Oral Solid Dosage Contract Manufacturing Market Outlook 2025-2032 Highlights Global Growth Potential - Persistence Market Research

The global oral solid dosage (OSD) contract manufacturing market has emerged as a vital segment of the pharmaceutical industry, driven by the increasing need for cost-effective, scalable, and high-quality drug production. Oral solid dosage forms, such as tablets and capsules, remain the most widely used pharmaceutical delivery methods due to their convenience, ease of administration, and precise dosing. Consequently, pharmaceutical companies are increasingly relying on Contract Development and Manufacturing Organizations (CDMOs) to outsource their OSD production, allowing them to focus on research, development, and market expansion while leveraging specialized manufacturing expertise.

The market is projected to grow from a valuation of approximately US$ 38.0 billion in 2025 to around US$ 57.9 billion by 2032, reflecting a robust compound annual growth rate (CAGR) of 6.2% during the forecast period. This growth is supported by advancements in drug delivery technology, including controlled-release formulations and 3D printing techniques, which improve bioavailability and patient adherence. Additionally, digitalization in manufacturing, automated process monitoring, and enhanced quality control are driving efficiency and reducing production costs, making contract manufacturing a compelling option for pharmaceutical companies across the globe.

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Tablets are currently the leading segment in OSD contract manufacturing, representing 39.4% of the market in 2025, due to their affordability, patient compliance, and ease of mass production. Geographically, North America dominates the market with a projected 40.5% share in 2025, supported by strong pharmaceutical infrastructure, robust regulatory frameworks, and government initiatives that encourage innovation in drug development. The presence of established CDMOs, coupled with significant R&D investments by major pharmaceutical firms, positions the region as a hub for advanced oral solid dosage manufacturing.

Key Highlights from the Report

• The demand for cost-efficient drug production is driving pharmaceutical companies to outsource OSD manufacturing to specialized CDMOs.
• Tablets are expected to dominate the market in 2025, holding a 39.4% share due to their widespread use and production efficiency.
• Immediate release formulations are projected to capture a 52.3% share in 2025, driven by rapid drug absorption and effectiveness in acute therapies.
• Big pharma and biotech companies are anticipated to account for 43.4% of end users in 2025, highlighting reliance on contract manufacturers for scalable production.
• Drug product development applications are projected to hold a 60.3% share, indicating increasing demand for innovative oral solid dosage formulations.
• North America is forecasted to hold a 40.5% share of the market in 2025, supported by strong infrastructure and regulatory incentives.

Market Segmentation

The oral solid dosage contract manufacturing market is segmented based on product type, dosage form, end-user, and application. Tablets and capsules dominate product-type segmentation, with tablets holding the largest market share due to ease of administration, controlled release capability, and widespread acceptance among patients. Capsules, including soft and hard gelatin types, are gaining popularity for their enhanced stability and suitability for novel drug formulations.

Segmentation by dosage form includes immediate release, controlled release, and extended-release formulations. Immediate release forms are favored for acute conditions due to rapid absorption, while controlled and extended-release formulations are increasingly developed to improve therapeutic outcomes and patient adherence. End-user segmentation includes big pharmaceutical companies, biotech firms, and generic drug manufacturers. Big pharma and biotech companies lead demand, leveraging CDMOs for large-scale production, specialized expertise, and regulatory compliance. Applications of OSD contract manufacturing span drug product development, formulation optimization, and large-scale commercial production, with drug development accounting for the largest share due to the growing need for novel therapies and efficient time-to-market solutions.

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Regional Insights

The global oral solid dosage contract manufacturing market is geographically diverse, with North America, Europe, and Asia Pacific emerging as key regions. North America is the largest market, driven by significant investment in pharmaceutical R&D, robust infrastructure, and regulatory support. Programs like the FDA's Commissioner's National Priority Voucher (CNPV) accelerate approvals for innovative oral solid dosage products, reinforcing the region's leadership in advanced manufacturing.

Europe is recognized for its strong emphasis on innovation and research in pharmaceutical manufacturing. Investments by companies like Ardena and Recipharm in acquiring facilities and expanding drug development capabilities have strengthened Europe's position in high-complexity oral solid dosage production. Regulatory support from agencies such as the EMA further encourages technological innovation and efficiency in drug manufacturing.

The Asia Pacific region is rapidly emerging as a critical hub for contract manufacturing due to cost-effective production, a skilled workforce, and favorable regulatory environments. Countries like China and India are witnessing significant expansion in pharmaceutical manufacturing capacity, while Singapore is positioning itself as a center for high-quality OSD production. Outsourcing to Asia Pacific offers global pharmaceutical firms opportunities to scale production efficiently, though differences in regulatory frameworks and potential supply chain disruptions remain challenges.

Market Drivers

The oral solid dosage contract manufacturing market is primarily driven by the need for cost-effective and scalable drug production. Outsourcing OSD manufacturing allows pharmaceutical companies to optimize their resources, reduce overheads, and mitigate risks associated with in-house production. Advanced manufacturing technologies, such as continuous processing, automated systems, and AI-driven quality control, enhance production efficiency and reduce operational costs, further encouraging the adoption of CDMO services.

Additionally, rising demand for specialized drug formulations, including controlled-release and modified-release tablets, is fueling market growth. Increasing prevalence of chronic and infectious diseases has prompted pharmaceutical firms to focus on developing innovative oral solid dosage products. Collaborative agreements between CDMOs and pharmaceutical companies facilitate faster drug development, enhance process optimization, and improve patient adherence through precise and reliable dosing.

Market Restraints

Despite robust growth, the OSD contract manufacturing market faces challenges related to regulatory compliance and quality control. Stringent Good Manufacturing Practices (GMP) regulations enforced by agencies such as the FDA, EMA, and PMDA pose a significant barrier, especially for small-scale CDMOs with limited resources. Non-compliance can result in production halts, product recalls, and financial penalties, which can negatively impact market expansion.

Moreover, outsourcing to low-cost manufacturing regions like India and China introduces potential risks such as supply chain disruptions, variations in regulatory standards, and communication challenges. These factors can delay drug approval timelines and hinder market growth in developed regions, where adherence to strict quality standards is mandatory.

Market Opportunities

The increasing complexity of drug formulations, particularly in biologics and specialty medications, is driving pharmaceutical companies to outsource manufacturing to specialized CDMOs. This trend presents significant growth opportunities for contract manufacturers offering advanced technologies, high-quality production, and regulatory expertise.

Investments in facility expansions, adoption of digital manufacturing, and development of next-generation oral solid dosage forms create new avenues for market growth. For instance, Catalent's expansion in Oxfordshire, U.K., and Lonza's multi-million-dollar investment in biologics manufacturing capacity highlight the potential for CDMOs to capitalize on the growing demand for complex oral dosage solutions. Additionally, mergers and acquisitions among CDMOs provide opportunities to consolidate fragmented markets and enhance global market presence.

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Company Insights

The oral solid dosage contract manufacturing market is highly competitive, dominated by leading CDMOs and pharmaceutical companies offering integrated services. Key players in the market include:

• Recipharm
• Aenova Holding
• Catalent
• AbbVie
• Patheon N.V. (Thermo Fisher Scientific)
• NextPharma
• Lonza Group AG
• Merck KGaA
• Aurobindo Pharma Limited
• Siegfried AG
• Piramal Pharma Solutions
• Corden Pharma
• HERMES PHARMA GmbH
• Medipaams India Private Limited
• Alpex Pharma
• Abaris Healthcare Pvt Ltd
• Ardena Holdings N.V
• Aphena Pharma Solutions
• Actiza Pharmaceutical Private Limited
• Sunwin Healthcare PVT. LTD
• Kosher Pharmaceuticals
• Boehringer Ingelheim BioXcellence

Oral Solid Dosage Contract Manufacturing Market Segmentation

By Dosage Form

Tablets
Capsules
Softgels
Powders
Granules
Others

By Mechanism

Immediate Release
Delayed Release
Controlled Release

By Application

Drug Product Development
Fill & Finish Product Manufacturing
Packaging /Labelling
Others

By End User

Pharmaceutical Companies
Biopharmaceutical Companies
Emerging/Virtual Pharma Companies
Nutraceutical Companies

By Region

North America
Europe
East Asia
South Asia and Oceania
Middle East and Africa
Latin America

Recent Developments:

• In November 2024, Thermo Fisher Scientific launched AcceleratorTM Drug Development to offer expanded clinical research and CDMO services, optimizing cost and time for drug developers.
• In October 2024, Catalent agreed to sell its oral solids development and small-scale manufacturing facility in Somerset, New Jersey, to Ardena, enhancing CDMO capabilities across Europe.

Conclusion

The global oral solid dosage contract manufacturing market is poised for substantial growth over the next decade, fueled by increasing outsourcing trends, technological advancements, and rising demand for innovative drug formulations. Tablets and immediate release formulations dominate the market, reflecting their widespread acceptance and production efficiency. North America remains the leading region due to strong infrastructure, regulatory support, and investment in pharmaceutical innovation, while Asia Pacific and Europe present significant opportunities for cost-effective production and advanced research.

Market expansion is underpinned by drivers such as cost reduction, scalability, and enhanced manufacturing technologies, while challenges like regulatory compliance and quality control necessitate strategic planning by CDMOs. As pharmaceutical companies increasingly prioritize outsourcing to specialized contract manufacturers, opportunities for mergers, acquisitions, and technological innovation will continue to shape the competitive landscape. Overall, the oral solid dosage contract manufacturing market offers a robust growth trajectory, presenting a lucrative environment for CDMOs and pharmaceutical stakeholders aiming to meet the evolving needs of global healthcare.

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