Oral Transmucosal Drugs Market is projected to reach USD 24,441.4 million by 2030 | Top key players - Pfizer Inc., IntelGenx Corp, Indivior PLC.

Market Size and Growth:

The Global Oral Transmucosal Drugs Market size reached USD 15,005.2 million in 2022 and is projected to witness lucrative growth by reaching up to USD 24,441.4 million by 2030. The market is expected to exhibit a CAGR of 6.4% during the forecast period (2024-2031). The Market is driven by increasing demand for rapid drug absorption, improved patient compliance, and the rising prevalence of chronic and pain-related disorders. According to DataM Intelligence

To Download a Free Sample PDF (Use Corporate email ID to Get Higher Priority) at: https://datamintelligence.com/download-sample/oral-transmucosal-drugs-market?sz

The Oral Transmucosal Drugs Market refers to pharmaceutical formulations administered through the mucosal membranes of the mouth, such as buccal, sublingual, and gingival routes, allowing rapid drug absorption into the bloodstream. This delivery method enhances bioavailability, bypasses the gastrointestinal tract, and offers an effective alternative for patients with swallowing difficulties or requiring quick therapeutic action.

Industry Recent Developments: United States:

✅ October 2025: The U.S. oral transmucosal drugs market continues to grow due to increasing prevalence of neurological disorders like Parkinson's and Alzheimer's, as well as demand for non-invasive, rapid drug delivery systems especially for pain and opioid use disorder management.

✅ September 2025: The oral transmucosal drug market saw robust growth with key drivers including enhanced bioavailability, adoption of formulations such as tablets and films, and innovations in liquid sprays for acute pain, with a projected market size reaching above USD 10 billion.

✅ August 2025: Rising chronic disease burden and need for fast-acting, patient-friendly treatment options are spurring market expansion; major pharma companies invest in oral transmucosal delivery technologies with focus on cardiovascular and acute pain management applications.

Industry Recent Developments: Japan

✅ October 2025: The Japanese oral transmucosal drugs market focuses on addressing chronic health conditions, including cancer and cardiovascular diseases, with increasing adoption of sublingual and buccal formulations for improved patient compliance.

✅ September 2025: Market development in Japan emphasizes innovation in product efficacy and safety, along with growth in personalized medicine approaches using oral transmucosal drug delivery to treat chronic conditions.

✅ August 2025: The oral transmucosal drugs market in Japan benefits from the rising need for non-invasive methods, with segments such as tablets and sublingual administration dominating; ongoing efforts target expanding use in opioid dependence and acute therapeutic areas.

Get Customization in the report as per your requirements + Exclusive Bundle & Multi-User Discounts: https://datamintelligence.com/customize/oral-transmucosal-drugs-market?sz

FDA Approvals in 2025:

✅ Product-specific guidances / PSG activity affecting OTM dosage forms: the FDA published or recommended product-specific guidance documents for buccal/film forms in 2025 (example: a diazepam buccal film PSG recommended May 2025). These PSGs matter because they shape bioequivalence, in-vitro/in-vivo testing and ANDA strategies for OTM generics.

✅ Draft guidances and regulatory attention on bioequivalence and oral dosage forms (CDER activity in 2025 that impacts formulation/bioequivalence approaches used for thin films and transmucosal products). These FDA program/guidance items make generic/ANDA pathways clearer for OTM developers.

Regulatory Approvals (2025):

✅ Europe (EMA): There were orodispersible / film-format approvals and positive regulatory moves in 2025 in Europe (examples reported in 2025 include orodispersible rivaroxaban / other film generics gaining EMA support). These broaden the commercial footprint for OTM products.

Mergers & acquisitions (2025):

✅ Roquette - IFF Pharma Solutions (completed May 1, 2025): Roquette completed the acquisition of IFF's Pharma Solutions business in 2025. this is a major excipient / pharma-solutions M&A that strengthens the excipient, formulation and fill/finish ecosystem used by OTM manufacturers (excipients, film substrates, manufacturing know-how).

✅ Merck (MSD) - Cyprumed licence (Apr 15, 2025): Merck signed a licensing & option agreement with Cyprumed to use its oral peptide delivery platform (deal potentially worth up to ~$493M in milestones). licensing deals like this accelerate oral delivery of peptides and expand technologies that can be combined with thin-film/transmucosal formats.

✅ Industry financing / smaller corporate moves: several thin-film / OTF developers and specialty pharma companies raised financing or closed offerings in 2025 (examples include financings and registered offerings for companies active in thin-film/sublingual markets). These affect commercialization capacity for OTM products.

Major Key Players:

Pfizer Inc.
ZIM Laboratories Limited
Aquestive Therapeutics, Inc
IntelGenx Corp
Indivior PLC
C.L.Pharm Co., Ltd
Seoul Pharmaceuticals
Shilpa Therapeutics
Sunovion Pharmaceuticals, Inc
CURE Pharmaceutical.

Segments Covered in the Oral Transmucosal Drugs Market:

By Product Type: Tablets, Films, Liquids & Spray, Others.

By Indication: Neurological Disorders, Opioid Dependence, Nausea and Vomiting, Erectile Dysfunction, Neurological Disorders.

By Route of Administration: Sublingual Mucosa, Buccal Mucosa, Others.

By Distribution Channel: Hospital Pharmacies, Retail Pharmacies, Online.

Regional Analysis for Oral Transmucosal Drugs Market:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

Looking For Full Report? Get it Here: https://www.datamintelligence.com/buy-now-page?report=oral-transmucosal-drugs-market

Chapter Outline:

⏩ Market Overview: It contains five chapters, as well as information about the research scope, major manufacturers covered, market segments, Oral Transmucosal Drugs market segments, study objectives, and years considered.

⏩ Market Landscape: The competition in the Global Oral Transmucosal Drugs Market is evaluated here in terms of value, turnover, revenues, and market share by organization, as well as market rate, competitive landscape, and recent developments, transaction, growth, sale, and market shares of top companies.

⏩ Companies Profiles: The global Oral Transmucosal Drugs market's leading players are studied based on sales, main products, gross profit margin, revenue, price, and growth production.

⏩ Market Outlook by Region: The report goes through gross margin, sales, income, supply, market share, CAGR, and market size by region in this segment. North America, Europe, Asia Pacific, Middle East & Africa, and South America are among the regions and countries studied in depth in this study.

⏩ Market Segments: It contains the deep research study which interprets how different end-user/application/type segments contribute to the Oral Transmucosal Drugs Market.

⏩ Market Forecast: Production Side: In this part of the report, the authors have focused on production and production value forecast, key producers forecast, and production and production value forecast by type.

⏩ Research Findings: This section of the report showcases the findings and analysis of the report.

⏩ Conclusion: This portion of the report is the last section of the report where the conclusion of the research study is provided.

Unlock 360° Market Intelligence with DataM Subscription Services: https://www.datamintelligence.com/reports-subscription

Frequently asked questions:

➠ What is the global sales value, production value, consumption value, import and export of Oral Transmucosal Drugs market?

➠ Who are the global key manufacturers of the Oral Transmucosal Drugs Industry? How is their operating situation (capacity, production, sales, price, cost, gross, and revenue)?

➠ What are the Oral Transmucosal Drugs market opportunities and threats faced by the vendors in the global Oral Transmucosal Drugs Industry?

➠ Which application/end-user or product type may seek incremental growth prospects? What is the market share of each type and application?

➠ What focused approach and constraints are holding the Oral Transmucosal Drugs market?

➠ What are the different sales, marketing, and distribution channels in the global industry?

Contact Us -
Company Name: DataM Intelligence
Contact Person: Sai Kiran
Email: Sai.k@datamintelligence.com
Phone: +1 877 441 4866
Website: https://www.datamintelligence.com

About Us -
DataM Intelligence is a Market Research and Consulting firm that provides end-to-end business solutions to organizations from Research to Consulting. We, at DataM Intelligence, leverage our top trademark trends, insights and developments to emancipate swift and astute solutions to clients like you. We encompass a multitude of syndicate reports and customized reports with a robust methodology.
Our research database features countless statistics and in-depth analyses across a wide range of 6300+ reports in 40+ domains creating business solutions for more than 200+ companies across 50+ countries; catering to the key business research needs that influence the growth trajectory of our vast clientele.

This release was published on openPR.