U.S. Point of Care Molecular Diagnostics Market Size, Share & Trends Analysis Report By Test Location (OTC, POC), By Application (Infectious Diseases, Oncology, Prenatal Testing), By Technology, By End-use (Decentralized Labs, Hospitals), And Segment Forecasts, 2025

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, the analyst 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
HIV POC
Clostridium difficile POC
HBV POC
Pneumonia or Streptococcus associated infections
Respiratory syncytial virus (RSV) POC
HPV POC
Influenza/Flu POC
HCV POC
MRSA POC
TB and drug-resistant TB POC
HSV POC
Other Infectious Diseases
Oncology
Hematology
Complete blood count (CBC)
Prothrombin time (PT)
Partial Thromboplastin Time (PTT)
Others
Prenatal Testing
Endocrinology
Other Applications

Test Location Outlook (Revenue, USD Million, 2021 - 2033)

End-use Outlook (Revenue, USD Million, 2021 - 2033)

Decentralized Labs
Hospitals
Home-care
Assisted Living Healthcare Facilities
Others

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Market estimates and forecasts from 2018 to 2030
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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. 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

List of Tables

Table 1 List of abbreviations
Table 2 U.S. Point-of-Care Molecular Diagnostics market, by test location, 2021 - 2033 (USD Million)
Table 3 U.S. Point-of-Care Molecular Diagnostics market, by application, 2021- 2033 (USD Million)
Table 4 U.S. Point-of-Care Molecular Diagnostics market, by technology, 2021 - 2033 (USD Million)
Table 5 U.S. Point-of-Care Molecular Diagnostics market, by end use, 2021 - 2033 (USD Million)

List of Figures

Fig. 1 Market research process
Fig. 2 Data triangulation techniques
Fig. 3 Primary research pattern
Fig. 4 Primary interviews in the U.S.
Fig. 5 Market research approaches
Fig. 6 Value-chain-based sizing & forecasting
Fig. 7 QFD modeling for market share assessment
Fig. 8 Market formulation & validation
Fig. 9 U.S. Point-of-Care Molecular Diagnostics market: market outlook
Fig. 10 U.S. Point-of-Care Molecular Diagnostics competitive insights
Fig. 11 Parent market outlook
Fig. 12 Related/ancillary market outlook
Fig. 13 Penetration and growth prospect mapping
Fig. 14 Industry value chain analysis
Fig. 15 U.S. Point-of-Care Molecular Diagnostics market driver impact
Fig. 16 U.S. Point-of-Care Molecular Diagnostics market restraint impact
Fig. 17 U.S. Point-of-Care Molecular Diagnostics market strategic initiatives analysis
Fig. 18 U.S. Point-of-Care Molecular Diagnostics market: Application movement analysis
Fig. 19 U.S. Point-of-Care Molecular Diagnostics market: Application outlook and key takeaways
Fig. 20 Point-of-Care Molecular Diagnostics Infectious Diseases market, 2021 - 2033 (USD Million)
Fig. 21 Point-of-Care Molecular Diagnostics HIV POC market, 2021 - 2033 (USD Million)
Fig. 22 Point-of-Care Molecular Diagnostics Clostridium difficile POC market, 2021 - 2033 (USD Million)
Fig. 23 Point-of-Care Molecular Diagnostics HBV POC market, 2021 - 2033 (USD Million)
Fig. 24 Point-of-Care Molecular Diagnostics Pneumonia or Streptococcus associated infections market, 2021 - 2033 (USD Million)
Fig. 25 Point-of-Care Molecular Diagnostics Respiratory syncytial virus (RSV) POC market, 2021 - 2033 (USD Million)
Fig. 26 Point-of-Care Molecular Diagnostics HPV POC market, 2021 - 2033 (USD Million)
Fig. 27 Point-of-Care Molecular Diagnostics Influenza/Flu POC market, 2021 - 2033 (USD Million)
Fig. 28 Point-of-Care Molecular Diagnostics HCV POC market, 2021 - 2033 (USD Million)
Fig. 29 Point-of-Care Molecular Diagnostics MRSA POC market, 2021 - 2033 (USD Million)
Fig. 30 Point-of-Care Molecular Diagnostics TB and drug-resistant TB POC market, 2021 - 2033 (USD Million)
Fig. 31 Point-of-Care Molecular Diagnostics HSV POC market, 2021 - 2033 (USD Million)
Fig. 32 Point-of-Care Molecular Diagnostics Other Infectious Diseases market, 2021 - 2033 (USD Million)
Fig. 33 Point-of-Care Molecular Diagnostics Oncology market, 2021 - 2033 (USD Million)
Fig. 34 Point-of-Care Molecular Diagnostics Hematology market, 2021 - 2033 (USD Million)
Fig. 35 Point-of-Care Molecular Diagnostics Complete blood count (CBC) market, 2021 - 2033 (USD Million)
Fig. 36 Point-of-Care Molecular Diagnostics Prothrombin time (PT) market, 2021 - 2033 (USD Million)
Fig. 37 Point-of-Care Molecular Diagnostics Partial Thromboplastin Time (PTT) market, 2021 - 2033 (USD Million)
Fig. 38 Point-of-Care Molecular Diagnostics Others market, 2021 - 2033 (USD Million)
Fig. 39 Point-of-Care Molecular Diagnostics Prenatal Testing market, 2021 - 2033 (USD Million)
Fig. 40 Point-of-Care Molecular Diagnostics Endocrinology market, 2021 - 2033 (USD Million)
Fig. 41 Point-of-Care Molecular Diagnostics Other Applications market, 2021 - 2033 (USD Million)
Fig. 42 U.S. Point-of-Care Molecular Diagnostics market: Technology movement Analysis
Fig. 43 U.S. Point-of-Care Molecular Diagnostics market: Technology outlook and key takeaways
Fig. 44 Point-of-Care Molecular Diagnostics PCR-based market, 2021 - 2033 (USD Million)
Fig. 45 Point-of-Care Molecular Diagnostics Genetic Sequencing-based market, 2021 - 2033 (USD Million)
Fig. 46 Point-of-Care Molecular Diagnostics Hybridization-based market, 2021 - 2033 (USD Million)
Fig. 47 Point-of-Care Molecular Diagnostics Microarray-based market, 2021 - 2033 (USD Million)
Fig. 48 Point-of-care Molecular Diagnostics revenue share, by test location, 2021 - 2033
Fig. 49 Point-of-Care Molecular Diagnostics OTC market, 2021 - 2033 (USD Million)
Fig. 50 Point-of-Care Molecular Diagnostics POC market, 2021 - 2033 (USD Million)
Fig. 51 U.S. Point-of-Care Molecular Diagnostics market: End Use movement analysis
Fig. 52 U.S. Point-of-Care Molecular Diagnostics market: End Use outlook and key takeaways
Fig. 53 Point-of-Care Molecular Diagnostics Decentralized Labs market, 2021 - 2033 (USD Million)
Fig. 54 Point-of-Care Molecular Diagnostics Hospitals market, 2021 - 2033 (USD Million)
Fig. 55 Point-of-Care Molecular Diagnostics Home-care market, 2021 - 2033 (USD Million)
Fig. 56 Point-of-Care Molecular Diagnostics Assisted Living Healthcare Facilities market, 2021 - 2033 (USD Million)
Fig. 57 Point-of-Care Molecular Diagnostics Other uses market, 2021 - 2033 (USD Million)
Fig. 58 U.S. Point-of-Care Molecular Diagnostics market share and leading players
Fig. 59 U.S. market share and leading players
Fig. 60 U.S. SWOT
Fig. 61 U.S. market estimates and forecasts, 2021 - 2033
Fig. 62 Market share of key market players- U.S. Point-of-Care Molecular Diagnostics market

Companies Mentioned

QIAGEN
Danaher
Thermo Fisher Scientific, Inc.
BD
F. Hoffman-La Roche AG
Charles River Laboratories
Quest Diagnostics Incorporated
Bio-Rad Laboratories, Inc.
Hologic Inc.
Agilent Technologies, Inc.

Table Information

Report Attribute	Details
No. of Pages	150
Published	July 2025
Forecast Period	2024 - 2033
Estimated Market Value ( USD ) in 2024	$ 3.23 Billion
Forecasted Market Value ( USD ) by 2033	$ 5.19 Billion
Compound Annual Growth Rate	5.4%
Regions Covered	United States
No. of Companies Mentioned	10

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U.S. Point of Care Molecular Diagnostics Market Size, Share & Trends Analysis Report By Test Location (OTC, POC), By Application (Infectious Diseases, Oncology, Prenatal Testing), By Technology, By End-use (Decentralized Labs, Hospitals), And Segment Forecasts, 2025 - 2033

Market Size & Trends

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

Technology Outlook (Revenue, USD Million, 2021 - 2033)

Application Outlook (Revenue, USD Million, 2021 - 2033)

Test Location Outlook (Revenue, USD Million, 2021 - 2033)

End-use Outlook (Revenue, USD Million, 2021 - 2033)

Why should you buy this report?

This report addresses:

Table of Contents

Companies Mentioned

Table Information

Market Size & Trends

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

Technology Outlook (Revenue, USD Million, 2021 - 2033)

Application Outlook (Revenue, USD Million, 2021 - 2033)

Test Location Outlook (Revenue, USD Million, 2021 - 2033)

End-use Outlook (Revenue, USD Million, 2021 - 2033)

Why should you buy this report?

This report addresses:

Table of Contents

Companies Mentioned

Table Information

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