South Korea Medical Device Outsourcing Market Size, Share, and COVID-19 Impact Analysis, By Service (Regulatory Consulting, Product Design and Development, Product Testing and Sterilization, Product Implementation, Product Upgrade, and Product Maintenance), By Therapeutics (Cardiology, Diagnostic Imaging, Orthopedic, IVD, Ophthalmic, General and Plastic Surgery, Drug Delivery, Dental, Endoscopy, and Diabetes Care), and South Korea Medical Device Outsourcing Market Insights, Industry Trend, Forecasts to 2035

South Korea Medical Device Outsourcing Market Insights Forecasts to 2035

• The South Korea Medical Device Outsourcing Market Size was Estimated at USD 2,499.5 Million in 2024
• The Market Size is Expected to Grow at a CAGR of around 12.25% from 2025 to 2035
• The South Korea Medical Device Outsourcing Market Size is Expected to Reach USD 8,908.8 Million by 2035

According to a Research Report Published by Spherical Insights & Consulting, the South Korea Medical Device Outsourcing Market Size is Anticipated to Reach USD 8,908.8 Million by 2035, Growing at a CAGR of 12.25% from 2025 to 2035. The product's cost effectiveness, the region's highly qualified labor force, the market's close proximity to important markets, the speed at which technology is developing, the government's positive backing, strategic alliances, and regulatory knowledge are some of the major reasons propelling the industry.

Market Overview

The term "South Korea medical device outsourcing market" describes the practice of local medical device businesses assigning specific functions to outside service providers, including production, regulatory affairs, product testing, and quality assurance. Businesses can save operating expenses, accelerate product time-to-market, and concentrate on their core strengths with this strategy. Additionally, With the rise in popularity of wearable medical devices, digital health innovations are revolutionizing the Korean medical device industry. These gadgets, which track everything from blood sugar levels to heart rate, are getting more advanced and easier to use. By integrating IoT (Internet of Things) technology, these gadgets improve patient care and compliance by collecting essential data and syncing easily with hospital systems and mobile apps.

Report Coverage

This research report categorizes the market for the South Korea medical device outsourcing market based on various segments and regions and forecasts revenue growth and analyses trends in each submarket. The report analyses the key growth drivers, opportunities, and challenges influencing the South Korea medical device outsourcing market. Recent market developments and competitive strategies such as expansion, product launch, and development, partnership, merger, and acquisition have been included to draw the competitive landscape in the market. The report strategically identifies and profiles the key market players and analyses their core competencies in each sub-segment of the South Korea medical device outsourcing market. Moreover, Advanced medical equipment is becoming more and more necessary as the population ages in order to diagnose and treat chronic illnesses like diabetes, heart disease, and cancer. In South Korea, this need is creating opportunities for both domestic and international medical device manufacturers. Investment in state-of-the-art imaging technology, such as CT scanners, MRI machines, and ultrasound equipment, is growing, making it a profitable market for new businesses.

Driving Factors

The market for medical devices in South Korea is expanding significantly due to the country's sophisticated healthcare system and rising public health consciousness. According to current predictions, the market is expected to grow significantly and continue on its upward trend. A strong manufacturing ecosystem and a strong government push for healthcare innovation are the main drivers of this expansion. The aging of South Korea's population is another factor driving market growth, as it raises demand for medical devices that address age-related health concerns and chronic diseases.

Restraining Factors

The South Korean market has a shortage of qualified and experienced regulatory affairs specialists. For medical device businesses looking to improve their regulatory affairs capabilities, the specific knowledge needed to traverse the complex regulatory system can be a major obstacle.

Market Segmentation

The South Korea medical device outsourcing market share is classified into service and therapeutics.

• The product design and development segment held a significant share in 2024 and is expected to grow at a significant CAGR during the forecast period.

The South Korea medical device outsourcing market is segmented by service into regulatory consulting, product design and development, product testing and sterilization, product implementation, product upgrade, and product maintenance. Among these, the product design and development segment held a significant share in 2024 and is expected to grow at a significant CAGR during the forecast period. As businesses look for creative ways to produce high quality medical devices while adhering to regulatory norms, this sector is vital to the industry.

• The diagnostic imaging segment held a significant share in 2024 and is expected to grow at a significant CAGR during the forecast period.

The South Korea medical device outsourcing market is segmented by therapeutics into cardiology, diagnostic imaging, orthopedic, IVD, ophthalmic, general and plastic surgery, drug delivery, dental, endoscopy, and diabetes care. Among these, the diagnostic imaging segment held a significant share in 2024 and is expected to grow at a significant CAGR during the forecast period. The strong demand for cutting-edge imaging technology, such as MRI, CT scanners, and ultrasound systems, is the reason this market is so dominant. South Korea is a pioneer in this field thanks to its robust R&D skills and technological developments in medical imaging.

Competitive Analysis:

The report offers the appropriate analysis of the key organizations/companies involved within the South Korea medical device outsourcing market along with a comparative evaluation primarily based on their product offering, business overviews, geographic presence, enterprise strategies, segment market share, and SWOT analysis. The report also provides an elaborative analysis focusing on the current news and developments of the companies, which includes product development, innovations, joint ventures, partnerships, mergers & acquisitions, strategic alliances, and others. This allows for the evaluation of the overall competition within the market.

List of Key Companies

• Black Eye Endoscopic Marker
• MediHeroes
• AIRS Medical
• KPI Healthcare Korea
• Selvas Healthcare
• Others

Recent Developments:

• In February 2025, JNPMEDI, a clinical trial consulting and platform company, has launched its specialized unit, the MedTech & Globalization Offering Group, dedicating it to providing comprehensive, end-to-end support for the medical device industry. This new unit was designed to maximize on-demand service capabilities across all stages of the medical device business, offering innovative solutions in key areas such as domestic and international regulatory approvals, digital healthcare validation, and global market expansion strategies.

Key Target Audience

• Market Players
• Investors
• End-users
• Government Authorities 
• Consulting and Research Firm
• Venture capitalists
• Value-Added Resellers (VARs)

Market Segment

This study forecasts revenue at South Korea, regional, and country levels from 2020 to 2035. Spherical Insights has segmented the South Korea Medical Device Outsourcing Market based on the below-mentioned segments:

South Korea Medical Device Outsourcing Market, By Service

• Regulatory Consulting
• Product Design and Development
• Product Testing and Sterilization
• Product Implementation
• Product Upgrade
• Product Maintenance

South Korea Medical Device Outsourcing Market, By Therapeutics

• Cardiology
• Diagnostic Imaging
• Orthopedic
• IVD
• Ophthalmic
• General and Plastic Surgery
• Drug Delivery
• Dental
• Endoscopy
• Diabetes Care