US Investigational New Drug CDMO Market 2025 – 2034

As per the US Investigational New Drug CDMO Market analysis conducted by the CMI team, the US investigational new drug CDMO market is expected to record a CAGR of 10.32% from 2025 to 2034. In 2025, the market size was USD 2.39 billion. By 2034, the valuation is anticipated to reach USD 5.84 billion.

Overview

The US investigational new drug CDMO market is witnessing significant growth. This could be reasoned with a complex and extensive early-stage pipeline, especially in areas of rare diseases, oncology, and advanced modalities. Additionally, aspects such as supply chain resilience and quicker regulatory pathways are encouraging outsourcing further. Implementing structured tech transfers, platform processes, and phase-appropriate quality measures aids in mitigating program risks, thereby making comprehensible IND facilitation conducive to outsourcing.

Additionally, the rise in technological advancements, especially in modality-specific approaches and digital capabilities, is contributing to market growth. Adopting AI-assisted Design of Experiments (DoE), automated batch recording, and digital twin technology helps in shortening timelines and improving execution precision.

Expertise in several domains such as lipid nanoparticles/mRNA, plasmids, and viral vectors. And highly potent active pharmaceutical ingredients (HPAPI) is improving through flow chemistry, process analytics technology (PAT), and solid-state control. Also, data is being integrated through laboratory information management systems (LIMS) and electronic quality management systems (eQMS).

Key Trends & Drivers

• Rise in Clinical Trials

Increased clinical trials in the US are a major factor driving the growth of the US investigational new drug CDMO market. Research states that the US alone has clocked over 158,321 (29%) of the overall clinical trials as of May 2025. In other words, expanding complex therapies inclusive of monoclonal antibodies and mRNA vaccines, which need specialized production capabilities, is capable of leading to a rise in clinical trials.

Pharmaceutical manufacturers are outsourcing their drug manufacturing activities to CDMOs owing to the complexity of production. This helps pharmaceutical companies to emphasize core competencies and curtail production costs. The CDMOs do have well-established equipment, well-established facilities, and expertise for producing clinical materials, thereby notably shortening the timeline for certified good production practice compliances.

What’s trending in the US Investigational New Drug CDMO Market?

Increased investments in biopharmaceutical research are leading to the rise in demand for IND-support services as the key players intend to bring innovative therapies to the clinical trials quicker and within an effective framework. Also, increased complexity of biologics coupled with the development of customized medicines does demand specific kinds of manufacturing expertise. This is encouraging the pharmaceutical companies to collaborate with CDMOs that could offer customized IND-enabling support.

What would be Business Impact of the US tariffs on the US Investigational New Drug CDMO Market?

US tariffs are likely to result in raised costs of raw materials, thereby resulting in delays in IND-enabling studies and production of clinical trial materials. This could, in turn, restrain profit margins for the CDMOs, especially the smaller ones, and adversely affect timelines for investigational new drug submissions. Disruptions in supply chains due to tariffs are likely to delay availability of necessary materials and hamper good manufacturing practice (GMP) production. There could be cuts in R&D activities or redirection of resources with companies trying tohigher expenses.

Key Threats

Regulatory complexities are amongst the factors basically restraining the growth of the investigational new drug CDMO market. The process starting from non-clinical stage research to investigational new drug (IND) approval is pretty complex and covered by the US FDA’s and EMA’s regulatory overlays. CDMOs need to ascertain compliance with Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), and Good Laboratory Practices (GLP) that need exhaustive documentation, validated processes, continual audits, and quality control systems. IN 2024, various CDMOs faced operational delays as the US FDA raised scrutiny over drug contamination and drug development data integrity, particularly in the context of gene therapy and biologics manufacturing.

Opportunities

The increasing emphasis on expansion as well as the launching of manufacturing facilities in the US is fueling the production of biopharmaceutical drugs. With longer waiting times taken for the US FDA’s “Safe To Proceed” signal to come through, the market players are taking advantage of pre-IND labeling and packaging strategy for clinical studies. In October 2023, Ampio Pharmaceuticals Inc. announced that it had chosen Ascendia Pharmaceuticals Inc. for providing services supporting OA-201’s clinical development. It is a new drug meant to treat symptomatic osteoarthritis pain. Ascendia Pharmaceuticals is a CDMO responsible for aiding the former with the IND application process.

Category Wise Insights

By Service

• Contract Development

The contract development segment holds over 80% of the market share and the scenario is expected to remain unchanged during the forecast period. This could be credited to the rise in demand for contract development services, as the biopharmaceutical companies do search for phase-appropriate solutions for the early-stage assets.

There is a strong focus placed on comprehensible offerings that include analytical method development, pre-formulation, and process optimization for meeting accelerated timelines. The platform-based approaches for biologics, small molecules, and advanced modalities are being broadly adopted for minimizing costs and risks. Plus, integrating AI-driven modelling with high-throughput analytics is expected to strengthen the data input. As such, outsourcing continues to increase and contract development partnerships are likely to drive the need for the advanced IND submissions and ascertain regulatory alignment.

• Contract Manufacturing

The contract manufacturing segment’s growth is reasoned with growing demand for phase-appropriate GMP production and clinical trial materials. There is also a strong focus on flexible small-batch production, sterile operations, and aseptic fill-finish for supporting early clinical phases. Deploying single-use technologies with modular facilities does ensure speed and scalability in production. Also, high-potency API handling, viral vector production, and mRNA/LNP systems are outsourced owing to requirements for specialized infrastructure. With initial-stage pipelines continuing to expand, contract manufacturing has turned out to be necessary for the achievement of rapid IND enablement while lessening capital expenditure for the sponsors.

By End-use

• Pharmaceutical Companies

The pharmaceutical companies segment accounts for maximum market share. The pharmaceutical companies based in the US are turning toward CDMOs for advancing their IND programs amidst the expanding pipelines with resource limitations. The CDMOs are involved in analytical testing, CMC development, and GMP production for helping in accelerating timelines and mitigating operational risks.

Initial-stage collaborations are getting utilized for ensuring that the phase-appropriate quality standards with strong data packages are adhered to. Strategic partnerships are structured for offering flexibility in scaling efforts across several therapeutic areas, especially in rare diseases and oncology. The pharmaceutical companies, by outsourcing IND-enabling activities, are able to optimize the R&D productivity while letting internal resources concentrate on the core discoveries with the execution of clinical strategies.

• Biotech Companies

The biotech companies segment has been driven by increased early-stage drug innovations and expansion of product pipelines. The CDMOs do play an important role in providing analytical and production support, which aids the biotech companies in efficiently navigating IND submissions while looking after risks and costs.

With growth in cell and gene therapies, biologics, and regulatory complexities, the biotech firms are increasingly relying on specialized CDMOs. This partnership does improve clinical pipelines and also promotes innovation by incorporatingadvanced technologies like AI-driven trial design, data management systems, and modular manufacturing, thereby solidifying the US as one of the leading hubs of biopharmaceuticals.

How is AI impacting the US Investigational New Drug CDMO Market?

Adoption of AI is enhancing the precision, efficiency, and creativity of several essential components pertaining to drug production and development. AI-based predictive analysis and automation are facilitating optimization regarding the production of sterile injectables while subverting the potential for contamination.

AI tools do follow advanced inventory management practices, which do enable exercising control over lead time in the supply chain. The processes implemented using Ai include the usage of digital twins for modelling manufacturing parameters virtually and generative AI for predicting the need for the formulation of medicines at a pace quicker than conventional approaches. Besides, natural language processing helps in digitally automating documentation related to regulatory compliance.

Report Scope

Key Developments

The US investigational new drug CDMO market is witnessing a significant organic and inorganic expansion. Some of the key developments include –

• In October 2024, Pharmaceutics International, Inc. did announce launching its Accelevate Early Development Program. This platform has been designed for accelerating preparation of Investigational New Drug (IND) submissions, thereby offering small- to mid-sized pharmaceutical companies the ability to reach IND readiness within 100 days, particularly for aseptic products.

• In March 2024, Lonza signed an agreement to acquire a production facility in the US from Roche for USD 1.2 Billion. Lonza does plan an investment of an additional USD Mn for upgrading the facility and meeting demand for next-gen biologic therapies.

• In March 2023, Societal CDMO, Inc., announced that it had received approval from the US FDA for serving as the manufacturer of commercial tablets.

Leading Players

The US investigational new drug CDMO market is highly competitive, with a large number of service providers globally. Some of the key players in the market include:

• Catalent Inc.
• Lonza
• Recipharm AB
• Patheon Inc.
• Covance
• IQVIA Holdings Inc.
• Cambrex Corporation
• Charles River Laboratories International, Inc.
• Syneos Health
• Syngene International
• Jubilant Pharmova
• Piramal Pharma Solutions
• Reddy’s CPS
• Dishman Carbogen Amcis Ltd.
• Biocon Biologics
• Laurus Labs
• Others

These firms apply a plethora of strategies to enter the market, including innovations, mergers and acquisitions, and collaboration. The US investigational new drug CDMO market is shaped by the presence of diversified players that compete based on product innovation, vertical integration, and cost efficiency.

The US Investigational New Drug CDMO Market is segmented as follows:

By Service

• Contract Development
• Small Molecule
• Bioanalysis and DMPK Studies
• Toxicology Testing
• Pathology and Safety Pharmacology Studies
• Drug Substance Development
• Synthetic Route Development
• Process Development
• Form Selection Crystallization Process Development
• Scale-up of Drug Substance
• Formulation Development
• Pre-formulation
• Preclinical Formulation Selection
• First-in-Man Formulation/Process Development
• Analytical & Quality Services
• Analytical Method Development/Validation
• Release Testing of Drug Substance and Drug Product
• Formal Stability of Drug Substance and Drug Product
• Process Optimization
• Work Up Purification Steps
• Telescoping & Process Refining
• Initial Optimization
• Large Molecule
• Cell Line Development
• Process Development
• Upstream
• Microbial
• Mammalian
• Others
• Downstream
• MABs
• Recombinant Proteins
• Others
• Contract Manufacturing
• Small Molecule
• Oral Solids
• Semi-solids
• Liquids & Injectables
• Others
• Large Molecule
• MABs
• Recombinant Proteins
• Others

By End-use

• Pharmaceutical Companies
• Biotech Companies

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