The oral solid dose landscape is evolving at a rapid pace, driven by demands for personalized medicines, more efficient R&D pipelines, and innovations in formulation and manufacturing. As new technologies like 3D printing, continuous manufacturing, and novel excipient strategies gain traction, formulators and CDMOs must adapt to these oral solid dose trends to remain competitive.
Understanding these trends is critical. For UPM, a leader in formulation and analytical development and in technology transfer & scale-up support, staying ahead in OSD innovation not only reinforces credibility but helps attract clients seeking modern, reliable oral solid dose manufacturing partners.
Article Contents
Why Oral Solid Dosage Remains Central — and How It’s Changing
Oral solid dosage forms (tablets, capsules, granules) continue to dominate the pharmaceutical market due to their stability, ease of administration, and cost efficiency. Yet, new pressure points are shifting the paradigm:
- Patent cliffs and competitive generics push companies to innovate through new delivery methods and patient-centric formulations.
- The rise of high-potency APIs, peptides, and poorly soluble compounds demands more advanced formulation and process development.
- Outsourcing continues to grow as developers rely on CDMOs with specialized oral solid dose manufacturing infrastructure and expertise.
The foundation of oral solid dosage forms remains strong—but the way these products are developed, scaled, and delivered is transforming.
Key Trends Shaping the Future of OSD Development
The future of oral solid dose manufacturing is being shaped by a wave of scientific innovation, automation, and patient-centered design. From 3D printing and continuous manufacturing to novel excipients and digital modeling, the oral solid dosage forms of tomorrow will look very different from today’s standard tablets and capsules.
These emerging technologies are redefining how pharmaceutical products are formulated, scaled, and delivered, creating opportunities for companies to improve performance, streamline production, and differentiate their portfolios in an increasingly competitive global market.
1. Additive Manufacturing & 3D Printing for Tablets
Additive manufacturing is transforming how tablets can be designed and produced. This method allows for precise control over geometry, release profiles, and dosing customization.
- 3D printing enables layer-by-layer deposition, allowing customization of porosity, dissolution rates, and tablet shape.
- Binder-jet and powder-bed technologies are leading in feasibility for oral solids.
- Regulatory approval and scale-up challenges remain, but progress is accelerating, especially in niche, personalized, and pediatric markets.
UPM’s formulation and analytical development teams monitor emerging additive technologies to ensure readiness for future applications.
2. Continuous Manufacturing & Process Intensification
Continuous manufacturing replaces batch-based processes with integrated, steady-state systems that improve control and consistency.
- Benefits include shorter cycle times, reduced downtime, and real-time process analytics for improved product quality.
- The challenge lies in capital investment, validation complexity, and staff training for process analytical technology (PAT).
- Hybrid systems provide a viable solution for many CDMOs and manufacturers adopting this model.
3. Advanced Excipients and Co-Processed Materials
Innovation in excipients is unlocking new formulation opportunities.
- Lipid-based and co-processed excipients improve solubility, stability, and flow properties.
- Functional polymers and nanoparticulate carriers enhance the performance of poorly soluble APIs.
- Integrated excipient systems also help simplify manufacturing and reduce the risk of compatibility issues.
4. Personalization, Dose Flexibility & Patient-Centric Design
Personalized medicine is reshaping oral solid dosage forms, focusing on adaptability and patient comfort.
- Mini-tablets and modular systems enable flexible dosing, particularly for pediatric and geriatric patients.
- Orally disintegrating tablets and thin films enhance convenience and adherence.
- Smart tablets and digital tracking could one day monitor dose intake and adjust therapy in real time.
5. Data-Driven Development, AI & Predictive Modeling
Artificial intelligence is accelerating decision-making in formulation and process design.
- Predictive models simulate dissolution, compressibility, and stability before lab testing.
- Machine learning reduces experimental cycles and supports first-time-right development.
- Integrated digital systems unify analytical data, process parameters, and regulatory documentation.
6. Regulatory & Sustainability Trends
Regulators and sustainability initiatives are redefining how solid dose manufacturing operates.
- The FDA and EMA are advancing guidance for continuous and additive manufacturing.
- Green chemistry and energy-efficient processing are becoming standard expectations.
- Material sourcing and packaging sustainability are influencing partner selection and brand reputation.
Challenges & Barriers to Adoption
While innovation in oral solid dose manufacturing offers major advantages, implementation isn’t without its hurdles. Many pharmaceutical organizations—especially small and mid-size developers—face obstacles when attempting to modernize processes or integrate new technologies. Understanding these challenges early allows for better planning, risk mitigation, and smarter collaboration with a CDMO partner.
Regulatory Uncertainty and Approval Delays
New manufacturing approaches like 3D printing and continuous processing often outpace existing regulatory frameworks. Unclear guidance on validation protocols, comparability studies, and documentation requirements can create delays. Proactive dialogue with agencies and experienced regulatory support from a CDMO can help clarify expectations and accelerate approvals.
High Capital Investment and Operational Costs
Upgrading legacy facilities or installing new continuous manufacturing lines requires substantial upfront investment. Beyond equipment costs, companies must also budget for facility modifications, quality management upgrades, and digital monitoring systems. For many firms, partnering with an established CDMO offers access to these resources without the capital burden.
Supply Chain and Material Limitations
Novel excipients, polymers, and specialized materials often have limited global suppliers, creating potential bottlenecks or variability. Inconsistent material quality or availability can disrupt production timelines. A well-connected CDMO can mitigate this risk by qualifying alternative vendors and ensuring consistent sourcing.
Technical Complexity and Process Integration
Adopting AI, PAT, or hybrid continuous systems requires a deep understanding of the process and cross-functional coordination. Even small process deviations can affect tablet uniformity, dissolution, or bioavailability. CDMOs with integrated analytical and manufacturing capabilities help establish design spaces, validate process parameters, and ensure scalability.
Talent and Training Gaps
Implementing next-generation manufacturing demands expertise in data science, automation, and advanced formulation methods. Recruiting and training personnel with these skill sets can take time and divert internal resources. Outsourcing to experienced partners like UPM ensures access to specialized knowledge and continuous upskilling without disrupting internal operations.
Balancing Innovation with Risk Management
Rapid adoption of emerging technologies can expose organizations to regulatory, financial, or quality risks if not executed strategically. Establishing a structured risk assessment framework—supported by experienced CDMOs—ensures innovation happens safely and efficiently.
Ultimately, the companies that succeed in integrating these innovations will be those that balance ambition with pragmatism, leveraging trusted CDMO partnerships to fill capability gaps and manage complexity while maintaining focus on core R&D objectives.
How CDMO Partnerships Help Navigate OSD Trends
Partnering with a skilled CDMO partner for scale-up enables pharmaceutical companies to adopt new technologies efficiently and with lower risk.
- CDMOs provide ready access to advanced processing, testing, and validation equipment.
- Integrated teams align formulation, manufacturing, and analytical development seamlessly.
- Regulatory and quality frameworks are already in place, ensuring compliance from pilot to commercial scale.
- Strategic collaboration allows innovators to focus on drug design while their CDMO partner ensures manufacturability and scalability.
UPM offers comprehensive support across formulation, analytical development, and scale-up manufacturing, empowering clients to stay ahead of industry change.
Future Outlook: Preparing for What’s Next in Oral Solid Dose Development
As pharmaceutical trends in 2025 continue to evolve, companies that act early will shape the next generation of OSD innovation. The intersection of digitalization, sustainability, and patient personalization will drive competition in the coming decade.
Developers who invest in flexible manufacturing systems, digital modeling, and robust regulatory strategies will gain an edge. Partnering with CDMOs like UPM Pharmaceuticals, which already integrates these principles, ensures readiness for the challenges and opportunities ahead in oral solid dose manufacturing.
FAQs About Oral Solid Dose Trends
What regulatory challenges exist for introducing new excipients or novel dosage forms?
New excipients often need full safety and compatibility data; regulators may scrutinize their use in OSD. Novel approaches (e.g., 3D printing) require demonstration of reproducibility, process control, and equivalence to traditional methods. Regulatory bodies tend to favor well-characterized, established technologies unless a clear justification is provided.
How can pharmaceutical companies determine if a personalized oral solid dose approach is right for their pipeline?
Evaluate target population size, dosing flexibility requirements, formulation complexity, and viability of alternative presentations. Small patient groups (e.g., pediatrics, rare diseases) or precision therapies often justify personalization, while standard markets tend to favor traditional methods. Pilot feasibility studies with CDMO support help assess ROI and risk.
How can partnering with a CDMO help companies stay ahead of OSD trends?
A CDMO invested in innovation can provide access to advanced formulation techniques (e.g. 3D printing, continuous manufacturing), regulatory support, pilot testing, and risk mitigation, all without requiring capital investment by the developer. This collaboration enables more agile adaptation to oral solid dose trends.
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Partner with UPM Pharmaceuticals for Next-Generation Oral Solid Dose Manufacturing
Staying ahead of oral solid dose trends requires more than awareness. It demands collaboration with experts who understand the science, the process, and the regulatory landscape. UPM Pharmaceuticals combines decades of experience with a forward-thinking approach to help partners innovate, optimize, and scale efficiently.
Our expertise in solid dose handling and formulation development enables clients to accelerate timelines, reduce risk, and bring novel products to market successfully. Whether you’re exploring new excipients, continuous manufacturing, or patient-centric dosage forms, UPM provides the technical and regulatory support you need. Contact UPM Pharmaceuticals today.
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