Oral Solid Dosage Contract Manufacturing Market Predicted to Reach USD 57.9 Billion by 2032 - Persistence Market Research

Oral Solid Dosage Contract Manufacturing Market Overview

The Oral Solid Dosage Contract Manufacturing Market is experiencing robust growth as pharmaceutical companies increasingly rely on contract development and manufacturing organizations (CDMOs) to produce oral solid dose (OSD) products. This growth is driven by the need for cost-effective, scalable, and innovative production solutions. Oral solid dosage forms, such as tablets and capsules, are among the most widely used in the pharmaceutical industry due to their patient compliance, ease of administration, and versatility in drug delivery.

In 2025, the global market for oral solid dosage contract manufacturing is expected to be valued at USD 38 billion, with projections suggesting it will rise to USD 57.9 billion by 2032, growing at a CAGR of 6.2%. The market's key drivers include the increasing demand for specialized drug formulations, the growing complexity of biologics, and advancements in drug delivery technologies, such as controlled-release and targeted dosage forms. North America is anticipated to dominate the market in 2025, accounting for 40.5% of the global share, driven by a strong pharmaceutical infrastructure and ongoing investment in advanced manufacturing capabilities.

The tablets segment is expected to hold the largest share of the market, with an estimated 39.4% share in 2025, primarily due to their cost-effectiveness and widespread usage. The demand for immediate-release formulations, which are known for their rapid absorption and effectiveness in treating acute conditions, is also set to rise, holding a forecasted 52.3% market share in the same year. Furthermore, big pharma and biotech companies will continue to be the dominant end-users, accounting for 43.4% of the market share, as they increasingly outsource manufacturing to focus on core research and development activities.

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Key Highlights from the Oral Solid Dosage Contract Manufacturing Market

• The global market size for oral solid dosage contract manufacturing is forecasted to reach USD 57.9 billion by 2032.
• Tablets are expected to lead the market, holding a 39.4% share in 2025.
• Immediate release formulations are predicted to capture 52.3% of the market share in 2025.
• Big pharma and biotech companies will make up 43.4% of the end-user market share in 2025.
• North America is forecasted to dominate with 40.5% market share in 2025.
• Drug product development is expected to hold 60.3% of the application market share in 2025.

Market Segmentation

The Oral Solid Dosage Contract Manufacturing Market is segmented based on dosage form, end-user, application, and region. Tablets are the leading dosage form due to their widespread acceptance and cost-effectiveness. Capsules also contribute significantly to the market but are expected to see slower growth compared to tablets. Furthermore, the market is divided into categories like immediate-release formulations, extended-release formulations, and controlled-release formulations, with immediate-release products leading in demand due to their rapid action in treating acute conditions.

End-users of the market include big pharmaceutical companies, biotech firms, and generic drug manufacturers, with the big pharma and biotech sector leading due to their significant reliance on CDMOs for large-scale production. The drug product development segment is anticipated to be the most prominent application, given the increasing demand for innovative and customized solid dosage forms, particularly those designed to improve bioavailability, patient compliance, and therapeutic efficacy.

Regional Insights

North America is poised to maintain its dominance in the oral solid dosage contract manufacturing market, with a projected share of 40.5% in 2025. This dominance is fueled by the region's robust pharmaceutical infrastructure, a large number of research and development activities, and favorable regulatory environments that support innovation in drug development and manufacturing.

Meanwhile, Asia Pacific is emerging as a key region for contract manufacturing due to its low-cost production capabilities and the rapid expansion of pharmaceutical manufacturing facilities, particularly in countries like India, China, and Singapore. The region's ability to offer cost-effective solutions, combined with its skilled workforce and improving regulatory frameworks, makes it a prime destination for pharmaceutical companies seeking to outsource manufacturing operations.

Market Drivers

Several factors are propelling the growth of the oral solid dosage contract manufacturing market. The demand for cost-effective drug production is a significant driver, with pharmaceutical companies seeking to reduce overhead costs by outsourcing manufacturing to CDMOs. Innovations in controlled-release technology and the development of new drug delivery methods, such as 3D printing, have also expanded the capabilities of contract manufacturers. Furthermore, advancements in quality control driven by digital technologies, AI-based monitoring systems, and automation are helping improve production efficiency, ensuring better compliance with Good Manufacturing Practices (GMP).

The expansion of pharmaceutical manufacturing facilities in North America and Europe, along with increasing research and development activities, is expected to further fuel market growth. Additionally, outsourcing trends are gaining momentum as pharmaceutical companies aim to focus on their core competencies, such as drug discovery and clinical trials, while relying on specialized CDMOs for the efficient production of oral solid dosage forms.

Market Restraints

Despite its growth potential, the oral solid dosage contract manufacturing market faces several challenges. Regulatory compliance remains a significant hurdle, with CDMOs having to navigate stringent regulations from bodies like the FDA, EMA, and PMDA. Non-compliance with these regulations can result in product recalls, financial penalties, and delays in drug approvals. Quality control issues, including inconsistencies in manufacturing processes and product defects, can further impede market growth. Small and medium-sized CMOs, in particular, often face challenges related to high regulatory costs and complex documentation processes, which can delay the approval of new drug products.

Another key restraint is the fragmentation of the market, with a large number of small and medium-sized CDMOs that may struggle to meet the increasing demands for scale and innovation in production. This fragmentation could lead to slower adoption of new technologies and hinder the market's overall efficiency.

Market Opportunities

The outsource trend is a significant opportunity for CDMOs, as more pharmaceutical companies turn to contract manufacturers to reduce costs and streamline operations. CDMOs can capitalize on the growing demand for specialized drug formulations, including those required for biologics, targeted therapies, and specialty drugs. The rise in chronic diseases and the increasing prevalence of conditions like cancer and neurological disorders further solidify the demand for innovative oral solid dosage forms.

Additionally, strategic investments by leading CDMOs in advanced manufacturing technologies offer opportunities for market players to stay ahead of the competition. For instance, advancements in controlled-release technologies and biopharmaceutical manufacturing present growth avenues for CDMOs capable of producing high-quality, novel drug formulations that address unmet patient needs.

Reasons to Buy the Report

✔ Gain an in-depth understanding of the market trends and growth drivers that are shaping the future of the oral solid dosage contract manufacturing industry.
✔ Understand the market segmentation based on dosage forms, end-users, and regions, helping you make informed decisions on targeting key segments.
✔ Analyze the competitive landscape and key players operating in the market to stay ahead of industry developments and opportunities.
✔ Explore regional trends and forecasts to identify the most promising markets for expansion and investment.
✔ Learn about market challenges, including regulatory hurdles and quality control issues, and strategies to overcome these challenges.

Frequently Asked Questions (FAQs)

1. How big is the Oral Solid Dosage Contract Manufacturing Market?
2. Who are the key players in the global market for Oral Solid Dosage Contract Manufacturing?
3. What is the projected growth rate of the Oral Solid Dosage Contract Manufacturing Market?
4. What is the market forecast for the Oral Solid Dosage Contract Manufacturing Market in 2032?
5. Which region is estimated to dominate the Oral Solid Dosage Contract Manufacturing Market through the forecast period?

Company Insights

Key Players in the Market:

• Recipharm
• Aenova Holding
• Catalent
• AbbVie
• Lonza Group AG
• Merck KGaA
• Piramal Pharma Solutions
• NextPharma
• Patheon N.V. (Thermo Fisher Scientific)
• Corden Pharma

Recent Developments:

• Catalent announced the expansion of its U.S. facilities in March 2024 to meet rising demand for tablet and capsule production.

• Lonza revealed plans to invest in its Swiss OSD facility in April 2024, focusing on high-potency and controlled-release formulations.

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