Korea’s 2025 Medical Product Market – Digital Shift and Local Innovation

23 Jun 2026

South Korea’s medical products market is undergoing a massive transformation, driven by two clear forces: rapid digital adoption and a surge in homegrown clinical innovations. According to the Ministry of Food and Drug Safety’s (MFDS) latest report, a total of 1,397 pharmaceuticals and 7,675 medical devices entered the Korean market. 

The approval data also provides insight into broader developments across the Korean healthcare and medical technology sectors. Traditional healthcare boundaries are dissolving. Artificial intelligence (AI) approvals are soaring, digital therapeutics (DTx) are expanding into complex psychological treatments, and local manufacturers are increasingly dominating both the high-tech and aesthetic sectors. 

1. The Pharmaceutical Landscape: Homegrown Success and Chronic Care 

Korea’s drug market saw steady growth, characterized by a rise in novel therapies, modified drug formulations, and a strong focus on chronic disease management. 

2025 Pharmaceutical Approvals at a Glance: 

• New Drugs Approved: 26 (Up from 23 in 2024) 

• Modified Drugs: 20 (Mostly Hypertension & Diabetes) 

• Key Therapy Leader: Diabetes Medications (174 approvals) 

New and Homegrown Drug Approvals 

The MFDS approved 26 new drugs across 19 active ingredients, an increase of three from the previous year.The approvals also included several products developed by Korean manufacturers, reflecting continued activity in domestic pharmaceutical innovation.  

Key domestic approvals included the following: 

• Barythrax: A newly developed anthrax vaccine. 

• Nuviju (cholic acid): A submental fat reduction treatment targeting the aesthetic market. 

• Xcopri (cenobamate): An epilepsy treatment gaining significant international traction. 

The Rise of Modified Drugs 

Modified drugs, which alter the active ingredients, delivery mechanisms, or formulation ratios of existing drugs to improve patient compliance, saw 20 approvals. The vast majority of these targeted chronic, lifestyle-related conditions: 

• Hypertension: 10 products 

• Diabetes: 8 products 

Market Concentration by Therapeutic Class 

Chronic diseases dominated the volume of drug approvals. Diabetes treatments led the entire pharmaceutical sector with 174 approved products (particularly those utilizing empagliflozin). This was followed closely by: 

• Pain and Inflammation: 132 antipyretic, analgesic, and anti-inflammatory drugs. 

• Wellness: 92 vitamin products. 

• Cardiovascular: 78 antihypertensive agents. 

A Landmark Year for Rare Diseases and Biologics 

In a highly positive trend for patient access, approvals for rare disease biologics reached 16 products across 11 active ingredients. This represents the highest volume of rare disease biologic approvals in Korea over the last five years, signaling that regulatory pathways are becoming more receptive to niche, high-need therapies. 

2. The Medical Device Revolution: AI, DTx, and Aging 

The medical device sector saw 7,675 products approved, certified, or reported. The data highlights a clear shift toward digital health, geriatric care, and aesthetic medicine. 

AI and Digital Therapeutics (DTx) Take Center Stage) Take Center Stage 

The growing number of AI-based device approvals suggests that software is becoming an increasingly important component of clinical practice in South Korea.   

AI & Digital Health Surge (YoY Change): 

• AI-Based Device Approvals:  ▲ 41.6% (153 cases total) 

• Domestic Share of AI Tech:  77.7% 

• Cumulative DTx Approvals:   14 products (10 new in 2025) 

The 41.6% spike in AI-based medical devices points to rapid clinical adoption. Crucially, 77.7% of these AI tools are manufactured domestically, showing that Korea’s tech sector is successfully commercializing clinical software. 

Meanwhile, Digital Therapeutics (DTx) has hit a critical turning point. Previously, DTx approvals in Korea were confined strictly to cognitive behavioral therapy for insomnia. In 2025, the MFDS approved 10 new DTx products, bringing the nation’s cumulative total to 14—all of which are homegrown. 

More importantly, their clinical indications have expanded into highly complex areas: 

• Pediatric ADHD 

• Eating disorders 

• Tinnitus 

This diversification indicates growing regulatory acceptance of software-based therapeutic approaches across multiple clinical areas. 

Silver-Care and Dental Tech: Adapting to an Aging Population 

South Korea is aging faster than almost any other developed nation, and the 2025 medical device registry reflects this demographic reality. Demand for geriatric and dental prosthetic devices has surged. Highly approved categories included: 

• Dental implant superstructures: 98 cases 

• Dental implant surgical instruments: 89 cases 

• Air conduction hearing aids: 27 cases 

• Multifocal intraocular lenses: 10 cases (for cataracts and presbyopia) 

These numbers reflect a highly lucrative, sustained domestic market for devices that improve the quality of life for seniors. 

The K-Beauty Boom Drives Aesthetic Device Growth 

The global popularity of the “K-Beauty” brand continues to fuel the domestic aesthetic device market. Devices designed for wrinkle reduction, skin tightening, and tissue reconstruction maintained strong momentum. 

In particular, approvals for tissue repair biomaterials reached 122 cases, a 13% increase year-on-year. Showing an incredible level of market capture, over 95% of these newly approved aesthetic biomaterials were manufactured domestically. 

Key Takeaways for the Industry 

The MFDS 2025 report makes three macro-trends very clear: 

• Digital health technologies are gaining regulatory and commercial relevance in the Korean market.: With AI approvals up over 40% and DTx expanding into psychiatric and pediatric care, digital tools are now core mainstays of the Korean healthcare system. 

• Domestic Tech is Dominating: From DTx (100% domestic) to AI devices (77.7% domestic) and aesthetic biomaterials (95% domestic), Korean medical technology companies are successfully defending their home market against multinational giants. 

• Demographics Dictate the Market: Chronic disease treatments, geriatric care devices, and lifestyle/aesthetic products are the primary volume drivers for commercial success in South Korea. 

For international sponsors and domestic developers alike, the path forward in Korea requires clear alignment with digital integration and the clinical needs of an aging, lifestyle-conscious population. 

Navigating Korea’s Digital MedTech Revolution 

At TS Quality & Engineering, we see South Korea’s 2025 medical product market as a clear signal of where global healthcare is heading: digital integration, domestic innovation, and demographic‑driven demand. With AI approvals up over 40%, digital therapeutics expanding into complex psychiatric and pediatric care, and local manufacturers dominating high‑tech and aesthetic sectors, Korea is setting the pace for the next era of MedTech. 

Our expertise in ISO standards, MDR/IVDR compliance, AI governance, and advanced materials equips international sponsors and domestic developers to align with these trends. Whether it’s navigating regulatory pathways, embedding cybersecurity into AI devices, or scaling innovations for aging populations, TS Quality & Engineering helps organizations transform compliance into a competitive advantage.