May 10, 2025, London - With the increasing aging population and advances in medical technology, the application of medical grade silicone materials in fields such as medical devices, drug delivery, and artificial organs continues to expand due to their biocompatibility, non toxicity, and stability. According to market research institutions' predictions, the global demand for medical grade organosilicon will reach 450000 tons by 2025, with a market size exceeding 12 billion US dollars and a compound annual growth rate of 9.3%.
Implantable devices: from short-term to long-term
Traditional medical silicone is mainly used for short-term implantation of devices such as catheters and drainage tubes, while the new generation of materials is breaking through the limitations of long-term implantation. The "degradable siloxane hydrogel" developed by a research institute can be gradually hydrolyzed into silicic acid and ethanol in the human body, and finally discharged through metabolism. This material has been used in animal experiments and completely degraded after 6 months of implantation without inflammatory response. It may be applied in long-term implants such as heart stents in the future.
Drug delivery: innovation in controlled release technology
Organosilicon microspheres can achieve precise controlled drug release. The "core-shell structured silicone microspheres" developed by a certain enterprise use polylactic acid as the core and siloxane as the shell, and control the drug release rate by adjusting the shell thickness. In insulin delivery trials, the microspheres can reduce blood glucose fluctuations by 60%, and the number of daily injections for patients can be reduced from 3 to 1. At present, this technology has entered the second phase of clinical practice.
Artificial organs: breaking through the problem of biological fusion
High end devices such as artificial heart valves and artificial joints require extremely high material biocompatibility. A certain laboratory constructed a three-dimensional nanofiber network on the surface of silica gel by simulating the extracellular matrix structure, significantly improving the adhesion rate of fibroblasts. Animal experiments have shown that the endothelialization rate of artificial blood vessels implanted with this material reaches 95% after 6 months, approaching the level of autologous blood vessels.
Stricter regulation: promoting industry standardization
The EU Medical Device Regulation (MDR) imposes stricter requirements on the biosafety of medical materials, requiring the provision of 12 testing data including cytotoxicity and genotoxicity. The China National Medical Products Administration also released the "Guidelines for Quality Control of Medical Organosilicon Materials" in 2024, clarifying the impurity limit standards. The head of a certification body stated that by 2025, approximately 30% of medical silicone products worldwide will need to undergo a new biosafety assessment.
