Microsphere Patent Race Heats Up for Key Obesity Drug Technology

A fierce patent war is raging among domestic and international pharmaceutical companies over 'microspheres,' the core technology for obesity treatments. This technology is crucial for developing long-acting formulations that enhance patient convenience and maintain drug efficacy for extended periods, allowing for injections perhaps only once a month.

The market for GLP-1 based obesity and diabetes drugs is projected to grow to $100 billion (approximately 151 trillion won) by the mid-2030s, driven by the launch of new drugs like 'Wegovy' and 'Mounjaro.' Microsphere technology, which enables shorter injection intervals, serves as the backdrop for fierce competition among domestic pharmaceutical companies, driven by the massive global market size and high technical barriers.

Microsphere formulation development is notoriously difficult, with only a dozen or so cases receiving U.S. FDA approval since 1989 due to the high technical hurdles, including the complexity of elucidating drug release mechanisms. The key to microsphere technology is to slowly and steadily release the drug, maintaining blood concentration stably within the therapeutic range. However, the manufacturing of microspheres and their drug release mechanisms are not yet fully understood, leading to many development challenges. In particular, the 'initial burst release' problem, where a large amount of the drug is released all at once at the beginning, can not only hinder drug longevity but also threaten safety. For GLP-1, a peptide component that dissolves easily in water, it tends to migrate towards the outside of the microsphere, making it even more challenging to evenly encapsulate the drug and control initial release. Due to these technical difficulties, there are reportedly very few generic microsphere drugs currently on the market.

Pharmaceutical companies are focusing intently on developing microsphere technology. In the past two years, eight domestic patent applications related to microspheres have been filed, with G2G Bio and Owl Bio noted as having submitted multiple applications. Peptron, Nexpharm Korea, Dongkook Pharmaceutical, and HLB Pharmaceutical appear to be pursuing microsphere technology patents targeting next-generation obesity and diabetes drugs like semaglutide and tirzepatide. HLB Pharmaceutical has filed patents that compensate for weaknesses in existing ones, while G2G Bio has expanded its focus to next-generation drugs and secured patent registrations. The technological developments by these companies hold the potential to expand beyond the domestic market into overseas markets. The patent competition surrounding microspheres, characterized by a large market size and high technical barriers, is expected to continue.