In 2024, the U.S. market for small molecule innovator API CDMOs was valued at USD 8.80 billion, with projections indicating it will expand at a compound annual growth rate (CAGR) of 6.0% from 2025 to 2030. Key drivers fueling this growth include increasing outsourcing by pharmaceutical firms, sustained demand for small-molecule drugs, and the growing number of clinical trials conducted within the U.S.

The market is further propelled by rising investments in pharmaceutical R&D, which aim to support the development of innovative small-molecule APIs. Additional contributing factors include heightened demand for new therapies, increasing incidence of cancer, and the growing prevalence of age-related diseases.

The expansion of R&D and manufacturing operations within the U.S., coupled with a significant presence of leading pharmaceutical companies, also supports the market's upward trajectory. The emphasis on drug discovery and the increasing number of early-stage R&D initiatives are expected to enhance growth prospects in the near future. As an example, in March 2023, Catalent, Inc. entered into a partnership with Grunenthal to develop an oral dosage small molecule, a move that enhanced Catalent’s capabilities in the U.S. market.

Small-molecule drugs continue to dominate the pharmaceutical development pipeline and FDA approvals, prompting many firms to focus on advancing new small-molecule therapies. Consequently, the need for API CDMOs capable of delivering efficient and cost-effective manufacturing solutions remains strong. According to the U.S. FDA, 50 novel drugs received approval in 2024, slightly down from 55 in 2023, yet still the second-highest annual figure in the last 30 years. Of these, 31 were small molecules, accounting for 62% of total approvals, underscoring the significant role of small molecules in current drug development trends.

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Market Trends and Insights

• The clinical segment, broken down into Phase I, Phase II, and Phase III, led the market with a 54.68% revenue share in 2024.
• The contract manufacturing segment emerged as the leading segment, driven by growing demand for scalable and cost-effective production models.
• The pharmaceutical segment held the dominant position in 2024, supported by rising demand for novel therapies and increasing R&D and manufacturing outsourcing.
• The oncology segment accounted for the largest share of market revenue in 2024 and is projected to grow at the fastest rate through 2030, owing to increasing cancer prevalence, higher R&D investment, and a rising need for innovative oncology drugs.

Market Size and Forecast

• 2024 Market Size: USD 8.80 Billion
• 2030 Forecasted Market Size: USD 12.60 Billion
• CAGR (2025–2030): 6.0%

Key Industry Developments

Market leaders are adopting a range of inorganic growth strategies—such as mergers, acquisitions, partnerships, and service expansions—to strengthen their market position. For example, in June 2024, Formosa Laboratories acquired Synchem Inc., a U.S.-based contract research organization. This move expanded Formosa's footprint in the U.S. and enhanced its service capabilities.

Leading Companies in the U.S. Small Molecule Innovator API CDMO Market

• Lonza
• Novo Holdings (Catalent, Inc.)
• Thermo Fisher Scientific, Inc.
• Siegfried Holding AG
• Recipharm AB
• CordenPharma International
• Samsung Biologics
• Labcorp
• Ajinomoto Bio-Pharma Services
• Piramal Pharma Solutions
• Jubilant Life Sciences (Jubilant Biosys Limited)

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Conclusion

The U.S. small molecule innovator API CDMO market is poised for sustained growth, supported by increasing pharmaceutical outsourcing, expanding clinical pipelines, and strong demand for cost-effective and scalable manufacturing solutions. The dominance of small molecules in drug approvals and the robust pace of R&D investment underscore the market’s long-term viability. As strategic collaborations and acquisitions continue to reshape the competitive landscape, the market is expected to reach USD 12.60 billion by 2030, reflecting a healthy 6.0% CAGR over the forecast period.