The Market and Potential for Molecular Point of Care Diagnostic Tests

Table of Contents

ONE: EXECUTIVE SUMMARY

MOLECULAR POINT-OF-CARE DIAGNOSTICS DEFINED

STRENGTHS AND WEAKNESS OF MOLECULAR POINT-OF-CARE TESTING

Table 1-1 Advantages of Molecular Point-of-care by Setting

Table 1-2: Disadvantages of Point-of-Care Diagnostics by Setting – Hospital POC, POL/Outpatient, Low-Resource and Developing Areas

COMPONENT TECHNOLOGIES OF MOLECULAR POINT-OF-CARE DIAGNOSTICS

Microfluidics

qPCR

Microarrays

Isothermal Amplification

Test Automation

Primers and Probes

Detection

Next-Generation Sequencing

Table 1-3: Molecular POC Products on the Market

SCOPE AND METHODOLOGY

SIZE AND GROWTH OF THE MARKET

Figure 1-1: Molecular Point of Care Market, 2017-2023 ($ millions)

Conclusions

Table 1-4: Growth Areas for Molecular POC and Rapid Tests

TWO: WHAT IS MOLECULAR POINT-OF-CARE DIAGNOSTICS?

ADVANTAGES AND DISADVANTAGES OF MOLECULAR POINT-OF-CARE

COMMON TESTS AND ANALYTES IN POC DIAGNOSTICS

MOLECULAR DIAGNOSTICS

Real-Time PCR (qPCR)

Isothermal Amplification Methods

Microarrays

Sequencing

Common Tests and Analytes in Molecular Diagnostics

Table 2-1: Selected POCTs for the diagnosis of illnesses covered by Emergency Use Authorizations (EUAs) currently in effect

POINT-OF-CARE DIAGNOSTICS IN BRIEF

Examples of POCT settings

THREE: MOLECULAR POC SYSTEMS ON THE MARKET AND IN DEVELOPMENT

INTRODUCTION

Advances in Molecular Diagnostics

Microfluidics

Isothermal Amplification

Table 3-1: Selected Isothermal Amplification Methods and Platform Examples

Test Automation

Primers and Probes

DETECTION

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 Molcular 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

Next-Generation Sequencing

Table 3-6: Selected NGS Platforms for Decentralized and POC Sequencing

MOLECULAR PLATFORMS AND PRODUCTS FOR DECENTRALIZED TESTING

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)

Table 3-9: Hospital and POC Molecular Diagnostic Platforms in Development (Vendor, Assay Menu, Procedure Integration, Test Principles)

Table 3-10: Menu Expansions for Hospital and POC Molecular Platforms (Vendor, Platform, Menu Addition, Time to Results, CLIA-waiver, US/EU Availability)

Table 3-11: Market-Available Molecular Diagnostic Platforms for Emerging Markets and the Developing World (Vendor, Assay Menu, Planned Assays, Regulatory Status, Procedure Integration, Test Principles) .. 71

Table 3-12: Molecular Diagnostic Platforms in Development for Emerging Markets and the Developing World (Vendor, Assay Menu, Procedure Integration, Test Principles)

Table 3-13: Line Probe Assays and Other Molecular Lateral Flow Test Strips (Vendor, Assay Menu, Planned Assays, Regulatory Status)

Table 3-14: Potential Entrants into Molecular POC Diagnostics (Vendor, Current Platform[s], Primary Market for Platform, Assay Menu, Applicable Tech)

Table 3-15: Selected Developmental Molecular POC-Enabling Technologies and Platforms by Vendor

APPLICATIONS AND POTENTIAL APPLICATIONS FOR MOLECULAR POINT-OF-CARE

Major Testing Applications for Molecular POC Diagnostics

Hospital-Acquired Infections (HAIs)

Strep A

Respiratory Syncytial Virus (RSV)

Influenza

Other Respiratory Infections

Group B Streptococcus

Human Papillomavirus

Chlamydia and Gonorrhea

Herpes Simplex Virus

Vaginitis

Human Immunodeficiency Virus (HIV)

Tuberculosis

Hepatitis

Malaria

Other Tropical and Neglected Diseases

Gastrointestinal Infections

Bloodstream Infections (BSIs)

Pharmacogenetics

Hereditary Disease

Cancer

URGENT CARE CLINICS

Table 3-16: Urgent Care Centers vs. Retail Clinics and Physician Practices

RETAIL CLINICS

FOUR: MARKET ANALYSIS

SIZE AND GROWTH OF THE MARKET

Figure 4-1: Market Analysis, Molecular Point of Care – 2017-2023 ($ millions)

Challenges for Molecular POC

MARKET LEADERS

Abbott / Alere i

Biocartis: An Ascendant Player

Cepheid Gene Xpert and, Xpert Xpress and Xpert Omni

Roche cobas Liat

Biomerieux BioFire Film Array

MARKET BY GEOGRAPHY

Figure 4-2: Molecular Point of Care Market by Geography

MARKET ESTIMATE AND MARKET POTENTIAL BY TYPE OF DISEASE

Table 4-1: Market for Molecular POC by Test (Influenza, Strep A, RSV, Other Resp., CT/NG, GBS, HPV, HSV, TV, TB, HIV, Hep, Malaria, Tropical/Other Neglected, HAIs, Other Molecular POC)

Figure 4-3: Molecular POC Market by Category, 2017 (Flu/Resp. Vs. All Other)

Influenza

Strep A, RSV and Other Respiratory

CT/NG

HPV

HSV

HIV

Hepatitis

Malaria

Other Molecular POC Testing

FIVE: COMPANY PROFILES

AHRAM BIOSYSTEMS

AKONNI BIOSYSTEMS

ALERE (ABBOTT)

Table 5-1: Alere Revenue (2014-H1 2017)

ANALYTIK JENA

ATLAS GENETICS

AXXIN

BECTON, DICKINSON AND COMPANY

Table 5-2: Becton, Dickinson & Co. (BD) Revenue (2014-2017)

BIOCARTIS

Table 5-3: Biocartis NV Revenue (2014-2017)

BIOMERIEUX

Table 5-4: bioMérieux Revenue (2014-2017)

CANON BIOMEDICAL

CEPHEID

Table 5-5: Cepheid Revenue (2013-2016)

Molecular Healthcare-Acquired Infection (HAI) Testing

Molecular Sexual Health and Women’s Health Testing

Molecular Critical Infectious Disease Testing

Molecular Oncology/Genetics Testing

CURETIS

DESTINA GENOMICS

DIAGNOSTICS FOR ALL

DIAGNOSTICS FOR THE REAL WORLD

DIASORIN

Table 5-6: DiaSorin Revenue (2014-Q3 2017)

DIASSESS

EIKEN CHEMICAL

Table 5-7: Eiken Chemical Revenue (FY 2014-2017)

ENTOPSIS

ERBA MOLECULAR

GENEDRIVE PLC (FORMERLY EPISTEM)

Table 5-8: genedrive Revenue (FY 2014-2017)

GENEFLUIDICS

GENEPOC

GENEREACH BIOTECHNOLOGY

GREINER BIO-ONE

HAI KANG LIFE

HAIN LIFESCIENCE

ILLUMINA

Table 5-9: Illumina Revenue (FY 2014-2017)

IMMUNEXPRESS

INSILIXA

LUCIGEN

MAST GROUP

MBIO DIAGNOSTICS

MERIDIAN BIOSCIENCE

Table 5-10: Meridian Bioscience Revenue (FY 2014-2017)

MESA BIOTECH

METAARA MEDICAL TECHNOLOGIES

MICRONICS (SONY)

MOLBIO

MP BIOMEDICALS

NANODETECTION TECHNOLOGY

NANOIVD

NANŌMIX

NANOSPHERE (LUMINEX)

Table 5-11: Nanosphere Revenue (2013-2016)

OPTIGENE

ORION DIAGNOSTICA

Table 5-12: Orion Diagnostica Revenue (2014-Q3 2017)

POSITIVEID

Table 5-13: PositiveID Revenue (2014-Q3 2017)

PRETECT

QIAGEN

Table 5-14: QIAGEN Revenue (2014-Q3 2017)

HPV

Other Activities (Development, Licensing, Investment)

QUANTUMDX

QUIDEL

Table 5-15: Quidel Corporation Revenue (2013-2016)

RHEONIX

ROCHE DIAGNOSTICS

Table 5-16: Roche Diagnostics Revenue (2014-2017)

SCANOGEN

SEEGENE

Table 5-17: Seegene Revenue (2014-Q3 2017)

SPARTAN BIOSCIENCE

STAT-DX

T2 BIOSYSTEMS

Table 5-18: T2 Biosystems Revenue (2014-Q3 2017)

THERMAL GRADIENT

UBIQUITOME

USTAR BIOTECHNOLOGIES

VEREDUS LABORATORIES

WAVE 80 BIOSCIENCE