PERSONALISED MEDICINE & POINT-of-CARE TESTS, POCT ABA 310

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1 DIAGNOSTICS BUSINESS ANALYSIS SERIES: PERSONALISED MEDICINE & POINT-of-CARE TESTS, POCT ABA 310 By ADAMS BUSINESS ASSOCIATES April April 2014 ABA 310 1

2 Personalised Medicine & Point-of-Care Tests, POCT April 2014 CONTENTS LIST 1. Introduction & Purpose for Business Analysis of Point-of-Care Diagnostics 1 2. Technologies Technology Overview Office Laboratory Tests Classical Chemistries Lateral Flow Tests Microarray Tests Biosensor Tests Molecular Diagnostics, MDx Platform Developments Point-of-Care Medical Devices Comparative Technology Development Status Manufacturing Considerations Commercial Issues for Manufacture Lateral Flow Manufacture for POCT Microarray Manufacture for POCT Microspheres & Beads Manufacture for POCT Microfluidics for POCT Use Manufacturing Guidelines for POCT Regulatory & Reimbursement Impact Regulatory & Reimbursement Dynamics Regulatory Systems & POCT Reimbursement for POCT 61 2

3 5. Market Segments Applications & Market Quantification Non-Invasive Testing & Impact of Non-Clinical POCT Applications Non-Invasive Testing Dynamics Non-Invasive Testing Value to the User & Patient Non-Invasive Testing Technologies Non-Invasive Testing Business Areas & Implementation Issues Impact of Non-Clinical POCT testing Commercial Positions in POCT Companion Diagnostics, Personalised Medicine & POCT Definitions Research Funding for Personalised & Stratified Medicine Commercial Collaborations Future Development of POCT for Personalised Medicine & Companion Diagnostics Strategic Marketing Implications for POCT Marketing Philosophy Implementation of POCT Strategic Tools & Their Use in POCT 143 3

4 FIGURES 1. Introduction & Purpose for Business Analysis of Point-of-Care Diagnostics 1 Figure Reports for ABA Global Library for Life Science Research 1 Figure ABA Global Library for Life Science Research Reports Second Edition Figure Diagnostics Procedure Implementation Rationale 3 Figure Biological Cascade for Life Sciences 5 Figure Basic Features of the Technology S-Curve 8 Figure Technology S-Curve for the IVD Sector in Figure Market Drivers for POCT IVDs, 2013 & Figure Healthcare Dynamics for POCT IVDs, Figure Healthcare Dynamics for Medical Devices, Technologies 13 Figure Dip Stick Test Profile Example 14 Figure Lateral Flow Test Basic Format 15 Figure Typical Microarray Test Result Format 17 Figure Biosensor Type Product, Abbott i-stat 20 Figure Main MDx Technology Principles 23 Figure Layout of a Lab-on-a-Chip Device 26 Figure Interactive Scheme for Homecare & Patient Monitoring 29 Figure Physiological POCT Parameters Measured by Medical Devices Figure Thermo Fisher Bench Top Mass Spectrometer & Agilent Bench Top HPLC 31 Figure POCT Technology Development S-Curve, Manufacturing Considerations 34 Figure POCT Technology Business Financial Structure, Figure POCT Lateral Flow Technology Manufacturing Processes, Figure Microarray Technology Manufacturing Processes, Figure MicroFluidics Manufacture General Scheme 45 Figure POCT Platform Guidelines, Figure Global Cleaning Equipment Technology Market,

5 4 Regulatory & Reimbursement Impact 48 Figure Diagnostic Products & Electromedical Equipment 52 Figure Diagnostic Products IVD Reagents & Instruments 53 Figure European IVD-MDD Product Classifications, Figure Summary of Class Approval Procedures for CE Mark Assignment 56 Figure Summary of Laboratory & POCT Sample Pathways 62 5 Market Segments 66 Figure Overview of Diagnostic Testing Laboratory & POCT Segments, Applications & Market Quantification 72 Figure Overview of IVD Diagnostic Testing Markets, Figure Regional Distribution of Global POCT Market, Figure European Regional Distribution of POCT, Figure Common & Less Used POCT Tests, Figure POCT Application Markets, Figure POCT Application Markets, Figure Global Professional Point-of-Care Testing Markets, 2013 in $US 79 Figure Professional Pont-of-Care Testing Market USA, 2013 in $US 80 Figure POCT Application Products by Specified Segment, Figure POCT Implementation Messages & Actions, UK NHS & Commercial, Figure POCT Implementation Factors for POCT Cardiac Markets 84 Figure POCT Barriers to Adoption by Different Groups for Cardiac Markers 86 7 Non-Invasive Testing & Impact of Non-Clinical POCT Applications 90 Figure Non-Invasive Sampling & Assays 91 Figure Non-Invasive Technologies for Diagnostics, History 97 Figure Overall Market Segment Structure for Veterinary Diagnostics, Figure Global Veterinary Diagnostic Market by Species,

6 8 Commercial Positions in POCT 105 Figure Overview of Commercial Point-of-Care Test Companies, Figure Generalised Basis of Competition for Point-of-Care Test Companies, Figure Company Profile Summary Abaxis Inc 112 Figure Company Profile Summary Abbott Diagnostics 113 Figure Company Profile Summary Alere Inc. 114 Figure Company Profile Summary biomerieux 115 Figure Company Profile Summary Enigma Diagnostics 115 Figure Company Profile Summary Instrumentation Laboratories 116 Figure Company Profile Summary Radiometer 116 Figure Company Profile Summary OraSure Technologies 117 Figure Company Profile Summary Roche Diagnostics 118 Figure Company Profile Summary Life Scan 119 Figure Company Profile Summary Response Biomedical 120 Figure Company Profile Summary Menarini Diagnostics 121 Figure Company Profile Summary Nova Biomedical Companion Diagnostics, Personalised Medicine & POCT 124 Figure European Funding for Personalised Medicine, Figure Companion Diagnostic Partnerships, Strategic Marketing Implications for POCT 136 Figure Point-of-Care Diagnostic Market in 2013/ Figure Typical Key Elements in POCT Diagnostic Purchase Decisions 141 Figure Economic Value of Health to USA Society, Figure Technology Basis of Competition Ranking for Diabetes Self-Test, Figure Technology Basis of Competition for Non-Invasive POCT Devices,

TECHNOLOGIES, PRODUCTS & SERVICES for MOLECULAR DIAGNOSTICS, MDx ABA 298

DIAGNOSTICS BUSINESS ANALYSIS SERIES: TECHNOLOGIES, PRODUCTS & SERVICES for MOLECULAR DIAGNOSTICS, MDx ABA 298 By ADAMS BUSINESS ASSOCIATES MAY 2014. May 2014 ABA 298 1 Technologies, Products & Services