According to latest report, the U.S. Pharmaceutical CDMO market size is calculated at 43.62 billion in 2025 and is projected to surpass USD 84.33 billion by 2034 with a remarkable CAGR of 7.6% from 2025 to 2034.
U.S Pharmaceutical CDMO Market Report Highlights
- Based on product, the active pharmaceutical ingredient (API) segment led the market with the largest revenue share of 81.10% in 2024. The segment growth is driven by competitive drug development and growing demand for end-to-end Contract Development & Manufacturing Organization (CDMO) services. In addition, advancements in API manufacturing, growth of the biopharmaceutical sector, and increasing geriatric population are some of the key factors propelling segment growth
- Based on the workflow, the commercial segment held the largest market share in 2024 attributed to robust demand for pharmaceutical products, such as biosimilar medications, generic medications, and regenerative therapies. This is where commercial CDMOs may help by providing knowledge, saving time, and being cost-effective
- Based on application, the oncology segment dominated the market with the largest revenue share of 21.32% in 2024. The segment is driven by an increasing number of cancer cases globally. In addition, increasing pharmaceutical R&D investments, patent expirations, and demand for oncology drugs & biologic innovations are the factors driving the oncology market
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The Rising outsourcing trends are estimated to drive the growth of the market. Pharma and biotech companies, especially small and mid-sized firms, lack in-house manufacturing capabilities and prefer outsourcing to CDMOs. Even large pharma companies are shifting non-core activities to CDMOs to reduce costs and increase flexibility. The key players operating in the market are focused on the adoption of inorganic growth strategies like partnership and collaboration to develop advanced technology for pharmaceutical CDMO, which is estimated to drive the growth of the market in the near future.
The U.S. pharmaceutical CDMO market for biologics, cell & gene therapies, and mRNA vaccines is expanding, requiring specialized manufacturing expertise that CDMOs provide. High investment costs in biologics manufacturing push companies to partner with CDMOs. Companies such as Aldevron, a top global Contract Development and Manufacturing Organization (CDMO) that supplies premium plasmid DNA, RNA, and proteins for research, therapeutics, and diagnostics, are signing non-exclusive license and supply agreements with TriLink BioTechnologies (TriLink), a Maravai LifeSciences company and worldwide supplier of life science reagents and services. With this partnership with Aldevron, TriLink furthers its goal of giving those creating vital mRNA-based medicines and vaccines more access to CleanCap mRNA capping technology. In accordance with the agreement, TriLink will provide its patented CleanCapM6, CleanCap AG 3'OMe, CleanCap AG, and CleanCap AU cap analogs for use in pre-clinical through Phase IlI programs of Aldevron's mRNA development and production services. Compared to traditional capping techniques, CleanCap technology creates ideal 5'Cap structures with over 95% efficiency, resulting in a co-transcriptional capping solution that enhances mRNA yield and process time.
There is significant growth in generic & biosimilar markets, with patent expirations of blockbuster drugs driving demand for generic drugs and biosimilars, increasing the need for CDMO support. Companies Simcere Zaiming Pharmaceutical Co., Ltd., a pharmaceutical company, announced that the cetuximab beta injection (Enlituo; formerly CMAB009) as a first-line treatment for RAS/BRAF wild-type metastatic colorectal cancer (mCRC) has been approved by China's National Medical Products Administration (NMPA) for marketing in conjunction with leucovorin, fluorouracil, and irinotecan (FOLFIRI). This biosimilar to cetuximab is a recombinant EGFR monoclonal antibody that was independently created in China. It was intended to successfully prevent glycosylation modification, which could cause hypersensitivity in patients using the medication.
The globalization of drug supply chains is allowing companies to expand into new markets, requiring CDMOs with global manufacturing and distribution capabilities. The pandemic has driven growth in the vaccine and drug manufacturing market. COVID-19 accelerated the need for rapid drug development and manufacturing, solidifying the role of CDMOs in vaccine and therapeutic production.
AI integration is transforming the U.S. pharmaceutical CDMO market by improving efficiency, reducing costs, and enhancing drug development and manufacturing processes. AI helps identify optimal drug formulations by analyzing vast datasets on solubility, stability, and bioavailability. AI-driven simulations reduce the time and cost of experimental trials in drug discovery and development. AI monitors equipment performance, predicts failures, and schedules proactive maintenance, reducing downtime. Machine learning (ML) models adjust manufacturing conditions in real time for consistent quality and higher yields. AI-driven sensors analyze production data, detecting deviations early to ensure compliance with FDA, EMA, and GMP regulations. AI-powered image recognition and data analytics streamline quality assurance processes. AI predicts raw material demand, preventing shortages and optimizing inventory. AI assesses geopolitical, regulatory, and logistical risks, improving supply chain resilience.
AI enables real-time adjustments in continuous manufacturing to produce personalized drugs. AI-driven simulations create virtual models of production processes for optimization before physical implementation. AI reduces human errors by generating and managing regulatory submissions and audit trails. AI-based image recognition and NLP (Natural Language Processing) streamline compliance checks. AI processes vast datasets from R&D, production, and market demand to provide data-driven insights.
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U.S. Pharmaceutical CDMO Market Report Scope
|
Report Attribute |
Details |
|
Market size value in 2025 |
USD 43.62 billion |
|
Revenue forecast in 2030 |
USD 84.33 billion |
|
Growth rate |
CAGR of 7.6% from 2024 to 2034 |
|
Base year for estimation |
2024 |
|
Historical data |
2018 - 2024 |
|
Forecast period |
2025 - 2034 |
|
Quantitative units |
Revenue in USD million/billion and CAGR from 2024 to 2034 |
|
Report coverage |
Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
|
Segments covered |
Product, workflow, application, end-use, region |
|
Key companies profiled |
Lonza; Thermo Fisher Scientific, Inc.; Recipharm AB; Laboratory Corporation of America Holdings (LabCorp); Catalent, Inc.; WuXi AppTec, Inc.; Samsung Biologics; Piramal Pharma Solutions; Siegfried Holding AG; CordenPharma International; Cambrex Corporation; Bushu Pharmaceuticals Ltd.; Nipro Corporation |
U.S. Pharmaceutical CDMO Market Trends
• Emphasis on Innovation and Flexibility: CDMOs are prioritizing innovation and flexibility to meet evolving client needs. This approach enhances their value proposition and strengthens partnerships with pharmaceutical companies.
• Recovery Amid Positive Macroeconomic Trends: After facing challenges in 2024, the CDMO sector is poised for recovery in 2025, supported by favorable macroeconomic conditions and industry-specific developments. Analysts express cautious optimism for the sector's outlook.
• Strategic Focus on Core CDMO Services: Companies like Lonza are refocusing on core CDMO services by divesting non-core segments. Lonza plans to exit its capsules and health ingredients business to concentrate on contract development and manufacturing, aiming for a sales growth of nearly 20% by 2025. These trends underscore the CDMO industry's dynamic evolution, highlighting the importance of adaptability, strategic focus, and market responsiveness in 2025 and beyond.
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U.S. Pharmaceutical CDMO Market Segment Insights
Product Insights
By product, the active pharmaceutical ingredient (API) segment registered its dominance over the U.S. pharmaceutical CDMO market. Small molecule APIs remain the backbone of pharmaceutical treatments, especially in chronic diseases like cardiovascular, diabetes, and cancer. Despite the growth of biologics, small molecules still account for a large share of drug approvals and commercialized therapies. Pharma companies, especially smaller firms, lack in-house API manufacturing capabilities and prefer outsourcing to CDMOs. Even large pharma companies outsource API production to focus on R&D and commercialization. Producing high-quality APIs requires compliance with Good Manufacturing Practices (GMP), FDA, and EMA regulations. CDMOs specializing in API manufacturing ensure compliance and help pharma companies navigate global regulations. API production involves complex synthesis and expensive infrastructure, making outsourcing to specialized CDMOs more cost-effective. CDMOs offer economies of scale, reducing manufacturing costs for pharma companies. Growth in high-potency APIs (HPAPIs) & specialty APIs in the U.S. is estimated to drive the growth of the segment over the forecast period. Demand for HPAPIs, used in oncology and targeted therapies, is rising, requiring specialized manufacturing capabilities. CDMOs with contained manufacturing facilities for HPAPIs are in high demand. Patent expirations of blockbuster drugs drive the demand for generic APIs, benefiting CDMOs that specialize in cost-efficient API production.
The synthesis segment is anticipated to grow with the highest CAGR in the market during the studied years. Strong demand for small molecule APIs has been estimated to drive the growth of the synthesis segment over the forecast period. The majority of approved drugs in the U.S. are small molecules, requiring chemical synthesis. Small molecules remain easier to manufacture, store, and distribute compared to biologics. Many U.S.-based pharma companies prefer outsourcing synthetic API production to CDMOs to focus on R&D and commercialization. Even large firms with in-house manufacturing capabilities use CDMOs to reduce operational costs and improve efficiency. U.S. CDMOs lead in process development, green chemistry, and continuous manufacturing to improve efficiency and reduce waste. Continuous manufacturing allows for faster production, higher yields, and cost savings. The rising demand for oncology drugs, targeted therapies, and specialty APIs drives the need for sophisticated synthesis capabilities. U.S. CDMOs with expertise in HPAPI production and contained manufacturing facilities are in high demand. The FDA's strict regulations require high-quality manufacturing standards, which CDMOs specializing in synthetic APIs can meet. U.S.-based CDMOs benefit from strong reputations for compliance and quality, attracting both domestic and international clients. While biologics are growing, many biotech firms require synthetic processes for peptides, oligonucleotides, and small molecules used in targeted therapies. The U.S. government is encouraging domestic API production to reduce dependence on foreign suppliers (e.g., China and India). Federal funding and incentives boost U.S.-based CDMOs specializing in synthetic API production. The synthesis segment grows at the fastest rate in the U.S. pharmaceutical CDMO industry due to high demand for small molecules, increasing outsourcing, regulatory compliance, and the shift towards advanced synthetic techniques. Emerging trends like continuous manufacturing, HPAPIs, and RNA-based therapies will further strengthen this segment. Thermo Fisher Scientific is a global leader offering comprehensive CDMO services, including drug substance manufacturing and development. The company has expanded its capabilities through strategic acquisitions and investments in advanced technologies.
Workflow Insights
By workflow insights, the commercial segment held a dominant presence in the U.S. pharmaceutical CDMO market in 2024. Big Pharma and biotech companies are increasingly outsourcing commercial-scale production to CDMOs to focus on R&D, marketing, and distribution. This trend is driven by cost savings, faster time-to-market, and access to specialized expertise. The U.S. is a leader in biologics, cell & gene therapies, and mRNA vaccines, requiring highly specialized commercial-scale manufacturing. CDMOs with biologics manufacturing capabilities (e.g., Lonza, Thermo Fisher) are expanding rapidly. CDMOs are investing in continuous manufacturing and modular facilities to improve efficiency and meet regulatory compliance. These technologies enhance cost-effectiveness and scalability for commercial production. Commercial manufacturing in the U.S. requires compliance with FDA Current Good Manufacturing Practices (cGMP), making CDMOs with regulatory expertise highly valuable. CDMOs provide regulatory filing support, validation, and compliance management, ensuring seamless commercial production. The U.S. market is seeing rising demand for oncology drugs, precision medicine, and specialty APIs, requiring high-containment commercial facilities. CDMOs with HPAPI capabilities dominate the commercial manufacturing space. The dominance of commercial workflows in the market is driven by outsourcing trends, biologics growth, regulatory compliance, flexible manufacturing, and government incentives. With the increasing demand for specialty drugs and HPAPIs, CDMOs with strong commercial-scale production capabilities will continue to lead. For instance, Novo Holdings' acquisition of Catalent was US$16.5 billion, with plans to double Catalent's size over the next five years. This move aligns with anticipated U.S. manufacturing expansion and reflects the dynamic investment landscape within the CDMO sector.
By workflow, the clinical segment is expected to be the fastest-growing in the U.S. pharmaceutical CDMO market. The U.S. is the largest hub for clinical trials, with thousands of Phase I–III studies conducted annually. Growing biopharma R&D investments drive demand for clinical-stage drug manufacturing. The growth of biologics, cell & gene therapies, and mRNA-based treatments require specialized clinical manufacturing capabilities. CDMOs with small-batch, flexible production for clinical trials are in high demand. Startups and mid-sized biotechs, which drive a large share of clinical-stage drug development, rely on CDMOs due to a lack of in-house manufacturing. CDMOs offer early-phase development, scale-up expertise, and regulatory support. AI and digital platforms streamline clinical trial supply chain management, process optimization, and regulatory filings. CDMOs investing in AI-driven automation gain a competitive advantage. The clinical segment grows at the fastest rate in the U.S. pharmaceutical CDMO market due to strong clinical trial activity, biotech reliance on outsourcing, regulatory complexities, and the rise of biologics & personalized medicine. As AI, automation, and advanced therapies continue to evolve, demand for specialized clinical-stage manufacturing will further expand.
Application Insights
By application insights, the oncology segment accounted for the largest revenue share in 2024. Cancer remains a leading cause of death in the U.S., and the need for innovative treatments continues to rise. This demand fuels investment in oncology drug development. Many new oncology drugs are biologics, including monoclonal antibodies, cell and gene therapies, and antibody-drug conjugates (ADCs). These complex therapies require specialized manufacturing capabilities, which CDMOs provide. Many oncology drugs involve high-potency active pharmaceutical ingredients (HPAPIs), which require containment facilities and specialized expertise, making CDMOs essential. Oncology leads in clinical pipeline activity and FDA approvals. The expedited approval pathways (e.g., Breakthrough Therapy, Fast Track, and Priority Review) create a faster turnaround for CDMOs. Oncology drugs often command premium pricing and strong reimbursement support, making them attractive for pharmaceutical companies and CDMOs alike. The shift toward targeted therapies, nanomedicines, and complex formulations (liposomal and polymer-based delivery systems) requires advanced capabilities that specialized CDMOs offer.
The infectious diseases segment is anticipated to grow with the highest CAGR in the U.S. pharmaceutical CDMO market during the studied years. Infectious diseases, including COVID-19, influenza, HIV, hepatitis, and emerging threats like antimicrobial-resistant (AMR) bacteria, remain a major focus for public health initiatives. Government agencies (e.g., BARDA, NIH, and CDC) provide funding and incentives for infectious disease drug development, driving demand for CDMO services. The COVID-19 pandemic accelerated vaccine and antiviral drug production, highlighting the need for rapid manufacturing scale-up. Ongoing pandemic preparedness efforts continue to fuel investment in CDMO partnerships, ensuring readiness for future outbreaks. The rise of mRNA and recombinant protein vaccines (e.g., COVID-19 vaccines from Pfizer-BioNTech and Moderna) has led to increased demand for specialized CDMO expertise in biologics manufacturing. Traditional vaccines (influenza, pneumococcal, HPV) still require large-scale manufacturing capabilities, often outsourced to CDMOs. U.S. government contracts for strategic stockpiles (e.g., Tamiflu, smallpox vaccines) generate recurring demand for CDMO services. Non-profit organizations (e.g., Gates Foundation, CEPI) fund infectious disease research and contract CDMOs for large-scale manufacturing, particularly for global health initiatives.
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U.S. Pharmaceutical CDMO Market Top Key Companies:
- Adare Pharma Solutions
- AGC Biologics
- Agilent Technologies
- Catalent Pharma Solutions
- Exela Pharma Sciences
- PCI Pharma Services
- Pfizer CentreOne
- Scorpius BioManufacturing
- Sharp Services
- Single Use Support
- Thermo Fisher Scientific
- UPM Pharmaceuticals, Inc.
Recent Developments:
• In February 2025, Avid Bioservices, Inc., a specialized biologics contract development and manufacturing organization (CDMO) that works to enhance patient lives by offering pharmaceutical and biotechnology companies top-notch development and manufacturing services, announced the launch of its new corporate website. The new website, which is accessible at www.avidbio.com, combines enhanced functionality and navigation with Avid's heightened brand story and visual identity with the goal of improving the visitor experience, especially for existing and potential customers.
• In September 2024, a new GMP biologics manufacturing facility in Mississauga, Ontario, is being built by Eurofins CDMO Alphora Inc. to produce protein therapeutics and monoclonal antibodies (mAbs) for use in clinical and commercial settings. With the help of the Strategic Initiative Fund (SIF) and significant backing from the Federal Government of Canada, this investment will strengthen Canada's biomanufacturing capabilities and readiness for future pandemics, as well as the country's biologics ecosystem and job base. On the 14-acre campus of Eurofins CDMO Alphora in the Sheridan Research Park in Mississauga, Ontario, a new 112,000-square-foot structure will house the 50,000-square-foot biologics production plant, which is expected to be completed in April 2026.
U.S. Pharmaceutical 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 2019 to 2034. For this study, Statifacts has segmented the global U.S. Pharmaceutical CDMO Market
By Product
• API
o Type
o Traditional Active Pharmaceutical Ingredient (Traditional API)
o Highly Potent Active Pharmaceutical Ingredient (HP-API)
o Antibody Drug Conjugate (ADC)
o Others
o Synthesis
o Synthetic
o Solid
o Liquid
o Biotech
o Drug
o Innovative
o Generics
o Manufacturing
o Continuous manufacturing
o Batch manufacturing
• Drug Product
o Oral solid dose
o Semi-solid dose
o Liquid dose
o Others
By Workflow
• Clinical
• Commercial
By Application
• Oncology
o Small Molecules
o Biologics
• Infectious Diseases
• Neurological Disorders
• Cardiovascular Disease
• Metabolic Disorders
• Autoimmune Diseases
• Respiratory Diseases
• Ophthalmology
• Gastrointestinal Disorders
• Hormonal Disorders
• Hematological Disorders
• Others
By End-use
• Small Pharmaceutical Companies
• Medium Pharmaceutical Companies
• Large Pharmaceutical Companies
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