SEOUL, South Korea, December 31, 2025 /PRNewswire/ — KLMBio, a manufacturer and exporter of human tissue-based medical devices, is accelerating its global business expansion by strengthening its portfolio of high-value tissue-based products to target the rapidly growing global bone graft market.
The global bone graft market is a high-growth medical device sector, driven by ever-increasing usage in orthopedic surgery, spinal procedures and dental implants. The market is expected to reach approximately $6.66 billion by 2032. In particular, human tissue products continue to grow in popularity and profitability due to their limited supply and continued high demand.
In line with these market trends, KLMBio focuses on the production of high-value human tissue products, including bone grafts, ligaments and secondarily processed bone materials. The company has ensured a stable supply chain of raw materials through partnerships with US-based tissue banks and operates in-house Level II sterilization and freeze-drying manufacturing facilities. Additionally, its US subsidiary, MRTbio, is registered as an FDA tissue bank and operates direct distribution networks in the US and Canada.
KLMBio implements a global marketing strategy under the slogan “Korean Specialized Manufacturer of Tissue-Based Therapeutic Materials”. The company has obtained key regulatory certifications, including AATB and FDA in the United States, KFDA in Korea, and CTO certification in Canada. Leveraging these credentials, KLMBio is expanding its global presence in 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 core next-generation 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 US subsidiary MRTbio, KLMBio provides OEM customers with comprehensive local support, including consultations, exhibitions, product sampling and regulatory affairs (RA) assistance. This strategy reinforces confidence in KLMBio as a reliable global partner for manufacturing tissue-based medical devices while ensuring a stable supply of products.
Going forward, KLMBio plans to allocate approximately 40% of its total investment toward expanding its production capacity, including the construction of a second manufacturing facility with clean rooms 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 its regulatory capabilities through GMP and AATB certifications, and expand its specialized workforce to further improve its global competitiveness.
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SOURCE KLMBio
