As the industry looks toward 2026, oral solid dosage forms remain firmly at the center of pharmaceutical and nutraceutical innovation — but the forces shaping the market are becoming more complex and interconnected. Speed to market, regulatory preparedness, and formulation sophistication are now inseparable, driving demand for integrated outsourcing models, advanced excipients, and smarter development, manufacturing and analytical strategies.
At the same time, shifts in consumer expectations, the rise of oral obesity treatments, and renewed investment in domestic manufacturing are redefining the OSD landscape. Together, these trends point to a market that is not just growing, but fundamentally evolving — where success will depend on combining technical excellence, operational agility, and patient-centric thinking from the earliest stages of development.
Here’s a look at what industry leaders in pharmaceuticals and nutraceuticals are predicting for the coming year.
Quality and Regulatory Compliance
Speed to market and regulatory preparedness will be key
Advancements in manufacturing technology and polymer science continue to reshape the capsule landscape. Cellulose-based capsules are now firmly established as a preferred option, offering enhanced stability and reduced reliance on gelatin-based raw materials. While cost considerations remain, the drive for faster market entry and first-time-right development is accelerating the adoption of these vegetarian alternatives.
Regulatory scrutiny of synthetic colors has intensified across regulated markets. Recent bans and evolving guidance — often lacking clarity — have created industry concern. As this is a rapidly developing area, collaboration among stakeholders is essential. A unified approach to understanding regulatory rationale, assessing risk, and establishing practical mitigation pathways will be critical to avoiding development disruptions and ensuring continued access to quality medicines. The EMA decision to permit continued use of titanium dioxide (TiO₂) provides welcome stability. Collectively, these developments are strengthening regulatory preparedness and supporting the industry’s commitment to delivering safe, high-quality products worldwide.
- Subhashis Chakraborty, Ph.D., General Manager, Head of Global Product Management, ACG Capsules
Companies will review data integrity strategies for electronic data
With increased FDA focus on electronic record integrity in testing data, 2026 will be the year that we see companies expand their efforts to assess and address the need for real data integrity in much more of their electronic data than just in final results.
21 CFR Part 11 and data integrity requirements have been around for many years now. But as companies migrated to electronic records for all data and parameters related to final results, the goal became employing some form of compliance for all instruments involved in creating the record. However, companies are now realizing that a user login, an electronic method, and a report, which, for example, were common practice in stand-alone instruments like dissolution testers, do not constitute compliance. Last year, this was reinforced by audit findings both abroad and domestically. This was a wake-up call to companies that using electronic records for all aspects of testing requires truly compliant solutions based on local PC or server-based software. We expect to see them review their compliance strategies for each part of the data generation chain and make adjustments needed to bring them into compliance.
- Ishai Nir, Small Molecule Product Manager, Distek Inc.
Industry will move towards semi-automation in dissolution testing
2026 will see an acceleration of the trend towards semi-automation in dissolution testing by replacing media preparation/dispensing and manual sampling with automated solutions.
Fully automated dissolution testing has existed for over 40 years, however, cost, reliability and validation continue to be a challenge. Instead, a global trend of automating the most critical, labor-intensive, error-prone parts of the test, while leaving other operations manual, is gaining momentum. (For example, lab techs are very efficient at post-run cleaning, remaining the best solution for that job.) Where automation offers the biggest payback is media preparation/dispensing and sampling. Proper degassing and dispensing is still one of the most common causes of failed tests. Consistent manual sampling is also a big challenge, with missed time points and variation common. The adoption of dedicated media prep solutions and autosamplers to eliminate these without the complexity of full automation is growing. This trend is not just about labor savings but also elimination of OOS runs, meaning it is becoming prevalent even in countries with inexpensive labor.
- Jeff Seely, Vice President of Sales & Business Development, Distek Inc.
Market Growth
OSD is ready for the resurgence of U.S.-based manufacturing
As we look toward 2026, I believe the compression tablet industry is entering a new year of opportunity. Manufacturing is returning to the United States, and, more importantly, manufacturers are reinvesting here with purpose. Rising global uncertainty, supply chain lessons learned, and renewed confidence in domestic capabilities are driving strategic investments in equipment, talent and training. OSD remains the most efficient and scalable dosage form across the entire value chain, positioning it ideally for the resurgence of U.S.-based manufacturing. In 2026, success will be defined by how well manufacturers leverage innovation and workforce development to maximize productivity and consistency. Smaller, agile manufacturers will continue to grow, while larger organizations will focus on standardization, unified processes, and robust training programs to scale efficiently across sites. Those who invest now — in people, technology and process optimization — will be best positioned to compete, grow and lead as U.S. manufacturing accelerates forward.
- Dale Natoli, President and CEO, Natoli Engineering
The OSD market will continue to grow
2026 points to continued growth in an already healthy oral solid dose market. Tablets, which remain the largest segment of delivery, will remain strong with continued expansion through CDMOs, investment in controlled-release formulation, and product breakthroughs in targeted therapies. Regionally, we should continue to see strong performance in North America and Asia Pacific. Challenges for this period may include political pressure, impurity controls, supply chain difficulties, and continued concerns from alternative delivery technologies.
- Tony Galvin, Segment Manager – Pharmaceutical, Camfil APC
Oral obesity treatments will transform the market
In 2026, the pharmaceutical market will be transformed by the rapid adoption of oral obesity treatments, supported by excipient innovation, advanced film coatings, and moisture-protection technologies.
The global obesity epidemic is driving demand for patient-friendly oral formulations that replace injections with tablets and capsules. The current pipeline of more than 50 oral molecules highlights a decisive shift from injectable GLP-1 receptor agonists to oral delivery, improving patient adherence and convenience. Excipients will play a pivotal role in stabilizing moisture-sensitive peptides and enabling scalable manufacturing. Film coatings will enhance swallowability, aesthetics, and brand differentiation, while also providing critical protection against degradation. Moisture control strategies, including desiccant packaging options, will safeguard GLP-1 receptor agonists, ensuring long-term stability and efficacy. Together, these innovations will improve adherence, reduce stigma, and expand access to obesity therapies. Soon, oral GLP-1 treatments will dominate, setting new standards for accessibility and excipient-driven drug design.
- Rita Steffenino, Market Insights Manager, Colorcon
Technology as a Competitive Advantage
Companies will integrate AI with DOE in formulation
2026 will see a dramatic increase in the integration of AI to minimize the time-consuming physical experimentation portion of the DOE associated with formulation development.
Integrating AI with design of experiments (DOE) can significantly shorten pharmaceutical formulation development timelines. DOE provides a structured, statistically sound framework for exploring formulation and process variables, but it can still require extensive experimentation. AI enhances this approach by rapidly analyzing historical data, identifying nonlinear relationships, and predicting optimal parameter ranges before physical trials begin. Machine-learning algorithms can simulate hundreds of experimental combinations, allowing teams to prioritize only the most informative and high-value experiments. As results are generated, AI models continuously learn and refine predictions, accelerating convergence on robust formulations. This synergy reduces trial-and-error cycles, minimizes resource use, and enables earlier identification of critical quality attributes. Ultimately, combining AI with DOE leads to faster decision-making, more efficient experimental designs, and significantly reduced development time while maintaining high scientific rigor and regulatory compliance.
- Jeff Brinker, President, Distek Inc.
OSD manufacturing will look to new technologies to meet challenges
By 2026, oral solid dose manufacturing will face a convergence of challenges that extend beyond technology: stricter regulatory frameworks, supply chain resilience, sustainability and digital integration. These forces will not hinder progress but act as catalysts for innovation. The industry will embrace continuous manufacturing, modular architectures, and digital twins to ensure efficiency, compliance, and environmental responsibility. Success will depend on turning complexity into opportunity, building resilient, future-ready ecosystems that combine flexibility, data integrity and sustainability. At IMA Active, we see this transition as the foundation of Pharma 5.0, where smarter technologies and global support networks enable manufacturers to achieve stability, speed-to-market, and long-term competitiveness.
- Luca Cavazzini, Sales & Marketing Director, IMA Active
Companies that combine oral innovation with patient insights will have an advantage
As the industry moves toward oral GLP-1 availability for weight loss, payers will face significant new cost considerations tied to broader eligibility and long-term use. Increased demand will also bring heightened scrutiny of safety and utilization patterns across patient populations. To navigate both competitive pressure and cost containment, oral solid dose manufacturers will need stronger clarity on which patients respond best to therapy based on underlying biology. Advances in AI-enabled diagnostics and prognostics can help match treatments to individuals more effectively, reducing avoidable side effects and trial-and-error prescribing. In 2026, the companies that successfully combine oral innovation with precision insights will gain a competitive advantage in a market where access is expanding and expectations around value are rising.
- Mark Bagnall, CEO, Phenomix Sciences
Integrated Outsourcing Models
Demand for integrated OSD formulation services will grow as companies prioritize speed
We are seeing increasing demand for OSD formulation services across all regions. Small molecules remain our core focus, while interest in oral peptide formulations is also rising, reflecting the rapid growth of this field. For early-phase programs, speed to IND has become increasingly critical, leading more customers to engage in preformulation activities earlier than before, often during late discovery or even earlier stages. As a result, integrated development approaches encompassing both API and drug product have gained popularity, as they significantly reduce timelines, with OSD continuing to be the primary dosage form of choice. Demand for amorphous solid dispersion (ASD) formulations remains strong, as the majority of programs we support face bioavailability challenges and require phase-appropriate formulation strategies to achieve the necessary drug exposure for phase 1 studies.
- Hong Li, Ph.D. Vice President, Formulation, BioDuro
The next wave of OSD advancement is coming
Oral solid dosage forms remain the foundation of global drug delivery, and their importance is expected to grow further in 2026. At the same time, OSD development is poised to advance further in sophistication, reflecting increased demand for multiparticulates, customized release profiles, and patient-centric dosage forms. Additive manufacturing technologies like 3D screen printing that deliver greater precision without sacrificing scalability are also gaining momentum and in 2026 are poised to play a larger role in bringing greater speed and innovation to product development.
Ongoing capital constraints are reinforcing the need for efficient, scalable development pathways that minimize risk. In response, sponsors in 2026 will continue to favor integrated CDMO models that align development, manufacturing, and packaging considerations earlier in the process.
- Tom Sellig, CEO, Adare Pharma Solutions
Partners that combine speed, compliance and adaptability will prevail
After more than two decades in the industry, our company sees the coming year as a continuation of the trends that shaped 2025, with both opportunities and headwinds defining the landscape. In an uncertain economy, brands are increasingly reluctant to invest in their own equipment, turning instead to seasoned co-packers who can scale quickly.
Regulatory pressure is also reshaping the field. Stricter labeling, traceability, and compliance requirements elevate the value of partners who already operate at high standards — particularly in blister packaging, where precision and documentation are non-negotiable. Tariffs are pushing raw material costs upward, and passing those increases through to customers remains difficult. Many brands, wary of economic volatility, are placing smaller, more frequent orders to avoid sitting on excess inventory. In this environment, co-packers with strong quality systems — GMP certification, USP compliance and FDA drug licensing — will be the ones to capture market share.
- Rob Lonas, CEO, EW Packaging
The shift toward ultra-high potency will accelerate
The small-molecule landscape will be increasingly shaped by assets sitting at the upper end of the potency spectrum. As precision oncology, targeted protein degraders, molecular glues and next-generation payloads advance, more candidates will exceed the assumptions historically embedded in ‘HPAPI,’ accelerating the shift toward what many now describe as ultra-high potency. These molecules carry narrower therapeutic indices, sub-microgram to single digit nanogram-level exposure limits and complex toxicology, placing new pressure on development organizations and outsourcing partners.
Sponsors entering early clinical phases will prioritize CDMOs with validated OEB 5-6 totally enclosed manufacturing capability (rigid-wall isolation, automated transfers, negative pressure processing) and analytical methods sensitive enough to operate at ultra-low detection limits. Small-batch manufacturing, enhanced cleaning strategies and tighter segregation will become standard expectations rather than specialist features. By late 2026, ‘ultra-high potency-ready’ infrastructure and transparency around containment verification will emerge as a defining differentiator, as developers seek partners capable of managing the heightened technical and regulatory stakes of this upper potency tier.
- David O’Connell, Director Scientific and Technical Affairs, PCI Pharma Services
Consumer-Driven Nutraceutical Needs
Consumers will seek holistic, preventative approaches to wellness
Consumers are increasingly moving away from quick fixes and towards more holistic, preventative approaches to health. In 2026, this shift will continue to drive sustained growth in everyday supplementation, particularly in categories that support long-term well-being. Sleep remains a leading wellness priority, with growing demand for trusted, evidence-backed ingredients that promote calm, cognitive recovery and quality rest. At the same time, the rise of GLP-1s is creating new opportunities for companion nutrition, including supplements that support muscle retention, gut health, micronutrient balance and sustained energy. Younger consumers are also reshaping the longevity conversation through ‘positive aging,’ investing earlier in mobility, cognition, immunity and recovery. This is supporting continued growth across joint, bone and cognitive health. Women’s health remains a strong growth engine, spanning hormonal balance, menopause, fertility and beauty-from-within, while personalized nutrition is moving into the mainstream through targeted, customizable solutions.
- Aaron Quinn, Deputy General Manager, Vantage Nutrition
Natural and non-synthetic colorants will define the nutraceutical market
In 2026, the nutraceutical market will be defined by a decisive move toward natural and non-synthetic colorants, reflecting consumer demand for transparency and clean-label authenticity. Tablets, soft gels, and gummies will increasingly feature natural pigments, offering vibrant aesthetics without reliance on synthetic dyes. Alternative opacifiers will emerge as titanium dioxide replacements. Talc-free formulations will also become standard, further aligning with consumer preferences.
Manufacturers will focus on label friendly development, recognizing how different formulation strategies will influence pigment stability and opacity performance. Stability enhancements such as advanced film coating systems will be critical to preserving the integrity of natural pigments against moisture, light and processing stress. Overall, 2026 will mark a turning point where nutraceuticals showcase natural colors, TiO₂-free opacity, and talc-free formulations, reshaping consumer trust and driving sustainable growth.
- Charlie Cunningham, Technical Director NALAN, Colorcon
Consumers will seek multi-benefit nutraceuticals
Looking ahead to 2026, products designed to deliver multiple benefits are expected to play a larger role in the nutraceutical market, as consumer interest in convenience continues to shape how brands think about product design, formulation and manufacturing. Rather than expanding product portfolios with additional SKUs, brands are evaluating whether a single, well-engineered dosage format can deliver complementary physiological benefits with precision and consistency. Advances in excipient functionality, compression science, coating systems, and lipid-based delivery are expanding the practical limits of combination design, enabling more sophisticated formulations than were previously feasible. At the same time, multi-benefit formats introduce higher formulation complexity, particularly around ingredient compatibility, dose uniformity, and long-term stability. Switching to new formats that allow for both convenience and higher doses also will bring added value for supplement consumers.
Success depends on aligning dosage-format selection, release behavior, and manufacturing strategy early in development, ensuring that added complexity supports performance rather than compromises it.
- Mark Dewis, GM Americas, Sirio Pharma
Packaging Evolution
Industry will see a broad transformation in packaging design
As we look to 2026, pharmaceutical packaging is set for a significant shift driven by tightening sustainability expectations and evolving regulations. Growing concern about aclar film is prompting pharma packaging developers to explore alternative high-barrier solutions. At the same time, the industry is exploring PVC free thermoforming options, with APET-based blister formats, serving the wider spectrum of barrier requirements, gaining traction as safer, more future-proof options. This transition extends beyond films: Cold form with PVC free options, nitrocellulose and halogen-free heat seal lacquer and primers are becoming more common, while interest in online printing continues to rise as brands look to reduce waste, minimize inventory and boost production agility.
Together, these trends signal a broader transformation in packaging design. Performance remains essential, but sustainability, regulatory resilience and supply chain efficiency are now equally central to material selection and innovation.
- Akbar Ali, Ph.D., General Manager, Head of Development & Technology, ACG Packaging
Packaging will face stringent stability requirements
In 2026, OSD drugs will require unprecedented moisture protection. As formulations grow more complex, with APIs and excipients increasingly hygroscopic, stability challenges will intensify. Controlled-release technologies and biologically derived compounds will be especially vulnerable to humidity, making moisture management critical for therapeutic efficacy. This need will be amplified as peptide-based and biological therapies transition from injectables to solid dosage forms, where moisture control is essential.
In this evolving landscape, primary packaging must do more. Traditional bottles and blisters will no longer suffice alone. Packaging will incorporate technologies that actively regulate internal humidity, utilizing both novel barrier materials and active agents. Desiccants will be central to this strategy, integrated into closures, containers, and blister packs. Alongside these innovations, traditional canisters and packets will remain vital, offering proven, flexible solutions that complement integrated systems. These approaches will help meet stringent stability requirements and ensure medicines deliver full therapeutic value.
- Mark Florez, Functional Packaging Technology Manager, Colorcon