Growth Strategy Shifting Toward the Clinical Stage

In South Korea’s bio industry, a clear trend has emerged toward shifting the center of development to the clinical stage, based on the view that value recovery is limited when candidate compounds are handed off too early. On the ground, domestic clinical research R&D investment has grown to 1.0922 trillion won, but with only a 7.9% chance that a new drug candidate entering Phase 1 clinical trials will ultimately reach final marketing approval, funding and institutional design capable of sustaining programs through later stages have emerged as critical tasks.

For this reason, companies are also hurrying to move away from dependence on a single successful product and toward a structure that advances multiple pipelines into clinical development. Plans for up to three next-generation drug candidates to enter Phase 1 clinical trials next year and the case of the first patient dosing in the global Phase 1b/2 trial 'JET' show that Korean companies are entering a full-scale development phase that goes beyond simple exploration to include combination strategies and indication expansion.

Differentiation Competition Beyond GLP-1

In the obesity and metabolic therapeutics market, the benchmark is shifting away from simple weight-loss competition and toward improving dosing convenience and long-term treatment adherence. The reason Korean companies are focusing on long-acting formulations such as once-monthly dosing or platform businesses at the level of a global blockbuster’s Phase 3 'Dupixent SC' clinical trial is that they are seeking to secure negotiating power through clear usability improvements rather than competing purely on capital strength.

This is because latecomers find it difficult to directly challenge leading companies in the same indications. Focusing on factors that change the treatment experience—such as reducing side effects, combination therapies, and changes in the method of administration—increases the chances of leading to technology transfer or co-development, and can also help Korean companies establish an independent position within the global supply chain.

Development Foundations Reshaped by Data and Testing Systems

As competition in new drug development intensifies, the factors determining success or failure are not just the candidate compounds themselves but also the precision of the data and testing methods used to validate them. This is also the backdrop to the government’s effort to promote AI utilization and the spread of advanced statistical methods through the '2026 Clinical Trials and Research Industry-Academia-Government Joint Statistics Conference', while human-centered experimental platforms such as a biomimetic three-dimensional skeletal muscle microtissue model are being evaluated as a foundation for improving the reliability of early efficacy validation.

These changes are leading toward lower R&D costs and reduced risk of failure. Efforts to promote joint AI and data research even in traditional medicine indicate a growing recognition that, regardless of the industrial field, standardized data, interpretable evidence, and internationally collaborative validation systems are necessary to speed up market entry.

A Shift in Policy Focus

The industry now believes that merely accumulating research capabilities is no longer enough. If clinical execution capabilities do not translate into actual investment and faster patient access, the value created in Korea will be dispersed at the overseas commercialization stage, and demands to accelerate the introduction of new drugs are becoming intertwined with discussions on institutional reform.

Ultimately, the significance of this trend is that Korean biotech is moving from a stage of demonstrating research outcomes to one of trying to control late-stage development and commercialization as well. To support this, government assistance must also shift away from a focus on identifying early-stage projects and toward clinical investment, data infrastructure, and improvements in value assessment and listing systems. Only then can both the negotiating power of Korean companies and patient access be improved together.