미국의 의료용 CDMO(개발·제조 수탁 기관) 시장 규모, 점유율, 동향 분석 : 유형별, 제품별, 서비스별, 워크플로우별, 치료 영역별, 최종 용도별, 부문별 예측(2025-2033년)

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

The U.S. healthcare contract development and manufacturing organization market size was estimated at USD 65.3 billion in 2024 and is projected to reach USD 144.2 billion by 2033, growing at a CAGR of 9.41% from 2025 to 2033. The U.S. healthcare CDMO market is expanding rapidly, driven by rising demand for biologics, biosimilars, and advanced therapies, including cell and gene therapies. Besides, pharmaceutical companies are increasingly focused on R&D in oncology, rare diseases, and immunology, creating the need for highly specialized manufacturing expertise.

CDMOs provide critical infrastructure, scalability, and technical capabilities that many firms lack internally. Growth is further reinforced by strong pipeline activity, patent expirations of biologics, and the acceleration of personalized medicine. This has led CDMOs to become essential partners in enabling faster development timelines, cost efficiency, and compliant production of complex therapies. Pharmaceutical and biotech companies are partnering with CDMOs to reduce operational costs and accelerate product development. Besides, among pharmaceutical companies, establishing in-house facilities requires substantial capital investment, workforce training, and regulatory compliance, which may slow innovation, which has further led to the rise of CDMO services.

In addition, CDMOs offer pharmaceutical and medical device companies' immediate access to advanced technologies, large-scale facilities, and flexible production models. This partnership supports minimizing the financial risks and allows pharma companies to focus on core R&D while leveraging CDMOs for clinical and commercial manufacturing. In a highly competitive market where speed is critical, CDMOs offer an agile and cost-efficient pathway to bring drugs to market faster, ensuring competitive advantage and profitability.

The U.S. healthcare industry operates under stringent FDA and global regulatory frameworks, requiring strict adherence to GMP standards, validation, and documentation. Besides, navigating these compliance requirements can be highly resource-intensive for pharma companies. CDMOs, however, possess deep regulatory expertise, established quality systems, and experience managing global submissions, reducing the risk of delays and non-compliance. Their ability to consistently meet evolving regulatory standards enhances trust and reliability. In addition, CDMOs are investing in digitalization, automation, and data-driven compliance systems to strengthen oversight. This regulatory know-how makes CDMOs indispensable strategic partners, enabling pharma companies to focus on innovation while ensuring product quality and patient safety.

U.S. Healthcare Contract Development And Manufacturing Organization 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. healthcare 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
• Medical Device
• Diagnostics
• Therapeutics
• Product Outlook (Revenue, USD Million, 2021 - 2033)
• Pharmaceutical
• API
  • Traditional API
  • HP-API
  • Biologics
  • Others
• Drug Product
  • Oral topical dose
  • Semi-solid dose
  • Liquid dose
  • Others
• Medical Devices
• Class I
• Class II
• Class III
• Service Outlook (Revenue, USD Million, 2021 - 2033)
• Contract Development
• Pre-formulation & Formulation Development Service
• Process Development & Optimization
• Analytical Testing & Method Validation
• Scale-up & Tech Transfer
• Contract Manufacturing
• API Manufacturing
• Finished drug products Manufacturing
• Medical Devices & Combination Products
• 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)
• Pharmaceutical & Biotechnology Companies
• Medical Device Companies
• Others

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. Service
  • 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. 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. Healthcare 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
• 3.3. 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 Force Analysis
  • 3.7.2. PESTEL by SWOT Analysis

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

• 4.1. U.S. Healthcare Contract Development and Manufacturing Organization Market, By Type: Segment Dashboard
• 4.2. U.S. Healthcare Contract Development and Manufacturing Organization Market, By Type: Movement Analysis
• 4.3. U.S. Healthcare 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)
• 4.6. Medical Device
  • 4.6.1. Medical Device Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.6.2. Diagnostics
    • 4.6.2.1. Diagnostics Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.6.3. Therapeutics
    • 4.6.3.1. Therapeutics Market Estimates and Forecasts, 2021 - 2033 (USD Million)

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

• 5.1. U.S. Healthcare Contract Development and Manufacturing Organization Market, By Product: Segment Dashboard
• 5.2. U.S. Healthcare Contract Development and Manufacturing Organization Market, By Product: Movement Analysis
• 5.3. U.S. Healthcare Contract Development and Manufacturing Organization Market Estimates & Forecasts, By Product, 2021 - 2033 (USD Million)
• 5.4. Pharmaceutical
  • 5.4.1. Pharmaceutical Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.4.2. API
    • 5.4.2.1. API Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 5.4.2.2. Traditional API
      • 5.4.2.2.1. Traditional API Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 5.4.2.3. HP-API
      • 5.4.2.3.1. HP-API Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 5.4.2.4. Biologics
      • 5.4.2.4.1. Biologics Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 5.4.2.5. Others
      • 5.4.2.5.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.4.3. Drug Product
    • 5.4.3.1. Drug Product Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 5.4.3.2. Oral Topical Dose
      • 5.4.3.2.1. Oral Topical Dose Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 5.4.3.3. Semi-Solid Dose
      • 5.4.3.3.1. Semi-Solid Dose Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 5.4.3.4. Liquid Dose
      • 5.4.3.4.1. Liquid Dose Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 5.4.3.5. Others
      • 5.4.3.5.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.5. Medical Devices
  • 5.5.1. Medical Devices Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.5.2. Class I
    • 5.5.2.1. Class I Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.5.3. Class II
    • 5.5.3.1. Class II Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.5.4. Class III
    • 5.5.4.1. Class III Market Estimates and Forecasts, 2021 - 2033 (USD Million)

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

• 6.1. U.S. Healthcare Contract Development and Manufacturing Organization Market, By Service: Segment Dashboard
• 6.2. U.S. Healthcare Contract Development and Manufacturing Organization Market, By Service: Movement Analysis
• 6.3. U.S. Healthcare 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. Preformulation & Formulation Development Service
    • 6.4.2.1. Preformulation & 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)
  • 6.5.4. Medical Devices & Combination Products
    • 6.5.4.1. Medical Devices & Combination Products 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. Healthcare Contract Development and Manufacturing Organization Market: Workflow Estimates & Trend Analysis

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

• 8.1. U.S. Healthcare Contract Development and Manufacturing Organization Market, By Therapeutic Area: Segment Dashboard
• 8.2. U.S. Healthcare Contract Development and Manufacturing Organization Market, By Therapeutic Area: Movement Analysis
• 8.3. U.S. Healthcare 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 Disease
  • 8.7.1. Cardiovascular Disease 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. Healthcare Contract Development and Manufacturing Organization Market: End Use Estimates & Trend Analysis

• 9.1. U.S. Healthcare Contract Development and Manufacturing Organization Market, By End Use: Segment Dashboard
• 9.2. U.S. Healthcare Contract Development and Manufacturing Organization Market, By End Use: Movement Analysis
• 9.3. U.S. Healthcare Contract Development and Manufacturing Organization Market Estimates & Forecasts, By End Use, 2021 - 2033 (USD Million)
• 9.4. Pharmaceutical & Biotechnology Companies
  • 9.4.1. Pharmaceutical & Biotechnology Companies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 9.5. Medical Device Companies
  • 9.5.1. Medical Device Companies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 9.6. Others
  • 9.6.1. Others 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. Catalent 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. Siegfried Holding AG
    • 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. Thermo Fisher Scientific, 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. Labcorp Drug Development
    • 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. Jabil Inc
    • 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. Syngene International Limited
    • 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. IQVIA Inc.
    • 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. Almac Group
    • 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. Ajinomoto Bio-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. Adare Pharma Solutions
    • 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. Alcami Corporation
    • 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. Vetter Pharma International
    • 10.3.14.1. Company Overview
    • 10.3.14.2. Financial Performance
    • 10.3.14.3. Service Benchmarking
    • 10.3.14.4. Strategic Initiatives