Oral Transmucosal Drugs Market Driven by Growing Demand for Pain and CNS Disorder Treatments - Persistence Market Research

The global oral transmucosal drugs market is witnessing strong expansion as advancements in drug delivery systems reshape the pharmaceutical landscape. Valued at US$ 38.43 billion in 2025, the market is projected to reach US$ 62.55 billion by 2032, growing at a CAGR of 7.2% during the forecast period. Oral transmucosal drug delivery, which involves the absorption of active pharmaceutical agents through the oral mucosa, offers significant advantages over conventional routes. By bypassing the gastrointestinal tract and hepatic first-pass metabolism, these formulations achieve faster onset of action, enhanced bioavailability, and improved patient compliance.

The growing prevalence of chronic and neurological conditions, such as Parkinson's disease, Alzheimer's, dysphagia, and chronic pain, is a key factor driving market growth. The tablet segment currently dominates due to its efficiency and convenience, while films are emerging as the fastest-growing product category thanks to their rapid dissolution and high absorption rates. North America leads the global market, bolstered by its aging population, advanced healthcare infrastructure, and increasing adoption of non-invasive drug delivery systems. This regional dominance is supported by robust regulatory guidance and technological innovation, ensuring continued expansion throughout the forecast period.

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Key Highlights from the Report

• Increasing demand for advanced drug delivery systems driven by the global rise in chronic diseases.
• The tablet segment dominates the market due to high bioavailability and rapid onset of action.
• Films segment expected to be the fastest-growing due to superior dissolution and convenience.
• North America remains the leading region with strong clinical adoption and supportive regulations.
• Technological advances such as 3D-printed applicators and microneedle systems are redefining delivery efficiency.
• Aging populations and growing neurological disease prevalence continue to accelerate global demand.

Market Segmentation
Product Type Insights

Based on product type, the oral transmucosal drugs market is segmented into tablets, films, sprays, and others, with tablets accounting for approximately 65% of the global market share. Oral transmucosal tablets are specifically designed to dissolve within the oral cavity, allowing active ingredients to pass directly into systemic circulation via the buccal or sublingual mucosa. This design avoids the gastrointestinal tract and liver metabolism, enabling faster therapeutic action and enhanced bioavailability. Drugs such as fentanyl buccal tablets (Fentora®) have become essential in oncology for managing breakthrough pain. These formulations are particularly beneficial for patients who face swallowing difficulties, such as elderly individuals, pediatric patients, and those in palliative care.

The films segment, however, is projected to witness the fastest growth rate during the forecast period. Buccal films-thin, flexible sheets designed to adhere to the oral mucosa-dissolve quickly and release active pharmaceutical ingredients directly into the bloodstream. Studies have demonstrated that pectin-based buccal films with glycerol enhance mucoadhesion and modulate drug release rates effectively. Additionally, nanostructured lipid carrier (NLC) technologies are enabling customizable and controlled drug release through 3D printing, broadening therapeutic possibilities. These films offer superior ease of use, discretion, and comfort, making them increasingly popular among geriatric and pediatric patients.

End-User Insights

From an end-use perspective, the hospital pharmacy segment dominates the global oral transmucosal drugs market, accounting for around 55% of total market revenue. Hospital pharmacies remain crucial for ensuring the safe and efficient distribution of transmucosal medications, especially for inpatients requiring close clinical monitoring. As chronic diseases and neurological disorders continue to rise, hospital pharmacies play a pivotal role in managing acute conditions that demand rapid and targeted therapeutic interventions. Additionally, healthcare infrastructure expansion across emerging economies such as India, China, and Singapore further fuels growth in this segment.

Conversely, the online pharmacy segment is anticipated to grow at the fastest CAGR throughout the forecast period. The rapid adoption of digital healthcare platforms, e-commerce, and telemedicine services has significantly enhanced access to oral transmucosal medications. Online channels such as Amazon Pharmacy, CVS Health, and Walgreens, along with regional players like PharmEasy and 1mg, provide patients with convenient, at-home access to vital medications, particularly for chronic pain, anxiety, or addiction therapy. The combination of digital health solutions and efficient logistics is driving an unprecedented shift toward patient-centric, technology-enabled healthcare.

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Regional Insights
North America

North America holds the largest share of the global oral transmucosal drugs market, accounting for over 45% of total revenue. This dominance stems from the region's aging population, high prevalence of neurological and chronic pain conditions, and strong regulatory support from the U.S. Food and Drug Administration (FDA) and Health Canada. The U.S. alone represents the most lucrative national market, with over 76% of adults reporting at least one chronic condition. Innovations such as Rapid Dose Therapeutics' QuickStripTM technology exemplify North America's leadership in adopting cutting-edge transmucosal solutions. Major players, including BIAL, Tonix Pharmaceuticals, and Vestige Marketing, continue to drive the region's research and commercialization efforts.

Asia Pacific

The Asia Pacific region is emerging as the fastest-growing market for oral transmucosal drugs, fueled by demographic transitions, expanding healthcare infrastructure, and rising awareness of patient-friendly therapies. Countries such as Japan and South Korea are at the forefront of developing mucoadhesive films and dissolvable oral systems to address age-related conditions. With Japan's geriatric population projected to reach 38% by 2050, demand for non-invasive therapies is accelerating rapidly. Local pharmaceutical innovators such as C.L Pharm, Cure Pharmaceutical, and Seoul Pharmaceuticals are investing heavily in R&D for buccal and sublingual formulations. China also shows robust growth, supported by healthcare investments, government initiatives, and a vast patient population requiring advanced pain management and neurological care.

Europe

Europe maintains steady growth driven by favorable regulatory frameworks and increasing adoption of transmucosal therapies among the elderly population. The European Medicines Agency (EMA) has streamlined pathways for approving oral transmucosal drugs, enhancing innovation and safety. Partnerships such as Aquestive Therapeutics and Pharmanovia's collaboration for Libervant (diazepam buccal film) highlight Europe's focus on expanding its non-invasive drug portfolio. France is the fastest-growing market within Europe, buoyed by government support for pharmaceutical innovation, expanded healthcare spending, and a large elderly demographic facing chronic neurological conditions.

Market Drivers

The primary force propelling the oral transmucosal drugs market is the growing burden of chronic diseases and the demand for non-invasive, patient-friendly drug delivery systems. Conditions such as Parkinson's disease, Alzheimer's, chronic pain, and opioid use disorder require therapies that act quickly and avoid gastrointestinal degradation. Oral transmucosal routes, including buccal, sublingual, and oromucosal, offer rapid drug absorption and convenience for patients who may struggle with traditional dosage forms.

Furthermore, technological advancements have transformed this market. Innovations in mucoadhesive polymers, enzyme inhibitors, and permeation enhancers have significantly improved drug absorption rates through oral mucosa. The integration of 3D printing technologies enables the development of personalized intraoral devices for controlled drug release, optimizing therapeutic outcomes. As the global population ages and chronic disease rates soar, the need for efficient, accessible, and pain-free drug administration methods continues to expand.

Market Restraints

Despite its strong potential, the oral transmucosal drugs market faces several regulatory and technical challenges. Regulatory bodies, such as the FDA and EMA, impose stringent guidelines to ensure dosage uniformity, stability, and patient safety. Achieving consistency in drug content, dissolution rate, and mucoadhesion properties poses a significant formulation challenge.

Additionally, the potential for misuse of opioid-based transmucosal drugs has led to strict Risk Evaluation and Mitigation Strategies (REMS). These regulations require prescribers and pharmacists to verify opioid tolerance, monitor patient registries, and provide detailed administration guidance. The discontinuation of several transmucosal immediate-release fentanyl products in 2024 underscores the regulatory scrutiny surrounding potent formulations. Moreover, manufacturing complexity, high R&D costs, and the need for precise labeling and patient education continue to hinder large-scale adoption in some regions.

Market Opportunities

Amid regulatory complexities, significant growth opportunities lie in technological innovation and product differentiation. Advances in nanocarrier-based systems, functionalized polymers, and bioadhesive formulations are unlocking new possibilities in transmucosal drug delivery. Functionalized chitosan derivatives, modified with thiol or catechol groups, enhance mucosal adhesion, enabling sustained release and improved patient outcomes.

Moreover, the growing adoption of fast-dissolving tablets (FDTs) and buccal films for pediatric and geriatric care presents a high-value opportunity. These dosage forms require no water and are convenient for patients with swallowing difficulties. Emerging intraoral medical devices, such as microneedle patches and iontophoretic systems, also represent the next frontier in personalized and controlled-release therapies. Pharmaceutical companies investing in R&D collaborations, 3D printing, and smart delivery systems are likely to secure competitive advantages in the evolving oral transmucosal drugs landscape.

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Company Insights

The global oral transmucosal drugs market is characterized by a fragmented yet competitive landscape, with several key players focusing on research innovation, product launches, and strategic partnerships to expand their global footprint.

Key Players:
• GSK
• Hikma Pharmaceuticals
• Bristol Myers Squibb
• Teva Pharmaceutical Industries
• Novartis
• Sanofi
• AbbVie
• Eli Lilly
• Boehringer Ingelheim
• Pfizer

Market Segmentation

By Product Type

Tablets
Films
Liquid & Spray
Others

By Route of Administration

Sublingual Mucosa
Buccal Mucosa
Others

By End-user

Hospital Pharmacies
Retail Pharmacies
Online Pharmacies

By Region

North America
Europe
Asia Pacific
South Asia and Oceania
Latin America
Middle East and Africa

Recent Developments

In March 2024, BIAL launched KYNMOBI, a sublingual film for the intermittent treatment of OFF episodes in adult patients with Parkinson's disease in Germany.

In March 2024, Tonix Pharmaceuticals partnered with Almac Pharma Services to launch Tonmya, a centrally acting non-opioid analgesic for fibromyalgia treatment in the U.S.

These developments reflect the industry's strategic shift toward non-invasive delivery systems, addressing patient comfort, and enhancing therapeutic efficacy in chronic disease management.

Conclusion

The oral transmucosal drugs market is on a promising trajectory, driven by the convergence of innovative pharmaceutical technologies, rising chronic disease prevalence, and increasing demand for patient-friendly drug delivery. By bypassing the gastrointestinal system and ensuring rapid absorption through the oral mucosa, transmucosal drug delivery offers unmatched therapeutic advantages. While regulatory hurdles and formulation challenges persist, ongoing advancements in nanotechnology, mucoadhesive polymers, and 3D printing continue to redefine the boundaries of drug delivery science.

With North America maintaining dominance and Asia Pacific emerging as a dynamic growth hub, the global market is poised for sustained expansion. The next decade will see continued innovation in product design and manufacturing technologies, further solidifying oral transmucosal systems as an integral component of modern pharmaceutical care.

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