Point-of-care testing is the fastest-growing site-of-testing segment in IVD globally — expected to grow at a CAGR approximately double that of central laboratory testing through 2030. The COVID-19 pandemic permanently shifted patient and clinician expectations toward faster, more convenient diagnostic results — and the IVD industry is responding with a new generation of connected, miniaturized, and multiplex POC platforms. Abbott's i-STAT and ID NOW, Roche's cobas Liat, bioMérieux's BIOFIRE FILMARRAY, and Siemens' point-of-care portfolio are competing across emergency departments, physician offices, urgent care centers, and increasingly the home. The regulatory pathway for home-use IVD — FDA OTC clearance and the EU IVDR self-test classification — has become more navigable as the COVID-19 home test market demonstrated consumer readiness at scale.
This report provides significant competitor information, analysis, and insight critical to the development and implementation of effective marketing and R&D programs.
Topics Covered
• POC and Decentralized Testing Market Size and Forecast 2025-2030 by Segment and Region
• Emergency Department POC — Critical Care, Cardiac, and Rapid Infectious Disease Testing
• Physician Office and Urgent Care — Respiratory, Strep, Flu, and Metabolic Testing
• Home Testing — COVID-19, Pregnancy, STI, and Chronic Disease Monitoring
• Connected POC Platforms — Bluetooth, Cloud Connectivity, and EHR Integration
• Multiplex POC Testing — Syndromic Panels at the Point of Care
• CLIA Waiver Strategy — Regulatory Path for POC Test Deployment in the U.S.
• Competitive Landscape — Abbott, Roche, bioMérieux, Siemens, BD, and New Entrants
• Regional Analysis — POC Adoption and Decentralization Trends Across 92 Countries
• Investment and Partnership Opportunities — Platform Technology and Channel Access
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Table of Contents
1. Executive Summary
- Key findings and strategic implications
- Highest-priority opportunities
- Competitive landscape summary
- Strategic recommendations
2. Market Overview
- Market definition, scope and segmentation by site of testing
- Key demand drivers and restraints
- Regulatory environment — CLIA waiver, FDA OTC, and EU IVDR self-test
3. Emergency Department POC
- Critical care and cardiac testing at the bedside
- Rapid infectious disease testing
- Platform competition — Abbott, Roche, Siemens, and bioMérieux
4. Physician Office and Urgent Care
- Respiratory and infectious disease testing
- Metabolic and chronic disease monitoring
- CLIA waiver strategy and channel dynamics
5. Home Testing
- OTC market development and regulatory framework
- Consumer behavior and adoption drivers
- Subscription models and telehealth integration
6. Connected POC Platforms
- Bluetooth and cloud connectivity
- EHR integration and result capture
- Population health analytics from connected POC data
7. Multiplex POC Testing
- Syndromic panels at the physician office level
- Quantitative multiplex platforms
- Technology development and competitive landscape
8. Competitive Landscape
- Abbott, Roche, bioMérieux, Siemens, BD, and new entrants
- Consumer diagnostics companies entering the POC space
- M&A and partnership activity 2023-2025
9. Regional Market Analysis
- 9.1 North America (U.S., Canada, Mexico)
- 9.2 Europe (38 countries)
- 9.3 Asia-Pacific (18 countries)
- 9.4 Latin America (22 countries)
- 9.5 Middle East (11 countries)
- 9.6 Africa and Rest of World
10. Strategic Conclusions and Recommendations
- Highest-priority opportunities by site and region
- Market entry and expansion strategies
- Platform technology and channel access priorities
11. Appendix
- Research methodology
- Abbreviations and definitions
- List of tables and figures
List of Tables
Table 1. Emergency Department POC — Platform Comparison and Leading Suppliers 2025
Table 2. Physician Office and Urgent Care POC — Application Landscape 2025
Table 3. Home Testing — Market Segments and Regulatory Framework by Region 2025
Table 4. Connected POC Platforms — Connectivity Standards and Leading Suppliers 2025
Table 5. Multiplex POC Testing — Product Landscape and Development Pipeline 2025
Table 6. CLIA Waiver Status by Test Category 2025
Table 7. Leading Suppliers and Competitive Positioning 2025
Table 8. M&A and Partnership Activity 2023-2025
Table 9. Regulatory Pathway Summary by Site of Testing and Region 2025
Table 10. Key Risks and Mitigation Strategies
Abbott Diagnostics
Bio-Rad Laboratories
bioMérieux
Danaher (Beckman Coulter, Cepheid, Radiometer)
DiaSorin
Hologic
QuidelOrtho
Roche Diagnostics
Siemens Healthineers
Sysmex
