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The Oral Solid Dosage (OSD) Contract Manufacturing Market size is estimated to grow 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 trends and factors. The expiry of patents for numerous branded drugs and the increasing demand for generic drugs equivalents are driving market growth. Additionally, the rising demand for generic drugs and the adoption of novel drug delivery technology is expanding the capacity for OSD production. However, capacity utilization and other constraints pose challenges for market players. To address these challenges, companies are investing in advanced technologies and strategic partnerships to enhance their manufacturing capabilities and meet the growing demand for OSD products. The market is expected to continue its growth trajectory, driven by these trends and the ongoing demand for affordable and effective pharmaceutical solutions.
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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 15.10 billion in 2018. 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 45% to the growth of the global market during the forecast period. Technavioâs 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 a significant sector in the pharmaceutical industry, focusing on the production of tablets, capsules, and other oral solid dosages for drug developers. Novel formulations of Oral solids, including disintegrating tablets (ODTs) and combination products, are in high demand due to their ability to address medication adherence problems. Contract manufacturing companies provide specialized solid doses for large molecule counterparts, utilizing multidisciplinary expertise to ensure patient-centric solutions. API solubility and bioavailability are critical factors in OSD manufacturing. Stringent regulatory requirements and the need for high potency APIs necessitate the involvement of multiple suppliers. 3D printing technology is increasingly being adopted to create customized and complex dosage forms, enhancing precision and efficiency in drug production. Complex formulations require advanced technology and expertise, making contract manufacturing an attractive option for drug developers. Pediatric populations present unique challenges, necessitating customized solutions in OSD manufacturing. The development of active pharmaceutical ingredients (APIs) for modified oral solid formulations, including prolonged release dosage forms, controlled release dosage forms, and sustained release dosage forms, aims to address routine operations related challenges and is increasingly focused on being patient centric, particularly for the pediatric population. These companies provide early development formulations and offer services for highly potent APIs, ensuring medication adherence and addressing the medication adherence problem. The market is expected to grow significantly due to the increasing demand for patient-centric solutions and the production of complex formulations. Our researchers analyzed the data with 2023 as the base year, along with the key drivers, trends, and challenges.
Patent expiry and increasing demand for generic drugs is notably driving market growth. Oral solid dosage (OSD) contract manufacturing plays a significant role in producing novel formulations of tablets and capsules as oral solids, which are essential for delivering drugs to patients. Contract manufacturing companies offer expertise in creating specialized solid doses, including disintegrating tablets (ODTs), combination products, and formulations for large molecule counterparts. These offerings address patient-centric concerns, such as medication adherence problems, by providing easier-to-take forms. API solubility and bioavailability are critical factors in drug development, and contract manufacturing companies possess multidisciplinary expertise to address these challenges.
Furthermore, stringent regulatory requirements, multiple suppliers, and the need to cater to various populations, such as the pediatric and geriatric populations, necessitate the production of granules, sachets, powders, dry powder inhalers, lozenges, and other forms. Physical and chemical stability, dosing, coating methods, swallowing, shape modification, and color modification are essential aspects of OSD production. Contract manufacturing companies invest in advanced technologies and adhere to stringent quality control measures to ensure the highest standards of production costs. These companies collaborate closely with drug developers to create early development formulations and complex formulations, enabling the timely delivery of effective treatments to patients. Thus, such factors are driving the growth of the market during the forecast period.
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. . 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. 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 innovatorâs stage to the laggardâs 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 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.
The market is a significant segment in the pharmaceutical industry, focusing on producing tablets, capsules, and other oral solid dosages for drug developers. OSDs encompass a wide range of forms, including granules, sachets, powders, dry powder inhalers, lozenges, and specialized solid doses. 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. Contract manufacturing companies offer expertise in creating complex formulations for large molecule counterparts, addressing medication adherence problems through disintegrating tablets (ODTs) and combination products. The market caters to various populations, such as pediatric and geriatric, ensuring patient-centric solutions. API solubility and bioavailability are crucial factors in OSD development. Contract manufacturers employ multidisciplinary expertise to navigate stringent regulatory requirements and work with multiple suppliers.
Furthermore, they provide highly potent APIs and early development formulations, ensuring physical and chemical stability during production, transport, and dosing. Coating methods, shape modification, color modification, and dosing are essential aspects of oral solid dose (OSD) manufacturing. Production costs are a significant consideration, with contract manufacturers offering competitive pricing and innovative solutions to meet client needs. The treatment package for high value dosage forms must address potential issues such as physical stability and swallowing difficulties while also mitigating risks related to toxicity, quality deviations, and utility or transportation disruptions, which can cause significant bottlenecks in the supply chain. In summary, the market plays a vital role in the pharmaceutical industry, delivering patient-centric solutions for various drugs and populations while addressing the challenges of API solubility, bioavailability, and regulatory compliance.
Market Scope |
|
Report Coverage |
Details |
Page number |
169 |
Base year |
2023 |
Historic period |
2018 - 2022 |
Forecast period |
2024-2028 |
Growth momentum & CAGR |
Accelerate at a CAGR of 6.84% |
Market growth 2024-2028 |
USD 14.2 billion |
Market structure |
Fragmented |
YoY growth 2023-2024(%) |
6.35 |
Regional analysis |
Asia, North America, Europe, and Rest of World (ROW) |
Performing market contribution |
Asia at 45% |
Key countries |
China, US, Japan, Canada, and Germany |
Competitive landscape |
Leading Companies, Market Positioning of Companies, 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, Perkin Elmer 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 growth inducers and obstacles, Fast-growing and slow-growing segment analysis, Market growth and Market Forecasting, COVID 19 impact and recovery analysis and future consumer dynamics, Market condition analysis for market forecast period |
Customization purview |
If our report has not included the data that you are looking for, you can reach out to our analysts and get segments customized. |
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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 Opportunity/Restraints
11 Competitive Landscape
12 Competitive Analysis
13 Appendix
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