SEOUL, South Korea, Dec. 31, 2025 /PRNewswire/ — KLMBio, a manufacturer and exporter of human tissue-based medical devices, is accelerating its global business expansion by strengthening its high-value tissue-based product portfolio to target the rapidly growing global bone graft market.
The global bone graft market is a high-growth medical device sector, driven by steadily increasing usage in orthopedic surgery, spinal procedures, and dental implants. The market is projected to reach approximately USD 6.66 billion by 2032. In particular, human tissue-based products continue to gain market preference and profitability due to their limited supply and consistently strong demand.
Aligned with these market trends, KLMBio focuses on the production of high-value human tissue-based products, including bone grafts, ligaments, and secondary processed bone materials. The company has secured a stable raw material supply chain through partnerships with U.S.-based tissue banks and operates in-house Class II-level sterilization and freeze-drying manufacturing facilities. In addition, its U.S. subsidiary, MRTbio, is registered as an FDA Tissue Bank and operates direct distribution networks across the United States and Canada.
KLMBio is implementing a global marketing strategy under the slogan “Korea’s Specialized Manufacturer of Tissue-Based Therapeutic Materials.” The company has obtained key regulatory certifications, including AATB and FDA approvals in the United States, KFDA approval in Korea, and CTO certification in Canada. Leveraging these credentials, KLMBio is expanding its global presence across North America, Asia, and the Middle East. The company participates in major international exhibitions and academic conferences twice a year while continuously monitoring patent trends in the field of tissue engineering.
KLMBio has positioned high-complexity tissue-based products as its next-generation core pipeline and continues to strengthen its research and development efforts. As part of its global outreach, the company plans to participate in the New York Dental Meeting in December 2025. KLMBio aims to increase its overseas sales ratio from the current 10% to a balanced 50:50 split between domestic and international markets after 2026.
Through its U.S. subsidiary MRTbio, KLMBio provides OEM customers with comprehensive local support, including consultation, exhibitions, product sampling, and regulatory affairs (RA) assistance. This strategy enhances trust in KLMBio as a reliable global manufacturing partner for tissue-based medical devices while ensuring stable product supply.
Looking ahead, KLMBio plans to allocate approximately 40% of its total investment toward expanding production capacity, including the construction of a second manufacturing facility with cleanrooms and additional sterilization, freeze-drying, and packaging equipment. The company will also accelerate the commercialization of high-value products such as DBM Fiber, Dental Plug, and Amnion, strengthen regulatory capabilities through GMP and AATB certifications, and expand its specialized workforce to further enhance global competitiveness.
