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U.S. Large Molecule Drug Substance CDMO Market Size, Share, Trends, Industry Analysis Report By Product, By Service, By Source , and By End-use – Market Forecast, 2025–2034

Publisher Polaris Market Research & Consulting LLP
Published Nov 01, 2025
Length 128 Pages
SKU # PLRS20638186

Description

The U.S. large molecule drug substance CDMO market size is expected to reach USD 25.37 Billion by 2034, according to a new study by Polaris Market Research. The report “U.S. Large Molecule Drug Substance CDMO Market Size, Share, Trends, Industry Analysis Report By Product, By Service, By Source , and By End-use – Market Forecast, 2025–2034” gives a detailed insight into current market dynamics and provides analysis on future market growth.

The U.S. large molecule drug substance CDMO market delivers contract development and manufacturing services for biologics, including monoclonal antibodies, cell therapies, gene therapies, and recombinant proteins.

Furthermore, the adoption of single-use bioreactors, continuous manufacturing platforms, and advanced analytics is strengthening the operational efficiency and flexibility of U.S.-based large molecule CDMOs.

U.S. Large Molecule Drug Substance CDMO Market Report Highlights
Based on product, the biologics segment dominated in 2024, supported by rising demand for monoclonal antibodies, cell and gene therapies, and advanced biologics for oncology and autoimmune disorders.
In terms of service, contract manufacturing held the largest share, owing to the growing reliance of pharmaceutical and biotechnology companies on CDMOs for large-scale GMP-compliant production to accelerate commercialization timelines.
In terms of source, mammalian expression systems led the market, due to their proven suitability for producing complex biologics such as monoclonal antibodies and recombinant proteins with high precision and safety.
Based on end use, biotech companies dominated the market, propelled by their dependence on CDMOs for process development, clinical-scale supply, and commercial manufacturing to avoid high infrastructure investments.
Key players in the global market include AGC Biologics, Inc., Boehringer Ingelheim International GmbH, Catalent, Inc., Eurofins Scientific SE, FUJIFILM Diosynth Biotechnologies U.S.A., Inc., Lonza Group AG, Patheon Inc. (Thermo Fisher Scientific Inc.), Recipharm AB, Rentschler Biopharma SE, Samsung Biologics Co., Ltd., Sartorius AG, Siegfried Holding AG, Syngene International Limited, Wuxi Biologics (Cayman) Inc., and Zymo Research Corp.
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Polaris Market Research has segmented the market report based on product, services, source, end-use, and region:
By Product Outlook (Revenue, USD Billion, 2020–2034)

Biologics
Biosimilar
By Services Outlook (Revenue, USD Billion, 2020–2034)

Contract Manufacturing
Clinical
Commercial
Contract Development
Cell Line Development
Process Development
By Source Outlook (Revenue, USD Billion, 2020–2034)

Mammalian
Microbial
Others
By End-Use Outlook (Revenue, USD Billion, 2020–2034)

Biotech Companies
CRO
Others

Table of Contents

128 Pages
1. Introduction
1.1. Report Description
1.1.1. Objectives of the Study
1.1.2. Market Scope
1.1.3. Assumptions
1.2. Stakeholders
2. Executive Summary
2.1. Market Highlights
3. Research Methodology
3.1. Overview
3.1.1. Data Mining
3.2. Data Sources
3.2.1. Primary Sources
3.2.2. Secondary Sources
4. U.S. Large Molecule Drug Substance CDMO Market Insights
4.1. U.S. Large Molecule Drug Substance CDMO Market – Market Snapshot
4.2. U.S. Large Molecule Drug Substance CDMO Market Dynamics
4.2.1. Drivers and Opportunities
4.2.1.1. Strategic Investments Fuelling U.S. Biomanufacturing Capacity Growth
4.2.1.2. Rising Healthcare Expenditure Elevating Demand for Biologic Therapies
4.2.2. Restraints and Challenges
4.2.2.1. High Production Cost and Facility Validation Requirements
4.3. Porter’s Five Forces Analysis
4.3.1. Bargaining Power of Suppliers (Moderate)
4.3.2. Threats of New Entrants: (Low)
4.3.3. Bargaining Power of Buyers (Moderate)
4.3.4. Threat of Substitute (Moderate)
4.3.5. Rivalry among existing firms (High)
4.4. PESTEL Analysis
4.5. U.S. Large Molecule Drug Substance CDMO Market Trends
4.6. Value Chain Analysis
5. U.S. Large Molecule Drug Substance CDMO Market, by Product
5.1. Key Findings
5.2. Introduction
5.2.1. U.S. Large Molecule Drug Substance CDMO Market, by Product, 2020-2034 (USD Billion)
5.3. Biologics
5.3.1. U.S. Large Molecule Drug Substance CDMO Market, by Biologics, 2020-2034 (USD Billion)
5.4. Biosimilar
5.4.1. U.S. Large Molecule Drug Substance CDMO Market, by Biosimilar, 2020-2034 (USD Billion)
6. U.S. Large Molecule Drug Substance CDMO Market, by Service
6.1. Key Findings
6.2. Introduction
6.2.1. U.S. Large Molecule Drug Substance CDMO Market, by Service, 2020-2034 (USD Billion)
6.3. Contract Manufacturing
6.3.1. U.S. Large Molecule Drug Substance CDMO Market, by Contract Manufacturing, 2020-2034 (USD Billion)
6.3.1.1. U.S. Large Molecule Drug Substance CDMO Market, by Clinical, 2020-2034 (USD Billion)
6.3.1.2. U.S. Large Molecule Drug Substance CDMO Market, by Commercial, 2020-2034 (USD Billion)
6.4. Contract Development
6.4.1. U.S. Large Molecule Drug Substance CDMO Market, by Contract Development, 2020-2034 (USD Billion)
6.4.1.1. U.S. Large Molecule Drug Substance CDMO Market, by Cell Line Development, 2020-2034 (USD Billion)
6.4.1.2. U.S. Large Molecule Drug Substance CDMO Market, by Process Development, 2020-2034 (USD Billion)
7. U.S. Large Molecule Drug Substance CDMO Market, by Source
7.1. Key Findings
7.2. Introduction
7.2.1. U.S. Large Molecule Drug Substance CDMO Market, by Source, 2020-2034 (USD Billion)
7.3. Mammalian
7.3.1. U.S. Large Molecule Drug Substance CDMO Market, by Mammalian, 2020-2034 (USD Billion)
7.4. Microbial
7.4.1. U.S. Large Molecule Drug Substance CDMO Market, by Microbial, 2020-2034 (USD Billion)
7.5. Others
7.5.1. U.S. Large Molecule Drug Substance CDMO Market, by Others, 2020-2034 (USD Billion)
8. U.S. Large Molecule Drug Substance CDMO Market, by End-Use
8.1. Key Findings
8.2. Introduction
8.2.1. U.S. Large Molecule Drug Substance CDMO Market, by End-Use, 2020-2034 (USD Billion)
8.3. Biotech Companies
8.3.1. U.S. Large Molecule Drug Substance CDMO Market, by Biotech Companies, 2020-2034 (USD Billion)
8.4. CRO
8.4.1. U.S. Large Molecule Drug Substance CDMO Market, by CRO, 2020-2034 (USD Billion)
8.5. Others
8.5.1. U.S. Large Molecule Drug Substance CDMO Market, by Others, 2020-2034 (USD Billion)
9. Competitive Landscape
9.1. Expansion and Acquisition Analysis
9.1.1. Expansion
9.1.2. Acquisitions
9.2. Partnerships/Collaborations/Agreements/Exhibitions
10. Company Profiles
10.1. AGC Biologics, Inc.
10.1.1. Company Overview
10.1.2. Financial Performance
10.1.3. Product Benchmarking
10.1.4. Recent Development
10.2. Boehringer Ingelheim International GmbH
10.2.1. Company Overview
10.2.2. Financial Performance
10.2.3. Product Benchmarking
10.2.4. Recent Development
10.3. Catalent, Inc.
10.3.1. Company Overview
10.3.2. Financial Performance
10.3.3. Product Benchmarking
10.3.4. Recent Development
10.4. Eurofins Scientific SE
10.4.1. Company Overview
10.4.2. Financial Performance
10.4.3. Product Benchmarking
10.4.4. Recent Development
10.5. FUJIFILM Diosynth Biotechnologies U.S.A., Inc.
10.5.1. Company Overview
10.5.2. Financial Performance
10.5.3. Product Benchmarking
10.5.4. Recent Development
10.6. Lonza Group AG
10.6.1. Company Overview
10.6.2. Financial Performance
10.6.3. Product Benchmarking
10.6.4. Recent Development
10.7. Patheon Inc. (Thermo Fisher Scientific Inc.)
10.7.1. Company Overview
10.7.2. Financial Performance
10.7.3. Product Benchmarking
10.7.4. Recent Development
10.8. Recipharm AB
10.8.1. Company Overview
10.8.2. Financial Performance
10.8.3. Product Benchmarking
10.8.4. Recent Development
10.9. Rentschler Biopharma SE
10.9.1. Company Overview
10.9.2. Financial Performance
10.9.3. Product Benchmarking
10.9.4. Recent Development
10.10. Samsung Biologics Co., Ltd.
10.10.1. Company Overview
10.10.2. Financial Performance
10.10.3. Product Benchmarking
10.10.4. Recent Development
10.11. Sartorius AG
10.11.1. Company Overview
10.11.2. Financial Performance
10.11.3. Product Benchmarking
10.11.4. Recent Development
10.12. Siegfried Holding AG
10.12.1. Company Overview
10.12.2. Financial Performance
10.12.3. Product Benchmarking
10.12.4. Recent Development

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