Exclusive Summary

• - Patent barriers for HIV rapid antibody tests are largely expired; market entry hinges on regulatory approval and performance data.
• - About 39 million people live with HIV globally, ~5.4 million remain undiagnosed, and ~1.3 million new infections occur annually, sustaining strong testing demand.
• - WHO lists HIV rapid tests on the Essential Diagnostics List and recommends RDTs as first-line tools for screening and diagnosis in public programs.
• - Despite dozens of WHO-PQ competitors, differentiation is achievable via high-temperature stability, superior sensitivity/specificity, and reliable large-scale supply.
• - With scaled manufacturing, professional-use RDTs can land at US$0.35–0.80/test, well below many branded private-market prices.

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