Global Oral Thin Films Market Size USD 5,357.18 million by 2031 | CAGR of 8.47%

Introduction

An oral thin film (OTF) is a very thin film composed of a mono or multi-layer polymeric matrix applied in the mouth. OTFs are commonly soluble, water-based polymers designed for rapid drug administration. The oral route is the most advised method for delivering therapeutic drugs due to its simplicity, low cost of therapy, and high patient compliance rate. Tablets and capsules are the two oral solid dose forms most frequently used. Patients who are bedridden, old, or young patients, however, have trouble swallowing regular oral dosage forms. After successfully overcoming this obstacle, oral rapid-dissolving films, referred to as oral thin films (OTFs), have gained broad attention.

Market Dynamics

Growing Burden of Target Diseases Drives the Global Market

Patients with specific conditions, such as Migraine, schizophrenia, Parkinson's disease, Alzheimer's disease, and others, are given oral thin films to make them feel better. The market for oral thin films is expected to grow over the projected period since older people can take prescriptions less easily. Migraine, a common neurological disorder, is one of the most common medical conditions in the world.

According to the American Migraine Foundation, migraines are the third most common ailment, affecting one in seven people globally. It affects about 37 million Americans. The disease will affect 148 million people worldwide in the upcoming years. As a result, it is projected that as migraine incidence rises, there will be an increase in demand for oral medicine delivery modalities. Due to enhanced absorption and an earlier beginning of the action, Zolmitriptan sublingual film has been demonstrated to be a better option for treating acute migraine attacks than standard dosages.

Growing Demand for Sublingual FilmCreates Tremendous Opportunities 

Thin films are studied by pharmaceutical experts worldwide as a cutting-edge medication delivery technique. It has been noticed that thin films can be used as an alternative to conventional dose forms. The sublingual route is utilized to administer drugs with high mucosal permeability and is intended to treat acute disorders. The active components are administered systemically via diffusing through the tongue's ventral surface and the floor of the mouth. Additionally, sublingual films with characteristics including dissolution rates, adhesion, film thickness, material composition, taste-masking, and active medicinal ingredient absorption rates are available on the market. Dissolution may begin in reaction to a specific biological fluid, pH, or other situation. Products with many layers could be made for optimum bioavailability and stability.

Regional Analysis 

North America is the most significant revenue contributor and is expected to grow at a CAGR of 8.13% during the forecast period. The United States has the largest market share in North America since a significant portion of the population is considering schizophrenia drug therapy due to their hectic lifestyles. The National Alliance on Mental Illness estimates that every year in the United States, 1.5 million adults will develop schizophrenia. Schizophrenia symptoms appear earlier in males than women, typically diagnosed in young individuals between late adolescence and early adulthood. Throughout the projected period, market growth is anticipated to be fueled by the launch of new products and the presence of prominent industry players. Due to factors such as the rising prevalence of specific ailments, the advantages of oral thin films like rapid absorption, and collaboration among market participants, the industry is growing. The prospect of rising drug and addiction rates may also help Mexico's market expansion despite the confluence of local and global factors. Market participants' strategic steps to advertise their presence in the Mexican market aid the industry's expansion.

Europe is expected to grow at a CAGR of 8.93% during the forecast period. The market for oral thin films in Germany is projected to expand quickly due to the country's sophisticated healthcare system and developing nanotechnology-based pharmaceutical sector. Several market players also fuel the expansion of the domestic market. For instance, Vektor Pharma TF GmbH and its personnel have innovated in designing, testing, and producing thin-film pharmaceutical formulations. The market's expansion is also aided by the strategic agreement reached by market participants to improve their national positions. It is projected that factors such as the rising incidence of mental illnesses, the volume of research and development initiatives, and the launch of new products with cutting-edge technology will boost the market for oral thin films in the United Kingdom. Apomorphine sublingual film treats OFF episodes in Parkinson's patients, and Sunovion Pharmaceuticals Inc. agreed to give BIAL exclusive commercial license rights in Europe. Product distribution throughout the European Union (EU), the European Economic Area (EEA), and the United Kingdom are mandated under this agreement for BIAL. The market may benefit as a result of this.

Key Highlights

• The global oral thin films market size was valued at USD 2,577.18 million in 2022. It is projected to reach USD 5,357.18 million by 2031, growing at a CAGR of 8.47% during the forecast period (2023-2031).

• Based on product, the global oral thin film market is bifurcated into sublingual, fast dissolving dental/buccal film. The sublingual film segment is the highest contributor to the market and is estimated to grow at a CAGR of 8.26% during the forecast period.

• Based on disease indication, the global oral thin films market is bifurcated into schizophrenia, Migraine, opioid dependence, nausea and vomiting, and other disease indications. The opioid dependence segment is the highest contributor to the market and is estimated to grow at a CAGR of 8.71% during the forecast period.

• Based on distribution channels, the global oral thin films market is bifurcated into hospital pharmacies, retail pharmacies, and other distribution channels. The retail pharmacies segment is the highest contributor to the market and is estimated to grow at a CAGR of 8.59% during the forecast period.

• North America is the most significant revenue contributor and is expected to grow at a CAGR of 8.13% during the forecast period.

Competitive Players

1. Aquestive Therapeutics Inc.
2. IntelGenx Corp.
3. LTS Lohmann
4. Therapie-Systeme AG
5. NAL Pharma6.
6. ZIM Laboratories Limited
7. Sunovion Pharmaceuticals, Inc
8. Cure Pharmaceutical
9. C.L.Pharm
10. Viatris
11. MonoSol Rx
12. Indivior
13. ALLERGAN
14. IntelGenx
15. BioAlliance Pharma
16. Paladin Labs
17. Labte

Recent Developments

Company Market Share

Key players are employing various strategies, such as developing innovative products with advanced technology, forging collaborations with other firms, expanding their outlets, and making corporate investments. By integrating these methods, they enhance their competitive edge and drive growth in the market.

CD Formulation: An emerging player in the OTFs market

CD Formulation is a leading manufacturer and supplier of active pharmaceutical ingredients, cosmetic ingredients, food ingredients, and pharmaceutical excipients, serving the pharmaceutical and personal care industry to help it improve the performance of its products.

Recent developments in CD Formulation include:

• In February 2024, CD Formulation, a prominent drug formulation company, announced the launch of Oral Thin Film Technology. This cutting-edge drug delivery system is poised to revolutionize medication administration, offering patients a more convenient and effective treatment method.

Recent Developments

• March 2024- Redwood Scientific Technologies Inc. announced an initiation plan to build oral thin manufacturing in the U.S. This initiative aims to make the company self-reliant by minimizing dependency on foreign-sourced pharmaceutical goods.

Analyst Opinion

As per our analyst, the global OTFs market is poised for significant growth in the coming years, fueled by escalating consumer demand for convenient and effective drug delivery methods. The rising prevalence of chronic diseases, coupled with advancements in formulation technologies, is expected to enhance the market's overall appeal. Moreover, the increasing emphasis on patient compliance and the development of innovative formulations tailored to specific therapeutic areas will likely attract substantial investment and drive market expansion.

Furthermore, the ongoing shift towards personalized medicine and the integration of digital health solutions are set to reshape the landscape of oral thin films, making them more accessible and user-friendly. Overall, the OTFs market is strategically positioned for robust growth, as it addresses the evolving needs of patients and healthcare providers, offering a flexible and efficient alternative to traditional drug delivery systems.

Segmentation

Oral Thin Films Market Segmentation

1. By Product
   1. Sublingual Film
   2. Fast Dissolving Dental/Buccal Film
2. By Disease Indication
   1. Schizophrenia
   2. Migraine
   3. Opioid Dependence
   4. Nausea and Vomiting
   5. Others
3. By Distribution Channel
   1. Hospital Pharmacies
   2. Retail Pharmacies
   3. Online Pharmacies