Samil PwC: "Now Is the Right Time for Korean Bioindustry to Achieve Global Competitiveness... Strategic Ecosystem Needed"

Strategic Report on Structural Transformation of the Bioindustry
"Building an Integrated Ecosystem through Government, Private Sector, and Academia Collaboration"

The bioindustry is establishing itself as a core sector of national strategy, going beyond healthcare, amid a complex environment shaped by the restructuring of global supply chains, domestic regulatory reforms, and technological hegemony competition. As major countries around the world accelerate their structural transitions, there are calls for South Korea to build a strategic ecosystem that connects technology, markets, and policy.

On the 18th, Samil PwC announced the publication of its report, "Golden Time for K-Bio: Strategic Transition Model Learned from Japanese Structural Design." This report was prepared to present strategic directions for the Korean bioindustry to become a globally competitive sector.

The report defines the bioindustry not simply as a technological field but as a national strategic industry, focusing on the cases of major countries such as the United States, the European Union (EU), and Japan, which are fostering it as a future growth engine. In particular, it evaluated that Japan has established a structural ecosystem spanning from basic research to clinical trials, commercialization, and global expansion through strategies led by large corporations and a comprehensive government support system. Notable achievements cited as results of this strategic approach include Daiichi Sankyo’s "Enhertu," the leading product in the antibody-drug conjugate (ADC) market; "Leqembi," an Alzheimer’s treatment developed through a global partnership with Biogen in the United States; and Astellas’ acquisition of Iveric Bio.

The report assessed that the Korean government has created the conditions for the industry’s advancement by establishing institutional foundations such as ▲ shortening the new drug review period (from 360 days to within 240 days), ▲ preparing guidelines for advanced regenerative medicine, and ▲ expanding the use of medical data. It also analyzed that moves to build a strategic ecosystem led by large corporations are beginning, as seen in SK Biopharmaceuticals’ success in new drug development, Samsung’s spin-off and listing of its biosimilar unit and establishment of a new drug development subsidiary, and Celltrion’s ADC-based pipeline. However, it pointed out that "high-risk and high-cost technological areas such as cell and gene therapies and RNA-based therapeutics are still mainly driven by venture companies, so broader private sector participation and leadership are now required."

The report stated, "Now is the right timing for the Korean bioindustry to achieve structural transformation and secure global competitiveness," and proposed strategic measures to enhance industrial competitiveness. First, at the government level, it suggested reviewing the establishment of a full-cycle funding support system connecting basic research, clinical trials, and commercialization, as well as expanding policy finance tools to mitigate risks for private capital. It emphasized that companies should strengthen investment in late-stage clinical trials and global approval strategies, and seek strategic entry through mergers and acquisitions (M&A) and technology internalization with promising bio ventures.

Finally, the report added that academia and hospitals need to work together to build the foundation for industry-wide innovation by expanding hospital-centered clinical trial networks, establishing systems for technology transfer between basic research and clinical practice, and operating AI-based collaborative research platforms to enhance data-driven clinical design and predictive capabilities.

Suh Yongbeom, Partner and Leader of the Pharmaceutical and Bioindustry at Samil PwC, stated, "Now, as government regulatory support and strategic investments by large corporations are gaining momentum, is the golden time for the Korean bioindustry to secure global competitiveness." He added, "If the government, companies, and academia cooperate to build an integrated ecosystem by benchmarking Japan’s successful cases, structural transformation and global advancement of K-Bio will be possible."

This content was produced with the assistance of AI translation services.