Description
Molecular point-of-care (mPOC) diagnostic solutions offer enhanced sensitivity and specificity compared to existing near-patient and rapid tests. They expand diagnostic capabilities in critical care units, physician offices, outpatient clinics, and community health posts, aiming to assess conditions or admit patients accurately. The concept blends the accessibility of point-of-care (POC) testing with the precision of molecular technology. Kalorama Information has been covering mPOC on a regular basis since 2013.
Our latest report, The Market and Future Potential for Molecular Point-of-Care (mPOC), 2024, is a valuable resource for understanding the size and growth potential of the molecular POC market from 2023-2028. mPOC has transitioned from a novel trend to a significant contributor to the market. Instruments from companies like Abbott, BioMérieux, Cepheid, and others play a substantial role in the IVD point-of-care market. Understanding these markets is crucial for assessing the opportunity in point-of-care testing and microbiology IVD.
The Market and Future Potential for Molecular Point-of-Care (mPOC), 2024 provides market sizing, forecasting, trend mapping, and competitive analysis for POC tests using PCR or other molecular technology, offering fast turnaround times and usability in near-patient settings.
Kalorama reports provide real-world analysis and modeling for relevant circumstances. Analysts offer insights into near-patient molecular testing using small instruments.
The data in The Market and Future Potential for Molecular Point-of-Care (mPOC), 2024 includes information on systems, competitor analysis, and the size and growth of the market.
- What are the mPOC market opportunities beyond COVID-19?
- What are the current systems on the market? Who’s winning?
- What’s the size of the Molecular Point-of-Care Market: 2023-2028
- Geographic Breakout of the Molecular Point-of-Care Market, 2023 (N. America, Europe, APAC, RoW)
- Segment Breakout of Molecular Point-of-Care Market, 2023 (Respiratory vs. Other)
- Near Patient Molecular IVD Market: 2023-2028
- Near Patient Molecular Market Share by Vendor, 2023
- Company Profiles
Competitive Analysis
Companies covered in this report, in profiles and/or product tables and market developments discussion include:
- Abbott Laboratories
- Aidian Oy
- Akonni Biosystems
- Anitoa
- binx health, inc.
- Biocartis NV
- BioGX
- bioMérieux SA
- Cepheid
- Credo Bioscience
- Cue Health
- Curetis NV
- Curiosity Diagnostics (Bio-Rad)
- DiaSorin S.p.A
- Domus Diagnostics
- Fluxergy
- GenMark Diagnostics
- Genomadix
- Greiner Bio-One GmbH
- LEX Diagnostics
- Meridian Bioscience, Inc.
- Mesa Biotech, Inc.
- MicroGEM
- Minute Molecular
- Nanopath
- QIAGEN NV
- QuantuMDx Group
- Quidel Corporation
- Roche
- Rover Diagnostics
- Sekisui Diagnostics LLC
- T2 Biosystems
Scope
The market definition for molecular point-of-care can be challenging compared to other markets that Kalorama Information covers as there are competing ideas about point-of-care or near-patient tests. But the future promise of molecular point-of-care is in sample-to-answer workflows and short result times that would make systems useful for a physician lab office. Therefore, systems like Roche’s cobas Liat, Abbott’s ID NOW (formerly the Alere i), and bioMérieux’s Biofire FilmArray 2.0 are the type of systems principally considered in market scope.
For the purposes of this report, systems must be capable of running CLIA-waived tests or have that capability in the near future. That being said there are a wide variety of molecular systems that could be classified as near-patient or rapid. Since sales of these systems may affect core markets, Kalorama also includes in the discussion and in some additional market considerations rapid molecular testing that may be challenging to define as point-of-care but have a point-of-care-like quality such as HAI or STI testing.
Table of Contents
Chapter 1: Executive Summary
- Figure 1-1: Molecular Point-of-Care Market (mPOC), 2023-2028 ($M)
- Figure 1-2: Near Patient Molecular Systems Market, 2023-2028 ($M)
Where is Molecular Point-of-Care in 2024?
- Table 1-1: Molecular Point-of-Care Market, 2023-2028 ($M)
Molecular Point-of-Care Market Analysis
Table 1-2: Molecular Point-of-Care Market Growth, 2023-2028 (%)
- Figure 1-3: mPOC Market by Disease Indication, 2023 (%; Respiratory, Other)
Market Observations
“Near-Patient” Molecular Systems Market
- Table 1-3: Near Patient Molecular Systems Market, 2023-2028 ($M)
- Table 1-4: Near Patient Molecular Systems Market Growth, 2023-2028 (%)
- Figure 1-4: mPOC and Near-Patient Market, 2023-2028 ($M)
- Table 1-5: mPOC and Near-Patient Market, 2023-2028 ($M)
Current Trends
Molecular Point-of-Care Diagnostics Defined
Usage of Molecular Point-of-Care
Leading mPOC Platforms
- Table 1-6: Molecular POC Diagnostic Platforms and Technologies
Trends
Scope and Methodology
Chapter 2: Molecular Point-of-Care Market Development and Trends
COVID-19 and Molecular POC
- Table 2-1: Molecular POC COVID-19 Emergency Authorizations
CDC Initial Response, Long Term Situation
COVID-19’s Unique Challenge
BARDA Directs Funding to mPOC
Regulatory Developments
Consortia, Funding, Prizes
Deals
- Table 2-2: Deals in Molecular Point-of-Care, April 2019-Feb 2024
Advantages and Disadvantages of Molecular Point-of-Care
- Table 2-3: Disadvantages of Molecular Point-of-Care, by Setting (Physician Office Laboratory (POL) / Other Outpatient Settings, Developing and Low-Resource Areas, and Hospital POC)
Justification: The Sensitivity/Specificity Argument
New Systems and Menu Expansion
Mesa Biotech Strep A Approval
Combination Tests Changing Market: SARS-CoV-2, Flu A, Flu B, and RSV
STI Continues to Be a Growth Area
Deals, Investment in mPOC Systems
Roche Acquires LumiraDx for up to $350M
Thermo Acquires Mesa Biotech
EU Researchers Awarded €3M to Develop POC Molecular Tests
Scope Fluidics AST System Sees Investment
China as a POC Market
Common Tests and Analytes in POC Diagnostics
Component Technologies of Molecular Point-of-Care Diagnostics
Microfluidics
qPCR
Microarrays
Isothermal Amplification
Test Automation
Primers and Probes
Detection
Next-Generation Sequencing
Molecular Diagnostics
Real-Time PCR (qPCR)
Isothermal Amplification Methods
Line Probe Assays
Next-Generation Sequencing
Applications and Potential Applications for Molecular Point-of-Care
Major Testing Applications for Molecular POC Diagnostics
Influenza
Reclassification of RIDTs
Hospital-Acquired Infections (HAIs)
Strep A
Respiratory Syncytial Virus (RSV)
Emerging Applications
Zika
Other Respiratory Infections
Group B Streptococcus
Human Papillomavirus
Herpes Simplex Virus
Vaginitis
Tuberculosis
Malaria
Other Tropical and Neglected Diseases
Cancer
European Device Regulations
Chapter 3: Market Analysis
Molecular Point-of-Care Market Analysis
- Table 3-1: Molecular Point-of-Care Market, 2023-2028 ($M, %)
- Figure 3-1: Molecular Point-of-Care Market, 2023-2028 ($M)
- Table 3-2: Geographic Breakout of the Molecular Point-of-Care Market, by Region (North America, Europe, APAC, RoW), 2023 ($M, %)
- Table 3-3: Segment Breakout of Molecular Point-of-Care Market, by Area (COVID-Respiratory vs. Other), 2023 ($M, %)
- Figure 3-2: Breakout of Molecular Point-of-Care Market (Respiratory, Other), 2023 (%)
“Near Patient Molecular” Market
- Table 3-4: Near Patient Molecular Systems Market, 2023-2028 ($M, %)
Market Share Near Patient
- Figure 3-3: Market Share, Near Patient Molecular Testing
- Table 3-5: Market Share, Near Patient Molecular Testing, by Vendor (Abbott, bioMérieux, Cepheid, Roche, Other), 2023 (%)
Chapter 4: Company Profiles
Abbott Laboratories
Aidian Oy
Akonni Biosystems
binx health, inc.
Biocartis NV
bioMérieux SA
- Table 4-1: bioMérieux FilmArray Est. Systems per Quarter, Q4 ’18-Q3 ’23
- Figure 4-1: FilmArray Systems Installed by Quarter, Q4 2018-Q3 2022
Cepheid (Danaher)
Molecular Healthcare-Acquired Infection (HAI) Testing
Molecular Sexual Health and Women’s Health Testing
Molecular Critical Infectious Disease Testing
Molecular Oncology/Genetics Testing
Credo Diagnostics Biomedical Pte. Ltd.
Cue Health
Curetis NV (OpGen)
DiaSorin S.p.A
GenMark Diagnostics (Roche)
Greiner Bio-One GmbH
Lucira Health (Pfizer)
Meridian Bioscience, Inc. (SD Biosensor)
Mesa Biotech, Inc. (Thermo)
QIAGEN NV
QuantuMDx Group
QuidelOrtho Corporation
Roche
Sekisui Diagnostics LLC
T2 Biosystems
