Emergence of Alternative Technologies in the Dominated Global CGM Market

Currently, the global continuous glucose monitoring (CGM) market is dominated by major players such as Abbott Laboratories (FreeStyle Libre) and Dexcom (G7), holding approximately 98% of the market share. However, startups are rapidly catching up by incorporating non-invasive or minimally invasive technologies to address patients' fear of needles and the issue of disposable sensor waste. In particular, new technologies utilizing the dermis or ocular tissues are overcoming regulatory hurdles and driving market diversification. This shift is expected to not only improve convenience but also enhance patient compliance, positively impacting long-term diabetes management.

FDA Approval and Innovative Micro-Sensor Technology from Biolinq

One of the most notable innovative companies, Biolinq, received De Novo approval from the U.S. Food and Drug Administration (FDA) for its intradermal micro-sensor, Biolinq Shine, in September 2025. This device implements needle-free blood glucose monitoring by using an array of micro-sensors located in the dermal papillae instead of conventional subcutaneous needles. The device is designed with a built-in light-emitting diode (LED) indicator, allowing patients to intuitively check their blood glucose levels in real-time without a smartphone. In April 2025, Biolinq successfully secured $100 million in Series C funding, paving the way for full-scale commercialization.

Senseonics Accelerates Commercialization of its One-Year Lifespan Implantable Sensor

Publicly traded Senseonics Holdings (SENS) received FDA approval for Eversense 365, which only needs to be implanted once a year, in September 2024, and is accelerating its commercialization. The device consists of a fluorescent polymer sensor implanted subcutaneously, which detects glucose concentration in the interstitial fluid and transmits it to a transmitter. Recently, Senseonics regained exclusive commercialization rights from its existing distribution partner, Ascensia Diabetes Care, and began strengthening its direct marketing efforts. With its strong advantage of annual replacement, it is gaining recognition for targeting the niche market of existing CGMs that require replacement every 10-15 days.

Clinical Progress in Direct Blood Vessel Measurement and Spectroscopic Technology

GlucoTrack (GCTK) is developing a fully implantable CGM system that measures blood glucose directly in real-time by inserting it into the subclavian vein, and is preparing for FDA Investigational Device Exemption (IDE) approval and U.S. clinical trials in the second half of 2026. In a human clinical trial conducted in Brazil with 10 subjects, it recorded an excellent Mean Absolute Relative Difference (MARD) of 7.7%, demonstrating its accuracy. Meanwhile, DiaMonTech of Germany is conducting clinical trials for D-Pocket, which uses mid-infrared spectroscopy (MIR Spectroscopy) to measure blood glucose with just a finger touch, and is expanding the possibilities of non-invasive technology with a MARD of 19.6%.