Core Insights - BioNxt Solutions Inc. is addressing the significant issue of dysphagia, which affects up to 40% of adults and is particularly prevalent in autoimmune disease patients, impacting treatment adherence and therapeutic success [1][3][7] - The company has developed a proprietary rapid-dissolving thin-film drug delivery platform, recently securing its first national patent, which is a crucial step towards commercialization in high-value autoimmune markets [2][8] Market Opportunity - The global market for Multiple Sclerosis (MS) drugs is projected to reach approximately USD 40-45 billion by 2033, while the Myasthenia Gravis (MG) treatment market is expected to grow to between USD 2.7-4.7 billion by 2032 [4] - BioNxt's thin-film technology offers a swallow-free and needle-free alternative, addressing the challenges posed by large tablets and injectable therapies for autoimmune patients [5][6] Product Development - The thin film formulation melts rapidly under the tongue, allowing for improved absorption and bioavailability, which is particularly beneficial for chronic autoimmune conditions [6][11] - BioNxt has completed GMP clinical batch manufacturing for its product BNT23001 and is preparing for a comparative human bioequivalence study in early 2026, anticipating an accelerated regulatory pathway due to the existing approval of cladribine tablets [9][10] Intellectual Property and Scalability - The newly granted Eurasian patent for BNT23001 protects a proprietary sublingual cladribine film, covering over 200 million people across eight member states, and is part of BioNxt's expanding global IP estate [8][11] - The company's thin-film technology is designed to be scalable, allowing for the reformulation of multiple approved drugs across various autoimmune and chronic disease markets, projected to exceed USD 75-80 billion annually over the next decade [11][13] Industry Trends - The oral transmucosal drug-delivery market is expected to grow from approximately USD 45.8 billion in 2025 to nearly USD 96.8 billion by 2033, indicating a shift towards patient-friendly drug delivery formats [13]