Oral Solid dosage (OSD) Contract Manufacturing Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product (Tablets, Capsules, Powders, Granules, Others), By End User (Large-size companies, Small & medium size companies, Startups and generic pharmaceutical companies), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 41.02 Billion
CAGR (2026-2031)	6.77%
Fastest Growing Segment	Granules
Largest Market	North America
Market Size (2031)	USD 60.77 Billion

Market Overview

The Global Oral Solid dosage (OSD) Contract Manufacturing Market will grow from USD 41.02 Billion in 2025 to USD 60.77 Billion by 2031 at a 6.77% CAGR. Global Oral Solid Dosage (OSD) Contract Manufacturing entails the outsourcing of solid drug formulation production, such as tablets and capsules, to specialized third-party providers. Market growth is propelled by pharmaceutical companies seeking cost efficiencies and access to advanced technologies for complex compounds without incurring heavy capital expenditures. Additionally, the expiration of patents for major drugs has necessitated increased external capacity for high-volume generic production. According to the Association for Accessible Medicines, in 2024, generic and biosimilar medicines accounted for 90% of all prescriptions filled in the United States, demonstrating the critical volume demand driving the contract manufacturing sector.

Nevertheless, the industry faces a substantial challenge in navigating a stringent global regulatory environment. Contract manufacturers must maintain compliance with divergent international quality standards, requiring significant ongoing resource allocation. This regulatory complexity can cause extended approval timelines and supply chain vulnerabilities, serving as a potential impediment to the sustained expansion of the market.

Key Market Drivers

The proliferation of small and mid-sized biopharmaceutical innovators is a primary engine for market expansion, fundamentally altering the outsourcing landscape. Unlike traditional large pharmaceutical entities, these emerging firms often possess robust research pipelines but lack the capital-intensive infrastructure required for commercial-scale solid dose production. Consequently, they engage in strategic partnerships with contract manufacturers to navigate development phases without incurring fixed costs. This reliance is intensified by aggressive investment in early-stage discovery; according to Harris Williams, August 2024, in the 'Outsourced Pharma Services: New Data Shows Resurgence Is Underway' report, R&D spending for biotech and small to mid-sized pharmaceutical companies is projected to increase by 9% to 12%, outpacing the growth rate of larger industry players. This capital influx directly translates into increased contract volumes for OSD providers capable of offering flexible, end-to-end development services.

Simultaneously, the expansion of capabilities for High-Potency Active Pharmaceutical Ingredients (HPAPIs) and complex formulations is reshaping technical requirements within the sector. As modern drug discovery shifts toward oncology and rare diseases, molecules are becoming increasingly potent and challenging to formulate due to poor bioavailability. Manufacturers are compelled to invest in specialized containment and advanced solubility enhancement technologies to handle these sensitive compounds safely and effectively. According to Lonza, January 2025, in the 'Full-Year Report 2024', their Small Molecules division reported sales growth of 9.3% in 2024, a performance explicitly driven by the continued portfolio shift toward high-value, complex service offerings. This trend is underpinned by the enduring dominance of traditional chemistries; according to Lonza, in 2025, small molecules continue to comprise 54% of all molecules in the global clinical development pipeline, necessitating sustained specialized manufacturing capacity.

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Key Market Challenges

Navigating a stringent global regulatory environment presents a formidable obstacle to the expansion of the Global Oral Solid Dosage (OSD) Contract Manufacturing Market. As contract development and manufacturing organizations (CDMOs) operate across multiple jurisdictions, they must align with divergent quality standards and documentation requirements enforced by different national health authorities. This fragmentation necessitates the maintenance of extensive quality assurance teams and often requires duplicative testing protocols, which significantly increases operational costs and erodes profit margins. Consequently, resources that could be invested in capacity expansion or facility upgrades are instead diverted toward maintaining continuous compliance.

The intensifying pressure of this regulatory burden is evident in recent industry data regarding facility oversight. According to the European Federation of Pharmaceutical Industries and Associations (EFPIA), in 2024, the frequency of 'for cause' inspections—assessments triggered by specific compliance concerns—doubled compared to the previous year. This sharp increase in regulatory scrutiny creates a volatile operating environment where approval timelines are unpredictable. Such uncertainty hampers the ability of manufacturers to guarantee strict delivery schedules, ultimately constraining the market's ability to scale efficiently in response to rising global demand.

Key Market Trends

Accelerated adoption of continuous manufacturing technologies is fundamentally changing the production landscape for oral solid dosages by replacing traditional batch processes with fully integrated flow systems. This operational shift allows contract manufacturers to significantly reduce development timelines and footprint requirements while enhancing product quality through real-time monitoring. Such capabilities are increasingly critical for handling the growing volume of precision medicines and facilitating flexible small-volume production. According to Hovione, October 2025, in the press release 'Hovione Completes Initial $100M Investment Cycle to Expand U.S. Operations at New Jersey Manufacturing Site', the company finalized a major facility expansion that explicitly integrates commercial-scale continuous tableting capacity to meet the evolving technical demands of North American pharmaceutical clients.

Strategic reshoring and nearshoring of manufacturing supply chains have become a primary priority for the industry as companies seek to mitigate geopolitical risks and reduce dependency on fragmented global networks. This trend is driving a substantial migration of oral solid dosage production capacity back to domestic hubs in the United States and Europe to ensure supply security for essential medicines. Consequently, large pharmaceutical entities are directing massive capital inflows into local infrastructure to establish robust and self-reliant production ecosystems. According to Think Global Health, November 2025, in the article 'Tracking Pharma's Progress on U.S. Onshoring Efforts to Avoid Tariffs', thirteen major pharmaceutical companies have collectively pledged more than $480 billion in investments toward expanding U.S. manufacturing capabilities over the next decade.

Segmental Insights

Market intelligence indicates that Granules are the fastest-growing segment within the Global Oral Solid Dosage (OSD) Contract Manufacturing Market. This surge is primarily driven by the escalating demand for patient-centric formulations tailored to geriatric and pediatric demographics, where dysphagia presents a significant challenge. Granules provide a critical solution by offering easier administration and superior stability compared to liquid alternatives. Furthermore, the segment benefits from the increasing adoption of stick packs and sachets for high-dose medications. Support from regulatory institutions like the US FDA for age-appropriate dosage forms continues to validate and propel this expansion.

Regional Insights

North America dominates the Global Oral Solid Dosage Contract Manufacturing Market due to the high concentration of major pharmaceutical companies and their increasing reliance on outsourcing strategies. The strict regulatory framework established by the U.S. Food and Drug Administration (FDA) drives this demand, as companies seek partners capable of meeting rigorous compliance requirements. Additionally, the region attracts significant investment in drug development, creating a steady need for external manufacturing capacities. This combination of regulatory enforcement and industrial activity maintains North America's leading status in the global market.

Recent Developments

• In October 2025, Quotient Sciences entered into a strategic partnership with Biorasi, a global clinical research organization, to accelerate early-phase clinical trials and optimize drug development timelines. This collaboration integrates Quotient Sciences' proprietary Translational Pharmaceutics® platform, which combines formulation development, real-time drug product manufacturing, and clinical testing, with Biorasi’s speed-to-market operational strategies. The alliance aims to support small and mid-sized biopharmaceutical companies by streamlining the transition from First-in-Human studies to Proof-of-Concept, thereby reducing development risks and costs. The partnership specifically leverages Quotient’s specialized capabilities in oral solid dosage formulation and manufacturing to deliver fully integrated solutions for complex small molecule programs.
• In August 2025, Piramal Pharma Solutions announced a significant expansion of its manufacturing capabilities through a collaboration with NewAmsterdam Pharma Company N.V. The company unveiled a dedicated oral solid dosage (OSD) suite at its facility in Sellersville, Pennsylvania, established to support the commercial production of a fixed-dose combination therapy for cardiovascular disease. This multi-million-dollar investment includes the installation of advanced equipment for granulation, compression, and coating, specifically designed to manufacture complex multi-layer tablets. The new suite highlights Piramal’s patient-centric approach and its ability to utilize a global network for dual sourcing, ensuring a reliable supply of high-quality oral solid medications.
• In December 2024, Lonza launched a tailored service offering designed to support the development and manufacturing of smart capsules for orally delivered biologic therapies. This new capability, introduced at the company’s Innovaform® Accelerator in Colmar, France, addresses the technical challenges faced by developers of ingestible devices that deliver drugs to specific regions of the gastrointestinal tract. The offering combines Lonza’s expertise in capsule engineering and polymer science with specialized bi-layer manufacturing technologies to enhance the bioavailability of oral biologics. This launch targets the emerging market for non-invasive delivery systems, providing a comprehensive solution from initial prototyping to commercial-scale manufacturing of these innovative oral solid dosage forms.
• In December 2024, Cambrex signed a strategic agreement with Eli Lilly and Company to provide accelerated access to clinical development and manufacturing services for the pharmaceutical company's biotech collaborators. Under this arrangement, Cambrex will partner with Lilly’s external innovation arm to supply critical drug substance and drug product capabilities, including oral solid dosage formulation and manufacturing. The services will be primarily executed at Cambrex’s facility in Longmont, Colorado, which specializes in early-stage development and small molecule production. This partnership aims to expedite the progression of investigational new drugs into clinical trials by leveraging Cambrex’s scientific expertise and flexible manufacturing capacity to support Lilly’s network of innovators.

Key Market Players

• AbbVie Inc.
• Acino International AG
• Aenova Holding GmbH
• Beximco Pharmaceuticals Ltd
• Boehringer Ingelheim International GmbH
• Catalent Inc.
• Corden Pharma International GmbH,
• PerkinElmer Inc.
• Pyramid Laboratories Inc.
• Siegfried AG

By Product	By End User	By Region
Tablets Capsules Powders Granules Others	Large-size companies Small & medium size companies Startups and generic pharmaceutical companies	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Oral Solid dosage (OSD) Contract Manufacturing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Oral Solid dosage (OSD) Contract Manufacturing Market, By Product:

• Tablets
• Capsules
• Powders
• Granules
• Others

• Oral Solid dosage (OSD) Contract Manufacturing Market, By End User:

• Large-size companies
• Small & medium size companies
• Startups and generic pharmaceutical companies

• Oral Solid dosage (OSD) Contract Manufacturing Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE