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If we start right at the turn of the century, around 2000 or 2001, that's when most of the volatility began to creep in, and the dynamics in terms of market share started to change globally. I'll describe the instrumentation that was out there. There were really four primary players at that time. The Coulter brand, Beckman Coulter, still held the global number one position, largely driven by dominance in the US market. Sysmex had started to make significant inroads into Europe and Asia-Pacific because they had products and solutions geared towards those markets.
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Sysmex implemented two crucial innovations. First, they concentrated a reagent and developed a reconstitution capability, which they had already tested as a proof of concept during the E-5000 days in their commercial labs in Japan before introducing it to the West.
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Secondly, they adapted their reagent system to stabilize red cells in blood samples older than eight, 10, or 12 hours. As cells age in a blood tube, they lose their ability to maintain size integrity, causing them to swell when placed in a diluent. This is problematic for diagnostic work in hematology. Sysmex's reagent system addressed this issue, whereas Beckman Coulter's reagent system naturally stabilized the process due to its different tonicity, although it didn't completely eliminate the problem. These two innovations were pivotal for the commercial reference laboratory.
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