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%.
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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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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.
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
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
Historical Data Available for
US$ Mn for Value & ‘000 Units for Volume
Key Regions Covered
Key Countries Covered
Key Segments Covered
Key Companies Profiled
Customization & Pricing
Available upon Request
Key Market Segments
- Sublingual Oral Thin Films
- Fast Dissolving Oral Thin Films
- Buccal Oral Thin Films
- Pain Management
- Neurological Disorders
- Nausea & Vomiting
- Opioid Dependence
- Oral Thin Films Sold at Hospital Pharmacies
- Oral Thin Films Sold at Retail Pharmacies
- Oral Thin Films Sold through Online Pharmacies
- 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)
Oral Thin Films Market- Scope of Report
A recent study by Fact.MR on the oral thin films market offers a 10-year forecast for 2021 to 2031. The study analyzes crucial trends that are currently determining the growth of the market. This report explicates on vital dynamics, such as the drivers, restraints, and opportunities for key market players along with key stakeholders as well as emerging players associated with offering oral thin films.
The study also provides the dynamics that are responsible for influencing the future status of market over the forecast period. A detailed assessment of value chain analysis, business execution, and supply chain analysis across regional markets has been covered in the report.
A list of prominent companies manufacturing oral thin films, along with their product portfolios, enhances the reliability of this comprehensive research study.
The study offers comprehensive analysis on diverse features, including production capacities, demand, product developments, revenue generation, and sales of oral thin films across the globe.
A comprehensive estimate on the market has been provided through an optimistic as well as a conservative scenario, taking into account the sales of oral thin films during the forecast period. Price point comparison by region with global average price is also considered in the study.
Key Questions Answered in Report
- Which are the most lucrative markets for oral thin films?
- Which factors will impact the growth of the oral thin films market?
- How will changing trends impact the strategies of market players?
- How can market players capture the low-hanging opportunities across regions?
- Which companies are leading manufacturers of oral thin films?
- What are the winning strategies of stakeholders in the market?
Analysis on Market Size Evaluation
The market has been analyzed for each market segment in terms of volume (‘000 Units) and value (US$ Mn).
Market estimates at global and regional levels for oral thin films are available in terms of “US$ Mn” for value and in “‘000 Units” for volume. A Y-o-Y growth contrast on prominent market segments, along with market attractiveness evaluation, has been incorporated in the report. Furthermore, absolute dollar opportunity analysis of all the segments adds prominence to the report. Absolute dollar opportunity plays a crucial role in assessing the level of opportunity that a manufacturer/distributor can look to achieve, along with identifying potential resources, considering the sales and distribution perspective in the global oral thin films market.
Inspected Assessment on Regional Segments
Key sections have been elaborated in the report, which have helped deliver projections on regional markets. These chapters include regional macros (political, economic, and business environment outlook), which are expected to have a momentous influence on the growth of the oral thin films market during the forecast period.
Country-specific valuation on demand for oral thin films has been offered for each regional market, along with market scope estimates and forecasts, price index, and impact analysis of the dynamics of prominence in regions and countries. For all regional markets, Y-o-Y growth estimates have also been incorporated in the report.
Detailed breakup in terms of value and volume for emerging countries has also been included in the report.
In-depth Analysis on Competitive Landscape
The report sheds light on leading manufacturers of oral thin films, along with their detailed profiles. Essential and up-to-date data related to market performers who are principally engaged in the production of oral thin films has been brought with the help of a detailed dashboard view. Market share analysis and comparison of prominent players provided in the report permits report readers to take preemptive steps in advancing their businesses.
In Fact.MR’s study, a unique research methodology is utilized to conduct extensive research on the growth of the oral thin films market, and reach conclusions on the future growth parameters of the market. This research methodology is a combination of primary and secondary research, which helps analysts ensure the accuracy and reliability of the drawn conclusions.
Secondary resources referred to by analysts during the preparation of the market study include statistics from governmental organizations, trade journals, white papers, and internal and external proprietary databases. Analysts have interviewed senior managers, product portfolio managers, CEOs, VPs, marketing/product managers, and market intelligence managers, all of whom have contributed to the development of the research report as a primary resource.
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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.