(MENAFN- GlobeNewsWire - Nasdaq) Key opportunities in the U.S. small molecule CDMO market include catering to increased outsourcing demands from small to mid-sized biotechs, supporting FDA-approved small molecule drugs, and capitalizing on strong U.S.-based regulatory compliance. Investments in capacity expansion and green chemistry further enhance growth potential.

Dublin, Nov. 21, 2025 (GLOBE NEWSWIRE) -- The "U.S. Small Molecule CDMO Market Size, Share & Trends Analysis Report by Drug Type (Generics, Innovators), by Product (APIs, Finished Drug Products), by Application (Oncology, CVD, CNS Conditions), and Segment Forecasts, 2025-2033" report has been added to ResearchAndMarkets's offering.
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).

Why should you buy this report?

• Comprehensive Market Analysis: Gain detailed insights into the industry across major regions and segments.
• Competitive Landscape: Explore the market presence of key players.
• Future Trends: Discover the pivotal trends and drivers shaping the future of the market.
• Actionable Recommendations: Utilize insights to uncover new revenue streams and guide strategic business decisions.

This report addresses:

• Market intelligence to enable effective decision-making
• Market estimates and forecasts from 2018 to 2030
• Growth opportunities and trend analyses
• Segmental and regional revenue forecasts for market assessment
• Competition strategy and market share analysis
• Product innovation listings for you to stay ahead of the curve
• COVID-19's impact and how to sustain in these fast-evolving markets

Key Attributes:

Report Attribute	Details
No. of Pages	120
Forecast Period	2024 - 2033
Estimated Market Value (USD) in 2024	$26.85 Billion
Forecasted Market Value (USD) by 2033	$47.38 Billion
Compound Annual Growth Rate	6.6%
Regions Covered	United States

Key Topics Covered:
Chapter 1. Methodology and Scope
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)
4.5. Finished Drug Products
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
5.5. Generics
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
6.5. Cardiovascular Disease
6.6. Central Nervous System (CNS) Conditions
6.7. Autoimmune/Inflammation
6.8. Others
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
Chapter 8. Competitive Landscape
8.1. Company Categorization
8.2. U.S. Small Molecule CDMO Market Share Analysis, 2024
8.3. Company Profiles

• Lonza, Catalent, Inc
• Thermo Fisher Scientific Inc.
• Cambrex Corporation
• Bellen Chemistry
• Siegfried Holding AG
• Recipharm AB
• Eurofins Scientific
• Aurigene Pharmaceutical Services Ltd.
• CordenPharma International

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• U.S. Small Molecule CDMO Market

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