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

Transcription

1 DIAGNOSTICS BUSINESS ANALYSIS SERIES: TECHNOLOGIES, PRODUCTS & SERVICES for MOLECULAR DIAGNOSTICS, MDx ABA 298 By ADAMS BUSINESS ASSOCIATES March March 2017 ABA 298 1

2 Technologies, Products & Services for Molecular Diagnostics, MDx, May 2014 & December 2016 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 Technology Developments 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 Clinical Application Developments 104 2

3 3.9. Non-Clinical Applications of Molecular Diagnostics Challenges for Technology & Applications for Molecular Diagnostics Regulatory, Reimbursement & Ethical Impact for Molecular Diagnostics Regulatory Dynamics & Impact Reimbursement Impact for Molecular Diagnostics Regulatory Developments for Molecular Diagnostics Ethical Impact for Molecular Diagnostics Market Segments & Quantification for Molecular Diagnostics Total Market & Sector Dynamics Application Markets for Molecular Diagnostic Test in vitro Diagnostics Application Markets for Molecular Diagnostic Test Research & Non-Clinical Diagnostics Company Profiles & Status for Molecular Diagnostics, Company Profile Introduction Established Diagnostic Companies Focussed Molecular Diagnostic Companies Molecular Diagnostic Service Laboratories Life Science Research Molecular Diagnostic Companies Other Companies for Molecular Diagnostic Products Companies Commercial Activity & Market Status Strategic Marketing Implications for Molecular Diagnostics Marketing Philosophy Technology Status Marketing Tools & Generic Strategic Marketing Strategies Applied to MDx 209 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 Third Edition Figure Biotechnology as a Sector or an Enabling Technology, Figure Basic Features of the Technology S-Curve 5 Figure Technology S-Curve for the IVD Sector in 2013/14 6 Figure Biological Cascade for Life Sciences 8 Figure Healthcare Dynamics for IVDs, Figure Healthcare Dynamics for in vitro Diagnostics & Medical Devices, Figure Genomics and Proteomics Links for in vitro Diagnostics Research 12 Figure Genomic Research & Drug Discovery for MDx Analysis, Technology Procedures for Molecular Diagnostics 16 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 35 Figure DNA Amplification Technology for Diagnostic Applications 37 Figure Molecular Diagnostics Leading Amplification Technologies, Figure Amplification Method Comparison, Figure qpcr Amplification Systems, Figure Molecular Diagnostics Technology Uses in Pathway Analysis Figure A Isothermal Enzyme Amplification Products & Technology Examples, 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 59 Figure Technologies for SNP Determinations 2. Triplex Forming Probes 59 Figure Possible SNP Applications in Gene Analysis 59 Figure Commercial SNP Platforms & Products,

5 Figure microrna Profiling Service Companies, Figure Companies Providing microrna Products, Applications of DNA Analysis & Molecular Diagnostics 71 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 77 Figure Cancer Diagnostics Molecular Diagnostics Applications 79 Figure Infectious Disease Molecular Diagnostic Applications 80 Figure Example Genomic Analysis, microrna & Epigenetic Products & Applications 84 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 94 Figure Early Examples & Development Diagnostics of Companion Diagnostics 97 Figure Benefits & Hurdles for MDx Companion Diagnostics, CDx 98 Figure Potential Impact of Synthetic Biology Involving Molecular Diagnostics Regulatory, Reimbursement & Ethical Impact for Molecular Diagnostics 109 Figure European IVD-MMD Product Classifications, 2014/ Figure Summary of Class Approval Procedures for CE Mark Assignment Market Quantification & Dynamics for Molecular Diagnostics 140 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, Figure Molecular Diagnostic Test Segment Distribution, Figure Molecular Diagnostic Test Segment Distribution in Europe, 2013/ Figure Molecular Diagnostic Global Technology Distribution, Figure Clinical & Genetic Testing Molecular Diagnostic Product Group Markets, Figure Genetic Testing Molecular Diagnostic Product Group Markets, Figure IVD & Diagnostic Molecular Biology Technology Usage, Figure IVD & Diagnostic Molecular Biology Technology Usage, Figure IVD Molecular Diagnostics Product Group Markets, 2016 & Figure Regional Clinical Applications of Molecular Diagnostic Product Groups, Figure Regional Clinical Applications of Molecular Diagnostic Product Groups,

6 Figure Clinical Diagnostics Approved in the USA, Figure European Infectious Disease MDx - Clinical Diagnostics Markets by Country, Figure Potential Areas for Future Molecular Diagnostics Clinical Application Areas 162 Figure Research Areas for Molecular Diagnostics Development & Applications, Figure Regional Research & Clinical Research MDx Product Groups, Figure Non-Clinical Molecular Diagnostic Application Markets, Figure Overall Molecular Diagnostic Applications Market, Figure Overall Molecular Diagnostic Applications Market, Figure Various Other Applications for Molecular Diagnostics, $M 2016 & Company Profiles & Status for Molecular Diagnostics, 2013/ Figure Company Profile Summary Abbott Diagnostics 172 Figure Company Profile Summary Becton Dickinson 173 Figure Company Profile Summary biomerieux 173 Figure Company Profile Summary Bio Rad Laboratories 174 Figure Company Profile Summary Grifols 174 Figure Company Profile Summary Danaher [Beckman Coulter & Cepheid] 175 Figure Company Profile Summary Roche Molecular Diagnostics 176 Figure Company Profile Summary Siemens 177 Figure Broad Based Diagnostic Company Business Shares, Figure Company Profile Summary Agilent [Dako, etc] 179 Figure Company Profile Summary Hologic [Gen Probe & Third Wave Technologies] 180 Figure Company Profile Summary Qiagen 181 Figure Company Profile Summary Enigma Diagnostics 182 Figure Emerging MDx Company Summary Figure Molecular Biology Based MDx Company Market Positions, Figure Company Profile Summary Myriad Genetics 185 Figure Company Profile Summary Locus Development Inc. [Genomic Health] 185 Figure Molecular Diagnostic Services for MDx Products, Figure Company Profile Summary Illumina 188 Figure Company Profile Summary Sequenom 189 Figure Company Profile Summary Fluidigm 189 Figure Company Profile Summary Thermo Fisher [Affymetrix] 190 Figure Overview of Commercial Molecular Diagnostic Companies, March Strategic Marketing Implications for Molecular Diagnostics 204 Figure Typical Key Elements in MDx Basis of Competition Analysis 204 Figure S-Curve Technology Analysis for Molecular Diagnostics,