Shanghai, China, August 10, 2025- With biodegradable silicone rubber vascular stents entering the clinical stage, medical grade silicone rubber is rising from auxiliary materials to core components of high-end medical equipment. According to the prediction of Zhongyan Puhua, the size of China's medical silicone market will exceed 30 billion yuan in 2028, with a compound annual growth rate of 28%. The proportion of implant materials is expected to increase from the current 12% to 35%.

Innovative products break through certification barriers
For a long time, the high threshold for FDA and CE certification has kept most Chinese companies out of the high-end market. But this situation is changing: the neural repair catheter developed by Maipu Medical has tripled the cell adhesion rate through surface topology modification technology, becoming the first Chinese product to enter the EU centralized procurement catalog; The bioabsorbable occluder developed by Xianjian Technology uses LSR and polylactic acid composite material, which completely degrades within 6 months after completing heart defect repair. Clinical data shows that its complication rate is 60% lower than that of metal products.

Policy dividends unleash market potential
The introduction of the "Key Points for Technical Evaluation of Medical Organosilicon Materials" by the National Medical Products Administration lays the foundation for the standardized development of the industry. The document clearly lists silicone rubber as a "priority review" category, and the approval cycle has been compressed from 18 months to 9 months. At the same time, the National Manufacturing Fund has set up a special fund of 5 billion yuan to support enterprises in building GMP level clean workshops. Our newly built 100000 level purification workshop can produce 5 million sets of silicone rubber components for insulin pumps annually, completely replacing imported products, "said Wang Qiang, General Manager of Guangdong Silicon Treasure Technology

Cross border integration gives birth to new business models
Driven by 3D printing technology, personalized medical silicone rubber products have entered an explosive period. The liquid silicone rubber 3D printer developed in collaboration between Shanghai Lianying Medical and Xin'an Chemical can achieve printing accuracy of 0.05 millimeters and has been used to manufacture cochlear implant shells. More noteworthy is that the rise of the humanoid robot industry has opened up a new track for medical silicone rubber. The Walker X robot released by Ubiquitous Technology features a biomimetic skin made of conductive silicone rubber material, with tactile sensitivity reaching the level of human fingertips.

The international competitive landscape is undergoing changes
Faced with the rise of Chinese enterprises, multinational giants are accelerating their localization layout. The medical grade LSR production line put into operation by Wacker Chemie in Zhangjiagang, Germany, adopts modular design to meet the needs of small batch customization; Dow Corning has partnered with Alibaba Health to build a medical silicone rubber e-commerce platform. However, industry experts believe that Chinese companies still have advantages in cost and response speed, and are expected to occupy 40% of the global medical silicone rubber market by 2027.

Clinical feedback: Li Jianguo, Director of Cardiovascular Surgery at Peking Union Medical College Hospital, pointed out that "the bending strength of biodegradable silicone rubber stents reaches 45MPa, fully meeting the requirements for coronary artery implantation, and their biocompatibility is even better than some metal materials