Summary

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

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Table of Contents

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