Orally Dissolving Strips Market, Global Outlook and Forecast 2025-2032

MARKET INSIGHTS

Global Orally Dissolving Strips market was valued at USD 587 million in 2024 and is projected to reach USD 961 million by 2032, exhibiting a CAGR of 7.5% during the forecast period. The U.S. currently represents the largest market, while China is anticipated to witness the fastest growth rate through 2032. The Orodispersible Film segment is expected to dominate product type offerings due to its widespread adoption in pharmaceutical applications.

Orally Dissolving Strips (ODS) are thin, fast-dissolving polymer films designed for oral drug delivery or nutraceutical administration. These innovative dosage forms dissolve rapidly on the tongue without water, making them particularly valuable for pediatric, geriatric, and dysphagic patients. The technology encompasses two primary variants: Orodispersible Films (dissolving in the mouth) and Oromucosal Films (absorbed through oral mucosa).

The market growth is primarily driven by increasing demand for convenient drug delivery systems, rising prevalence of neurological disorders requiring quick medication, and expanding applications in nutraceuticals. Recent developments include Aquestive Therapeutics' January 2024 FDA approval for their epilepsy treatment strip, demonstrating the technology's therapeutic potential. Key players like IntelGenx and BioDelivery Sciences are actively investing in film formulation technologies to expand their product portfolios.

MARKET DYNAMICS

MARKET DRIVERS

Growing Preference for Convenient Drug Delivery Systems to Fuel Market Expansion

The global orally dissolving strips market is experiencing robust growth driven by increasing consumer demand for convenient and patient-friendly drug delivery systems. Unlike traditional oral dosage forms, these strips dissolve rapidly in the mouth without water, making them ideal for pediatric, geriatric, and dysphagia patients. The market is projected to grow at a CAGR of 7.5% through 2032, reaching $961 million, as healthcare providers increasingly recognize their advantages in medication adherence and ease of administration. The technology's ability to mask bitter drug tastes and provide precise dosing is particularly valuable in markets with high chronic disease burdens.

Expanding Pharmaceutical Applications Create New Growth Vectors

Pharmaceutical companies are actively expanding the therapeutic applications of oral dissolving films beyond traditional breath fresheners and OTC products. Recent innovations include strips delivering complex APIs for conditions ranging from migraine relief to anti-nausea medications. The oro-dispersible film segment, currently dominating the market, is seeing particularly strong growth in neurological and psychiatric applications where rapid onset is clinically beneficial. Manufacturers are investing heavily in proprietary technologies to overcome formulation challenges, with several new strip-based drug formulations receiving regulatory approvals in major markets.

➤ Notably, over 20% of current R&D in pediatric formulations now involves oral film technologies, reflecting strong industry confidence in this delivery platform.

Additionally, the COVID-19 pandemic accelerated adoption of self-administered medications, creating lasting demand growth. The strips' portability and stability under various environmental conditions make them particularly suited for emergency medication kits and travel health products.

MARKET RESTRAINTS

High Production Costs and Manufacturing Complexities Limit Market Penetration

While demand grows robustly, the orally dissolving strips market faces significant production challenges that restrain wider adoption. The specialized equipment required for precision coating and drying processes represents substantial capital expenditure, with complete production lines often exceeding $2 million. This creates high barriers to entry for smaller manufacturers and keeps product costs approximately 30-40% higher than equivalent tablet formulations. The need for stringent humidity controls during manufacturing and packaging further adds to operational expenses.

Other Key Restraints

API Loading Limitations
Current film technologies struggle with consistent API incorporation above certain thresholds, restricting their use for high-dose medications. Most commercial strips are limited to drug loads below 50mg, excluding many therapeutic categories from this delivery format.

Moisture Sensitivity
The hygroscopic nature of film formulations necessitates specialized packaging solutions, adding approximately 15-20% to total product costs. This sensitivity also creates distribution challenges in tropical climates and impacts product shelf life.

MARKET CHALLENGES

Regulatory Hurdles and Standardization Issues Pose Implementation Barriers

The orally dissolving strips market faces evolving regulatory landscapes across different regions that challenge market participants. Unlike conventional oral dosage forms, strip formulations require unique characterization methods for dissolution profiles and bioavailability assessment. Regulatory agencies are still developing specific guidelines for this emerging drug delivery format, creating uncertainty in the approval pathway. Several promising strip-based drug applications have faced delays due to requirements for additional clinical data regarding mucosal absorption kinetics.

Other Challenges

Patent Litigation Risks
The market has seen increasing intellectual property disputes as companies compete to protect proprietary film technologies. Recent patent infringement cases have delayed product launches by 12-18 months in key markets, discouraging some investors.

Physician Prescribing Habits
Despite patient preference for strip formats, many healthcare providers remain unfamiliar with their clinical advantages. Industry surveys indicate over 60% of general practitioners require additional education about appropriate use cases before widely adopting these products.

MARKET OPPORTUNITIES

Emerging Markets and Cannabis Sectors Present Untapped Potential

Asia-Pacific represents the fastest growing regional market for orally dissolving strips, with projected 9.2% CAGR through 2032. Rising healthcare expenditures combined with cultural preferences for convenient medicine formats are driving adoption in countries like India and China. Local manufacturers are developing cost-effective production solutions tailored to emerging market price points, with several Asian firms now exporting to Western markets.

The legal cannabis industry is also creating important new opportunities for strip technologies. THC and CBD oral films provide discrete, precisely dosed administration preferred by medical cannabis patients. Recent legalization waves have spurred over 50 new cannabis strip products in North American markets, with formulations that combine multiple cannabinoids and terpenes in stable film matrices.

Furthermore, advancements in buccal absorption enhancement technologies are expanding the range of drugs suitable for strip delivery. Novel permeation enhancers and nanoparticle formulations may soon overcome current API loading limitations, potentially adding $150-200 million in annual market value by enabling more systemic drug delivery through oral films.

Segment Analysis:

By Type

Orodispersible Film Segment Leads Due to High Patient Compliance and Ease of Administration

The market is segmented based on type into:

• Orodispersible Film

  • Subtypes: Single-layer films, multi-layer films

• Oromucosal Film

By Application

Hospital and Clinic Segment Dominates with Growing Preference for Over-the-Counter Medications

The market is segmented based on application into:

• Hospital and Clinic

• Drug Store

• E-commerce

By Therapeutic Area

CNS Disorders Segment Shows Strong Growth Potential Due to Rising Mental Health Awareness

The market is segmented based on therapeutic area into:

• CNS Disorders

• Pain Management

• Allergy and Respiratory

• Gastrointestinal Disorders

• Others

By Distribution Channel

Retail Pharmacies Hold Major Share with Increasing Self-Medication Trend

The market is segmented based on distribution channel into:

• Hospital Pharmacies

• Retail Pharmacies

• Online Pharmacies

COMPETITIVE LANDSCAPE

Key Industry Players

Innovation and Market Expansion Drive Competition in Oral Dissolving Film Sector

The orally dissolving strips market exhibits a moderately fragmented competitive structure, with established pharmaceutical companies competing alongside specialized drug delivery firms. Aquestive Therapeutics has emerged as a market leader, commanding a significant share due to its proprietary PharmFilm® technology and FDA-approved product pipeline. The company's recent partnerships with major pharma brands have further solidified its position in North America and Europe.

Kyukyu Pharmaceutical and BioDelivery Sciences International (BDSI) are also key contenders, particularly in the therapeutic segment of oral films. These companies have gained traction through their focus on pain management and neurological disorder treatments, with BDSI's BELBUCA® (buprenorphine) film generating substantial revenue since its 2016 FDA approval.

Market players are actively pursuing two strategic paths: expanding therapeutic applications through R&D investments, and broadening geographical reach through distribution agreements. Several companies are developing combination products that integrate oral film technology with novel drug formulations, creating barriers to entry for competitors.

Meanwhile, IntelGenx and ZIM Laboratories are differentiating themselves through manufacturing efficiency and proprietary dissolution technologies. IntelGenx's VersaFilmâ„¢ platform has enabled partnerships with twenty pharmaceutical companies, while ZIM's proprietary ODF technology serves over fifty markets globally. Both companies are increasing production capacity to meet growing demand.

List of Key Orally Dissolving Strip Companies Profiled

• Aquestive Therapeutics (U.S.)

• Kyukyu Pharmaceutical (Japan)

• BioDelivery Sciences International (U.S.)

• IntelGenx Corp. (Canada)

• Tapemark (U.S.)

• Shilpa Therapeutics (India)

• CL Pharm (South Korea)

• Lubrizol Life Science (U.S.)

• Adhex Pharma (France)

• DK Livkon (India)

• Arx Pharma (U.S.)

• Aavishkar (India)

• ZIM Laboratories (India)

• Umang Pharmaceuticals (India)

• Cure Pharmaceutical (U.S.)

An emerging trend is the increased activity among contract manufacturers, with companies like Lubrizol Life Science and Adhex Pharma offering white-label oral film production services. This has lowered the barrier to entry for pharmaceutical companies seeking to add oral strip products without developing in-house manufacturing capabilities. However, intellectual property around specialized film formulations remains a key competitive advantage for technology innovators.

ORALLY DISSOLVING STRIPS MARKET TRENDS

Expanding Applications in Pediatric and Geriatric Care Drive Market Growth

The global Orally Dissolving Strips market, valued at $587 million in 2024, is witnessing significant traction due to their increasing adoption in pediatric and geriatric care. These patient populations often face difficulties swallowing traditional tablets or capsules, making orally dissolving strips an ideal alternative. Studies indicate that approximately 40% of adults over 60 experience dysphagia, creating substantial demand for innovative drug delivery systems. Pharmaceutical companies are actively reformulating existing medications into strip formats, particularly for pain management, allergy relief, and vitamin supplements. The U.S. and European markets lead this trend due to higher healthcare expenditure and aging populations, while emerging economies are catching up with improved access to healthcare infrastructure.

Other Trends

Technological Advancements in Film Formulation

Recent breakthroughs in polymer science and nanotechnology have enhanced the performance of orally dissolving strips. Manufacturers are now producing ultra-thin films (under 50 microns) with improved drug-loading capacities and faster dissolution rates (under 30 seconds). Smart films incorporating taste-masking technologies now cover 85% of bitter-tasting APIs, significantly improving patient compliance. The Orodispersible Film segment, projected to grow at a robust CAGR, benefits from these innovations, especially in neurological and psychiatric applications where rapid drug absorption is critical.

Growing Preference for Non-Invasive Drug Delivery Systems

The shift toward patient-centric medical solutions is accelerating demand for orally dissolving strips across multiple therapeutic areas. In the nutraceutical sector, vitamin strips now account for 22% of dietary supplement launches globally, thanks to their convenience and precise dosing capabilities. The hospital segment dominates current usage, but e-commerce channels are growing rapidly at 18% year-over-year as consumers seek OTC medications with home delivery options. Regulatory approvals for novel strip-based drugs—including those for migraine and Parkinson’s disease—further validate the technology’s potential to transform medication administration paradigms.

Regional Analysis: Orally Dissolving Strips Market

North America
The North American market for orally dissolving strips is driven by increased healthcare innovation and the growing demand for patient-friendly drug delivery systems. With the U.S. accounting for a significant share, pharmaceutical advancements and rising adoption of OTC nutraceutical strips contribute to market expansion. Regulatory agencies like the FDA have approved multiple oral film products, particularly for conditions such as migraine relief (e.g., Rizaport® by IntelGenx) and nicotine replacement therapy. The region's aging population and preference for easy-to-administer medication formats further boost demand. However, strict clinical trial requirements and intellectual property challenges may restrain rapid market growth.

Europe
Europe's market benefits from strong pharmaceutical R&D investments and a growing geriatric population that favors alternative drug delivery mechanisms. The EU’s regulatory framework ensures high-quality standards, driving adoption in countries like Germany and France. Buccal and sublingual film applications, including pain management and antipsychotic treatments (e.g., Sublinox® by Aquestive Therapeutics), are expanding. Sustainability in packaging—such as biodegradable film materials—is gaining traction due to stringent environmental policies. However, reimbursement limitations and competition from traditional tablet formulations pose challenges for broader penetration.

Asia-Pacific
As the fastest-growing region, Asia-Pacific thrives on rising healthcare expenditure, expanding middle-class populations, and increasing awareness of self-medication options. India and China lead due to cost-effective manufacturing capabilities, boosting domestic production. Local players like ZIM Laboratories and Umang Pharmaceuticals have gained prominence by supplying affordable oral films for vitamin supplements and pediatric medications. Japan also shows strong demand for prescription-based oral strips in geriatric care. While adoption lags in rural areas due to low awareness, urbanization and e-commerce expansion are expected to drive future growth.

South America
This region presents niche opportunities, primarily driven by Brazil and Argentina, where pharmaceutical companies are investing in generic oral film formulations. However, economic instability and limited healthcare infrastructure hinder wide adoption. The market is gradually growing for over-the-counter (OTC) products, particularly in sports nutrition and analgesics. Regulatory gaps and reliance on imported raw materials also slow down expansion, though local manufacturing initiatives are emerging to reduce dependency.

Middle East & Africa
The MEA market remains underpenetrated but holds potential due to rising chronic disease prevalence and hospital-driven adoption. The UAE and Saudi Arabia are key markets, leveraging healthcare modernization programs to introduce oral films for diabetes and CNS disorders. South Africa shows moderate growth in private healthcare chains, while limited awareness in other nations restricts demand. Strategic partnerships between global and regional players may accelerate development, though pricing sensitivity remains a hurdle.

Report Scope

This market research report offers a holistic overview of global and regional markets for the forecast period 2025–2032. It presents accurate and actionable insights based on a blend of primary and secondary research.

Key Coverage Areas:

• ✅ Market Overview

  • Global and regional market size (historical & forecast)

  • Growth trends and value/volume projections

• ✅ Segmentation Analysis

  • By product type or category

  • By application or usage area

  • By end-user industry

  • By distribution channel (if applicable)

• ✅ Regional Insights

  • North America, Europe, Asia-Pacific, Latin America, Middle East & Africa

  • Country-level data for key markets

• ✅ Competitive Landscape

  • Company profiles and market share analysis

  • Key strategies: M&A, partnerships, expansions

  • Product portfolio and pricing strategies

• ✅ Technology & Innovation

  • Emerging technologies and R&D trends

  • Automation, digitalization, sustainability initiatives

  • Impact of AI, IoT, or other disruptors (where applicable)

• ✅ Market Dynamics

  • Key drivers supporting market growth

  • Restraints and potential risk factors

  • Supply chain trends and challenges

• ✅ Opportunities & Recommendations

  • High-growth segments

  • Investment hotspots

  • Strategic suggestions for stakeholders

• ✅ Stakeholder Insights

  • Target audience includes manufacturers, suppliers, distributors, investors, regulators, and policymakers

FREQUENTLY ASKED QUESTIONS:

What is the current market size of Global Orally Dissolving Strips Market?

-> The Global Orally Dissolving Strips market was valued at USD 587 million in 2024 and is projected to reach USD 961 million by 2032 at a CAGR of 7.5%.

Which key companies operate in Global Orally Dissolving Strips Market?

-> Key players include Aquestive Therapeutics, Kyukyu Pharmaceutical, BioDelivery (BDSI), IntelGenx, Tapemark, Shilpa Therapeutics, CL Pharm, Lubrizol Life Science, Adhex Pharma, and DK Livkon, among others. The top five players held approximately 45% market share in 2024.

What are the key growth drivers?

-> Key growth drivers include rising demand for alternative drug delivery systems, increasing geriatric population, and advantages over traditional tablets (ease of administration, rapid absorption).

Which region dominates the market?

-> North America currently leads the market (2024), while Asia-Pacific is projected to grow at the fastest CAGR through 2032, driven by expanding healthcare infrastructure.

What are the emerging trends?

-> Emerging trends include personalized dosage forms, expansion into nutraceuticals, and development of multi-layer films for combination therapies.