This is Vol.71 Newsletter for January 2026.
This issue covers the global pharmaceutical market’s shift toward metabolic diseases from 2026 and the post-GLP-1 competitive landscape, intensifying US–China competition driven by China’s surge in new drug approvals, rapid growth of Korea’s CGM market alongside heavy import dependence, and major outcomes from the pan-ministerial medical device R&D program. It also highlights Korea’s ₩1 trillion investment in medical AI, MFDS’s overhaul of drug and biotech development guidelines, new guidance on digital data collection in clinical trials, updated medical device trial site designations, MFDS’s recognition as a WHO Listed Authority across all functions, and the government’s plan to directly supply rare and essential medicines.
Korea’s CGM boom lifts glucose monitor market 60%,
but imports still dominate
Korea’s glucose monitoring market grew rapidly, driven by continuous glucose monitoring, which now accounts for nearly half of spending and dominates home care. However, heavy import dependence and limited insurance reimbursement will determine how widely CGM adoption expands and whether domestic suppliers can compete.
Pan‑ministerial fund drives Korea medical device firms to secure 467 projects and ₩550bn investment
Korea’s Medical Device Development Fund reported strong first-phase results after six years, backing 467 projects with nearly 948 billion won. Outcomes included thousands of papers and patents, major private investment, KOSDAQ listings, and award-winning innovations. A second phase launches next year with similar-scale funding.
China to Overtake the US in New Drug Approvals by 2025…
46 FDA Approvals, 68 NMPA Approvals
China surpassed the US in new drug approvals in 2025, reflecting intensifying biotech competition. FDA approvals declined, while oncology and ADCs dominated. Formulation innovations like subcutaneous Keytruda highlighted a shift toward improved patient convenience and differentiated drug delivery.
Cancer is on the decline, metabolic diseases are on the rise…
A generational shift in the global pharmaceutical market by 2026.
The global biopharma industry is shifting its growth focus to metabolic diseases from 2026. Obesity and diabetes therapies are becoming core revenue drivers, led by GLP-1 innovation. Formulation, mechanism differentiation, and post-patent pipeline strategies will define future competitiveness.
MFDS Fully Listed for All Functions
as a WHO Listed Authority(WLA)
MFDS has been recognized by the WHO as a Listed Authority (WLA) across all regulatory functions. The designation confirms Korea’s regulatory maturity in drug and vaccine review, clinical trials, and inspections, strengthening global trust, international procurement eligibility, and export competitiveness.
Rare Medicines Once Imported by Patients to Be Supplied Directly by Government
Korea’s MFDS will directly supply rare and essential medicines previously imported by patients, cutting delivery times from months to one day and reducing costs. The plan expands emergency imports, insurance coverage, and domestic contract manufacturing to secure stable access to critical drugs and medical devices for rare disease patients.
