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市场调查报告书
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1842148

美国大型聚合物药物原料药CDMO市场：市场规模、份额和趋势分析（按产品、服务、供应来源、最终用途和国家/地区划分），细分市场预测（2025-2033年）

U.S. Large Molecule Drug Substance CDMO Market Size, Share & Trends Analysis Report By Product (Biologics, Biosimilar), By Service (Contract Manufacturing, Contract Development), By Source, By End Use, By Country, And Segment Forecasts, 2025 - 2033
出版日期: | 出版商: Grand View Research | 英文 120 Pages | 商品交期: 2-10个工作天内

价格

市场规模与趋势：

2024 年美国聚合物活性原料药CDMO 市场规模估计为 122.2 亿美元，预计到 2033 年将达到 225.6 亿美元，2025 年至 2033 年的复合年增长率为 7.06%。

由于慢性病盛行率不断上升，生技药品（如单株抗体、细胞疗法、基因疗法等）的需求进一步增长，该市场正经历显着增长。此外，製药和生技公司为降低成本、获取专业知识和加速商业化进程而日益增长的外包趋势也促进了市场成长。

生技药品市场的发展主要受生技药品需求成长的驱动，以满足慢性复杂疾病有效治疗方案日益增长的需求。癌症、自体免疫疾病和代谢紊乱在全球范围内的日益流行，导致对更先进疗法的需求不断增长。单株抗体、重组蛋白、细胞疗法和基因疗法等生物製剂已成为极具前景的解决方案，但其研发和生产过程相对复杂，需要先进的基础设施。因此，製药和生物技术公司正转向合约研发受託製造厂商（CDMO），以简化营运并应对大分子药物研发日益复杂的挑战。这些因素有望帮助企业减轻高额资本投资负担，避免冗长的设施建设时间，并快速获得确保合规性和高品质生产的专业知识。

此外，美国不断增长的技术创新和监管支持，为合约研发生产机构（CDMO）创造了有利的环境，也促进了市场成长。生物製程技术的持续进步，例如向一次性系统的转变和连续生产技术的应用，使生技药品的生产更加高效、灵活且经济。这些改进不仅有助于生产商满足日益增长的全球需求，也使CDMO能够处理更复杂的研发管线，包括随着重磅生物製剂专利到期而迅速涌现的生物相似生技药品。

目录

第一章 分析方法和范围

第二章执行摘要

第三章美国大型聚合物药物原料药药CDMO市场：驱动因素、趋势与范围

  • 市场联动展望
    • 母市场展望
    • 相关/附随市场展望
  • 市场动态
    • 市场驱动因素分析
    • 市场限制因素分析
  • 技术格局
  • 定价模式分析
  • 关税影响分析
  • 产业分析工具
    • 波特五力分析
    • PESTEL分析与SWOT分析

第四章：美国高分子药物原料药CDMO市场：依产品分類的估算与趋势分析

  • 美国大型聚合物药物原料药CDMO市场：产品概览
  • 美国大型聚合物药物原料药CDMO市场：波动分析（依产品分类）
  • 依产品划分（2021-2033 年）
  • 生技药品
  • 生物相似药

第五章：美国高分子药物原料药CDMO市场：按服务类型分類的估算与趋势分析

  • 美国大型聚合物药物原料药CDMO市场：按服务分类的概览
  • 美国大型聚合物药物原料药CDMO市场：按服务类型分類的差异分析
  • 依服务年资（2021-2033）
  • 契约製造
    • 临床
    • 商业的
  • 合约开发
    • 细胞株构建
    • 製程开发

第六章：美国高分子药物原料药CDMO市场：依供应来源分類的估算与趋势分析

  • 美国大型聚合物药物原料药药CDMO市场供应来源概览
  • 美国大型聚合物药物原料药CDMO市场：按供应来源分類的差异分析
  • 依供应来源划分（2021-2033 年）
  • 哺乳动物
  • 微生物
  • 其他的

第七章：美国高分子药物原料药CDMO市场：依最终用途分類的估算与趋势分析

  • 美国大型聚合物药物原料药CDMO市场：按最终用途分類的概览
  • 美国大型聚合物药物原料药CDMO市场：依最终用途分類的差异分析
  • 依最终用途划分（2021-2033 年）
  • 生技公司
  • CRO（委外研发机构）
  • 其他的

第八章 竞争情势

  • 主要参与企业的分类
    • 市场领导
    • 新兴企业
  • 市占率/估值分析（热力图分析），2024 年
  • 公司简介
    • Eurofins Scientific
    • WuXi Biologics
    • Samsung Biologics
    • Catalent, Inc.
    • Rentschler Biopharma SE
    • AGC Biologics
    • Recipharm AB
    • Siegfried Holding AG
    • Boehringer Ingelheim
    • FUJIFILM Diosynth Biotechnologies
Product Code: GVR-4-68040-748-4

Market Size & Trends:

The U.S. large molecule drug substance CDMO market size was estimated at USD 12.22 billion in 2024 and is projected to reach USD 22.56 billion by 2033, growing at a CAGR of 7.06% from 2025 to 2033. This market is experiencing significant growth due to the growing prevalence of chronic diseases, further driving the demand for biologics such as monoclonal antibodies, cell therapies, and gene therapies. Moreover, increasing outsourcing trends by pharmaceutical and biotech companies to reduce costs, access specialized expertise, and accelerate commercialization are also some of the factors contributing to the market growth.

The market is driven by the growing demand for biologics to meet the growing demand for effective therapeutic options for chronic and complex diseases. The increasing prevalence of cancer, autoimmune disorders, and metabolic diseases globally is leading to the growing demand for more advanced therapies. Biologics such as monoclonal antibodies, recombinant proteins, cell therapies, and gene therapies have emerged as prominent solutions, but their development and manufacturing processes are comparatively complex and require advanced infrastructure. Therefore, several pharmaceutical and biotechnology companies increasingly turn to contract development and manufacturing organizations to streamline operations and address the growing complexity of large molecule drug development. Thus, these factors would help companies to reduce the burden of high capital investments, avoid lengthy facility set-ups, and gain faster access to specialized expertise that ensures regulatory compliance and high-quality production.

Furthermore, growing innovation and regulatory support to create a favorable environment for CDMOs in the U.S. is also contributing to the market growth. Continuous advancements in bioprocessing technologies, such as the shift towards single-use systems and the adoption of continuous manufacturing, are making biologics production more efficient, flexible, and cost-effective. These improvements not only help manufacturers meet the rising global demand but also enable CDMOs to handle more complex pipelines, including biosimilars that are rapidly emerging as patents for blockbuster biologics expire.

U.S. Large Molecule Drug Substance CDMO 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. large molecule drug substance CDMO market report based on product, service, source, and end use.

  • Product Outlook (Revenue, USD Million, 2021 - 2033)
  • Biologics
  • Biosimilar
  • Service Outlook (Revenue, USD Million, 2021 - 2033)
  • Contract Manufacturing
    • Clinical
    • Commercial
  • Contract Development
    • Cell Line Development
    • Process Development
  • Source Outlook (Revenue, USD Million, 2021 - 2033)
  • Mammalian
  • Microbial
  • Others
  • End Use Outlook (Revenue, USD Million, 2021 - 2033)
  • Biotech Companies
  • CRO
  • Others

Table of Contents

Chapter 1. Research Methodology and Scope

  • 1.1. Market Segmentation & Scope
  • 1.2. Segment Definitions
    • 1.2.1. Product
    • 1.2.2. Service
    • 1.2.3. Source
    • 1.2.4. 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. Large Molecule Drug Substance 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
  • 3.3. Technology Landscape
  • 3.4. Pricing Model Analysis
  • 3.5. Tariff Impact Analysis
  • 3.6. Industry Analysis Tools
    • 3.6.1. Porter's Five Force Analysis
    • 3.6.2. PESTEL by SWOT Analysis

Chapter 4. U.S. Large Molecule Drug Substance CDMO Market: Product Estimates & Trend Analysis

  • 4.1. U.S. Large Molecule Drug Substance CDMO Market, By Product: Segment Dashboard
  • 4.2. U.S. Large Molecule Drug Substance CDMO Market, By Product: Movement Analysis
  • 4.3. U.S. Large Molecule Drug Substance CDMO Market Estimates & Forecasts, By Product, 2021 - 2033 (USD Million)
  • 4.4. Biologics
    • 4.4.1. Biologics Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 4.5. Biosimilar
    • 4.5.1. Biosimilar Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 5. U.S. Large Molecule Drug Substance CDMO Market: Service Estimates & Trend Analysis

  • 5.1. U.S. Large Molecule Drug Substance CDMO Market, By Service: Segment Dashboard
  • 5.2. U.S. Large Molecule Drug Substance CDMO Market, By Service: Movement Analysis
  • 5.3. U.S. Large Molecule Drug Substance CDMO Market Estimates & Forecasts, By Service, 2021 - 2033 (USD Million)
  • 5.4. Contract Manufacturing
    • 5.4.1. Contract Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 5.4.2. Clinical
      • 5.4.2.1. Clinical Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 5.4.3. Commercial
      • 5.4.3.1. Commercial Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 5.5. Contract Development
    • 5.5.1. Contract Development Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 5.5.2. Cell Line Development
      • 5.5.2.1. Cell Line Development Market Estimates and Forecasts, 2021 - 2033 (USD Million)
    • 5.5.3. Process Development
      • 5.5.3.1. Process Development Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 6. U.S. Large Molecule Drug Substance CDMO Market: Source Estimates & Trend Analysis

  • 6.1. U.S. Large Molecule Drug Substance CDMO Market, By Source: Segment Dashboard
  • 6.2. U.S. Large Molecule Drug Substance CDMO Market, By Source: Movement Analysis
  • 6.3. U.S. Large Molecule Drug Substance CDMO Market Estimates & Forecasts, By Source, 2021 - 2033 (USD Million)
  • 6.4. Mammalian
    • 6.4.1. Mammalian Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.5. Microbial
    • 6.5.1. Microbial Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.6. Others
    • 6.6.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 7. U.S. Large Molecule Drug Substance CDMO Market: End Use Estimates & Trend Analysis

  • 7.1. U.S. Large Molecule Drug Substance CDMO Market, By End Use: Segment Dashboard
  • 7.2. U.S. Large Molecule Drug Substance CDMO Market, By End Use: Movement Analysis
  • 7.3. U.S. Large Molecule Drug Substance CDMO Market Estimates & Forecasts, By End Use, 2021 - 2033 (USD Million)
  • 7.4. Biotech Companies
    • 7.4.1. Biotech Companies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.5. CRO
    • 7.5.1. CRO Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.6. Others
    • 7.6.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 8. Competitive Landscape

  • 8.1. Key Participant Categorization
    • 8.1.1. Market Leaders
    • 8.1.2. Emerging Players
  • 8.2. Market Share/Assessment Analysis, 2024 (Heat Map Analysis)
  • 8.3. Company Profiles
    • 8.3.1. Eurofins Scientific
      • 8.3.1.1. Company Overview
      • 8.3.1.2. Financial Performance
      • 8.3.1.3. Service Benchmarking
      • 8.3.1.4. Strategic Initiatives
    • 8.3.2. WuXi Biologics
      • 8.3.2.1. Company Overview
      • 8.3.2.2. Financial Performance
      • 8.3.2.3. Service Benchmarking
      • 8.3.2.4. Strategic Initiatives
    • 8.3.3. Samsung Biologics
      • 8.3.3.1. Company Overview
      • 8.3.3.2. Financial Performance
      • 8.3.3.3. Service Benchmarking
      • 8.3.3.4. Strategic Initiatives
    • 8.3.4. Catalent, Inc.
      • 8.3.4.1. Company Overview
      • 8.3.4.2. Financial Performance
      • 8.3.4.3. Service Benchmarking
      • 8.3.4.4. Strategic Initiatives
    • 8.3.5. Rentschler Biopharma SE
      • 8.3.5.1. Company Overview
      • 8.3.5.2. Financial Performance
      • 8.3.5.3. Service Benchmarking
      • 8.3.5.4. Strategic Initiatives
    • 8.3.6. AGC Biologics
      • 8.3.6.1. Company Overview
      • 8.3.6.2. Financial Performance
      • 8.3.6.3. Service Benchmarking
      • 8.3.6.4. Strategic Initiatives
    • 8.3.7. Recipharm AB
      • 8.3.7.1. Company Overview
      • 8.3.7.2. Financial Performance
      • 8.3.7.3. Service Benchmarking
      • 8.3.7.4. Strategic Initiatives
    • 8.3.8. Siegfried Holding AG
      • 8.3.8.1. Company Overview
      • 8.3.8.2. Financial Performance
      • 8.3.8.3. Service Benchmarking
      • 8.3.8.4. Strategic Initiatives
    • 8.3.9. Boehringer Ingelheim
      • 8.3.9.1. Company Overview
      • 8.3.9.2. Financial Performance
      • 8.3.9.3. Service Benchmarking
      • 8.3.9.4. Strategic Initiatives
    • 8.3.10. FUJIFILM Diosynth Biotechnologies
      • 8.3.10.1. Company Overview
      • 8.3.10.2. Financial Performance
      • 8.3.10.3. Service Benchmarking
      • 8.3.10.4. Strategic Initiatives

List of Tables

  • Table 1 List of Secondary Sources
  • Table 2 List of Abbreviations
  • Table 3 U.S. Large Molecule Drug Substance CDMO Market Estimates and Forecasts, by Product, 2021 - 2033 (USD Million)
  • Table 4 U.S. Large Molecule Drug Substance CDMO Market Estimates and Forecasts, by Service, 2021 - 2033 (USD Million)
  • Table 5 U.S. Large Molecule Drug Substance CDMO Market Estimates and Forecasts, by Source, 2021 - 2033 (USD Million)
  • Table 6 U.S. Large Molecule Drug Substance CDMO Market Estimates and Forecasts, by End Use, 2021 - 2033 (USD Million)

List of Figures

  • Fig. 1 Market research process
  • Fig. 2 Information procurement
  • Fig. 3 Primary research pattern
  • Fig. 4 Market research approaches
  • Fig. 5 Market formulation & validation
  • Fig. 6 Commodity flow analysis
  • Fig. 7 Value-chain-based sizing & forecasting
  • Fig. 8 QFD model sizing & forecasting
  • Fig. 9 Bottom-up approach
  • Fig. 10 Market snapshot
  • Fig. 11 Segment snapshot 1
  • Fig. 12 Segment snapshot 2
  • Fig. 13 Competitive landscape snapshot
  • Fig. 14 Parent market outlook, 2024 (USD Billion)
  • Fig. 15 Ancillary market outlook, 2024 (USD Billion)
  • Fig. 16 Large Molecule Drug Substance Market Dynamics
  • Fig. 17 Porter's five forces analysis
  • Fig. 18 PESTEL analysis
  • Fig. 19 U.S. Large Molecule Drug Substance CDMO Market: Product outlook and key takeaways
  • Fig. 20 U.S. Large Molecule Drug Substance CDMO Market: Product movement analysis
  • Fig. 21 Biologics Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 22 Biosimilar Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 23 U.S. Large Molecule Drug Substance CDMO Market: Service outlook and key takeaways
  • Fig. 24 U.S. Large Molecule Drug Substance CDMO Market: Service movement analysis
  • Fig. 25 Contract Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 26 Clinical Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 27 Commercial Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 28 Contract Development Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 29 Cell Line Development Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 30 Process Development Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 31 U.S. Large Molecule Drug Substance CDMO Market: Source outlook and key takeaways
  • Fig. 32 U.S. Large Molecule Drug Substance CDMO Market: Source movement analysis
  • Fig. 33 Mammalian Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 34 Microbial Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 35 Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 36 U.S. Large Molecule Drug Substance CDMO Market: End Use outlook and key takeaways
  • Fig. 37 U.S. Large Molecule Drug Substance CDMO Market: End Use movement analysis
  • Fig. 38 Biotech Companies Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 39 CRO Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 40 Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • Fig. 41 Key company categorization
  • Fig. 42 Service heat map analysis
  • Fig. 43 Strategic framework