United States Oral Solid Dosage Contract Manufacturing Market By Product Type (Tablets, Capsules, Powders, Granules, Others), By Mechanism (Immediate Release, Delayed Release, Controlled Release), By End-user (Large Size Companies, Medium & Small Size Companies, Others), By Region, Competition, Opportunities, and Forecast, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 8.79 BIllion
CAGR (2026-2031)	5.79%
Fastest Growing Segment	Capsules
Largest Market	Midwest
Market Size (2031)	USD 12.32 BIllion

Market Overview

The United States Oral Solid Dosage Contract Manufacturing Market will grow from USD 8.79 BIllion in 2025 to USD 12.32 BIllion by 2031 at a 5.79% CAGR. Oral Solid Dosage Contract Manufacturing defines the process where pharmaceutical firms delegate the formulation and production of solid medications, such as tablets and capsules, to external partners. This sector expands as companies prioritize cost reduction and allocate capital toward research rather than facility maintenance. Furthermore, the expiration of patents for popular drugs increases the requirement for generic drug production. According to the Association for Accessible Medicines, in 2024, generic and biosimilar medicines constituted 90 percent of all prescriptions filled in the United States, demonstrating the substantial production volume that sustains the contract manufacturing industry.

However, the market confronts a notable obstacle in the form of rigorous regulatory oversight. The Food and Drug Administration enforces strict adherence to quality standards, and any failure to comply can trigger production stoppages or financial penalties. This regulatory environment compels manufacturers to direct significant funds toward quality assurance protocols, which can restrict profit margins and hinder the ability to swiftly expand operational capacity.

Key Market Drivers

Supply chain resiliency initiatives driving onshoring of production fundamentally reshape the sector. Pharmaceutical companies are re-evaluating offshore dependencies to mitigate geopolitical risks, compelling United States-based contract partners to upgrade solid dosage infrastructure. The urgency is acute; according to the American Society of Health-System Pharmacists, in 2024, active drug shortages reached a record high of 323 medications, underscoring the necessity for reliable local manufacturing to maintain patient access. Consequently, domestic facilities are positioning themselves as stable alternatives. This shift addresses a critical exposure highlighted by the industry's current supply structure. According to the Biotechnology Innovation Organization, March 2024, in the 'BIO Member Survey on National Security', 79 percent of responding biopharmaceutical companies reported having at least one contract or product with a China-based manufacturer, creating substantial demand for US-based capacity as these supply chains realign.

The acceleration of generic drug launches following major patent expirations serves as a second catalyst for volume expansion. As blockbuster small-molecule drugs lose exclusivity, generic firms necessitate rapid scalability that internal facilities often lack, forcing reliance on external partners for high-speed tableting and encapsulation. This dynamic provides a steady revenue stream for contract organizations capable of handling large-scale solid dose runs. According to the Food and Drug Administration, February 2024, in the 'Office of Generic Drugs 2023 Annual Report', the agency noted it approved or tentatively approved 956 generic drug applications during the fiscal year. This continuous pipeline of solid dosage products ensures contract manufacturers maintain high asset utilization rates while supporting immediate commercial production needs.

Download Free Sample Report

Key Market Challenges

The rigorous regulatory oversight enforced by the Food and Drug Administration presents a substantial barrier to the growth of the United States Oral Solid Dosage Contract Manufacturing Market. Manufacturers are required to maintain strict compliance with Current Good Manufacturing Practice standards, which necessitates continuous investment in quality control systems, specialized personnel, and documentation processes. This financial burden diverts capital that could otherwise be used for expanding production capacity or upgrading facility infrastructure. Consequently, the high cost of compliance compresses profit margins and creates a significant entry barrier for new contract manufacturing organizations, while existing firms face the constant risk of operational delays due to inspections.

These regulatory pressures frequently result in production interruptions that destabilize the market. When quality standards are not met, the resulting enforcement actions can lead to facility shutdowns and supply chain gaps. According to the American Society of Health-System Pharmacists, in 2024, the United States recorded an all-time high of 323 active drug shortages, a situation significantly driven by manufacturing quality issues and regulatory halts. This statistic underscores the volatility introduced by the regulatory environment, as manufacturers must often pause operations to address compliance concerns. This dynamic prevents the contract manufacturing sector from maintaining the consistent output velocity required to meet increasing demand.

Key Market Trends

There is a significant trend toward upgrading facilities with specialized containment suites to handle High-Potency Active Pharmaceutical Ingredients (HPAPI), driven by the surging pipeline of oncology drugs and targeted therapies requiring low-dose, high-toxicity handling. Manufacturers are retrofitting standard lines with advanced isolators and wash-in-place capabilities to manage these potent compounds safely without cross-contamination. Highlighting this shift within the domestic market, according to Cambrex, March 2024, in the press release 'Cambrex Nears Completion of 5-year, $100-Million-Dollar Investment Plan', the company finalized a major capacity expansion at its Charles City, Iowa facility which included the addition of new manufacturing suites specifically designed for small-volume and highly potent API production.

CDMOs are actively investing in advanced processing techniques such as hot-melt extrusion and spray drying to address the growing prevalence of poorly soluble molecules in the drug discovery pipeline. This shift toward bioavailability-enhancement technologies allows manufacturers to formulate complex compounds that would otherwise fail to achieve therapeutic efficacy, moving beyond simple tableting into specialized particle engineering. Demonstrating this commitment to specialized infrastructure, according to Hovione, November 2024, in the press release 'Hovione Expands Global Spray Drying Capacity with Significant Investment in the USA and Ireland', the company completed a $100 million investment cycle that included doubling its spray drying capacity at its East Windsor, New Jersey facility to support commercial-scale amorphous solid dispersion projects.

Segmental Insights

The Capsules segment represents the fastest growth trajectory within the United States Oral Solid Dosage Contract Manufacturing Market due to its distinct advantages in processing complex active pharmaceutical ingredients. Drug developers increasingly select encapsulation to accelerate clinical trial timelines, as this method often requires fewer excipients and formulation steps compared to tableting. Additionally, the rising prevalence of potent compounds necessitates the superior containment capabilities offered by capsule technologies. This demand is further supported by contract manufacturers scaling operations to meet rigorous United States Food and Drug Administration compliance standards for specialized oral delivery systems.

Regional Insights

The Midwest United States dominates the United States Oral Solid Dosage Contract Manufacturing Market due to its extensive industrial infrastructure and strategic central location which facilitates efficient distribution. This region maintains a high concentration of contract development and manufacturing organizations that specialize in high-volume production. Manufacturers in the Midwest benefit from lower operational costs and a skilled labor pool compared to coastal pharmaceutical hubs. Furthermore, the strong presence of facilities compliant with Food and Drug Administration regulations ensures the region remains the primary destination for outsourcing pharmaceutical manufacturing.

Recent Developments

• In October 2024, Catalent, Inc. entered into a definitive agreement to sell its oral solids development and small-scale manufacturing facility in Somerset, New Jersey, to Ardena. The divestiture of the Somerset site, which also served as the company's headquarters, allowed the buyer to establish its first footprint in the United States Oral Solid Dosage Contract Manufacturing Market. The facility specializes in the development and clinical manufacturing of oral solid dosage forms, including high-potency compounds, and the transaction enabled Catalent to focus on its larger-scale commercial oral solid dose facilities elsewhere in its network.
• In September 2024, Thermo Fisher Scientific Inc. announced a significant expansion of its oral solid dose development and manufacturing capabilities across its North American network. The company invested approximately $22 million to upgrade its facilities in Cincinnati, Ohio, and Bend, Oregon, aiming to address the early development challenges faced by pharmaceutical and biotechnology clients. The investment in Cincinnati added dedicated research and development space for rapid project initiation, while the expansion in Bend doubled the site's existing footprint for research, development, and testing of oral solid drug formulations, including spray drying and hot-melt extrusion technologies.
• In September 2024, Adare Pharma Solutions announced plans to relocate its global headquarters to Pennsylvania and expand its manufacturing and packaging operations in Philadelphia. The contract development and manufacturing organization committed to investing approximately $16.8 million to upgrade its two existing facilities in the city, which focus on the development and production of oral dosage forms. This expansion was designed to enhance the company's capacity to serve the United States Oral Solid Dosage Contract Manufacturing Market, specifically by increasing its workforce and improving its integrated end-to-end services for pharmaceutical clients.
• In April 2024, Bora Pharmaceuticals Co., Ltd. successfully completed the acquisition of Upsher-Smith Laboratories, LLC, a generics manufacturer and marketer based in Minnesota. This strategic transaction provided the company with its first commercial manufacturing footprint in the United States, adding two facilities in Plymouth and Maple Grove, Minnesota, to its global network. The acquisition included a portfolio of 48 generic products and significantly expanded the company’s capabilities in the United States Oral Solid Dosage Contract Manufacturing Market, allowing it to offer end-to-end services from development to commercial packaging for oral solid dosage forms.

Key Market Players

• Catalent, Inc.
• Lonza Group
• AbbVie Inc.
• Aenova Group
• Adare Pharma Solutions
• Boehringer Ingelheim International GmbH
• Jubilant Pharmova Limited
• Patheon Pharma Services
• Recipharm AB
• Corden Pharma International

By Product Type	By Mechanism	By End-user	By Region
Tablets Capsules Powders Granules Others	Immediate Release Delayed Release Controlled Release	Large Size Companies Medium & Small Size Companies Others	Northeast Midwest South West

Report Scope:

In this report, the United States Oral Solid Dosage Contract Manufacturing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• United States Oral Solid Dosage Contract Manufacturing Market, By Product Type:

• Tablets
• Capsules
• Powders
• Granules
• Others

• United States Oral Solid Dosage Contract Manufacturing Market, By Mechanism:

• Immediate Release
• Delayed Release
• Controlled Release

• United States Oral Solid Dosage Contract Manufacturing Market, By End-user:

• Large Size Companies
• Medium & Small Size Companies
• Others

• United States Oral Solid Dosage Contract Manufacturing Market, By Region:

• Northeast
• Midwest
• South
• West