경구 경점막 약물 시장 : 시장 점유율 분석, 산업 동향 및 통계, 성장 예측(2025-2030년)

The Oral Transmucosal Drugs Market size is estimated at USD 17.69 billion in 2025, and is expected to reach USD 24.52 billion by 2030, at a CAGR of 6.75% during the forecast period (2025-2030).

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.

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

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
• 4.2 Market Drivers
  • 4.2.1 Growing Burden of Target Diseases
  • 4.2.2 Rise in R&D Activities and Product Launches
• 4.3 Market Restraints
  • 4.3.1 Disadvantages Associated With Oral Transmucosal Drug Delivery
• 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)

• 5.1 By Product Type
  • 5.1.1 Tablets
  • 5.1.2 Films
  • 5.1.3 Liquid & Spray
  • 5.1.4 Others
• 5.2 By Route of Administration
  • 5.2.1 Sublingual Mucosa
  • 5.2.2 Buccal Mucosa
  • 5.2.3 Others
• 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
• 5.4 By Distribution Channel
  • 5.4.1 Hospital Pharmacies
  • 5.4.2 Retail Pharmacies
  • 5.4.3 Online Pharmacies
• 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

• 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.

7 MARKET OPPORTUNITIES AND FUTURE TRENDS