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市場調查報告書
商品編碼
1869866

美國生物製藥合約開發市場：市場規模、佔有率、趨勢分析（按原料、產品服務和適應症分類）、細分市場預測，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個工作天內

價格

美國生物製藥合約開發市場摘要

據估計，2024年美國生物製藥合約開發市場價值為28.2億美元，預計到2033年將達到44.8億美元。

預計從 2025 年到 2033 年，該市場將以 5.3% 的複合年成長率成長。推動市場成長的因素包括併購活動活性化、生物生產中先進技術的日益普及、投資增加、開發中國家臨床試驗法規環境改善以及製藥和生物製藥公司研發活動外包的增加。

由於前期成本高昂、監管負擔重以及需要快速上市，許多製藥和生物技術公司將研發和生產外包給合約研發生產機構（CDMO）。生物製藥合約研發產業的中小型企業，尤其是在美國，由於自身能力有限，主要依賴CDMO。

此外，心血管疾病、神經系統疾病和癌症等慢性病的日益流行，推動了對新型生物製藥療法的需求。根據美國疾病管制與預防美國（CDC）2024年2月發布的報告，心臟病、糖尿病和肥胖等慢性病是美國面臨的主要健康挑戰，影響約1.29億人。許多美國人患有多種慢性病，給醫療保健系統帶來了沉重的負擔，全國每年4.1兆美元的醫療支出中，約90%用於治療這些疾病。

目錄

第1章調查方法和範圍

第2章執行摘要

第3章美國生物製藥合約開發市場變數、趨勢與範圍

  • 市場體系展望
    • 母市場展望
    • 相關/輔助市場展望
  • 市場動態
    • 市場促進因素分析
    • 市場限制因素分析
  • 美國生物製藥合約開發市場分析工具
    • 產業分析—波特五力分析
    • PESTEL 分析

第4章：美國生物製藥合約開發市場：按原料分類的估算與趨勢分析

  • 按原料細分儀表板
  • 美國生物製藥合約開發市場：按原料分類的波動分析
  • 美國生物製藥合約開發市場規模及趨勢分析（依材料分類，2021-2033年）
    • 微生物
    • 哺乳動物
    • 其他

第5章：美國生物製藥合約開發市場：按產品服務分類的估算與趨勢分析

  • 按產品服務細分儀表板
  • 美國生物製藥合約開發市場：按產品服務分類的波動分析
  • 美國生物製藥合約開發市場規模及產品服務趨勢分析（2021-2033年）
    • 細胞株構建
    • 製程開發

第6章：美國生物製藥合約開發市場：依適應症分類的估算與趨勢分析

  • 指示細分儀表板
  • 美國生物製藥合約開發市場：按適應症分析波動情況
  • 美國生物製藥合約開發市場規模及趨勢分析（依適應症分類，2021-2033年）
    • 腫瘤學
    • 免疫疾病
    • 心血管疾病
    • 血液疾病
    • 其他

第7章 競爭情勢

  • 主要市場參與企業的最新趨勢和影響分析
  • 公司/競爭對手分類
  • 供應商概況
    • 主要企業熱力圖分析，2024 年
  • 公司簡介
    • 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)