History & Major Events

US Market Leader Product Generations

The US diabetic test strip market is defined by the product generations of four major manufacturers: LifeScan, Roche, Ascensia, and Abbott.

Key Generational Trends:

1. Sensing Technology: A complete shift from Photometric (light-based) to Electrochemical (current-based) sensing, improving speed and accuracy.

2. Enzyme Chemistry: Evolution from Glucose Oxidase (GOX) to GDH-PQQ (which suffered from maltose interference/safety recalls) to the current standard of GDH-FAD and Mut. Q-GDH, which offer high specificity and oxygen independence.

3. User Experience: Reduction in blood sample volume (from 10µL down to 0.3µL), the elimination of manual coding ("No-Code" systems), and the introduction of "Second-Chance" sampling (Ascensia) to prevent wasted strips.

4. Accuracy: Modern generations (Contour Next, Accu-Chek Guide) utilize multi-pulse technology and complex algorithms to exceed FDA and ISO 15197:2013 accuracy standards.

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US Diabetic Test Strip Market Leaders

The US market is led by four big players: LifeScan, Roche, Ascensia, and Abbott.

They drive innovation and competition.

  • Sensing Tech: Companies shift to electrochemical sensing for faster and more accurate results.
  • Enzyme Chemistry: New enzymes like GDH-PQQ, GDH-FAD, and Mut. Q-GDH boost specificity and independence from oxygen.
  • User Experience: Users now need less blood, no coding, and get a 'Second-Chance' to sample.
  • Accuracy: Modern systems like Contour Next and Accu-Chek Guide exceed FDA and ISO 15197:2013 standards with multi-pulse tech and complex algorithms.

References

  1. Evolution of Self-Monitoring of Blood Glucose (SMBG) TechnologySource
  2. FDA Guidance: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter UseSource

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