미국의 의약품 CDMO(위탁개발생산기관) 시장 규모, 점유율, 동향 분석 보고서 : 종류별, 제품별, 서비스별, 워크플로우별, 치료 분야별, 최종 용도별 및 부문별 예측(2026-2033년)

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

The U.S. pharmaceutical CDMO market size was valued at USD 38.8 billion in 2025 and is projected to grow from USD 41.2 billion 2026 to USD 65.3 billion by 2033, at a CAGR of 6.8% from 2026 to 2033. The U.S. pharmaceutical 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 therapies such as 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. 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.

In addition, to cut expenses, shorten turnaround times, and concentrate on core skills like research and development and marketing, pharmaceutical corporations in the U.S. are increasingly contracting with CDMOs to handle drug development and manufacture. Small and mid-sized biotech companies, which make up the majority of the U.S. innovation scene, can obtain specialized knowledge, innovative technologies, and regulatory support through outsourcing without making significant infrastructure investments. CDMOs are essential partners in the changing pharmaceutical value chain because they provide flexible capacity, scalability, and compliance with strict FDA standards. As biologics, cell and gene therapies, and specialty medication formulations become more sophisticated, this trend is expected to speed up. U.S. leads globally in clinical research, with thousands of active clinical trials supported by a robust biotech and pharmaceutical ecosystem.

The growing number of innovative drugs in the pipeline, particularly in oncology, rare diseases, and immunotherapies, drives demand for CDMO services across preclinical, clinical, and commercial stages. CDMOs provide essential expertise in formulation development, manufacturing clinical trial material, analytical testing, and regulatory submissions. As small biotech firms dominate innovation but lack in-house production facilities, they increasingly rely on CDMOs to accelerate time-to-market, reduce risks, and ensure compliance with evolving FDA guidelines, reinforcing their critical role in the pharmaceutical landscape.

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

This report forecasts revenue growth at the country level 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 Contract Development and Manufacturing Organization 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 (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
  • 3.2.3. 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, 2025
• 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 Force Analysis
  • 3.10.2. PESTEL by SWOT Analysis

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

• 4.1. U.S. Pharmaceutical Contract Development and Manufacturing Organization (CDMO) Market, By Type: Segment Dashboard
• 4.2. U.S. Pharmaceutical Contract Development and Manufacturing Organization (CDMO) Market, By Type: Movement Analysis
• 4.3. U.S. Pharmaceutical Contract Development and Manufacturing Organization (CDMO) 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 (CDMO) Market: Product Estimates & Trend Analysis

• 5.1. U.S. Pharmaceutical Contract Development and Manufacturing Organization (CDMO) Market, By Product: Segment Dashboard
• 5.2. U.S. Pharmaceutical Contract Development and Manufacturing Organization (CDMO) Market, By Product: Movement Analysis
• 5.3. U.S. Pharmaceutical Contract Development and Manufacturing Organization (CDMO) 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 (CDMO) Market: Service Estimates & Trend Analysis

• 6.1. U.S. Pharmaceutical Contract Development and Manufacturing Organization (CDMO) Market, By Service: Segment Dashboard
• 6.2. U.S. Pharmaceutical Contract Development and Manufacturing Organization (CDMO) Market, By Service: Movement Analysis
• 6.3. U.S. Pharmaceutical Contract Development and Manufacturing Organization (CDMO) 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 (CDMO) Market: Workflow Estimates & Trend Analysis

• 7.1. U.S. Pharmaceutical Contract Development and Manufacturing Organization (CDMO) Market, By Workflow: Segment Dashboard
• 7.2. U.S. Pharmaceutical Contract Development and Manufacturing Organization (CDMO) Market, By Workflow: Movement Analysis
• 7.3. U.S. Pharmaceutical Contract Development and Manufacturing Organization (CDMO) 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 (CDMO) Market: Therapeutic Area Estimates & Trend Analysis

• 8.1. U.S. Pharmaceutical Contract Development and Manufacturing Organization (CDMO) Market, By Therapeutic Area: Segment Dashboard
• 8.2. U.S. Pharmaceutical Contract Development and Manufacturing Organization (CDMO) Market, By Therapeutic Area: Movement Analysis
• 8.3. U.S. Pharmaceutical Contract Development and Manufacturing Organization (CDMO) 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 (CDMO) Market: End-Use Estimates & Trend Analysis

• 9.1. U.S. Pharmaceutical Contract Development and Manufacturing Organization (CDMO) Market, By End-Use: Segment Dashboard
• 9.2. U.S. Pharmaceutical Contract Development and Manufacturing Organization (CDMO) Market, By End-Use: Movement Analysis
• 9.3. U.S. Pharmaceutical Contract Development and Manufacturing Organization (CDMO) 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, 2025 (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. Delpharm
    • 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. Jubilant Pharmova / HollisterStier
    • 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. Eurofins CDMO
    • 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. Almac Pharma Services
    • 10.3.14.1. Company Overview
    • 10.3.14.2. Financial Performance
    • 10.3.14.3. Service Benchmarking
    • 10.3.14.4. Strategic Initiatives