Molecular Diagnostics: a primer on an emerging sector

Product Code DAT13851
Publication Date November 2008
Publisher Datamonitor
Product Type Report
Pages 147
ISBN Number not applicable
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Molecular Diagnostics: a primer on an emerging sector

Introduction

This report analyzes the emerging sector of molecular diagnostics. It provides a clear classification, assessing the leading technologies and key tests which are positioned in this exciting area of diagnostics. The current MDx market size and leading players are analyzed, with a market forecast of the MDx segment as well as the total in vitro diagnostic (IVD) market from 200713 also provided

Scope

  • A definitive classification system for in vitro diagnostics (IVD) and molecular diagnostics (MDx), and the differing regulatory pathways in the US/EU
  • Market size and forecast growth rates to 2013 for IVD and MDx segments
  • A detailed analysis of emerging 'companion diagnostics' (the synergy of targeted prescription therapies with diagnostics)
  • A database detailing c.120 MDx products on the market

Highlights

The MDx market is a small but fast growing segment of the global IVD market, with an estimated 200713 CAGR of 14.0%. Total MDx sales are expected to outpace the total IVD market (200713 CAGR of 5.0%) over the next six years Of particular interest is the role of MDx in companion diagnostics (the synergy between targeted prescription pharmaceuticals and molecular diagnostic tests). Datamonitor has identified seven key therapeutics and more than 12 MDx tests which exemplify this marriage The report also details a MDx database containing more than 120 MDx tests. The key tests are positioned in the therapy areas of infectious diseases, hematology and oncology by key MDx players such as Roche Diagnostics, GenProbe, Abbott Molecular and Myriad

Reasons to Purchase

  • Compare the differing growth dynamics of the MDx segment and that of the wider IVD market
  • Assess the potential of 'companion diagnostics' and its role in influencing physician selection of molecular targeted therapies
  • Identify the key diagnostic tests and players in the MDx segment

Contents

  • Chapter 1 Executive Summary
  • Key Findings
    • What This Report Will Tell You
    • Molecular Diagnostic Classification
    • Molecular Diagnostics Regulatory Pathway
    • The In Vitro Diagnostic And Molecular Diagnostic Market Sizes
    • Key Molecular Diagnostic Tests
    • Targeted Therapies Movement Fuels Mdx Development
  • Chapter 2 Definition Of Molecular Diagnostics
  • Key Findings
    • Classification Of Molecular Diagnostics
    • Level 1 Classification
    • Level 2 Classification
    • Level 3 Classification
    • Level 4 Classification
    • Mdx Subclassification
    • Key Applications Of Pharmacogenetics Introducing 'Personalized Medicine'
  • Chapter 3 Regulatory And Development Pathway
  • Key Findings
  • Introduction
    • Classification Of Devices Us
    • Regulatory Pathway
    • Multiple Pathways For 'Approval' In The Us
    • Premarket Notification, 510(K)
    • Premarket Approval (Pma)
    • AnalyteSpecific Reagent (Asr)
    • LaboratoryDeveloped Test 'Home Brews'
    • Four Strategic Routes For Approval Of A Diagnostic Test In The Us
    • The European Union: Gaining The Ce Mark
    • Requirements Of Manufacturers
    • The Ce Mark
    • Development Pathway
    • The Diagnostics Market Is Much Smaller Than The Rx Market
    • ...Although It Can Offer Some Attractions To Investors
    • However, There Are Some Downsides
    • Challenges Facing The Mdx Industry: Intellectual Property
  • Chapter 4 The Molecular Diagnostic Market
  • Key Findings
  • Introduction
    • The Global In Vitro Diagnostic (Ivd) And Molecular Diagnostic (Mdx) Markets
    • Historical Ivd And Mdx Performance, 200107
    • Current Market: Ivd And Mdx The Key Players
    • The Ivd Market
    • The Mdx Market
    • Mdx Set To Increase In Importance
  • Introduction To Pharmavitae's Mdx Database
    • The Three Broad Functions Of Mdx Tests
    • Mdx Tests For Diagnosis
    • Mdx Tests For Risk Assessment/Predictive
    • Mdx Tests For Drug Compatibility
    • Company Analysis
    • Therapy Area Analysis
  • Chapter 5 The Key Molecular Diagnostic Tests
  • Key Findings
    • Oncology
    • Her2/Neu Receptor
    • Invitrogen's SpotLight
    • Ventana's Her2 Pathway
    • Abbott's Pathvysion
    • Siemens's Oncogene Elisa Her2
    • Dako's Her2 Parmdx Fish
    • Dako's Herceptest
    • KRas Mutation
    • Dxs's Therascreen
    • Genzyme Genetic's Kras Mutations
    • Trimgen's Mutector Ii Kras
    • Hpv
    • Roche's Amplicor Hpv And Linear Array Hpv Test
    • Biomerieux's Nuclisens Easy Q Hpv
    • Qiagen's Digenehpv Test
    • Egfr
    • Dxs's Therascreen Egfr29
    • Dako's Egfr Pharmdx
    • Estrogen/Progesterone Receptors
    • Ipsogen's Mapquant Dx
    • Dako's Er/Pr Pharmdx
    • CKit
    • Dako's CKit Pharmdx
    • Ventana's CKit Pathway
    • BcrAbl
    • Cepheid Genexpert
    • Trimgen's Mutector Ii BcrAbl
    • Ugt1a1
    • Thirdwave's Invader
    • Brca1/2
    • Myriad's Brac Analysis
    • P16 Gene/Cdkn2a
    • Myriad's Melaris
    • Mlh1, Msh2, & Msh6
    • Myriad's Colaris
    • Dpyd & Tyms
    • Myriad's Theraguide 5fu
    • Mll Gene
    • Cytocell's Chromoprobe/Multiprobe
    • Upa & Pai1
    • American Diagnostica's Femtelle
    • PmlRar Alpha
    • Ipsogen's Fusionquant
    • Various Genes/Gene Profiling
    • Intergenetics Oncovue
    • Genomic Health's Oncotypedx
    • Agendia's Mammaprint
    • Abbott's Urovysion
    • Abbott's Cep 12 Dna Probe
    • Abbott's Cep X/Y Dna Probe
    • Infectious Diseases
    • Hiv1
    • Siemens's Trugene
    • Abbott's M2000 & Realtime Hiv1 Viral Load Test
    • Cobas Ampliprep/Cobas Taqman Hiv1 Using Amplicor
    • Abbott/Celera's Viroseq
    • Biomerieux's Nuclisens Easy Q Hiv1
    • Hiv1/2
    • Orasure's Oraquick
    • Cxxr4, Ccr5Tropic Hiv1
    • Monogram's Trofile Assay
    • Hepatitis C Virus
    • Roche's Cobas Ampliscreen Hcv Test
    • Siemens Versant Hcv Rna Test
    • Hepatitis B Virus
    • Roche's Cobas Taqman Hbv Test
    • Cytomegalovirus
    • Roche's Cobas Amplicor Cmv Monitor Test
    • Multiple Viral Strains
    • Biomerieux's Nuclisens Easy Q Technology
    • Abbott Through Luminex's Xtag Respiratory Viral Panel (Rvp)
    • Cepheid Genexpert
    • Hematology
    • Cyp2c9/Vkorc1
    • Nanosphere's Verigene
    • Autogenomics's Infiniti Warfarin Assay
    • Osmetech's Esensor Xt8
    • Various Therapy Areas
    • Cyp2d6/2d19
    • Roche's Amplichip Cyp450
  • Chapter 6 Appendix
    • Key Technologies
    • Other Mdx Tests
    • Hematology
    • Factor Ii
    • Autogenomics's Infiniti Analyzer
    • Roche's Factor Ii Prothrombin G20210a Kit
    • Factor V Leiden
    • Autogenomics's Infiniti Analyzer
    • Roche's Factor V Leiden Kit
    • Factor Viii/Ix
    • Affinity Biologicals Visulize Fviii/Fix
    • AS13
    • American Diagnostica's Immunibind
    • Alpha + / 0 Defects
    • Biorad's Mdx Alpha Gene 1 Kit
    • Various Genes/Analytes
    • Biorad's Mdx Beta Gene Kit
    • Cardiovascular
    • Cetp
    • Wako Diagnostics's Cetp Test
    • Troponin I
    • Nanogen's Cardiac Status
    • Myoglobin, Troponin & Ck/Imb
    • Nanogen's 3 In 1 Cardiac Status
    • AclH5/AntiB2gp11
    • American Diagnostica's Imuclone
    • XlFdp
    • American Diagnostica's DDimer Actiscreen XiFdf Assay
    • Various Genes
    • Clinical Data's Famillion Test
    • Respiratory
    • Cftr
    • Celera's Cystic Fibrosis Genotypic Assay
    • Third Wave's Inplexcf
    • Immunology & Inflammation
    • Various Genes
    • Xdx's Allomap
    • References
    • Journals
    • Websites
    • Datamonitor Reports
  • List Of Tables
    • Table 1: The Historical Ivd And Mdx Market ($M), 200107
    • Table 2: Leading Mdx Players
    • Table 3: The Forecast Ivd And Mdx Market, 200713
    • Table 4: Mdx Tests For Diagnosis
    • Table 5: Mdx Tests For Risk Assessment/Predictive
    • Table 6: Mdx Tests For Drug Compatibility
    • Table 7: Invitrogen's SpotLight Her2 Cish
    • Table 8: Ventana's Her2 Pathway
    • Table 9: Abbott's Her2 Pathvysion
    • Table 10: Siemens's Oncogene Elisa Her2
    • Table 11: Dako's Her2 Pharmdx Fish
    • Table 12: Dako's Herceptest
    • Table 13: Dxs's Therascreen
    • Table 14: Genzyme Genetic's Kras Mutation
    • Table 15: Trimgen's Mutector Ii
    • Table 16: Roche's Amplicor Hpv And Linear Array Hpv Test
    • Table 17: Biomerieux's Nuclisens Easy Q Hpv
    • Table 18: Qiagen's Digenehpv Test
    • Table 19: Dxs's Therascreen Egfr29
    • Table 20: Dako's Egfr Pharmdx
    • Table 21: Ipsogen's Mapquant Dx
    • Table 22: Dako's Er/Pr Pharmdx
    • Table 23: Dako's CKit Pharmdx
    • Table 24: Ventana's CKit Pathway
    • Table 25: Cepheid Genexpert
    • Table 26: Trimgen's Mutector Ii BcrAbl
    • Table 27: Thirdwave's Invader
    • Table 28: Myriad's Brac Analysis
    • Table 29: Myriad's Melaris
    • Table 30: Myriad's Colaris
    • Table 31: Myriad's Theraguide 5fu
    • Table 32: Cytocell's Chromoprobe/Multiprobe
    • Table 33: American Diagnostica's Femtelle
    • Table 34: Ipsogen's Fusionquant
    • Table 35: Intergenetics Oncovue
    • Table 36: Genomic Health's Oncotypedx
    • Table 37: Agendia's Mammaprint
    • Table 38: Abbott's Urovysion
    • Table 39: Abbott's Cep 8 Dna Probe
    • Table 40: Abbott's Cep 12 Probe
    • Table 41: Abbott's Cep X/Ydna Probe Kit
    • Table 42: Siemens's Trugene
    • Table 43: Abbott's M2000 & Realtime Hiv1 Viral Load Test
    • Table 44: Cobas Ampliprep/Cobas Taqman Hiv1 Using Amplicor
    • Table 45: Abbott/Celera's Viroseq
    • Table 46: Biomerieux's Nuclisens Easy Q Hiv1
    • Table 47: Orasure's Oraquick
    • Table 48: Monogram's Trofile Assay
    • Table 49: Roche's Hcv Test
    • Table 50: Siemens's Versant
    • Table 51: Roche's Cobas Taqman Hbv Test
    • Table 52: Roche's Cobas Amplicor Cmv Monitor Test
    • Table 53: Biomerieux's Nuclisens Easy Q
    • Table 54: Abbott/Luminex's Xtag Rvp
    • Table 55: Cepheid's Genexpert
    • Table 56: Nanosphere's Verigene
    • Table 57: Autogenomics's Infiniti Warfarin Assay
    • Table 58: Osmetech's Esensor Xt8
    • Table 59: Roche's Amplichip Cyp450
    • Table 60: Mdx Key Technologies
    • Table 61: Autogenomics's Infiniti Analyzer
    • Table 62: Roche's Factor Ii Prothrombin G20210a Kit
    • Table 63: Autogenomics's Infiniti Analyzer
    • Table 64: Roche's Factor V Leiden Kit
    • Table 65: Affinity Biologicals Visulize Fviii Kit
    • Table 66: American Diagnostica's Immunibind
    • Table 67: Biorad's Mdx Alpha Gene 1 Kit
    • Table 68: Biorad's Mdx Beta Gene Kit
    • Table 69: Wako Diagnostics's Cetp Test
    • Table 70: Nanogen's Cardiac Status
    • Table 71: Nanogen's 3 In 1 Cardiac Status
    • Table 72: American Diagnostica's Imuclone
    • Table 73: American Diagnostica's DDimer Actiscreen XiFdf Assay
    • Table 74: Clinical Data's Famillion Test
    • Table 75: Celera's Cystic Fibrosis Genotypic Assay
    • Table 76: Third Wave's Inplexcf
    • Table 77: Xdx's Allomap
  • List Of Figures
    • Figure 1: The Four Key Areas Covered In This Report
    • Figure 2: Pharmavitae's Mdx Classification Scheme
    • Figure 3: The Us Vs. Eu Regulatory Pathways
    • Figure 4: The Ivd And Mdx Market Size 2007 And 2013f
    • Figure 5: The Key Mdx Tests
    • Figure 6: Datamonitor's Classification Of 'Molecular Diagnostics'
    • Figure 7: Mdx Subclassification
    • Figure 8: The Connection Of Diagnostics With Prescription Pharmaceuticals
    • Figure 9: Us Classification Of Medical Devices
    • Figure 10: The Global Ivd And Mdx Markets ($M), 200113
    • Figure 11: Historical Absolute Growth Of The Ivd And Mdx Sectors ($M), 200107
    • Figure 12: Approximate Market Share Of Ivd And Mdx Markets, 2007
    • Figure 13: Forecast Absolute Growth Of The Ivd And Mdx Sectors ($M), 200713
    • Figure 14: The Increasing Importance Of Mdx To The Total Ivd Market
    • Figure 15: Split Of Mdx Test Function
    • Figure 16: Count Of Mdx Companies With Multiple Tests
    • Figure 17: Count Of Mdx Tests By Therapy Area