Introduction to Multi-Analyte Sensing in Continuous [Glucose Monitoring](/) (CGM)
The continuous glucose monitoring (CGM) market is undergoing a significant transformation with the advent of multi-analyte sensing, enabling the simultaneous measurement of glucose alongside other crucial biomarkers such as ketones, lactate, and cortisol [1]. This technological advancement expands the total addressable market (TAM) beyond diabetes management to include athletic performance and critical care.
Key Innovations in Multi-Analyte Sensing
The development of multi-analyte sensing technology has led to several key innovations:
- Glucose + Ketone Monitoring: The most mature pipeline technology, led by Abbott, is designed to prevent diabetic ketoacidosis (DKA) in type 1 diabetes [2]. This innovation has the potential to significantly improve the management of diabetes by providing real-time monitoring of both glucose and ketone levels.
- Glucose + Lactate Monitoring: This technology is targeted at athletes and hospital monitoring for conditions such as sepsis and hypoxia [3]. Startups like PKvitality, with their microneedle technology, and established players are exploring this space, highlighting the growing interest in multi-analyte sensing.
- Underlying Technology: The multi-analyte sensing technology relies on multi-working electrode architectures [4]. In this setup, distinct enzymes (e.g., glucose oxidase and hydroxybutyrate dehydrogenase) share a reference electrode on a single filament, allowing for the simultaneous measurement of multiple analytes.
Challenges in Multi-Analyte Sensing
Despite the promising innovations, several challenges need to be addressed:
- Enzyme Stability: The stability of secondary enzymes is a concern, as they often degrade faster than glucose oxidase [5]. This complicates the sensor lifespan and requires careful consideration in the design and development of multi-analyte sensors.
- Regulatory Hurdles: The validation of dual-analyte devices poses regulatory challenges, as it requires simultaneous validation, which can increase the risk of trial failures [6].
- Manufacturing Complexity: The higher complexity in deposition processes for multi-analyte sensors can reduce yield and increase costs, making it essential to optimize manufacturing processes [7].
Strategic Impact of Multi-Analyte Sensing
The strategic impact of this technology is significant, allowing oligopoly leaders like Abbott and Dexcom to segment the market into medical (Rx) and consumer (OTC) verticals using the same underlying hardware form factors [8]. This segmentation can lead to expanded market reach and increased competitiveness.
Conclusion
In conclusion, multi-analyte sensing in CGM represents a significant advancement in the field, offering improved diabetes management, athletic performance monitoring, and critical care applications. While challenges exist, the potential benefits of this technology make it an exciting and promising area of research and development.