Oral Thin Film Market

Oral Thin Film Market Outlook (2024 to 2034)

The global oral thin film market size is set to be valued at US$ 3.7 billion in 2024 and thereafter expand at a CAGR of 8.9% to end up at a size of US$ 8.7 billion by 2034.

Oral thin films (OTFs) are drug delivery systems designed to dissolve or disintegrate rapidly in the mouth. They offer an alternative to traditional oral dosage forms such as tablets and capsules. OTFs are composed of hydrophilic polymers that enable them to dissolve quickly when they come in contact with saliva.

The oral route is the most preferred method for administering therapeutic drugs because it is simple to use, has a cheap cost of therapy, and has a high rate of patient compliance. Tablets and capsules are the most widely used oral solid dose forms. Geriatric, pediatric, and bedridden patients, however, have trouble swallowing typical oral dosage forms.

Key Market Growth Drivers

• Rapid drug action is achieved through oral disintegrating films, which dissolve medication in the buccal cavity. Over the past decade, oral thin films have gained commercial significance in both generic and branded markets, establishing themselves as a global business asset.
• Administering drugs through the oral mucosa shows promise for providing a quick onset of action or enhanced bioavailability for medications subject to high first-pass metabolism. There is growing interest in developing orally fast disintegrating strips that allow rapid absorption directly into the systemic circulation via the oral mucosa, thereby expanding the oral thin film market.
• OTFs bypass the gastrointestinal (GI) tract as they are absorbed directly into the systemic circulation through the mouth. This bypass offers several significant advantages, creating new market opportunities.
• Primary benefit of bypassing the GI tract is the elimination of many common side effects associated with other orally delivered medications, such as pills or chewable tablets. Many patients experience gastrointestinal distress from such medications, but OTFs are less likely to cause this issue because they are not ingested, contributing to oral thin film market growth.
• Oral thin films are also considered a form of 'precision medicine', with perforations in a single film allowing for accurate and flexible dosing. These products are appealing to adults who need partial doses of medication due to their dosing flexibility. While pediatric applications benefit from this flexibility since children require smaller and more variable dosages than adults, OTFs also suit various other applications, which is expected to drive market expansion in the future.

Report Attribute	Details
Oral Thin Film Market Size (2024E)	US$ 3.7 Billion
Projected Market Value (2034F)	US$ 8.7 Billion
Global Market Growth Rate (2024 to 2034)	8.9% CAGR
Latin America Market Growth Rate (2024 to 2034)	6.4% CAGR
North America Market Growth Rate (2034)	11.1% CAGR
Revenue from Hospital Pharmacies (2024)	US$ 2.01 Billion
Sales of Oromucosal Films (2024)	US$ 3.05 Billion
Key Companies Profiled	ZIM Laboratories Ltd.; Indivior Plc.; Aquestive Therapeutics Inc.; LIVKON Pharmaceuticals Pvt. Ltd.; Sunovion Pharmaceuticals Inc.; NAL Pharma; CURE Pharmaceutical; IntelGenx Corp.; Kyu Pharmaceutical Co. Ltd.; C.L. Pharm.

What Makes Oral Thin Films Particularly Patient-Friendly?

“Larger Surface Area of OTFs for Faster Wetting, Disintegration, and Dissolution”

Oral thin films are increasingly being used as a drug delivery platform due to their ability to incorporate poorly soluble medicines; however, their primary advantage is their patient-friendly nature. The significantly larger surface area of OTFs compared to conventional drug delivery methods allows for faster wetting, disintegration, and dissolution. Saliva alone is sufficient to diffuse or spread the medication load of these films; no water, chewing, or swallowing is needed. To appeal to young children, OTFs can also be made with pleasant colors and flavors. These films are easy to handle and transport.

Production of oral thin films is facilitated by their final form, and advancements in solvent-free, aqueous-based, powderless film manufacturing allow for continuous, around-the-clock production. This method is faster and involves only two steps: mixing and casting. In contrast, making tablets and capsules is a much more complex process. Drugs with expiring patents are also excellent candidates for reformulation into OTFs, as doing so can provide an additional three years of market exclusivity if a unique oral film application is approved.

Which Limitations of Oral Thin Films are Restricting Their Adoption?

“Sensitivity to Moisture and Temperature Variations and Limited Medication Load Capacity”

As a novel and evolving mode of drug delivery, OTFs come with associated challenges. Only recently have OTFs begun incorporating medications that are not water-soluble. Tablets and capsules typically include components to aid in drug dissolution. In contrast, OTFs primarily use polymers to enhance a drug's solubility, making them a more efficient delivery mechanism.

To improve the solubility of water-insoluble medications in OTFs and thereby increase the functionality of OTF technology, scientists are exploring new particle engineering techniques. Another limitation of OTFs is their capacity to carry only a small medication load of 10 to 20 mg. Additionally, due to their larger surface area, OTFs are more susceptible to humidity and temperature. All of these challenges are restricting the expansion of the oral thin film market size.

Country-wise Insights

The market in East Asia is projected to grow at a significant rate during the forecast period driven by the presence of local and global oral thin film manufacturers, an increase in the geriatric population, and a surge in healthcare expenditure.

North America is poised to hold a substantial global oral thin film market share of 33.2% by 2034. Increased R&D investments, as well as the approval and launch of new oral thin films, are driving market growth in the region.

Which Conditions are Being Treated by Medications in Oral Thin Film Form in the United States?

“Rising Use of Medications in OTF Form in Treating Schizophrenia, ALS, and Opioid Addiction”

Attribute	United States
Market Value (2024E)	US$ 1.07 Billion
Growth Rate (2024 to 2034)	10.5% CAGR
Projected Value (2034F)	US$ 2.91 Billion

Oral thin films are being extensively used in the United States, mostly for the treatment of illnesses such as schizophrenia, ALS, and opioid addiction. In addition, many more OTFs are being developed to address chronic illnesses like migraines and Alzheimer's disease. The Food and Drug Administration (FDA) is currently approving over 11 oral film products.

OTFs have proven to be a highly effective method for major pharmaceutical companies to protect their products once their patents expire. With patent protection lasting up to 20 years, new oral film applications of reformulated medications can gain an additional 3 years of market exclusivity, which can be extended up to 7 years if approved as orphan drugs by the FDA.

How Do Oral Thin Films Align with Cultural Preferences in Japan?

“OTFs Offering Discreet and Non-Invasive Way to Take Medication”

Attribute	Japan
Market Value (2024E)	US$ 202 Million
Growth Rate (2024 to 2034)	2.9% CAGR
Projected Value (2034F)	US$ 268.8 Million

Japan has a growing aging population. Oral thin films (OTFs) are preferred by older adults who have difficulty swallowing pills or capsules, making them an ideal dosage form for this group. OTFs dissolve quickly in the mouth and do not require water, offering convenience and ease of administration, especially for people on the go or those with mobility issues. This convenience factor is particularly important in Japan's fast-paced urban environment.

Manners and etiquette are highly valued in Japanese culture, including how medication is taken. OTFs provide a discreet and non-invasive way to take medication, aligning with cultural preferences for subtlety and politeness. Japan is also well-known for its advanced technology and innovative healthcare practices, which is also a key oral thin film market trend.

Category-wise Insights

Oral thin films are being widely used for treating neurological disorders and pain management. These disorders are poised to account for market shares of 28.4% and 36%, respectively in 2024. In terms of product type, oromucosal films are set to hold a substantial market share of 82.2% in 2024.

Hospital pharmacies are expected to hold a market share of 54.2% in terms of distribution channels in 2024. Retail pharmacies are set to account for a market share of 35.3% in 2024, followed by online pharmacies with an estimated share of around 10%.

Why are Medications in OTF Form Widely Used for Treating Neurological Disorders?

“Risk of Choking and Respiratory Cycle Disturbances with Solid Drugs”

Attribute	Neurological Disorders
Segment Value (2024E)	US$ 1.33 Billion
Growth Rate (2024 to 2034)	8.6% CAGR
Projected Value (2034F)	US$ 3.05 Billion

OTFs are being extensively used to treat a range of neurological illnesses, including schizophrenia and Alzheimer's disease. The majority of these patients-4 out of 5-prefer orally disintegrating dosage forms to traditional solid oral dosage forms.

In addition to concerns about choking and respiratory cycle disturbances, people with neurological diseases and central nervous system disorders often have trouble chewing or swallowing solid drugs. Consequently, oral thin films are growing in popularity. Medical professionals highly favor these films as routes of administration due to their quick hydration and disintegration rates.

How are Retail Pharmacies Contributing to Sales of Oral Thin Films?

“Increased Convenience in Selecting Diverse Range of Oral Thin Film Products”

Attribute	Retail Pharmacies
Segment Value (2024E)	US$ 1.31 Billion
Growth Rate (2024 to 2034)	8.6% CAGR
Projected Value (2034F)	US$ 2.99 Billion

The retail pharmacies distribution channel segment is expected to account for a leading share in 2024. Easy availability of a wide range of products, home delivery services, and an increase in the number of retail pharmacies in developing countries are all driving this segment forward. The expansion of the e-commerce sector and the increased convenience of selecting from a diverse range of oral thin film products are also benefitting patients.

Competitive Landscape

Growing demand for effective drug delivery systems is projected to provide significant growth opportunities for key players in the oral thin films market. Companies are investing heavily in research and development to create more effective and patient-friendly OTFs. This includes enhancing drug solubility and developing multi-layered films for complex drug regimens.

• IntelGenx Corp. announced in October 2022 that the first-in-human clinical study of an oral thin film psychedelic drug candidate would begin in collaboration with Atai Life Sciences.
• In June 2021, Shilpa Medicare Ltd., a research-led global integrated pharmaceutical company, announced the launch of Oral Thin Film formulation, a pediatric dose of paracetamol oral thin film, under the brand name Molshil. Shilpa Medicare Ltd. has received approval for Molshil Oral Thin Films after meeting all bioequivalence requirements.
• In March 2021, Aquestive Therapeutics Inc. demonstrated an extensive review of the science, clinical results, and development strategy of its PharmFilm oral sublingual film for administering epinephrine. This product is touted to effectively treat allergic reactions, including anaphylaxis.

Fact.MR provides detailed information about the price points of key providers of oral thin films positioned across the world, sales growth, production capacity, and speculative technological expansion, in this updated market report.

Segmentation of Oral Thin Film Market Research

• By Product Type :

  • Oromucosal
  • Orodispersible

• By Indication :

  • Pain Management
  • Neurological Disorders
  • Nausea & Vomiting
  • Opioid Dependence

• By Distribution Channel :

  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies

• By Region :

  • North America
  • Latin America
  • Middle East & Africa
  • Western Europe
  • Eastern Europe
  • East Asia
  • South Asia & Pacific