美國活性藥物原料藥CDMO 市場：市場規模、佔有率、趨勢分析（按產品、合成、藥物、應用和工作流程）、細分市場預測（2025-2033 年）

市場規模與趨勢：

美國活性藥物原料藥合約開發和受託製造廠商(CDMO) 市場規模預計在 2024 年達到 363.9 億美元，預計到 2033 年將達到 726.5 億美元，2025 年至 2033 年的複合年成長率為 8.09%。

這個市場受到許多因素的驅動：多家生物製藥公司在全球的佈局、對先進高效價活性藥物原料藥(API) 日益成長的需求，以及為降低成本和加快上市縮短時間而採用外包的趨勢。此外，由於學名藥專利到期，學名藥需求不斷成長，也為 CDMO 創造了龐大的商機。

此外，不斷成長的生技藥品和生物相似藥產品線（需要大規模發酵和細胞培養能力）也推動了市場成長。個人化醫療的轉變日益推動製藥公司尋求能夠為特定患者群體提供靈活時間安排的最高品質生產解決方案的CDMO。此外，癌症和心血管疾病等慢性疾病的發生率上升也推動了對新型藥物輸送系統空間的需求，進一步增強了對CDMO的依賴，因為CDMO不僅能夠提供技術可行性，還能提供監管專業知識。

此外，製藥公司越來越重視供應鏈最佳化和嚴格的FDA合規性，這使得美國本土的CDMO成為美國市場的重要合作夥伴。透過外包生產，公司可以控制成本、保護智慧財產權，並且比外包供應商更快完成監管核准流程。此外，美國在綠色化學、永續製造和環保實踐方面的投資不斷增加，也推動了全球製藥公司對美國CDMO的需求。

目錄

第1章調查方法與範圍

第2章執行摘要

第 3 章美國原料藥CDMO 市場：變數、趨勢和範圍

• 市場體系展望
• 市場動態
• 技術格局
• 定價模式分析
• 法律規範
• 供應鏈分析
• 關稅影響分析
• 市場分析工具

第 4 章：美國活性藥物原料藥CDMO 市場：按產品估算和趨勢分析

• 細分儀表板
• 美國活性藥物原料藥CDMO 市場：依產品進行波動分析
• 美國活性藥物原料藥CDMO 市場規模與趨勢分析（按產品）（2021-2033 年）
• 常規原料藥（常規 API）
• 高效原料藥（HP-API）
• 生技藥品

第5章：美國活性藥物原料藥CDMO 市場：綜合估算與趨勢分析

• 細分儀表板
• 美國活性藥物原料藥CDMO 市場：依合成進行變異分析
• 美國活性藥物原料藥CDMO 市場規模與趨勢分析（以合成方式）（2021-2033 年）
• 合成
• 生物技術

第6章：美國活性藥物原料藥CDMO 市場：依藥物的估計與趨勢分析

• 細分儀表板
• 美國活性藥物原料藥CDMO 市場：依藥物進行波動分析
• 美國活性藥物原料藥CDMO 市場規模及趨勢分析（按藥物類型）（2021-2033 年）
• 創新的
• 學名藥

第 7 章：美國活性藥物原料藥CDMO 市場：按應用估算和趨勢分析

• 細分儀表板
• 美國活性藥物原料藥CDMO 市場：依應用進行波動分析
• 美國活性藥物原料藥CDMO 市場規模與趨勢分析（按應用）（2021-2033 年）
• 腫瘤學
• 荷爾蒙
• 青光眼
• 心血管疾病
• 糖尿病
• 其他

第 8 章：美國活性藥物原料藥CDMO 市場：依工作流程估算與趨勢分析

• 細分儀表板
• 美國活性藥物原料藥CDMO 市場：依工作流程進行變異分析
• 美國活性藥物原料藥CDMO 市場規模與趨勢分析（按工作流程）（2021-2033 年）
• 臨床
• 上市

第9章 競爭態勢

• 公司分類
  • 市場領導
  • 新興企業
• 各公司市佔率/估值分析（2024年）
• 公司簡介
  • 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