Oral Solid Dosage (OSD) drug formulations account for 84 percent of medications on the market, largely due to their stability and ease of administration for patients.
The well-established oral solid dosage contract manufacturing market is experiencing robust growth, driven by increasing demand for cost-effective drug delivery solutions and the rising adoption of outsourced manufacturing services.
This comprehensive market report examines the current landscape, market drivers, inhibitors, and critical considerations for pharmaceutical executives seeking to navigate the OSD contract manufacturing ecosystem.
What is Oral Solid Dosage?
Oral solid dosage (OSD) refers to pharmaceutical formulations that are taken by mouth in a solid form, such as tablets, capsules, or powders. These dosage forms are designed to be swallowed and dissolved in the gastrointestinal tract, allowing for the systematic delivery of the active pharmaceutical ingredient to the body.
Oral solid dosage products come in different forms, including tablets, buccal and sublingual tablets, chewable tablets, and capsules.
- Tablets are the most common form of OSD and are made by compressing a mixture of active pharmaceutical ingredients (API) and excipients
- Buccal and sublingual tablets are designed to dissolve in the mouth and are often used for drugs with a rapid onset of action
- Chewable tablets are formulated for patients who have difficulty swallowing tablets or capsules
- Capsules consist of a shell that encloses the API and excipients in either a powder or granule form
Each of these forms can have variable bioavailability and rate of release. Depending on the therapeutic use of the OSD product, it will have an immediate, sustained, controlled, or extended-release. These factors influence drug manufacturing platforms and the equipment and technology used in the manufacturing process.
The overall goal for OSD processing regardless of the type of product is to create a formulation that ensures each dose–a single tablet or capsule–is consistent. Each one has a repeatable distribution of ingredients, and there is a consistency of dissolution and bioavailability to ensure that the drug product is safe and effective.
Oral Solid Dosage Contract Manufacturing
The global oral solid dosage contract manufacturing sector is experiencing robust growth, driven by increasing demand for cost-effective drug delivery solutions and the rising adoption of outsourced manufacturing services.
The global market size is forecast to grow from USD 22.5 billion in 2024 to USD 36.52 billion by 2035, representing a compound annual growth rate (CAGR) of 4.49%.
Oral Solid Dosage Manufacturing
Oral solid dosage (OSD) forms represent the most widely accepted and utilised pharmaceutical delivery systems in the global healthcare market. These formulations encompass a variety of formats, including tablets, capsules, powders, and granules, each designed to deliver active pharmaceutical ingredients (APIs) through oral administration.
At their core, OSD forms consist of two primary components:
- Active Pharmaceutical Ingredients (APIs): The therapeutic compound responsible for the medicinal effect
- Excipients: Inactive ingredients that serve various functions, including:
- Improving manufacturability
- Enhancing stability
- Controlling drug release
- Facilitating absorption
- Improving palatability
- Ensuring consistent bioavailability
“One of the big focuses currently in Oral Solid Dose (OSD) development and manufacturing is
how to increase oral bioavailability of solubility- and permeability-challenged molecules.” says- Dr. Brittany L Hayes – Director, Global Highly Potent & Oncology Platform at CordenPharma.
“Approximately 70-90% of New Molecular Entities (NMEs) in today’s drug pipeline are poorly soluble or have low permeability, which complicates delivery and results in poor bioavailability. It’s important to evaluate different formulation approaches, as one technology does not fit for all molecules. And, when evaluating multiple technologies, it’s equally important to have access to small-scale equipment so that expensive API isn’t wasted making prototypes.”
“CordenPharma’s Drug Product Innovation Centre of Excellence in Plankstadt, Germany embodies this approach – we have a multi-technology offering that starts with small non-GMP equipment which can
generate ~100 grams of material for prototypes that can then lead to scale-up and GMP
manufacturing of clinical supplies.”
Release Mechanisms
OSD products are engineered to provide specific drug release profiles based on therapeutic requirements:
- Immediate Release: Designed to dissolve rapidly after administration, providing quick onset of therapeutic action. These formulations typically dissolve within 30 minutes of ingestion.
- Sustained Release: Engineered to maintain therapeutic drug levels over an extended period, typically 8-12 hours, reducing dosing frequency and improving patient compliance.
- Controlled Release: Precisely manages the rate and location of drug release throughout the gastrointestinal tract, optimising therapeutic effect whilst minimising side effects.
- Extended Release: Provides prolonged drug delivery over 12-24 hours, ideal for maintaining steady therapeutic levels with once-daily dosing.
Manufacturing Processes
OSD drug products are typically composed of a dry powder formulation that includes the active pharmaceutical ingredient (API), excipients, and fillers. Final product characteristics, like particle size, density, and flowability, dictate the processing method used. Here are the four primary processing methods in OSD manufacturing:
Wet Granulation
In wet granulation, a mix of liquids and powders is combined using a granulator to form dense granules that can be compressed or encapsulated. The process involves binding particles with a solution, which is introduced either through high shear (intense mixing) or low shear (gentle mixing). Wet granulation enhances dust control, improves flowability, and enables consistent particle size, compaction, and controlled solubility.
Dry Granulation
Dry granulation compacts powders into dense granules without any liquid binder. A roller compactor presses the powders to form solid particles with minimal dust. The process improves flowability, ensures particle uniformity, allows controlled dissolution, and enhances bulk density.
Direct Compression
Direct compression combines powders uniformly through gentle tumbling without changing particle structure. It is ideal for ingredients that can be directly compressed into tablets and offers ingredient homogeneity without altering particle form.
Particle Coating
In particle coating, powders are coated with a solution to enhance characteristics like taste masking, stability, and delayed release. Using a fluid bed coater, the process applies multiple layers on each granule, providing a smooth surface, controlled release, and protection from environmental factors. Applications include:
- Taste masking
- Stability enhancement
- Controlled release properties
- Environmental protection
- Aesthetic improvements
“With over 80% of current pipeline candidates, poorly soluble APIs dominate today’s global R&D pipeline,” says Dr Klaus Pollinger, Group Director Global Product Development at
Aenova.
“These compounds require specific formulation and technology platforms since the API cannot be absorbed in the intestine due to its low aqueous solubility.
Aenova has therefore strengthened its offering for improving the bioavailability of poorly soluble active ingredients. Specific programs allow for fast-track pharmaceutical development that shortens the time to market for New Chemical Entities.
In this context, Aenova is expanding its capabilities for more complex and difficult-to- manufacture formulations, particularly in novel technologies to improve drug bioavailability, such as hot melt extrusion (HME), spray drying and lipid-based systems. This is supported by implementing a rapid and API-saving pre-formulation program following a science-based selection of formulation and technology platforms.”
Advanced Manufacturing Technologies
Beyond traditional methods, the industry continues to evolve with innovative approaches:
- Single-Pot Processing
- Integrates multiple unit operations in one vessel, reducing transfer steps and contamination risks
- Continuous Manufacturing
- Enables uninterrupted production flow, improving efficiency and consistency while reducing costs
- Hot-Melt Extrusion
- Provides solutions for poorly soluble drugs through thermal processing.
- Spray Drying
- Offers precise particle engineering capabilities for enhanced drug delivery
“Recent trends highlight a focus on the development of large molecules for oral delivery, with new technologies enabling the oral administration of medications that were traditionally available only as sterile injectables. This advancement offers greater efficacy and enhances the popularity and potential of OSD formulations. These trends pave the way for expanded capabilities in early development, particularly as more molecules enter the market. ” says Sanjay Konagurthu, PhD, Sr. Director, Science and Innovation, Pharma Services, Thermo Fisher Scientific
Continuous manufacturing, which has been commercially utilised for a decade, remains a significant approach with potential for wider adoption. The success of molecules reaching the market through this unified manufacturing technique motivates companies to integrate continuous manufacturing from the outset of their programs, aligning with the increasing opportunities in early-stage development.
Given the rising complexities and demand for these drug formulations across various modalities, it is essential for organizations to leverage predictive modelling and artificial intelligence (AI)/machine learning (ML) tools to mitigate risks and accelerate the development process
Key CDMO Players
The OSD contract manufacturing market features numerous established and innovative players.
The latest European CDMO Landscape infographic covers all modalities and can be downloaded here:
Notable CDMOs for oral solid dosage include:
- Abbott
- AbbVie
- Adare Pharma Solutions
- Aenova Group
- Alcami
- Alkem
- Almac
- Ardena
- Boehringer Ingelheim
- Cambrex
- Catalent
- CMIC Group
- Contract Pharmacal
- CordenPharma
- Delpharm
- Evonik Industries
- Famar
- GEA
- Granules
- Hermes Pharma
- Hetero Drugs
- Jubilant Pharmova
- Lonza
- Micro Labs
- NextPharma
- Patheon
- Pfizer CentreOne
- Piramal Pharma
- Recipharm
- Siegfried Holding
- Shanghai Haoyuan Chemexpress
- Thermo Fisher Scientific
- Upperton Pharma Solutions
OSD Contract Manufacturing Market Dynamics
Growth Drivers
The OSD contract manufacturing market is experiencing robust growth, driven by several key factors:
Technology Advancement
- Continuous evolution of drug delivery systems
- Implementation of Industry 4.0 technologies
- Development of novel coating technologies
- Advanced process analytical technology (PAT) integration
Economic Factors
- Cost-effective manufacturing solutions
- Reduced capital investment requirements
- Operational efficiency improvements
- Supply chain optimisation opportunities
Market Demands
- Rising generic drug requirements
- Increasing need for complex formulations
- Growing preference for outsourced manufacturing
- Expansion of pharmaceutical markets in emerging economies
Strategic Considerations
- Focus on core competencies by pharmaceutical companies
- Risk mitigation through manufacturing partnerships
- Access to specialised technologies and expertise
- Flexible capacity management
Manufacturing Challenges
The production of oral solid dosage forms presents several complex challenges that pharmaceutical companies and their CDMO partners must address:
High-Potency API Management
Manufacturing high-potency oral solid dosage forms requires exceptional attention to:
- Containment Systems: Implementation of sophisticated containment technologies and isolation systems to protect operators and prevent cross-contamination. These systems must maintain their integrity throughout the manufacturing process whilst allowing efficient operation.
- Operator Safety: Development and maintenance of robust safety protocols, including appropriate personal protective equipment (PPE) and handling procedures. This extends to all aspects of the manufacturing process, from raw material handling to finished product packaging.
- Environmental Controls: Implementation of advanced air handling systems, pressure cascades, and cleaning protocols to prevent the spread of potent compounds throughout the facility. These systems require regular monitoring and validation to ensure continued effectiveness.
Quality Control and Consistency
Maintaining consistent quality across batches requires attention to:
- Particle Size Distribution: Careful control of granulation and milling processes to ensure uniform particle size, which directly impacts dissolution rates and bioavailability. This requires sophisticated analytical techniques and ongoing process monitoring.
- Content Uniformity: Implementation of robust mixing and sampling protocols to guarantee consistent API distribution throughout the batch. This is particularly challenging with low-dose formulations or when working with APIs that have poor flow properties.
- Process Validation: Development and execution of comprehensive validation protocols to demonstrate consistent product quality across multiple batches and manufacturing campaigns.
Scale-up Complications
The transition from development to commercial manufacturing presents unique challenges:
- Process Parameters: Careful adjustment and optimisation of process parameters during scale-up to maintain product quality attributes. This includes considerations for mixing times, compression forces, and coating parameters.
- Equipment Differences: Management of equipment variations between development and commercial scale, including different geometric ratios and process dynamics that can affect product characteristics.
- Validation Requirements: Implementation of robust validation protocols to demonstrate process consistency and product quality at commercial scale.
Regulatory Compliance
Meeting global regulatory requirements demands:
- Documentation Systems: Maintenance of comprehensive documentation covering all aspects of the manufacturing process, including batch records, validation protocols, and change control procedures.
- Quality Management: Implementation of robust quality management systems that meet current Good Manufacturing Practice (cGMP) requirements across multiple regulatory jurisdictions.
- Regulatory Updates: Continuous monitoring and implementation of evolving regulatory requirements and guidelines affecting oral solid dosage manufacturing.
Recent M&A and deal-making in the OSD Market
October 2024: Catalent has agreed to sell its oral solids development and small-scale manufacturing facility in Somerset, NJ to Ardena, a European CDMO.
September 2024: Thermo Fisher Scientific Inc. is growing its oral solid dose (OSD) capabilities with a $22 million investment across its Cincinnati, Ohio, and Bend, Oregon sites.
April 2024: Seven Recipharm OSD Facilities Sold to Blue Wolf Capital for New CDMO
The drive for faster time to market means biotech’s need to select CDMO partners based on their expertise, resources, infrastructure, and ability to support them through the product lifecycle.” says Nikki Whitfield, CEO – Upperton.
“By selecting a CDMO that can demonstrate flexibility when challenges arise and can provide both relevant and necessary technical expertise, it can lead to more efficient decision-making and reduced timelines.”
How to select the right CDMO partner for OSD Manufacturing
When choosing a Contract Development and Manufacturing Organization (CDMO) for oral solid dosage manufacturing, pharmaceutical companies should focus on these key factors:
- Qualified CDMO Expertise
- Partner with a CDMO that has proven expertise in OSD formulation and manufacturing.
- Ensure the partner can manage the full production process efficiently and safely.
- API Properties & Formulation Type
- Evaluate the Active Pharmaceutical Ingredient (API) stability, sensitivity to heat/moisture, and excipient compatibility.
- Choose a CDMO with experience in challenging formulations for optimal results.
- Desired Release Profile
- Match the release profile (immediate, sustained, or controlled release) with therapeutic goals.
- Ensure the formulation is validated for efficacy and safety.
- Patient-Centric Needs
- Consider patient preferences and ease of use (e.g., chewable tablets or liquid forms for those who have trouble swallowing).
- Select a formulation that enhances patient compliance and treatment outcomes.
- Continuous Manufacturing & Testing Standards
- Adopt continuous manufacturing to streamline production.
- Ensure rigorous quality testing to meet safety and regulatory standards.
“In today’s pharmaceutical landscape, bringing an innovative oral solid dose (OSD) formulation to market is complex, critical, and requires expertise in all areas ranging from preclinical to clinical through commercialisation. The path from molecule to medicine involves navigating complex formulation and process challenges, regulatory requirements and meeting evolving market demands, all while racing against time to deliver better treatments to patients and stay ahead of the competition.”
Choosing the right CDMO is critical, as it requires science, technology and world-class expertise. It also requires a strategic partnership—bonded by key elements such as trust, communication and collaboration. The ideal CDMO partnership fuels success and embeds the elements of partnership into every operation, interaction and steps throughout the drug development journey.
The right CDMO can navigate everything from complex supply chain issues and compressed timelines to evolving regulations. Knowing the challenges and developing solutions you can trust can help in bringing the sponsor’s treatment to patients and market faster – says Sanjay Konagurthu, PhD, Sr. Director, Science and Innovation, pharma services, Thermo Fisher Scientific
Integration is the New Frontier says Shanghai Haoyuan Chemexpress.
“The CDMO sector is seeing a rise in demand for “one-stop shop” solutions, appealing to drug sponsors seeking speed, scalability, and customer support efficiency.
Pharmaceutical companies and CDMOs are forming more collaborative partnerships, sharing competencies, knowledge, and capabilities. The strategic partnership enables specialized oral solid dosage manufacturing capabilities, including formulation development, scale-up, and commercial production.”
For sponsors to get the most from CDMOs in this market, opt for CDMOs offering comprehensive services from formulation to production to reduce time-to-market and ensure quality.
- Seek CDMOs with end-to-end services expertise in oral solid dosage formulation and manufacturing, and a transparent team for open communication.
- Access Advanced Tech & Expertise: CDMOs provide specialized tech and expertise that sponsors may lack, enabling innovative product development. For example, the development of amorphous solid dispersion technology has been instrumental in enhancing the solubility and bioavailability of certain drugs, leading to more consistent and effective treatment options for patients.
- Collaborate on Custom Solutions: Work with CDMOs to create tailored formulations and processes that meet patient needs and market demands.
- Ensure Regulatory Compliance: Partner with CDMOs who understand regulations and have a proven compliance record to minimize regulatory risks.
- Plan for Long-Term Partnerships: Build long-term relationships with CDMOs for trust, efficient collaboration, cost savings, and quality improvement.
“One way to get the most from a CDMO is to choose one that can do both early-phase development and manufacturing of clinical supplies, as well as late-phase registration, validation, and commercial launch. This avoids having to transfer the product to another manufacturer midway through development, the need for transfer costs, as well as keeps the technical know-how within the same company.
A reliable CDMO becomes an extension of a pharmaceutical developer’s own team by building mutual trust with regular, transparent communication. What is important is not if an issue arises- because it will – but how the CDMO responds to it. So flexibility, timely communication and anticipation of challenges with a clear pathway forward are key to getting the most from a CDMO.” – Dr. Brittany L Hayes, Director, Global Highly Potent & Oncology Platform, Corden Pharma
For sponsors to get the most from CDMOs in this market, one may consider the following strategies,” says Yuan Wang, Ph.D., Founder and General Manager of 2Y-Chem, Ltd., a subsidiary of Chemexpress
Choose the Right CDMO:
Seek CDMOs with expertise in oral solid dosage formulation and manufacturing, and ensure a transparent team for open communication.
Leverage End-to-End Services:
Opt for CDMOs offering comprehensive services from formulation to production, which helps reduce time-to-market while ensuring high quality.
Access Advanced Tech & Expertise:
CDMOs provide specialized technology and expertise that sponsors may lack, enabling innovative product development. For example, amorphous solid dispersion technology has been key in enhancing solubility and bioavailability of certain drugs, improving treatment consistency.
Collaborate on Custom Solutions:
Work closely with CDMOs to create tailored formulations and processes that meet patient needs and market demands.
Ensure Regulatory Compliance:
Partner with CDMOs who understand regulations and have a proven compliance track record to minimize risks associated with regulatory hurdles.
Plan for Long-Term Partnerships:
Build long-term relationships with CDMOs to foster trust, ensure efficient collaboration, save costs, and drive quality improvements.
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