Table of Contents
Oral drug delivery technologies form an integral part of the pharmaceutical industry. From the conventional tablets / capsules to modern-day fast disintegrating and rapidly acting tablets / films, the market has come a long way. Lower bioavailability of oral solid drugs, inconvenience of administering injections, inaccurate dosing by liquid formulations have turned the focus of pharmaceutical companies to develop novel oral dosage forms that eliminateseveral known limitations. In addition, dysphagia, a common problem due to difficulty in swallowing in people of all ages, especially paediatric, geriatric, psychiatric, uncooperative and nauseated patients, has led to increase in demand of an alternative dosage formthat provides rapid dissolution without the need of water and rapid onset of action when delivered through oral mucosa.
Oral thin films are able to meet most of these challenges. The concept isn’t new and several over-the-counter oral thin films are readily available.Good acceptance from the users and anincreasing demand of over-the-counter oral film products has led to the development of prescription drugs into oral thin films. These films not only offer a range of benefits to specific patient population segments but also provide a number of additional benefits to other stakeholders in the industry.The emerging area has gained attention from both established and start- up pharmaceutical firms.
Companies are utilizing their oral thin film technologies to develop different types of oral thin films (e.g. oral dispersible, sublingual, buccal). In addition to the drugs, several hormones and vaccines are also being formulated into oral thin films with the aim of providing improved patient compliance. Some of the key players in this area include MonoSol Rx, Applied Pharma Research/ Labtec GmbH, BioDelivery Sciences and NAL Pharma. Many companies are collaborating with these technology providers and utilizing oral thin films as a life cycle management tool for their branded drugs that have lost patent in other dosage forms.
There are not many prescription oral thin films currently available in the market; however, the pipeline holds a wider promise. Despite the uncertainties related to the development, approval and penetration rate, the market is likely to witness stable growth in the coming decade.
SCOPE OF THE REPORT
The ‘Oral Thin Films’ market report provides a comprehensive analysis of the current state of the market and the likely future evolution over the next ten years. Starting with the basic introduction to the oral transmucosal route, its advantages and disadvantages, the report lays emphasis on the unmet needs fulfilled by oral thin films. Although oral thin films have been available in the forms of breath freshening strips, vitamin strips and other over-the-counter products for the past few decades, pharmaceutical companies have recently directed their focus towards formulating prescription products into oral thin films.
The study includes all prescription oral thin films, not necessarily delivered through oral mucosa. For these products, we have provided detailed profiles, underlying technologies being used to develop them and information on the key companies leading the efforts. We have also provided a detailed view on the key drivers behind the growth of this market, likely challenges and upcoming threats under the SWOT framework.
Many patients primarily paediatric, geriatric and dysphasia find it difficult to swallow traditional tablets and capsules. Moreover, some diseases require rapid onset of action. This is possible through injections; some patients, though, find it inconvenient and painful to administer injections. Oral thin films provide the best alternative dosage form for administering drug for such patients. It is important to highlight that not many prescription oral thin film products are commercially available yet. Several companies are developing innovative technologies to formulate oral thin films, which provide the advantage of rapid dissolution without the need of water and rapid onset of action when delivered through mucosa.
Given the specific advantages offered by these films and their ability to overcome the current unmet needs, the future holds significant potential. In fact, one of the primary objectives of this report is to estimate size of this future promise offered by marketed oral thin films and those currently under development. We have identified the sales potential of various oral thin films for the period 2015 - 2025. Owing to the uncertain nature of this market, we have presented three scenarios for our market forecast; these scenarios represent different growth tracks of the industry likely to be influenced by variable adoption, pricing and the evolving competitive landscape.
1. There are 10 prescription oral thin films currently in the market. In addition, there are 29 such films which are currently in different stages of clinical / pre-clinical development. Of these, six products are expected to get launched in 2015 / 2016 in their respective geographies.
2. Approximately 54% of these products are oral transmucosal thin films. These films can be administered through sublingual, buccal or oral mucosal route, providing advantage of rapid onset of action.
3. A number of these products (approx. 38%) are based on either MonoSol’s PharmFilm technology or Applied Pharma Research / Labtec’s RapidFilm technology. In addition to these two, there are over 10 other proprietary oral thin film technologies; some of these are currently being utilized for formulating over-the-counter products.
4. Some start-ups such as FFT Medical and Cynapsus Therapeutics have also recently emerged; these new companies are coming up with their oral transmucosal thin film products and are likely to foster more innovation in the coming few years.
5. Of all the marketed products, Suboxone film has found a strong acceptance in a short span of time; other marketed products such as Breakyl, Onsolis and Zuplenz are also gaining ground in different geographies. Overall, as more products get launched, we expect the market to sustain the growth momentum.
Most of the data presented in this report has been gathered by secondary research. For specific studies, we also conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will shape up across different regions and drug segments. Where possible, the available data has been checked for accuracy from multiple sources of information.
The secondary sources of information include:
- Annual reports
- Investor presentations
- SEC filings
- Industry databases
- News releases from company websites
- Government policy documents
- Other analysts’ opinion reports
While the focus has been on forecasting the market over the coming ten years, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.
Chapter 2 provides an executive summary of the insights captured in our research. The summary offers a high level view on the likely evolution of oral thin films market.
Chapter 3 provides a general introduction to the oral transmucosal route, covering details on different oral mucosal sites including the most common sublingual and buccal. The chapter also talks about the various sublingual and buccal dosage forms available in the market.
Chapter 4 provides an introduction to oral thin films, their features, advantages and disadvantages. The chapter provides details on the composition, manufacturing methods,storage and packaging of the oral thin films.
Chapter 5 highlights various developments which have taken place in the field of oral thin films. We have looked at prescription oral thin films (both marketed and in different stages of development) and some of the most common over-the-counter oral thin films. The chapter also lists the various technologies which are being used by pharmaceutical companies for developing oral thin films.
Chapter 6 provides detailed profiles on various drugs and vaccines being targeted for formulation into oral thin films. Starting with the introduction, these profiles cover historical developments of specific drugs / vaccines in other dosage forms, target population, historical sales and recent developments.
Chapter 7 looks at the future state of oral thin films market till 2025. It highlights the leading oral thin film products which are likely to drive the upcoming growth and the relative market size of oral thin films in terms of sales.
Chapter 8 provides the SWOT analysis of oral thin films market giving strategic insights to the major factors that are likely to contribute to future growth while also highlighting the weakness and threats that can negatively impact the evolution.
Chapter 9 includes profiles of the key companies active in this market. It covers detailed information on the technology provided by the each company,financial performance, marketed / pipeline products, recent developments, collaborations and future growth plans.
Chapter 10 summarizes the overall report. In this chapter, we provide a recap of the key takeaways and our independent opinion based on the research and analysis described in the previous chapters.
Chapter 11 is an appendix, which provides tabulated data and numbers for all the figures presented in the report.
Chapter 12 is an appendix, which provides a list of companies and organizations mentioned in this report.
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