미국의 생물제제 수탁 개발 시장 : 규모, 점유율, 동향 분석(원료별, 제품 서비스별, 적응증별), 부문별 예측(2025-2033년)

U.S. Biologics Contract Development Market Summary

The U.S. biologics contract development market size was estimated at USD 2.82 billion in 2024 and is projected to reach USD 4.48 billion by 2033, growing at a CAGR of 5.3% from 2025 to 2033. Factors such as growing M&A activities; increasing adoption of advanced technologies for biological production; investment, a favorable regulatory environment for clinical trials in developing countries, and a rise in outsourcing of R&D activities by pharma and biopharma companies are driving the market.

High upfront costs, regulatory burdens, and the need for speed-to-market have led many pharmaceutical and biotech firms to outsource development and manufacturing to Contract Development and Manufacturing Organization (CDMOs). Small and mid-sized biotech companies in the U.S. biologics contract development industry, in particular, rely mostly on CDMOs due to limited in-house capabilities.

Furthermore, the rising prevalence of chronic diseases, such as cardiovascular disorders, neurological disorders, and cancer, fuels the demand for novel biologic therapies. According to a report published by the CDC in February 2024, chronic diseases such as heart disease, diabetes, and obesity are a major health challenge in the U.S., affecting about 129 million people. Many Americans live with more than one chronic condition, which is putting heavy pressure on the healthcare system, as about 90% of the country's USD 4.1 trillion annual healthcare spending goes toward managing these illnesses.

U.S. Biologics Contract Development 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. biologics contract development market report based on source, product service, and indication:

• Source Outlook (Revenue, USD Million, 2021 - 2033)
• Mammalian
• Microbial
• Others
• Product Service Outlook (Revenue, USD Million, 2021 - 2033)
• Cell Line Development
  • Microbial
  • Mammalian
  • Others
• Process Development
  • Upstream
  • Microbial
  • Mammalian
  • Others
  • Downstream
  • Bioanalytical methods
  • Impurity, isolation, & identification
  • Physicochemical characterization
  • Pharmaceutical analysis
  • Others
  • Product
  • MABs
  • Recombinant proteins
  • Others
• Indication Outlook (Revenue, USD Million, 2021 - 2033)
• Oncology
• Immunological Disorders
• Cardiovascular Disorders
• Hematological Disorders
• Others

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation & Scope
• 1.2. Segment Definitions
  • 1.2.1. Source
  • 1.2.2. Product Service
  • 1.2.3. Indication
  • 1.2.4. Estimates and forecasts timeline
• 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
  • 1.4.5. Details of primary research
• 1.5. Information or Data Analysis
  • 1.5.1. Data analysis models
• 1.6. Market formulation & Validation
• 1.7. Model Details
• 1.8. List of Secondary Sources
• 1.9. List of Primary Sources
• 1.10. Objectives

Chapter 2. Executive Summary

• 2.1. Market Outlook
• 2.2. Segment Outlook
  • 2.2.1. Source Outlook
  • 2.2.2. Product Service Outlook
  • 2.2.3. Indication Outlook
• 2.3. Competitive Insights

Chapter 3. U.S. Biologics Contract Development 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. U.S. Biologics Contract Development Market Analysis Tools
  • 3.3.1. Industry Analysis - Porter's
    • 3.3.1.1. Supplier Power
    • 3.3.1.2. Buyer Power
    • 3.3.1.3. Substitution Threat
    • 3.3.1.4. Threat of New Entrant
    • 3.3.1.5. Competitive Rivalry
  • 3.3.2. PESTEL Analysis
    • 3.3.2.1. Political Landscape
    • 3.3.2.2. Technological Landscape
    • 3.3.2.3. Economic Landscape

Chapter 4. U.S. Biologics Contract Development Market: Source Estimates & Trend Analysis

• 4.1. Source Segment Dashboard
• 4.2. U.S. Biologics Contract Development Market: Source Movement Analysis
• 4.3. U.S. Biologics Contract Development Market Size & Trend Analysis, by Source, 2021 - 2033 (USD Million)
  • 4.3.1. Microbial
    • 4.3.1.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)
  • 4.3.2. Mammalian
    • 4.3.2.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)
  • 4.3.3. Others
    • 4.3.3.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)

Chapter 5. U.S. Biologics Contract Development Market: Product Service Estimates & Trend Analysis

• 5.1. Product Service Segment Dashboard
• 5.2. U.S. Biologics Contract Development Market: Product Service Movement Analysis
• 5.3. U.S. Biologics Contract Development Market Size & Trend Analysis, by Product Service, 2021 - 2033 (USD Million)
  • 5.3.1. Cell Line Development
    • 5.3.1.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)
    • 5.3.1.2. Microbial
      • 5.3.1.2.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)
    • 5.3.1.3. Mammalian
      • 5.3.1.3.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)
    • 5.3.1.4. Others
      • 5.3.1.4.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)
  • 5.3.2. Process Development
    • 5.3.2.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)
    • 5.3.2.2. Upstream
      • 5.3.2.2.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)
      • 5.3.2.2.2. Microbial
        • 5.3.2.2.2.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)
      • 5.3.2.2.3. Mammalian
        • 5.3.2.2.3.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)
      • 5.3.2.2.4. Others
        • 5.3.2.2.4.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)
    • 5.3.2.3. Downstream
      • 5.3.2.3.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)
      • 5.3.2.3.2. Bioanalytical Methods
        • 5.3.2.3.2.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)
        • 5.3.2.3.2.2. Impurity, isolation, & identification
          • 5.3.2.3.2.2.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)
        • 5.3.2.3.2.3. Physicochemical characterization
          • 5.3.2.3.2.3.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)
        • 5.3.2.3.2.4. Pharmaceutical analysis
          • 5.3.2.3.2.4.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)
        • 5.3.2.3.2.5. Others
          • 5.3.2.3.2.5.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)
      • 5.3.2.3.3. Product
        • 5.3.2.3.3.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)
        • 5.3.2.3.3.2. MABs
          • 5.3.2.3.3.2.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)
        • 5.3.2.3.3.3. Recombinant proteins
          • 5.3.2.3.3.3.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)
        • 5.3.2.3.3.4. Others
          • 5.3.2.3.3.4.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)

Chapter 6. U.S. Biologics Contract Development Market: Indication Estimates & Trend Analysis

• 6.1. Indication Segment Dashboard
• 6.2. U.S. Biologics Contract Development Market: Indication Movement Analysis
• 6.3. U.S. Biologics Contract Development Market Size & Trend Analysis, by Indication, 2021 - 2033 (USD Million)
  • 6.3.1. Oncology
    • 6.3.1.1. Market Estimates and Forecasts 2021 - 2033 (USD million)
  • 6.3.2. Immunological Disorders
    • 6.3.2.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)
  • 6.3.3. Cardiovascular Disorders
    • 6.3.3.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)
  • 6.3.4. Hematological Disorders
    • 6.3.4.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)
  • 6.3.5. Others
    • 6.3.5.1. Market Estimates and Forecasts 2021 - 2033 (USD Million)

Chapter 7. Competitive Landscape

• 7.1. Recent Developments & Impact Analysis, By Key Market Participants
• 7.2. Company/Competition Categorization
• 7.3. Vendor Landscape
  • 7.3.1. Key company heat map analysis, 2024
• 7.4. Company Profiles
  • 7.4.1. WuXi Biologics.
    • 7.4.1.1. Company overview
    • 7.4.1.2. Financial performance
    • 7.4.1.3. Product benchmarking
    • 7.4.1.4. Strategic initiatives
  • 7.4.2. Abzena
    • 7.4.2.1. Company overview
    • 7.4.2.2. Financial performance
    • 7.4.2.3. Product benchmarking
    • 7.4.2.4. Strategic initiatives
  • 7.4.3. FUJIFILM Diosynth Biotechnologies.
    • 7.4.3.1. Company overview
    • 7.4.3.2. Financial performance
    • 7.4.3.3. Product benchmarking
    • 7.4.3.4. Strategic initiatives
  • 7.4.4. KBI Biopharma
    • 7.4.4.1. Company overview
    • 7.4.4.2. Financial performance
    • 7.4.4.3. Product benchmarking
    • 7.4.4.4. Strategic initiatives
  • 7.4.5. AGC Biologics.
    • 7.4.5.1. Company overview
    • 7.4.5.2. Financial performance
    • 7.4.5.3. Product benchmarking
    • 7.4.5.4. Strategic initiatives
  • 7.4.6. Thermo Fisher Scientific Inc.
    • 7.4.6.1. Company overview
    • 7.4.6.2. Financial performance
    • 7.4.6.3. Product benchmarking
    • 7.4.6.4. Strategic initiatives
  • 7.4.7. Curia Global, Inc.
    • 7.4.7.1. Company overview
    • 7.4.7.2. Financial performance
    • 7.4.7.3. Product benchmarking
    • 7.4.7.4. Strategic initiatives
  • 7.4.8. GenScript
    • 7.4.8.1. Company overview
    • 7.4.8.2. Financial performance
    • 7.4.8.3. Product benchmarking
    • 7.4.8.4. Strategic initiatives
  • 7.4.9. Bionova Scientific LLC
    • 7.4.9.1. Company overview
    • 7.4.9.2. Financial performance
    • 7.4.9.3. Product benchmarking
    • 7.4.9.4. Strategic initiatives
  • 7.4.10. Boehringer Ingelheim International
    • 7.4.10.1. Company overview
    • 7.4.10.2. Financial performance
    • 7.4.10.3. Product benchmarking
    • 7.4.10.4. Strategic initiatives
  • 7.4.11. STC Biologics
    • 7.4.11.1. Company overview
    • 7.4.11.2. Financial performance
    • 7.4.11.3. Product benchmarking
    • 7.4.11.4. Strategic initiatives