미국의 의약품 CDMO 시장 : 시장 규모, 점유율 및 동향 분석(유형별, 제품별, 서비스별, 워크플로우별, 치료 영역별, 최종 용도별), 부문별 예측(2025-2033년)

U.S. Pharmaceutical Contract Development & Manufacturing Organization Market Summary

The U.S. pharmaceutical contract development and manufacturing organization market size was estimated at USD 36.5 billion in 2024 and is projected to reach USD 65.3 billion by 2033, growing at a CAGR of 6.74% from 2025 to 2033. The U.S. pharmaceutical contract development & manufacturing organization (CDMO) is advancing, driven by the growth of biologics, biosimilars, and advanced therapies, rising demand for outsourcing in drug development, and increasing clinical trial activity and pipeline expansion.

The U.S. market is witnessing significant growth in biologics, biosimilars, and advanced cell and gene therapies, fueling demand for specialized CDMO services. Developing and manufacturing these therapies requires advanced capabilities like single-use bioprocessing systems, viral vector production, and personalized medicine expertise, which many pharma companies lack in-house.

CDMOs provide infrastructure, regulatory knowledge, and innovation platforms to accelerate development while meeting FDA standards. With rising approvals of biologics and biosimilars in the U.S., CDMOs are becoming indispensable partners in scaling production, ensuring supply chain resilience, and enabling faster time-to-market for complex, high-value therapeutics.

U.S. Pharmaceutical Contract Development and Manufacturing Organization Market Report Segmentation

This report forecasts revenue growth at global, regional, 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. pharmaceutical CDMO market report based on type, product, service, workflow, therapeutic area, and end use:

• Type Outlook (Revenue, USD Million, 2021 - 2033)
• Small Molecule
  • Branded
  • Generic
• Large Molecule
  • Biologics
  • Biosimilar
• Product Outlook (Revenue, USD Million, 2021 - 2033)
• API
  • Traditional Active Pharmaceutical Ingredient (Traditional API)
  • Highly Potent Active Pharmaceutical Ingredient (HP-API)
  • Biologics
  • Others
• Drug Product
  • Oral solid dose
  • Semi-solid dose
  • Liquid dose
  • Others
• Service Outlook (Revenue, USD Million, 2021 - 2033)
• Contract Development
  • Pre-formulation & Formulation Development Services
  • Process Development & Optimization
  • Analytical Testing & Method Validation
  • Scale-up & Tech Transfer
• Contract Manufacturing
  • API Manufacturing
  • Finished Drug Products Manufacturing
• Packaging and Labelling
• Regulatory Affairs
• Others
• Workflow Outlook (Revenue, USD Million, 2021 - 2033)
• Clinical
• Commercial
• Therapeutic Area Outlook (Revenue, USD Million, 2021 - 2033)
• Oncology
• Infectious Diseases
• Neurological Disorders
• Cardiovascular Disease
• Metabolic Disorders
• Autoimmune Diseases
• Respiratory Diseases
• Ophthalmology
• Gastrointestinal Disorders
• Orthopedic Diseases
• Dental Diseases
• Others
• End Use Outlook (Revenue, USD Million, 2021 - 2033)
• Small Pharmaceutical Companies
• Medium Pharmaceutical Companies
• Large Pharmaceutical Companies

Table of Contents

Chapter 1. Research Methodology and Scope

• 1.1. Market Segmentation & Scope
• 1.2. Segment Definitions
  • 1.2.1. Type
  • 1.2.2. Product
  • 1.2.3. Services
  • 1.2.4. Workflow
  • 1.2.5. Therapeutic Area
  • 1.2.6. 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. Pharmaceutical Contract Development and Manufacturing Organization 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
  • 3.2.3. Market Opportunity Analysis
• 3.3. R&D Spending Analysis
• 3.4. Industry Ecosystem Analysis
  • 3.4.1. Demand Analysis
  • 3.4.2. Supply Chain Analysis
• 3.5. Technology Landscape
• 3.6. Clinical Trial Volume Analysis, 2024
• 3.7. Pricing Analysis
• 3.8. Tariff and Trade Agreement Impact Analysis
• 3.9. Value Chain Analysis
  • 3.9.1. Supply Trends
  • 3.9.2. Demand Trends
• 3.10. Market Analysis Tools
  • 3.10.1. Porter's Five Forces Analysis
  • 3.10.2. PESTEL by SWOT Analysis

Chapter 4. U.S. Pharmaceutical Contract Development and Manufacturing Organization Market: Type Estimates & Trend Analysis

• 4.1. U.S. Pharmaceutical Contract Development and Manufacturing Organization Market, By Type: Segment Dashboard
• 4.2. U.S. Pharmaceutical Contract Development and Manufacturing Organization Market, By Type: Movement Analysis
• 4.3. U.S. Pharmaceutical Contract Development and Manufacturing Organization Market Estimates & Forecasts, By Type, 2021 - 2033 (USD Million)
• 4.4. Small Molecule
  • 4.4.1. Small Molecule Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.4.2. Branded
    • 4.4.2.1. Branded Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.4.3. Generic
    • 4.4.3.1. Generic Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.5. Large Molecule
  • 4.5.1. Large Molecule Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.5.2. Biologics
    • 4.5.2.1. Biologics Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.5.3. Biosimilar
    • 4.5.3.1. Biosimilar Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 5. U.S. Pharmaceutical Contract Development and Manufacturing Organization Market: Product Estimates & Trend Analysis

• 5.1. U.S. Pharmaceutical Contract Development and Manufacturing Organization Market, By Product: Segment Dashboard
• 5.2. U.S. Pharmaceutical Contract Development and Manufacturing Organization Market, By Product: Movement Analysis
• 5.3. U.S. Pharmaceutical Contract Development and Manufacturing Organization Market Estimates & Forecasts, By Product, 2021 - 2033 (USD Million)
• 5.4. API
  • 5.4.1. API Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.4.2. Traditional Active Pharmaceutical Ingredient (Traditional API)
    • 5.4.2.1. Traditional Active Pharmaceutical Ingredient (Traditional API) Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.4.3. Highly Potent Active Pharmaceutical Ingredient (HP-API)
    • 5.4.3.1. Highly Potent Active Pharmaceutical Ingredient (HP-API) Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.4.4. Biologics
    • 5.4.4.1. Biologics Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.4.5. Others
    • 5.4.5.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.5. Drug Product
  • 5.5.1. Drug Product Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.5.2. Oral Solid Dose
    • 5.5.2.1. Oral Solid Dose Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.5.3. Semi-Solid Dose
    • 5.5.3.1. Semi-Solid Dose Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.5.4. Liquid Dose
    • 5.5.4.1. Liquid Dose Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.5.5. Others
    • 5.5.5.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 6. U.S. Pharmaceutical Contract Development and Manufacturing Organization Market: Service Estimates & Trend Analysis

• 6.1. U.S. Pharmaceutical Contract Development and Manufacturing Organization Market, By Service: Segment Dashboard
• 6.2. U.S. Pharmaceutical Contract Development and Manufacturing Organization Market, By Service: Movement Analysis
• 6.3. U.S. Pharmaceutical Contract Development and Manufacturing Organization Market Estimates & Forecasts, By Service, 2021 - 2033 (USD Million)
• 6.4. Contract Development
  • 6.4.1. Contract Development Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.4.2. Pre-formulation & Formulation Development Services
    • 6.4.2.1. Pre-formulation & Formulation Development Services Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.4.3. Process Development & Optimization
    • 6.4.3.1. Process Development & Optimization Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.4.4. Analytical Testing & Method Validation
    • 6.4.4.1. Analytical Testing & Method Validation Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.4.5. Scale-up & Tech Transfer
    • 6.4.5.1. Scale-up & Tech Transfer Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.5. Contract Manufacturing
  • 6.5.1. Contract Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.5.2. API Manufacturing
    • 6.5.2.1. API Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.5.3. Finished Drug Products Manufacturing
    • 6.5.3.1. Finished Drug Products Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.6. Packaging and Labelling
  • 6.6.1. Packaging and Labelling Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.7. Regulatory Affairs
  • 6.7.1. Regulatory Affairs Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.8. Others
  • 6.8.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 7. U.S. Pharmaceutical Contract Development and Manufacturing Organization Market: Workflow Estimates & Trend Analysis

• 7.1. U.S. Pharmaceutical Contract Development and Manufacturing Organization Market, By Workflow: Segment Dashboard
• 7.2. U.S. Pharmaceutical Contract Development and Manufacturing Organization Market, By Workflow: Movement Analysis
• 7.3. U.S. Pharmaceutical Contract Development and Manufacturing Organization Market Estimates & Forecasts, By Workflow, 2021 - 2033 (USD Million)
• 7.4. Clinical
  • 7.4.1. Clinical Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 7.5. Commercial
  • 7.5.1. Commercial Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 8. U.S. Pharmaceutical Contract Development and Manufacturing Organization Market: Therapeutic Area Estimates & Trend Analysis

• 8.1. U.S. Pharmaceutical Contract Development and Manufacturing Organization Market, By Therapeutic Area: Segment Dashboard
• 8.2. U.S. Pharmaceutical Contract Development and Manufacturing Organization Market, By Therapeutic Area: Movement Analysis
• 8.3. U.S. Pharmaceutical Contract Development and Manufacturing Organization Market Estimates & Forecasts, By Therapeutic Area, 2021 - 2033 (USD Million)
• 8.4. Oncology
  • 8.4.1. Oncology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 8.5. Infectious Diseases
  • 8.5.1. Infectious Diseases Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 8.6. Neurological Disorders
  • 8.6.1. Neurological Disorders Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 8.7. Cardiovascular Diseases
  • 8.7.1. Cardiovascular Diseases Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 8.8. Metabolic Disorders
  • 8.8.1. Metabolic Disorders Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 8.9. Autoimmune Diseases
  • 8.9.1. Autoimmune Diseases Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 8.10. Respiratory Diseases
  • 8.10.1. Respiratory Diseases Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 8.11. Ophthalmology
  • 8.11.1. Ophthalmology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 8.12. Gastrointestinal Disorders
  • 8.12.1. Gastrointestinal Disorders Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 8.13. Orthopedic Diseases
  • 8.13.1. Orthopedic Diseases Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 8.14. Dental Diseases
  • 8.14.1. Dental Diseases Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 8.15. Others
  • 8.15.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 9. U.S. Pharmaceutical Contract Development and Manufacturing Organization Market: End Use Estimates & Trend Analysis

• 9.1. U.S. Pharmaceutical Contract Development and Manufacturing Organization Market, By End Use: Segment Dashboard
• 9.2. U.S. Pharmaceutical Contract Development and Manufacturing Organization Market, By End Use: Movement Analysis
• 9.3. U.S. Pharmaceutical Contract Development and Manufacturing Organization Market Estimates & Forecasts, By End Use, 2021 - 2033 (USD Million)
• 9.4. Small Pharmaceutical Companies
  • 9.4.1. Small Pharmaceutical Companies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 9.5. Medium Pharmaceutical Companies
  • 9.5.1. Medium Pharmaceutical Companies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 9.6. Large Pharmaceutical Companies
  • 9.6.1. Large Pharmaceutical Companies Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 10. Competitive Landscape

• 10.1. Key Participant Categorization
  • 10.1.1. Market Leaders
  • 10.1.2. Emerging Players
• 10.2. Market Share/Assessment Analysis, 2024 (Heat Map Analysis)
• 10.3. Company Profiles
  • 10.3.1. Thermo Fisher Scientific, Inc
    • 10.3.1.1. Company Overview
    • 10.3.1.2. Financial Performance
    • 10.3.1.3. Service Benchmarking
    • 10.3.1.4. Strategic Initiatives
  • 10.3.2. Lonza
    • 10.3.2.1. Company Overview
    • 10.3.2.2. Financial Performance
    • 10.3.2.3. Service Benchmarking
    • 10.3.2.4. Strategic Initiatives
  • 10.3.3. Recipharm AB
    • 10.3.3.1. Company Overview
    • 10.3.3.2. Financial Performance
    • 10.3.3.3. Service Benchmarking
    • 10.3.3.4. Strategic Initiatives
  • 10.3.4. Catalent, Inc
    • 10.3.4.1. Company Overview
    • 10.3.4.2. Financial Performance
    • 10.3.4.3. Service Benchmarking
    • 10.3.4.4. Strategic Initiatives
  • 10.3.5. WuXi AppTec, Inc
    • 10.3.5.1. Company Overview
    • 10.3.5.2. Financial Performance
    • 10.3.5.3. Service Benchmarking
    • 10.3.5.4. Strategic Initiatives
  • 10.3.6. Samsung Biologics
    • 10.3.6.1. Company Overview
    • 10.3.6.2. Financial Performance
    • 10.3.6.3. Service Benchmarking
    • 10.3.6.4. Strategic Initiatives
  • 10.3.7. Piramal Pharma Solutions
    • 10.3.7.1. Company Overview
    • 10.3.7.2. Financial Performance
    • 10.3.7.3. Service Benchmarking
    • 10.3.7.4. Strategic Initiatives
  • 10.3.8. Siegfried Holding AG
    • 10.3.8.1. Company Overview
    • 10.3.8.2. Financial Performance
    • 10.3.8.3. Service Benchmarking
    • 10.3.8.4. Strategic Initiatives
  • 10.3.9. Corden Pharma International
    • 10.3.9.1. Company Overview
    • 10.3.9.2. Financial Performance
    • 10.3.9.3. Service Benchmarking
    • 10.3.9.4. Strategic Initiatives
  • 10.3.10. Cambrex Corporation
    • 10.3.10.1. Company Overview
    • 10.3.10.2. Financial Performance
    • 10.3.10.3. Service Benchmarking
    • 10.3.10.4. Strategic Initiatives
  • 10.3.11. Vetter Pharma
    • 10.3.11.1. Company Overview
    • 10.3.11.2. Financial Performance
    • 10.3.11.3. Service Benchmarking
    • 10.3.11.4. Strategic Initiatives
  • 10.3.12. Delpharm
    • 10.3.12.1. Company Overview
    • 10.3.12.2. Financial Performance
    • 10.3.12.3. Service Benchmarking
    • 10.3.12.4. Strategic Initiatives
  • 10.3.13. Jubilant Pharmova / HollisterStier
    • 10.3.13.1. Company Overview
    • 10.3.13.2. Financial Performance
    • 10.3.13.3. Service Benchmarking
    • 10.3.13.4. Strategic Initiatives
  • 10.3.14. Eurofins CDMO
    • 10.3.14.1. Company Overview
    • 10.3.14.2. Financial Performance
    • 10.3.14.3. Service Benchmarking
    • 10.3.14.4. Strategic Initiatives
  • 10.3.15. Almac Pharma Services
    • 10.3.15.1. Company Overview
    • 10.3.15.2. Financial Performance
    • 10.3.15.3. Service Benchmarking
    • 10.3.15.4. Strategic Initiatives