미국의 저분자 의약품 CDMO 시장 규모, 점유율, 동향 분석 보고서 : 의약품 유형별, 제품별, 용도별, 부문별 예측(2025-2033년)

U.S. Small Molecule CDMO Market Summary

The U.S. small molecule CDMO market size was estimated at USD 26.85 billion in 2024 and is projected to reach USD 47.38 billion by 2033, growing at a CAGR of 6.68% from 2025 to 2033. The growth of the market is due to the rising demand for outsourcing across the pharmaceutical value chain. Pharmaceutical companies, especially small to mid-sized firms and virtual biotech's, increasingly rely on CDMOs to reduce time-to-market, optimize R&D expenditure, and access specialized capabilities in formulation, process development, and regulatory compliance.

In addition, consolidation in the pharmaceutical industry and growing cost pressures have pushed both innovator and generic drug companies to streamline internal operations and focus on core competencies. This has expanded opportunities for U.S.-based CDMOs to support not only domestic but also clients seeking quality and compliance with stringent FDA regulations. Increasing investments in capacity expansion, continuous manufacturing, and green chemistry processes by leading CDMOs are also contributing to long-term growth.

The U.S. small molecule CDMO market is mainly driven by the ongoing dominance of small molecule drugs in FDA approvals and active pipelines. In 2023, over 60% of the new molecular entities (NMEs) approved by the U.S. FDA were small molecules, including drugs like Ogsiveo (for desmoid tumors) and Zurzuvae (for postpartum depression). This steady trend creates a significant and recurring demand for CDMOs that can provide comprehensive services such as formulation, scale-up, and regulatory batch manufacturing. Small and mid-sized biotech companies, which make up most of the early-stage R&D in the U.S., often lack in-house manufacturing capabilities and instead depend on CDMOs for both preclinical and commercial production. The need to reduce time-to-market for high-value therapeutics-especially in fields like oncology, rare diseases, and CNS disorders-further speeds up outsourcing to flexible, U.S.-based CDMOs with Phase I-III support capabilities.

Moreover, the strategic investment by CDMO companies to expand their U.S. manufacturing and development footprint, catering to both domestic innovators and foreign biopharma looking for U.S. market access. For instance, Cambrex invested over $50 million in its High Point, North Carolina facility to expand process development and API manufacturing capacity for small molecules. Similarly, Thermo Fisher Scientific has been expanding its U.S. capacity through its acquisition of Patheon and subsequent upgrades across its U.S. network. There's also a strong regulatory and logistics advantage for U.S.-based CDMOs, as manufacturing within the U.S. reduces supply chain complexity and supports compliance with FDA current Good Manufacturing Practices (cGMP).

U.S. Small Molecule 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. small molecule CDMO market report based on product, drug type, application and region.

• Product Outlook (Revenue, USD Million, 2021 - 2033)
• Active Pharmaceutical Ingredients (API)
• Finished Drug Products
• Drug Type Outlook (Revenue, USD Million, 2021 - 2033)
• Innovators
• Generics
• Application Outlook (Revenue, USD Million, 2021 - 2033)
• Oncology
• Cardiovascular Disease
• Central Nervous System (CNS) Conditions
• Autoimmune/Inflammation
• 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. Small Molecule CDMO Market: Variables, Trends, & Scope

• 3.1. Market Lineage Outlook
  • 3.1.1. Parent Market Outlook
  • 3.1.2. Ancillary Market Outlook
• 3.2. U.S. Small Molecule CDMO 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. U.S. Small Molecule CDMO Market: Analysis Tools
  • 3.5.1. Porter's Five Forces Analysis
  • 3.5.2. PESTEL Analysis

Chapter 4. U.S. Small Molecule CDMO Market: Product Estimates & Trend Analysis

• 4.1. Segment Dashboard
• 4.2. U.S. Small Molecule CDMO Market Product Movement Analysis
• 4.3. U.S. Small Molecule CDMO Market Size & Trend Analysis, by Product, 2021 to 2033 (USD Million)
• 4.4. Active Pharmaceutical Ingredients (API)
  • 4.4.1. Active Pharmaceutical Ingredients (API) Market Estimates and Forecasts, 2021 - 2033 (USD million)
• 4.5. Finished Drug Products
  • 4.5.1. Finished Drug Products Market Estimates and Forecasts, 2021 - 2033 (USD million)

Chapter 5. U.S. Small Molecule CDMO Market: Drug Type Estimates & Trend Analysis

• 5.1. Segment Dashboard
• 5.2. U.S. Small Molecule CDMO Market Drug Type Movement Analysis
• 5.3. U.S. Small Molecule CDMO Market Size & Trend Analysis, by Drug Type, 2021 to 2033 (USD Million)
• 5.4. Innovators
  • 5.4.1. Innovators Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.5. Generics
  • 5.5.1. Generics Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 6. U.S. Small Molecule CDMO Market: Application Estimates & Trend Analysis

• 6.1. Segment Dashboard
• 6.2. U.S. Small Molecule CDMO Market Application Movement Analysis
• 6.3. U.S. Small Molecule CDMO Market Size & Trend Analysis, by Application, 2021 to 2033 (USD Million)
• 6.4. Oncology
  • 6.4.1. Oncology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.5. Cardiovascular Disease
  • 6.5.1. Cardiovascular Disease Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.6. Central Nervous System (CNS) Conditions
  • 6.6.1. Central Nervous System (CNS) Conditions Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.7. Autoimmune/Inflammation
  • 6.7.1. Autoimmune/Inflammation Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.8. Others
  • 6.8.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 7. U.S. Small Molecule CDMO Market: Regional Estimates & Trend Analysis by Product, Drug Type, Application

• 7.1. Regional Market Dashboard
• 7.2. Global Regional Market Snapshot
• 7.3. Market Size, & Forecasts, Trend Analysis, 2021 to 2033
• 7.4. North America
  • 7.4.1. North America Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.4.2. U.S.
    • 7.4.2.1. Key Country Dynamics
    • 7.4.2.2. Competitive Scenario
    • 7.4.2.3. Regulatory Framework
    • 7.4.2.4. U.S. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.4.3. Canada
    • 7.4.3.1. Key Country Dynamics
    • 7.4.3.2. Competitive Scenario
    • 7.4.3.3. Regulatory Framework
    • 7.4.3.4. Canada Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.4.4. Mexico
    • 7.4.4.1. Key Country Dynamics
    • 7.4.4.2. Competitive Scenario
    • 7.4.4.3. Regulatory Framework
    • 7.4.4.4. Mexico Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 7.5. Europe
  • 7.5.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.5.2. UK
    • 7.5.2.1. Key Country Dynamics
    • 7.5.2.2. Competitive Scenario
    • 7.5.2.3. Regulatory Framework
    • 7.5.2.4. Europe Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.5.3. Germany
    • 7.5.3.1. Key Country Dynamics
    • 7.5.3.2. Competitive Scenario
    • 7.5.3.3. Regulatory Framework
    • 7.5.3.4. Germany Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.5.4. France
    • 7.5.4.1. Key Country Dynamics
    • 7.5.4.2. Competitive Scenario
    • 7.5.4.3. Regulatory Framework
    • 7.5.4.4. France Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.5.5. Italy
    • 7.5.5.1. Key Country Dynamics
    • 7.5.5.2. Competitive Scenario
    • 7.5.5.3. Regulatory Framework
    • 7.5.5.4. Italy Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.5.6. Spain
    • 7.5.6.1. Key Country Dynamics
    • 7.5.6.2. Competitive Scenario
    • 7.5.6.3. Regulatory Framework
    • 7.5.6.4. Spain Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.5.7. Denmark
    • 7.5.7.1. Key Country Dynamics
    • 7.5.7.2. Competitive Scenario
    • 7.5.7.3. Regulatory Framework
    • 7.5.7.4. Denmark Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.5.8. Sweden
    • 7.5.8.1. Key Country Dynamics
    • 7.5.8.2. Competitive Scenario
    • 7.5.8.3. Regulatory Framework
    • 7.5.8.4. Sweden Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.5.9. Norway
    • 7.5.9.1. Key Country Dynamics
    • 7.5.9.2. Competitive Scenario
    • 7.5.9.3. Regulatory Framework
    • 7.5.9.4. Norway Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 7.6. Asia Pacific
  • 7.6.1. Asia Pacific Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.6.2. Japan
    • 7.6.2.1. Key Country Dynamics
    • 7.6.2.2. Competitive Scenario
    • 7.6.2.3. Regulatory Framework
    • 7.6.2.4. Japan Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.6.3. China
    • 7.6.3.1. Key Country Dynamics
    • 7.6.3.2. Competitive Scenario
    • 7.6.3.3. Regulatory Framework
    • 7.6.3.4. China Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.6.4. India
    • 7.6.4.1. Key Country Dynamics
    • 7.6.4.2. Competitive Scenario
    • 7.6.4.3. Regulatory Framework
    • 7.6.4.4. India Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.6.5. Australia
    • 7.6.5.1. Key Country Dynamics
    • 7.6.5.2. Competitive Scenario
    • 7.6.5.3. Regulatory Framework
    • 7.6.5.4. Australia Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.6.6. South Korea
    • 7.6.6.1. Key Country Dynamics
    • 7.6.6.2. Competitive Scenario
    • 7.6.6.3. Regulatory Framework
    • 7.6.6.4. South Korea Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.6.7. Thailand
    • 7.6.7.1. Key Country Dynamics
    • 7.6.7.2. Competitive Scenario
    • 7.6.7.3. Regulatory Framework
    • 7.6.7.4. Thailand Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 7.7. Latin America
  • 7.7.1. Latin America Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.7.2. Brazil
    • 7.7.2.1. Key Country Dynamics
    • 7.7.2.2. Competitive Scenario
    • 7.7.2.3. Regulatory Framework
    • 7.7.2.4. Brazil Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.7.3. Argentina
    • 7.7.3.1. Key Country Dynamics
    • 7.7.3.2. Competitive Scenario
    • 7.7.3.3. Regulatory Framework
    • 7.7.3.4. Argentina Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 7.8. MEA
  • 7.8.1. MEA Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.8.2. South Africa
    • 7.8.2.1. Key Country Dynamics
    • 7.8.2.2. Competitive Scenario
    • 7.8.2.3. Regulatory Framework
    • 7.8.2.4. South Africa Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.8.3. Saudi Arabia
    • 7.8.3.1. Key Country Dynamics
    • 7.8.3.2. Competitive Scenario
    • 7.8.3.3. Regulatory Framework
    • 7.8.3.4. Saudi Arabia Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.8.4. UAE
    • 7.8.4.1. Key Country Dynamics
    • 7.8.4.2. Competitive Scenario
    • 7.8.4.3. Regulatory Framework
    • 7.8.4.4. UAE Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.8.5. Kuwait
    • 7.8.5.1. Key Country Dynamics
    • 7.8.5.2. Competitive Scenario
    • 7.8.5.3. Regulatory Framework
    • 7.8.5.4. Kuwait Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 8. Competitive Landscape

• 8.1. Company Categorization
• 8.2. U.S. Small Molecule CDMO Market Share Analysis, 2024
• 8.3. Company Profiles
  • 8.3.1. Lonza, Catalent, Inc.
    • 8.3.1.1. Company overview
    • 8.3.1.2. Financial performance
    • 8.3.1.3. Product benchmarking
    • 8.3.1.4. Strategic initiatives
  • 8.3.2. Thermo Fisher Scientific Inc.
    • 8.3.2.1. Company overview
    • 8.3.2.2. Financial performance
    • 8.3.2.3. Product benchmarking
    • 8.3.2.4. Strategic initiatives
  • 8.3.3. Cambrex Corporation
    • 8.3.3.1. Company overview
    • 8.3.3.2. Financial performance
    • 8.3.3.3. Product benchmarking
    • 8.3.3.4. Strategic initiatives
  • 8.3.4. Bellen Chemistry
    • 8.3.4.1. Company overview
    • 8.3.4.2. Financial performance
    • 8.3.4.3. Product benchmarking
    • 8.3.4.4. Strategic initiatives
  • 8.3.5. Siegfried Holding AG
    • 8.3.5.1. Company overview
    • 8.3.5.2. Financial performance
    • 8.3.5.3. Product benchmarking
    • 8.3.5.4. Strategic initiatives
  • 8.3.6. Recipharm AB
    • 8.3.6.1. Company overview
    • 8.3.6.2. Financial performance
    • 8.3.6.3. Product benchmarking
    • 8.3.6.4. Strategic initiatives
  • 8.3.7. Eurofins Scientific
    • 8.3.7.1. Company overview
    • 8.3.7.2. Financial performance
    • 8.3.7.3. Product benchmarking
    • 8.3.7.4. Strategic initiatives
  • 8.3.8. Aurigene Pharmaceutical Services Ltd
    • 8.3.8.1. Company overview
    • 8.3.8.2. Financial performance
    • 8.3.8.3. Product benchmarking
    • 8.3.8.4. Strategic initiatives
  • 8.3.9. CordenPharma International
    • 8.3.9.1. Company overview
    • 8.3.9.2. Financial performance
    • 8.3.9.3. Product benchmarking
    • 8.3.9.4. Strategic initiatives