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Point of Care Molecular Diagnostics Market - Global Forecast 2025-2032

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    Report

  • 191 Pages
  • November 2025
  • Region: Global
  • 360iResearch™
  • ID: 5639415
UP TO OFF until Jan 01st 2026
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The point of care molecular diagnostics market is rapidly evolving, driven by urgent demand for rapid, reliable, and decentralized testing to support timely clinical decisions across diverse healthcare environments.

Market Snapshot: Point of Care Molecular Diagnostics

The Point of Care Molecular Diagnostics Market grew from USD 5.26 billion in 2024 to USD 5.64 billion in 2025. It is expected to continue growing at a CAGR of 7.61%, reaching USD 9.47 billion by 2032. This growth highlights expanding adoption among healthcare providers seeking streamlined, near-patient diagnostic capabilities for infectious diseases, genetic testing, and oncology, alongside increasing technological integration. The market is shifting towards advanced software and intelligent platforms, supporting data-driven care and efficient health system operations.

Scope & Segmentation

  • Product Types: Instruments, reagents & kits, and software solutions power real-time molecular analysis and robust data management.
  • Technologies: Includes genetic sequencing-based, hybridization-based, isothermal nucleic acid amplification technology (INAAT), microarray-based, and PCR-based methodologies, enabling a range of rapid testing platforms.
  • Applications: Cardiology, genetic testing (carrier screening, newborn screening, prenatal testing), infectious disease (gastrointestinal, respiratory, sexually transmitted, tropical), and oncology (liquid biopsy, mutation profiling, oncogene panels).
  • End Users: Clinics, diagnostic laboratories, home care settings, and hospitals deploy point of care molecular diagnostics for decentralized and integrated care pathways.
  • Geographies: Coverage includes Americas (North America, Latin America), Europe, Middle East & Africa, and Asia-Pacific—with granular insight across key countries such as the United States, Canada, Brazil, United Kingdom, Germany, China, Japan, Australia, and others.
  • Companies Profiled: Notable players include Abbott Laboratories, Becton, Dickinson and Company, ACON LABS INC., Binx Health, bioMérieux SA, Cardinal Health, Chembio Diagnostics, Co-Diagnostics, Danaher Corporation, DiaSorin, EKF Diagnostics Holdings, FHoffmann-La Roche AG, Genomadix, Henry Schein, Meridian Bioscience, Novartis AG, OraSure Technologies, Pfizer, QIAGEN, Quidel Corporation, SD Biosensor, Sekisui Diagnostics, SHUWEN BIOTECH, Siemens Healthineers, Sysmex Corporation, Thermo Fisher Scientific, among others.

Key Takeaways for Senior Decision-Makers

  • Portable and benchtop solutions now deliver near-laboratory quality diagnostics directly at the patient interface, reducing the turnaround from sample to action.
  • Integration of software and cloud-based analytics enables remote monitoring, proactive patient management, and seamless workflow integration with electronic health records.
  • Segment-specific innovation addresses cardiology, genetic testing, infectious disease, and oncology applications, supporting more precise and rapid clinical pathways.
  • Decentralized testing is expanding beyond hospitals, with adoption in clinics, home care, and remote settings driving patient-centric models.
  • Regional adoption dynamics vary, with North America advancing emergency preparedness, Europe focusing on value-based care, and Asia-Pacific leveraging manufacturing capacities for cost and scale efficiencies.
  • Strategic collaboration across manufacturers, reagent suppliers, and technology startups enables market leaders to continuously evolve diagnostic offerings and maintain a competitive edge.

Tariff Impact on Industry Dynamics

Recent tariff schedule adjustments in 2025 have altered cost structures for point of care molecular diagnostics, impacting both manufacturers and healthcare providers. Import duties on instruments, reagents, and software have prompted a reevaluation of procurement strategies, driving increased sourcing from alternative geographies and adaptation of pricing models. Regulatory requirements for documentation and customs clearance intensified, with companies focusing on local partnerships and production to maintain product availability and supply resilience.

Methodology & Data Sources

This analysis is based on a rigorous research framework combining secondary source review, primary expert interviews with executives and laboratory directors, and systematic multi-layer validation. Data triangulation with press releases, trade associations, and company disclosures supports accuracy. Additional quality assurance included peer review and updates regarding geopolitical and tariff considerations.

Why This Report Matters

  • Senior executives and decision-makers gain actionable insights for strategic planning, procurement optimization, and investment in point of care molecular diagnostics.
  • Comprehensive segmentation and regional coverage help organizations identify growth opportunities tailored to specific clinical applications and geographic markets.
  • The report’s forward-looking analysis supports technology selection, partnership strategies, and navigation of regulatory and trade policy shifts.

Conclusion

Point of care molecular diagnostics is accelerating the shift toward decentralized and data-driven healthcare delivery. Organizations aligning innovation with clinical and operational needs will sustain growth and realize meaningful impact across the care continuum.

 

Additional Product Information:

  • Purchase of this report includes 1 year online access with quarterly updates.
  • This report can be updated on request. Please contact our Customer Experience team using the Ask a Question widget on our website.

Table of Contents

1. Preface
1.1. Objectives of the Study
1.2. Market Segmentation & Coverage
1.3. Years Considered for the Study
1.4. Currency & Pricing
1.5. Language
1.6. Stakeholders
2. Research Methodology
3. Executive Summary
4. Market Overview
5. Market Insights
5.1. Integration of CRISPR-based detection methods into portable point-of-care platforms for rapid pathogen identification
5.2. Adoption of smartphone-enabled molecular diagnostic devices for decentralized patient testing
5.3. Implementation of AI-driven predictive analytics in point-of-care molecular diagnostic result interpretation
5.4. Expansion of multiplex PCR assays for simultaneous detection of multiple infectious diseases at point of care
5.5. Development of isothermal amplification technologies for low-cost, field-deployable molecular testing solutions
5.6. Regulatory approvals accelerating commercialization of next-generation cartridge-based molecular diagnostic systems
5.7. Partnerships between diagnostics firms and telehealth providers to streamline remote molecular testing workflows
5.8. Growth of home-based molecular testing kits for at-home infectious disease monitoring and management
5.9. Emergence of paper-based microfluidic platforms for ultra-low-cost point-of-care molecular diagnostics in resource-limited settings
5.10. Increasing demand for rapid oncology biomarker assays in outpatient clinics and decentralized care settings
6. Cumulative Impact of United States Tariffs 2025
7. Cumulative Impact of Artificial Intelligence 2025
8. Point of Care Molecular Diagnostics Market, by Product Type
8.1. Instruments
8.2. Reagents & Kits
8.3. Software
9. Point of Care Molecular Diagnostics Market, by Technology
9.1. Genetic Sequencing-based
9.2. Hybridization-based
9.3. Isothermal Nucleic Acid Amplification Technology (INAAT)
9.4. Microarray-based
9.5. PCR-based
10. Point of Care Molecular Diagnostics Market, by Application
10.1. Cardiology
10.2. Genetic Testing
10.2.1. Carrier Screening
10.2.2. Newborn Screening
10.2.3. Prenatal Testing
10.3. Infectious Disease
10.3.1. Gastrointestinal Infections
10.3.2. Respiratory Infections
10.3.3. Sexually Transmitted Infections
10.3.4. Tropical Diseases
10.4. Oncology
10.4.1. Liquid Biopsy
10.4.2. Mutation Profiling
10.4.3. Oncogene Panel
11. Point of Care Molecular Diagnostics Market, by End User
11.1. Clinics
11.2. Diagnostic Laboratories
11.3. Home Care Settings
11.4. Hospitals
12. Point of Care Molecular Diagnostics Market, by Region
12.1. Americas
12.1.1. North America
12.1.2. Latin America
12.2. Europe, Middle East & Africa
12.2.1. Europe
12.2.2. Middle East
12.2.3. Africa
12.3. Asia-Pacific
13. Point of Care Molecular Diagnostics Market, by Group
13.1. ASEAN
13.2. GCC
13.3. European Union
13.4. BRICS
13.5. G7
13.6. NATO
14. Point of Care Molecular Diagnostics Market, by Country
14.1. United States
14.2. Canada
14.3. Mexico
14.4. Brazil
14.5. United Kingdom
14.6. Germany
14.7. France
14.8. Russia
14.9. Italy
14.10. Spain
14.11. China
14.12. India
14.13. Japan
14.14. Australia
14.15. South Korea
15. Competitive Landscape
15.1. Market Share Analysis, 2024
15.2. FPNV Positioning Matrix, 2024
15.3. Competitive Analysis
15.3.1. Abbott Laboratories
15.3.2. Becton, Dickinson and Company
15.3.3. ACON LABS INC.
15.3.4. Binx Health, inc.
15.3.5. bioMérieux SA
15.3.6. Cardinal Health, Inc.
15.3.7. Chembio Diagnostics Inc.
15.3.8. Co-Diagnostics, Inc.
15.3.9. Danaher Corporation
15.3.10. DiaSorin S.p.A
15.3.11. EKF Diagnostics Holdings
15.3.12. FHoffmann-La Roche AG
15.3.13. Genomadix Inc. by LuminUltra Technologies Ltd.
15.3.14. Henry Schein, Inc.
15.3.15. Meridian Bioscience, Inc.
15.3.16. Novartis AG
15.3.17. OraSure Technologies, Inc.
15.3.18. Pfizer, Inc.
15.3.19. QIAGEN N.V.
15.3.20. Quidel Corporation
15.3.21. SD Biosensor
15.3.22. Sekisui Diagnostics
15.3.23. SHUWEN BIOTECH CO., LTD
15.3.24. Siemens Healthineers AG
15.3.25. Sysmex Corporation
15.3.26. Thermo Fisher Scientific Inc.

Companies Mentioned

The companies profiled in this Point of Care Molecular Diagnostics market report include:
  • Abbott Laboratories
  • Becton, Dickinson and Company
  • ACON LABS INC.
  • Binx Health, inc.
  • bioMérieux SA
  • Cardinal Health, Inc.
  • Chembio Diagnostics Inc.
  • Co-Diagnostics, Inc.
  • Danaher Corporation
  • DiaSorin S.p.A
  • EKF Diagnostics Holdings
  • FHoffmann-La Roche AG
  • Genomadix Inc. by LuminUltra Technologies Ltd.
  • Henry Schein, Inc.
  • Meridian Bioscience, Inc.
  • Novartis AG
  • OraSure Technologies, Inc.
  • Pfizer, Inc.
  • QIAGEN N.V.
  • Quidel Corporation
  • SD Biosensor
  • Sekisui Diagnostics
  • SHUWEN BIOTECH CO., LTD
  • Siemens Healthineers AG
  • Sysmex Corporation
  • Thermo Fisher Scientific Inc.

Table Information