Report

The Oral Thin Films Market size is estimated at USD 3.30 billion in 2025, and is expected to reach USD 5.21 billion by 2030, at a CAGR of 9.56% during the forecast period (2025-2030).

The growing burden of target diseases and the advantages associated with thin films are the primary drivers for the oral thin films market. For instance, in August 2023, an article published in the Frontiers in Molecular Neuroscience mentioned that more than 10.0 million people were living with Parkinson's disease globally. Additionally, in December 2022, the Parkinson's Foundation reported that the new study represented a 50% higher incidence of Parkinson's disease in the United States, with 90,000 diagnoses each year as compared to the earlier year's estimates of 60,000 annual diagnoses. Moreover, the risk of Parkinson's disease increases with age; thus, the rising aging population worldwide is also expected to impact the market positively. Furthermore, it is likely that by 2030, there will be an increase of 1.2 million people who have Parkinson's disease. Oral thin films are considered one of the most effective treatments for Parkinson's disease. Therefore, the increasing prevalence of Parkinson's disease is anticipated to propel the demand for oral thins, thereby surging market growth over the coming years.

Drug delivery via oral thin films offers several advantages, which are the major factors driving market growth. For instance, in July 2023, an article published in the Journal of Pharmaceuticals mentioned various advantages of oral thin films used for mental disorders, such as faster disintegration and dissolving ability in the oral cavity, quicker onset action through oral mucosa, and flexible packaging, which facilitates transportation and storage and accuracy in the administration of dose and easy swallowing. They directly cause drugs to enter the circulatory system through oral and sublingual absorption. This prevents the medication from being exposed to the harsh conditions of the stomach by allowing this drug delivery system to deliver a more significant proportion of the active compound per dose. Thus, due to the abovementioned factors, the market studied is expected to grow during the forecast period.

To cater to the growth in demand, various companies are developing oral thin films to expand their portfolio. For instance, in September 2023, Gensco Pharma, in collaboration with IntelGenx, launched RizaFilm, an oral dissolvable film formulation of rizatriptan available for treating acute migraine. Similarly, in May 2022, Rapid Dose Therapeutics announced agreements to accelerate the development and commercialization of its QuickStripVax orally dissolvable film. The agreements resulted in Oakland Health, operating as RD Therapeutics, taking a 5.0% stake in a newly created RDT subsidiary that would be granted the exclusive worldwide license to sell products derived from the IP behind the QuickStripVax. Such product launches are expected to boost market growth over the forecast period.

On the other hand, the technical limitations of oral thin films are likely to impede market growth for a short period over the coming years.

Oral Thin Films Market Trends

The Sublingual Film Segment is Expected to Witness Considerable Growth Over the Forecast Period

Sublingual administration involves placing a thin film under the tongue. The drug dissolves and is absorbed into the blood through the tissue. The sublingual route is targeted for delivering drugs exhibiting high permeability across the mucosa and is commonly utilized to treat acute disorders. Factors such as the growing burden of targeted diseases (including various neurological disorders and other diseases), increasing research and development activities related to oral thin films, and rising product launches and collaborative and strategic initiatives being undertaken by market players are expected to drive the growth of the sublingual film segment over the forecast period.

The various research studies to develop sublingual films for multiple drugs also drive the segment's growth. For instance, in June 2022, a study published in PLOS ONE reported the formation of sublingual trilaminated Eszopiclone, a dissolving film used for the treatment of insomnia, and showed optimized uniformity content, surface pH, film thickness, and a good taste feeling. In January 2024, Awakn Life Sciences completed its investigation study AWKN-002 for the dissociative effect of a proprietary and patent pending S-ketamine formulation administered sublingually via an oral thin film indicated for alcohol-use disorders.

Health regulatory bodies are adopting strategic initiatives to improve the accessibility of advanced sublingual formulations. For instance, in October 2023, Centers for Medicare and Medicaid Services issued a permanent J-code to BioXcel Therapeutics Inc. for the development of IGALMI (dexmedetomidine) sublingual film, indicated for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. The IGALMI J-Code J1105 was projected to become effective from January 2024. Thus, IGALMI will be reimbursed separately under the J-code for the hospital's outpatient facilities, eliminating economic barriers and boosting the adoption rate.

The launch of new products by different market players across different regions also propels the market's growth. For instance, in April 2022, BioXcel Therapeutics announced the US FDA's approval of the IGALMI (dexmedetomidine) sublingual film for acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. Owing to the abovementioned factors, the sublingual films segment of the oral thin films market is expected to grow over the forecast period.

North America is Expected to Witness Significant Growth Over the Forecast Period

North America will dominate the oral thin films market over the forecast period. The growth is due to rising cases of target diseases, increased use of oral thin films owing to their advantages, and increased product launches by key players. For instance, in June 2023, the Miles for Migraine Organization reported that around 18.7% of individuals aged from 18 to 44 years living in the United States reported migraine or severe headache symptoms. Furthermore, according to the Migraine Research Foundation Journal published in September 2022, more than 39.0 million US citizens suffer from migraines every year, while women are three times more likely to get migraines than men. Moreover, in September 2023, according to the Schizophrenia Society of Canada, around 300,000 people living in Canada were affected with schizophrenia. Therefore, the considerable burden of mental disorders fuels the demand for oral thin formulations, which is expected to result in market growth in North America.

Key product launches, high concentration of market players or manufacturers, increasing acquisitions and partnerships among significant players, and increasing cases of target diseases in the region are some factors driving the growth of the North American oral thin films market. Furthermore, the ongoing clinical trials are also driving the market's growth. For instance, in January 2024, Tharimmune Inc. conducted a phase 1 clinical trial of TH-104 oral thin film in the United States to evaluate the safety tolerability and bioavailability for treating multiple liver-related and other pruritogenic inflammatory conditions. The positive results from the clinical trials could lead to the development of new products and boost the market's growth.

In February 2022, Aquestive Therapeutics announced the FDA's clearance of an investigational new drug application (IND) for AQST-109 epinephrine oral film. In September 2022, the company announced that it had entered a license and supply agreement for Libervant (diazepam) Buccal Film with Pharmanovia worldwide. Therefore, owing to the abovementioned factors, the growth of the North American oral thin films market is anticipated over the forecast period.

Oral Thin Film Industry Overview

The oral thin films market is moderately competitive and consists of several market players. Companies are engaging in rapid product developments and launches to maximize their market shares. The competitive landscape includes an analysis of a few international as well as local companies that hold market shares and are well known, including Aquestive Therapeutics Inc., IntelGenx Corp., C.L. Pharm, CURE Pharmaceutical, and ZIM Laboratories Limited.

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