美國大型聚合物藥物原料藥CDMO市場：市場規模、佔有率和趨勢分析（按產品、服務、供應來源、最終用途和國家/地區分類），細分市場預測（2025-2033年）

市場規模與趨勢：

2024 年美國聚合物活性原料藥CDMO 市場規模估計為 122.2 億美元，預計到 2033 年將達到 225.6 億美元，2025 年至 2033 年的複合年成長率為 7.06%。

由於慢性病盛行率不斷上升，生技藥品（如單株抗體、細胞療法、基因療法等）的需求進一步成長，該市場正經歷顯著成長。此外，製藥和生技公司為降低成本、獲取專業知識和加速商業化進程而日益成長的外包趨勢也促進了市場成長。

生技藥品市場的發展主要受生技藥品需求成長的驅動，以滿足慢性複雜疾病有效治療方案日益成長的需求。癌症、自體免疫疾病和代謝紊亂在全球範圍內的日益流行，導致對更先進療法的需求不斷成長。單株抗體、重組蛋白、細胞療法和基因療法等生物製劑已成為極具前景的解決方案，但其研發和生產過程相對複雜，需要先進的基礎設施。因此，製藥和生物技術公司正轉向合約研發受託製造廠商（CDMO），以簡化營運並應對大分子藥物研發日益複雜的挑戰。這些因素有望幫助企業減輕高額資本投資負擔，避免冗長的設施建設時間，並快速獲得確保合規性和高品質生產的專業知識。

此外，美國不斷成長的技術創新和監管支持，為合約研發生產機構（CDMO）創造了有利的環境，也促進了市場成長。生物製程技術的持續進步，例如向一次性系統的轉變和連續生產技術的應用，使生技藥品的生產更加高效、靈活且經濟。這些改進不僅有助於生產商滿足日益成長的全球需求，也使CDMO能夠處理更複雜的研發管線，包括隨著重磅生物製劑專利到期而迅速湧現的生物相似生技藥品。

目錄

第1章 分析方法和範圍

第2章執行摘要

第3章美國大型聚合物藥物原料藥藥CDMO市場：促進因素、趨勢與範圍

• 市場聯動展望
  • 母市場展望
  • 相關/附隨市場展望
• 市場動態
  • 市場促進因素分析
  • 市場限制因素分析
• 技術格局
• 定價模式分析
• 關稅影響分析
• 產業分析工具
  • 波特五力分析
  • PESTEL分析與SWOT分析

第4章：美國高分子藥物原料藥CDMO市場：依產品分類的估算與趨勢分析

• 美國大型聚合物藥物原料藥CDMO市場：產品概覽
• 美國大型聚合物藥物原料藥CDMO市場：波動分析（依產品分類）
• 依產品分類（2021-2033 年）
• 生技藥品
• 生物相似藥

第5章：美國高分子藥物原料藥CDMO市場：按服務類型分類的估算與趨勢分析

• 美國大型聚合物藥物原料藥CDMO市場：按服務分類的概覽
• 美國大型聚合物藥物原料藥CDMO市場：按服務類型分類的差異分析
• 依服務年資（2021-2033）
• 契約製造
  • 臨床
  • 商業的
• 合約開發
  • 細胞株構建
  • 製程開發

第6章：美國高分子藥物原料藥CDMO市場：依供應來源分類的估算與趨勢分析

• 美國大型聚合物藥物原料藥藥CDMO市場供應來源概覽
• 美國大型聚合物藥物原料藥CDMO市場：按供應來源分類的差異分析
• 依供應來源分類（2021-2033 年）
• 哺乳動物
• 微生物
• 其他

第7章：美國高分子藥物原料藥CDMO市場：依最終用途分類的估算與趨勢分析

• 美國大型聚合物藥物原料藥CDMO市場：按最終用途分類的概覽
• 美國大型聚合物藥物原料藥CDMO市場：依最終用途分類的差異分析
• 依最終用途分類（2021-2033 年）
• 生技公司
• CRO（委外研發機構）
• 其他

第8章 競爭情勢

• 主要參與企業的分類
  • 市場領導
  • 新興企業
• 市佔率/估值分析（熱力圖分析），2024 年
• 公司簡介
  • Eurofins Scientific
  • WuXi Biologics
  • Samsung Biologics
  • Catalent, Inc.
  • Rentschler Biopharma SE
  • AGC Biologics
  • Recipharm AB
  • Siegfried Holding AG
  • Boehringer Ingelheim
  • FUJIFILM Diosynth Biotechnologies

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