Exposure of Bottlenecks in Clinical Competition

Domestic new drug development and investment in Korea by global pharmaceutical companies continue to increase, and last year the total R&D investment related to domestic clinical research by global pharmaceutical companies operating in Korea reached KRW 1.0922 trillion. However, at the operational front where development speed is determined, 53% of Phase 2 and 3 clinical trials were delayed, showing that patient recruitment difficulties, the burden on trial institutions, and procedural complexity are all rising at once, revealing a structure in which increased investment does not immediately lead to stronger competitiveness.

In this environment, even companies with promising candidate materials face greater financial pressure. Cases such as Voronoi, which is conducting clinical trials across 29 sites in 10 countries, show that even when early outcomes are favorable, the longer a company continues self-development, the more costs and operational burden grow together, ultimately shifting the landscape toward one in which more refined decisions must be made about clinical trial design and the timing of technology transfers.

China’s Rise and Korea’s Response Tasks

In the global technology in-licensing market, the presence of Chinese companies is expanding rapidly. Behind the increase in overseas technology exports from 94 cases in 2024 to 157 in 2025 lies not only competitiveness in next-generation platforms such as antibody-drug conjugates and multispecific antibodies, but also an industrial foundation in which large patient pools, clinical networks, and financing structures are organically linked.

Korea is also producing achievements such as technology exports for rare disease treatments worth up to KRW 630 billion, and late-stage development targeting growing domestic markets, such as new drugs for gastroesophageal reflux disease, is also progressing. However, it has become clearer that individual deals or clinical successes alone are not enough, and that creating persuasive data in early-stage trials and accelerating global business development are necessary to slow the widening gap with China.

Standardization and Security Becoming Industrial Competitiveness

The government and industry now see not only research outcomes but also the very way data is handled as a core element of competitiveness. In manufacturing, KRW 115.8 billion was included in the 2027 government budget proposal to build a national manufacturing data foundation equipped with standardization and security systems. Conversely, in the clinical administrative sphere, an incident involving the leak of personal information affecting 1,195 people confirmed that failures in data management can directly damage trust.

For this reason, standardization is expanding beyond simple administrative reorganization into a foundation for building market trust. Moves in the diagnostic field to establish standard testing methods for seven test items to improve consistency in test values, as well as measures in the art market to unify appraisal certificate formats and required entries, show that even across different sectors, the trend of the state setting clearer standards for transactions and judgment is growing stronger.

Verification Systems Take Priority Over Efficacy Claims

The criteria for judging the value of products or treatments are also shifting from efficacy promotion to verification-centered systems. Cases such as the suspension of new administration of a vasculitis treatment in Japan, and concerns raised in the National Assembly over pharmacopuncture that does not go through MFDS product approval or clinical trials, show that if clinical evidence and management responsibility are unclear, market entry can still be halted even after launch.

The same standards are being applied in consumer goods and healthcare devices. While strategies are being strengthened to prove functionality through test results such as eliminating 99.99% of harmful bacteria for products like mouthwash, in beauty devices, expressions such as proven facial skin lifting effects can become problematic if they exceed the actual scope of verification. Going forward, what matters more as a competitive factor will be not what is claimed, but what evidence and procedures are used to prove it.