Market Trends of Oral Thin Films Industry
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.
