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, 2020-2030F

Market Overview

Global Oral Solid dosage (OSD) Contract Manufacturing Market was valued at USD 40.92 Billion in 2024 and is expected to reach USD 59.86 Billion in the forecast period with a CAGR of 6.52% through 2030. The Global Oral Solid Dosage (OSD) Contract Manufacturing Market is witnessing substantial growth due to the increasing demand for cost-effective pharmaceutical production, outsourcing trends among pharmaceutical companies, and technological advancements in drug formulation. OSD forms, including tablets, capsules, and powders, remain the preferred choice for drug manufacturers due to their stability, ease of administration, and extended shelf life. Pharmaceutical companies are increasingly outsourcing OSD manufacturing to contract development and manufacturing organizations (CDMOs) to optimize costs, improve efficiency, and focus on core competencies such as research and development. This outsourcing trend is further fueled by the growing complexity of drug formulations, which requires specialized expertise and advanced manufacturing capabilities. The rising prevalence of chronic diseases, coupled with a growing geriatric population, is driving the demand for solid oral dosage forms, particularly in therapeutic areas such as cardiovascular diseases, oncology, and central nervous system disorders.

Technological advancements and innovation in drug formulation are shaping the market landscape, with a focus on bioavailability enhancement, controlled-release formulations, and patient-centric dosage forms. The development of novel excipients and advanced manufacturing technologies, such as continuous manufacturing and 3D printing, is enabling pharmaceutical companies to improve drug efficacy and production efficiency. Regulatory agencies are emphasizing stringent compliance requirements, pushing contract manufacturers to invest in quality control, Good Manufacturing Practices (GMP), and automation to ensure consistent product quality. Sustainability has also emerged as a key trend, with companies increasingly adopting eco-friendly manufacturing processes, optimizing waste management, and reducing carbon footprints. The shift towards personalized medicine and precision dosing has led to increased demand for flexible manufacturing solutions that allow for smaller batch sizes and customized formulations, further driving innovation in the sector.

Challenges in the Global OSD Contract Manufacturing Market include regulatory hurdles, pricing pressures, and supply chain disruptions. Stringent compliance requirements across different regions demand substantial investments in regulatory expertise and facility upgrades, increasing operational costs for contract manufacturers. Competitive pricing strategies among CDMOs exert downward pressure on profit margins, making it essential for companies to differentiate through value-added services and technological capabilities. Supply chain complexities, including raw material shortages, transportation delays, and geopolitical uncertainties, pose risks to manufacturing timelines and product availability. Intellectual property concerns and data security issues also impact outsourcing decisions, particularly in markets with stringent confidentiality requirements. Despite these challenges, the market presents significant growth opportunities, particularly with increasing demand for high-potency drugs, pediatric formulations, and geriatric-friendly dosage forms, driving investments in advanced formulation techniques and manufacturing innovations.

Key Market Drivers

Focus on Core Competencies

Pharmaceutical companies are increasingly focusing on their core competencies, such as drug discovery, research, and commercialization, while outsourcing manufacturing to specialized contract development and manufacturing organizations (CDMOs). This strategic shift is a key driver for the Global Oral Solid Dosage (OSD) Contract Manufacturing Market, allowing pharmaceutical firms to enhance efficiency, reduce operational costs, and allocate resources toward innovation and market expansion. The complexity of modern drug development, coupled with stringent regulatory requirements, has made in-house manufacturing less viable for many companies, prompting them to rely on CDMOs that offer expertise in formulation, production, and compliance.

CDMOs provide end-to-end manufacturing solutions, including process optimization, quality control, and packaging, which help pharmaceutical companies accelerate time-to-market for new drugs. By outsourcing OSD manufacturing, companies can mitigate the risks associated with facility maintenance, equipment upgrades, and workforce management. This is particularly beneficial for small and mid-sized pharmaceutical firms that lack the infrastructure to establish large-scale production facilities. Access to advanced manufacturing technologies, such as continuous manufacturing and automation, allows pharmaceutical companies to improve product quality while ensuring regulatory adherence without making significant capital investments.

The increasing complexity of oral drug formulations, including controlled-release tablets, orally disintegrating tablets (ODTs), and high-potency active pharmaceutical ingredients (HPAPIs), has further fueled the demand for specialized CDMO services. Pharmaceutical companies seek manufacturing partners with the expertise and infrastructure to handle sophisticated formulations while maintaining production efficiency. Global pharmaceutical firms are also leveraging CDMOs to support geographic expansion, enabling localized manufacturing and regulatory compliance in multiple markets. This trend is expected to continue as companies prioritize core activities while relying on contract manufacturers to handle the complexities of large-scale OSD production. The shift toward outsourcing is transforming the pharmaceutical landscape, positioning CDMOs as essential partners in the industry’s growth.

Increasing Drug Development

The increasing drug development pipeline is significantly driving the growth of the Global Oral Solid Dosage (OSD) Contract Manufacturing Market. In 2023, the U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER) approved 55 novel drugs, marking the second-highest count in the past 30 years. This surge in approvals reflects the pharmaceutical industry's intensified research and development (R&D) efforts. Notably, the world's top 20 pharmaceutical companies collectively invested USD 145 billion in R&D during 2022-2023, up from USD 139 billion in the previous year. This substantial investment underscores the commitment to introducing innovative therapies across various disease areas, including cardiovascular disorders, neurological conditions, metabolic diseases, and infectious diseases.

The growing prevalence of chronic illnesses and the need for affordable treatments have fueled the expansion of generic drug manufacturing, leading to a higher demand for contract manufacturing services. As pharmaceutical firms focus on optimizing resources and reducing production costs, they are increasingly outsourcing drug manufacturing to specialized contract development and manufacturing organizations (CDMOs) with expertise in OSD formulations.

Advancements in drug discovery techniques, such as artificial intelligence-driven drug design and high-throughput screening, have accelerated the pace of new drug development. This surge in pipeline candidates necessitates scalable and flexible manufacturing solutions to support clinical trials and commercial-scale production. CDMOs play a crucial role in expediting the transition from drug development to market launch by offering expertise in formulation optimization, regulatory compliance, and large-scale manufacturing capabilities. The complexity of modern drug formulations, including combination therapies and high-potency active pharmaceutical ingredients (HPAPIs), requires specialized manufacturing technologies that many pharmaceutical companies lack in-house.

The rise of orphan drugs and targeted therapies has increased the demand for smaller, flexible batch production, allowing contract manufacturers to cater to personalized medicine requirements. The growing emphasis on lifecycle management strategies, such as reformulating existing drugs for improved efficacy and patient compliance, is also contributing to market expansion. With an increasing number of drug approvals and the continuous need for innovation in oral dosage forms, the role of OSD contract manufacturers is becoming more integral to the pharmaceutical industry’s growth and sustainability.

Technological Advancements

Technological advancements are significantly propelling the growth of the Global Oral Solid Dosage (OSD) Contract Manufacturing Market by enhancing production efficiency, improving drug formulations, and ensuring higher quality standards. The integration of automation, robotics, and artificial intelligence (AI) into manufacturing processes has markedly reduced human errors, improved consistency, and increased production scalability. Automated systems enable real-time monitoring of critical parameters, leading to better control over batch quality and minimizing the risk of deviations. AI-driven predictive analytics optimize supply chain management, allowing contract manufacturers to forecast demand accurately and manage raw material procurement efficiently.

Innovations in drug formulation technologies are facilitating the development of more effective and patient-friendly oral solid dosage forms. Advancements in controlled-release and multi-layer tablet formulations enhance drug bioavailability, reduce dosing frequency, and improve patient adherence. The adoption of hot-melt extrusion, spray drying, and nanotechnology-based drug delivery systems enables contract manufacturers to handle poorly soluble active pharmaceutical ingredients (APIs) and develop formulations with improved stability. Continuous manufacturing technologies are replacing traditional batch processes, offering higher production efficiency, reduced waste, and faster product turnaround times. This transition aids pharmaceutical companies in bringing new drugs to market more swiftly while maintaining stringent regulatory compliance.

Regulatory agencies are actively encouraging the adoption of advanced manufacturing technologies to enhance product quality and consistency. In March 2023, the U.S. Food and Drug Administration (FDA) issued the International Council for Harmonisation (ICH) final guidance, Q13 Continuous Manufacturing of Drug Substances and Drug Products, outlining scientific and regulatory considerations for implementing continuous manufacturing. 

The FDA has also established a framework for Process Analytical Technology (PAT) to support innovation and efficiency in pharmaceutical development, manufacturing, and quality assurance. The implementation of real-time release testing (RTRT) and PAT streamlines quality assurance by enabling in-line monitoring and reducing the need for extensive post-production testing. Digitalization and cloud-based manufacturing execution systems (MES) facilitate seamless data integration, ensuring transparency, traceability, and compliance with evolving regulatory standards. The rise of Industry 4.0 in pharmaceutical manufacturing is transforming OSD contract manufacturing by making processes more efficient, cost-effective, and adaptable to the growing demand for high-quality pharmaceutical products.

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Key Market Challenges

Quality Control and Assurance

Quality Control (QC) and Quality Assurance (QA) are paramount in the Oral Solid Dosage (OSD) Contract Manufacturing Market, ensuring that pharmaceutical products meet stringent quality standards throughout the manufacturing process. QC encompasses the systematic inspection and testing of raw materials, in-process samples, and finished dosage forms to verify their compliance with predetermined specifications. This involves a series of analytical techniques, such as chromatography, spectroscopy, and dissolution testing, to assess attributes like potency, purity, and dissolution rates. Simultaneously, QA focuses on the overarching systems, procedures, and processes that safeguard product quality from the initial development phase to the final delivery of the product to the market. This includes establishing and maintaining robust quality management systems, implementing GMP guidelines, conducting audits, and overseeing compliance with regulatory requirements. In the OSD Contract Manufacturing Market, ensuring QC and QA is critical for several reasons. Firstly, pharmaceutical products must consistently meet safety and efficacy standards to protect patient health and maintain regulatory compliance. Secondly, pharmaceutical companies rely on contract manufacturers to maintain high-quality standards to safeguard their reputation and prevent regulatory penalties. Thirdly, the global nature of pharmaceutical markets means that products manufactured by OSD CMOs may need to meet different regulatory requirements in various regions, making comprehensive QA and QC systems indispensable. Finally, the complexity of OSD manufacturing processes, the multitude of dosage forms, and the evolving regulatory landscape necessitate a commitment to ongoing QA and QC improvements, including the implementation of cutting-edge analytical technologies and process controls to ensure the highest quality standards are met. Ultimately, QC and QA play a pivotal role in the OSD Contract Manufacturing Market by guaranteeing the safety, efficacy, and consistency of pharmaceutical products, fostering trust between contract manufacturers and pharmaceutical companies, and facilitating compliance with global regulatory standards.

Intellectual Property Issues

Intellectual Property (IP) issues in the Oral Solid Dosage (OSD) Contract Manufacturing Market pertain to the protection of proprietary information, formulations, and technologies during the outsourcing of manufacturing processes to Contract Manufacturing Organizations (CMOs). Pharmaceutical companies often possess valuable IP related to drug formulations, manufacturing methods, and other critical processes. When outsourcing OSD production to CMOs, there is a risk of unintentional IP exposure or infringement if adequate safeguards are not in place. Securing IP rights and managing these issues are essential challenges. One major concern is the protection of confidential information and trade secrets. Pharmaceutical firms must ensure that sensitive data, including proprietary formulations and production techniques, is not disclosed or misappropriated during the manufacturing process. Non-disclosure agreements (NDAs) and confidentiality clauses in contracts are common tools used to address this concern. Another aspect of IP issues is patent protection. Pharmaceutical companies hold patents on drug formulations and processes, and outsourcing OSD manufacturing requires careful consideration of patent rights. Contract manufacturers need access to patented information to carry out production but must do so within the bounds of licensing agreements. Additionally, there are concerns related to data exclusivity and regulatory data protection. Some countries provide exclusivity periods during which the original drug manufacturer has exclusive rights to the data submitted for regulatory approval. Contract manufacturers must adhere to these exclusivity periods when working with clients' proprietary data. Dispute resolution mechanisms and clear contractual agreements are vital to addressing IP issues. Contracts should define ownership of IP developed during the manufacturing process and outline procedures for dispute resolution in case of IP-related conflicts. Overall, navigating intellectual property issues in OSD contract manufacturing requires a delicate balance between sharing necessary information for production and safeguarding valuable IP rights. Careful legal and contractual considerations are essential to protect the interests of both pharmaceutical companies and contract manufacturers.

Key Market Trends

Growing Shift towards Biopharmaceuticals and Complex Formulations

The Global Oral Solid Dosage (OSD) Contract Manufacturing Market is experiencing a significant shift towards biopharmaceuticals and complex formulations, driven by the need for innovative drug delivery solutions and enhanced patient compliance. Advancements in formulation science have enabled the development of oral solid biopharmaceuticals, including peptide and protein-based drugs, which were traditionally administered via injection. This transition to oral forms not only improves patient adherence but also broadens therapeutic options for chronic conditions such as diabetes, autoimmune disorders, and oncology. Contract Development and Manufacturing Organizations (CDMOs) are investing in specialized technologies, such as enteric coatings, lipid-based delivery systems, and nanoparticle formulations, to enhance the bioavailability and stability of these complex molecules.

The demand for high-potency active pharmaceutical ingredients (HPAPIs) is on the rise, necessitating advanced containment systems and sophisticated manufacturing capabilities. The adoption of modified-release and multi-layer tablet technologies allows for precise control over drug release profiles, thereby improving therapeutic efficacy. Pharmaceutical companies are increasingly leveraging the expertise of CDMOs in these areas to develop customized solutions that meet stringent regulatory standards while maintaining production efficiency. Continuous manufacturing processes are gaining traction, offering benefits such as improved scalability, cost reduction, and shorter production timelines compared to traditional batch processing methods.

The integration of artificial intelligence (AI) and digital analytics into formulation development is revolutionizing the industry by enabling data-driven decision-making, optimizing drug design, and accurately predicting stability outcomes. Regulatory agencies, including the U.S. Food and Drug Administration (FDA), are actively exploring the application of AI in drug manufacturing to enhance process control and product quality. Sustainability concerns are also prompting manufacturers to adopt eco-friendly excipients, solvent-free production techniques, and energy-efficient processes. As pharmaceutical pipelines increasingly incorporate biologics and complex oral formulations, CDMOs that invest in specialized capabilities, regulatory expertise, and advanced process controls are well-positioned to capitalize on this evolving market landscape.

Sustainability and Green Manufacturing

The Global Oral Solid Dosage (OSD) Contract Manufacturing Market is witnessing a significant shift toward sustainability and green manufacturing practices, driven by environmental regulations and industry initiatives. The U.S. Environmental Protection Agency (EPA) reports that the industrial sector accounts for approximately 30% of U.S. greenhouse gas emissions, primarily from energy use in manufacturing plants. In response, pharmaceutical companies and contract manufacturers are adopting environmentally responsible production methods to reduce their carbon footprints.

One notable trend is the integration of advanced manufacturing technologies that enhance efficiency and minimize environmental impact. The U.S. Food and Drug Administration (FDA) supports the growth of advanced manufacturing, noting that such platforms can significantly reduce the environmental impact of pharmaceutical production. Continuous manufacturing techniques, for instance, streamline production processes, leading to reduced energy consumption and waste generation compared to traditional batch processing.

Pharmaceutical companies are also focusing on product-specific sustainability initiatives. For example, leading firms are developing environmentally friendly asthma inhalers to reduce greenhouse gas emissions. Modifying the propellant in inhalers has the potential to cut a company's carbon footprint by over 40%. Such efforts reflect a broader industry commitment to redesign products and processes for environmental sustainability.

Regulatory bodies are playing a crucial role in promoting green manufacturing practices. The EPA's enforcement activities have led to commitments from industries to reduce, treat, or eliminate over 73 million pounds of pollution in fiscal year 2023. These regulatory pressures, combined with consumer and investor interest in environmentally responsible business practices, are compelling pharmaceutical manufacturers to adopt energy-efficient technologies, utilize eco-friendly materials, and implement comprehensive waste management systems.

In summary, the OSD contract manufacturing sector is increasingly embracing sustainability and green manufacturing. This transition is driven by regulatory requirements, technological advancements, and a growing recognition of the environmental impact of pharmaceutical production. As companies continue to innovate and implement eco-conscious practices, the industry is poised to achieve significant environmental benefits while maintaining operational efficiency.

Segmental Insights

Product Insights

Based on the Product, Tablets emerged as the dominant segment in the Global Oral Solid dosage (OSD) Contract Manufacturing Market in 2024. This is driven by their widespread preference among pharmaceutical companies and consumers. Tablets offer advantages such as ease of administration, longer shelf life, cost-effectiveness, and precise dosing, making them the most commonly prescribed oral dosage form. Their stability compared to liquid formulations enhances their appeal for large-scale contract manufacturing, ensuring longer storage periods and reduced transportation challenges. Pharmaceutical companies increasingly outsource tablet production to contract manufacturers to optimize costs and focus on core competencies such as drug discovery and marketing. Contract manufacturing organizations (CMOs) specialize in high-volume tablet production using advanced technologies like continuous manufacturing and film coating, ensuring consistency, scalability, and regulatory compliance. Additionally, the rising demand for modified-release and orally disintegrating tablets has further driven contract manufacturing partnerships to cater to evolving patient preferences. Generic drug manufacturers also rely heavily on contract manufacturing for tablet production, as they seek cost-efficient solutions to meet the rising demand for affordable medicines. These factors collectively contribute to the dominance of tablets in the OSD contract manufacturing market.

End User Insights

Based on the End User, Large-size companies emerged as the dominant segment in the Global Oral Solid dosage (OSD) Contract Manufacturing Market in 2024. This is driven by their extensive outsourcing strategies to optimize production efficiency and reduce operational costs. Large pharmaceutical companies increasingly partner with contract manufacturing organizations (CMOs) to enhance scalability, streamline supply chains, and ensure compliance with stringent regulatory standards. These companies focus on research, development, and commercialization, while CMOs handle bulk production, enabling faster market entry and cost-effective manufacturing solutions. The growing complexity of drug formulations, including sustained-release and combination therapies, has further propelled large pharmaceutical companies to rely on specialized CMOs with advanced capabilities in tablet and capsule manufacturing. As blockbuster drugs lose patent protection, these firms seek contract manufacturers to efficiently produce high-volume generics and expand market reach without investing heavily in new production facilities. Additionally, stringent regulatory requirements across regions such as the U.S. FDA and the European Medicines Agency (EMA) have made compliance a critical factor, compelling large firms to collaborate with CMOs that offer expertise in Good Manufacturing Practices (GMP). The increasing prevalence of chronic diseases and rising demand for oral solid dosage formulations in both developed and emerging markets have further strengthened the dominance of large-size companies in the OSD contract manufacturing market.

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Regional Insights

North America emerged as the dominant region in the Global Oral Solid dosage (OSD) Contract Manufacturing Market in 2024. This is due to its strong pharmaceutical industry, advanced manufacturing infrastructure, and stringent regulatory compliance standards. The presence of leading pharmaceutical companies and contract manufacturing organizations (CMOs) in the region has fueled market expansion, as firms increasingly outsource production to optimize efficiency, reduce costs, and accelerate time-to-market for new drug formulations. The region’s well-established supply chain, coupled with high investment in research and development, has further strengthened its leadership in the OSD contract manufacturing sector. Stringent regulatory frameworks set by the U.S. Food and Drug Administration (FDA) and Health Canada have necessitated compliance with Good Manufacturing Practices (GMP), prompting pharmaceutical companies to collaborate with CMOs that specialize in regulatory adherence. Additionally, the increasing prevalence of chronic diseases, including cardiovascular disorders, diabetes, and neurological conditions, has driven demand for oral solid dosage forms such as tablets and capsules. This has led to heightened outsourcing activities by both branded and generic pharmaceutical manufacturers in the region.

The rapid adoption of advanced technologies, including continuous manufacturing, high-potency active pharmaceutical ingredient (HPAPI) handling, and precision dosing, has further positioned North America as the leader in the OSD contract manufacturing market. The rising need for cost-effective, large-scale production and strong presence of key market players have solidified the region’s dominance.

Recent Development

• In February 2025, Jabil Inc. completed the acquisition of Pharmaceutics International, Inc. (Pii), a CDMO specializing in aseptic filling, lyophilization, and oral solid dose manufacturing for early-stage, clinical, and commercial production.
• In November 2024, Thermo Fisher Scientific launched Accelerator Drug Development, a comprehensive CDMO and CRO service suite, integrating capabilities from PPD and Patheon. Announced at CPHI Milan 2024, the “360°” drug development solutions aim to enhance efficiency in pharmaceutical research, development, and manufacturing.
• In October 2024, Rottendorf Pharma, a leading contract development and manufacturing organization (CDMO) based in Germany, selected ValGenesis VLMS to streamline and digitize its corporate validation process. The decision followed a comprehensive evaluation of digital validation solutions, reinforcing Rottendorf Pharma’s commitment to enhancing operational efficiency, compliance, and data integrity through advanced digital technologies.
• In October 2024, Catalent, Inc. announced a definitive agreement to sell its oral solids development and small-scale manufacturing facility in Somerset, NJ to Ardena, a CDMO with operations in Belgium, Spain, the Netherlands, and Sweden.
• In September 2024, Thermo Fisher Scientific announced the expansion of its oral solid dose (OSD) development and manufacturing capabilities across North America. With a USD 22 million investment since 2021, the company is enhancing its Cincinnati, Ohio, and Bend, Oregon sites to support biotech and pharmaceutical firms in overcoming early development challenges. The expansion doubles the footprint of the Bend facility and continues a multi-year investment plan in Cincinnati, strengthening Thermo Fisher’s global CDMO and CRO network by advancing R&D, manufacturing, and testing of OSD drug formulations.

• 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

 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:

o   Tablets

o   Capsules

o   Powders

o   Granules

o   Others

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

o   Large-size companies

o   Small & medium size companies

o   Startups and generic pharmaceutical companies

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

o   North America

§  United States

§  Canada

§  Mexico

o   Europe

§  France

§  United Kingdom

§  Italy

§  Germany

§  Spain

o   Asia-Pacific

§  China

§  India

§  Japan

§  Australia

§  South Korea

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Oral Solid dosage (OSD) Contract Manufacturing Market.

Available Customizations:

Global Oral Solid dosage (OSD) Contract Manufacturing Market report with the given Market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional Market players (up to five).

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