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The Oral Solid Dosage (OSD) Contract Manufacturing Market size is estimated to grow by USD 11.57 billion at a CAGR of 6% between 2022 and 2027. The market is experiencing robust growth, fueled by the rising demand for generic drugs and the adoption of novel drug delivery technology. Governments worldwide are endorsing generic pharmaceuticals to enhance healthcare accessibility and affordability, driving the market forward. With the patent expiration of numerous branded medications, there's a surge in demand for controlled-release technologies and 3D printing for oral solid dose (OSD) forms production. Collaborative R&D efforts between pharmaceutical companies and contract manufacturers are accelerating innovation in drug delivery technologies, catering to the growing needs of patients with chronic illnesses like cardiovascular disease and diabetes. As healthcare systems emphasize low-cost solutions and patient compliance, OSD contract manufacturing emerges as a vital component in providing affordable medicines globally.
It also includes an in-depth analysis of drivers, trends, and challenges. Our report examines historic data from 2017 to 2021 besides analyzing the current market scenario.
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Technavio has segmented the market into End-user, Product, and Geography segments.
The large-size companies segment is estimated to witness significant growth during the forecast period. Large-size companies or big pharmaceutical companies can be referred to as the world's largest publicly traded pharmaceutical companies. This segment can have separate divisions that manufacture OSD forms. These companies are mostly bigger than those companies which only focus on medical devices. These large-size companies usually outsource their technological resources to a CMO in order to minimize their overhead cost. There is a growing awareness in the pharmaceutical sector about the benefits of working with CMO in both clinical and commercial-stage manufacturing due to the increasing demand for generic drugs.
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The large-size companies segment was the largest segment and was valued at USD 14.29 billion in 2017. One of the main factors which is influencing the growth of CMOs is the increasing demand for cutting-edge manufacturing methods that have been shown to be highly effective in satisfying regulatory criteria. There is an increasing focus on core competencies as well as production procedures and R&D operations by pharmaceutical companies in order to remain competitive in the market. For example, Pfizer has been partnering with CMOs to manufacture more OSD forms and offer them to more people. Therefore, CMOs assist big pharmaceutical companies to discover and generate approvals for new OSD forms by incurring some of the costs associated with the clinical research stage. Hence, such factors are expected to fuel the growth of this segment which in turn will drive the market growth during the forecast period.
One of the most widely used OSD forms is tablets due to several factors such as ease of administration, accurate dosing, stability, and patient-friendly attributes. CMOs play a major role in the production of tablets for pharmaceutical companies. Some of the key processes involved in the manufacturing of tablets are the development of formulation, granulation, compression, coating, and packaging. Additionally, CMOs help in assisting pharmaceutical companies in providing expertise, facilities, and regulatory compliance to ensure the manufacturing of high-quality tablets. Some of the prominent companies which outsource their tablet production to CMOs include Merck KGaA, and Lonza Group Ltd., in order to utilize their high level of expertise and cost-effective manufacturing capabilities.
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Asia is estimated to contribute 39% to the growth of the global market during the forecast period. Technavio’s analysts have elaborately explained the regional trends and drivers that will shape the market during the forecast period. Some of the main reasons which are significantly contributing to the growth of the market in Asia are due to the factors such as the increasing market penetration of generic drugs and the growing adoption of advanced technologies in developing economies, such as India and China. One of the significant markets in Asia, which has a rapid growth of the CMO market is India due to its cost-effectiveness. Additionally, there is a growing popularity of developing economies such as India and China across the world as CMO markets when compared to other regions such as Europe and North America. Factors such as the widespread availability of resources, such as labor and APIs, and the availability of land at a low cost for setting up manufacturing facilities are expected to drive the market in the region during the forecast period.
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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. The report also includes detailed analyses of the competitive landscape of the market and information about 20 market companies, including:
AbbVie Inc: The company offers oral solid dosage contract manufacturing services such as blister packaging and strip packaging.
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.
The market is experiencing significant growth, fueled by advancements in drug delivery technology and the emergence of novel therapies. Key players in the pharmaceutical industry are increasingly turning to contract manufacturing for the production of tablets, capsules, and powders, leveraging controlled-release technologies and 3D printing for innovative solutions. The market is witnessing a surge in demand for generic pharmaceuticals, driven by low-cost healthcare solutions and the need for patient compliance in treating chronic illnesses like cardiovascular disease and diabetes.
Pharmaceutical companies, including both established corporations and generic medicine producers, are investing in collaborative R&D efforts to meet the rising demand for oral solid dose (OSD) forms. Compliance with regulatory standards such as those set by the European Medicines Agency (EMA) and adherence to Good Manufacturing Practices (GMP) are paramount for contract manufacturing firms. As healthcare spending continues to rise globally, the OSD contract manufacturing market is poised for further expansion, driven by the need for efficient production of prescription medications and active pharmaceutical ingredients (APIs) in oral solids.
There are multiple factors influencing market growth. Our researchers analyzed the data with 2022 as the base year, along with the key drivers, trends, and challenges.
A key factor shaping the market growth is the increasing number of US FDA-approved manufacturing facilities. Some of the main leading countries in the OSD contract manufacturing market are China and India. India is one of the most preferred countries for the outsourcing of services with 400 US FDA-approved manufacturing facilities. For instance, India has 230 approved API facilities and 150 US FDA-recognized facilities as well as 147 facilities for formulations.
Moreover, some of the other countries that are witnessing an increase in the approval of manufacturing facilities include China, India, Mexico, and Brazil. Additionally, several foreign OSD manufacturing companies are outsourcing the manufacture of OSDs to CMOs in China, which is fuelling the number of CMOs. Hence, such factors are expected to positively impact the market growth, which, in turn, will drive the global market during the forecast period.
Capacity utilization and other constraints are one of the key challenges hindering the market growth. Capacity utilization can be referred to as a measure of the production that a manufacturing unit can undertake when in comparison to the actually established production capacity of the company. It is one of the important aspects of the manufacturing of therapeutics due to its various complex manufacturing processes.
In addition, the main factor that can lead to capacity constraints is the limited number of approved manufacturing facilities. Furthermore, other factors that can significantly influence the manufacturing constraints in the market include the lack of new and experienced scientists, technical staff, and production staff; the shortage of cost-effective single-use products; and the limitations in advanced upstream performance. Hence, such factors can hinder the market growth during the forecast period.
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The market 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 growth strategies.
Global Market Customer Landscape
The market report forecasts market growth by revenue at global, regional & country levels and provides an analysis of the latest trends and growth opportunities from 2017 to 2027.
The market is witnessing robust growth, driven by the rising demand for generic pharmaceuticals and novel therapies. As the prevalence of chronic illnesses like cardiovascular disease, diabetes, and respiratory ailments continues to rise, there's a pressing need for affordable healthcare solutions. Contract manufacturing organizations (CMOs) and Contract Development Manufacturing Organizations (CDMOs) play a crucial role in meeting this demand, leveraging their pharmaceutical production capabilities to deliver high-quality oral solid dose (OSD) forms.
To ensure stringent regulatory compliance with authorities like the FDA and European Medicines Agency (EMA), these organizations adhere to Good Manufacturing Practices (GMP) and maintain quality management systems. With the middle-class population seeking low-cost healthcare options, generic medicine producers and established pharmaceutical corporations collaborate on collaborative R&D to develop tailored medicines and controlled-release technologies. This market evolution is further fueled by advancements in drug delivery technology, including 3D printing for targeted drug delivery and sustained-release dosage forms, enhancing patient compliance and improving drug adherence.
Moreover, the market is experiencing robust growth, fueled by the convergence of digital technologies and the rising demand for low-cost healthcare solutions in providing long-term treatment options. Manufacturers are increasingly focusing on developing modified-release formulations and combination medications to address complex medical needs while adhering to stringent regulatory requirements such as FDA regulations. This market growth is further propelled by the escalating healthcare spending worldwide and the expansion of healthcare infrastructure to accommodate the production of active pharmaceutical ingredients (APIs) and prescription medications in oral solids format. Collaboration with contract manufacturers ensures compliance with global regulatory norms and streamlines documentation procedures, facilitating efficient production processes within an interactive laboratory environment. Additionally, the integration of laser test and measurement systems enhances quality control measures, reinforcing the market's trajectory towards sustainable expansion.
Oral Solid Dosage (OSD) Contract Manufacturing Market Scope |
|
Report Coverage |
Details |
Page number |
163 |
Base year |
2022 |
Historic period |
2017-2021 |
Forecast period |
2023-2027 |
Growth momentum & CAGR |
Accelerate at a CAGR of 6% |
Market growth 2023-2027 |
USD 11.57 billion |
Market structure |
Fragmented |
YoY growth 2022-2023(%) |
5.85 |
Regional analysis |
Asia, North America, Europe, and the Rest of the World (ROW) |
Performing market contribution |
Asia at 39% |
Key countries |
US, Canada, Germany, China, and Japan |
Competitive landscape |
Leading Vendors, Market Positioning of Vendors, Competitive Strategies, and Industry Risks |
Key companies profiled |
AbbVie Inc., 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, PerkinElmer Inc., Piramal Enterprises Ltd., Pyramid Laboratories Inc., Recipharm AB, Siegfried Holding AG, Thermo Fisher Scientific Inc., and Viatris Inc. |
Market dynamics |
Parent market analysis, Market forecasting, Market growth inducers and obstacles, Fast-growing and slow-growing segment analysis, COVID-19 impact and recovery analysis and future consumer dynamics, Market condition analysis for the forecast period. |
Customization purview |
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1 Executive Summary
2 Market Landscape
3 Market Sizing
4 Historic Market Size
5 Five Forces Analysis
6 Market Segmentation by End-user
7 Market Segmentation by Product
8 Customer Landscape
9 Geographic Landscape
10 Drivers, Challenges, and Trends
11 Vendor Landscape
12 Vendor Analysis
13 Appendix
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