Oral Solid Dosage Contract Manufacturing Market Size 2024-2028 

The oral solid dosage (OSD) contract manufacturing market size is forecast to increase by USD 14.2 billion at a CAGR of 6.84% between 2023 and 2028. The market is experiencing significant growth due to several key factors. With the aging population in the US, there is a rising demand for various OSD formulations, including geriatric-specific treatments in the form of granules, powders, and sachets. Additionally, there is an increasing preference for advanced delivery systems such as dry powder inhalers and lozenges. Physical stability and package design are crucial considerations for OSD manufacturers to ensure effective treatment and transportation. Capacity utilization and patent expiry are also driving market growth, as more US FDA-approved manufacturing facilities come online to meet the increasing demand for generic drugs. However, challenges remain, including regulatory compliance and ensuring consistent product quality. To stay competitive, OSD contract manufacturers must continuously innovate and invest in technology to meet the evolving needs of their customers.

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The market is a significant segment within the pharmaceutical industry, focusing on the production of tablets, capsules, and other oral solid forms of drugs. This market caters to various needs, including the development of novel formulations for large molecule counterparts and addressing medication adherence problems. Patient-centric solutions are increasingly becoming essential in the OSD market. Modified oral solid formulations, including prolonged release dosage forms, controlled release dosage forms, and sustained release dosage forms, are designed to improve drug delivery by maintaining therapeutic levels over an extended period, enhancing patient compliance and treatment outcomes. One such solution is Disintegrating Tablets (ODTs), which offer advantages like faster disintegration and improved bioavailability. These tablets are particularly beneficial for patients who struggle with swallowing traditional solid dosage forms.

Moreover, contract manufacturing companies play a crucial role in the OSD market, providing specialized solid doses for drug developers. These companies offer multidisciplinary expertise in formulation development, production, and quality control, ensuring the production of high-quality OSDs. The manufacturing of OSDs, including tablets and capsules, requires addressing challenges such as API solubility and bioavailability. Contract manufacturing companies employ advanced technologies and techniques to optimize these aspects, ensuring the efficacy and safety of the final product. The market caters to various sectors, including pediatric populations, for whom specialized formulations are essential. Contract manufacturing companies offer solutions tailored to these populations, ensuring the production of age-appropriate dosage forms and flavors.

Furthermore, combination products, which consist of a drug and a device, are gaining popularity in the OSD market. Contract manufacturing companies provide expertise in the production of these complex formulations, ensuring compliance with stringent regulatory requirements. The OSD market also caters to the needs of drug developers working with highly potent APIs. Contract manufacturing companies offer solutions to handle these substances safely and effectively, ensuring the production of high-quality OSDs. Early development formulations are another area where contract manufacturing companies excel. These companies offer services from preclinical development through to commercial production, ensuring a seamless transition from lab to market.

Market Segmentation

The market research report provides comprehensive data (region-wise segment analysis), with forecasts and estimates in "USD billion" for the period 2024-2028, as well as historical data from 2018-2022 for the following segments.

• End-user
  • Large-size companies
  • Small and medium size companies
  • Startups and generic pharmaceutical companies
• Product
  • Tablets
  • Capsules
  • Powders
  • Granules and others
• Geography
  • Asia
    • China
    • Japan
  • North America
    • Canada
    • US
  • Europe
    • Germany
  • Rest of World (ROW)

By End-user Insights

The large-size companies segment is estimated to witness significant growth during the forecast period. The market has experienced significant growth in the past 25 years, particularly among large pharmaceutical companies. These companies, also known as big pharma, often have separate divisions dedicated to producing OSD forms. Outsourcing to a Contract Manufacturing Organization (CMO) allows these companies to expand their technological resources without incurring higher overhead costs. OSD forms, including tablets and capsules, require complex manufacturing processes. Chemical stability is crucial during production to ensure the dosing accuracy and effectiveness of the medication. Coating methods, such as enteric coating and film coating, are used to improve swallowing and modify color. Shape modification and color modification are also important for patient compliance and market differentiation.

Furthermore, production costs, toxicity, quality deviations, utility disruptions, and transportation disruptions are challenges that CMOs must address to maintain the highest standards in OSD manufacturing. Pharmaceutical clients rely on CMOs to produce high-quality OSD forms for both clinical and commercial-stage manufacturing. The increasing demand for generic drugs and biologics, the capital-intensive nature of the pharmaceutical industry, and the complex manufacturing requirements make CMOs an essential partner for big pharma.

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The large-size companies segment was valued at USD 15.10 billion in 2018 and showed a gradual increase during the forecast period.

Regional Insights

Asia is estimated to contribute 45% to the growth of the global market during the forecast period. Technavio's analysts have elaborately explained the regional trends and drivers that shape the market during the forecast period.

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The Asian market is projected to experience substantial expansion over the forecast period. This growth can be attributed to the substantial market penetration of generic medications and the rising adoption of sophisticated technologies in emerging economies, such as India and China. India is projected to be the most rapidly expanding CMO market due to its cost-effective manufacturing solutions. However, China presently leads the CMO market in Asia and is anticipated to maintain its dominance throughout the forecast period. Both China and India are increasingly preferred by companies due to their cost advantages compared to developed countries in Europe and North America. Advanced technologies, including nano milling and 3D printing, are being employed in agile, responsive, and reproducing manufacturing processes to reduce operating costs, enhance product quality, and expedite time to market. These factors collectively contribute to the strong growth of the Asian OSD contract manufacturing market.

Our researchers analyzed the data with 2023 as the base year, along with the key drivers, trends, and challenges. A holistic analysis of drivers will help companies refine their marketing strategies to gain a competitive advantage.

Market Driver

Patent expiry and increasing demand for generic drugs is the key driver of the market. The market encompasses the production of novel formulations in the form of tablets and capsules for various drugs, including their large molecule counterparts. This sector is experiencing significant growth due to the increasing focus on patient-centric solutions that address medication adherence issues. One such innovation is disintegrating tablets (ODTs), which offer improved convenience and compliance. Furthermore, the development of combination products and addressing API solubility challenges are other key trends driving market expansion. The generic drugs industry is thriving due to the increasing need to reduce healthcare costs. Governments worldwide are advocating for the use of affordable generic medications.

Furthermore, in emerging markets like South Korea, over 50 patents affecting approximately 150 pharmaceutical products are set to expire in 2023, providing ample opportunities for OSD contract manufacturers. In the United States, the OSD Contract Manufacturing Market is witnessing substantial growth due to the increasing demand for cost-effective and efficient drug production solutions. The market is driven by the need for novel formulations, addressing patient compliance issues, and the development of combination products. The focus on improving medication adherence through innovative formulations and the production of ODTs is expected to fuel market growth. Additionally, the ongoing trend of API solubility enhancement is a significant factor contributing to market expansion.

Market Trends

An increasing number of US FDA-approved manufacturing facilities is the upcoming trend in the market. The market encounters challenges with capacity utilization, a critical factor determining the production output of a manufacturing unit compared to its established capacity. Capacity utilization plays a significant role in the production of various therapeutic formulations, including granules, powders, sachets, lozenges, and dry powder inhalers.

Furthermore, approximately 35% of Contract Manufacturing Organizations (CMOs) encounter minor constraints, such as time, cost, and resource-related issues, during the manufacturing process. Conversely, 20% of CMOs face moderate to severe constraints, impacting the physical stability and transportation of these OSD treatments. Ensuring optimal capacity utilization is essential for maintaining treatment quality and meeting the growing demands of the geriatric population, who rely on these formulations for various health conditions.

Market Challenge

Capacity utilization and other constraints is a key challenge affecting the market growth. The market is a critical sector in the pharmaceutical industry, catering to the needs of drug developers by producing specialized solid doses. This process involves ensuring optimal bioavailability of drugs, which can be challenging due to the complexities of manufacturing highly potent APIs and early development formulations. Contract manufacturing companies require multidisciplinary expertise to navigate stringent regulatory requirements and deliver complex formulations.

Furthermore, capacity utilization is a significant concern in this market, with approximately 35% of contract manufacturing organizations (CMOs) encountering minor constraints, such as time, cost, and resources, during the manufacturing process. Meanwhile, 20% of CMOs face moderate to major constraints due to capacity limitations. Meeting the needs of the pediatric population, another crucial aspect of the OSD market, adds to the complexity of the manufacturing process. To remain competitive, CMOs must maintain high levels of efficiency and quality, making it essential to work with multiple suppliers and stay updated on the latest industry trends.

Exclusive Customer Landscape

The market forecasting report includes the adoption lifecycle of the market, covering from the innovator's stage to the laggard's stage. It focuses on adoption rates in different regions based on penetration. Furthermore, the report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their market growth analysis strategies.

 Customer Landscape

Key Companies & Market Insights

Companies are implementing various strategies, such as strategic alliances, partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the market.

AbbVie Inc: The company offers oral solid dosage contract manufacturing services such as blister packaging and strip packaging.

The market research and growth report includes detailed analyses of the competitive landscape of the market and information about key companies, including:

• Acino International AG
• Aenova Holding GmbH
• Beximco Pharmaceuticals Ltd.
• Boehringer Ingelheim International GmbH
• Catalent Inc.
• Corden Pharma International GmbH
• Inglasia Pharma Solutions
• Jubilant Pharmova Ltd.
• Koninklijke DSM NV
• Lonza Group Ltd.
• Merck KGaA
• NextPharma GmbH
• Perkin Elmer Inc.
• Piramal Enterprises Ltd.
• Pyramid Laboratories Inc.
• Recipharm AB
• Siegfried Holding AG
• Thermo Fisher Scientific Inc.
• Viatris Inc.

Qualitative and quantitative analysis of companies has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key market players. Data is qualitatively analyzed to categorize companies as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize companies as dominant, leading, strong, tentative, and weak.

Research Analyst Overview

The oral solid dosage (OSD) market encompasses the production of tablets, capsules, and other specialized solid doses of drugs for various populations, including those with novel formulations for large molecule counterparts. Contract manufacturing companies play a crucial role in addressing the medication adherence problem by providing patient-centric solutions. Oral solids, such as disintegrating tablets (ODTs), combination products, and granules, are increasingly popular due to their improved bioavailability and ease of administration. API solubility and bioavailability are critical factors in OSD manufacturing, requiring multidisciplinary expertise from drug developers and contract manufacturing companies. Stringent regulatory requirements mandate high levels of physical and chemical stability, making it essential for companies to invest in cutting-edge technologies like nano milling, 3D printing technology, and agile manufacturing processes.

Furthermore, the OSD market caters to various populations, including pediatric and geriatric, with formulations tailored to their specific needs. Pediatric and geriatric drugs, anti-abuse drugs, controlled release drugs, and taste-masked drugs are among the niche enabling technologies that contract manufacturing companies offer. Production costs, toxicity, quality deviations, and transportation disruptions are common challenges faced by contract manufacturing companies in the highly competitive market. To mitigate these challenges, companies employ cost-effective manufacturing methods, such as batch manufacturing and continuous manufacturing, and responsive manufacturing processes that minimize bottlenecks and ensure timely delivery. Investment costs and operating costs are significant factors in the OSD market. Product quality, time to market, and patient safety are top priorities for drug developers and contract manufacturing companies, making it essential to maintain high standards throughout the manufacturing process. The market for OSDs is vast and diverse, encompassing best-selling pharmaceuticals, small molecules, and biologics, making it a dynamic and exciting field for innovation and growth.

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What are the Key Data Covered in this Market Research and Growth Report?

• CAGR of the market during the forecast period
• Detailed information on factors that will drive the market growth and forecasting between 2024 and 2028
• Precise estimation of the size of the market  and its contribution of the market in focus to the parent market
• Accurate predictions about upcoming market growth and trends and changes in consumer behaviour
• Growth of the market across Asia, North America, Europe, and Rest of World (ROW)
• Thorough analysis of the market's competitive landscape and detailed information about companies
• Comprehensive analysis of factors that will challenge the growth of market companies

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