Point-of-Care Testing Devices
The U.S. point-of-care testing device market is growing with rising demand for rapid diagnostics, decentralized testing, and faster clinical decision-making across healthcare settings. Our research provides actionable insights into market size, technology adoption, competitive developments, and investment opportunities across molecular diagnostics, immunoassays, glucose testing, and infectious disease testing devices.
The U.S. Multi-Analyte Point-of-Care Testing Devices Market was valued at USD 1.85 billion in 2025 and is projected to reach USD 5.88 billion by 2035, driven by multiplex molecular testing, rapid critical-care diagnostics, decentralized testing, and CLIA-waived platform adoption.
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The U.S. Multiplex Point-of-Care Testing Devices Market is projected to expand from USD 0.54 billion in 2025 to USD 1.78 billion by 2035 at a 12.67% CAGR, driven by decentralized molecular diagnostics, respiratory multiplex testing, CLIA-waived platforms, and rapid adoption across hospitals and urgent care settings.
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The U.S. Single-Use Point-of-Care Testing Devices Market is projected to grow from USD 10.62 billion in 2025 to USD 31.09 billion by 2035 at an 11.34% CAGR, driven by decentralized diagnostics, rapid molecular testing, disposable cartridges, home testing, urgent-care adoption, and expanding CLIA-waived workflows.
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The U.S. Disposable Point-of-Care Testing Devices Market is projected to grow from USD 11.52 billion in 2025 to USD 28.95 billion by 2035 at a 9.65% CAGR, driven by decentralized testing, disposable molecular diagnostics, respiratory testing, diabetes monitoring, and growing home-based diagnostics.
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The U.S. Benchtop Point-of-Care Testing Devices Market is projected to grow from USD 2.58 billion in 2025 to USD 6.22 billion by 2035 at a 9.20% CAGR, supported by decentralized molecular diagnostics, chronic disease testing, and rapid near-patient clinical workflows.
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The U.S. Handheld Point-of-Care Testing Devices Market is projected to rise from USD 6.48 billion in 2025 to USD 15.77 billion by 2035 at a 9.30% CAGR, driven by decentralized diagnostics, rapid clinical decision-making, connected testing platforms, and expanding hospital and ambulatory POC adoption.
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The U.S. portable POC testing devices market is projected to grow from $8.75B in 2025 to $21.98B by 2035 at a 9.65% CAGR, driven by decentralized diagnostics, rapid molecular testing, connected analyzers, and expansion across hospitals, urgent care, physician offices, and ambulatory settings
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The U.S. Rapid Point-of-Care Testing Devices Market is projected to grow from USD 6.40 billion in 2025 to USD 15.43 billion by 2035, driven by rapid molecular diagnostics, decentralized testing, CLIA-waived platforms, and expanding urgent-care and outpatient adoption.
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The U.S. CLIA-Waived Point-of-Care Testing Devices Market is projected to grow from USD 5.85 billion in 2025 to USD 14.11 billion by 2035 at a 9.20% CAGR, driven by rapid molecular diagnostics, decentralized testing, chronic disease screening, and expansion across physician offices, urgent care centers, pharmacies, and community health settings.
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The U.S. Point-of-Care Diagnostics Devices Market is projected to grow from USD 16.99 billion in 2025 to USD 42.50 billion by 2035, driven by decentralized testing, CLIA-waived diagnostics, molecular POC platforms, rapid infectious disease testing, and expanding home diagnostics.
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