Global Oral Transmucosal Drugs Market Insights Forecasts to 2033

• The Global Oral Transmucosal Drugs Market Size was Valued at USD 33.2 Billion in 2023.
• The Market Size is Growing at a CAGR of 6.5% from 2023 to 2033.
• The Worldwide Oral Transmucosal Drugs Market Size is Expected to Reach USD 62.3 Billion by 2033.
• Europe is expected to grow the fastest during the forecast period.

The Global Oral Transmucosal Drugs Market Size is Anticipated to Exceed USD 62.3 Billion by 2033, Growing at a CAGR of 6.5% from 2023 to 2033.

Market Overview

Transdermal drug delivery devices, which transport medications through the skin for therapeutic purposes, are a viable alternative to oral intravascular, subcutaneous, and transmucosal routes. The transmucosal drug delivery system has several advantages over traditional drug administration routes, making it a lucrative market for companies involved in its value chain. One of the most significant advantages of transmucosal medication administration is that it allows pharmaceuticals to avoid the body's natural defense mechanisms. The transmucosal drug delivery devices market is expected to grow during the forecast period as a large target audience may require regular drug delivery devices for diagnosis and treatment. Oral transmucosal drugs provide a more effective and rapid route of administration, making them useful for pain management and certain medical conditions. Furthermore, advances in pharmaceutical formulations and technology have enabled the development of novel oral transmucosal drug products, broadening their applications across a variety of therapeutic areas.

Report Coverage

This research report categorizes the market for the global oral transmucosal drugs market based on various segments and regions forecasts revenue growth and analyzes trends in each submarket. The report analyses the key growth drivers, opportunities, and challenges influencing the global oral transmucosal drugs market. Recent market developments and competitive strategies such as expansion, product launch, and development, partnership, merger, and acquisition have been included to draw the competitive landscape in the market. The report strategically identifies and profiles the key market players and analyses their core competencies in each sub-segment of the global oral transmucosal drugs market.

Driving Factors

The rising prevalence of chronic diseases will be a major driver of market growth. Along with this, the rising incidence of gastrointestinal diseases will accelerate the growth of the transmucosal drugs market. The rising consumption of drugs and therapeutic pharmaceuticals will drive up demand for transmucosal drugs. Furthermore, the increasing adoption of self-injectable devices will have a significant impact on the transmucosal drugs market growth rate. The emergence of various health issues, such as autoimmune diseases and respiratory problems, will boost demand for transmucosal drugs and accelerate the market's growth rate. Another significant factor driving market growth is technological advancement. Furthermore, increased healthcare spending capacity and advancements in healthcare infrastructure are major drivers of market growth. The adoption rate of third-generation transdermal drug delivery systems, such as iontophoresis, will have an impact on the market growth rate for transmucosal drug delivery devices.

Restraining Factors

The disadvantages of oral transmucosal drug delivery are expected to limit the market's growth. Regulatory challenges and approval processes are there which delay process. Also, limited awareness among healthcare professionals and patients may hamper the market growth during forecast period. Potential side effects or adverse reactions also hindering market growth.

Market Segmentation

The global oral transmucosal drugs market share is classified into product type, route of administration, indication and distribution channel.

• The tablets segment is expected to hold the largest share of the global oral transmucosal drugs market during the forecast period.   

Based on the product type, the global oral transmucosal drugs market is categorized into tablets and films. Among these, the tablets segment is expected to hold the largest share of the global oral transmucosal drugs market during the forecast period. Tablets are widely used for medication administration due to their ease of use and familiarity among patients. Drug absorption has become more convenient and efficient thanks to innovations such as quick-dissolving tablets in the mouth. Tablets are widely used to treat a variety of medical conditions, including pain, and doctors prescribe them for both clinical and home use. Tablets' solid form and adaptability to various drug formulations have made them popular among drug manufacturers and healthcare providers, contributing to their market dominance.

• The sublingual mucosa segment is expected to hold a significant share of the oral transmucosal drugs market during the forecast period.   

Based on the route of administration, the global oral transmucosal drugs market is categorized into sublingual mucosa, buccal mucosa, and others. Among these, the sublingual mucosa segment is expected to hold the largest share of the global oral transmucosal drugs market during the forecast period. Sublingual drugs deliver medicine faster and more efficiently than other methods. They work by being absorbed through blood vessels, which have a large blood supply and a thin mucosa, allowing drugs to enter the bloodstream more quickly. This makes sublingual drugs especially useful for treating acute medical conditions, such as pain, where prompt relief is required. With ongoing advancements in research and technology in this industry, the sublingual mucosa segment is expected to continue to lead the oral transmucosal medicines market. Millions of people in the United States depend on heroin. To address this, oral transmucosal drugs, including sublingual medications, have proven to be effective at delivering medication to people suffering from opioid dependence.

• The opioid dependence segment is expected to grow at fastest CAGR growth of the oral transmucosal drugs market during the forecast period.   

Based on the indication, the global oral transmucosal drugs market is categorized into opioid dependence, nausea and vomiting, erectile dysfunction, neurological disorders, and others. Among these, the opioid dependence segment is expected to hold the largest share of the global oral transmucosal drugs market during the forecast period. This growth is due to the rising prevalence of opioid addiction and the demand for more advanced and effective treatment. In July 2023, the National Institutes of Health (NIH) published a research article highlighting the growing issues of opioid use disorder (OUD) and addiction in the US and around the world. It was discovered that approximately three million people in the United States and six million people worldwide have experienced OUD. Furthermore, approximately half a million Americans rely on heroin. To address this, oral transmucosal drugs, including sublingual medications, have proven to be effective at delivering medication to people suffering from opioid dependence. These drugs allow for rapid drug absorption through the thin mucosa under the tongue, providing quick relief from withdrawal symptoms while lowering the risk of relapse.

• The hospital pharmacies segment is expected to hold the substantial growth of the oral transmucosal drugs market during the forecast period.   

Based on the distribution channel, the global oral transmucosal drugs market is categorized into hospital pharmacies, retail pharmacies, and online pharmacies. Among these, the hospital pharmacies segment is expected to hold the largest share of the global oral transmucosal drugs market during the forecast period. Hospital pharmacies distribute medications, including oral transmucosal drugs, and provide pharmaceutical services. Healthcare professionals rely on these pharmacies to provide medications to patients in a safe and closely monitored environment. They serve a diverse patient population, including those with acute medical conditions, making them an important channel for managing their medication requirements. This critical role positions hospital pharmacies as the dominant distributors of oral transmucosal drugs.

Regional Segment Analysis of the Global Oral Transmucosal Drugs Market

• North America (U.S., Canada, Mexico) 
• Europe (Germany, France, U.K., Italy, Spain, Rest of Europe)
• Asia-Pacific (China, Japan, India, Rest of APAC)
• South America (Brazil and the Rest of South America) 
• The Middle East and Africa (UAE, South Africa, Rest of MEA)

North America is anticipated to hold the largest share of the global oral transmucosal drugs market over the predicted timeframe.

North America is projected to hold the largest share of the global oral transmucosal drugs market over the forecast period. The high prevalence of Parkinson's, Alzheimer's, and dysphagia among target populations contributes to the growth. Furthermore, the market benefits from an increasing geriatric population and a strong willingness to adopt novel oral transmucosal medications. North America's market growth is also aided by proactive regional players and the availability of medications to treat opioid use disorders, according to a 2022 Stat Pearls article. It highlighted the ongoing global opioid use disorder and addiction crisis. Furthermore, notable developments, such as Aquestive Therapeutics, Inc.'s acceptance of a new drug application for Libervant by the US FDA in July 2021, are expected to support the market's growth in the region.

The Europe market is expected to grow at the fastest CAGR growth around 29% during the forecast period due to the existence of a large population suffering from stress and mental conditions. The market in Europe is being driven by increased demand for pain management and active regional market participants. For instance, in September 2022, Aquestive Therapeutics, Inc., a pharmaceutical company that develops drugs to solve patients' problems with current standards of care and provides transformative products to improve their lives, announced that it had entered into a license and supply agreement with Pharmanovia for Libervant (diazepam) Buccal Film. This agreement enables Pharmanovia to market Libervant (diazepam) Buccal Film in the European Union, the United Kingdom, and other countries.

Competitive Analysis:

The report offers the appropriate analysis of the key organizations/companies involved within the global oral transmucosal drugs market along with a comparative evaluation primarily based on their product offering, business overviews, geographic presence, enterprise strategies, segment market share, and SWOT analysis. The report also provides an elaborative analysis focusing on the current news and developments of the companies, which includes product development, innovations, joint ventures, partnerships, mergers & acquisitions, strategic alliances, and others. This allows for the evaluation of the overall competition within the market.

List of Key Companies

• ZIM Laboratories Limited
• Sunovion Pharmaceuticals, Inc
• C.L.Pharm Co., Ltd
• IntelGenx Corp
• CURE Pharmaceutical
• Seoul Pharmaceuticals
• Aquestive Therapeutics, Inc
• Jazz Pharmaceuticals, plc
• NAL Pharma
• Novartis AG
• Pfizer Inc
• Teva Pharmaceutical Industries Limited
• Others

Key Target Audience

• Market Players
• Investors
• End-users
• Government Authorities 
• Consulting And Research Firm
• Venture capitalists
• Value-Added Resellers (VARs)

Recent Developments

• In October 2023, atai Life Sciences successfully completed a Phase 1 study on VLS-01, an innovative oral transmucosal film (OTF) that contains DMT. The study found that VLS-01 is well tolerated and has a good safety profile among healthy participants.

• In May 2022, ZIM Laboratories Limited's European subsidiary, SIA ZIM Laboratories Limited, has received marketing authorization from AEPMS for "Sildenafil 50 mg" ODS in Spain.

Market Segment

This study forecasts revenue at global, regional, and country levels from 2020 to 2033. Spherical Insights has segmented the global oral transmucosal drugs market based on the below-mentioned segments: 

Global Oral Transmucosal Drugs Market, By Product Type

• Tablets
• Films

Global Oral Transmucosal Drugs Market, By Route of Administration

• Sublingual mucosa
• Buccal mucosa
• Others

Global Oral Transmucosal Drugs Market, By Indication

• Opioid dependence
• Nausea and vomiting
• Erectile dysfunction
• Neurological disorders
• Others

Global Oral Transmucosal Drugs Market, By Distribution Channel

• Hospital pharmacies
• Retail pharmacies
• Online pharmacies

Global Oral Transmucosal Drugs Market, Regional Analysis

• North America
  • US
  • Canada
  • Mexico
• Europe
  • Germany
  • Uk
  • France
  • Italy
  • Spain
  • Russia
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Australia
  • Rest of Asia Pacific
• South America
  • Brazil
  • Argentina
  • Rest of South America
• Middle East & Africa
  • UAE
  • Saudi Arabia
  • Qatar
  • South Africa
  • Rest of the Middle East & Africa