Despite a slight decrease in overall export value due to the base effect from high performance in the same period last year, South Korea's bio-health industry found a sturdy pillar in its flagship item, biopharmaceuticals, which recorded double-digit growth.

According to the "KoBIA Insight: Bio-Health Signal (September Settlement)" published by the Korea Bio Pharmaceuticals Association (KoBIA) Management Planning Team, total exports for the bio-health industry in September 2026 stood at $1.55 billion, marking an 8.6% decrease compared to the same month last year. However, amidst the overall downward trend, biopharmaceutical exports recorded $680 million, representing a clear growth trajectory with a 14.1% increase year-on-year.

Alongside these export achievements, the global bio market is undergoing rapid restructuring centered around deregulation and the adoption of next-generation technologies. First, global regulatory agencies are relaxing comparative efficacy trial (CES) requirements against reference drugs in biosimilar development, shifting their evaluation paradigm toward quality and pharmacokinetic (PK) data. Analysts suggest that domestic companies must likewise strengthen their precision quality analysis capabilities to match this trend.

Notably, in the case of Japanese pharmaceuticals, it was confirmed that the contribution of CES among core evidence explaining quality differences with reference drugs is only 6%. Consequently, uniform clinical requirements are being relaxed, and international regulatory harmonization (ICH M18) is being actively pursued.

In the field of next-generation therapeutics, "In Vivo CAR-M" technology targeting solid tumors is gaining fresh attention. By directly delivering gene vectors to in-body monocytes and macrophages to recognize and engulf cancer cells, this technology eliminates the need for ex vivo cell processing and pre-conditioning lymphodepletion. This significantly reduces costs and preparation time, while the exceptional tissue penetration of macrophages provides an advantage in accessing solid tumors.

However, managing toxicity and excessive immune-inflammatory responses arising from non-specific tissue delivery remains a key challenge for commercialization.

Structural changes in the labor market driven by the proliferation of artificial intelligence (AI) were also addressed in depth. Between 2022 and 2026, 94.0% of the decline in youth jobs was concentrated in industries heavily impacted by AI. As entry-level tasks such as document drafting and basic analysis become automated by AI, the early career ladders for junior talent to gain practical experience are shrinking.

In response, experts suggest redesigning work and training to foster human capabilities in directly understanding, verifying, and applying AI outcomes rather than blindly trusting them. They also recommend strengthening senior mentoring and verification processes to maintain talent development pipelines.

In terms of regulatory science, the importance of New Approach Methodologies (NAMs)—which are moving beyond mere alternatives or reductions to animal testing to become official evidentiary data for drug safety evaluation—is growing. As major regulatory agencies like the FDA, MHRA, and EMA push forward principles for animal-free evaluations or voluntary submission pilot programs, companies must proactively clarify which safety questions they can answer through early-stage consultations with regulators and systematically accumulate data proving reliability and reproducibility.

Additionally, innovative therapeutic approaches are being presented in chronic disease fields. In the treatment of polycythemia vera, which previously carried heavy burdens of frequent phlebotomy, iron deficiency, and side effects, subcutaneous siRNA therapeutics (such as divesiran) are emerging as a new alternative. These treatments suppress TMPRSS6 protein production in hepatocytes, increase the iron-regulatory hormone hepcidin, and reduce iron supply to the bone marrow to control excessive red blood cell production, with effects observed for up to 56 days after a single administration, greatly relieving patients' phlebotomy burdens.

Furthermore, research is active in utilizing the anti-inflammatory and neuroprotective effects of stem cells to treat neonatal and premature brain injury caused by lack of oxygen and blood flow. Efforts are continuing beyond short-term monitoring to prove long-term neurodevelopmental recovery effects and link them with cell-free therapeutic technologies such as exosomes.

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