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市场调查报告书
商品编码
1869866

美国生物製药合约开发市场：市场规模、份额、趋势分析（按原料、产品服务和适应症划分）、细分市场预测，2025-2033年

U.S. Biologics Contract Development Market Size, Share, & Trends Analysis Report By Source (Mammalian, Microbial), By Product Service (Cell-line Development, Process Development), By Indication, And Segment Forecasts, 2025 - 2033
出版日期: | 出版商: Grand View Research | 英文 100 Pages | 商品交期: 2-10个工作天内

价格

美国生物製药合约开发市场摘要

据估计，2024年美国生物製药合约开发市场价值为28.2亿美元，预计到2033年将达到44.8亿美元。

预计从 2025 年到 2033 年，该市场将以 5.3% 的复合年增长率成长。推动市场成长的因素包括併购活动活性化、生物生产中先进技术的日益普及、投资增加、开发中国家临床试验法规环境改善以及製药和生物製药公司研发活动外包的增加。

由于前期成本高昂、监管负担重以及需要快速上市，许多製药和生物技术公司将研发和生产外包给合约研发生产机构（CDMO）。生物製药合约研发产业的中小型企业，尤其是在美国，由于自身能力有限，主要依赖CDMO。

此外，心血管疾病、神经系统疾病和癌症等慢性病的日益流行，推动了对新型生物製药疗法的需求。根据美国疾病管制与预防美国（CDC）2024年2月发布的报告，心臟病、糖尿病和肥胖等慢性病是美国面临的主要健康挑战，影响约1.29亿人。许多美国人患有多种慢性病，给医疗保健系统带来了沉重的负担，全国每年4.1兆美元的医疗支出中，约90%用于治疗这些疾病。

目录

第一章调查方法和范围

第二章执行摘要

第三章美国生物製药合约开发市场变数、趋势与范围

  • 市场体系展望
    • 母市场展望
    • 相关/辅助市场展望
  • 市场动态
    • 市场驱动因素分析
    • 市场限制因素分析
  • 美国生物製药合约开发市场分析工具
    • 产业分析—波特五力分析
    • PESTEL 分析

第四章：美国生物製药合约开发市场：按原料分類的估算与趋势分析

  • 按原料细分仪表板
  • 美国生物製药合约开发市场：按原料分類的波动分析
  • 美国生物製药合约开发市场规模及趋势分析（依材料划分，2021-2033年）
    • 微生物
    • 哺乳动物
    • 其他的

第五章：美国生物製药合约开发市场：按产品服务分類的估算与趋势分析

  • 按产品服务细分仪表板
  • 美国生物製药合约开发市场：按产品服务分類的波动分析
  • 美国生物製药合约开发市场规模及产品服务趋势分析（2021-2033年）
    • 细胞株构建
    • 製程开发

第六章：美国生物製药合约开发市场：依适应症分類的估算与趋势分析

  • 指示细分仪表板
  • 美国生物製药合约开发市场：按适应症分析波动情况
  • 美国生物製药合约开发市场规模及趋势分析（依适应症划分，2021-2033年）
    • 肿瘤学
    • 免疫疾病
    • 心血管疾病
    • 血液疾病
    • 其他的

第七章 竞争情势

  • 主要市场参与企业的最新趋势和影响分析
  • 公司/竞争对手分类
  • 供应商概况
    • 主要企业热力图分析，2024 年
  • 公司简介
    • WuXi Biologics.
    • Abzena
    • FUJIFILM Diosynth Biotechnologies.
    • KBI Biopharma
    • AGC Biologics.
    • Thermo Fisher Scientific Inc.
    • Curia Global, Inc.
    • GenScript
    • Bionova Scientific LLC
    • Boehringer Ingelheim International
    • STC Biologics
Product Code: GVR-4-68040-777-3

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

List of Tables

  • Table 1 List of abbreviations
  • Table 2 U.S. biologics contract development market, by source, 2021 - 2033 (USD Million)
  • Table 3 U.S. biologics contract development market, by product service, 2021 - 2033 (USD Million)
  • Table 4 U.S. biologics contract development market, by indication, 2021 - 2033 (USD Million)

List of Figures

  • Fig. 1 Market research process
  • Fig. 2 Data triangulation techniques
  • Fig. 3 Primary research pattern
  • Fig. 4 Primary interviews
  • Fig. 5 Market research approaches
  • Fig. 6 Value-chain-based sizing & forecasting
  • Fig. 7 QFD modeling for market share assessment
  • Fig. 8 Market formulation & validation
  • Fig. 9 U.S. biologics contract development market: market outlook
  • Fig. 10 U.S. biological contract development competitive insights
  • Fig. 11 Parent market outlook
  • Fig. 12 Related/ancillary market outlook
  • Fig. 13 Penetration and growth prospect mapping
  • Fig. 14 Industry value chain analysis
  • Fig. 15 U.S. biologics contract development market driver impact
  • Fig. 16 U.S. biologics contract development market restraint impact
  • Fig. 17 U.S. biologics contract development market strategic initiatives analysis
  • Fig. 18 U.S. biologics contract development market: source movement analysis
  • Fig. 19 U.S. biologics contract development market: source outlook and key takeaways
  • Fig. 20 Microbial market estimates and forecast, 2021 - 2033 (USD Million)
  • Fig. 21 Mammalian market estimates and forecast, 2021 - 2033 (USD Million)
  • Fig. 22 Others estimates and forecast, 2021 - 2033 (USD Million)
  • Fig. 23 U.S. biologics contract development market: product service movement analysis
  • Fig. 24 U.S. biologics contract development market: product service outlook and key takeaways
  • Fig. 25 Cell line development (2-17 years) market estimates and forecast, 2021 - 2033 (USD Million)
  • Fig. 26 Microbial market estimates and forecast, 2021 - 2033 (USD Million)
  • Fig. 27 Mammalian market estimates and forecast, 2021 - 2033 (USD Million)
  • Fig. 28 Others market estimates and forecast, 2021 - 2033 (USD Million)
  • Fig. 29 Process development market estimates and forecast, 2021 - 2033 (USD Million)
  • Fig. 30 Upstream market estimates and forecast, 2021 - 2033 (USD Million)
  • Fig. 31 Microbial market estimates and forecast, 2021 - 2033 (USD Million)
  • Fig. 32 Mammalian market estimates and forecast, 2021 - 2033 (USD Million)
  • Fig. 33 Others market estimates and forecast, 2021 - 2033 (USD Million)
  • Fig. 34 Downstream market estimates and forecast, 2021 - 2033 (USD Million)
  • Fig. 35 Analytical methods market estimates and forecast, 2021 - 2033 (USD Million)
  • Fig. 36 Impurity, isolation, & identification market estimates and forecast, 2021 - 2033 (USD Million)
  • Fig. 37 Physicochemical characterization market estimates and forecast, 2021 - 2033 (USD Million)
  • Fig. 38 Pharmaceutical analysis market estimates and forecast, 2021 - 2033 (USD Million)
  • Fig. 39 Others market estimates and forecast, 2021 - 2033 (USD Million)
  • Fig. 40 Product market estimates and forecast, 2021 - 2033 (USD Million)
  • Fig. 41 MABs market estimates and forecast, 2021 - 2033 (USD Million)
  • Fig. 42 Recombinant proteins market estimates and forecast, 2021 - 2033 (USD Million)
  • Fig. 43 Others market estimates and forecast, 2021 - 2033 (USD Million)
  • Fig. 44 U.S. biologics contract development market: indication movement analysis
  • Fig. 45 U.S. biologics contract development market: indication outlook and key takeaways
  • Fig. 46 Hospital pharmacy estimates and forecast, 2021 - 2033 (USD Million)
  • Fig. 47 Oncology market estimates and forecast, 2021 - 2033 (USD Million)
  • Fig. 48 Immunological Disorders market estimates and forecast, 2021 - 2033 (USD Million)
  • Fig. 49 Cardiovascular Disorders market estimates and forecast, 2021 - 2033 (USD Million)
  • Fig. 50 Hematological Disorders market estimates and forecast, 2021 - 2033 (USD Million)
  • Fig. 51 Others market estimates and forecast, 2021 - 2033 (USD Million)