(MENAFN- GlobeNewsWire - Nasdaq) The U.S. IND CDMO market offers growth via extensive pipelines in oncology and rare diseases, driven by technological advancements, outsourcing trends, regulatory efficiencies, and modular GMP investments. Opportunities favor CDMOs with digital prowess, modality depth, and robust supply chains, aiming for rapid IND approvals.

Dublin, Oct. 27, 2025 (GLOBE NEWSWIRE) -- The "U.S. Investigational New Drug CDMO Market Size, Share & Trends Analysis Report by Service (Contract Development, Contract Manufacturing), End Use (Pharmaceutical Companies, Biotech Companies), and Growth Forecasts, 2025-2033" report has been added to ResearchAndMarkets's offering.
The U.S. investigational new drug CDMO market size was estimated at USD 1.87 Billion in 2025 and is projected to reach USD 3.58 billion by 2033, growing at a CAGR of 9.38% from 2025 to 2033.

The Investigational New Drug (IND) CDMO is experiencing significant growth in the U.S., driven by an extensive and complex early-stage pipeline, particularly in areas such as oncology, rare diseases, and advanced modalities.
Besides, emerging biopharma companies are focusing on cost efficiency and swift IND readiness as they depend on external partners for Chemistry, Manufacturing, and Controls (CMC), as well as nonclinical and clinical materials. Aspects like supply-chain resilience, a preference for domestic capacity, and faster regulatory pathways are further encouraging outsourcing. The implementation of platform processes, structured tech transfers, and phase-appropriate quality measures has helped mitigate program risks, thereby making comprehensive IND enablement more favorable outsourcing market.
In addition, growing technological advancements, particularly in digital capabilities and modality-specific approaches, have contributed to market growth. The adoption of AI-assisted Design of Experiments (DoE), digital twin technology, and automated batch-recording is helping to shorten timelines and improve execution accuracy. The use of single-use and continuous processing methods is being extended into Phase I manufacturing where feasible, and high-throughput analytics and advanced bioassays are being employed to reduce CMC package risks. Expertise in various domains, such as mRNA/Lipid Nanoparticles (LNP), viral vectors, plasmids, and highly potent active pharmaceutical ingredients (HPAPI), has been enhanced through techniques, including flow chemistry, solid-state control, and Process Analytical Technology (PAT). Besides, data integrity is being firmly integrated through electronic Quality Management Systems (eQMS) and Laboratory Information Management Systems (LIMS).
Moreover, growing investments in modular Good Manufacturing Practice (GMP), aseptic fill-finish capabilities, vector, and plasmid production capacity, microfluidic LNP platforms, and expandable Quality Control (QC) laboratories support the market growth. IND-enabling toxicology and bioanalytical capabilities are being scaled up to ensure single-contract accountability. Strategic mergers and acquisitions are being undertaken to incorporate essential capabilities and geographic redundancy, while new builds and retrofits are being prioritized for speed. Funding for workforce development and technician training is aimed at alleviating bottlenecks in biologics and sterile operations. The adoption of commercial constructs that include milestone-based pricing and reserved capacity options is intended to align incentives closely.
Furthermore, the regulatory landscape is being influenced by FDA expectations regarding phase-appropriate CMC as outlined in ICH Q8-Q12, strict data integrity measures (coded as 21 CFR Part 11), and well-defined comparability strategies. Pre-IND engagements are being utilized to ensure alignment on control strategies, analytical validation methods, and stability requirements. Expedited designations such as Fast Track, Breakthrough Therapy, and Regenerative Medicine Advanced Therapy (RMAT) status are being employed, necessitating robust processes and thorough documentation early in development. Standards for sterile products regarding aseptic processing and contamination control practices are being established from the beginning, while the incorporation of digital audit trails and Computer Software Assurance (CSA)-based validation has become a standard practice. Thus, the industry is witnessing a divide between full-service IND enablers and hyper-specialized providers.
Operational frameworks are being refined to leverage standardized platforms, simultaneous workstreams, and integrated project management, which are key to reducing cycle times. Preferred-provider agreements and long-term master service contracts are gaining traction to ensure priority access to limited resources such as vectors and sterile filling. Risk-sharing mechanisms are being employed through success-fee models and capacity reservations. Hence, the market is likely to see further consolidation and selective specialization, with growth opportunities favoring CDMOs that can demonstrate digital sophistication, depth in various modalities, and resilient domestic supply chains, all while consistently achieving first-pass IND approvals.
U.S. Investigational New Drug CDMO Market Report Segmentation
This report forecasts revenue growth at and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, the analyst has segmented the U.S. investigational new drug CDMO market report based on service and end use.
Key Topics Covered:
Chapter 1. Research Methodology and Scope
Chapter 2. Executive Summary
2.1. Market Outlook
2.2. Segment Outlook
2.3. Competitive Insights
Chapter 3. U.S. Investigational New Drug CDMO Market Variables, Trends & Scope
3.1. Market Lineage Outlook
3.2. Market Dynamics
3.2.1. Market Driver Analysis
3.2.1.1. Increasing outsourcing services by pharmaceutical companies
3.2.1.2. Rising investment in R&D
3.2.1.3. Growing pharmaceutical industry
3.2.1.4. Stringent regulatory requirements
3.2.2. Market Restraint Analysis
3.2.2.1. Compliance issues while outsourcing
3.2.2.2. Changing scenario in developing countries
3.3. Technology Landscape
3.4. Pricing Model Analysis
3.5. Tariff Impact Analysis
3.6. Value Chain Analysis
3.7. Market Analysis Tools
Chapter 4. U.S. Investigational New Drug CDMO Market: Service Estimates & Trend Analysis
4.1. U.S. Investigational New Drug CDMO Market, by Service: Segment Dashboard
4.2. U.S. Investigational New Drug CDMO Market, by Service: Movement Analysis
4.3. U.S. Investigational New Drug CDMO Market Estimates & Forecasts, by Service
4.4. Contract Development
4.5. Contract Development
Chapter 5. U.S. Investigational New Drug CDMO Market: by End Use Estimates & Trend Analysis
5.1. U.S. Investigational New Drug CDMO Market, by End Use: Segment Dashboard
5.2. U.S. Investigational New Drug CDMO Market, by End Use: Movement Analysis
5.3. U.S. Investigational New Drug CDMO Market Estimates & Forecasts, by End Use
5.4. Pharmaceutical Companies
5.5. Biotech Companies
5.6. Others
Chapter 6. Competitive Landscape
6.1. Key Participant Categorization
6.2. Market Share/Assessment Analysis, 2024 (Heat Map Analysis)
6.3. Company Profiles

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

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