Oral thin films (OTFs) are the most advanced and promising new approaches for drug delivery as it offers more flexibility and comfort. Oral thin films allow for convenient and flexible drug delivery. OTFs are placed on or under the tongue or buccally. They are immediately absorbed by the oral mucosa and the active substance is directly transported into the bloodstream. These films are loaded with active substances that are used for drug delivery. They are taken orally and dissolve immediately in the mouth or applied to the mucosa. Oral thin films provide quick release of an active pharmaceutical ingredient when placed on the tongue. The emergence of oral thin films has resulted in dramatic improvements in compliance and drug therapy outcomes in pediatric and geriatric patients.
Market Statistics:
The global oral thin films market is estimated to account for US$ 2,651.5 Mn in terms of value by the end of 2022.
Drivers:
Increasing demand for oral thin film drug delivery systems due to increasing awareness among people about the benefits of oral thin films are some major factors expected to augment growth of the global oral thin films market during the forecast period. For instance, in October 2021, ARx LLC partnered with clients to custom design and manufacture specialty oral and mucosal dissolvable thin film and transdermal patch drug delivery systems. Whether branded or generic, each single or multi-layered system is uniquely tailored to achieve the intended delivery profile and maximum benefit to the patient. ARx is an innovator of the oral thin film dosage form.
Opportunities:
Growing burden of target diseases across the world is expected to provide significant growth opportunities for players in the global oral thin films market. For instance, in December 2020, MSN Group’s marketing partner, Breckenridge Pharmaceutical, received final approval for its Abbreviated New Drug Application (ANDA) for Asenapine Sublingual Tablets, in 2.5 mg and 10 mg strengths, with the U.S. Food and Drug Administration (FDA). It is a generic for Saphris, indicated for the treatment of patients suffering from schizophrenia and bipolar disorder. It is developed in collaboration MSN and Breckenridge Pharmaceutical.
Restraints:
Limitations associated with oral thin films and availability of substitute drugs are major factors expected to hamper growth of the global oral thin films market. For instance, relative to other drug delivery systems, oral thin films (OTFs) are a newer concept in medicine. Therefore, the adoption rate of oral thin films is limited. Like any other drug delivery system, oral thin films have their own set of limitations. For instance, due to the size of oral thin films, the drug load they can bear is limited to relatively small amounts. Moreover, thin films cannot deliver doses in the gram range while retaining their rapid release properties and remaining palatable.
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Global Oral Thin Films Market - Impact of Coronavirus (Covid-19) Pandemic
Pharmaceutical and healthcare companies have been under pressure for drug innovations to treat COVID-19 patients. Advanced drug delivery systems, such as oral thin films, are being considered a boon for the repurposing of drugs. Nevertheless, companies in the oral thin films market are increasing their R&D (research and development) efforts. Revive Therapeutic, for instance, is carrying out research and development to explore the potentials of Bucillamine for thin film products that treat coronavirus (COVID-19). In July 2022, Revive Therapeutics Ltd. provided an update on the Company’s U.S. FDA Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine, an oral drug with anti-inflammatory and antiviral properties, in patients with mild to moderate COVID-19.
Key Takeaways:
The global oral thin films market was valued at US$ 2,450.6 Mn in 2021 and is forecast to reach a value of US$ 4,379.9 Mn by 2028 at a CAGR of 8.7% between 2022 and 2028.
Among product, sub-lingual films segment held dominant position in the global oral thin films market in 2022, accounting for 72.1% share in terms of value, increasing approval and launch of new products is expected to propel growth of the segment during the forecast period.
Market Trends:
- Growing geriatric population across the globe is expected to propel the growth of the global oral thin films market. For instance, the use of oral thin films has increased or increasing due to ease in drug administration among older adults. According to the World Health Organization (WHO), in 2019, the number of people aged 60 years and older was 1 billion, and this number is expected to reach around 1.4 billion by 2030 and 2.1 billion by 2050.
- Introduction of novel products by market players is expected to drive growth of the global oral thin films market. For instance, in November 2019, Aquestive Therapeutics announced that Exservan (riluzole) Oral Film received early-action approval from the U.S. Food and Drug Administration (FDA) for the treatment of amyotrophic lateral sclerosis, an orphan disease.
Competitive Landscape:
Major players operating in the global oral thin films market include
C L Pharm, Cure Pharmaceutical, Sunovion Pharmaceuticals Inc., ZIM Laboratories Limited, NAL Pharma, Viatris, LTS Lohmann Therapie-Systeme AG, IntelGenx Corp., and Aquestive Therapeutics Inc., among others.
Recent Developments:
In July 2020, IntelGenx Corp. and Cybin Corp. teamed up to develop an orally-dissolving film for the delivery of pharmaceutical-grade psilocybin.
In May 2021, CURE Pharmaceutical Holding Corporation received the ISO 9001 certification for its Oxnard, California, manufacturing, and research facility.
In March 2021, Viatris Inc. expanded its business into Costa Rica with commercial operations, such as importing and distributing medicines. The company made an initial investment of USD 1,400,000 in the country for its operations.