The U.S. pharmaceutical CDMO market is estimated at USD 39.14 billion in 2025 and is projected to reach approximately USD 68.57 billion by 2034, expanding at a CAGR of 6.43% over the forecast period. According to a study by Towards Healthcare, a sister firm of Precedence Research, the U.S. pharmaceutical CDMO market was valued at USD 36.77 billion in 2024 and is projected to reach approximately USD 68.57 billion by 2034, growing at a CAGR of 6.43%. The rising commercial scale-up in different therapeutic areas in the US and growing adoption of digital technologies are fueling overall market expansion.\n\nBy product, the API segment dominated the U.S. pharmaceutical CDMO market in 2024 and is expected to grow fastest during the forecast period. By workflow, the commercial segment held the largest revenue share of the market in 2024. By application, the oncology segment registered dominance in the market in 2024. By end-use, the large pharmaceutical companies segment was dominant in the U.S. pharmaceutical CDMO market in 2024 and is expected to grow rapidly in the study years.\n\nCompanies that are offering comprehensive services to different pharmaceutical and biotechnology companies, including both drug development and manufacturing in the US, are referred to as U.S. pharmaceutical CDMO market. Primarily, they provide expertise and resources for these companies. In 2025, they are focusing on novel drug discovery and development in oncology and other chronic conditions with the increased adoption of advanced production technologies. Moreover, the US is widely investing in robust and advanced infrastructure to fulfil the requirements of the increasing demand for specialized services, particularly in areas like biologics, sterile injectables, and gene and cell therapies.\n\nThe U.S. pharmaceutical CDMO market has major dominating factors in its expansion, including crucial support to small and mid-sized pharmaceutical companies. These companies are facing the limitations of infrastructure for large-scale production with enhanced dependence on CDMOs for numerous stages of development and manufacturing. Also, benefits of pharmaceutical CDMOs, like scalability, flexibility, and cost-effectiveness, are fueling the expansion of the market with reduced capital investments. Besides this, experts working in CDMOs can navigate the complex regulatory landscape and check the compliance with standards like GMP (Good Manufacturing Practices).\n\nDifferent companies in the US are highly adopting outsourcing production to CDMOs to handle expenses and emphasis on competencies. Alongside, continuous advances in technologies and regulatory frameworks also play a crucial role in this market development.\n\nChallenges connected with the U.S. pharmaceutical CDMO market include geopolitical stress, lack of raw material, and pandemic-related disturbances, which contribute as barriers in the production and delivery. Along with this, the rising need for a skilled workforce and specialized knowledge in continuous manufacturing and advanced bioprocessing demands vital investment in training and development.\n\nThe U.S. pharmaceutical CDMO market is experiencing widespread expansion due to broader demand for a variety of biologics and biosimilars which are used in novel rare cases and other severe health issues. Besides this, ongoing technological breakthroughs in process chemistry and manufacturing automation are boosting the efficiency and quality of drug production, further propelling the adoption of CDMO services. As well as escalating cases of diverse cancers is assisting the development of novel cancer therapies, including targeted therapies and immunotherapies.\n\nBy product analysis: The API segment was dominant in the market in 2024 and will grow rapidly during 2025-2034. An escalating demand for both traditional and complex APIs, especially in small molecule drugs, is fueling the segment's growth. In this segment, synthetic APIs experienced major demand, which are highly employed in numerous therapeutic areas such as cardiovascular, analgesic, and CNS drugs, making them an important driver in the API CDMO market. Also, this segment is moving towards continuous manufacturing, process analytical technology (PAT), sustainability, and digitalization, with enhanced focus on specialized CDMOs catering to niche therapeutic areas and expansion in biotech API development.\n\nBy workflow analysis: In the U.S. pharmaceutical CDMO market, the commercial segment captured a major revenue share in 2024. Across the globe, one of the vital factors contributing to the overall market expansion is improved focus on the large-scale manufacturing of pharmaceuticals and biopharmaceuticals for commercial distribution. Moreover, widespread involvement of specialized expertise in biologics, cell & gene therapies, and mRNA vaccines necessitates sophisticated and specialized manufacturing capabilities. Additionally, CDMOs are boosting their service offerings by expanding collaboration with other organizations and companies to incorporate the complete drug development and manufacturing lifecycle, from early development to commercial launch.\n\nBy application analysis: The oncology segment registered dominance with the biggest share of the market in 2024. Eventual growth in cancer cases, with the progression of personalized therapies and targeted treatments, is impacting segment expansion. US CDMOs are stepping towards the transformation of advanced therapies, especially cell and gene therapies, antibody-drug conjugates, and bispecific antibodies, which are a major part of oncology clinical trials. These therapies are widely propelling demand for specialized facilities and expertise in handling potent APIs, cytotoxic compounds, and sterile injectables.\n\nBy end-use analysis: The large pharmaceutical companies segment led the U.S. pharmaceutical CDMO market in 2024 and is anticipated to witness the fastest growth during 2025-2034. Nowadays, a rise in innovation investments, mainly in data analytics and AI, is assisting overall drug development processes and ultimately enhancing productivity. Apart from this, these companies are focusing on the utilization of advanced formulation technologies in specific areas, especially oral peptide formulations and permeation enhancers, to optimize drug delivery. These companies frequently grasp their robust infrastructure, scientific expertise, and global networks, which make them attractive for further collaborations and outsourcing to CDMOs in the US.\n\nOngoing Developments in the U.S. Pharmaceutical CDMO Market: In July 2025, ESTEVE acquired Regis Technologies, a United States-based Contract Development and Manufacturing Organization (CDMO), to accelerate its contract development and manufacturing services for small-molecule active pharmaceutical ingredients from pre-clinical to commercial manufacturing in the US. In May 2025, Purdue University and a collaboration of leaders in AI, pharmaceutical manufacturing, and public policy launched a national effort in the Dirksen Senate Office Building to boost pharmaceutical manufacturing in the United States by revealing cutting-edge AI and advanced manufacturing technologies. In May 2025, Benuvia Operations, LLC, a U.S.-based global Contract Development and Manufacturing Organization (CDMO) and Active Pharmaceutical Ingredient (API) supplier, signed a multi-year supply agreement with a prominent U.S. pharmaceutical company to support the company's product development activities.\n\nKey Players in the U.S. Pharmaceutical CDMO Market: Adare Pharma Solutions, AGC Biologics, Agilent Technologies, Catalent Pharma Solutions, Exela Pharma Sciences, PCI Pharma Services, Pfizer CentreOne, Scorpius BioManufacturing, Sharp Services, Thermo Fisher Scientific, UPM Pharmaceuticals, Inc.

U.S. Pharmaceutical CDMO Market Valuation to Surpass USD 68.57 Billion by 2034

The U.S. pharmaceutical CDMO market is projected to grow from USD 39.14 billion in 2025 to USD 68.57 billion by 2034, at a CAGR of 6.43%. The market is driven by rising demand for biologics, biosimilars, and advanced therapies such as oncology treatments, cell and gene therapies, and mRNA vaccines. Key growth factors include scalability, cost-effectiveness, regulatory expertise, and adoption of digital technologies and continuous manufacturing. The API segment dominates by product, the commercial segment by workflow, and oncology by application. The large pharmaceutical companies segment is the leading end-user and is expected to grow rapidly. Recent developments include ESTEVE acquiring Regis Technologies, Purdue University launching an AI-driven national initiative with industry leaders, and Benuvia Operations signing a multi-year supply agreement with a major U.S. pharmaceutical company. Major players include Adare Pharma Solutions, AGC Biologics, Agilent Technologies, Catalent Pharma Solutions, Exela Pharma Sciences, PCI Pharma Services, Pfizer CentreOne, Scorpius BioManufacturing, Sharp Services, Thermo Fisher Scientific, and UPM Pharmaceuticals, Inc.