U.S. Small Molecule CDMO Market Size Worth USD 49.82 Billion by 2034 | CAGR: 6.4%

The U.S. small molecule CDMO market size is expected to reach USD 49.82 billion by 2034, according to a new study by Polaris Market Research. The report “U.S. Small Molecule CDMO Market Size, Share, Trend, Industry Analysis Report By Drug Type (Innovators, Generics), By Product, By Application, By Region – Market Forecast, 2025–2034” gives a detailed insight into current market dynamics and provides analysis on future market growth.

The U.S. small molecule CDMO market encompasses contract development and manufacturing services dedicated to producing small molecule drugs, supporting pharmaceutical companies across the drug lifecycle from early-stage development to commercial manufacturing. The market is driven by a rising shift toward outsourcing to reduce operational costs, accelerate time-to-market, and access specialized capabilities, particularly in complex chemistries and high-potency active pharmaceutical ingredients. Growing demand for targeted therapies, along with the expansion of pipelines in oncology, cardiovascular, and central nervous system disorders, is fueling the need for flexible and scalable manufacturing solutions. Industry trends indicate a strong move toward continuous manufacturing, advanced analytical services, and integration of digital platforms for process optimization and quality assurance. Increasing investments in high-containment facilities and specialized formulation technologies are enhancing the ability to handle niche and high-value products.

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Opportunities lie in supporting innovators developing novel therapies, as well as generic manufacturers seeking cost-efficient production solutions amid patent expirations. Expansion into highly regulated and specialized segments such as oncology APIs, low-volume high-potency compounds, and complex oral solid dosage forms offers significant growth potential. Strategic collaborations, technology adoption, and tailored service models are enabling CDMOs to strengthen client relationships and differentiate in a competitive landscape. The convergence of advanced manufacturing approaches, regulatory compliance expertise, and specialized capabilities positions the market for sustained growth as pharmaceutical companies continue to rely on outsourcing partners for both development and commercial supply.

Top of FormU.S. Small Molecule CDMO Market Report Highlights

• By product, the active pharmaceutical ingredient segment dominated the market in 2024 due to the rising complexity of drug formulations and the growing need for specialized manufacturing capabilities.
• Based on drug type, the innovators segment held the largest revenue share in 2024 due to a surge in novel small molecule development pipelines, particularly in oncology, neurology, and metabolic disorders.
• A few key players in the U.S. small molecule CDMO market include Aurigene Pharmaceutical Services Ltd.; Bellen Chemistry; Cambrex Corporation; Catalent, Inc.; CordenPharma International; Eurofins Scientific; Lonza; Recipharm AB; Siegfried Holding AG; and Thermo Fisher Scientific Inc.

Polaris Market Research has segmented the market report on the basis of product, drug type, and application:

By Product Outlook (Revenue, USD Billion, 2020–2034)

• Active Pharmaceutical Ingredients (API)
• Finished Drug Products

By Drug Type Outlook (Revenue, USD Billion, 2020–2034)

• Innovators
• Generics

By Application Outlook (Revenue, USD Billion, 2020–2034)

• Oncology
• Cardiovascular Disease
• Central Nervous System (CNS) Conditions
• Autoimmune/Inflammation
• Others