US Investigational New Drug CDMO Market Size Likely to Grow at a CAGR of 10.32% By 2034

Market Size and Growth

As per the US Investigational New Drug CDMO Market size 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

As per the industry experts at CMI, the U.S. investigational new drug CDMO market is likely to witness a double-digit CAGR during the forecast period. This could be attributed to rising demand for outsourcing, advanced therapies with reduced overheads, and the effectiveness of CDMOs in supporting complex development of the new drug candidates with their clinical trials. As per the 20^th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production published in April 2023, the biomanufacturers did incur more expenses through in-house production.

Key Trends & Drivers

• Outsourcing Trends to Determine Growth: Biotech and pharmaceutical companies are strongly relying on Contract Development and Manufacturing Organizations (CDMOs) for handling complex tasks of developing as well as producing investigational drugs for various clinical trials. This outsourcing is capable of offering cost savings, thereby letting drug developers emphasize their core competencies.

• Emphasis on Advanced Therapies to Catalyze the Market: The investigational new drug CDMO market is witnessing a notable growth potential in advanced therapeutic areas such as antibody-drug conjugates (ADCs), gene therapy, and RNA therapies, which need specialized production capabilities that could be provided by CDMOs. A strong pipeline of new drugs at investigational stages does create higher demand for the CDMO services.

Report Scope

SWOT Analysis

• Strengths: CDMOs do offer in-depth knowledge in multi-step synthesis, regulatory compliance, and high-potency API handling, which various pharma companies find difficult to cope with. Investments by CDMOs in state-of-the-art equipment, quality control systems, and process automation facilitate meeting stern standards apart from complex production needs. Moreover, as CDMOs are capable of scaling operations down or up fast, they offer flexibility to the clients.

• Weaknesses: Niche or smaller CDMOs are likely to encounter limitations with respect to skilled personnel, capital, or capacity for handling complex/high-volume projects. Also, the growth of the market is linked with the success and depth of the clients’ drug pipelines, thereby creating a degree of dependency. Outsourcing could also raise concerns regarding the protection of IP and proprietary drug information.

• Opportunities: Growing trend of personalized medicine and gene and cell therapies, along with the other advanced modalities, does present a rising demand for specialized services offered by CDMOs. The U.S. market is also likely to benefit from growth in biopharmaceutical R&D activities and a rise in the need for innovative drug development. Inking strategic partnerships with the pharma companies for initial-stage development could foster long-term collaborative ties.

• Threats: Continual changes in regulations by the U.S. FDA with emerging quality standards could pose challenges for the CDMOs for maintaining compliance. Monetary fluctuations/shifts in government funding for R&D activities could adversely impact demand for CDMO services, thereby adversely affecting clients’ monetary stability.

List of the prominent players in the US Investigational New Drug CDMO Market:

• 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

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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