Table of Contents
ONE: EXECUTIVE SUMMARY
Introduction
Molecular Point-of-Care Diagnostics Defined
Strengths and Weakness of Molecular POC Testing
Component Technologies of Molecular POC Diagnostics
Microfluidics
qPCR
Microarrays
Isothermal Amplification
Test Automation
Primers and Probes
Detection
Next-Generation Sequencing
Leading Platforms in Molecular POC Diagnostics
Investment in Decentralized Molecular Diagnostics – Venture Financing and Public
Offerings (2009-2015)
Global Molecular POC Diagnostics Market (2015-2020)
Major Conclusions
TWO: INTRODUCTION TO MOLECULAR POINT OF CARE DIAGNOSTICS
Introduction
Point-of-Care Diagnostics in Brief
Common Tests and Analytes in POC Diagnostics
Market Drivers for POC Diagnostics
Market Barriers for POC Diagnostics
Molecular Diagnostics
Real-Time PCR (qPCR)
Isothermal Amplification Methods
Microarrays
Sequencing
Common Tests and Analytes in Molecular Diagnostics
Advantages and Disadvantages of Molecular Diagnostics at the Point of Care
Summary
THREE: MOLECULAR POINT OF CARE DIAGNOSTICS DEVELOPMENT AND APPLICATIONS
Introduction
Advances in Molecular Diagnostics
Microfluidics
Isothermal Amplification
Test Automation
Primers and Probes
Detection
Next-Generation Sequencing
Molecular Platforms and Products for Decentralized Testing
Major Testing Applications for Molecular POC Diagnostics
Influenza
Strep A
Respiratory Syncytial Virus (RSV)
Other Respiratory Infections
Chlamydia and Gonorrhea
Group B Streptococcus
Human Papillomavirus
Herpes Simplex Virus
Vaginitis
Human Immunodeficiency Virus (HIV)
Tuberculosis
Hepatitis
Malaria
Other Tropical and Neglected Diseases
Gastrointestinal Infections
Hospital-Acquired Infections (HAIs)
Bloodstream Infections (BSIs)
Pharmacogenetics
Hereditary Disease
Cancer
Conclusions
FOUR: MARKETS FOR MOLECULAR POINT-OF-CARE DIAGNOSTICS
Introduction
Investment in Decentralized Molecular Diagnostics – Venture Financing and Public
Offerings (2009-2015)
Respiratory Tract Infections
Women’s Health and Sexual Health
High-Burden Diseases
Gastrointestinal, Hospital-Acquired and Bloodstream Infections
Non-Infectious Disease Tests – Pharmacogenetics, Hereditary Traits and Cancer
Conclusions
FIVE: COMPANY PROFILES
Abacus Diagnostica
Advanced Liquid Logic (Illumina)
Ahram Biosystems
Akonni Biosystems
Alere (Abbott)
Amplino
Analytik Jena
Aquila Diagnostic Systems
Atlas Genetics
Axxin
Becton, Dickinson & Co. (BD)
Biocartis
Biomeme
bioMérieux
Canon BioMedical
Cepheid
Molecular Healthcare-Acquired Infection (HAI) Testing
Molecular Sexual Health and Women’s Health Testing
Molecular Critical Infectious Disease Testing
Molecular Oncology Testing
Coris BioConcept
Coyote Bioscience
Curetis
DestiNA Genomics
Diagnostics For All
Diagnostics for the Real World
DiaSorin
DiAssess
DNA Electronics
DxNA
Eiken Chemical
Enigma Diagnostics
Entopsis
Epistem
ERBA Molecular (Lumora)
Espira
GenapSys
GeneFluidics
GenePOC
GeneReach Biotechnology
GnuBIO (Bio-Rad)
Great Basin Scientific
Greiner Bio-One
Hai Kang Life
Hain Lifescience
HiberGene Diagnsotics
iCubate
Immunexpress
InSilixa
Lucigen
Mast Group
MBio Diagnostics
Meridian Bioscience
Mesa Biotech
Metaara Medical Technologies
Micronics (Sony)
Molbio Diagnostics
MP Biomedicals
MycroLab Diagnostics
Nanobiosym
NanoBioSys
NanoDetection Technology
NanoIVD
Nanomix
Nanosphere
OptiGene
Orion Diagnostica
Oxford Nanopore Technologies
PositiveID
PreTect
QIAGEN
HPV
Other Activities (Development, Licensing, Investment)
QuantuMDX
Quidel
Rheonix
Roche Diagnostics
Scanogen
Seegene
Spartan Bioscience
STAT-Diagnostica
T2 Biosystems
Thermal Gradient
Ubiquitome
Ustar Biotechnologies
Veredus Laboratories
Wave 80 Biosciences
Xagenic
LIST OF EXHIBITS
ONE: EXECUTIVE SUMMARY
Table 1-1: Advantages of Point-of-Care Diagnostics by Setting – Hospital POC,
POL/Outpatient, Low-Resource and Developing Areas
Table 1-2: Disadvantages of Point-of-Care Diagnostics by Setting – Hospital POC,
POL/Outpatient, Low-Resource and Developing Areas
Table 1-3: Market-Available Molecular POC Diagnostic Platforms (Vendor, Assay
Menu, Planned Assays, Regulatory Status, Procedure Integration, Test
Principles)
Figure 1-1: Investments in Decentralized Molecular Diagnostics Companies
(2014-2015)
Figure 1-2: Molecular POC Diagnostics Market (2015-2020) ($ millions)
TWO: INTRODUCTION TO MOLECULAR POINT OF CARE DIAGNOSTICS
Table 2-1: Advantages of Point-of-Care Diagnostics by Setting – Hospital POC,
POL/Outpatient, Low-Resource and Developing Areas
Table 2-2: Disadvantages of Point-of-Care Diagnostics by Setting – Hospital POC,
POL/Outpatient, Low-Resource and Developing Areas
Table 2-3: Selected Isothermal Amplification Methods and Platform Examples
THREE: MOLECULAR POINT OF CARE DIAGNOSTICS DEVELOPMENT AND APPLICATIONS
Table 3-1: Selected Isothermal Amplification Methods and Platform Examples
Table 3-2: Selected Analyzer Platforms for Decentralized and POC Molecular Testing
with Image Sensor Detectors (CCD, CMOS)
Table 3-3: Selected Analyzer Platforms for Decentralized and POC Molecular Testing
with Photodiode Detectors
Table 3-4: Selected Analyzer Platforms for Decentralized and POC Molecular Testing
with Electrochemical Detectors
Table 3-5: Selected Analyzer Platforms for Decentralized and POC Molecular Testing
with Immunochromatographic Detection
Table 3-6: Selected NGS Platforms for Decentralized and POC Sequencing
Table 3-7: Market-Available Molecular POC Diagnostic Platforms (Vendor, Assay
Menu, Planned Assays, Regulatory Status, Procedure Integration, Test
Principles)
Table 3-8: Market-Available Hospital Molecular Diagnostic Platforms (Vendor, Assay
Menu, Planned Assays, Regulatory Status, Procedure Integration, Test Principles) … 83
Table 3-9: Hospital and POC Molecular Diagnostic Platforms in Development (Vendor,
Assay Menu, Procedure Integration, Test Principles)
Table 3-10: Market-Available Molecular Diagnostic Platforms for Emerging Markets
and the Developing World (Vendor, Assay Menu, Planned Assays, Regulatory Status,
Procedure Integration, Test Principles)
Table 3-11: Molecular Diagnostic Platforms in Development for Emerging Markets
and the Developing World (Vendor, Assay Menu, Procedure Integration, Test
Principles)
Table 3-12: Line Probe Assays and Other Molecular Lateral Flow Test Strips (Vendor,
Assay Menu, Planned Assays, Regulatory Status)
Table 3-13: Potential Entrants into Molecular POC Diagnostics (Vendor, Current
Platform[s], Primary Market for Platform, Assay Menu, Applicable Tech)
Table 3-14: Selected Developmental Molecular POC-Enabling Technologies and
Platforms by Vendor
FOUR: MARKETS FOR MOLECULAR POINT-OF-CARE DIAGNOSTICS
Figure 4-1: Investments in Decentralized Molecular Diagnostics Companies
(2014-2015)
Table 4-1: Investments in Decentralized Molecular Diagnostics Companies
(2014-2015)
Figure 4-2: Molecular Influenza Test POC Market (2015-2020) ($ millions) – Sales /
Market Opportunity
Figure 4-3: Molecular Strep A Test POC Market (2015-2020) ($ millions) – Sales /
Market Opportunity
Figure 4-4: Molecular RSV POC Market (2015-2020) – Sales / Market Opportunity … 135
Figure 4-5: Molecular POC Market for Other Respiratory Infections (2015-2020) –
Sales / Market Opportunity
Table 4-2: Molecular POC Market for Respiratory Tract Infections – Influenza, Strep
A, RSV, Others (2015-2020) – Sales / Market Opportunity
Figure 4-6: Molecular CT/NG POC Market (2015-2020) – Sales / Market
Opportunity
Figure 4-7: Molecular GBS POC Market (2015-2020) – Sales / Market Opportunity … 142
Figure 4-8: Molecular HPV POC Market (2015-2020) – Sales / Market Opportunity .. 144
Figure 4-9: Molecular HSV POC Market (2015-2020) – Sales / Market Opportunity … 146
Figure 4-10: Molecular Vaginitis POC Market (2015-2020) – Sales / Market
Opportunity
Table 4-3: Molecular POC Market for Women’s Health and Sexual Health – CT/NG,
GBS, HPV, HSV, Vaginitis (including TV) (2015-2020) – Sales / Market
Opportunity
Figure 4-11: Molecular HIV POC Market (2015-2020) – Sales / Market Opportunity . 152
Figure 4-12: Molecular TB POC Market (2015-2020) – Sales / Market Opportunity
Figure 4-13: Molecular Hepatitis POC Market (2015-2020) – Sales / Market
Opportunity
Figure 4-14: Molecular Malaria POC Market (2015-2020) – Sales / Market
Opportunity
Figure 4-15: Molecular POC Market for Other Tropical and Neglected Diseases (2015-
2020) – Sales / Market Opportunity
Table 4-4: Molecular POC Market for High-Burden Diseases – HIV, TB, Hepatitis,
Malaria, Other Tropical and Neglected Diseases (2015-2020) – Sales / Market
Opportunity
Figure 4-16: Molecular POC Market for GI Pathogens (2015-2020) – Sales / Market
Opportunity
Figure 4-17: Molecular POC Market for HAIs (2015-2020) – Sales / Market
Opportunity
Figure 4-18: Molecular POC Market for Bloodstream Infections (2015-2020) – Sales /
Market Opportunity
Table 4-5: Molecular POC Market for GI Pathogens, HAIs and Bloodstream Infections
(2015-2020) – Sales / Market Opportunity
Figure 4-19: Molecular POC Market for PGx and Other Genetics Testing (2015-2020) –
Sales / Market Opportunity
Figure 4-20: Molecular POC Market for Cancer Testing (2015-2020) – Sales / Market
Opportunity
Table 4-6: Molecular POC Market for Non-Infectious Diseases – Pharmacogenetics /
Hereditary Traits and Cancer (2015-2020) – Sales / Market Opportunity
Table 4-7: Molecular POC Test Markets for Respiratory Tract Infections, Women’s
Health and Sexual Health, High-Burden Diseases, GI Pathogens, HAIs, Bloodstream
Infections, Pharmacogenetics, Other Genetics, and Cancer Testing (2015-2020) –
Sales / Market Opportunity
FIVE: COMPANY PROFILES
Table 5-1: Alere Revenue (2012-2015)
Table 5-2: Analytik Jena Revenue (FY 2011-2014)
Table 5-3: Becton, Dickinson & Co. (BD) Revenue (FY 2012-2015)
Table 5-4: Biocartis NV Revenue (2012-2015)
Table 5-5: bioMérieux Revenue (2012-2015)
Table 5-6: Cepheid Revenue (2012-2015)
Table 5-7: DiaSorin Revenue (2012-2015)
Table 5-8: Eiken Chemical Revenue (FY 2012-2015)
Table 5-9: Epistem Revenue (FY 2012-2015)
Table 5-10: Great Basin Corporation Revenue (2012-2015)
Table 5-11: Meridian Bioscience Revenue (FY 2012-2015)
Table 5-12: Nanosphere Revenue (2012-2015)
Table 5-13: Orion Diagnostica Revenue (2012-2015)
Table 5-14: PositiveID Revenue (2012-2015)
Table 5-15: QIAGEN Revenue (2012-2015)
Table 5-16: Quidel Corporation Revenue (2012-2015)
Table 5-17: Roche Diagnostics Revenue (2012-2015)
Table 5-18: Seegene Revenue (2012-2015)
Table 5-19: T2 Biosystems Revenue (FY 2012-FY 2015)
