Medical devices: Rapid growth is expected, with substantial room for import substitution. From an industry perspective, China’s medical device market has surpassed RMB 300 billion, making it the second-largest globally. However, medical device spending accounts for only 17% of the overall pharmaceutical market—just 40% of the level in developed countries. With population aging and rising health‑insurance reimbursement levels, the market is projected to expand by at least another 5 percentage points over the next five years, translating into additional market growth exceeding RMB 300 billion.

　　At the micro level, China’s medical device manufacturers are small and fragmented, with over 90% being SMEs whose annual revenues remain below RMB 20 million. Mid- to high-end medical devices still rely heavily on imports, while domestic firms primarily occupy the lower‑value‑added segments of the industry chain, leaving substantial room for import substitution.

　　Policy support continues to act as a catalyst, with benefits steadily being realized. Import substitution hinges on technological breakthroughs in domestically produced equipment, while the key driver is robust, top-down policy initiatives that have broken the ice.

　　In recent years, China has implemented a comprehensive policy package—encouraging innovation, expediting regulatory reviews, combating corruption in the healthcare sector, and supporting the procurement and use of domestically produced medical devices—which has, on the one hand, elevated the innovative manufacturing capabilities of domestic brands and, on the other, reshaped the market landscape to create entry opportunities for homegrown equipment. As a result, cost‑effective Chinese‑made medical devices are now experiencing a period of robust growth.

　　 “Space + Technology + Model”: Identifying Import-Substitution Opportunities Across Three Dimensions

　　IVD sector: Chemiluminescence offers the greatest potential for import substitution. With higher sensitivity and greater automation, chemiluminescence is clearly poised to replace enzyme-linked immunoassays.

　　In the domestic market, foreign‑brand manufacturers, leveraging their technological and service advantages, already command 90%–95% of the share. Leading companies such as Antu Biotech, Xin Industry, Mindray Bio, and Mindray Medical have achieved technological breakthroughs in both instruments and reagents while offering superior cost‑effectiveness. Driven by “technological upgrading” and “import substitution,” conservative estimates project that the domestic chemiluminescence market will maintain a compound annual growth rate of 32.95% over the next five years, resulting in rapid expansion and increasing market penetration.

　　Medical Imaging: Digital Radiography (DR) is poised for new growth opportunities. For a long time, the domestic medical imaging market has been heavily dominated by foreign players, with “GPS” brands accounting for 83.3%, 85.7%, and 69.4% of the CT, MRI, and ultrasound markets, respectively.

　　As demand for equipment procurement rises in grassroots markets and private hospitals, and as tertiary hospitals face mounting pressure to combat corruption and control costs, domestically produced high-end digital radiography systems are poised to seize substitution opportunities.

　　At present, Wandong Medical has achieved independent R&D of core components across the entire imaging chain and is actively piloting models such as telemedicine and standalone imaging centers. Looking ahead, the domestic DR market is expected to maintain growth of 10%–15%, becoming the fastest-growing and largest product line in the radiological imaging sector.

　　Cardiovascular and surgical devices: import substitution for pacemakers and endoscopic anastomosis devices is imminent. In China, the number of pacemaker implantations per million people remains less than 5% of that in developed countries, and market demand has yet to be fully unleashed due to price constraints and limited affordability. Currently, Lepu Medical’s domestically produced dual-chamber pacemaker is being successfully launched and promoted, while the pacemaker developed through a collaboration between MicroPort and Sorin has already received approval, and a product resulting from the partnership between Sino‑Med and Medtronic is also poised for market launch. The domestic pacemaker industry is well positioned to replicate the import‑substitution trajectory seen in the coronary stent sector.

　　Anastomosis devices represent the largest category of surgical instruments. Among them, laparoscopic anastomosis devices, owing to their stringent technical requirements, have evolved into a competitive landscape dominated by foreign firms with domestic players playing a supporting role. Currently, companies such as Ningbo Bingkun, a subsidiary of Lepu Medical, have swiftly embarked on import substitution following significant technological breakthroughs.

　　Hemodialysis: the next blue‑ocean market for chronic diseases, with the rollout of chain‑operated dialysis centers accelerating. China has approximately 2 million patients with end‑stage renal disease, yet hemodialysis penetration stands at just 15%. With the expansion of major‑illness medical insurance and the rapid scaling up of dialysis center infrastructure, a market opportunity worth hundreds of billions is poised to materialize.

　　At present, dialyzers and dialysis machines—products with relatively high technological barriers—remain dominated by foreign players. In contrast, domestic brands now account for over 90% of the market for hemodialysis powder and dialysis concentrate, while domestic companies hold nearly 50% of the dialysis tubing market, indicating that import substitution is well underway. Meanwhile, companies like Baolite, which boast strong resource‑synergy capabilities, have established a full‑chain business model in hemodialysis that integrates “equipment + consumables + distribution channels + services,” enabling synergistic interactions between devices and services and accelerating the monetization of market demand.