Summary

Market Size & Trends

The U.S. point of care molecular diagnostics market size was estimated at USD 3.23 billion in 2024 and is expected to grow at a CAGR of 5.45% from 2025 to 2033. The market is centered around rapid and decentralized molecular testing that supports quicker clinical decisions at or near the site of patient care. These diagnostic platforms are increasingly adopted for applications such as infectious disease screening, respiratory tract infections, and sexually transmitted disease detection, driven by the need for immediate and accurate results in outpatient and emergency settings.

Market growth is supported by the rising demand for quick and easy testing outside traditional labs, especially in emergency rooms and clinics. The growing number of infectious disease cases and the need for fast results are pushing the use of point-of-care molecular tests. New technologies, such as portable PCR machines and simple sample processing tools, make these tests more accurate and easier to use. In addition, the focus on faster testing after the COVID-19 pandemic is helping the market grow further.

Moreover, point-of-care molecular diagnostics in primary care settings cover a wide range of uses, from basic glucose tests to more complex blood clotting checks. Many clinics across the U.S. are moving away from traditional lab-based testing to point-of-care methods, which help reduce delays linked to sample handling and transport. This switch allows for quicker decisions during patient visits, leading to faster results, lower costs, and improved care.

In addition, the growing elderly population is expected to support the growth of the U.S. point of care molecular diagnostics industry. Based on the U.S. National Cancer Institute’s SEER Database, 38% of women and 43% of men are likely to develop cancer during their lifetime. Nearly two-thirds of all new cancer cases are found in people aged 65 and older, showing that aging increases vulnerability to cancer. Molecular diagnostics play a key role in managing cancer, infectious diseases, and heart conditions, making them an essential part of timely diagnosis and treatment in older adults.

Furthermore, market players are actively developing new point-of-care molecular testing products to address growing diagnostic needs. In April 2023, Curative, Inc., based in Los Angeles, announced the spin-off of Sensible Diagnostics to commercialize a desktop PCR testing platform. This system is designed to deliver lab-quality results in approximately 10 minutes, at a cost similar to lateral flow antigen tests. It is intended for use in retail clinics, urgent care centers, and other near-patient environments.

In August 2023, Sensible Diagnostics received a NIH RADx Tech award of approximately USD 1 million to support the development of a multiplex respiratory viral panel for point-of-care use. These efforts reflect growing investment in rapid, accurate molecular testing solutions that support timely diagnosis and improve clinical workflows across decentralized care settings.

U.S. Point of Care Molecular Diagnostics Market Report Segmentation

This report forecasts revenue growth and provides an analysis of the latest trends in each of the sub-segments from 2021 to 2033. For this report, Grand View Research has segmented the U.S. point of care molecular diagnostics market report based on application, technology, test location, and end-use:

• Technology Outlook (Revenue, USD Million, 2021 - 2033)
• PCR-based
• Genetic Sequencing-based
• Hybridization-based
• Microarray-based
• Application Outlook (Revenue, USD Million, 2021 - 2033)
• Infectious Diseases
o HIV POC
o Clostridium difficile POC
o HBV POC
o Pneumonia or Streptococcus associated infections
o Respiratory syncytial virus (RSV) POC
o HPV POC
o Influenza/Flu POC
o HCV POC
o MRSA POC
o TB and drug-resistant TB POC
o HSV POC
o Other Infectious Diseases
• Oncology
• Hematology
o Complete blood count (CBC)
o Prothrombin time (PT)
o Partial Thromboplastin Time (PTT)
o Others
• Prenatal Testing
• Endocrinology
• Other Applications
• Test Location Outlook (Revenue, USD Million, 2021 - 2033)
• OTC
• POC
• End-use Outlook (Revenue, USD Million, 2021 - 2033)
• Decentralized Labs
• Hospitals
• Home-care
• Assisted Living Healthcare Facilities
• Others

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Table of Contents

Table of Contents

Chapter 1. Methodology and Scope
1.1. Market Segmentation & Scope
1.2. Segment Definitions
1.2.1. Test Location
1.2.2. Application
1.2.3. Technology
1.2.4. End Use
1.2.5. Estimates and forecasts timeline
1.3. Research Methodology
1.4. Information Procurement
1.4.1. Purchased database
1.4.2. GVR’s internal database
1.4.3. Secondary sources
1.4.4. Primary research
1.4.5. Details of primary research
1.4.5.1. Data for primary interviews in the U.S.
1.5. Information or Data Analysis
1.5.1. Data analysis models
1.6. Market Formulation & Validation
1.7. Model Details
1.7.1. Commodity flow analysis (Model 1)
1.7.2. Approach 1: Commodity flow approach
1.7.3. Volume price analysis (Model 2)
1.7.4. Approach 2: Volume price analysis
1.8. List of Secondary Sources
1.9. List of Primary Sources
1.10. Objectives
Chapter 2. Executive Summary
2.1. Market Outlook
2.2. Segment Outlook
2.2.1. Test Location and Application Snapshot
2.2.2. Technology Snapshot
2.2.3. End Use Snapshot
2.3. Competitive Insights
Chapter 3. U.S. Point-of-Care Molecular Diagnostics Market Variables, Trends & Scope
3.1. Market Lineage Outlook
3.1.1. Parent market outlook
3.1.2. Related/ancillary market outlook
3.2. Market Dynamics
3.2.1. Market driver analysis
3.2.1.1. Growing demand for rapid and decentralized testing
3.2.1.2. Rising prevalence of infectious diseases
3.2.1.3. Technological advancements in molecular platforms
3.2.2. Market restraint analysis
3.2.2.1. High cost of molecular POC devices and consumables
3.2.2.2. Regulatory and quality assurance challenges
3.3. U.S. Point-of-Care Molecular Diagnostics Market Analysis Tools
3.3.1. Industry Analysis – Porter’s
3.3.1.1. Supplier power
3.3.1.2. Buyer power
3.3.1.3. Substitution threat
3.3.1.4. Threat of new entrants
3.3.1.5. Competitive rivalry
3.3.2. PESTEL Analysis
3.3.2.1. Political landscape
3.3.2.2. Technological landscape
3.3.2.3. Economic landscape
Chapter 4. Technology Business Analysis
4.1. Point-of-Care Molecular Diagnostics Market: Technology Movement Analysis
4.2. PCR-based
4.2.1. PCR-based market, 2021 - 2033 (USD Million)
4.3. Genetic Sequencing-based
4.3.1. Genetic Sequencing-based market, 2021 - 2033 (USD Million)
4.4. Hybridization-based
4.4.1. Hybridization-based market, 2021 - 2033 (USD Million)
4.5. Microarray-based
4.5.1. Microarray-based market, 2021 - 2033 (USD Million)
Chapter 5. Application Business Analysis
5.1. Point-of-Care Molecular Diagnostics Market: Application Movement Analysis
5.2. Infectious Diseases
5.2.1. Infectious Diseases market, 2021 - 2033 (USD Million)
5.2.2. HIV POC
5.2.2.1. HIV POC market, 2021 - 2033 (USD Million)
5.2.3. Clostridium difficile POC
5.2.3.1. Clostridium difficile POC market, 2021 - 2033 (USD Million)
5.2.4. HBV POC
5.2.4.1. HBV POC market, 2021 - 2033 (USD Million)
5.2.5. Pneumonia or Streptococcus associated infections
5.2.5.1. Pneumonia or Streptococcus associated infections market, 2021 - 2033 (USD Million)
5.2.6. Respiratory Syncytial Virus (RSV) POC
5.2.6.1. Respiratory Syncytial Virus (RSV) POC market, 2021 - 2033 (USD Million)
5.2.7. HPV POC
5.2.7.1. HPV POC market, 2021 - 2033 (USD Million)
5.2.8. Influenza/Flu POC
5.2.8.1. Influenza/Flu POC market, 2021 - 2033 (USD Million)
5.2.9. HCV POC
5.2.9.1. HCV POC market, 2021 - 2033 (USD Million)
5.2.10. MRSA POC
5.2.10.1. MRSA POC market, 2021 - 2033 (USD Million)
5.2.11. TB and drug-resistant TB POC
5.2.11.1. TB and drug-resistant TB POC market, 2021 - 2033 (USD Million)
5.2.12. HSV POC
5.2.12.1. HSV POC market, 2021 - 2033 (USD Million)
5.2.13. Other Infectious Diseases
5.2.13.1. Other Infectious Diseases market, 2021 - 2033 (USD Million)
5.3. Oncology
5.3.1. Oncology market, 2021 - 2033 (USD Million)
5.4. Hematology
5.4.1. Hematology market, 2021 - 2033 (USD Million)
5.4.2. Complete blood count (CBC)
5.4.2.1. Complete blood count (CBC) market, 2021 - 2033 (USD Million)
5.4.3. Prothrombin time (PT)
5.4.3.1. Prothrombin time (PT) market, 2021 - 2033 (USD Million)
5.4.4. Partial Thromboplastin Time (PTT)
5.4.4.1. Partial Thromboplastin Time (PTT) market, 2021 - 2033 (USD Million)
5.4.5. Others
5.4.5.1. Others market, 2021 - 2033 (USD Million)
5.5. Prenatal Testing
5.5.1. Prenatal Testing market, 2021 - 2033 (USD Million)
5.6. Endocrinology
5.6.1. Endocrinology market, 2021 - 2033 (USD Million)
5.7. Others
5.7.1. Others market, 2021 - 2033 (USD Million)
Chapter 6. Test Location Business Analysis
6.1. Point-of-Care Molecular Diagnostics Market: Test Location Movement Analysis
6.2. OTC
6.2.1. OTC market, 2021 - 2033 (USD Million)
6.3. POC
6.3.1. POC market, 2021 - 2033 (USD Million)
Chapter 7. End Use Business Analysis
7.1. Point-of-Care Molecular Diagnostics Market: End Use Movement Analysis
7.2. Decentralized Labs
7.2.1. Decentralized Labs market, 2021 - 2033 (USD Million)
7.3. Hospitals
7.3.1. Hospitals market, 2021 - 2033 (USD Million)
7.4. Home-care
7.4.1. Home-care market, 2021 - 2033 (USD Million)
7.5. Assisted Living Healthcare Facilities
7.5.1. Assisted Living Healthcare Facilities market, 2021 - 2033 (USD Million)
7.6. Others
7.6.1. Others market, 2021 - 2033 (USD Million)
Chapter 8. Competitive Landscape
8.1. Company Categorization
8.2. Strategy Mapping
8.2.1. New Products and Services Launch
8.2.2. Partnerships
8.2.3. Acquisition
8.2.4. Collaboration
8.2.5. Funding
8.3. Key Company Market Share Analysis, 2024
8.4. Company Heat Map Analysis
8.5. Company Profiles
8.5.1. QIAGEN
8.5.1.1. Company Overview
8.5.1.2. Financial Performance
8.5.1.3. Products and Services Benchmarking
8.5.1.4. Strategic Initiatives
8.5.2. DANAHER
8.5.2.1. Company Overview
8.5.2.2. Financial Performance
8.5.2.3. Products and Services Benchmarking
8.5.2.4. Strategic Initiatives
8.5.3. THERMO FISHER SCIENTIFIC, INC.
8.5.3.1. Company Overview
8.5.3.2. Financial Performance
8.5.3.3. Products and Services Benchmarking
8.5.3.4. Strategic Initiatives
8.5.4. BD
8.5.4.1. Company Overview
8.5.4.2. Financial Performance
8.5.4.3. Products and Services Benchmarking
8.5.4.4. Strategic Initiatives
8.5.5. F. HOFFMAN-LA ROCHE AG
8.5.5.1. Company Overview
8.5.5.2. Financial Performance
8.5.5.3. Products and Services Benchmarking
8.5.5.4. Strategic Initiatives
8.5.6. CHARLES RIVER LABORATORIES
8.5.6.1. Company Overview
8.5.6.2. Financial Performance
8.5.6.3. Products and Services Benchmarking
8.5.6.4. Strategic Initiatives
8.5.7. QUEST DIAGNOSTICS INCORPORATED
8.5.7.1. Company Overview
8.5.7.2. Financial Performance
8.5.7.3. Products and Services Benchmarking
8.5.7.4. Strategic Initiatives
8.5.8. BIO-RAD LABORATORIES, INC.
8.5.8.1. Company Overview
8.5.8.2. Financial Performance
8.5.8.3. Products and Services Benchmarking
8.5.8.4. Strategic Initiatives
8.5.9. HOLOGIC INC.
8.5.9.1. Company Overview
8.5.9.2. Financial Performance
8.5.9.3. Products and Services Benchmarking
8.5.9.4. Strategic Initiatives
8.5.10. AGILENT TECHNOLOGIES, INC.
8.5.10.1. Company Overview
8.5.10.2. Financial Performance
8.5.10.3. Products and Services Benchmarking
8.5.10.4. Strategic Initiatives