TECHNOLOGIES, PRODUCTS & SERVICES for MOLECULAR DIAGNOSTICS, MDx ABA 298
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1 DIAGNOSTICS BUSINESS ANALYSIS SERIES: TECHNOLOGIES, PRODUCTS & SERVICES for MOLECULAR DIAGNOSTICS, MDx ABA 298 By ADAMS BUSINESS ASSOCIATES MAY May 2014 ABA 298 1
2 Technologies, Products & Services for Molecular Diagnostics, MDx, May 2014 CONTENTS LIST 1. Introduction & Purpose for Business Analysis of Molecular Diagnostics 1 2. Technology Procedures for Molecular Diagnostics Technology Overview Accessories for DNA Analysis & MDx Technologies for Molecular Diagnostics Descriptions DNA Probes for DNA Analysis & MDx Amplification Methods for DNA Analysis & MDx DNA Sequencing for DNA Analysis & MDx Custom Services for DNA Analysis & MDx BioInformatics for DNA Analysis & MDx Targets for DNA Analysis & Molecular Diagnostics Single Nucleotide Polymorphisms, SNPs RNA Interference, RNAi & sirna & MicroRNA, mirna Whole Genome Targeting or Genome Wide Association Studies, GWAS Epigenetics DNA methylation, Histone Modification Applications of DNA Analysis & Molecular Diagnostics Application Overview Clinical Diagnostics Genomics & Inherited Disease Diagnostics Drug Discovery & Toxicology Personalised Medicine & Companion Diagnostics POCT and Molecular Diagnostics Cytogenetics and Molecular Diagnostics Non-Clinical Applications of Molecular Diagnostics Challenges for Technology & Applications for Molecular Diagnostics 106 2
3 4. Regulatory, Reimbursement & Ethical Impact for Molecular Diagnostics Regulatory Dynamics & Impact Reimbursement Impact for Molecular Diagnostics Ethical Impact for Molecular Diagnostics Market Segments & Quantification for Molecular Diagnostics Total Market & Sector Dynamics Application Markets for Molecular Diagnostic Test Company Profiles & Status for Molecular Diagnostics, 2013/ Company Profile Introduction Established Diagnostic Companies Focussed Molecular Diagnostic Companies Molecular Diagnostic Service Laboratories Life Science Research Molecular Diagnostic Companies Strategic Marketing Implications for Molecular Diagnostics Marketing Philosophy Technology Status Marketing Tools & Generic Strategic Marketing Strategies Applied to MDx 191 3
4 FIGURES 1. Introduction & Purpose for Business Analysis of Molecular Diagnostics 1 Figure Reports for ABA Global Library for Life Science Research & Diagnostics 1 Figure ABA Global Library for Life Science Research Reports Second Edition Figure Biotechnology as a Sector or an Enabling Technology, Figure Basic Features of the Technology S-Curve 6 Figure Technology S-Curve for the IVD Sector in 2013/14 6 Figure Biological Cascade for Life Sciences 9 Figure Healthcare Dynamics for IVDs, Figure Healthcare Dynamics for in vitro Diagnostics & Medical Devices, Figure Genomics and Proteomics Links for in vitro Diagnostics Research 13 Figure Genomic Research & Drug Discovery for MDx Analysis, Technology Procedures for Molecular Diagnostics 17 Figure DNA Analysis Technologies Used in Figure DNA Analysis Product Listings, Figure Microarray Systems & Products, Figure Thermal Cycler Key Features & Importance Rating, Figure DNA Analysis & MDx Accessories Vendor Listing, Figure DNA Analysis Product Listings, Figure DNA Probe Products & Accessory Supplier Examples, Figure DNA Amplification Technology 36 Figure DNA Amplification Technology for Diagnostic Applications 38 Figure Molecular Diagnostics Leading Amplification Technologies, Figure Amplification Method Comparison, Figure qpcr Amplification Systems, Figure Molecular Diagnostics Technology Uses in Pathway Analysis Figure DNA Sequencing Technology Commercial Suppliers Figure Genomics & DNA Analysis & MDx Service Provider Companies, Figure Genomics & Proteomics Bioinformatics Products & Suppliers, Figure Technologies for SNP Determinations 1. MALDI-TOF Mass Spectroscopy 55 Figure Technologies for SNP Determinations 2. Triplex Forming Probes 55 Figure Possible SNP Applications in Gene Analysis 55 Figure Commercial SNP Platforms & Products, Figure microrna Profiling Service Companies, Figure Companies Providing microrna Products,
5 3. Applications of DNA Analysis & Molecular Diagnostics 67 Figure Proposed Major Applications for Molecular Diagnostics as of Figure Technology Application Status for MDx Applications, Figure Technology & Application Status for Molecular Diagnostics, Figure Microarrays & DNA Analysis Applications 73 Figure Cancer Diagnostics Molecular Diagnostics Applications 75 Figure Infectious Disease Molecular Diagnostic Applications 76 Figure Example Genomic Analysis, microrna & Epigenetic Products & Applications 80 Figure Example Next Generation Sequencing Products, Figure MDx Applications & Focus Areas for Drug Discovery, Figure MDx Applications in the Drug Discovery Process, Figure Examples of Major Drug Response Rates 91 Figure Early Examples & Development Diagnostics 93 Figure Benefits & Hurdles for MDx Companion Diagnostics, CDx 94 Figure Potential Impact of Synthetic Biology Involving Molecular Diagnostics Regulatory, Reimbursement & Ethical Impact for Molecular Diagnostics 109 Figure European IVD-MMD Product Classifications, 2013/ Figure Summary of Class Approval Procedures for CE Mark Assignment Market Quantification & Dynamics for Molecular Diagnostics 130 Figure Global Molecular Diagnostics Market Figures & Projections, Figure Molecular Diagnostic Tests & Products from LabMedica May Figure Molecular Diagnostic Test Regional IVD Market Distribution, 2004 & Figure IVD and Molecular Diagnostic Tests Regional Market Distribution, 2013/ Figure Molecular Diagnostic Test Segment Distribution, 2013/ Figure Molecular Diagnostic Test Segment Distribution in Europe, 2013/ Figure Molecular Diagnostic Global Technology Distribution, 2013/ Figure Clinical & Genetic Testing Molecular Diagnostic Product Group Markets, Figure Genetic Testing Molecular Diagnostic Product Group Markets, Figure Regional Clinical Applications of Molecular Diagnostic Product Groups, Figure Regional Clinical Applications of Molecular Diagnostic Product Groups, Figure Clinical Diagnostics Approved in the USA, Figure European Infectious Disease Clinical Diagnostics Markets by Country, Figure Potential Areas for Future Molecular Diagnostics Clinical Application Areas 149 5
6 Figure Research Areas for Molecular Diagnostics Development & Applications, Figure Regional Research & Clinical Research MDx Product Groups, Figure Non-Clinical Molecular Diagnostic Application Markets, Company Profiles & Status for Molecular Diagnostics, 2013/ Figure Company Profile Summary Abbott Diagnostics 155 Figure Company Profile Summary Becton Dickinson 156 Figure Company Profile Summary biomerieux 156 Figure Company Profile Summary Bio Rad Laboratories 157 Figure Company Profile Summary Danaher [Beckman Coulter] 157 Figure Company Profile Summary Grifols 158 Figure Company Profile Summary Roche Molecular Diagnostics 159 Figure Company Profile Summary Siemens 160 Figure Broad Based Diagnostic Company Business Shares, Figure Company Profile Summary Cepheid 162 Figure Company Profile Summary Agilent [Dako, etc] 163 Figure Company Profile Summary Hologic [Gen Probe & Third Wave Technologies] 164 Figure Company Profile Summary Qiagen 165 Figure Company Profile Summary Enigma Diagnostics 166 Figure Molecular Biology Based MDx Company Market Positions, Figure Company Profile Summary Myriad Genetics 168 Figure Company Profile Summary Locus Development Inc. [Genomic Health] 169 Figure Molecular Diagnostic Services for MDx Products, Figure Company Profile Summary Illumina 172 Figure Company Profile Summary Sequenom 173 Figure Company Profile Summary Affymetrix 173 Figure Company Profile Summary Fluidigm 174 Figure Life Science Research Suppliers of MDx Products, Figure Overview of Commercial Molecular Diagnostic Companies, Strategic Marketing Implications for Molecular Diagnostics 186 Figure Typical Key Elements in MDx Basis of Competition Analysis 187 Figure S-Curve Technology Analysis for Molecular Diagnostics,
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