[Reporter's Notebook] Conditions for Competitiveness in Korea's Pharmaceutical and Biotech Industries

Transition to a 'Negative Regulatory System'
Must Be Declared a National Future Industry

"China? From now on, we will have to compete with countries like Thailand and India."

Lee Seungkyu, Vice Chairman of the Korea Biotechnology Industry Organization, shared this insight with a reporter at the '2025 BIO International Convention (BIO USA)' held in Boston, United States, on June 16 (local time). This was immediately after he had pointed out at a previous press briefing that "at this rate, the Korean pharmaceutical and biotech industry could lose its competitiveness in as little as three years, or at most five years." He explained that the situation surrounding Korea is becoming increasingly challenging, to the point where we must now keep an eye on latecomers who are catching up rapidly, as China has already raised its pharmaceutical and biotech competitiveness to a level where we need to view it as we do the United States or Europe.

It is difficult to deny the remarkable growth of Korea's pharmaceutical and biotech industries. There are clear grounds for the market consensus that leading companies?such as Samsung Biologics, Celltrion, Yuhan, GC Green Cross, Chong Kun Dang, Hanmi Pharmaceutical, and Daewoong Pharmaceutical?will record double-digit growth in the second quarter of this year. The unusual attention paid by the industry to Samsung Electronics Chairman Lee Jae-yong's recent visit to Samsung Biologics' site in Songdo, Incheon, is rooted in the perception and expectation that "the future of pharmaceuticals and biotech is the future of industry itself."

The problem is how solidly this growth can be maintained, and many experts are raising questions about this. At the BIO USA event, it was not difficult to hear industry insiders express concerns that the momentum allowing companies to drive innovation and for new drug development startups to boldly invest in research and development (R&D) and enter the global market seems to be fading. Specifically, compared to the United States, Europe, or China, many point to excessively rigid and strong regulations as obstacles to growth. Examples include inflexible and traditional regulations applied at stages such as clinical trials after candidate substances are discovered, and the reality that even companies with promising technologies are forced out of the market if they fail to achieve a certain level of sales within a few years.

One of the main solutions proposed to break through the current situation is a fundamental shift to a 'negative regulatory system.' Negative regulation, which allows anything that is not explicitly prohibited, is advantageous for developing new technologies. While many industries argue for its necessity, it is even more urgent in the pharmaceutical and biotech sectors. This is because the combination of powerful regulations with the decade-plus time and hundreds of billions to trillions of won in costs required for new drug development can push countless companies to the brink of survival. At a national level, it is more urgent than ever to clearly declare pharmaceuticals and biotech, alongside artificial intelligence (AI) and semiconductors, as core future industries, and to overhaul the industrial foundation with regulatory innovation at the center.