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Oral Thin Films Market

Oral Thin Films Market

Oral Thin Films Market, Forecast, Trend, Analysis & Competition Tracking - Global Market Insights 2021 to 2031

Oral Thin Films Market
  • Apr-2021
  • List of Tables : 24
  • List of Figures : 65
  • 170 Pages
  • Healthcare

About the Report

The global oral thin films market is expected to surge ahead at a healthy CAGR of around 9% over the next ten years. Demand for sublingual oral thin films is set to see a boost over the coming years.

Rapid advancements in drug delivery technologies have provided a significant stimulus to the demand for oral thin films. Incorporation of key breakthroughs as biotechnology and polymerization has greatly assisted prominent manufacturers in developing highly effective product portfolios, expanding their revenue pools and attracting a huge customer base.

Prominent pharmaceutical companies, therefore, are investing in large-scale capacity expansion projects so as to aid their product developments. Lucrative growth prospects are in store across the neurological disorders and opioid dependency segments.

In its new study, consulting firm Fact.MR offers insights about key factors driving demand for oral thin films. The report tracks global sales of oral thin films in 20+ high-growth markets, along with analyzing the impact COVID-19 has had on the healthcare domain in general, and on oral thin film demand in particular.

Will Future Projections Outpace Historical Sales?

The global oral thin films market has posted significant gains in the recent past, as rapid advancements in oral drug delivery has highlighted the importance of targeted drug delivery in improving patient outcomes.

As the global burden of chronic conditions, especially neurological disorders increase, swallowing problems are making it difficult for patients to consume tablets or other oral medicinal intake.

Hence, oral thin films are emerging as a highly effective alternative. Amidst the COVID-19 pandemic, the importance of oral thin films have only served to heighten, with numerous clinical trials underway to develop potential antiviral oral thin films, including Molnupiravir, a recently discovered antiviral drug.

According to Fact.MR, the market is projected to surpass US$ 6 billion by 2031, expanding at a CAGR of approximately 9%.

How is Nanotechnology Influencing Oral Thin Film Uptake?

Medicine delivery is an indispensable part of healthcare administration. The application of advanced drug delivery techniques, including oral thin films, has revolutionized patient care in recent years. Oral films offer definite advantages with regards to dosage convenience, ease of administration sans the need for any adjunct solvent, and suitability for patients with swallowing issues.

Fast dissolving thin films are especially gaining significant momentum, attributed to their enhanced efficacy. A significant development is the incorporation of polymer technology. A combination of both natural and synthetic-origin polymers, ranging from carbohydrates, proteins, resins, and polysaccharides to cellulose derivatives, vinyl and acrylic polymers. A typical oral film comprises of 1-30% of the actual drug, 40-50% of film forming polymers, 0-20% plasticizers, 2-6% saliva stimulating agents and 3-6% sweetening agents.

The polymer employed should be non-toxic, non-irritant and devoid of leachable impurities. It should have good wetting and spreading properties. It should exhibit sufficient peel, shear and tensile strengths. The film obtained should be tough enough so that there won't be any damage while handling or during transportation.

A combination of microcrystalline cellulose and maltodextrin has been used to formulate oral strips of piroxicam made by hot melt extrusion technique. Pullulan has been the most widely used film former, and is used in such formulations as Listerine PocketPak and Benadryl.

How is Growing Opioid Overdose Heightening Oral Thin Film Adoption?

According to the World Health Organization, around 269 million people, or 5.3% of the global population aged 15-64 years used drugs at least once in 2018. Among them, approx. 58 million people suffered from opioid dependence, while more than 35 million people suffered from drug use disorders. While most people dependent on opioids used illicitly cultivated and manufactured heroin, the proportion of people abusing prescription opioids is growing.

Worldwide, about 0.5 million deaths are attributable to drug use. More than 70% of these deaths are related to opioids, with more than 30% of those deaths caused by overdose. According to WHO estimates, approximately 115 000 people died of opioid overdose in 2017. Opioid overdoses that do not lead to death are several times more common than fatal overdoses. Based on these statistics, demand for combating such abuse is heightening, leading to increased demand for oral thin films.

Numerous manufacturers have been investigating various approaches, translating into numerous product launches. A major breakthrough in this regard is the introduction of Revia® (naltrexone), a special narcotic drug that blocks the effects of other narcotic and opioid medicines, which is generally taken orally. While it is mostly available in tablet form, efforts are underway to increase production of film formats.

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Country-wise Analysis

How is Protection of Pharmaceutical Business Interests Driving Oral Thin Film Adoption in the U.S.?

The United States has been steadily generating high demand for oral thin films, majorly for treating opioid addiction, amyotrophic lateral sclerosis (ALS) and schizophrenia, among other disorders. Furthermore, many more are in the pipeline to treat such chronic conditions as migraine Alzheimer’s disease. Presently, the Food & Drug Administration has approved nearly 11 oral film products.

More recently, in March 2021, BioXcel Therapeutics submitted a New Drug Application (NDA) to the FDA for BXCL501 (dexmedetomidine) for the acute treatment of agitation associated with schizophrenia and bipolar disorders I and II. The NDA submission is supported by data from the double-blind, placebo-controlled, parallel group phase 3 SERENITY I studies.

Furthermore, oral thin films have proven highly useful for key pharmaceutical companies to protect their products in the wake of their offerings going off-patent. Novel oral film applications of reformulated drugs, for instance, can acquire additional 3 years of market exclusivity from the FDA, extending up to seven years in case of an orphan drug candidate, with a patent protection of up to 20 years.

Will Rising Opioid Abuse Cases Stimulate Sales of Oral Thin Films in the U.K.?

According to a report published by the Office of National Statistics (ONS), there were nearly 4400 drug poisoning deaths across England and Wales in 2019. Moreover, opioid prescription rates have registered a 14% increase with respect to long-term users, mostly due to old age, social deprivation and a history of substance abuse. Furthermore, the UK has the largest reported opioid-using population across Europe.

In 2018, opioids were mentioned or implicated in around 80% of registered deaths in each of the countries within the UK, with Scotland attaining the highest position (86%). Lifetime use of powder cocaine amongst teenagers in England increased from 2% in 2013 to 4.2% in 2018. Also, 13% of people starting drug treatment in Great Britain since 2018 reported primary use of powder cocaine.

Realizing the magnitude of the situation, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced that opioid medications in the UK will now have better warning labels about the risk of addiction and dependence. This is also expected to bolster addiction treatment approaches, thereby widening oral thin films growth prospects in forthcoming years.

How is Germany Expected to Generate Growth Frontiers?

The German market is poised to open up new growth frontiers amid increasing progress towards incorporating nanotechnology-based medicine to attain highly precision based treatment for numerous chronic and infectious disorders. As the focus shifts from administering small-sized easy to administer drugs, the German market is experiencing and upswing in oral thin films manufacturing.

Harro Hofliger, for instance, is a prominent face in the German oral thin films landscape. The company offers oral (ODF) and buccal (MBF) film strips which dissolve quickly and distribute the active ingredient. These are based on a transdermal patch technology. A typical ODF is rectangular and between 2 and 10 square centimeters in size.

Also, Vektor Pharma TF GmbH, leaders in transdermal patches manufacturing, plans to unveil a new commercial drug manufacturing facility in 2021, in Biberach, near its current laboratory, and is currently in the due diligence process to ensure suitability of the land for construction and use as a commercial drug manufacturing and laboratory site. Such initiatives are expected to significantly widen prospects for oral thin films manufacturing in the long-run.

Why is France Likely to Emerge as a High Potential Market for Oral Thin Films?

The French market is set to offer highly lucrative growth opportunities to oral thin films manufacturers, attributed to the presence of a robust pharmaceutical industry. According to figures published by Les entreprises du medicament (LEEM), prominent pharmaceutical companies generated nearly € 56 billion in revenue as of 2018.

Furthermore, as of 2015, total amounted invested to fund R&D amounted to € 4.5 billion. Moreover, the country generates over 3% of the global pharmaceutical market revenue since 2018. Also, France is the 2nd largest European market and one of the world’s largest consumers of pharmaceutical products.

AdhexPharma is a prominent oral thin films manufacturers across the French landscape, manufacturing its own range of OTFs. AdhexPharma’s OTF technologies increase patient compliance as they are easy to swallow and do not require water to consume. They can be customized to either be absorbed through a gastrointestinal pathway or through the oral mucosa.

Category-wise Insights

Why is Demand for Sublingual Films Increasing Rapidly?

By product, sublingual oral films are expected to be the most widely used oral thin films across the forecast period. High dissolvability rate is attributed as the primary catalyst for its enhanced adoption. When placed in the oral cavity, it rapidly disintegrates, releasing medication for oromucosal and intragastric absorption, without the need for chewing or water intake.

Numerous manufacturers have been operating in the sublingual oral films domain. These include Aavishkar Films, AdhexPharma, ARx Drug Delivery Systems, Croient Pharma and Flagship Biotech International Pvt. Ltd. among others. Such robust presence of a multitude of manufacturers is expected to largely enhance the uptake of sublingual oral films in the future.

How are Neurological Disorders Stimulating Demand for Oral Thin Films?

Based on indication, oral thin films are witnessing high uptake to treat various neurological disorders, including schizophrenia and Alzheimer’s disease. Statistics have revealed that four out of five patients prefer orally disintegrating dosage forms over conventional solid oral dosages forms.

People suffering from neurological conditions and central nervous system disorders experience difficulty in swallowing or chewing solid medications, amid fears of choking and disruption in breathing cycles. Hence, oral thin films are becoming highly popular. Due to their rapid hydration and disintegration rate, these films are highly preferred routes of administration adopted by medical practitioners.

Why are Retail Pharmacies Emerging as Primary Distribution Channels for Oral Thin Films?

By distribution channel, retail pharmacies are expected to be the primary oral thin films distribution channels in the forthcoming decade. Easy availability in over-the-counter settings and convenience in terms of proximity to households are expected to drive retail pharmacies distribution.

At the same time, hospital pharmacies will remain major point of sales for oral thin films, particularly for more severe ailments such as neurological and opioid disorders. Moreover, recent years have led to a surge in the popularity of online pharmacies amid the growing reliance on virtual platforms to source key pharmaceutical products.

An Adaptive Approach to Modern-day Research Needs

Competitive Landscape

The aforementioned key market players of oral thin films majorly rely on new product launches based on latest technological developments, as well as strategic expansion initiatives which include mergers & acquisitions and partnerships or collaborations.

  • In August 2020, ZIM Laboratories Ltd. signed an exclusive licensing agreement with the Hypera Pharma Group to extensively market Vitamin D3 in a novel oral thin film. As per the agreement, ZIM Laboratories will license the developed product to COSMED for importing and marketing under Hypera Pharma’s ADDERA D3 brand as ADDERA D3 Flash
  • 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. The company has submitted multiple US and foreign patent applications for its AQST-88 and AQST-109 prodrug candidates used in the film
  • Regarding product offering, Shilpa Therapeutics Pvt. Ltd. is a prominent face in the South Asian market, being India’s first oral thin films manufacturer. The company currently offers a multitude of films for various purpose, including ondansetron hydrochloride (chemotherapy-induced vomiting & nausea), simethicone (anti-flatulent), sildenafil citrate (erectile dysfunction), tadalafil (erectile dysfunction) and methylocobalamin (diabetic & peripheral neuropathy) respectively

Report Scope



Forecast Period


Historical Data Available for


Market Analysis

US$ Mn for Value & ‘000 Units for Volume

Key Regions Covered

  • North America
  • Latin America
  • Europe
  • Asia-Pacific
  • Middle East & Africa

Key Countries Covered

  • US
  • Canada
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Japan
  • China
  • India
  • Australia & New Zealand
  • Brazil
  • Mexico
  • GCC
  • South Africa

Key Segments Covered

  • Product
  • Indication
  • Distribution Channel

Key Companies Profiled

  • ZIM Laboratories Ltd.
  • Indivior Plc.
  • Aquestive Therapeutics Inc.
  • LIVKON Pharmaceuticals Pvt. Ltd.
  • Shilpa Therapeutics Pvt. Ltd.
  • Sunovion Pharmaceuticals Inc.
  • NAL Pharma
  • CURE Pharmaceutical
  • IntelGenx Corp.
  • Dr. Reddy’s Laboratories
  • Kyu Pharmaceutical Co. Ltd.
  • Seoul Pharma Co. Ltd.
  • C.L. Pharm

Customization & Pricing

Available upon Request

Key Market Segments

  • Product

    • Sublingual Oral Thin Films
    • Fast Dissolving Oral Thin Films
    • Buccal Oral Thin Films
  • Indication

    • Pain Management
    • Neurological  Disorders
    • Nausea & Vomiting
    • Opioid Dependence
    • Others
  • Distribution Channel

    • Oral Thin Films Sold at Hospital Pharmacies
    • Oral Thin Films Sold at Retail Pharmacies
    • Oral Thin Films Sold through Online Pharmacies
  • Region

    • North America (US and Canada)
    • Europe (Germany, UK, France, Spain, Italy and Rest of Europe)
    • Asia-Pacific (Japan, China, India, Australia & New Zealand and Rest of APAC)
    • Latin America (Brazil, Mexico and Rest of LATAM)
    • Middle East & Africa (GCC, South Africa and Rest of MEA)

- FAQs -

The market growth is expected to accrue significant gains across 2031, attributed to increased prevalence of neurological disorders and opioid dependency rates.
Market growth is anticipated to receive stimulus amidst growing initiatives undertaken by prominent healthcare providers to investigate alternative oral therapeutic approaches. Moreover, players are also incorporating biotechnology and polymerization tech
According to Fact.MR’s analysis, North America is expected to remain the dominant market for oral thin films, amid surging prevalence rates of central nervous system and neurological disorders, including Alzheimer’s disease, schizophrenia and migraine amo
Some of the major oral thin films market players in Fact.MR’s report include ZIM Laboratories Ltd., Indivior Plc., Aquestive Therapeutics Inc., LIVKON Pharmaceuticals Pvt. Ltd., Shilpa Therapeutics Pvt. Ltd., Sunovion Pharmaceuticals Inc., NAL Pharma, CUR

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Is the market research conducted by Fact.MR?

Yes, the report has been compiled by expert analysts of Fact.MR, through a combination of primary and secondary research. To know more about how the research was conducted, you can speak to a research analyst.

What research methodology is followed by Fact.MR?

Fact.MR follows a methodology that encompasses the demand-side assessment of the market, and triangulates the same through a supply-side analysis. This methodology is based on the use of standard market structure, methods, and definitions.

What are the sources of secondary research?

Fact.MR conducts extensive secondary research through proprietary databases, paid databases, and information available in the public domain. We refer to industry associations, company press releases, annual reports, investor presentations, and research papers. More information about desk research is available upon request.

Who are the respondents for primary research?

Fact.MR speaks to stakeholders across the spectrum, including C-level executives, distributors, product manufacturers, and industry experts. For a full list of primary respondents, please reach out to us.

Is a sample of this report available for evaluation?

Yes, you can request a sample, and it will be sent to you through an email.