AI, Supply Chain Restructuring, Obesity Treatments... Five Key Hot Issues in K-Bio

This year, the bio industry is expected to reach a turning point as supply chains, policies, and technologies are simultaneously restructured.

According to the "2026 Bio Industry Outlook Report" compiled by the Korea Bio-Economy Research Center under the Korea Biotechnology Industry Organization on January 20, the catalyst for the change in the global bio order is the U.S. Biosecure Act, which took effect in December of last year. As restrictions on transactions with Chinese bio companies become a reality, the U.S. policies on pharmaceutical tariffs and drug price reductions are accelerating the redesign of supply chains for drug substances (DS) and drug products (DP). This is expected to intensify competition for securing "alternative production bases" and strategic partners among companies in Korea, India, Japan, and Europe. At the same time, China is accelerating the formation of a tripolar structure with the U.S. and Europe by boosting its new drug development and clinical capabilities through government-led bioindustry promotion and expanded investment in R&D. The report pointed out that the scale of technology transfers in China's biopharmaceutical sector surged from 94 cases worth 51.9 billion dollars (approximately 7.65 trillion yen) in 2024 to 150 cases worth 130 billion dollars (approximately 19.1 trillion yen) last year.

Domestically, the policy environment is also shifting its focus to bio from the perspective of "national growth strategy." The government is fostering the bio industry as a national strategic sector, speeding up policy implementation through integrated governance, and plans to strengthen support for global expansion by launching the National Bio Innovation Committee under the Prime Minister's Office, which will shorten approval and review periods. The "15 Leading Projects for Ultra-Gap Innovation," which include regulatory exemptions for data utilization and the creation of a clinical phase 3 specialized fund, have also been proposed as pillars to support the early achievement of results, particularly for mega bio projects.

From a market perspective, obesity treatments and contract development and manufacturing organizations (CDMOs) are expected to remain at the center of growth this year. With the GLP-1 (glucagon-like peptide-1) based obesity market projected to grow at an average annual rate of 20% through 2030, competition-centered on injectable formulations-is expanding into oral and long-acting formulations, making technological, clinical, and supply capabilities key variables for success. Increased production demand due to expanded new drug clinical trials and pipelines, capacity expansion based on long-term contract structures, and trends such as the expiration of original drug patents and diversification of production bases are cited as factors reshaping the competitive landscape of the CDMO market. For Korean companies, these policy changes are seen as an opportunity to establish a foundation for global competitiveness.

The key to industrial transformation is "Bio×AI." The report notes that AI is now a "basic infrastructure" rather than an option, with its application rapidly spreading across the entire new drug development value chain. The adoption of AI is expected to become an even clearer inflection point this year, widening the gap in productivity and success rates between companies. The use of simulations and data models to supplement or replace animal testing, as well as for clinical design, patient selection, and success rate prediction, is expanding, leading to fierce competition to become the "platform that maximizes development efficiency." Domestic AI-based drug development companies are also expected to enter a phase where their pipelines become visibly realized.

The final pillar is the expiration of patents and the activation of mergers and acquisitions (M&A). As major blockbuster products of global big pharma companies sequentially lose patent protection, revenue gaps are expected to emerge, likely leading to increased strategic M&As and licensing-out (L/O) deals to fill these gaps. The biosimilar market is projected to grow to 106 trillion won by 2030, with an average annual growth rate of 30%, and there is considerable potential for the value of CDMO and platform companies to be reassessed amid changes in market structure.