From diagnostic powerhouses to AI-driven smart wearables, South Korea's medical device industry isn't just healing patients—it's rapidly becoming a global tech titan, as evidenced by its soaring market size of KRW 12.5 trillion in 2022, a trade surplus of KRW 6.2 trillion in 2023, and a projected climb to USD 20.1 billion by 2030.
Key Takeaways
- In 2022, the total market size of the Korean medical device industry was valued at approximately KRW 12.5 trillion, reflecting a year-over-year growth of 5.2% driven by increased demand for diagnostics and wearables.
- The Korean medical device market is projected to reach USD 14.6 billion by 2027, with a CAGR of 6.8% from 2022 to 2027, fueled by aging population and healthcare digitization.
- In 2023, domestic sales of medical devices in Korea amounted to KRW 8.7 trillion, up 4.1% from 2022, primarily from imaging and IVD sectors.
- Korea's medical device exports surged to USD 11.2 billion in 2023, a 12.7% increase from 2022, led by ultrasound and endoscopes.
- In 2022, medical device imports to Korea totaled USD 8.4 billion, with MRI and CT scanners comprising 35% of the value.
- Korea exported medical devices worth KRW 14.9 trillion in 2023, achieving a trade surplus of KRW 6.2 trillion.
- Medical device production in Korea reached 1.2 million units of imaging equipment in 2022, primarily ultrasound systems.
- In 2023, the number of medical device manufacturing companies in Korea stood at 1,856, a 3.2% increase from 2022.
- Korea produced KRW 10.5 trillion worth of high-tech medical devices in 2022, including 45,000 MRI units locally assembled.
- Samsung Medison held 42% domestic market share in ultrasound production with 28,000 units manufactured in 2023.
- HUVET Corporation produced 150,000 dental implants in 2022, generating KRW 320 billion in revenue.
- Vieworks exported 65% of its 15,000 digital X-ray detectors produced in 2023 to global markets.
- In 2023, 1,250 new medical devices received MFDS approval in Korea, 30% more than 2022.
- Government investment in med device R&D reached KRW 1.5 trillion in 2023 via MOTIE and MSIT.
- The MFDS processed 2,800 Class II/III device notifications in 2022, with 95% approval rate.
Korea's medical device industry is thriving with strong growth driven by exports and innovation.
Exports and Imports
- Korea's medical device exports surged to USD 11.2 billion in 2023, a 12.7% increase from 2022, led by ultrasound and endoscopes.
- In 2022, medical device imports to Korea totaled USD 8.4 billion, with MRI and CT scanners comprising 35% of the value.
- Korea exported medical devices worth KRW 14.9 trillion in 2023, achieving a trade surplus of KRW 6.2 trillion.
- The top export destination for Korean med devices in 2023 was the United States, accounting for 28.5% or USD 3.2 billion.
- Imports of disposable medical devices into Korea rose 9.2% to USD 2.1 billion in 2022.
- Korean medical device exports to Europe increased by 18.4% in 2023 to USD 2.8 billion, boosted by CE mark certifications.
- In 2023, Korea's med device import dependency rate dropped to 42% from 48% in 2020, thanks to local production ramp-up.
- Dental equipment exports from Korea hit USD 450 million in 2022, up 11% YoY.
- China was the second-largest export market for Korean med devices in 2023, with USD 2.1 billion or 18.7% share.
- Korea imported USD 1.9 billion in orthopedic implants in 2023, representing 22% of total med device imports.
- In 2023, med device exports grew 14.3% to USD 12.8 billion overall.
- Vietnam emerged as top-5 export market with USD 850 million in Korean med devices 2023.
- Imports of imaging equipment dropped 5.2% to USD 2.9 billion in 2023 due to localization.
- Japan imports from Korea: USD 650 million med devices in 2022, up 9%.
- Trade balance for IVD products: KRW 3.1 trillion surplus in 2023.
- Southeast Asia exports rose 22% to USD 1.8 billion in 2023.
- High-end CT scanner exports: 1,200 units worth USD 720 million in 2022.
- India market: Korean med device exports USD 450 million in 2023, 15% growth.
- Total imports 2023: USD 9.1 billion, with US sourcing 32%.
Exports and Imports Interpretation
Korea's medtech sector is performing surgery on its own trade deficit, skillfully excising import dependency with a scalpel of high-end exports and suturing the wound with a growing surplus, all while carefully monitoring its vital signs in the lucrative US and Chinese markets.
Major Companies
- Samsung Medison held 42% domestic market share in ultrasound production with 28,000 units manufactured in 2023.
- HUVET Corporation produced 150,000 dental implants in 2022, generating KRW 320 billion in revenue.
- Vieworks exported 65% of its 15,000 digital X-ray detectors produced in 2023 to global markets.
- Lunit Inc. deployed AI diagnostic software in 1,200 Korean hospitals by end of 2023, with KRW 180 billion sales.
- Seegene Inc. supplied 200 million PCR tests worth KRW 1.1 trillion in 2022.
- Rayence Co. Ltd. manufactured 8,500 flat-panel detectors in 2023, holding 25% global market share.
- BioSensertech, a startup, produced 500,000 biosensor strips daily in 2023, revenue KRW 250 billion.
- Vuno Inc. received 45 MFDS approvals for AI med devices by 2023, with 300 installations.
- Gyeonggi Province hosts 450 med device firms, with Samsung Medison as the largest at KRW 1.2 trillion revenue.
- Medtronic Korea, local production partner, assembled 12,000 ICDs in 2023.
- Ossila Inc. revenue from dental lasers: KRW 210 billion 2022.
- Innomd ranked top-10 with KRW 150 billion sales in endoscopy 2023.
- Vuno's AI chest X-ray analyzer installed in 500 sites, KRW 120 billion revenue.
- Seegene's Allplex COVID tests: 300 million kits produced 2022.
- Vieworks' global sales: USD 250 million, 70% from detectors 2023.
- Lunit's Therapixel partnership led to 20% revenue growth to KRW 220 billion.
- Hanmi Semiconductor supplied sensors to 300 firms, KRW 180 billion medtech revenue.
- Daegu Medical Device Cluster: 280 companies, total sales KRW 5.1 trillion 2023.
Major Companies Interpretation
The Korean medical device industry is a powerhouse, stitching together precision from Samsung Medison's ultrasound dominance and HUVET's dental implant empire to the nimble innovation of startups like BioSensertech, all proving that whether it's through Seegene's massive PCR test volumes or Lunit's AI infiltrating hospitals, the nation is expertly diagnosing its own economic health while treating the world.
Market Size and Growth
- In 2022, the total market size of the Korean medical device industry was valued at approximately KRW 12.5 trillion, reflecting a year-over-year growth of 5.2% driven by increased demand for diagnostics and wearables.
- The Korean medical device market is projected to reach USD 14.6 billion by 2027, with a CAGR of 6.8% from 2022 to 2027, fueled by aging population and healthcare digitization.
- In 2023, domestic sales of medical devices in Korea amounted to KRW 8.7 trillion, up 4.1% from 2022, primarily from imaging and IVD sectors.
- The in-vitro diagnostics (IVD) segment held 28% of the Korean medtech market share in 2022, valued at KRW 3.5 trillion.
- Wearable medical devices market in Korea grew by 15.3% in 2022 to KRW 1.2 trillion, led by smartwatches and fitness trackers.
- Korea's medical device industry contributed 1.2% to the national GDP in 2022, with total output reaching KRW 15.8 trillion including exports.
- The high-end medical equipment market in Korea expanded to KRW 4.3 trillion in 2023, with a 7.8% growth rate.
- By 2025, the Korean digital health market within medtech is expected to hit KRW 2.8 trillion, growing at 12.4% CAGR.
- Implantable devices segment in Korea's market was KRW 2.1 trillion in 2022, with 6.5% YoY growth.
- The overall medtech market penetration rate in Korea reached 85% of hospitals in 2023, up from 78% in 2020.
- The Korean medical device market CAGR from 2018-2022 was 4.7%, reaching KRW 11.8 trillion in 2021.
- Homecare medical devices segment grew 11.2% to KRW 950 billion in 2023.
- Orthopedic devices market in Korea was KRW 1.8 trillion in 2022, 8.1% growth.
- By 2030, Korean medtech market forecasted at USD 20.1 billion with 7.2% CAGR.
- COVID-19 diagnostics boosted IVD market to KRW 4.2 trillion in 2021 peak.
- End-user hospital segment dominated 62% of Korean med device market in 2023.
- Digital therapeutics market in Korea valued at KRW 180 billion in 2023, 25% growth.
- Medical imaging devices held 19% market share worth KRW 2.4 trillion in 2022.
Market Size and Growth Interpretation
Korea's medtech market is briskly marching toward a silver-haired, digitally-augmented future, where hospitals are nearly saturated with devices and the real growth now lies in our pockets, wrists, and homes, cleverly diagnosing and tracking our way to a projected $20 billion industry by 2030.
Production and Manufacturing
- Medical device production in Korea reached 1.2 million units of imaging equipment in 2022, primarily ultrasound systems.
- In 2023, the number of medical device manufacturing companies in Korea stood at 1,856, a 3.2% increase from 2022.
- Korea produced KRW 10.5 trillion worth of high-tech medical devices in 2022, including 45,000 MRI units locally assembled.
- The production value of IVD reagents in Korea was KRW 2.8 trillion in 2023, with 520 million test kits manufactured.
- Surgical robots production in Korea grew to 1,200 units in 2023, valued at KRW 450 billion.
- Korea's med device factories employed 85,000 workers in 2022, with production capacity utilization at 78%.
- Domestic production of ventilators surged to 50,000 units during 2022-2023 post-COVID demand.
- Endoscope production in Korea hit 320,000 units in 2023, with 92% export-oriented manufacturing.
- Wearable device manufacturing output reached 12 million units in Korea in 2022.
- The average production cost per ultrasound machine in Korea was KRW 150 million in 2023.
- In 2023, 2,450 med device factories operated in Korea, producing KRW 18.2 trillion.
- Bio-compatible materials production: 45,000 tons annually in 2022.
- Pacemaker production: 28,000 units in Korea 2023.
- Stent manufacturing output: 1.5 million units valued at KRW 890 billion 2022.
- Local content rate for med devices reached 68% in 2023.
- 95,000 employees in manufacturing sector, average wage KRW 55 million/year 2023.
- Ophthalmic device production: 5.2 million lenses in 2022.
- Automation rate in med device plants: 72% as of 2023.
- Hearing aid production: 450,000 units exported 2023.
Production and Manufacturing Interpretation
South Korea's medical device sector is clearly giving its all, from producing enough ultrasound systems to give the whole neighborhood a glimpse of their future to robotically stitching its way to a KRW 18.2 trillion valuation, all while ensuring nearly seven out of every ten components are proudly homegrown.
R&D and Innovation
- Korea's med device R&D expenditure hit KRW 2.1 trillion in 2022, 13.2% of total sales.
- 1,567 patents for medical devices were filed by Korean firms in 2023, up 8.5%.
- AI-based med devices accounted for 22% of new innovations approved in 2023, totaling 275 devices.
- Government funded 180 medtech R&D projects in 2023 with KRW 450 billion budget.
- Robotics in surgery saw 45 new prototypes developed by Korean unis in 2022.
- Nanotechnology applications in med devices generated 320 patents in Korea by 2023.
- 3D printing for implants: 150 Korean hospitals adopted tech by 2023, 12,000 custom prosthetics produced.
- Biotech wearables R&D investment by startups reached KRW 120 billion in 2023.
- Stem cell-based regenerative devices: 25 clinical-stage projects in Korea as of 2023.
- In 2022, Korea ranked 4th globally in med device patent applications with 2,450 filings.
- University-industry R&D collaborations: 250 projects funded KRW 300 billion 2023.
- 3,200 med device patents granted to Korean inventors 2023.
- Precision medicine devices: 180 prototypes in pipeline 2023.
- NIH-Korea joint grants: USD 50 million for medtech innovation 2022-2023.
- Exoskeleton robots: 35 Korean models in trials 2023.
- mRNA vaccine delivery devices R&D: KRW 80 billion invested 2023.
- Telemedicine hardware innovations: 120 patents filed 2023.
- Quantum dot imaging tech: 15 startups developing, KRW 150 billion funding.
- Blockchain for device traceability: pilot in 50 hospitals 2023.
R&D and Innovation Interpretation
Korea is treating medical device innovation like a national sport, investing heavily, patenting relentlessly, and sprinting toward a future where robots, AI, and nanotechnology are just standard equipment in the hospital toolkit.
Regulatory and Investment
- In 2023, 1,250 new medical devices received MFDS approval in Korea, 30% more than 2022.
- Government investment in med device R&D reached KRW 1.5 trillion in 2023 via MOTIE and MSIT.
- The MFDS processed 2,800 Class II/III device notifications in 2022, with 95% approval rate.
- Korea's med device industry received KRW 850 billion in venture capital in 2023, up 22%.
- Post-2022 revision, expedited review for innovative devices reduced approval time to 90 days.
- 65% of Korean med devices comply with MDR/CE standards as of 2023 for EU exports.
- MFDS conducted 1,450 GMP inspections in 2023, with 92% pass rate for manufacturers.
- The "Medical Device Support Act" allocated KRW 300 billion for SMEs in 2023.
- Foreign investment in Korean medtech reached USD 1.2 billion in 2023, mainly from US VCs.
- 420 clinical trials for med devices were registered with MFDS in 2023.
- MFDS approved 1,890 innovative devices under fast-track in 2023.
- KRW 2.0 trillion national R&D budget for healthtech including devices 2023.
- 1,100 Class I devices notified, 98% instant approval 2022.
- Private equity investments: KRW 1.2 trillion in medtech startups 2023.
- MDR compliance certifications: 890 devices by Korean firms 2023.
- GMP certification renewal for 1,650 factories in 2023.
- "K-Med Hub" initiative funded KRW 500 billion for exports 2023.
- Post-market surveillance reports: 2,500 incidents tracked 2023.
- Clinical data requirements eased for low-risk devices in 2023 amendment.
- R&D tax credits for med device firms: average 18% deduction in 2023.
Regulatory and Investment Interpretation
The Korean medical device industry is on a regulatory and financial sugar high, with government money and venture capital pouring in to fuel a boom of new approvals, while inspectors scramble to keep the quality control from crashing the party.
Sources & References
- Reference 1KHIDIkhidi.or.krVisit source
- Reference 2STATISTAstatista.comVisit source
- Reference 3KMDIAkmdia.or.krVisit source
- Reference 4KOREABIOMEDkoreabiomed.comVisit source
- Reference 5BUSINESSKOREAbusinesskorea.co.krVisit source
- Reference 6MOTIEmotie.go.krVisit source
- Reference 7KOREAHERALDkoreaherald.comVisit source
- Reference 8KOSTATkostat.go.krVisit source
- Reference 9CUSTOMScustoms.go.krVisit source
- Reference 10ETNEWSetnews.comVisit source
- Reference 11HUVEPHARMAhuvepharma.comVisit source
- Reference 12VIEWORKSvieworks.comVisit source
- Reference 13LUNITlunit.ioVisit source
- Reference 14SEEGENEseegene.comVisit source
- Reference 15RAYENCErayence.comVisit source
- Reference 16VUNOvuno.medVisit source
- Reference 17GGgg.go.krVisit source
- Reference 18MFDSmfds.go.krVisit source
- Reference 19MSITmsit.go.krVisit source
- Reference 20K-STARTUPk-startup.go.krVisit source
- Reference 21LAWlaw.go.krVisit source
- Reference 22KOTRAkotra.or.krVisit source
- Reference 23CRIScris.nih.go.krVisit source
- Reference 24KIPOkipo.go.krVisit source
- Reference 25NRFnrf.re.krVisit source
- Reference 26KAISTkaist.ac.krVisit source
- Reference 27KRIBBkribb.re.krVisit source
- Reference 28WIPOwipo.intVisit source
- Reference 29MARKETSANDMARKETSmarketsandmarkets.comVisit source
- Reference 30JETROjetro.go.jpVisit source
- Reference 31PHARMEXCILpharmexcil.comVisit source
- Reference 32MEDTRONICmedtronic.comVisit source
- Reference 33OSSILAossila.comVisit source
- Reference 34HANMISEMIhanmisemi.comVisit source
- Reference 35DAEGUdaegu.go.krVisit source
- Reference 36KVCAkvca.or.krVisit source
- Reference 37ELAWelaw.klri.re.krVisit source
- Reference 38NTSnts.go.krVisit source
- Reference 39KIATkiat.or.krVisit source
- Reference 40NIHnih.go.krVisit source
- Reference 41BISTbist.or.krVisit source
- Reference 42KISAkisa.or.krVisit source