Oral Solid Dosage Manufacturing Market

Oral Solid Dosage Manufacturing Market - Distribution by Type of Finished Dosage Form, Type of Packaging, Scale of Operation, Company Size, Therapeutic Area, and Key Geographical Regions: Industry Trends and Global Forecasts, 2023-2035

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Oral Solid Dosage Manufacturing Overview

The global oral solid dosage contract manufacturing market size is estimated to grow from USD 21.5 billion in 2023 to USD 36.52 billion by 2035, representing a CAGR of 4.6% during the forecast period 2023-2035. 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.

Oral Solid Dosage Manufacturing Market, By Scale of Operation, 2024-2035 (USD Billion)


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.

Key Market Insights

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.

Key Benefits Offered by Oral Solid Dosage Formulations

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.

Need for Contract Manufacturing in the Oral Solid Dosage Market

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.

Current Opportunities for Contract Manufacturing Organizations of Oral Solid Dosage Forms

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.

Current Market Landscape of Oral Solid Dosage Manufacturing Companies: Majority Companies Provide Tablet Manufacturing and Capsule Manufacturing

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.

Recent Trends: Collaborations, Facility Expansions and Innovation with Continuous Manufacturing for Oral Solid Dose Products

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.

Technology Trends Shaping the Oral Solid Dosage Contract Manufacturing Market

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.

Oral Solid Dosage Contract Manufacturing Market Size: North America Market Growth Falls behind Asia Pacific 

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.

Key Contract Manufacturing Organizations in the Oral Solid Dosage Manufacturing Market

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.

Recent Developments in Oral Solid Dosage Manufacturing Market

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.

  • In July 2023, Bora Pharmaceuticals signed an agreement with Celltrion Partners to manufacture and commercialize a range of oral dosage form drugs across the Asia-Pacific region. 
  • In July 2023, Aenova entered into a strategic partnership with Galvita to enhance the development, formulation and production of oral dosage forms. 
  • In May 2023, Cambrex completed the expansion of 51,000 square-foot snapdragon chemistry facility in Massachusetts. 

Scope of the Report

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:

Report Attribute Details

Base Year

2022

Forecast Period

2023-2035

Market Size 2023

$21 billion

CAGR 2023-2035

~5%

Company Size

Small, Mid-Sized, Large, Very Large

Type of Finished Dosage Form

Tablet Manufacturing, Capsule Manufacturing, Multi-particulate Manufacturing, Powder Manufacturing, Others

Scale of Operation

Pre-commercial, Commercial

Type of Packaging

Blisters, Sachets, Inhalers, Bottles, Others

Therapeutic Area

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

Customization Scope

15% Free Customization Option (equivalent to 5 analysts working days)

PowerPoint Presentation (Complimentary)

Available

Excel Data Packs (Complimentary) Market Landscape, Company Competitiveness Analysis, Recent Expansions, Capacity Analysis, Demand Analysis, Total Cost of Ownership, Market Forecast and Opportunity Analysis

 

This image provides list of oral solid dosage manufacturing companies. Presently, over 300 companies claim to have the required expertise to offer contract manufacturing services for a broad spectrum of oral solid dosage forms, including modified release formulations of tablets and capsules The image looks at the competitive landscape acrossc contract manufacturing organizations. Owing to the rise in demand for complex oral solid formulations, the needs of drug innovators are evolving; as a result, service providers are upgrading their technical capabilities to cater to customized requests of their clients The image provides details on various expansions undertaken by oral solid dosage manufacturing companies. As part of their growth strategy, CMOs are investing in either expanding their existing facilities / capabilities or building facilities in other regions; majority of these initiatives were undertaken in North America


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:

  • An executive summary of the insights captured during our research. It offers a high-level view on the current state of oral solid dosage contract manufacturing market and its likely evolution in the mid-long term.
  • A general overview of oral solid dosage contract manufacturing, highlighting details on the various types and components of oral solid dose forms. Additionally, it presents information on the oral solid dosage manufacturing process. Further, it highlights the emerging trends in oral solid dosage manufacturing market, featuring information on the commonly outsourced manufacturing operations. The chapter concludes with a discussion on key considerations while selecting a CDMO partner, the affiliated risks and future perspectives of growth in this industry. 
  • A detailed assessment of the overall market landscape of the companies offering contract services for oral solid dosage manufacturing, based on several relevant parameters, including year of establishment, company size (in terms of number of employees), location of headquarters, company ownership (privately held and publicly owned), type of service(s) offered (pre-formulation / formulation development, process development, analytical, scale-up, packaging, regulatory and others), type of finished dosage form(s) manufactured (tablets, capsules, granules, multi-particulates and others), type of packaging offered (bottles, blisters, sachets / pouches / bags, inhalers, and others), scale(s) of operation (preclinical, clinical, and commercial) and additional manufacturing capabilities (continuous oral solid dosage manufacturing and highly potent oral solid dosage manufacturing. 
  • A detailed competitiveness analysis of oral solid dosage contract manufacturing service providers based on supplier strength (in terms of years of experience) and service strength (considering type of service(s) offered, type of finished dosage form(s), type of packaging offered, scale(s) of operation, regulatory certification(s) and location of facilities). 
  • A detailed analysis of the capabilities of oral solid dosage contract manufacturers established across the key geographical regions (North America, Europe, Asia-Pacific and Rest of the World), based on several relevant parameters, including type of type of service(s) offered, type of finished dosage form(s) manufactured, type of packaging offered and scale(s) of operation. It also features information on the location of manufacturing facilities of the service providers.
  • Elaborate profiles of key players engaged in the contract manufacturing of oral solids (shortlisted based on strength of service portfolio). Each profile includes a brief overview of the company, its financial information (if available), details on its oral solid dosage service portfolio, manufacturing capabilities and facilities, and recent developments and an informed future outlook. 
  • An insightful make versus buy framework, highlighting the various factors that need to be taken into consideration by oral solid dosage drug developers, while deciding whether to manufacture their respective products in-house or engage the services of a CMO or CDMO partner.
  • A detailed analysis of the recent expansions (since 2018) undertaken by various service providers in order to augment their respective oral solid dosage contract manufacturing portfolios, based on a several relevant parameters, including year of expansion, purpose of expansion (capability expansion, capacity expansion, facility expansion, new facility), type of An estimate of the global installed capacity (in terms of number of oral solid units and volume of API) for the manufacturing of oral solids, based on information provided by various industry stakeholders in the public domain. It also features distribution of the available capacity on the basis of company size (small, mid-sized, large and very large firms), scale of operation (preclinical, clinical and commercial), type of finished dosage form (tablets, capsules, and others) and key geographical regions (North America, Europe, and Asia-Pacific and Rest of the World). Overall, the analysis represents a holistic view of the supply-side of the market, allowing us to present an informed opinion on whether the present capacity will be able to meet the likely future demand.
This image looks at the manufacturing capacity across OSD manufacturing companies. As part of their growth strategy, CMOs are investing in either expanding their existing facilities / capabilities or building facilities in other regions; majority of these initiatives were undertaken in North America. It includes details on capsule manufacturing companies, tablet manufacturers, tablet manufacturing companies and softgel capsules. The global installed oral solid dosage contract manufacturing capacity is spread across various geographies; over 30% of this capacity is dedicated to the manufacturing of tablets on a commercial scale The infographic looks at the demand of various oral solid dosage formaulations such as capsule manufacturing companies, tablet manufacturers, tablet manufacturing companies and softgel capsules The image looks at the likely cost of ownership a company should expect while developing manufacturing facilities. Our proprietary total cost of ownership model offers an informed estimate of capital and operational expenses associated with the establishment and maintenance of a contract manufacturing facility, over a span of 20 years

 

  • An informed estimate of the annual clinical and commercial demand for oral solid doses (in terms of volume of API), across key geographical regions and therapeutic areas.
  • A detailed analysis of the total cost of ownership for an oral solid dosage contract manufacturing service provider, highlighting the expenses associated with the establishment and maintenance of an oral solid dosage manufacturing facility, over a period of 20 years. 
  • A detailed discussion on various guidelines laid down by major regulatory bodies, across different countries, featuring an elaborative assessment of over 300 CMOs engaged in this domain, along with information on their operational approvals, certifications received, and relative popularity of the key regulatory body. Additionally, the chapter features an insightful multi-dimensional bubble analysis, presenting a comparison of the current regulatory scenario in key geographies.
  • A case study on the current market landscape of taste masking service providers for oral solids, providing information on scale of operation (preclinical / clinical and commercial), manufacturing scalability, other service(s) offered along with information on type of formulation (tablets, granules, capsules, semi-solids and others), end users (pharmaceutical, nutraceutical and others), techniques used for taste masking (hot melt extrusion, microencapsulation, coating, ion exchange resin and others), branch of healthcare (pediatrics, geriatrics and others) and regional capability. Further, the chapter includes the current market landscape of taste masking technology providers, providing information on technology name, techniques used, type of finished dosage form (tablets, capsules, powder and others), end users (pharmaceutical, nutraceutical and others) along with information on patent, availability of technology for partnerships and licensing. In addition, the chapter provides details on the year of establishment, company size and location of headquarters of companies providing taste masking services and technologies for oral solids.
  • A case study on the overall market landscape of bioavailability enhancement service providers for oral solids, based on several relevant parameters, such as year of establishment, company size (in terms of number of employees), location of headquarters, bioavailability enhancement principle supported (solubility enhancement, absorption enhancement, sustained release and others), bioavailability enhancement approach employed, including [A] solid dispersion (spray-dried dispersion, hot melt extrusion, polymers, agglomeration / granulation, lyophilization, inclusion complexes, super critical fluid, solvent evaporation and other solid dispersion approaches), [B] size reduction (conversion to nanotechnology-based formulation, high pressure homogenization / micronization, bead layering, microfluidics, and other miscellaneous size reduction approach), [C] lipid-based (liposomes, self-emulsifying drug delivery system, excipients, micelles, lipid-nanotechnology based formulations and other lipid-based formulations), and other bioavailability enhancement approaches (co-crystallization, chemical modification, and other miscellaneous bioavailability enhancement technologies), type of dosage form supported (solids, fine particles and semi-solids).
The image provides details on the estimated gap between demand vs supply of oral solid dosage formulations. The demand for oral solid dosage contract manufacturing is rising significantly owing to the growing complexity of APIs; by 2035, it is anticipated to reach over 35,000 metric tonnes, across clinical and commercial scales This image provides details on oral solid dosage manufacturing market size. Driven by volume shifts from originators to generics and over-investments to create safety buffers, the contract manufacturing domain is currently witnessing an excess in capacity, thereby propelling consolidation efforts The image provides segmentaion of oral solid dosage manufacturing market. The oral solid dosage contract manufacturing market is likely to grow at a CAGR of ~6%, till 2035; the projected opportunity is likely to be distributed across different dosage forms, scales of operation and company sizes


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.

Frequently Asked Questions

Question 1: What is oral solid dosage?

Answer: Oral solid dosage is the final drug product, commonly tablets and capsules, that can be administered through oral route (by mouth)

Question 2: What is the global market size of oral solid dosage contract manufacturing market?

Answer: The current oral solid contract manufacturing market size is anticipated to be over USD 21 billion

Question 3: What is the current market landscape of oral solid dosage contract manufacturing market?

Answer: Presently, close to 570 companies are engaged in offering oral solid dosage contract manufacturing services through more than 880 manufacturing facilities worldwide

Question 4: How many contract service providers possess capabilities to handle oral solid therapies based on highly potent APIs (HPAPIs)?

Answer: Over 40% of the contract service providers engaged in oral solid dosage manufacturing claim to have the requisite capabilities for the safe handling and containment of highly potent oral solids.

Question 5: What are the factors driving the oral solid dosage contract manufacturing market?

Answer: The factors driving the oral solid dosage contract manufacturing market include the emergence of virtual pharmaceutical companies, and the surge in demand for novel oral solid formulations, such as such as pediatric / geriatric, taste-masked, abuse-deterrent and control release products that improve patient compliance

Question 6: Which region has the highest market share in the oral solid dosage contract manufacturing market?

Answer: North America captures around 60% share in the current oral solid dosage contract manufacturing market, followed by Europe

Question 7: What are the leading market segments in the oral solid dosage contract manufacturing market?

Answer: Currently, the oral solid dosage contract manufacturing market is dominated by tablet manufacturing and capsule manufacturing. This can be attributed to several advantages offered by these dosage forms, including portability, ease in swallowing, excellent bioavailability and medical adherence. Further, in terms of company size, established players (with over 10,000 employees) are likely to capture over 50% of the current and future market, owing to their enhanced capabilities and huge production capacities

Question 8: What is the growth rate (CAGR) in the oral solid dosage contract manufacturing market?

Answer: The oral solid dosage contract manufacturing market size is projected to grow at a CAGR of ~5% during the forecast period

Question 9: What are the upcoming trends in the oral solid dosage contract manufacturing market?

Answer: The market is presently witnessing the adoption of Industry 4.0 concepts, such as QbD and PAT. Further, several service providers are establishing / expanding their continuous manufacturing lines for the production of oral solids, thereby reducing manufacturing cost (by 15-30%), manpower (by 50-70%) and power consumption (by 40%)

Question 10: What are the current initiatives undertaken by big pharma players engaged in the oral solid dosage contract manufacturing market?

Answer: In order to tap the lucrative opportunity in this rapidly growing market, big pharma players have undertaken several initiatives, including strengthening product portfolio, establishing agreements, acquisitions and making investments. For instance, in August 2022, Catalent acquired Metrics Contract Services for USD 475 million to expand its high-potent and oral solid dosage manufacturing capabilities

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