Biomedical materials, as an effective tool for humans to fight against diseases, have a history dating back to BC. Today, third-generation biomedical materials with the function of promoting human self repair and regeneration have begun to be widely used.
Polymer degradable materials represented by polylactic acid (PLA) are one of the new types of materials. It has good biodegradability and can be completely degraded by microorganisms in nature after use, ultimately generating carbon dioxide and water. In the field of biomedicine, it has high safety for the human body and can be absorbed by tissues. For example, in the European and American markets, high molecular weight polylactic acid is widely used as a new type of orthopedic internal fixation material.
Due to the complex types of raw materials and different corresponding physical properties, polylactic acid materials prepared in China are mostly for industrial applications. Medical polylactic acid has strict requirements for raw materials, and its preparation and mass production have high process barriers. High quality raw materials are mainly imported from overseas. Therefore, biomedical polylactic acid is expensive.
The upstream raw materials are still struggling, and the midstream biomaterials products are also struggling to make progress. High end products are dominated by imports for a longer period of time. On the other hand, benefiting from policy guidance and the continuous growth of market demand, China's biomaterials industry is in a period of rapid development, and the number of enterprises and talents entering the industry is gradually increasing.
Lixin Science, a high-tech enterprise that closely meets clinical needs and realizes a closed-loop solution for recycled biomaterials in the entire industry chain, has entered our sight. In order to further understand the situation, Arterial Network interviewed Dr. Sun Yang, the founder.
It is reported that Lixin Science is based on the research and development of biomedical polymer degradation materials represented by polylactic acid, and has formed three routes: absorbable internal fixation products, bone filler products, and medical and aesthetic absorbable polymer products. Among them, artificial bone products have filled the global product gap with their excellent plasticity, anti liquid phase disintegration, and efficient bone induction regeneration performance.
The rapid development of the biomaterials industry is mainly due to the outbreak of downstream demand.
In recent years, aging has not only been a high-frequency buzzword in the whole society, but also triggered many industrial development trends. Orthopedics have the highest demand for biomaterials, accounting for approximately 38% of the entire market share. The aging population has brought about a large number of orthopedic patients, expanding the demand for treatment of orthopedic diseases.
At the same time, with the changes in people's lifestyles and the improvement of their quality of life, there is also a growing demand for sports medicine, dentistry, and plastic surgery. It is reported that from 2015 to 2020, the compound annual growth rate of orthopedic implants, sports medicine, oral implants, and injectable medical aesthetics in China exceeded 15%, with a total segmented market size of nearly 100 billion yuan.
Dr. Sun Yang, Chairman of Lixin Science, stated that there is a strong demand for biomaterials in the market. However, from the perspective of the entire industry, firstly, raw materials are mainly imported, and secondly, products that reach the terminal are mostly imported, especially high-end products. Faced with enormous market potential and import substitution opportunities, Lixin Science has decisively chosen to enter the biomaterials industry.
The focus of Lixin Science on the development of polylactic acid polymer materials is due to Sun Yang's academic experience. It is reported that Sun Yang studied at the School of Materials Science and Technology at Shanghai Jiao Tong University for his undergraduate degree, and later pursued his doctoral and postdoctoral studies in the Department of Materials Science and Technology at the National University of Singapore. His research topic was the study of composite materials of polylactic acid.
Lixin Science has formed three major product lines based on polylactic acid medical polymer raw materials.
The absorbable internal fixation series is designed for applications in sports medicine, orthopedics, dentistry, and other fields that require the fixation of soft tissues and bones. When developing this series of products, Lixin Science established a material platform. The platform produces biodegradable composite materials with high strength and toughness, which can be used to design a series of products with different structures. Sun Yang revealed that the first product in the internal fixation series is expected to obtain a registration certificate and be launched in the second half of 2022. Other products are continuously launched at a rate of 1-2 per year.
The bone filler series includes products such as orthopedic artificial bone and oral artificial bone. It is reported that there are currently over 400 bone fillers approved by the FDA, while only 50 domestically certified products are available. However, none of them can meet the global blank demand for plasticity, anti liquid phase disintegration, and efficient bone induction regeneration. Lixin Science's artificial bone product is the world's first absorbable artificial bone that can effectively meet the above blank requirements. The first generation product is currently in clinical trials and has been the first to submit for FDA certification. It is expected to be registered with the National Medical Products Administration by the end of 2022.
The medical and aesthetic absorbable polymer product series mainly includes facial fillers, thread carving absorbable threads, etc. The demand for regenerative medical beauty in the market is huge. Taking injection products as an example, according to relevant data, their market size will reach 4.927 billion yuan in 2025 and will continue to rise. Among them, the usage of PLLA products mainly made of L-polylactic acid (PLLA) is gradually increasing, and it is expected that the factory scale of the products will reach 1.987 billion yuan by 2025.
Sun Yang introduced that the layout of Lixin Science in the field of medical aesthetics is based on the production capacity of absorbable raw materials to create an independent brand of medical aesthetics biomaterials; On the other hand, we also provide OEM services and use material mass production technology to serve more medical beauty customers, creating a medical beauty material kingdom.