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The 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 by 2030, rising at a CAGR of 6.52%. 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. Speak directly to the analyst to clarify any post sales queries you may have.
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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.
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.
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.
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
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
Competitive Landscape
Company Profiles: Detailed analysis of the major companies present in the Global Oral Solid dosage (OSD) Contract Manufacturing Market.Available Customizations:
With the given market data, the publisher 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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Table of Contents
1. Product Overview
2. Research Methodology
3. Executive Summary
5. Global Oral Solid dosage (OSD) Contract Manufacturing Market Outlook
6. North America Oral Solid dosage (OSD) Contract Manufacturing Market Outlook
7. Europe Oral Solid dosage (OSD) Contract Manufacturing Market Outlook
8. Asia-Pacific Oral Solid dosage (OSD) Contract Manufacturing Market Outlook
9. South America Oral Solid dosage (OSD) Contract Manufacturing Market Outlook
10. Middle East and Africa Oral Solid dosage (OSD) Contract Manufacturing Market Outlook
11. Market Dynamics
12. Market Trends & Developments
13. Porters Five Forces Analysis
14. Competitive Landscape
Companies Mentioned
- 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
Table Information
Report Attribute | Details |
---|---|
No. of Pages | 182 |
Published | February 2025 |
Forecast Period | 2024 - 2030 |
Estimated Market Value ( USD | $ 40.92 Billion |
Forecasted Market Value ( USD | $ 59.86 Billion |
Compound Annual Growth Rate | 6.5% |
Regions Covered | Global |
No. of Companies Mentioned | 10 |