Oral Transmucosal Drugs Market Size

Oral Transmucosal Drugs Market was valued at around USD 34.3 billion in 2023 and is expected to register a CAGR of 6.7% during the forecast period. The market is expected to experience growth driven by the increasing prevalence of chronic diseases coupled with the rising demand for oral transmucosal drugs.

The increasing prevalence of chronic diseases presents a significant concern, as an increasing number of individuals grapple with persistent health conditions that are typically incurable. Factors such as genetic predisposition, sedentary lifestyles, and an aging population, among others, are contributing to this trend. According to the Centers for Disease Control and Prevention (CDC), chronic diseases like heart disease, cancer, and diabetes are the primary causes of death and disability in the U.S., accounting for a substantial portion of the nation's annual healthcare expenditure, estimated at USD 4.1 trillion. In 2021, coronary heart disease (CHD) alone claimed 375,476 lives in the U.S., establishing it as the most prevalent form of heart disease. Consequently, the rising prevalence of chronic diseases is expected to drive growth in the oral transmucosal drugs market.

Oral transmucosal drugs are medications designed to be administered through the mucous membranes lining the mouth. This route of administration allows for rapid absorption of the drug into the bloodstream, bypassing the gastrointestinal tract and avoiding first-pass metabolism in the liver.

Oral Transmucosal Drugs Market Trends

Advancements in drug delivery technologies have revolutionized the field of medicine, offering more efficient and targeted ways to administer medications.

• PLGA (poly lactic-co-glycolic acid) enhancers in implantable drug delivery systems (IDDS), represent a novel drug delivery systems technology, offering enhanced drug delivery capabilities. PLGA/PEG blend microparticles have been developed to serve as delivery enhancers in implantable drug delivery systems. These microparticles enable the controlled and sustained release of therapeutic agents, enhancing the efficacy and precision of drug delivery within the body, as a result increases the demand of oral transmucosal drugs.
  
• Additionally, needle-free drug delivery technologies are gaining traction, offering alternatives to traditional injections. Companies like PharmaJet and NovaXS are pioneering needle-free systems for vaccine and therapeutic delivery. For instance, the Biojector 2000 is a professional-grade needle-free injection system designed for healthcare providers, capable of delivering intramuscular, subcutaneous, and intradermal injections. Such technological advancements are gaining the attention of healthcare professionals resulting in its increasing demand in the market.
  

Oral Transmucosal Drugs Market Analysis

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Based on product type, market is segmented into tablets, films, liquid & spray, and other product types. The tablets segment held leading revenue share in 2023 and is anticipated to reach USD 30.1 billion by 2032.

• The convenience and ease of administration offered by tablets contribute significantly to improved patient compliance in the oral transmucosal drugs industry. Tablets designed for oral transmucosal delivery provide a user-friendly method that is more readily accepted by patients. This ease of use encourages adherence to prescribed medication regimens, reducing the likelihood of non-compliance. The patient-friendly nature of tablets enhances the overall treatment experience, promoting better medication adherence and contributing to favorable clinical outcomes.  
  
• Moreover, the oral transmucosal route, utilizing tablets, allows for direct drug entry through the mucous membranes in the mouth, ensuring a swift onset of action. This immediate absorption is particularly advantageous for medications requiring a quick and effective response, such as pain relief or emergency treatments. Patients benefit from the efficiency of tablets in delivering drugs through the oral mucosa, enhancing the overall therapeutic outcomes. Due to such advantages the segment is anticipated to grow over the forecast period.
  

Based on route of administration, the oral transmucosal drugs industry is segmented into sublingual mucosa, buccal mucosa, and other route of administrations. The sublingual mucosa segment held leading revenue share in 2023 and is anticipated to reach USD 29.6 billion by 2032.

• By bypassing the liver's first-pass metabolism, sublingual administration can increase drug bioavailability compared to oral administration. This can lead to more effective therapeutic outcomes with lower doses of medications, anticipating it as more preferred option by the patients and health professionals.  
  
• Additionally, sublingual medications can be formulated in various dosage forms, including tablets, films, sprays, and powders, offering flexibility to pharmaceutical manufacturers and healthcare providers to tailor formulations to patient needs and preferences, contributing to the market growth positively.
  

The oral transmucosal drugs market by indications is categorized into opioid dependence, nausea and vomiting, erectile dysfunction, neurological disorders, and other indications. The opioid dependence segment dominates the market with the revenue around USD 12.2 billion in 2023.

• The opioid epidemic has resulted in a significant increase in the number of individuals affected by opioid use disorder. This growing patient population creates a demand for effective medications and treatment options to help manage opioid withdrawal symptoms and cravings.   
  
• Moreover, pharmaceutical companies are continuously developing new medications and treatment modalities for opioid dependence. These include opioid agonists, partial agonists, and antagonists, as well as combination therapies that target different aspects of opioid dependence. The availability of a broader range of treatment options allows healthcare providers to tailor treatment plans to individual patient needs, driving the segmental growth.
  
  

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The global market by distribution channel is categorized into hospital pharmacies, retail pharmacies, and online pharmacies. The hospital pharmacies segment dominates the market with the revenue around USD 15.3 billion in 2023.

• Hospitals and pharmacies serve as central points where patients receive medical care and obtain their prescribed medications. They have direct access to patients who may require oral transmucosal drugs for various medical conditions. This increased access to patients makes the hospital pharmacies the prominent distributer of the oral transmucosal drugs.
  
• Moreover, hospitals and pharmacies have facilities equipped to store oral transmucosal drugs under appropriate conditions to maintain their stability and integrity. They adhere to strict guidelines and regulations for the storage and handling of medications to ensure their safety and efficacy. Hence, driving the growth of market.
  

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North America oral transmucosal drugs market accounted for USD 13.5 billion revenue in 2023 and is predicted to witness substantial market growth over the analysis timeline.

• The increasing prevalence of diabetes in North America, notably in the U.S., has reached significant proportions. According to the CDC, the total number of individuals affected by diabetes in the U.S. stands at 38.4 million, representing 11.6% of the population. Among them, 29.7 million have received a formal diagnosis, while an additional 8.7 million individuals remain undiagnosed. This surge in the anticipated affected population underscores the increasing demand for oral transmucosal drugs in the region
  
• Furthermore, regulatory agencies in North America, such as the U.S. Food and Drug Administration (FDA) and Health Canada, provide support for the development, approval, and marketing of oral transmucosal drugs. Favorable regulatory environments encourage pharmaceutical companies to invest in research and development of these medications, further fueling demand.
  

Oral Transmucosal Drugs Market Share

The oral transmucosal drugs industry is fragmented in nature, with several large multinationals and small and mid-sized companies competing in the industry. The development and launch of novel advanced product based on different technologies is among a key market strategy.

Oral Transmucosal Drugs Market Companies

Some of the eminent market participants operating in the oral transmucosal drugs industry include:

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

Oral Transmucosal Drugs Industry News:

• In October 2023, Aquestive Therapeutics, Inc., received the FDA approval on its pivotal Phase 3 pharmacokinetic (PK) clinical study protocol for Anaphylm (epinephrine) sublingual film. This approval is expected to improve the company’s reputation in the market and enhance its product offerings.
  
• In May 2022, ZIM Laboratories announced the grant of marketing authorization for 'Sildenafil 50 mg' in Spain, Europe. This strategy expanded the company’s market reach and enhanced its business revenue.
  

Oral transmucosal drugs market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2018 to 2032 for the following segments:

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Market, By Product Type

• Tablets
• Films
• Liquid & spray
• Other product types

Market, By Route of Administration 

• Sublingual mucosa
• Buccal mucosa
• Other routes of administration

Market, By Indication 

• Opioid dependence
• Nausea and vomiting
• Erectile dysfunction
• Neurological disorders
• Other indications

Market, By Distribution Channel 

• Hospital pharmacies
• Retail pharmacies
• Online pharmacies

The above information is provided for the following regions and countries:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • Australia
  • South Korea
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Rest of Latin America
• Middle East and Africa
  • Saudi Arabia
  • South Africa
  • UAE
  • Rest of Middle East and Africa