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Buccal Drug Delivery Systems Market

The market for Buccal Drug Delivery Systems was estimated at $5.0 billion in 2025; it is anticipated to increase to $6.8 billion by 2030, with projections indicating growth to around $9.2 billion by 2035.

Report ID:DS1806014
Author:Debadatta Patel - Senior Consultant
Published Date:
Datatree
Life Science
Other Healthcare
Buccal Drug Delivery Systems
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Report Summary
Market Data
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Global Buccal Drug Delivery Systems Market Outlook

Revenue, 2025

$5.0B

Forecast, 2035

$9.2B

CAGR, 2026 - 2035

6.4%

The Buccal Drug Delivery Systems industry revenue is expected to be around $5.0 billion in 2026 and expected to showcase growth with 6.4% CAGR between 2026 and 2035. The market shows strong potential because Buccal Drug Delivery Systems have become essential components of sophisticated buccal drug delivery methods which result from increasing numbers of people with chronic and lifestyle diseases and healthcare organizations focusing on patient friendly drug administration methods and scientific advancements in drug formulation development. The current applications of smoking cessation and pain management therapies total 63.7% because clinicians need non invasive treatments which deliver fast results and dependable drug absorption through the buccal mucosa. The Buccal Tablets Product leads all product segments because it achieved $2.14 billion in sales during 2025 through established mucoadhesive buccal tablets technology and doctor comfort with the treatment method and growing adoption of transmucosal drug delivery products.

Buccal Drug Delivery Systems function by placing medication between the gum and cheek which allows drugs to pass through buccal epithelium for better absorption and avoids liver metabolism for improved drug availability and better patient compliance than traditional oral administration. The system includes bio adhesive polymers which extend drug stay time and permeation enhancers and taste masking agents and controlled release formulations which enable customization of immediate and sustained therapeutic effects. The current medical field uses oromucosal drug delivery systems to treat smoking addiction and pain relief and various cardiovascular and central nervous system conditions and hormonal imbalances and cancer support treatment. The medical field uses oromucosal drug delivery platforms which include buccal tablets and films and sprays and patches to treat different conditions. The market shows increasing demand because scientists now create peptide and biologic substances which can be used in buccal drug delivery systems and because nanotechnology carriers have entered the market and because personalized data based transmucosal drug delivery systems have become popular for precision medicine applications.

Buccal Drug Delivery Systems market outlook with forecast trends, drivers, opportunities, supply chain, and competition 2025-2035
Buccal Drug Delivery Systems Market Outlook

Market Key Insights

  • The Buccal Drug Delivery Systems market is projected to grow from $5.0 billion in 2025 to $9.2 billion in 2035. This represents a CAGR of 6.4%, reflecting rising demand across Pain Management Therapy, Hormonal Therapy, and Treatment of Local Oral Conditions.

  • The market competition stems from GSK plc and Teva Pharmaceutical Industries Ltd. and Pfizer Inc. which operate as its leading companies.

  • The Buccal Drug Delivery Systems market depends on U.S. and Germany as its leading customer bases which will experience 4.2% to 6.1% annual growth rates from 2025 to 2030.

  • The research predicts Brazil, India and South Africa will experience the most significant market expansion at rates between 7.4% and 8.8% CAGR.

  • The market value chain of United States and Germany will experience greater influence from Transition like Innovation in Bio Adhesive Materials which will generate $169 million of additional value for Buccal Drug Delivery Systems industry revenue during 2030.

  • The Buccal Drug Delivery Systems market will experience a $4.3 billion growth span from 2025 to 2035 while Smoking Cessation & Angina Pectoris Application from manufacturers will dominate market expansion.

  • With

    increasing demand for non-invasive drug delivery methods, and

    Innovation in Biotechnology and Nanotechnology, Buccal Drug Delivery Systems market to expand 86% between 2025 and 2035.

buccal drug delivery systems market size with pie charts of major and emerging country share, CAGR, trends for 2025 and 2032
Buccal Drug Delivery Systems - Country Share Analysis

Opportunities in the Buccal Drug Delivery Systems

European biopharmaceutical start ups use Buccal Drug Delivery Systems with advanced technology to create new methods for peptide and biologic drug administration which replace injections with transmucosal drug delivery. The market segment shows 8.56% annual growth rate through 2030 because buccal gels with permeation enhancers and nanocarriers function as unique delivery systems which will also expand from $0.73 billion to $1.19 billion during this period. The system enables dose titration through flexible buccal films which creates an environment that supports strategic partnerships between CDMO companies and license agreements for autoimmune and metabolic and rare disease therapeutic development.

Growth Opportunities in North America and Asia-Pacific

The application of Smoking Cessation will continue to be the leading use for Buccal Drug Delivery Systems in North America because of public health regulations and workplace smoking cessation initiatives and insurance coverage for non invasive nicotine replacement therapy products. The market for oromucosal drug delivery products faces strong competition between established branded and generic products which forces new companies to create distinct products through their fast acting formulations and simple administration methods and digital tracking systems. The most promising market opportunities exist in high end patient focused Buccal Drug Delivery Systems which include taste hidden controlled release medications and small mucoadhesive buccal tablets that help prevent relapse and manage multiple medications in chronic pain treatment. The company needs to focus on obtaining real world evidence through studies which involve payers to prove the value of their products for achieving formulary placement and determining price points in integrated healthcare systems.
The most suitable application for Buccal Drug Delivery Systems in Asia Pacific would be Angina Pectoris because cardiovascular diseases continue to increase while doctors miss many heart attacks and patients need quick non surgical emergency treatments in region's with limited resources. The market competition includes powerful regional generic companies and hospital based suppliers who leave room for new transmucosal drug delivery systems which provide quicker drug absorption than standard oral tablets and maintain their stability in hot and humid environments. The company has three main business opportunities which involve developing Buccal Drug Delivery Systems at reduced costs for public procurement contracts and working with local manufacturers to create new products and developing combination medications which reduce the number of medications patients need to take for cardiovascular treatment. The company should direct its investment toward developing manufacturing capabilities which scale up and collecting clinical data from specific regions and physician training programs to establish buccal formulations as a workable substitute for injectable medications in emergency and outpatient cardiac care settings.

Market Dynamics and Supply Chain

01

Driver: Enhanced Patient Compliance and Rapid Systemic Absorption Through Innovative Buccal Technologies

Buccal drug delivery systems are also gaining traction due to improved patient compliance and the ability to achieve rapid systemic absorption, each driven by distinct industry dynamics. Non‑invasive formats such as mucoadhesive films, quick‑dissolve tablets, and adhesive patches make dosing simpler, particularly for populations with swallowing difficulties or aversion to injections, increasing adherence in chronic and acute settings. Simultaneously, the buccal mucosa’s rich blood supply and thin epithelial layer enable drugs to enter systemic circulation quickly, bypassing first‑pass metabolism that limits oral bioavailability. Technological advancements in polymer science and bio-adhesive materials further optimize contact time and drug release profiles, reinforcing the route’s pharmacokinetic advantages. Innovation in formulation design also supports potent molecules with narrow therapeutic windows, expanding therapeutic possibilities. Together, these trends attract both established pharmaceutical players and biotech innovators toward buccal platforms, elevating commercial interest and broadening potential applications across pain, hormonal, and local oral therapies while addressing unmet patient needs.
Market momentum for buccal drug delivery systems is also significantly propelled by the rising demand for non‑invasive administration routes that can also deliver localized therapies directly to oral tissues or systemic drugs without injections. Patients increasingly prefer administration methods that are also painless and convenient, especially for chronic conditions requiring frequent dosing. At the same time, clinicians and drug developers prioritize technologies that offer targeted delivery with minimized systemic side effects, particularly for oral mucosal diseases and breakthrough systemic needs such as pain management. This shift toward patient‑centric care and precision targeting encourages investment in buccal platforms, driving adoption in both hospital and outpatient care settings as part of broader healthcare modernization and personalized medicine approaches.
02

Restraint: Limited Drug Compatibility and Formulation Complexities Hinder Broader Therapeutic Adoption

Many active pharmaceutical ingredients are unsuitable for buccal delivery due to poor mucosal permeability, stability issues, or irritation potential, forcing costly formulation workarounds. These complexities raise R&D expenses and extend time‑to‑market, deterring some developers from investing in buccal platforms. For example, high‑molecular‑weight biologics and poorly soluble molecules often fail to achieve therapeutic levels buccally, narrowing the candidate pool and suppressing market revenue growth for new indications.
03

Opportunity: Rising geriatric cardiovascular population in Japan needing noninvasive buccal tablets and mucoadhesive films and Expanding chronic pain and oncology transmucosal therapies in United States outpatient care settings

The Japanese healthcare system needs to address two major issues which affect elderly cardiovascular patients who experience swallowing difficulties and multiple medication use through the implementation of Buccal Drug Delivery Systems for their chronic disease treatment. The delivery of antihypertensive medications through mucoadhesive buccal tablets and oromucosal films provides better patient compliance and minimizes drug related adverse reactions. The worldwide market for buccal films will expand from $1.57 billion to $2.12 billion during the period from 2025 to 2030 but Japanese cardiovascular treatment centers have not only adopted these products at a significant rate. The Japanese market will experience film products becoming more popular than tablets because patients will receive more personalized treatments through local partnerships for development.
The United States healthcare system uses Buccal Drug Delivery Systems to provide fast acting pain relief and nausea treatment through skin application instead of swallowing medication or receiving injections which supports opioid conservation and chemotherapy treatment in outpatient settings. The hospital to home programs contain unexplored potential because buccal tablets and films can substitute for injectable medications to treat breakthrough pain and nausea. The worldwide market for buccal tablets will expand from 2.14 billion dollars to 3.18 billion dollars during the period from 2025 to 2030. The 8.56% annual growth rate of buccal gels enables companies to develop exclusive premium products for oncology supportive care treatments.
04

Challenge: Regulatory Uncertainty and Lack of Clear Global Guidelines Slow Commercialization

Inconsistent regulatory frameworks for buccal drug delivery formulations across regions create uncertainty for manufacturers, complicating approval pathways and prolonging clinical development. Without harmonized standards for bioequivalence, mucosal safety, and manufacturing controls, companies may delay launches or limit geographical reach. This restraint dampens investor confidence, slows product rollouts, and can reduce demand as competing traditional delivery methods remain easier to authorize and scale globally.

Supply Chain Landscape

1

Mucoadhesive Excipients Supply

BASF SEEvonik Industries AGColorcon Inc
2

Buccal Drug-Delivery Systems

ARx LLCTeva Pharmaceutical Industries Ltd
3

Oral Transmucosal Manufacturing

Pfizer Inc.GSK plcCatalent Pharma Solutions
4

Clinical Therapeutic Applications

Pain ManagementHormone Replacement TherapySmoking Cessation
Buccal Drug Delivery Systems - Supply Chain

Use Cases of Buccal Drug Delivery Systems in Pain Management Therapy & Treatment of Local Oral Conditions

Pain Management Therapy : Buccal drug delivery systems play a key role in pain management therapy by enabling rapid and reliable systemic absorption of analgesics through the mucosal lining of the cheek. Fast‑dissolving buccal films and mucoadhesive tablets are the most commonly used formats for acute and breakthrough pain, offering quicker onset of action versus conventional oral tablets by bypassing first‑pass hepatic metabolism and entering the bloodstream directly. Well‑known products such as fentanyl buccal soluble films have been used for breakthrough cancer pain, demonstrating strong clinical efficacy and patient adherence. Leading pharmaceutical companies including Teva Pharmaceutical Industries Ltd., Pfizer Inc., Indivior PLC, and BioDelivery Sciences International develop and market buccal pain products, leveraging technologies that maximize bioavailability while enhancing patient compliance.
Hormonal Therapy : In hormonal therapy, buccal drug delivery systems provide an alternative to traditional oral or injectable hormone administration by offering controlled release and stable hormone levels without the gastrointestinal degradation and first‑pass metabolism that can reduce efficacy. Buccal patches and mucoadhesive films are particularly suitable for hormone replacement applications, allowing sustained delivery of agents like estrogens over prolonged periods with improved patient convenience. While buccal formats for hormonal therapy are less prevalent than for pain management, several market players such as Pfizer, Teva, and niche manufacturers focus on expanding these formulations to address menopausal and endocrine disorders efficiently. The buccal route’s advantages of non‑invasiveness and enhanced adherence make it attractive for patients requiring long‑term hormone therapy.
Treatment of Local Oral Conditions : Buccal delivery systems are uniquely positioned for treating local oral conditions like mucositis, periodontal disease, and fungal infections by applying drug‑loaded films, gels, and tablets directly to the affected mucosal surfaces, increasing localized drug concentration while minimizing systemic exposure and side effects. Thin mucoadhesive films and gels adhere to the oral mucosa, releasing therapeutic agents where needed and promoting healing and symptom relief. This targeted delivery enhances therapeutic outcomes, reduces dosing frequency, and improves patient comfort. Key market competitors such as GSK plc, Pfizer, and Teva leverage advanced buccal film technologies to create formulations tailored for local oral therapies within hospital and clinic settings, reinforcing their positions through R&D investment and product breadth.

Recent Developments

Recent developments in buccal drug delivery systems highlight advances in mucoadhesive delivery, improved bioavailability, and digital enhancements driving patient adherence. Pharma innovation is focused on smart formulations like rapid‑dissolve buccal films and controlled‑release patches that bypass first‑pass metabolism and support personalized therapy. A key market trend is integration with connected health technologies for real‑time dosing feedback. These shifts are expanding applications in pain management, hormonal therapy, and localized oral treatments while strengthening competitive positioning for leading drug developers.

December 2024 : Novo Holdings finalized the $16.5 billion acquisition of Catalent, a major drug delivery technology and CDMO provider, which strengthens Catalent’s global formulation and manufacturing capabilities, indirectly supporting buccal and other advanced delivery systems.
April 2023 : DifGen Pharmaceuticals LLC acquired Aveva Drug Delivery Services Inc., enhancing its R&D and manufacturing for complex dosage forms, including buccal delivery platforms, improving supply reliability and innovation potential in this segment.

Impact of Industry Transitions on the Buccal Drug Delivery Systems Market

As a core segment of the Other Healthcare industry, the Buccal Drug Delivery Systems market develops in line with broader industry shifts. Over recent years, transitions such as Innovation in Bio-Adhesive Materials and Digitization and Personalized Medicine have redefined priorities across the Other Healthcare sector, influencing how the Buccal Drug Delivery Systems market evolves in terms of demand, applications and competitive dynamics. These transitions highlight the structural changes shaping long-term growth opportunities.
01

Innovation in Bio-Adhesive Materials

The Buccal Drug Delivery Systems market experiences a fundamental shift because advanced bio adhesive materials continue to advance at a rapid pace which drives product design changes and affects both value capture and competitive market dynamics. The development of advanced mucoadhesive polymers enables better drug absorption and extended drug release which leads to improved drug availability and controlled delivery and enhanced patient adherence in oral transmucosal drug delivery for treating chronic diseases. The United States and Germany value chains show the greatest change because their pharmaceutical development investments for advanced drug formulations and specific drug delivery systems will produce $169 million in new industry revenue through 2030. The market access of biopharma and specialty drug manufacturers becomes faster while they gain better positions in valuable therapeutic region's through their use of these advanced technologies which enable them to charge higher prices. The global Buccal Drug Delivery Systems market allows these manufacturers to achieve better market entry and higher drug prices through their implementation of these advanced delivery systems.
02

Digitization and Personalized Medicine

Digitization and personalized medicine are reshaping the buccal drug delivery systems landscape by enabling tailored therapies that align with individual patient needs. Advanced digital tools, including smart sensors, mobile health apps, and connected dosing devices, allow real‑time monitoring of drug release and patient adherence, improving therapeutic outcomes. For instance, buccal films integrated with micro-sensors can track hormone or analgesic release, providing clinicians with precise data to adjust dosing. This transition also impacts associated sectors like chronic pain management, endocrine therapy, and oral healthcare by reducing side effects, enhancing patient compliance, and enabling targeted localized treatment. Pharmaceutical companies such as Teva, Pfizer, and BioDelivery Sciences are leveraging these technologies to develop next-generation buccal platforms, combining convenience with precision for more effective and patient-centric therapies.