Domestic Substitution Accelerates: New Opportunities for China's Biosensor Electrode Industry

The Strategic Urgency of Domestic Substitution

For a long time, high-precision biosensor electrodes—especially precious-metal bioelectrodes used in blood glucose monitoring, blood ketone testing, and blood gas analysis—have relied heavily on imports. Imported electrodes typically require lead times of 8–12 weeks or longer, and expose buyers to supply-chain risks from exchange-rate volatility and shifts in the international trade environment; should a critical material be cut off, downstream IVD production lines could grind to a halt. At the same time, imported electrodes often account for more than 30% of a POCT strip's material cost, with little room for negotiation, directly eroding domestic manufacturers' margins and pricing flexibility. Against the backdrop of medical-device self-reliance, domestic substitution of core electrode materials has shifted from an option to a necessity.

Policy and Market Opportunities

In recent years, China has rolled out sustained policies to promote the localization of high-end medical devices and critical components, with in vitro diagnostics included in key support catalogs in many provinces. Volume-based procurement and priority review mechanisms are also guiding end brands to evaluate domestic supply chains first. On the market side, China's POCT sector continues to grow at double-digit rates, while home self-testing scenarios such as blood glucose monitoring, blood ketone testing, and uric acid and lactate testing are expanding rapidly, driving upstream electrode demand in tandem. For domestic electrode makers with nanoscale precision-manufacturing capability, this is a rare window of opportunity.

Technical Breakthroughs: From "Can Make" to "Can Make Consistently"

For domestically produced precious-metal electrodes to truly replace imports, the key lies not in single-point performance but in three indicators:

• Film-thickness uniformity: the thickness of gold or platinum functional layers directly affects electron-transfer rates and background noise, requiring magnetron sputtering to keep thickness deviation at the nanoscale;
• Batch-to-batch consistency: IVD strips are high-volume consumables, and inter-batch variation translates directly into the coefficient of variation (CV) of test results;
• Yield and cost: only at high yield and scale can domestic electrodes deliver a genuine, sustainable cost advantage.

Magnetron sputtering—vacuum coating by atom-by-atom deposition—is the core process route to these goals, producing dense, strongly adherent, and highly repeatable films that are naturally suited to the mass production of precious-metal bioelectrodes.

Huili Biotech's Domestic-Substitution Practice

Founded in August 2023 in the Changzhou Science and Education Town, Jiangsu, Huili Biotech (Changzhou) Co., Ltd. focuses on the R&D and manufacturing of magnetron-sputtered precious-metal biosensor electrodes. The company has built a complete production line covering sputtered gold electrodes (Au ≥ 99.99%), sputtered platinum electrodes, sputtered silver electrodes, screen-printed carbon electrodes, and alloy/ceramic electrodes, achieving ±5% film-thickness control, batch CV ≤ 5%, and annual capacity exceeding one million pieces. Leveraging Changzhou's location in the Yangtze River Delta and the Science and Education Town industrial cluster, Huili Biotech offers domestic IVD/POCT customers rapid-response service—1–2 weeks for samples and 2–4 weeks for batch delivery, with an MOQ from 1,000 pieces—significantly shortening the cycle from design validation to mass-production introduction for new products.

The Value of Domestic Electrodes for IVD Companies

The value of domestic substitution ultimately shows up in customers' operating metrics: shorter lead times mean lower safety stock and faster cash-flow turnover; local technical collaboration allows joint optimization of electrode patterns, film structures, and strip formulations; and scaled domestic manufacturing creates sustainable cost headroom. For companies developing blood glucose, blood ketone, blood gas, and continuous glucose monitoring (CGM) products, choosing a domestic electrode partner with precision vacuum-coating capability and a robust consistency-control system safeguards both supply-chain security and product competitiveness. Huili Biotech looks forward to advancing the localization of core electrodes together with industry partners through its OEM/ODM model.