ORAL DOSAGE FORMS - The Future of Oral Dosage: Innovations, Challenges & the Path Forward in 2025

INTRODUCTION

Oral dosage forms have long been the backbone of phar­maceutical development, past, present and fast-approaching fu­ture. The category has come a long way since the introduction of the first aspirin tablets in 1897, with sales of orally administered drugs now accounting for more than 80% of the total pharma­ceutical market.^1-3 Just as the size and shape of the oral dosage segment has evolved over the intervening century, so too have the drugs themselves. Where once there was relatively little choice over medication form and function – beyond perhaps selecting either tablet or capsule – today, scientific and technological ad­vances have opened up the potential for a myriad of highly tar­geted or even fully personalized drugs.

With viable alternatives to the traditional one-size-fits-all ap­proach continuing to emerge, the time is ripe to pause, take stock of the current oral dosage market – and consider where it could shift next.

Read on as we explore the latest industry challenges, cut­ting-edge manufacturing techniques and patient needs defining today’s oral delivery methods, and break down some of the ways drug producers can ride, or even define, the next wave of oral drug delivery.

THE VIEW FROM THE TOP: INDUSTRY CHANGE & CHALLENGES

At the quarter mark of the twenty-first century, the oral dosage market finds itself in a place of contrast. On the one hand, a wave of patent expirations looms on the horizon, with potential to remove $200 billion in annual revenue from top play­ers over the next five years. The introduction of Medicare-con­trolled price limits for the US’ best-selling drugs is also squeezing margins for manufacturers – big names and generics producers alike.^4,5 Conversely, the advent of artificial intelligence (AI), con­tinued digitalization and the increasing viability of practices, such as continuous manufacturing and 3D printing (3DP), have the potential to smooth the path to launching profit-earning pharma products.⁶

This contradiction in trends has prompted various responses, one of the most interesting being the rise of drug premiumization and hyper-personalization – whether in the form of individualized dosing, custom delivery methods or even bespoke manufacture-to-order medications. For the top brands in particular, the poten­tial to produce fully customized medicines on-demand via 3DP presents a more attractive opportunity than competing with con­tract development and manufacturing organizations (CDMOs) on the price of out-of-patent, mass-produced generic drugs. Indeed, commentators surveying the potential of the technology in phar­maceuticals, as well as other fields, such as biomechanics and surgery, point to an eye-opening future market value of 1.9 billion USD.⁷ Although, as with most advancements, accessing this is all dependent on the turning of the regulatory tide.

Concerns surrounding safety, quality and consistency have so far barred 3DP from mainstream acceptance, with bodies like the US Food and Drug Administration (FDA) unable to establish broadly applicable guidelines for approved 3DP drug formula­tions or their AI support systems.^8,9 The immediate outlook is com­plex yet promising, with proponents of these technologies, such as China-based pharma manufacturers, Triastek Inc., pushing regulators to ap­prove 3DP Investigational New Drugs (INDs), like their ulcerative colitis medica­tion T21.¹⁰ In the near future, therefore, we could see the revolutionary potential of 3D drug printing fully unleashed.

Then, there are the perennial chal­lenges facing oral drug producers – prin­cipally sustainability and patient compliance. These topics simmer beneath the surface as newer concerns capture the headlines, only to occasionally burst through when their scale and severity be­come impossible to overlook. Impact as­sessments on the environmental cost of drug manufacturing are fairly sparse in comparison to other major industrial fields, but it has been estimated that pharma’s emission intensity is 55% higher than that of the automotive sector – raising thorny questions with regard to net posi­tives and the trade-off between human health and that of the planet.^11,12

Figures relating to rates of medication adherence are equally concerning, with as many as 50% of patients not taking their medicines as prescribed, costing health authorities across Europe and North America 415 billion US dollars annu­ally.^13,14 As pill fatigue is commonly cited among the key causes of medication non­compliance, designing new, more conven­ient and appealing oral dosage formats takes on a whole new level of importance for global health outcomes.¹⁵

The current picture is mixed but packed with truly electrifying advance­ments. The question therefore becomes, what can oral dosage do to turn up the voltage and turn possible into probable?

ON THE (PRODUCTION) LINE: ORAL DOSAGE MANUFACTURING TRENDS

First, there is the matter of physically producing orally administered drugs, and technologies’ capacity to enhance it. While the theory behind continuous manufactur­ing (CM) is far from new, its increased adoption, particularly among CDMOs, is a more recent development.¹⁶

Promoting a constant flow of raw ma­terials in at the top of the line to finished drugs at the end, the main advantages of CM are improved production efficiency through the use of real-time release testing (RTRT) and tools such as Process Analytical Technology (PAT), smaller space, equip­ment and staffing requirements, and greater supply chain resilience.^17-19 De­spite the clear benefits of CM, however, many larger or more traditionally minded producers are not yet comfortable with its implementation.²⁰ Most, if not all, of the training given to current manufacturing line workers, drug developers and testers alike was based on the assumption of batch-processing, meaning each and every CM project presents a steep learning curve.²¹ This uncertainty has created a self-perpetuating cycle; a limited portfolio of approved CM drugs leaves producers unclear on regulatory expectations, dis­couraging development and compound­ing authorities’ lack of experience with the medium.²² As a result, regulators have been slow to co-sign the use of CM, with only seven continuously produced drugs approved by major international bodies between 2015-2021.²³ The other major barriers to CM adoption – set-up cost and complexity –are starting to erode, though, thanks to the accelerating adoption of AI technologies.

Slotting neatly into the well-estab­lished industrial digitalization movement, AI-enabled machine learning, smart inte­grated machinery and predictive monitor­ing software allow site managers to design, integrate and run highly sophisti­cated RTRT and PAT systems, which in the past may have taken months to install. The value of such technologies also extends well beyond the set-up phase. Equipped with comprehensive data from every stage of the integrated CM production line, AI models can make real-time adjustments to optimize quality, throughput and equip­ment performance, and afford producers the vital opportunity to spot issues early, and avoid costly recalls.²⁴ Taken together, CM and AI could be the perfect combina­tion to help generics producers protect and even boost their margins in 2025 and be­yond.

A NEW DIMENSION: ADVANCEMENTS IN 3D-PRINTED PHARMACEUTICALS

While the mass-market segment stands to profit through an update to ex­isting manufacturing practices, the more premium end of the sector is exploring a whole new perspective on orally delivered drugs. As previously alluded, the potential of 3DP pharmaceuticals is vast, if a little uncertain. To make the vision of precisely tailored, low waste, print-on-demand oral dosage forms a reality, what producers need most is concrete formulation guid­ance – for their own peace of mind, as well as that of regulators.

Fortunately, such protocols are slowly starting to emerge. Focusing on the most commonly used pharmaceutical printing method, fused deposition modeling (FDM), successful drug production rests on selecting the right excipient – in this case a thermoplastic polymer.²⁵ The ideal can­didate is a safe, pharmacopeia-compliant material with the correct thermophysical properties to be melted, extruded accord­ing to the pre-programmed design, fused and finally solidified – quickly – before the next layer is added.²⁶ Over the short history of modern drug printing, oil- based polymers like polyvinylpyrrolidone, polyvinyl alcohol, and polylactic acid have typically won the draft.²⁷ That said how­ever, their synthetic status has hindered regulators’ and patients’ acceptance of 3DP as a safe, scalable and environmen­tally sound production method.²⁸

Enter a newcomer to 3D drug manu­facturing: modified starches (MS). Already widely pharmacopeia-compliant and plant based, MS, like hydroxypropyl methylcel­lulose (HPMC), present a safer and more sustainable alternative to existing 3DP ex­cipients. To confirm the suitability of MS for FDM production models, the authors of a recent study devised two model formula­tions. The first featured pregelatinized hy­droxypropyl pea starch as its excipient, the other a combination of pregelatinized po­tato starch and hydroxypropyl methylcel­lulose (HPMC). In both models, the selected polymers were combined with mannitol and sorbitol to act as plasticizers, while stearic acid was added as a lubri­cant. Upon testing, both preparations were able to yield extrudable filaments with good printability, capable of achieving im­mediate and controlled API release for BCS Class 1 drugs.²⁹

Results like these are incredibly signif­icant for the future of 3DP technology in pharmaceuticals. Not only do they suggest a more sustainable formulation route with­out the need for synthetic polymers, but mainstream acceptance of FDM could also drastically cut time to prototype for new oral dosage designs. What’s more, faster routes to market for rare disease medica­tions could revolutionize the care of under­served or overlooked patient groups.³⁰ But before producers invest too heavily in a continuously manufactured, AI-driven and 3D-printed future, they must spare serious attention for the biggest and most endur­ing challenge that will inevitably follow in the new year.

WINNING HEARTS, MINDS & MOUTHS: PATIENT-CENTRICITY IN 2025

More than any other area of drug de­velopment, oral dosage is defined in con­versation with patient needs – making it one of the most dynamic, and at times, dif­ficult segments to navigate. In 2025, the themes shaping user experience are trust, transparency and tackling inequalities. Be­tween essential medicine shortages, price spikes, access issues and the increasing politicization of healthcare topics since the pandemic, the last three years have seen US consumers’ opinion of the pharmaceu­tical sector sour significantly.^31,32 Indeed, a 2023 Gallup poll reporting that 60% viewed the industry negatively, versus just 18% who expressed positive associa­tions.^33,34 Many of the factors underpin­ning this dip are partly or sometimes wholly out of the industry’s control, but re­gardless of their cause, drug manufactur­ers can play a significant part in turning the tide of negative feeling.

One route to reputational rehabilita­tion could be to focus on meeting previ­ously un- or under-met patient needs. The recent expansion of health consciousness across North America and around the world has laid bare the challenges faced by groups including women, the elderly, children and those diagnosed with psychi­atric disorders when trying to secure orally administered drugs tailored to their needs. Indeed, there was no congressionally mandated requirement to include people assigned female at birth in clinical drug tri­als until as late as 1993, and even today, clinicians are forced to prescribe off-label adult medications in the absence of drugs approved for use in pediatrics.^35,36 At best, these blind spots contribute to issues such as swallowing difficulties, dosing confusion and pill fatigue, all of which worsen pa­tient compliance and leave users feeling left behind by healthcare systems. Beyond ethical considerations, manufacturers have a strong business case for designing pa­tient-friendly drug delivery methods, par­ticularly as the lines between patient and consumer subtly begin to blur.

Bringing our discussion back to the potential of 3D printing, the promise of build-your-own medications, such as the bespoke, multi-action and staggered-re­lease pills printed in layers by researchers at the UK’s University of Nottingham, could allow patients with specialized needs full control over the format, delivery pro­file, color, size and shape of their medica­tions – with radical results for acceptability and compliance.^37-39 To further ameliorate user experiences, drug developers can combine the freedom of personalization with the convenience of alternative dosage forms, such as orally dispersible tablets and films (ODT/Fs), both of which are highly suited to 3D-printed production methods.⁴⁰ For a real-world example of the impact such interventions can have, a recent study found that more than half of 3-5-year-old children stated they liked their personalized, 3D-printed orodis­persible films “very much.”

Amid the excitement of new possibili­ties, however, manufacturers must still pay close attention to fundamentals, such as the choice of excipient. For tablets and films designed to dissolve in the mouth, excellent dispersibility upon contact with saliva is key, as well as good mechanical strength to keep doses stable and effective prior to administration. Achieving a pleas­ant taste and mouthfeel is so important it feels obvious. But selecting fillers, binders or coatings with an effective masking ele­ment becomes especially critical for un­locking more convenient delivery options for the most unpleasant-tasting APIs. The optimal approach to improving patient compliance in 2025 therefore appears to be one of cutting-edge technologies paired with tried and tested truths about patients and their needs.

RISING TO THE OCCASION

Let’s end as we began – with an ac­knowledgement of just how central oral dosage is to the global population’s health and well-being. Already the most widely used delivery format, breakthroughs in the development of 3D-printed drugs, innova­tive dosage forms and radically efficient manufacturing methods are only bolster­ing the category’s significance. Oral drug manufacturers therefore have a duty and responsibility to relentlessly pursue emerg­ing opportunities, while maintaining an unwavering focus on their fundamental mission: improving and safeguarding human health.

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Sébastien Croquet has over 16 years of experience in pharmaceutical technology, specializing in the development of highly functional excipients. After earning his bachelor’s degree in Pharmaceutical Technology from IMT Paris and a master’s in Business Development Management from EDHEC Business School, he joined Roquette Pharma Solutions. Throughout his career, he has held various roles in Customer Technical Service, contributing to innovation, research, and digital transformation. Now, as a Global Technical Developer – Pharma, he leads customer technical relationships and pharmaceutical development projects, supporting product development and technical studies to drive innovative solutions.