미국의 고분자 원료의약품 CDMO 시장 규모, 점유율, 동향 분석 보고서 : 제품별, 서비스별, 공급원별, 최종 용도별, 국가별, 부문별 예측(2025-2033년)

Market Size & Trends:

The U.S. large molecule drug substance CDMO market size was estimated at USD 12.22 billion in 2024 and is projected to reach USD 22.56 billion by 2033, growing at a CAGR of 7.06% from 2025 to 2033. This market is experiencing significant growth due to the growing prevalence of chronic diseases, further driving the demand for biologics such as monoclonal antibodies, cell therapies, and gene therapies. Moreover, increasing outsourcing trends by pharmaceutical and biotech companies to reduce costs, access specialized expertise, and accelerate commercialization are also some of the factors contributing to the market growth.

The market is driven by the growing demand for biologics to meet the growing demand for effective therapeutic options for chronic and complex diseases. The increasing prevalence of cancer, autoimmune disorders, and metabolic diseases globally is leading to the growing demand for more advanced therapies. Biologics such as monoclonal antibodies, recombinant proteins, cell therapies, and gene therapies have emerged as prominent solutions, but their development and manufacturing processes are comparatively complex and require advanced infrastructure. Therefore, several pharmaceutical and biotechnology companies increasingly turn to contract development and manufacturing organizations to streamline operations and address the growing complexity of large molecule drug development. Thus, these factors would help companies to reduce the burden of high capital investments, avoid lengthy facility set-ups, and gain faster access to specialized expertise that ensures regulatory compliance and high-quality production.

Furthermore, growing innovation and regulatory support to create a favorable environment for CDMOs in the U.S. is also contributing to the market growth. Continuous advancements in bioprocessing technologies, such as the shift towards single-use systems and the adoption of continuous manufacturing, are making biologics production more efficient, flexible, and cost-effective. These improvements not only help manufacturers meet the rising global demand but also enable CDMOs to handle more complex pipelines, including biosimilars that are rapidly emerging as patents for blockbuster biologics expire.

U.S. Large Molecule Drug Substance CDMO Market Report Segmentation

This report forecasts revenue growth at 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. large molecule drug substance CDMO market report based on product, service, source, and end use.

• Product Outlook (Revenue, USD Million, 2021 - 2033)
• Biologics
• Biosimilar
• Service Outlook (Revenue, USD Million, 2021 - 2033)
• Contract Manufacturing
  • Clinical
  • Commercial
• Contract Development
  • Cell Line Development
  • Process Development
• Source Outlook (Revenue, USD Million, 2021 - 2033)
• Mammalian
• Microbial
• Others
• End Use Outlook (Revenue, USD Million, 2021 - 2033)
• Biotech Companies
• CRO
• Others

Table of Contents

Chapter 1. Research Methodology and Scope

• 1.1. Market Segmentation & Scope
• 1.2. Segment Definitions
  • 1.2.1. Product
  • 1.2.2. Service
  • 1.2.3. Source
  • 1.2.4. 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. Botton-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. Large Molecule Drug Substance 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
  • 3.2.2. Market Restraint Analysis
• 3.3. Technology Landscape
• 3.4. Pricing Model Analysis
• 3.5. Tariff Impact Analysis
• 3.6. Industry Analysis Tools
  • 3.6.1. Porter's Five Force Analysis
  • 3.6.2. PESTEL by SWOT Analysis

Chapter 4. U.S. Large Molecule Drug Substance CDMO Market: Product Estimates & Trend Analysis

• 4.1. U.S. Large Molecule Drug Substance CDMO Market, By Product: Segment Dashboard
• 4.2. U.S. Large Molecule Drug Substance CDMO Market, By Product: Movement Analysis
• 4.3. U.S. Large Molecule Drug Substance CDMO Market Estimates & Forecasts, By Product, 2021 - 2033 (USD Million)
• 4.4. Biologics
  • 4.4.1. Biologics Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.5. Biosimilar
  • 4.5.1. Biosimilar Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 5. U.S. Large Molecule Drug Substance CDMO Market: Service Estimates & Trend Analysis

• 5.1. U.S. Large Molecule Drug Substance CDMO Market, By Service: Segment Dashboard
• 5.2. U.S. Large Molecule Drug Substance CDMO Market, By Service: Movement Analysis
• 5.3. U.S. Large Molecule Drug Substance CDMO Market Estimates & Forecasts, By Service, 2021 - 2033 (USD Million)
• 5.4. Contract Manufacturing
  • 5.4.1. Contract Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.4.2. Clinical
    • 5.4.2.1. Clinical Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.4.3. Commercial
    • 5.4.3.1. Commercial Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.5. Contract Development
  • 5.5.1. Contract Development Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.5.2. Cell Line Development
    • 5.5.2.1. Cell Line Development Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.5.3. Process Development
    • 5.5.3.1. Process Development Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 6. U.S. Large Molecule Drug Substance CDMO Market: Source Estimates & Trend Analysis

• 6.1. U.S. Large Molecule Drug Substance CDMO Market, By Source: Segment Dashboard
• 6.2. U.S. Large Molecule Drug Substance CDMO Market, By Source: Movement Analysis
• 6.3. U.S. Large Molecule Drug Substance CDMO Market Estimates & Forecasts, By Source, 2021 - 2033 (USD Million)
• 6.4. Mammalian
  • 6.4.1. Mammalian Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.5. Microbial
  • 6.5.1. Microbial Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.6. Others
  • 6.6.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 7. U.S. Large Molecule Drug Substance CDMO Market: End Use Estimates & Trend Analysis

• 7.1. U.S. Large Molecule Drug Substance CDMO Market, By End Use: Segment Dashboard
• 7.2. U.S. Large Molecule Drug Substance CDMO Market, By End Use: Movement Analysis
• 7.3. U.S. Large Molecule Drug Substance CDMO Market Estimates & Forecasts, By End Use, 2021 - 2033 (USD Million)
• 7.4. Biotech Companies
  • 7.4.1. Biotech Companies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 7.5. CRO
  • 7.5.1. CRO Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 7.6. Others
  • 7.6.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 8. Competitive Landscape

• 8.1. Key Participant Categorization
  • 8.1.1. Market Leaders
  • 8.1.2. Emerging Players
• 8.2. Market Share/Assessment Analysis, 2024 (Heat Map Analysis)
• 8.3. Company Profiles
  • 8.3.1. Eurofins Scientific
    • 8.3.1.1. Company Overview
    • 8.3.1.2. Financial Performance
    • 8.3.1.3. Service Benchmarking
    • 8.3.1.4. Strategic Initiatives
  • 8.3.2. WuXi Biologics
    • 8.3.2.1. Company Overview
    • 8.3.2.2. Financial Performance
    • 8.3.2.3. Service Benchmarking
    • 8.3.2.4. Strategic Initiatives
  • 8.3.3. Samsung Biologics
    • 8.3.3.1. Company Overview
    • 8.3.3.2. Financial Performance
    • 8.3.3.3. Service Benchmarking
    • 8.3.3.4. Strategic Initiatives
  • 8.3.4. Catalent, Inc.
    • 8.3.4.1. Company Overview
    • 8.3.4.2. Financial Performance
    • 8.3.4.3. Service Benchmarking
    • 8.3.4.4. Strategic Initiatives
  • 8.3.5. Rentschler Biopharma SE
    • 8.3.5.1. Company Overview
    • 8.3.5.2. Financial Performance
    • 8.3.5.3. Service Benchmarking
    • 8.3.5.4. Strategic Initiatives
  • 8.3.6. AGC Biologics
    • 8.3.6.1. Company Overview
    • 8.3.6.2. Financial Performance
    • 8.3.6.3. Service Benchmarking
    • 8.3.6.4. Strategic Initiatives
  • 8.3.7. Recipharm AB
    • 8.3.7.1. Company Overview
    • 8.3.7.2. Financial Performance
    • 8.3.7.3. Service Benchmarking
    • 8.3.7.4. Strategic Initiatives
  • 8.3.8. Siegfried Holding AG
    • 8.3.8.1. Company Overview
    • 8.3.8.2. Financial Performance
    • 8.3.8.3. Service Benchmarking
    • 8.3.8.4. Strategic Initiatives
  • 8.3.9. Boehringer Ingelheim
    • 8.3.9.1. Company Overview
    • 8.3.9.2. Financial Performance
    • 8.3.9.3. Service Benchmarking
    • 8.3.9.4. Strategic Initiatives
  • 8.3.10. FUJIFILM Diosynth Biotechnologies
    • 8.3.10.1. Company Overview
    • 8.3.10.2. Financial Performance
    • 8.3.10.3. Service Benchmarking
    • 8.3.10.4. Strategic Initiatives