Every tablet swallowed for blood pressure, every capsule taken for diabetes, and every oral cancer medicine on a pharmacy shelf represents years of research, formulation, manufacturing, and regulatory expertise. Today, many of these medicines are no longer produced entirely by pharmaceutical companies themselves. Instead, they are increasingly manufactured by specialized Contract Development and Manufacturing Organizations (CDMOs).
This shift is transforming the U.S. pharmaceutical industry. Drug developers are focusing on research and commercialization while relying on experienced manufacturing partners to accelerate production, improve quality, and reduce costs.
U.S. Market Enters a New Growth Phase
The U.S. oral solid dosage CDMO market is valued at USD 15.33 billion in 2026 and is projected to reach USD 27.2 billion by 2035, expanding at a CAGR of 6.58%.
The growth reflects increasing outsourcing by both established pharmaceutical companies and emerging biotech firms. Rising demand for generic medicines, specialized formulations, personalized therapies, and faster commercialization continues to strengthen the role of CDMOs across the country.
According to the latest 2026 U.S. FDA updates, thousands of approved prescription medicines continue to rely on oral solid dosage forms such as tablets and capsules, making them the most widely used pharmaceutical delivery systems in the United States.
The Centers for Disease Control and Prevention (CDC) 2026 also highlights that nearly 129 million Americans live with at least one major chronic disease, including cardiovascular disease, diabetes, obesity, or cancer. This growing patient population continues to drive long-term demand for oral medications.
Why Pharmaceutical Companies Are Outsourcing More Than Ever
Building and operating a pharmaceutical manufacturing facility requires billions of dollars in investment, highly trained personnel, advanced equipment, and strict regulatory compliance.
Instead of expanding internal facilities, many companies now outsource formulation development, process optimization, commercial manufacturing, packaging, and regulatory documentation to specialized CDMOs.
This strategy reduces operational costs while allowing pharmaceutical companies to launch medicines faster without compromising manufacturing quality.
Growing demand for continuous manufacturing, high-potency APIs, modified-release formulations, and patient-friendly dosage forms is further accelerating outsourcing across the U.S.
Market Segments Show Where Growth Is Happening
Among product types, tablets dominated the market with 56% share in 2025, reflecting their manufacturing efficiency and widespread use for chronic disease treatment.
Capsules accounted for 27% and are expected to record the fastest growth at 7.21% CAGR, supported by specialty formulations and better patient compliance.
Commercial manufacturing remained the largest service segment with 37% market share, while packaging and labeling captured 13% and is forecast to grow fastest due to serialization requirements and automated packaging technologies.
By therapeutic area, cardiovascular diseases represented 21% of the market, followed by oncology at 18%, which is projected to expand most rapidly with an 8.12% CAGR as precision medicine and targeted cancer therapies continue to grow.
Large pharmaceutical companies generated 42% of outsourcing demand, while small and emerging biopharmaceutical companies accounted for 26% and are expected to grow fastest at 8.13% CAGR.
Among end users, branded drug manufacturers held 44%, followed by generic drug manufacturers with 34%, while biotechnology companies are projected to witness the strongest future growth.
Advanced Manufacturing Is Becoming the New Standard
Modern oral solid dosage manufacturing looks very different from traditional pharmaceutical production.
Continuous manufacturing systems now monitor every production stage in real time, improving batch consistency while reducing waste and production costs.
Digital quality management systems, automated inspection technologies, predictive maintenance, and data-driven process monitoring are helping manufacturers achieve higher productivity while meeting stringent FDA quality standards.
These innovations are becoming especially valuable as demand rises for complex formulations including orally disintegrating tablets, controlled-release products, and high-potency oral medicines.
Leading Companies Expanding Manufacturing Capabilities
The competitive landscape includes several globally recognized CDMOs that continue investing heavily in U.S. manufacturing capacity.
| Company | Headquarters | Key Oral Solid Dosage Capabilities | Recent Strategic Focus |
|---|---|---|---|
| Catalent Inc. | Somerset, New Jersey | Zydis ODT, OptiShell, OptiMelt | Advanced oral technologies and commercial manufacturing |
| Thermo Fisher Scientific (Patheon) | Waltham, Massachusetts | Quick to Clinic, commercial manufacturing | End-to-end pharmaceutical development and manufacturing |
| Lonza Group | Basel, Switzerland | Capsugel, Vcaps Plus | Capsule technologies and formulation development |
| Cambrex Corporation | East Rutherford, New Jersey | HPAPI oral solid manufacturing | High-potency API manufacturing expansion |
| Piramal Pharma Solutions | Mumbai, India | InteliDose, SecureCore | Integrated global CDMO services |
| Recipharm AB | Stockholm, Sweden | ReciCap, Advance OSD | Flexible manufacturing for global clients |
| Aenova Group | Starnberg, Germany | Effervescent and granule technologies | Complex oral dosage manufacturing |
Curious about the insights top industry leaders use to stay ahead? Download your FREE customized sample today: https://www.towardshealthcare.com/download-sample/6996
Catalent Continues Setting Industry Benchmarks
Catalent remains one of the largest oral solid dosage CDMOs operating in North America.
Its proprietary technologies such as Zydis orally disintegrating tablets (ODT) have enabled pharmaceutical companies to improve patient convenience, particularly for pediatric and geriatric populations.
The company continues expanding commercial manufacturing, formulation development, packaging, and supply chain services while supporting both innovative and generic pharmaceutical products.
Its integrated manufacturing model allows customers to move efficiently from early clinical development through full commercial production.
New Investments Reflect Strong Industry Confidence
The U.S. CDMO landscape continues attracting significant investment.
In March 2026, Forma Life Sciences launched a new independent CDMO focused on oral solid dosage formulation development, clinical manufacturing, and commercial production.
Earlier in February 2026, Halo Pharma resumed operations under Noramco, strengthening manufacturing capabilities across solid, liquid, and semi-solid dosage forms.
These developments demonstrate growing confidence in outsourced pharmaceutical manufacturing as demand continues expanding.
Outlook: A Strong Decade Ahead
The future of the U.S. oral solid dosage CDMO industry remains highly promising.
Increasing chronic disease prevalence, expanding generic drug pipelines, personalized medicine, oncology innovation, and continuous manufacturing adoption will continue driving investment through 2035.
As pharmaceutical companies prioritize speed, flexibility, and cost efficiency, CDMOs are becoming long-term strategic partners rather than manufacturing vendors—positioning the U.S. as one of the world’s most advanced hubs for oral solid dosage drug development and production.
Access our exclusive, data-rich dashboard dedicated to the pharma industry – built specifically for decision-makers, strategists, and industry leaders. The dashboard features comprehensive statistical data, segment-wise market breakdowns, regional performance shares, detailed company profiles, annual updates, and much more. From market sizing to competitive intelligence, this powerful tool is one-stop solution to your gateway.Â
Access the Dashboard: https://www.towardshealthcare.com/access-dashboard
About Us
Healthcare WebWire is a part of Towards Healthcare Research and Consulting provides strategic intelligence and research expertise across the pharmaceutical market, including branded drugs, generic medicines, biologics, biosimilars, specialty pharmaceuticals, OTC products, and drug delivery systems. We support pharmaceutical companies with market analysis, pipeline assessment, and competitive insights to help drive innovation, strengthen commercialization strategies, and capture emerging growth opportunities in the evolving healthcare landscape.
You can place an order or ask any questions, please feel free to contact us at [email protected]
Europe Region – +44 778 256 0738
North America Region – +1 8044 4193 44
APAC Region: +91 9356 9282 04
Visit Our Website: https://www.towardshealthcare.com
Find us on social platforms: LinkedIn | Twitter | Instagram | Medium