United States Small Molecule CDMO Market By Product (Active Pharmaceutical Ingredients (API), Finished Drug Products, Others), By Application (Oncology, Cardiovascular Disease, Central Nervous System (CNS) Conditions, Autoimmune/Inflammation, Others), By Region, Competition, Forecast & Opportunities, 2020-2030F

Market Overview

United States Small Molecule CDMO Market was valued at USD 25.37 Billion in 2024 and is expected to reach USD 34.98 Billion by 2030 with a CAGR of 5.70%. As the pharmaceutical industry continues to evolve, companies are looking to CDMOs to streamline operations, reduce costs, and gain access to specialized capabilities in drug development and production especially for small molecule drugs, which remain a foundational component of many treatment regimens.

One of the primary growth drivers is the continued reliance on small molecule therapeutics, especially in areas such as oncology, infectious diseases, and chronic illnesses. These drugs are generally more stable, easier to manufacture, and less expensive to develop compared to biologics, which makes them highly attractive to pharmaceutical and biotech companies. At the same time, regulatory and geopolitical factors are influencing business decisions. Concerns about overreliance on overseas manufacturing, particularly from Asia, have prompted greater interest in domestic production.

Key Market Drivers

Growth in Healthcare Industry

The growth of the healthcare industry in the United States has become a key driver of the small molecule CDMO (Contract Development and Manufacturing Organization) market. In 2023, U.S. health care expenditures increased by 7.5%, totaling USD 4.9 trillion, which equates to USD 14,570 per capita. Health care spending represented 17.6% of the nation's Gross Domestic Product. As demand for pharmaceutical innovation rises, particularly in small molecule therapeutics, CDMOs have increasingly become strategic partners for pharmaceutical and biotech companies aiming to bring products to market more efficiently.

Approximately 129 million individuals in the U.S. are living with at least one major chronic condition such as heart disease, cancer, diabetes, obesity, or hypertension according to the U.S. Department of Health and Human Services. Notably, five of the top ten leading causes of death in the country are either directly caused by or closely linked to preventable and manageable chronic diseases. This surge in demand is primarily driven by the growing prevalence of chronic diseases such as cancer, cardiovascular conditions, and diabetes, which continue to dominate the therapeutic landscape. Small molecule drugs remain the preferred choice for treating these conditions due to their proven efficacy, oral bioavailability, and cost-effectiveness. As a result, there has been a steady increase in new drug approvals by the U.S. Food and Drug Administration (FDA), with small molecules accounting for the majority of new molecular entities approved in recent years.

Surge in Technological Advancements

The rapid pace of technological advancements has emerged as a critical driver of growth in the United States small molecule CDMO market. Innovations in process chemistry, continuous manufacturing, and advanced analytical techniques are significantly enhancing efficiency, scalability, and cost-effectiveness across the drug development and manufacturing lifecycle. For instance, the Flamma Group presents a distinctive opportunity to expedite your small molecule drug development by reducing the time to market. Leveraging FDA-inspected cGMP production facilities in Italy, a GMP-certified site in the USA, and a fully owned and operated GMP facility in China, Flamma ensures a reliable and secure supply chain for small molecule Active Pharmaceutical Ingredients (APIs), New Chemical Entities (NCEs), Registered Starting Materials (RSMs), and Key Intermediates, supporting needs from early-stage development through to commercial-scale delivery.

These technologies enable CDMOs to meet the increasingly complex requirements of pharmaceutical and biotech clients, particularly in the areas of high-potency compounds, accelerated development timelines, and regulatory compliance. Additionally, the integration of digitalization, automation, and data analytics is streamlining operations, improving quality control, and fostering greater transparency in production processes. As a result, CDMOs that adopt and invest in cutting-edge technologies are gaining a competitive edge, driving demand and fueling market expansion in the U.S.

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Key Market Challenges

High Capital Investment & Infrastructure Constraints

High capital investment and infrastructure constraints represent significant challenges for the United States small molecule CDMO market. Establishing and maintaining state-of-the-art manufacturing facilities requires substantial financial resources. Advanced technologies, specialized equipment, and compliance with stringent regulatory standards demand continuous investment, which can be a barrier for many CDMOs, particularly smaller and mid-sized companies.

The complexity of small molecule production, including the need for sophisticated synthesis processes and strict quality controls, means that infrastructure must be both flexible and scalable. However, building such versatile facilities is costly and time-consuming. Upgrading existing plants to meet evolving regulatory requirements or to adopt new technologies further increases capital expenditures, often without immediate returns.

Key Market Trends

Growing Prevalence of Cancer

The growing prevalence of cancer in the United States is a significant trend shaping the small molecule CDMO market. In 2025, it is projected that there will be 2,041,910 new cancer diagnoses and 618,120 cancer-related deaths in the United States. The cancer mortality rate has continued to decline through 2022, resulting in the prevention of nearly 4.5 million deaths. As cancer rates continue to rise due to factors such as an aging population, lifestyle changes, and improved diagnostic capabilities, there is an increasing demand for innovative and effective oncology treatments. Small molecule drugs play a critical role in cancer therapy, offering targeted mechanisms of action, oral administration, and the ability to reach intracellular targets that biologics often cannot.

This rising demand for oncology therapeutics has directly influenced pharmaceutical companies to invest heavily in research and development focused on small molecule anti-cancer agents. Given the complexity and specialized nature of manufacturing these compounds, many companies turn to contract development and manufacturing organizations to manage the development, synthesis, and scale-up processes efficiently and compliantly.

Segmental Insights

Product Insights

Based on Product, Active Pharmaceutical Ingredients (API) have emerged as the fastest growing segment in the United States Small Molecule CDMO Market in 2024. This is due to several key factors. Increasing demand for high-quality, complex APIs driven by the rise of specialty and generic drugs is fueling growth. Pharmaceutical companies are increasingly outsourcing API manufacturing to CDMOs to reduce capital investment, mitigate regulatory risks, and accelerate time-to-market. Additionally, the growing complexity of small molecule APIs, including high-potency and controlled substances, requires specialized expertise and advanced manufacturing capabilities that many CDMOs now provide.

Application Insights

Based on Application, Cardiovascular Disease have emerged as the fastest growing segment in the United States Small Molecule CDMO Market during the forecast period. This is due to the increasing prevalence of cardiovascular conditions, which remain a leading cause of illness and death across the country. As the demand for effective small molecule therapies rises, pharmaceutical companies are dedicating more resources to developing innovative drugs targeting cardiovascular health. This surge in drug development is driven in part by an aging population, which is more prone to cardiovascular issues, thus expanding the need for new and improved treatments.

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Regional Insights

Based on Region, Midwest have emerged as the dominating region in the United States Small Molecule CDMO Market in 2024. This is due to a combination of strategic advantages. The area benefits from a strong manufacturing infrastructure that supports efficient and scalable production of small molecules. This is complemented by a highly skilled workforce, including experienced chemists, engineers, and regulatory experts, nurtured by well-regarded universities and technical schools in the region.

Recent Development

• In July 2025, ESTEVE successfully acquired Regis Technologies, a prominent Contract Development and Manufacturing Organization (CDMO) headquartered in Chicago, United States. This strategic acquisition provides ESTEVE CDMO, operating under the Esteve Química brand, with a direct physical presence in the U.S. market. It significantly strengthens the company’s capacity to deliver comprehensive contract development and manufacturing services for innovative small-molecule active pharmaceutical ingredients (APIs). This expanded footprint enables ESTEVE to support clients across the full spectrum of the drug development lifecycle, from early pre-clinical phases through to large-scale commercial manufacturing.
• In October 2024, Recipharm, a leading contract development and manufacturing organization (CDMO), and Exela Pharma Sciences, a U.S.-based client-focused CDMO, announced an exclusive strategic alliance to enhance sterile manufacturing capabilities in the United States. Through this collaboration, Recipharm will gain access to Exela’s state-of-the-art, FDA-accredited manufacturing facility in Lenoir, North Carolina. Recognized by both CDER and CBER, the facility has a demonstrated track record of executing rapid “light speed” projects during the COVID-19 pandemic. The site specializes in the production of sterile injectable pharmaceuticals in both vial and pre-filled syringe (PFS) formats.

Key Market Players

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

Report Scope

In this report, the United States Small Molecule CDMO Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• United States Small Molecule CDMO Market, By Product:

o   Active Pharmaceutical Ingredients (API)

o   Finished Drug Products

o   Others

• United States Small Molecule CDMO Market, By Application:

o   Oncology

o   Cardiovascular Disease

o   Central Nervous System (CNS) Conditions

o   Autoimmune/Inflammation

o   Others

• United States Small Molecule CDMO Market, By Region:

o   Northeast

o   Midwest

o   South

o   West

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the United States Small Molecule CDMO Market.

Available Customizations:

United States Small Molecule CDMO Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

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