Oral Transmucosal Drugs Market Size
| Study Period | 2019 - 2029 |
| Market Size (2024) | USD 16.57 Billion |
| Market Size (2029) | USD 22.97 Billion |
| CAGR (2024 - 2029) | 6.75 % |
| Fastest Growing Market | Asia-Pacific |
| Largest Market | North America |
Major Players
*Disclaimer: Major Players sorted in no particular order |
Oral Transmucosal Drugs Market Analysis
The Oral Transmucosal Drugs Market size is estimated at USD 16.57 billion in 2024, and is expected to reach USD 22.97 billion by 2029, growing at a CAGR of 6.75% during the forecast period (2024-2029).
The COVID-19 pandemic had a short-term impact on the oral transmucosal drugs market. Transmucosal drug administration served as an alternative route of drug administration during the COVID-19 pandemic. According to a research study published in November 2020 in NCBI, the COVID-19 pandemic caused a surge in the need for alternative routes of drug administration for end-of-life and palliative care, particularly in community settings. Additionally, this route of drug administration resulted in an excellent method in palliative care to give quick symptom alleviation due to its rapid start of the action and reduced first-pass metabolism. This was crucial amid the COVID-19 pandemic since, in most cases, the patient's condition worsened immediately. Despite their benefits, these routes of administration had limitations, including a mucus barrier, a relatively small surface area for optimal drug absorption, and a small volume of fluid for drug dissolution. As a result, fewer medicines were suited for transmucosal delivery. Thus, due to these limitations, the studied market was adversely affected in the initial phase of the pandemic. However, as per the analysis, oral transmucosal drug manufacturers started capitalizing on the ability of the drugs to offer reduced first-pass metabolism with a speedy onset of action during the later phase of the coronavirus outbreak. These abilities made the drugs suitable for use in sedative treatments to offer prompt relief. Thus, owing to the aforementioned reasons, the market is expected to grow post-pandemic phase.
Moreover, the rise in R&D activities and product launches and the increase in the prevalence of targeted diseases are likely to drive market growth over the forecast period. For instance, in June 2021, Shilpa Medicare Ltd. launched Molshil, a pediatric dose of paracetamol oral thin film, in India. The company received approval after complying with bioequivalence requirements. Additionally, growth in the target population is anticipated to bolster the market's growth. As oral transmucosal fentanyl citrate is an opioid formulation that contains fentanyl in a lozenge and permits drug delivery via the buccal mucosa, this kind of absorption circumvents first-pass metabolism, rendering bioavailability more prominent than the oral route of administration. As a result, growing opioid dependence among the patient population for immediate relief of the pain caused by several disorders is likely to boost the demand for oral transmucosal drugs. For instance, according to the WHO, in 2021, approximately 275 million people used medications (drugs) at least once. Among them, approximately 62 million people used opioids.
Furthermore, the rising burden of Parkinson's disease (PD) and migraine is likely to propel the growth of the oral transmucosal drugs market over the forecast period. For instance, according to Parkinson's Foundation data published in January 2022, nearly one million people in the United States are living with Parkinson's disease. This number is expected to rise to 1.2 million by 2030. Parkinson's is the second-most common neurodegenerative disease after Alzheimer's disease. Approximately 60,000 Americans are diagnosed with PD each year. More than 10 million people worldwide live with PD. Thus, increasing incidences of such disorders are expected to increase the adoption of oral transmucosal drugs for the treatment of such disorders, resulting in better pain management and immediate relief. Thus, the above-mentioned factors are expected to increase the market's growth.
However, disadvantages associated with oral transmucosal drug delivery are expected to hinder the market's growth.
Oral Transmucosal Drugs Market Trends
Tablets segment is Expected to Hold a Significant Share Over the Forecast Period
The tablet sub-segment by product type is expected to witness growth over the forecast period. Oral transmucosal tablets easily dissolve in the mouth with little or no residue. As oral transmucosal tablets absorb quickly, they play a critical role during medical emergencies such as heart attacks.
Furthermore, the tablets segment is anticipated to hold a significant share of the market, owing to the advantages offered by oral transmucosal tablets, such as quick absorption, predictable potency, ease of administration, and reduced interaction with other medications. As per the research study published in the National Library of Medicine's Journal in August 2021, a decrease in salivary output is common among older adults having polypharmacy, and the study reported that dental carries risks in older adults increase by 60% with a low resting pH and a low stimulated salivary flow rate. It was also reported that the prevalence of caries in older adults in India was about 82%, while in Germany it was about 30% in 2020. Therefore, the expected rise in dental caries among elderly people resulted in determining an alternative route of medication administration than the oral route, which is expected to positively impact the studied segment.
Moreover, the rise in oral transmucosal tablet approvals is expected to drive segment growth over the forecast period. For instance, in May 2021, Breckenridge Pharmaceutical, Inc. received final approval from the US FDA for its abbreviated new drug application for asenapine (5 mg) sublingual tablets. The product was developed by Breckenridge Pharmaceutical, Inc., and MSN Laboratories, Private Limited. Such product approvals are expected to increase the market's growth.
Thus, the abovementioned factors are expected to increase the market segment's growth.
North America Dominates the Market and is Expected to do the Same in the Forecast Period
North America holds the major market share in the oral transmucosal drugs market and is expected to dominate the overall market throughout the forecast period owing to the high prevalence of target populations such as people suffering from PD, Alzheimer's, dental ailments, and dysphagia, along with the increase in the geriatric population, and the high acceptance of novel oral transmucosal drugs in the region.
According to CDC data, as of January 2021, one quarter (26%) of adults aged 65 or older had 8 or fewer teeth, and approximately 1 in 6 (17%) adults aged 65 or older had lost all their teeth in the United States. In addition, according to the same source's February 2022 data, 63% of adults aged 18 and over in the United States had a dental visit in the past year, and 85.9% of children aged 2-17 years had a dental visit in the year 2020. This increasing number of dental visits in the country is expected to drive the demand for oral transmucosal drugs such as midazolam and buprenorphine for sedation and pain relief.
Similarly, initiatives undertaken by the market players are expected to augment the market's growth further. For instance, in July 2021, Aquestive Therapeutics, Inc. received acceptance of a new drug application resubmission for Libervant from the US FDA. It is a diazepam buccal film developed for the management of seizure clusters. Thus, such approvals are expected to strengthen the market's growth.
Thus, the abovementioned factors are expected to increase the market's growth in the North American region.
Oral Transmucosal Drugs Industry Overview
The oral transmucosal drugs market is moderately competitive, with several major players across the globe. Some of the major players in the market are ZIM Laboratories Limited, Aquestive Therapeutics, Inc., IntelGenx Corp., Novartis AG, C.L.Pharm Co., Ltd., Seoul Pharmaceuticals, Shilpa Therapeutics, Sunovion Pharmaceuticals, Inc., Pfizer Inc., and GW Pharmaceuticals Plc., among others.
Oral Transmucosal Drugs 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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Novartis AG
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Sunovion Pharmaceuticals, Inc.
*Disclaimer: Major Players sorted in no particular order
Oral Transmucosal Drugs Market News
- In September 2021, IntelGenx Corp. launched RIZAPORT in Spain. Exeltis Healthcare S.L. is a commercialization partner of IntelGenx Corp. in the European Union for RIZAPORT. It is an oral film formulation of rizatriptan benzoate.
- In January 2021, CURE Pharmaceutical's product CUREfilm Blue, an oral soluble film containing sildenafil citrate (the active ingredient in Viagra) used in the treatment of erectile dysfunction, received FDA approval for an Investigational New Drug (IND) application.
Oral Transmucosal Drugs 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 Rise in R&D Activities and Product Launches
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4.3 Market Restraints
- 4.3.1 Disadvantages Associated With Oral Transmucosal Drug Delivery
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4.4 Porter's Five Force 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 Type
- 5.1.1 Tablets
- 5.1.2 Films
- 5.1.3 Liquid & Spray
- 5.1.4 Others
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5.2 By Route of Administration
- 5.2.1 Sublingual Mucosa
- 5.2.2 Buccal Mucosa
- 5.2.3 Others
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5.3 By Indication
- 5.3.1 Opioid Dependence
- 5.3.2 Nausea and Vomiting
- 5.3.3 Erectile Dysfunction
- 5.3.4 Neurological Disorders
- 5.3.5 Others
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5.4 By Distribution Channel
- 5.4.1 Hospital Pharmacies
- 5.4.2 Retail Pharmacies
- 5.4.3 Online Pharmacies
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5.5 Geography
- 5.5.1 North America
- 5.5.1.1 United States
- 5.5.1.2 Canada
- 5.5.1.3 Mexico
- 5.5.2 Europe
- 5.5.2.1 Germany
- 5.5.2.2 United Kingdom
- 5.5.2.3 France
- 5.5.2.4 Italy
- 5.5.2.5 Spain
- 5.5.2.6 Rest of Europe
- 5.5.3 Asia-Pacific
- 5.5.3.1 China
- 5.5.3.2 Japan
- 5.5.3.3 India
- 5.5.3.4 Australia
- 5.5.3.5 South Korea
- 5.5.3.6 Rest of Asia-Pacific
- 5.5.4 Middle East and Africa
- 5.5.4.1 GCC
- 5.5.4.2 South Africa
- 5.5.4.3 Rest of Middle East and Africa
- 5.5.5 South America
- 5.5.5.1 Brazil
- 5.5.5.2 Argentina
- 5.5.5.3 Rest of South America
6. COMPETITIVE LANDSCAPE
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6.1 Company Profiles
- 6.1.1 ZIM Laboratories Limited
- 6.1.2 Aquestive Therapeutics, Inc.
- 6.1.3 IntelGenx Corp.
- 6.1.4 Novartis AG
- 6.1.5 C.L.Pharm Co., Ltd.
- 6.1.6 Seoul Pharmaceuticals
- 6.1.7 Shilpa Therapeutics
- 6.1.8 Sunovion Pharmaceuticals, Inc.
- 6.1.9 Pfizer Inc.
- 6.1.10 GW Pharmaceuticals plc.
- *List Not Exhaustive
7. MARKET OPPORTUNITIES AND FUTURE TRENDS
** Subject To AvailablityOral Transmucosal Drugs Industry Segmentation
As per the scope of the report, oral transmucosal drugs are available in different dosage forms such as tablets, thin films, and gels, and are administered orally to dissolve immediately in the mouth. Oral transmucosal drugs can bypass hepatic first-pass metabolism and avoid drug degradation in the gastrointestinal tract. The Oral Transmucosal Drugs Market is Segmented by Product Type (Tablets, Films, Liquid & Spray, and Others), Route of Administration (Sublingual Mucosa, Buccal Mucosa, and Others), Indication (Opioid Dependence, Nausea and Vomiting, Erectile Dysfunction, Neurological Disorders, and Others), Distribution Channel (Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies), and Geography (North America, Europe, Asia-Pacific, Middle East, and 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 Type | Tablets | |
| Films | ||
| Liquid & Spray | ||
| Others | ||
| By Route of Administration | Sublingual Mucosa | |
| Buccal Mucosa | ||
| Others | ||
| By Indication | Opioid Dependence | |
| Nausea and Vomiting | ||
| Erectile Dysfunction | ||
| Neurological Disorders | ||
| Others | ||
| By Distribution Channel | Hospital Pharmacies | |
| Retail Pharmacies | ||
| Online Pharmacies | ||
| 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 and Africa | GCC |
| South Africa | ||
| Rest of Middle East and Africa | ||
| Geography | South America | Brazil |
| Argentina | ||
| Rest of South America |
Oral Transmucosal Drugs Market Research FAQs
How big is the Oral Transmucosal Drugs Market?
The Oral Transmucosal Drugs Market size is expected to reach USD 16.57 billion in 2024 and grow at a CAGR of 6.75% to reach USD 22.97 billion by 2029.
What is the current Oral Transmucosal Drugs Market size?
In 2024, the Oral Transmucosal Drugs Market size is expected to reach USD 16.57 billion.
Who are the key players in Oral Transmucosal Drugs Market?
ZIM Laboratories Limited, Aquestive Therapeutics, Inc., IntelGenx Corp., Novartis AG and Sunovion Pharmaceuticals, Inc. are the major companies operating in the Oral Transmucosal Drugs Market.
Which is the fastest growing region in Oral Transmucosal Drugs 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 Transmucosal Drugs Market?
In 2024, the North America accounts for the largest market share in Oral Transmucosal Drugs Market.
What years does this Oral Transmucosal Drugs Market cover, and what was the market size in 2023?
In 2023, the Oral Transmucosal Drugs Market size was estimated at USD 15.45 billion. The report covers the Oral Transmucosal Drugs Market historical market size for years: 2019, 2020, 2021, 2022 and 2023. The report also forecasts the Oral Transmucosal Drugs Market size for years: 2024, 2025, 2026, 2027, 2028 and 2029.
Oral Transmucosal Drugs Industry Report
Statistics for the 2024 Oral Transmucosal Drugs market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. Oral Transmucosal Drugs analysis includes a market forecast outlook to 2029 and historical overview. Get a sample of this industry analysis as a free report PDF download.
