Oral Transmucosal Drugs Market to Reach USD 24.44 Billion by 2031, United States Is Leading
Stay ahead in pharma: 2025 Oral Transmucosal Drugs Market growth, innovations, and revenue opportunities.
Oral Transmucosal Drugs Market in the USA was valued at USD 15,005.2M in 2022 and is projected to reach USD 24,441.4M by 2030 at 6.4% CAGR.”
AUSTIN, TX, UNITED STATES, October 3, 2025 /EINPresswire.com/ -- Market Size and Growth— DataM Intelligence
The Oral Transmucosal Drugs Market Size is on a strong growth trajectory, valued at USD 15,005.2 million in 2022 and projected to reach USD 24,441.4 million by 2030, expanding at a CAGR of 6.4% during 2024–2031. This growth reflects rising demand for non-invasive, fast-acting, and patient-friendly drug delivery systems for critical conditions including neurological disorders, opioid dependence, and acute pain management.
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The oral transmucosal route-administered via sublingual and buccal mucosa-offers significant advantages: rapid absorption, avoidance of first-pass metabolism, and enhanced patient compliance. From opioid dependence therapy to emergency migraine relief, erectile dysfunction treatments, and nausea control, oral transmucosal drugs are becoming the go-to therapeutic solution.
Regulatory approvals, rising adoption in hospitals, and growing online pharmacy penetration are accelerating the market, particularly in the U.S. and Japan.
Market Segmentation Insights
By Product Type
Tablets remained the dominant segment in 2022, contributing 45% of total revenues (USD 6.7 billion). Their convenience, stability, and precise dosage control make them highly preferred across indications.
Films, valued at USD 3.9 billion in 2022, are growing fastest, especially in psychiatric and neurological indications where ease of administration enhances compliance.
Liquids & Sprays accounted for USD 2.8 billion, driven by their use in emergency settings for nausea and opioid overdose. Other delivery formats, including lozenges and buccal patches, contributed USD 1.6 billion.
By Indication
Neurological disorders accounted for 40% of the market in 2022 (USD 6.0 billion). Rising cases of epilepsy, Alzheimer’s, and acute migraine have accelerated adoption of transmucosal formulations.
Opioid dependence treatments generated USD 4.1 billion in 2022. Drugs such as buprenorphine sublingual tablets are key drivers in the U.S., where the opioid crisis continues to demand rapid-access therapies.
Nausea and vomiting applications, valued at USD 2.1 billion, are widely used in oncology supportive care and surgical recovery.
Erectile dysfunction treatments, contributing USD 1.2 billion, are gaining traction with novel buccal and sublingual PDE-5 inhibitors offering faster onset compared to oral tablets.
By Route of Administration
Sublingual mucosa remained the largest route, valued at USD 8.3 billion in 2022. Rapid systemic absorption makes it ideal for neurological and pain therapies.
Buccal mucosa accounted for USD 5.6 billion, growing at a strong pace due to new product launches in oncology support care.
Other routes represented USD 1.1 billion.
By Distribution Channel
Hospital pharmacies accounted for USD 7.2 billion in 2022, owing to strong adoption for opioid overdose reversal and acute neurological treatments.
Retail pharmacies contributed USD 4.5 billion, led by chronic disease prescriptions for erectile dysfunction and neurological conditions.
Online pharmacies, valued at USD 3.3 billion, are the fastest-growing channel, driven by patient preference for discreet access to therapies, particularly in the U.S. and Japan.
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Regional Insights:
United States
The U.S. market, valued at USD 7.5 billion in 2022, dominates due to:
• High burden of neurological diseases (over 5.8 million Alzheimer’s patients).
• Strong adoption of buprenorphine sublingual therapies for opioid dependence.
• Expanding FDA approvals for oral transmucosal drugs across pain, psychiatry, and emergency care.
• Recent update (2025): Aquestive Therapeutics received FDA clearance for its sublingual film targeting epilepsy, strengthening the U.S. neurology portfolio.
Japan
Japan’s market, valued at USD 1.8 billion in 2022, is growing rapidly due to:
• An aging population with increasing cases of neurological disorders and oncology patients.
• Government support for innovative drug delivery systems.
• Recent highlight (2025): ZIM Laboratories and a Japanese partner launched co-developed buccal films for nausea management, improving access in oncology support therapy.
Industry Trends & 2025 Developments
• Shift to Films & Sprays: Ease of use, especially among geriatric and pediatric patients, is making films and sprays the fastest-growing delivery formats.
• Digital Integration: AI-driven adherence platforms are being bundled with transmucosal therapies for chronic conditions.
• Focus on Addiction Medicine: Rising opioid dependence is fueling investments in novel buccal and sublingual formulations.
• Global Collaborations: In 2025, Pfizer entered a strategic agreement with IntelGenx Corp to co-develop psychiatric transmucosal therapies targeting treatment-resistant depression.
• M&A Wave: Specialty pharma companies are acquiring formulation startups to expand product pipelines.
Competitive Landscape: Key Players
Pfizer Inc.
Pfizer leads with a broad transmucosal portfolio in neurology and pain. Its recent partnerships aim to expand buccal film applications in psychiatric care.
Aquestive Therapeutics, Inc.
Aquestive generated USD 450 million in 2024 from sublingual film products. The company is a pioneer in epilepsy and opioid dependence treatments.
IntelGenx Corp
IntelGenx focuses on film-based drug delivery platforms and has strategic partnerships with Pfizer and Johnson & Johnson.
Indivior PLC
A leader in opioid dependence therapies, Indivior reported USD 1.1 billion in 2024 revenues from buprenorphine sublingual formulations.
ZIM Laboratories Limited & C.L. Pharm
Both companies specialize in film-based generics, expanding aggressively in Asia, including Japan’s oncology segment.
Strategic Outlook
The Oral Transmucosal Drugs Market will continue expanding as patient demand for rapid-acting, non-invasive drug delivery systems rises. Strategic imperatives include:
1. Neurological Disorder Expansion – Accelerating development of transmucosal therapies for epilepsy, Alzheimer’s, and migraine.
2. Addiction Medicine Leadership – Strengthening buccal and sublingual drug pipelines for opioid crisis management.
3. Technological Differentiation – Films, sprays, and AI-supported adherence platforms will dominate future adoption.
4. Regional Growth – The U.S. remains the largest market, while Japan’s precision medicine ecosystem is fueling innovation.
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Conclusion
The global Oral Transmucosal Drugs Market, projected to grow from USD 15,005.2 million in 2022 to USD 24,441.4 million by 2030, is redefining drug delivery innovation. With the U.S. setting the pace in neurology and opioid dependence therapies and Japan driving innovation in oncology support care, this market presents compelling opportunities for investors, pharmaceutical leaders, and healthcare providers.
DataM Intelligence remains the trusted source of authoritative market insights, empowering executives with quantitative clarity and strategic foresight in the fast-evolving drug delivery landscape.
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Sai Kiran
DataM Intelligence 4Market Research LLP
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