U.S. Small Molecule Innovator API CDMO Market Size, Share & Trends Analysis Report By Stage Type (Preclinical, Clinical, Commercial), By Service, By Customer Type, By Therapeutic Area, By Region, And Segment Forecasts, 2025 - 2030

U.S. Small Molecule Innovator API CDMO Market Growth & Trends

The U.S. small molecule innovator API CDMO market size is anticipated to reach USD 12.60 billion by 2030 and is projected to grow at a CAGR of 6.0% from 2025 to 2030, according to a new report by Grand View Research, Inc. Agrowing outsourcing trend among pharmaceutical companies, increasing demand for small molecule drugs, and surge in clinical trials are anticipated to influence the U.S. market positively.

Small molecules continue to play an important role in developing new treatments globally. Specialty medicines are increasingly driving U.S. pharmaceutical growth, particularly in developed markets, with small molecule applications accounting for over half of specialty sales. In addition, enhanced efficiency serves as another pivotal driver for pharmaceutical outsourcing. With mounting pressure on pharmaceutical companies to expedite the introduction of new drugs to the market, outsourcing emerges as a solution to accelerate the drug development process. Leveraging their expertise, experience, and cutting-edge equipment, CDMOs facilitate the swift & efficient production of high-quality drugs, enabling pharmaceutical firms to adhere to their development schedules.

The pharmaceutical/biotechnology companies increasingly opt for CDMO services to leverage their expertise. CDMOs offer flexibility & scalability in manufacturing capacity, allowing pharmaceutical companies to adapt to changing market demands and accelerate time to market for new therapies. In addition to providing extended expertise and assisting in improved cash flow management, outsourcing brings significant manufacturing advantages, including reducing investment risks. In the context of early-stage technologies and products, establishing expensive in-house capabilities entails substantial risks across the product development phases. At the same time, outsourcing serves as a risk-averse alternative.

The preference for outsourcing small molecule API has grown as an effective strategy until market demand for products becomes well-established and understood. For instance, in May 2022, Piramal Pharma Limited’s Pharma Solutions business, a CDMO, inaugurated a new API facility at its site in Aurora, Ontario. This state-of-the-art plant has commenced operations & has completed its initial production runs.

U.S. Small Molecule Innovator API CDMO Market Report Highlights

• Based on stage, the clinical segment led the market with the largest revenue share of 54.68% in 2024. The segment growth can be attributed to the rising clinical trial (Phase I-III) activities, growing small molecule development pipeline, and increasing availability of expertise
• Based on the customer type, the pharmaceutical segment held the market with the largest revenue share in 2024, attributing to rising funding for drug development is propelling segment growth
• Based on therapeutic area, the oncology segment accounted for the largest revenue share in 2024. The segment is driven by increasing prevalence of cancer in U.S. In addition, high R&D investments in advanced therapeutics to minimize cancer disease burden are expected to boost segment growth
• West Group dominated the U.S. market with the largest revenue share of 33.07% in 2024. The presence of various factors, such as increasing prevalence of chronic diseases, demand for APIs & CDMO services and improving healthcare infrastructure is expected to drive market significantly