billion in 2025 at a compound annual growth rate (CAGR) of 10.7%. The growth during the historic period can be attributed to the rising incidence of infectious diseases, increased use of self-injection and home-administered injectables, growing government investments in domestic sterile manufacturing, the emergence of virtual pharma companies dependent on CDMOs, and the expansion of treatment options for rare diseases.
The sterile injectables CDMO market size is expected to see rapid growth in the next few years. It will grow to $9.89 billion in 2029 at a compound annual growth rate (CAGR) of 10.4%. The projected growth in the forecast period can be attributed to the increasing prevalence of chronic diseases, a growing elderly population, rising global demand for biologics and biosimilars, expanded use of monoclonal antibodies, and the widespread implementation of vaccination programs worldwide. Key trends expected during this period include advancements in aseptic processing and fill-finish technologies, adoption of isolators and restricted access barrier systems, increased automation and robotics in sterile injectable manufacturing, enhanced lyophilization methods, and the integration of digitalization and real-time monitoring to boost production efficiency.
The rising demand for biologics and biosimilars is expected to drive the growth of the sterile injectables CDMO market in the future. Biologics are medicines derived from living cells or organisms that target specific disease components, while biosimilars are nearly identical versions of approved biologics, matching them in quality, safety, and effectiveness. The increasing incidence of chronic and complex diseases is fueling demand for these therapies, as they provide more targeted and effective treatment options compared to conventional drugs. This growing demand leads to greater reliance on sterile injectable CDMO services, since these treatments are typically administered by injection and require strict sterile conditions to ensure safety, quality, and compliance with regulations. For example, in November 2023, Cardinal Health, a US-based healthcare company, reported that healthcare expenditures in the United States reached $4.5 trillion in 2022, with biologics accounting for $252 billion of that total. This amount increased from $4.3 trillion spent in 2021. Thus, the rising demand for biologics and biosimilars is fueling the expansion of the sterile injectables CDMO market.
Leading companies in the sterile injectables CDMO sector are focusing on innovative solutions such as automated aseptic filling systems to improve sterility assurance and minimize human involvement. These systems are specialized equipment used to fill sterile pharmaceutical or biological products into containers within a controlled environment, reducing the risk of contamination by limiting manual handling. For instance, in July 2022, Amaran Biotech, a biotechnology firm based in Taiwan, introduced Vanrx SA25, a fully automated robotic aseptic filling line. This system is designed specifically for the sterile processing of advanced biopharmaceuticals, including protein-based therapies, antibody treatments, and nanoparticle drugs. It incorporates the Cytiva Vanrx SA25 technology, which uses robotic components within a gloveless isolator to maintain a sterile environment throughout production. This approach minimizes manual contact, lowering contamination risk and ensuring sterility of injectable products. Additionally, the system supports various types of sterile injectable containers and complies with major global regulatory standards, such as those from the FDA, EMA, PIC/S, and ISPE.
In October 2023, Advent International and Warburg Pincus, two US-based private equity firms, acquired Baxter's BioPharma Solutions business for $4.25 billion. After the acquisition, the business became an independent contract development and manufacturing organization named Simtra BioPharma Solutions, continuing to provide sterile manufacturing, parenteral delivery, and specialized services for pharmaceutical and biotech clients. Supported by Advent and Warburg Pincus, Simtra now operates as a fully standalone CDMO, offering comprehensive services from clinical-stage development to commercial fill-finish production. Baxter International is a US-based provider of sterile injectable CDMO services.
Major players in the sterile injectables CDMO market are Pfizer Inc., Thermo Fisher Scientific Inc., Boehringer Ingelheim, Fresenius Kabi AG, Lonza Group Ltd., Catalent Inc., Samsung Biologics Co. Ltd., Fareva SA, Recipharm AB, PCI Pharma Services, Vetter Pharma, Delpharm, Kindeva Drug Delivery LP, Ajinomoto Bio-Pharma Services, Cenexi, Grand River Aseptic Manufacturing Inc., INCOG BioPharma Services, Aurigene Pharmaceutical Services, Jubilant HollisterStier LLC, Symbiosis Pharmaceutical Services Ltd., Afton Scientific Corp., and Amaran Biotechnology Inc.
North America was the largest region in the sterile injectables CDMO market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in sterile injectables CDMO report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.
The countries covered in the sterile injectables CDMO market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.
The sterile injectables CDMO market consists of revenues earned by entities by providing services such as microbiological testing, sterilization validation, labeling, and regulatory support. The market value includes the value of related goods sold by the service provider or included within the service offering. The sterile injectables CDMO market also includes sales of cartridges, emulsions, infusion bags, and implants. Values in this market are 'factory gate' values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.
The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).
The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.
Sterile Injectables CDMO Global Market Report 2025 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.
This report focuses on sterile injectables cdmo market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.
Where is the largest and fastest growing market for sterile injectables cdmo ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The sterile injectables cdmo market global report from the Business Research Company answers all these questions and many more.
The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.
The forecasts are made after considering the major factors currently impacting the market. These include the technological advancements such as AI and automation, Russia-Ukraine war, trade tariffs (government-imposed import/export duties), elevated inflation and interest rates.