美国活性药物原料药CDMO 市场：市场规模、份额、趋势分析（按产品、合成、药物、应用和工作流程）、细分市场预测（2025-2033 年）

市场规模与趋势：

美国活性药物原料药合约开发和受託製造厂商(CDMO) 市场规模预计在 2024 年达到 363.9 亿美元，预计到 2033 年将达到 726.5 亿美元，2025 年至 2033 年的复合年增长率为 8.09%。

这个市场受到许多因素的驱动：多家生物製药公司在全球的布局、对先进高效价活性药物原料药(API) 日益增长的需求，以及为降低成本和加快上市缩短时间而采用外包的趋势。此外，由于学名药专利到期，仿製药需求不断成长，也为 CDMO 创造了庞大的商机。

此外，不断增长的生技药品和生物相似药产品线（需要大规模发酵和细胞培养能力）也推动了市场成长。个人化医疗的转变日益推动製药公司寻求能够为特定患者群体提供灵活时间安排的最高品质生产解决方案的CDMO。此外，癌症和心血管疾病等慢性疾病的发生率上升也推动了对新型药物输送系统空间的需求，进一步增强了对CDMO的依赖，因为CDMO不仅能够提供技术可行性，还能提供监管专业知识。

此外，製药公司越来越重视供应链优化和严格的FDA合规性，这使得美国本土的CDMO成为美国市场的重要合作伙伴。透过外包生产，公司可以控製成本、保护智慧财产权，并且比外包供应商更快完成监管核准流程。此外，美国在绿色化学、永续製造和环保实践方面的投资不断增加，也推动了全球製药公司对美国CDMO的需求。

目录

第一章调查方法与范围

第二章执行摘要

第 3 章美国原料药CDMO 市场：变数、趋势和范围

• 市场体系展望
• 市场动态
• 技术格局
• 定价模式分析
• 法律规范
• 供应链分析
• 关税影响分析
• 市场分析工具

第 4 章：美国活性药物原料药CDMO 市场：按产品估算和趋势分析

• 细分仪表板
• 美国活性药物原料药CDMO 市场：依产品进行波动分析
• 美国活性药物原料药CDMO 市场规模与趋势分析（按产品）（2021-2033 年）
• 常规原料药（常规 API）
• 高效原料药（HP-API）
• 生技药品

第五章：美国活性药物原料药CDMO 市场：综合估算与趋势分析

• 细分仪表板
• 美国活性药物原料药CDMO 市场：依合成进行变异分析
• 美国活性药物原料药CDMO 市场规模与趋势分析（以合成方式）（2021-2033 年）
• 合成
• 生物技术

第六章：美国活性药物原料药CDMO 市场：依药物的估计与趋势分析

• 细分仪表板
• 美国活性药物原料药CDMO 市场：依药物进行波动分析
• 美国活性药物原料药CDMO 市场规模及趋势分析（按药物类型）（2021-2033 年）
• 创新的
• 学名药

第 7 章：美国活性药物原料药CDMO 市场：按应用估算和趋势分析

• 细分仪表板
• 美国活性药物原料药CDMO 市场：依应用进行波动分析
• 美国活性药物原料药CDMO 市场规模与趋势分析（按应用）（2021-2033 年）
• 肿瘤学
• 荷尔蒙
• 青光眼
• 心血管疾病
• 糖尿病
• 其他的

第 8 章：美国活性药物原料药CDMO 市场：依工作流程估算与趋势分析

• 细分仪表板
• 美国活性药物原料药CDMO 市场：依工作流程进行变异分析
• 美国活性药物原料药CDMO 市场规模与趋势分析（按工作流程）（2021-2033 年）
• 临床
• 上市

第九章 竞争态势

• 公司分类
  • 市场领导
  • 新兴企业
• 各公司市占率/估值分析（2024年）
• 公司简介
  • Cambrex Corporation
  • Recipharm AB
  • Thermo Fisher Scientific Inc.
  • CordenPharma International
  • Samsung Biologics
  • Lonza
  • Catalent, Inc.
  • Siegfried Holding AG
  • Piramal Pharma Solutions
  • Boehringer Ingelheim International GmbH

Market Size & Trends:

The U.S. active pharmaceutical ingredient CDMO market size was estimated at USD 36.39 billion in 2024 and is projected to reach USD 72.65 billion by 2033, growing at a CAGR of 8.09% from 2025 to 2033. The market is propelled by the presence of several biopharmaceutical companies globally, the growing demand for advanced and high-potency active pharmaceutical ingredient (APIs), and the trend of outsourcing to lower costs and speed time to market. Moreover, the increasing demand for generics, fueled by the patent expiry of blockbuster drugs, is also creating significant opportunities for the CDMOs.

In addition, the growing biologics and biosimilars pipeline that requires capabilities in large-scale fermentation and cell culture is also driving the market growth. A shift toward personalization of medicine has driven pharmaceutical companies to increasingly seek out CDMOs capable of delivering flexibly scheduled, highest quality manufacturing solutions for niche patient populations. Moreover, the increasing incidence of chronic diseases such as cancer and cardiovascular conditions is driving demand for space in new drug delivery systems, further increasing dependence on CDMOs that can not only provide technical feasibility but also regulatory expertise.

Furthermore, pharmaceutical companies increasingly prioritize optimized supply chains and strict FDA compliance, making domestic CDMOs a key partner in the U.S. market. Outsourcing production allows businesses to control expenses, safeguard intellectual property, and get through the regulatory approval process more quickly than if they use offshore providers. Furthermore, increased investment from the U.S. in green chemistry, sustainable manufacturing, and eco-friendly practices drives global pharma players' demand for U.S.-based CDMOs.

U.S. Active Pharmaceutical Ingredient 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. active pharmaceutical ingredient CDMO market report based on product, synthesis, drug, application, and workflow.

• Product Outlook (Revenue, USD Million, 2021 - 2033)
• Traditional Active Pharmaceutical Ingredient (Traditional API)
• Highly Potent Active Pharmaceutical Ingredient (HP-API)
• Biologics
• Synthesis Outlook (Revenue, USD Million, 2021 - 2033)
• Synthetic
• Biotech
• Drug Outlook (Revenue, USD Million, 2021 - 2033)
• Innovative
• Generics
• Workflow Outlook (Revenue, USD Million, 2021 - 2033)
• Clinical
• Commercial
• Application Outlook (Revenue, USD Million, 2021 - 2033)
• Oncology
• Hormonal
• Glaucoma
• Cardiovascular disease
• Diabetes
• Others

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation and Scope
• 1.2. Market Definitions
• 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 (Model 1)
  • 1.7.2. Value chain based analysis (Model 2)
  • 1.7.3. Multivariate Analysis (Model 3)
• 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 Snapshot
• 2.3. Competitive Landscape Snapshot

Chapter 3. U.S. Active Pharmaceutical Ingredient CDMO Market: Variables, Trends, & Scope

• 3.1. Market Lineage Outlook
  • 3.1.1. Parent Market Outlook
  • 3.1.2. Ancillary Market Outlook
• 3.2. Market Dynamics
  • 3.2.1. Market Driver Impact Analysis
  • 3.2.2. Market Restraint Analysis
• 3.3. Technological Landscape
• 3.4. Pricing Model Analysis
• 3.5. Regulatory Framework
• 3.6. Supply Chain Analysis
• 3.7. Tariff Impact Analysis
• 3.8. Market Analysis Tools
  • 3.8.1. Porter's Five Forces Analysis
  • 3.8.2. PESTEL by SWOT Analysis

Chapter 4. U.S. Active Pharmaceutical Ingredient CDMO Market: Product Estimates & Trend Analysis

• 4.1. Segment Dashboard
• 4.2. U.S. Active Pharmaceutical Ingredient CDMO Market Product Movement Analysis
• 4.3. U.S. Active Pharmaceutical Ingredient CDMO Market Size & Trend Analysis, by Product, 2021 to 2033 (USD Million)
• 4.4. Traditional Active Pharmaceutical Ingredient (Traditional API)
  • 4.4.1. Traditional Active Pharmaceutical Ingredient (Traditional API) Market Estimates and Forecasts, 2021 - 2033 (USD million)
• 4.5. Highly Potent Active Pharmaceutical Ingredient (HP-API)
  • 4.5.1. Highly Potent Active Pharmaceutical Ingredient (HP-API) Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.6. Biologics
  • 4.6.1. Biologics Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 5. U.S. Active Pharmaceutical Ingredient CDMO Market: Synthesis Estimates & Trend Analysis

• 5.1. Segment Dashboard
• 5.2. U.S. Active Pharmaceutical Ingredient CDMO Market Synthesis Movement Analysis
• 5.3. U.S. Active Pharmaceutical Ingredient CDMO Market Size & Trend Analysis, by Synthesis, 2021 to 2033 (USD Million)
• 5.4. Synthetic
  • 5.4.1. Synthetic Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.5. Biotech
  • 5.5.1. Biotech Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 6. U.S. Active Pharmaceutical Ingredient CDMO Market: Drug Estimates & Trend Analysis

• 6.1. Segment Dashboard
• 6.2. U.S. Active Pharmaceutical Ingredient CDMO Market Drug Movement Analysis
• 6.3. U.S. Active Pharmaceutical Ingredient CDMO Market Size & Trend Analysis, by Drug, 2021 to 2033 (USD Million)
• 6.4. Innovative
  • 6.4.1. Innovative Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.5. Generics
  • 6.5.1. Generics Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 7. U.S. Active Pharmaceutical Ingredient CDMO Market: Application Estimates & Trend Analysis

• 7.1. Segment Dashboard
• 7.2. U.S. Active Pharmaceutical Ingredient CDMO Market Application Movement Analysis
• 7.3. U.S. Active Pharmaceutical Ingredient CDMO Market Size & Trend Analysis, by Application, 2021 to 2033 (USD Million)
• 7.4. Oncology
  • 7.4.1. Oncology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 7.5. Hormonal
  • 7.5.1. Hormonal Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 7.6. Glaucoma
  • 7.6.1. Glaucoma Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 7.7. Cardiovascular disease
  • 7.7.1. Cardiovascular disease Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 7.8. Diabetes
  • 7.8.1. Diabetes Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 7.9. Others
  • 7.9.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 8. U.S. Active Pharmaceutical Ingredient CDMO Market: Workflow Estimates & Trend Analysis

• 8.1. Segment Dashboard
• 8.2. U.S. Active Pharmaceutical Ingredient CDMO Market Workflow Movement Analysis
• 8.3. U.S. Active Pharmaceutical Ingredient CDMO Market Size & Trend Analysis, by Workflow, 2021 to 2033 (USD Million)
• 8.4. Clinical
  • 8.4.1. Clinical Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 8.5. Commercial
  • 8.5.1. Commercial Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 9. Competitive Landscape

• 9.1. Company Categorization
  • 9.1.1. Market Leaders
  • 9.1.2. Emerging Players
• 9.2. Company Market Share/Assessment Analysis, 2024
• 9.3. Company Profiles
  • 9.3.1. Cambrex Corporation
    • 9.3.1.1. Company Overview
    • 9.3.1.2. Financial Performance
    • 9.3.1.3. Product/Service Benchmarking
    • 9.3.1.4. Strategic Initiatives
  • 9.3.2. Recipharm AB
    • 9.3.2.1. Company Overview
    • 9.3.2.2. Financial Performance
    • 9.3.2.3. Product/Service Benchmarking
    • 9.3.2.4. Strategic Initiatives
  • 9.3.3. Thermo Fisher Scientific Inc.
    • 9.3.3.1. Company Overview
    • 9.3.3.2. Financial Performance
    • 9.3.3.3. Product/Service Benchmarking
    • 9.3.3.4. Strategic Initiatives
  • 9.3.4. CordenPharma International
    • 9.3.4.1. Company Overview
    • 9.3.4.2. Financial Performance
    • 9.3.4.3. Product/Service Benchmarking
    • 9.3.4.4. Strategic Initiatives
  • 9.3.5. Samsung Biologics
    • 9.3.5.1. Company Overview
    • 9.3.5.2. Financial Performance
    • 9.3.5.3. Product/Service Benchmarking
    • 9.3.5.4. Strategic Initiatives
  • 9.3.6. Lonza
    • 9.3.6.1. Company Overview
    • 9.3.6.2. Financial Performance
    • 9.3.6.3. Product/Service Benchmarking
    • 9.3.6.4. Strategic Initiatives
  • 9.3.7. Catalent, Inc.
    • 9.3.7.1. Company Overview
    • 9.3.7.2. Financial Performance
    • 9.3.7.3. Product/Service Benchmarking
    • 9.3.7.4. Strategic Initiatives
  • 9.3.8. Siegfried Holding AG
    • 9.3.8.1. Company Overview
    • 9.3.8.2. Financial Performance
    • 9.3.8.3. Product/Service Benchmarking
    • 9.3.8.4. Strategic Initiatives
  • 9.3.9. Piramal Pharma Solutions
    • 9.3.9.1. Company Overview
    • 9.3.9.2. Financial Performance
    • 9.3.9.3. Product/Service Benchmarking
    • 9.3.9.4. Strategic Initiatives
  • 9.3.10. Boehringer Ingelheim International GmbH
    • 9.3.10.1. Company Overview
    • 9.3.10.2. Financial Performance
    • 9.3.10.3. Product/Service Benchmarking
    • 9.3.10.4. Strategic Initiatives

List of Tables

• Table 1 List of abbreviation
• Table 2 U.S. Active Pharmaceutical Ingredient CDMO Market Estimates and Forecasts, by Product, 2021 - 2033 (USD Million)
• Table 3 U.S. Active Pharmaceutical Ingredient CDMO Market Estimates and Forecasts, by Synthesis, 2021 - 2033 (USD Million)
• Table 4 U.S. Active Pharmaceutical Ingredient CDMO Market Estimates and Forecasts, by Drugs, 2021 - 2033 (USD Million)
• Table 5 U.S. Active Pharmaceutical Ingredient CDMO Market Estimates and Forecasts, by Application, 2021 - 2033 (USD Million)
• Table 6 U.S. Active Pharmaceutical Ingredient CDMO Market Estimates and Forecasts, by Workflow, 2021 - 2033 (USD Million)

List of Figures

• Fig. 1 US Active Pharmaceutical Ingredient CDMO Market segmentation
• Fig. 2 Market research process
• Fig. 3 Information procurement
• Fig. 4 Primary research pattern
• Fig. 5 Market research approaches
• Fig. 6 Market formulation & validation
• Fig. 7 Commodity flow analysis
• Fig. 8 Value-Chain-Based Sizing & Forecasting
• Fig. 9 QFD model sizing & forecasting
• Fig. 10 Bottom-up approach
• Fig. 11 Market snapshot
• Fig. 12 Segment snapshot
• Fig. 13 Segment snapshot
• Fig. 14 Segment snapshot
• Fig. 15 Competitive landscape snapshot
• Fig. 16 Parent market outlook, 2024 (USD Million)
• Fig. 17 Ancillary market outlook, 2024 (USD Million)
• Fig. 18 US Active Pharmaceutical Ingredient CDMO Market dynamics
• Fig. 19 Total R&D drug pipeline size, 2021-2024
• Fig. 20 Total drug pipeline by development phase, 2024
• Fig. 21 Porter's five forces analysis
• Fig. 22 PESTEL analysis
• Fig. 23 US Active Pharmaceutical Ingredient CDMO Market Product outlook: Segment dashboard
• Fig. 24 US Active Pharmaceutical Ingredient CDMO Market, by Product segment: Market share, 2025 & 2033
• Fig. 25 Traditional Active Pharmaceutical Ingredient (Traditional API) market estimates and forecasts, 2021 - 2033 (USD Million)
• Fig. 26 Highly Potent Active Pharmaceutical Ingredient (HP-API) market estimates and forecasts, 2021 - 2033 (USD Million)
• Fig. 27 Biologics market estimates and forecasts, 2021 - 2033 (USD Million)
• Fig. 28 Others market estimates and forecasts, 2021 - 2033 (USD Million)
• Fig. 29 US Active Pharmaceutical Ingredient CDMO Market Synthesis outlook: Segment dashboard
• Fig. 30 Active Pharmaceutical Ingredient CDMO Market, by Synthesis segment: Market share, 2025 & 2033
• Fig. 31 Synthetic market estimates and forecasts, 2021 - 2033 (USD Million)
• Fig. 32 Biotech market estimates and forecasts, 2021 - 2033 (USD Million)
• Fig. 33 US Active Pharmaceutical Ingredient CDMO Market Drug outlook: Segment dashboard
• Fig. 34 Active Pharmaceutical Ingredient CDMO Market, by Drug segment: Market share, 2025 & 2033
• Fig. 35 Innovative market estimates and forecasts, 2021 - 2033 (USD Million)
• Fig. 36 Generics market estimates and forecasts, 2021 - 2033 (USD Million)
• Fig. 37 US Active Pharmaceutical Ingredient CDMO Market Application outlook: Segment dashboard
• Fig. 38 Active Pharmaceutical Ingredient CDMO Market, by Application segment: Market share, 2025 & 2033
• Fig. 39 Oncology market estimates and forecasts, 2021 - 2033 (USD Million)
• Fig. 40 Hormonal market estimates and forecasts, 2021 - 2033 (USD Million)
• Fig. 41 Glaucoma market estimates and forecasts, 2021 - 2033 (USD Million)
• Fig. 42 Cardiovascular disease market estimates and forecasts, 2021 - 2033 (USD Million)
• Fig. 43 Diabetes market estimates and forecasts, 2021 - 2033 (USD Million)
• Fig. 44 Others market estimates and forecasts, 2021 - 2033 (USD Million)
• Fig. 45 US Active Pharmaceutical Ingredient CDMO Market Workflow outlook: Segment dashboard
• Fig. 46 Active Pharmaceutical Ingredient CDMO Market, by Workflow segment: Market share, 2025 & 2033
• Fig. 47 Clinical market estimates and forecasts, 2021 - 2033 (USD Million)
• Fig. 48 Commercial market estimates and forecasts, 2021 - 2033 (USD Million)
• Fig. 49 Market participant categorization
• Fig. 50 Heat map analysis