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Oral solid dosage contract manufacturing market is estimated to be USD 21 billion in 2023 and is anticipated to grow at a CAGR of ~5% during the forecast period. Over the years, rising complexity of active pharmaceutical ingredients (APIs) has led to the development of a myriad of novel formulations that enable efficient drug delivery to the intended site of action. Nonetheless, the demand for oral solid dosage (OSD) forms, including tablets and capsules, remains unparalleled. In fact, over two-thirds of the total drugs prescribed worldwide are dispensed in the form of oral solids. In addition to being cost effective and relatively more stable as compared to their large molecule counterparts, these orally administered small molecules are patient-centric, and therefore play a critical role in fixing the medication adherence problem.
Since the demand for oral solid drugs is rising, the development of modified oral solid formulations (including disintegrating tablets (ODTs), combination products and prolonged-, controlled-, and sustained- release dosage forms) that can improve API solubility and enhance bioavailability can offer the drug developers a huge opportunity to stand out in this mature and competitive market. However, the manufacturing of specialized solid doses, especially those containing highly potent APIs, from early development formulations to scale-up is a complex process that requires multidisciplinary expertise. Consequently, drug developers are increasingly relying on contract manufacturing companies with specialized equipment and a trained workforce to navigate the technical and routine operations-related challenges, including those associated with complex formulations, stringent regulatory requirements and multiple suppliers. Considering the immense popularity of oral solid dosage forms, especially amongst the pediatric and geriatric populations, we believe that the demand for conventional as well as modified oral solid formulations is likely to drive commendable market growth within the oral solid dosage contract manufacturing market during the forecast period.
The Oral Solid Dosage Contract Manufacturing Market: Distribution by Type of Finished Dosage Form (Tablets, Capsules, Powders, Multi-particulates and Others), Type of Packaging (Bottles, Blisters, Sachets, Inhalers and Others), Scale of Operation (Pre-commercial and Commercial), Company Size (Small, Mid-sized, Large and Very Large), Therapeutic Area (Oncological Disorders, Infectious Diseases, Cardiovascular Disorders, Metabolic Disorders, Neurological Disorders, Genetic Disorders, Respiratory Disorders, Immunological Disorders, and Other Disorders), and Key Geographical Regions (North America, Europe, Asia-Pacific, Latin America, and Middle East and North Africa): Industry Trends and Global Forecasts report features an extensive study of the current market landscape, market size and future opportunity for the companies involved in providing contract services for oral solid dosage manufacturing, over the forecast period. The market report answers many key questions related to this industry.
Oral solid dosage formulations, including tablets, capsules, granules, sachets, powders, dry powder inhalers, and lozenges represent the most preferred dosage forms that are widely accepted by patients, worldwide. These time-tested means of treatment are relatively easy to manufacture, package and transport, offer good physical and chemical stability, and facilitate simple and accurate dosing. In addition, various coating methods make them easier to swallow, and allow modification of shape and color for aesthetic purposes. Moreover, the low production costs of oral solid formulations make them an economical option for manufacturers, healthcare institutions and patients.
Despite being the oldest and most-well understood formulation, oral solid dosage development and manufacturing is associated with several complications and challenges, including toxicity associated with potent APIs, complexity of formulations, deviations in quality, utility or transportation disruption and bottlenecks in process scale-up. Further, manufacturing of high-value dosage forms, including pediatric, geriatric, anti-abuse, controlled-release, and taste-masked drugs require cutting-edge technologies which are expensive to acquire. As a result, around 60-70% of the companies engaged in this industry prefer to outsource their clinical and commercial manufacturing operations to contract manufacturing organizations (CMOs) or contract development and manufacturing organizations (CDMOs), enabling the former to focus on their core research and development competencies.
Although biologics have provided breakthroughs for the treatment of diseases with unmet medical needs, the approval of orally administered small molecule entities has been on the rise, recently. In fact, around 84% of the best-selling pharmaceuticals are administered orally. In addition, oral solid dose forms account for nearly 30% of the small molecules in the development pipeline. However, the oral solid dosage contract manufacturing market is highly competitive, as several in-house pharmaceutical operations are being converted to offer CMO services and existing service providers are expanding their service offerings. Moreover, owing to the increase in consolidation within the pharmaceutical industry, the customer base for contract manufacturers is declining. In order to navigate the growing competition, oral solid dosage contract manufacturers are making an active effort to enhance their offerings by manufacturing high and uniform quality products in a cost-effective manner, while accommodating the diverse expectations of sponsor companies. The oral solid dosage market is expected to continue to grow at a healthy rate, and as a result, we anticipate a surge in demand for the affiliated development and manufacturing support.
Presently, close to 570 contract manufacturing organizations have the required capabilities to offer services for oral solid dosage manufacturing across different scales of operation. More than 15% of these companies serve as one-stop-shops, possessing an extensive range of capabilities (from formulation and analytical development to quality, regulatory support and commercialization) to meet client requirements.
Tablet manufacturing and capsule manufacturing are the most popular OSD manufacturing capabilities, followed by the manufacturing of powders. There are at least 350 tablet manufacturing companies and 335 capsule manufacturing companies supporting the pharmaceutical industry to meet the growing demand for oral solid dose forms. Within capsule manufacturing, the companies have capability for production of hard gelatin as well as softgel capsules, the latter being available with limited number of contract manufacturing organizations. Softgel capsules are gaining popularity owing to their nature that makes them easy to swallow and avoids any unpleasant aftertaste.
In order to cater to the increasing demand for OSD products, several CMOs and CDMOs have established strategic partnerships with other industry players and carried out expansion projects, thereby differentiating their offerings through niche enabling technologies, formulation expertise and manufacturing capacities, across different scales of operations. In January 2022, Procaps Group acquired a 86,000 sq.ft. USFDA approved facility in Florida, US from Strides Pharma. The company aims to expand the production capacity of softgel capsules by 1.8 billion capsules each year. Another CDMO, Piramal Pharma Solutions, upgraded its oral solid dose manufacturing facility in Madhya Pradesh, India increasing its production capacity from 3 billion doses to 4.5 billion doses. As part of the upgrade, the company expanded its capability for wet granulation, direct compression, coating and packaging. As the global market demand for oral solid dosage contract manufacturing increases, more such expansions will be witnessed.
Another trend is the investment by CMOs in continuous manufacturing equipment for oral solid dosage manufacturing, particularly tablet manufacturing. In January 2023, a drug product continuous manufacturing line for oral solids became operational at WuXi STA’s WuXi city facility. The continuous manufacturing line includes equipment for dispensing, blending, lubrication, tablet compression, and coating.
Considering the evolving customer demands and continuous updates in the regulatory requirements, innovator companies and manufacturers of oral solid dosage products must upgrade their capabilities in order to maintain dominance in the overall pharmaceutical sector. From a regulatory perspective, concepts from Industry 4.0, including quality by design (QbD) and process analytical technology (PAT) principles, are increasingly being implemented to optimize and accelerate pharmaceutical processes. In addition, the paradigm shift from batch to continuous manufacturing is instrumental in lowering the investment and operating costs, while concurrently improving the product quality and reducing the time to market. The efforts to develop more agile, responsive, and reproducible manufacturing processes are being combined with the applications of advanced technologies, including track-and trace systems, nano-milling, 3D printing technology, which enable the production of highly engineered drug products in a streamlined manner.
The oral solid dosage form continues to play a major role in the contract manufacturing industry, representing about 60% of the market. In the foreseen future, as several promising leads move into the clinic and / or get commercialized, the oral solid dosage contract manufacturing market is projected to grow at a noteworthy rate, during the forecast period between 2023-2035. The opportunities for growth within this industry primarily exist in the high potency products as well as the niche products, including fixed dose combinations, orally disintegrating tablets, minitablets, flavored chewables, double-layered and multiple-layers tablets. In terms of geography, the oral solid dosage contract manufacturing market in the Asia-Pacific region is anticipated to grow at a relatively faster pace during the forecast period.
Examples of key CMOs engaged in this industry (which have also been captured in this report) include Aenova, Alcami, Almac, Cambrex, Catalent, Hetero Drugs, Ind-Swift, Laboratories, Lonza, and Rubicon Research. This market report includes an easily searchable excel database of all the contract manufacturers for oral solid dosage forms worldwide.
Several recent developments have taken place in the field of oral solid dosage manufacturing. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that have been outlined in our analysis.
The market report presents an in-depth analysis of the various firms / organizations that are engaged in this industry, across different segments as defined in the below table:
Market Size 2023
Small, Mid-Sized, Large, Very Large
Type of Finished Dosage Form
Tablet Manufacturing, Capsule Manufacturing, Multi-particulate Manufacturing, Powder Manufacturing, Others
Scale of Operation
Type of Packaging
Blisters, Sachets, Inhalers, Bottles, Others
Oncological Disorder, Neurological Disorder, Cardiovascular Disorder, Infectious Disease, Metabolic Disorder, Respiratory Disorder, Immunological Disorder, Genetic Disorder, Gastrointestinal Disorder, Others
|Key Geographical Regions
|North America, Europe, Asia-Pacific, Latin America, and Middle East and North Africa (MENA)
Key Companies Profiled
Aenova, Alcami, Almac, Cambrex, Catalent, Hetero Drugs, Ind-Swift, Laboratories, Lonza, Rubicon Research
15% Free Customization Option (equivalent to 5 analysts working days)
PowerPoint Presentation (Complimentary)
|Excel Data Packs (Complimentary)
|Market Landscape, Company Competitiveness Analysis, Recent Expansions, Capacity Analysis, Demand Analysis, Total Cost of Ownership, Market Forecast and Opportunity Analysis
The research report presents an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this market, across different geographies. Amongst other elements, the report includes:
One of the key objectives of the market report was to estimate the current opportunity and the future growth potential of the oral solid dosage contract manufacturing market in the forecast period. We have provided an informed estimate on the likely evolution of the market for the period, 2023-2035. Our year-wise projections of the current and forecasted opportunity have been further segmented based on relevant parameters, including type of finished dosage form (tablets, capsules, multi-particulates, powders and others), type of packaging (bottles, blisters, sachets, inhalers, and others), scale of operation (pre-commercial and commercial), company size (small, mid-sized, large and very large), therapeutic areas (oncological disorder, neurological disorder, cardiovascular disorder, infectious disease, metabolic disorder, respiratory disorder, immunological disorder, genetic disorder, gastrointestinal disorder and others), and key geographical regions (North America, Europe, Asia-Pacific, Latin America, and Middle East and North Africa). In order to account for future uncertainties associated with some of the key parameters and to add robustness to our model, we have provided three market forecast scenarios, portraying the conservative, base and optimistic scenarios of the industry’s evolution.
All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this market report are in USD, unless otherwise specified.