Summary

U.S. Investigational New Drug CDMO Market Summary

The U.S. investigational new drug CDMO market size was estimated at USD 1.82 billion in 2024 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, Grand View Research has segmented the U.S. investigational new drug CDMO market report based on service and end use.

• Service Outlook (Revenue, USD Million, 2021 - 2033
• Contract Development
o Small Molecule
o Bioanalysis and DMPK Studies
o Toxicology Testing
o Pathology and Safety Pharmacology Studies
o Drug Substance Development
o Synthetic Route Development
o Process Development
o Form Selection Crystallization Process Development
o Scale-up of Drug Substance
o Formulation Development
o Pre Formulation
o Preclinical Formulation Selection
o First In Man Formulation/ Process Development
o Analytical & Quality Services
o Analytical Method Development / Validation
o Release Testing of Drug Substance and Drug Product
o Formal Stability of Drug Substance and Drug Product
o Process Optimization
o Work Up Purification Steps
o Telescoping & Process Refining
o Initial Optimization
o Large Molecule
o Cell Line Development
o Process Development
o Upstream
o Microbial
o Mammalian
o Others
o Downstream
o MABs
o Recombinant Proteins
o Others
• Contract Manufacturing
o Small Molecule
o Oral Solids
o Semi-Solids
o Liquids & Injectables
o Others
o Large Molecule
o MABs
o Recombinant Proteins
o Others
• End Use Outlook (Revenue, USD Million, 2021 - 2033)
• Pharmaceutical Companies
• Biotech Companies
• Others

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Table of Contents

Table of Contents

Chapter 1. Research Methodology and Scope
1.1. Market Segmentation & Scope
1.2. Segment Definitions
1.2.1. Service
1.2.2. End Use
1.3. Research Methodology
1.4. Information Procurement
1.4.1. Purchased Database
1.4.2. GVR’s Internal Database
1.4.3. Secondary Sources
1.4.4. Primary Research
1.5. Information Or Data Analysis
1.5.1. Data Analysis Models
1.6. Market Formulation & Validation
1.7. Model Details
1.7.1. Commodity Flow Analysis
1.7.2. Top-Down Analysis
1.7.3. Bottom-Up Approach
1.7.4. Multivariate Analysis
1.8. List Of Secondary Sources
1.9. List Of Abbreviations
1.10. Objectives
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
3.1.1. Parent Market Outlook
3.1.2. Related/Ancillary Market 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
3.6.1. Supply Trends
3.6.2. Demand Trends
3.7. Market Analysis Tools
3.7.1. Porter’s Five Forces Analysis
3.7.2. PESTEL by SWOT Analysis
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, 2021 - 2033 (USD Million)
4.4. Contract Development
4.4.1. Contract Development Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.4.2. Small Molecule
4.4.2.1. Small Molecule Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.4.2.2. Bioanalysis and DMPK Studies
4.4.2.2.1. Bioanalysis and DMPK Studies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.4.2.3. Toxicology Testing
4.4.2.3.1. Toxicology Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.4.2.4. Pathology and Safety Pharmacology Studies
4.4.2.4.1. Pathology and Safety Pharmacology Studies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.4.2.5. Drug Substance Development
4.4.2.5.1. Drug Substance Development Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.4.2.5.2. Synthetic Route Development
4.4.2.5.2.1. Synthetic Route Development Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.4.2.5.3. Process Development
4.4.2.5.3.1. Process Development Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.4.2.5.4. Form Selection Crystallization Process Development
4.4.2.5.4.1. Form Selection Crystallization Process Development Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.4.2.5.5. Scale-up of Drug Substance
4.4.2.5.5.1. Scale-up of Drug Substance Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.4.2.6. Formulation Development
4.4.2.6.1. Formulation Development Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.4.2.6.2. Pre Formulation
4.4.2.6.2.1. Pre Formulation Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.4.2.6.3. Preclinical Formulation Selection
4.4.2.6.3.1. Preclinical Formulation Selection Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.4.2.6.4. First In Man Formulation/ Process Development
4.4.2.6.4.1. First In Man Formulation/ Process Development Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.4.2.7. Analytical & Quality Services
4.4.2.7.1. Analytical & Quality Services Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.4.2.7.2. Analytical Method Development / Validation
4.4.2.7.2.1. Analytical Method Development / Validation Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.4.2.7.3. Release Testing of Drug Substance and Drug Product
4.4.2.7.3.1. Release Testing of Drug Substance and Drug Product Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.4.2.7.4. Formal Stability of Drug Substance and Drug Product
4.4.2.7.4.1. Formal Stability of Drug Substance and Drug Product Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.4.2.8. Process Optimization
4.4.2.8.1. Process Optimization Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.4.2.8.2. Work Up Purification Steps
4.4.2.8.2.1. Work Up Purification Steps Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.4.2.8.3. Telescoping & Process Refining
4.4.2.8.3.1. Telescoping & Process Refining Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.4.2.8.4. Initial Optimization
4.4.2.8.4.1. Initial Optimization Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.4.3. Large Molecule
4.4.3.1. Large Molecule Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.4.3.2. Cell Line Development
4.4.3.2.1. Cell Line Development Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.4.3.3. Process Development
4.4.3.3.1. Process Development Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.4.3.3.2. Upstream
4.4.3.3.2.1. Upstream Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.4.3.3.2.2. Microbial
4.4.3.3.2.2.1. Microbial Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.4.3.3.2.3. Mammalian
4.4.3.3.2.3.1. Mammalian Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.4.3.3.2.4. Others
4.4.3.3.2.4.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.4.3.3.3. Downstream
4.4.3.3.3.1. Downstream Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.4.3.3.3.2. MABs
4.4.3.3.3.2.1. MABs Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.4.3.3.3.3. Recombinant Proteins
4.4.3.3.3.3.1. Recombinant Proteins Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.4.3.3.3.4. Others
4.4.3.3.3.4.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.5. Contract Development
4.5.1. Contract Development Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.5.2. Small Molecule
4.5.2.1. Small Molecule Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.5.2.2. Oral Solids
4.5.2.2.1. Oral Solids Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.5.2.3. Semi-Solids
4.5.2.3.1. Semi-Solids Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.5.2.4. Liquids & Injectables
4.5.2.4.1. Liquids & Injectables Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.5.2.5. Others
4.5.2.5.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.5.3. Large Molecule
4.5.3.1. Large Molecule Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.5.3.2. MABs
4.5.3.2.1. MABs Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.5.3.3. Recombinant Proteins
4.5.3.3.1. Recombinant Proteins Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.5.3.4. Others
4.5.3.4.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)
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, 2021 - 2033 (USD Million)
5.4. Pharmaceutical Companies
5.4.1. Pharmaceutical Companies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
5.5. Biotech Companies
5.5.1. Biotech Companies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
5.6. Others
5.6.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Chapter 6. Competitive Landscape
6.1. Key Participant Categorization
6.1.1. Market Leaders
6.1.2. Emerging Players
6.2. Market Share/Assessment Analysis, 2024 (Heat Map Analysis)
6.3. Company Profiles
6.3.1. Catalent, Inc.
6.3.1.1. Company Overview
6.3.1.2. Financial Performance
6.3.1.3. Service Benchmarking
6.3.1.4. Strategic Initiatives
6.3.2. Lonza
6.3.2.1. Company Overview
6.3.2.2. Financial Performance
6.3.2.3. Service Benchmarking
6.3.2.4. Strategic Initiatives
6.3.3. Recipharm AB
6.3.3.1. Company Overview
6.3.3.2. Financial Performance
6.3.3.3. Service Benchmarking
6.3.3.4. Strategic Initiatives
6.3.4. Siegfried Holding AG
6.3.4.1. Company Overview
6.3.4.2. Financial Performance
6.3.4.3. Service Benchmarking
6.3.4.4. Strategic Initiatives
6.3.5. Patheon Inc.
6.3.5.1. Company Overview
6.3.5.2. Financial Performance
6.3.5.3. Service Benchmarking
6.3.5.4. Strategic Initiatives
6.3.6. Covance
6.3.6.1. Company Overview
6.3.6.2. Financial Performance
6.3.6.3. Service Benchmarking
6.3.6.4. Strategic Initiatives
6.3.7. IQVIA Holdings Inc.
6.3.7.1. Company Overview
6.3.7.2. Financial Performance
6.3.7.3. Service Benchmarking
6.3.7.4. Strategic Initiatives
6.3.8. Cambrex Corporation
6.3.8.1. Company Overview
6.3.8.2. Financial Performance
6.3.8.3. Service Benchmarking
6.3.8.4. Strategic Initiatives
6.3.9. Charles River Laboratories International, Inc.
6.3.9.1. Company Overview
6.3.9.2. Financial Performance
6.3.9.3. Service Benchmarking
6.3.9.4. Strategic Initiatives
6.3.10. Syneos Health
6.3.10.1. Company Overview
6.3.10.2. Financial Performance
6.3.10.3. Service Benchmarking
6.3.10.4. Strategic Initiatives
6.3.11. Syngene International
6.3.11.1. Company Overview
6.3.11.2. Financial Performance
6.3.11.3. Service Benchmarking
6.3.11.4. Strategic Initiatives
6.3.12. Jubilant Pharmova
6.3.12.1. Company Overview
6.3.12.2. Financial Performance
6.3.12.3. Service Benchmarking
6.3.12.4. Strategic Initiatives
6.3.13. Piramal Pharma Solutions
6.3.13.1. Company Overview
6.3.13.2. Financial Performance
6.3.13.3. Service Benchmarking
6.3.13.4. Strategic Initiatives
6.3.14. Dr. Reddy’s CPS
6.3.14.1. Company Overview
6.3.14.2. Financial Performance
6.3.14.3. Service Benchmarking
6.3.14.4. Strategic Initiatives
6.3.15. Dishman Carbogen Amcis
6.3.15.1. Company Overview
6.3.15.2. Financial Performance
6.3.15.3. Service Benchmarking
6.3.15.4. Strategic Initiatives
6.3.16. Biocon Biologics
6.3.16.1. Company Overview
6.3.16.2. Financial Performance
6.3.16.3. Service Benchmarking
6.3.16.4. Strategic Initiatives
6.3.17. Laurus Labs
6.3.17.1. Company Overview
6.3.17.2. Financial Performance
6.3.17.3. Service Benchmarking
6.3.17.4. Strategic Initiatives