Oral Thin Films Market

Market Overview

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).

An Oral Thin Film (OTF) is a fragile film composed of a mono or multi-layer polymeric matrix applied in the mouth. OTFs are frequently water-based, soluble polymers intended for fast medication delivery. 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. The most prevalent oral solid dosage forms are tablets and capsules. However, patients who are bedridden, elderly, or children have difficulty ingesting standard oral dosage forms. Oral rapid-dissolving films, often known as oral thin films (OTFs), have achieved widespread recognition after successfully overcoming this challenge.

Market Dynamics

Global Oral Thin Films Market Drivers

Growing Burden of Target Diseases

Oral thin films are given to patients with designated disorders, such as migraine, schizophrenia, Parkinson's disease, Alzheimer's disease, and others, to help them feel better. The market for oral thin films is expected to grow over the projected period since older people can take prescriptions with less trouble. One of the world's most prevalent medical illnesses is migraine, a frequent neurological ailment. According to the American Migraine Foundation, one in seven individuals worldwide suffer from migraines, the third most prevalent condition. Nearly 37 million Americans are currently impacted. In the upcoming years, 148 million individuals will be affected by the disease globally. 

It is anticipated that there will be a rise in demand for oral medication delivery methods as migraine incidence rises. The oral film of the drug zolmitriptan was discovered to be a promising formulation showing better strength and a good drug release profile with no significant change in drug content and drug release profile, according to the study titled "Formulation and Evaluation of Fast Dissolving Oral Films of an Anti-Migraine Drug (Zolmitriptan)," published in 2019. Therefore, the sublingual film of Zolmitriptan is shown to be a superior option for treating acute migraine attacks than conventional dosages due to increased absorption and early onset of action, which could positively impact oral thin films market growth.

Global Oral Thin Films Market Restraint

Technical Limitations of Oral Thin Films

Numerous disorders, including migraine, opioid addiction, amyotrophic lateral sclerosis (ALS), and schizophrenia, have been treated with oral thin films. Oral thin films, like every delivery method, have their drawbacks. First, it is anticipated that adding water-insoluble medications to oral thin films may impede oral thin films market expansion. Components that aid the drug's dissolution might be included in tablets and capsules. Oral thin films, on the other hand, heavily rely on polymers to improve the drug's solubility. Water-insoluble medications are, therefore, only partially soluble in oral thin films.

Additionally, oral thin films can only transport a relatively limited drug load of 10 to 20 mg. The traditional oral drug administration technique has a higher drug load capacity. Additionally, an oral thin film's more significant surface area exposes it to greater susceptibility to humidity and temperature, which hinders the market's expansion.

Global Oral Thin Films Market Opportunities

Growing Demand for Sublingual Film

Pharmaceutical researchers from all across the world are investigating thin films as a cutting-edge drug delivery method. The use of thin films as an alternative to standard dosage forms has been noted. The sublingual route is used to treat acute diseases and is targeted to deliver medications with high mucosal permeability. Active chemicals diffuse via the underside of the tongue and the floor of the mouth to reach the rest of the body. Tailorable Dissolution times, adhesion, film thickness, material composition, taste-masking, and bioavailability of active medicinal ingredients are only a few features in sublingual films. Sometimes a specific chemical, biological fluid, or pH triggers the dissolution process. It was possible to create products with many layers for the best bioavailability and stability.

Regional Analysis

North America Dominates the Global Market

The global oral thin films market is divided into four regions: North America, Europe, Asia-Pacific, and LAMEA. 

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 had the largest oral thin films market share in North America for schizophrenia drugs because a sizable portion of the population is considering treatment due to the country's fast-paced culture. Furthermore, the nation offers cutting-edge healthcare with the ability for early intervention and government involvement in raising healthcare spending. This is accelerating the market's growth. The rise in schizophrenia cases is anticipated to accelerate market expansion. According to the National Alliance on Mental Illness, 1.5 million adults in the United States will develop schizophrenia yearly. Schizophrenia is typically identified in young people between late adolescence and early adulthood, with symptoms frequently manifesting earlier in men than in women.

New product introductions and the presence of significant market players are anticipated to fuel market expansion over the forecast period. The market is expanding due to factors such as the rising prevalence of targeted disorders, the benefits of oral thin films like quick absorption, and cooperation among market participants. Additionally, despite the convergence of national and international causes, the market expansion in Mexico may be boosted by the threat of rising drug and addiction rates. The industry's expansion is also aided by market participants' strategic actions to advertise their presence in the Mexican market.

Europe is expected to grow at a CAGR of 8.93%, generating USD 1,549.65 million during the forecast period. Germany's market for oral thin films is anticipated to proliferate due to the nation's advanced medical infrastructure and growing nanotechnology-based pharmaceutical industry. Several market participants also fuel the rise of the domestic market. For instance, Vektor Pharma TF GmbH and its staff have innovated in creating thin-film medicinal formulations, including their design, testing, and manufacturing. The strategic agreement among market participants to strengthen their national position also contributes to the oral thin films market's growth.

The market for oral thin films in the United Kingdom is anticipated to be driven by factors including the rising prevalence of mental diseases, the number of research and development projects, and the introduction of new products with cutting-edge technology. In a contract with BIAL, Sunovion Pharmaceuticals Inc. granted BIAL exclusive commercial license rights in Europe for apomorphine sublingual film, which is used to treat OFF episodes in patients with Parkinson's disease. This agreement calls for BIAL to distribute the product throughout the European Union (EU), the European Economic Area (EEA), and the United Kingdom. This could have a favorable effect on the market.

In China, due to the rising prevalence of disorders like migraine, opioid dependence, schizophrenia, erectile dysfunction, and others, as well as rising research and development costs and product launches, the Chinese oral thin films market is anticipated to expand over the forecast period. Population-based estimates of the 1-year prevalence of migraine in adults range from 7.9% to 14.3%, per an article titled "Migraine treatment and healthcare costs: retrospective analysis of the China Health Insurance Research Association (CHIRA) database," released in May 2020. Due to the high occurrence of migraines, there is a need for enhanced therapies, which will fuel the market's anticipated significant expansion. Oral thin film sales in India are expected to increase over the forecast year due to increased research activities, new product introductions, and the prevalence of conditions, including migraine and opioid dependence. Additionally, according to a study, "Development of Mucoadhesive Buccal Film for Rizatriptan: In Vitro and In Vivo Evaluation," published in May 2021, the relative bioavailability estimated was 245%, and the observed suitable usage criterion in buccal therapy was two-fold than the control. This study shows the potential of buccal films as a workable and different method for rizatriptan distribution, projected to drive the market's growth over the projection period.

The Arabian Gulf region is a section of the planet developing quickly. Idiopathic Parkinson's disease (PD) and schizophrenia are two conditions whose prevalence is anticipated to rise along with the average life expectancy. However, this may result from introducing new research facilities and adopting better healthcare policies and practices for the aging community. The prevalence of various neurological illnesses is rising, fueling oral thin films market expansion. Estimates from the UN Department of Economic and Social Affairs place the number of people over 60 in 2019 at 499,000. By 2030, this figure is anticipated to increase in Lebanon by 743,000. In addition to the previously indicated source, Iran had 1,040 thousand people aged 65 or older in 2019; by 2030, this figure is expected to rise to 1,361 thousand. The analyzed market in the Rest of the Middle East & Africa is thus anticipated to expand throughout the projected period due to the factors above.

Segmental Analysis

The global oral thin films market is segmented by product, disease indication, and distribution channel.

The global oral thin film market is bifurcated based on product 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. A thin coating is applied under the tongue when using the sublingual delivery method. Through the tissue, the medication dissolves and enters circulation. The sublingual route is used frequently to treat acute diseases and is targeted to deliver medications with high mucosal permeability. Over the forecast period, the sublingual administration market is anticipated to grow as a result of factors including the rising prevalence of targeted diseases (including a variety of neurological disorders and other diseases), research and development activities related to oral thin films, product launches, and strategic alliances and initiatives are taken by market players. The market is expanding due to the numerous research projects to create sublingual films for different medications. The segment's growth is also aided by strategic initiatives done by market participants to broaden their geographic reaches, such as collaborations and agreements. As an illustration, Sunovion Pharmaceuticals Inc. signed a contract with the pharmaceutical firm BIAL. According to the contract, Sunovion gave BIAL sole commercial license rights for apomorphine sublingual film in Europe (APL-130277). For the acute, intermittent treatment of OFF episodes in Parkinson's disease (PD) patients, it is approved under the brand name KYNMOBI.

Since fast-dissolving oral film (FDOF) dissolves quickly in the mouth and directly enters the systemic circulation, it is a unique technique. The intraoral, rapidly dissolving medication delivery method made of the film is perfect. Many medications, including analgesics, cardiovascular pharmaceuticals, antihistamines, anti-asthmatics, and medicines for erectile dysfunction, etc., can be made into mouth-dispersing films. The pharmaceutical industry quickly became interested in fast-dissolving thin oral films over disintegrating tablet technology because they are practical for patients who have trouble swallowing or digesting solid medication forms. SmileDirectClub introduced the Fast-Dissolving Whitening Strips in January 2022 as part of the company's dental care product range expansion. These 15-minute daily wear time strips are made for people who experience severe sensitivity to longer-wear whitening strips.

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 owns the highest market and is estimated to grow at a CAGR of 8.71% during the forecast period. Opioids are frequently used to alleviate pain because of their analgesic and sedative properties. Regular non-medical usage, use for an extended period, misuse, and use without a prescription can result in opioid dependence and other health issues. The market is expanding due to factors like the high prevalence of opioid overdose or consumption globally, along with clinical research for product development and partnerships among market participants. High non-medical drug usage may result in opioid dependence, increasing the need for oral thin films and propelling the market's expansion. For instance, according to a World Health Organization article updated in August 2021 titled "Opioid overdose: Key Facts," there are around 0.5 million deaths worldwide related to drug use. Overdoses account for more than 30% of these fatalities connected to opioids in more than 70% of cases. The high incidence of death from opioid overdose creates a need for thin film drug dependence to be reduced, which in turn fuels market growth. The introduction of identical molecular products by several market participants also contributes to the market segment expansion.

Vomiting and nausea are symptoms of various ailments rather than actual diseases, such as appendicitis, migraines, motion sickness, overeating, obstructed intestines, infections, food poisoning, concussions, or other brain injuries. The Commonwealth of Australia reports that in 2020, nausea was the most prevalent gastrointestinal symptom of pregnancy, occurring in 80–85% of first-trimester pregnancies and being accompanied by vomiting in about 52% of women. The need for oral films that cure nausea and vomiting rises with the global growth in pregnancies. The Centers for Disease Control and Prevention estimate that 61,000 Americans died in 2019 due to traumatic brain injury. This amount corresponds to around 166 TBI-related fatalities daily. The rising rate of brain injuries and subsequent treatment boosts the market. Therefore, situations that increase nausea and vomiting during the projection period will fuel the segment's expansion.

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. An independent pharmacy with a state license to administer pharmaceuticals to the general public at retail pricing is referred to as a "retail pharmacy." They are intended for usage by customers directly, and prescriptions are forwarded to any hospital pharmacy, government pharmacy, or non-profit organization. The general population increasingly uses the retail pharmacy as a one-stop shop for all OTC and prescription medicines. This market will expand because most medications that treat conditions like motion sickness and nausea are over-the-counter. Businesses like Cardinal Health that specifically assist retail pharmacies in regulated supply chains, professional consulting, and patient solutions to promote adherence have become very competitive in the healthcare distribution network. Additionally, consumers favor retail pharmacies because of the wide variety of products they offer, which supports the segment's expansion during the projection period.

Various departments oversee all hospital-related buying in numerous hospitals. These include medicines, medical gear, supplies, and other necessities, as well as facilities. With the aid of a designated committee, several persons manage the pharmacy department's purchasing of pharmaceuticals. Pharmaceutical corporations increasingly prefer using hospital pharmacies to get needed pharmaceuticals to patients as soon as possible. The significance of these services is undeniable, given that the outpatient department sees a disproportionately large volume of patients during the day. The preference for hospital pharmacies is increasing due to their quick and simple access to various pharmaceuticals and quality products. Additionally, the need for several hospital stays and visits during cancer treatment procedures that produce nausea, prenatal visits, and schizophrenia treatment procedures increases the purchase of these pharmaceuticals in pharmacies, hence promoting segment growth.

Recent Developments

• October 2022- Aquestive Therapeutics licensed Sympazan® (clobazam) Oral Film to Assertio Holdings Inc.
• October 2022- IntelGenx Corp. (the "Company" or "IntelGenx") provided an update on its collaboration with its strategic partner, Life Sciences, for the development of novel formulations of pharmaceutical-grade psychedelics based on IntelGenx's polymeric film technologies.