Oral Thin Films Market Size
| Study Period | 2019 - 2029 |
| Market Size (2024) | USD 3.01 Billion |
| Market Size (2029) | USD 4.75 Billion |
| CAGR (2024 - 2029) | 9.56 % |
| Fastest Growing Market | Asia Pacific |
| Largest Market | North America |
Major Players
*Disclaimer: Major Players sorted in no particular order |
Oral Thin Films Market Analysis
The Oral Thin Films Market size is estimated at USD 3.01 billion in 2024, and is expected to reach USD 4.75 billion by 2029, growing at a CAGR of 9.56% during the forecast period (2024-2029).
The outbreak of COVID-19 impacted the market. People suffering from schizophrenia and migraine had a higher risk of mortality from COVID-19. For instance, as per the JAMA Psychiatry journal published in January 2021, adults with a schizophrenia spectrum disorder diagnosis were associated with an increased risk for mortality with COVID-19. Furthermore, according to the University of Manchester health data published in December 2021, people with psychotic disorders, such as schizophrenia, were five times more likely to die from COVID-19 and three times more likely to be hospitalized. The same report also stated that among people with COVID-19, those with psychotic or bipolar disorder had the highest rates of infection leading to hospitalization: 35.8% and 37.3%, respectively, compared to 16.6% among those without severe mental illness. Therefore, the demand for oral thins increased during the initial days of the pandemic as it is one of the effective treatments for such conditions. With the advent of the later strains of the virus the demand kept growing further, and it is likely to keep following that trend during the forecast period as well.
The growing burden of target diseases and the advantages associated with thin films are the primary drivers for the market. For instance, according to Parkinson's Foundation 2021, more than 10.0 million people were living with Parkinson's disease globally. The same report also stated that around 1.0 million were living with Parkinson's disease in the United States in 2021. Moreover, the risk of Parkinson's disease increases with age, and thus the increasing aging population around the world is also expected to positively impact the market. Furthermore, according to the 2021 Parkinson's Foundation report, it is expected that by 2030 there will be an increase of 1.2 million people suffering from Parkinson's disease. Oral thins are considered one of the 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.
Drug delivery via oral thin films offer several advantages which are also the major factors driving the market growth. The primary advantages of these films are dosage flexibility and ease of administration. They are also fast-acting and can cause drugs to enter the circulatory system directly by oral and/or sublingual absorption. This prevents the drugs from being exposed to the harsh conditions of the stomach by allowing this drug delivery system to deliver a greater proportion of the active compound per dose. As per the research article titled 'Current Overview of Oral Thin Films,' published in February 2021, oral thin films have other advantages as well. They can be easily administered by patients themselves or their families, especially for dysphagia, geriatric, pediatric, or bedridden patients. They also provide rapid onset of effects in conditions requiring urgent intervention, such as allergic attacks, asthma, and intraoral diseases. Thus, due to the factors mentioned above the market studied is expected to grow during the forecast period.
Pertaining to the demand growth, various companies are developing oral thin films to expand their portfolio. In September 2021, IntelGenx, announced that Exeltis Healthcare S.L launched RIZAPORT, an oral thin film formulation of rizatriptan benzoate, a 5-HT1 receptor agonist and the active drug in Merck & Co.'s Maxalt. This is especially for those who suffer from migraine-related nausea, estimated to be approximately 80% of the total migraine patient population, and for patients suffering from dysphagia. Simillarly, in May 2022, Rapid Dose Therapeutics announced agreements intended to accelerate the development and commercialization of its QuickStripVax orally dissolvable film. The agreements see Oakland Health, operating as RD Therapeutics, take a 5.0% stake in a newly created RDT subsidiary that will be granted the exclusive worldwide license to sell products derived from the IP behind the QuickStripVax. Such products launches will boost the market growth over the forecast period.
On the other hand, technical limitations of oral thin films are likely to impede the market growth in the near future.
Oral Thin Films Market Trends
This section covers the major market trends shaping the Oral Thin Films Market according to our research experts:
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 the delivery of drugs exhibiting high permeability across the mucosa and is commonly utilized for the treatment of acute disorders. Factors such as the growing burden of targeted diseases (including various neurological disorders and other diseases), research and development activities related to oral thin films, product launches, and collaborative and strategic initiatives undertaken by market players are expected to drive the growth of the sublingual film segment over the forecast period.
The various research studies going on to develop sublingual films for various drugs are also driving the segment's growth. For instance, the Future Science Journal article titled "Development and characterization of sublingual films for enhanced bioavailability of selegiline hydrochloride," published in February 2021, concluded that the selegiline hydrochloride film could provide a potential opportunity for sublingual drug delivery. The positive results from such studies could help develop more drugs in the future.
The segment's growth is also boosted by strategic initiatives such as partnerships and agreements between market players to increase their reach in different geographical regions. For instance, in September 2021, Sunovion Pharmaceuticals Inc. entered an agreement with BIAL, a pharmaceutical company. As per the agreement, Sunovion granted BIAL exclusive commercial license rights in Europe for apomorphine sublingual film (APL-130277). It is approved as KYNMOBI for the acute, intermittent treatment of OFF episodes in Parkinson's disease (PD) patients.
Additionally, the launch of new products by different market players in different regions is propelling the market's growth. For instance, in April 2022, BioXcel Therapeutics announced FDA's approval of 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 is expected to dominate the overall oral thin films market over the forecast period. The growth is due to factors such as rising cases of target diseases, increased use of oral thin films owing to their several advantages, and product launches by key players. For instance, according to the JAMA article published in January 2022, 17.1% of women and 5.6% of men reported having migraine symptoms in 2021 in the United States. Furthermore, according to the Migraine Research Foundation journal published in September 2022, more than 39.0 million Americans suffers from migraine every year, while women are three times more likely to get migraine than men. Moreover, according to the report published by the Government of Canada in July 2020 and as per our analysis, schizophrenia is a psychotic disorder that affects about 1.0% of Canadians. Therefore, such instances indicate considerable market growth in this region.
Key product launches, high concentration of market players or manufacturers, acquisition & partnerships among major players, and increasing cases of target diseases in the region are some of the factors driving the growth of the oral thin films market. Furthermore, the ongoing clinical trials are also driving the growth of the market. For instance, as per clinicaltrials.gov, the study titled 'Vitamin D Replacement Using Oral Thin Film (OTF) Cholecalciferol in Patients Undergoing Hematopoietic Stem Cell Transplantation' was started in June 2021 in the United States and is expected to complete by June 2023. The positive results from the clinical trials could lead to the development of new products and thus boost the growth of the market.
In February 2022, Aquestive Therapeutics announced FDA clearance of an investigational new drug application (IND) for AQST-109 epinephrine oral film, and in September 2022, the company announced that it entered into a license and supply agreement for Libervant (diazepam) Buccal Film with Pharmanovia, across the world. Therefore, owing to the aforementioned factors, the growth of the studied market is anticipated in the North American region over the forecast period.
Oral Thin Films Industry Overview
The oral thin films market is moderately competitive and consists of several market players. Companies are involved 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.
Oral Thin Films Market Leaders
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ZIM Laboratories Limited
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Aquestive Therapeutics, Inc.
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IntelGenx Corp.
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C.L.Pharm
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CURE Pharmaceutical
*Disclaimer: Major Players sorted in no particular order
Oral Thin Films Market News
- In October 2022, IntelGenxCorp. announced that it had received a U.S. FDA Generic Drug User Fee Act ("GDUFA") for its Buprenorphine Buccal Film. Buprenorphine Buccal Film is a generic version of Belbuca, an opioid used to manage severe continuous pain and can be used for long-term treatment.
- In August 2022, AquestiveTherapeutics received Food & Drug Administration's (FDA) grant for Libervant (diazepam) Buccal Film for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity.
Oral Thin Films Market Report - Table of Contents
1. INTRODUCTION
- 1.1 Study Assumptions and Market Definition
- 1.2 Scope of the Study
2. RESEARCH METHODOLOGY
3. EXECUTIVE SUMMARY
4. MARKET DYNAMICS
- 4.1 Market Overview
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4.2 Market Drivers
- 4.2.1 Growing Burden of Target Diseases
- 4.2.2 Advantages Associated with the Thin Films
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4.3 Market Restraints
- 4.3.1 Technical Limitations of Oral Thin Films
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4.4 Porter's Five Forces Analysis
- 4.4.1 Threat of New Entrants
- 4.4.2 Bargaining Power of Buyers/Consumers
- 4.4.3 Bargaining Power of Suppliers
- 4.4.4 Threat of Substitute Products
- 4.4.5 Intensity of Competitive Rivalry
5. MARKET SEGMENTATION (Market Size by Value - USD Million)
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5.1 By Product
- 5.1.1 Sublingual Film
- 5.1.2 Other Products
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5.2 By Disease Indication
- 5.2.1 Opioid Dependence
- 5.2.2 Nausea and Vomiting
- 5.2.3 Other Disease Indications
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5.3 By Distribution Channel
- 5.3.1 Hospital Pharmacies
- 5.3.2 Retail Pharmacies
- 5.3.3 Other Distribution Channels
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5.4 Geography
- 5.4.1 North America
- 5.4.1.1 United States
- 5.4.1.2 Canada
- 5.4.1.3 Mexico
- 5.4.2 Europe
- 5.4.2.1 Germany
- 5.4.2.2 United Kingdom
- 5.4.2.3 France
- 5.4.2.4 Italy
- 5.4.2.5 Spain
- 5.4.2.6 Rest of Europe
- 5.4.3 Asia-Pacific
- 5.4.3.1 China
- 5.4.3.2 Japan
- 5.4.3.3 India
- 5.4.3.4 Australia
- 5.4.3.5 South Korea
- 5.4.3.6 Rest of Asia-Pacific
- 5.4.4 Middle East & Africa
- 5.4.4.1 GCC
- 5.4.4.2 South Africa
- 5.4.4.3 Rest of Middle East & Africa
- 5.4.5 South America
- 5.4.5.1 Brazil
- 5.4.5.2 Argentina
- 5.4.5.3 Rest of South America
6. COMPETITIVE LANDSCAPE
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6.1 Company Profiles
- 6.1.1 Aquestive Therapeutics Inc.
- 6.1.2 IntelGenx Corp.
- 6.1.3 LTS Lohmann Therapie-Systeme AG
- 6.1.4 Viatris
- 6.1.5 NAL Pharma
- 6.1.6 ZIM Laboratories Limited
- 6.1.7 Sunovion Pharmaceuticals, Inc
- 6.1.8 Cure Pharmaceutical
- 6.1.9 C.L.Pharm
- *List Not Exhaustive
7. MARKET OPPORTUNITIES AND FUTURE TRENDS
** Subject To AvailablityOral Thin Films Industry Segmentation
As per the scope, oral thin films (OTF) are thin, flexible films targeted for drug delivery. The thin films are taken orally and dissolve immediately in the mouth or are applied to the mucosa. For transmucosal films, the active substance enters the bloodstream directly via the oral mucosa, without having to first pass through the gastrointestinal tract. The Oral Thin Films Market is segmented by Product (Sublingual Film and Other Products), Disease Indication (Opioid Dependence, Nausea and Vomiting, and Other Disease Indications), Distribution Channel (Hospital Pharmacies, Retail Pharmacies, and Other Distribution Channels), and Geography (North America, Europe, Asia-Pacific, Middle East & Africa, and South America). The market report also covers the estimated market sizes and trends for 17 different countries across major regions globally. The report offers the value (in USD million) for the above segments.
| By Product | Sublingual Film | |
| Other Products | ||
| By Disease Indication | Opioid Dependence | |
| Nausea and Vomiting | ||
| Other Disease Indications | ||
| By Distribution Channel | Hospital Pharmacies | |
| Retail Pharmacies | ||
| Other Distribution Channels | ||
| Geography | North America | United States |
| Canada | ||
| Mexico | ||
| Geography | Europe | Germany |
| United Kingdom | ||
| France | ||
| Italy | ||
| Spain | ||
| Rest of Europe | ||
| Geography | Asia-Pacific | China |
| Japan | ||
| India | ||
| Australia | ||
| South Korea | ||
| Rest of Asia-Pacific | ||
| Geography | Middle East & Africa | GCC |
| South Africa | ||
| Rest of Middle East & Africa | ||
| Geography | South America | Brazil |
| Argentina | ||
| Rest of South America |
Oral Thin Films Market Research FAQs
How big is the Oral Thin Films Market?
The Oral Thin Films Market size is expected to reach USD 3.01 billion in 2024 and grow at a CAGR of 9.56% to reach USD 4.75 billion by 2029.
What is the current Oral Thin Films Market size?
In 2024, the Oral Thin Films Market size is expected to reach USD 3.01 billion.
Who are the key players in Oral Thin Films Market?
ZIM Laboratories Limited, Aquestive Therapeutics, Inc., IntelGenx Corp., C.L.Pharm and CURE Pharmaceutical are the major companies operating in the Oral Thin Films Market.
Which is the fastest growing region in Oral Thin Films Market?
Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2024-2029).
Which region has the biggest share in Oral Thin Films Market?
In 2024, the North America accounts for the largest market share in Oral Thin Films Market.
What years does this Oral Thin Films Market cover, and what was the market size in 2023?
In 2023, the Oral Thin Films Market size was estimated at USD 2.75 billion. The report covers the Oral Thin Films Market historical market size for years: 2019, 2020, 2021, 2022 and 2023. The report also forecasts the Oral Thin Films Market size for years: 2024, 2025, 2026, 2027, 2028 and 2029.
Oral Thin Film Industry Report
Statistics for the 2024 Oral Thin Film market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. Oral Thin Film analysis includes a market forecast outlook to 2029 and historical overview. Get a sample of this industry analysis as a free report PDF download.
