全球分子診斷市場

全球分子診斷市場 是由出版商Kalorama Information在2009年01月所出版的。 這份英文市場調查報告書包含450 Pages 價格從美金3995起跳。

簡介

目錄

Abstract

Molecular diagnostics represents a revolution postponed, perhaps, but one that is now clearly underway. DNA Testing has emerged fully from research into clinical practice and becoming a dominant platform in clinical medicine.

From Emerging to Emergent Technology

Instrumentation now automates many of the sample preparation and assay steps that were formerly labor intensive. New tests are being launched all the time. At each step of the way, Kalorama Information has reported on its progress, and in this latest market research report we look at the present state of the market, and the advances that have made DNA testing routine.

Many molecular tests are CE Marked and FDA-cleared and many more are in development. The result is that molecular testing is indicated in many areas of health care.

Molecular Testing Compiled and Analyzed and Explained by a Leading Expert

Authored by lead Kalorama diagnostic analyst Shara Rosen, Kalorama Information' s World Market for Molecular Diagnostics is the most comprehensive global market report available on the emergent field of molecular diagnostics.

This report covers key platforms of molecular diagnostics, including the following :

• Polymerase Chain Reaction (PCR)
• Non-PCR Amplification Technologies, including:
  • bDNA
  • TMA
  • SDA
  • LIPA
  • NASBA
  • Invader
  • Others
• In-situ Hybridization
• Sequencing
• Microarrays
• Laser Capture Microdissection (LCM) and Tissue Arrays
• Mass Spectroscopy
• Other Molecular Platforms

This report provides market estimates and analysis for molecular diagnostics in the following categories:

• Infectious Diseases (including HIV, Hepatitis GC/Chlamydia,Organism ID, MRSA, HAI et al, Mycobacteria, TB Respiratory, Others)
• Blood Screening
• Histology
• Oncology
• Prenatal
• Coagulation
• Tissue Typing
• Inherited Diseases
• Pharmacodiagnostics

The various clinical techniques and trends are discussed from the point of view of their present and potential market impact.

Market analysis in this report covers world markets for in vitro diagnostics, with focus on the developed areas of the globe -- North America and Western Europe. However public health and infectious disease are a growing global problem and where possible the report covers IVD products related to the globalization of diseases.

As part of its exhaustive coverage of nucleic acid testing, the report includes the following:

• Market Sizes and Forecasts
• Profile and Assessment of Over 140 Key Competitors
• Breakout of Molecular Diagnostic Market by Region (N. America, W. Europe, Asia, ROW)
• Medical and Technological Trends
• Discussion of Globalization of Markets and Diseases
• Information on Reimbursement of New Technologies
• Review of Novel Test Platforms
• Review of New Market Developments, Such as Consumer Genomics and Testing Services
• Discussion of Market Impact of Home Brew Tests
• Discussion of Diagnostic Biomarkers and Genetic Indicators

All market data are based on factory sales to the end user and not retail pricing or reimbursement payments. Data for the molecular test market are presented in U.S. dollar market size for categories of tests, and for specific analytes where possible. The dollar value of a market segment is directly proportional to the number of tests performed, because the cost of the instrumentation is generally buried in the per test price.

The report discusses tests and technologies that are currently available and those that are expected to take their place. Generally, current products and technologies establish the standard of care and its value to payers. Many of the assays and techniques presented in the report are expected to replace the standard of care in 2007/08, but with healthcare systems' emphasis on cost/benefit analysis for new technologies adoption, the market value and thus penetration capabilities of newer approaches may be limited.

Unsurpassed Breadth of Coverage

The information presented in this report is derived from publicly available information sources such as company, government, and medical organization reports. The analysis is based on the author' s industry knowledge combined with literature searches and interviews with industry professionals and experts in the areas of in vitro diagnostics and molecular pathologists.

Table of Contents

CHAPTER ONE: EXECUTIVE SUMMARY

• Introduction
• Scope and Methodology
• Size and Growth of the Market
• Market Trends
• Regulatory Issues and Molecular Tests
• The Promise of Companion Diagnostics
• From Research to Clinic
• Test Services

CHAPTER TWO: TECHNOLOGICAL TRENDS

• Background
• The In Vitro/In Vivo Mix
• Miniaturization and Multiplexed Biological Assays
• The search for Non-Invasive Tools
• Mechanisms of Gene Modification, Regulation and Expression
• Methylated Gene (meDNA) Patterns
• RNA - Ribonucleic Acid
• Transcription Factors
• Circulating Cell-free Nucleic Acids
• Sample Preparation and System Automation
• PCR Patent Update

CHAPTER THREE: MEDICAL TRENDS AND MARKET ISSUES

• Background
• New Testing Opportunities - Genes and Proteins
• Reimbursement of Novel Tests
• Medicare and Medicaid
• HMOs and Managed Care
• GTE Subscription Based Model
• Commercializing Molecular Diagnostics
• Increasing Efficiency
• Successful Patents
• Lab-Developed Test Services
• Regulatory Issues and Molecular Tests
• The Promise of Companion Diagnostics
• From Research to Clinic
• Test Services

CHAPTER FOUR: TECHNOLOGICAL TRENDS THAT ENABLE THE FUTURE OF MOLECULAR DIAGNOSTICS

• Background
• The In Vitro/In Vivo Mix
• Miniaturization and Multiplexed Biological Assays
• Microfluidic Devices
• Bead-Based Technologies
• The Search For Non-Invasive Tools
  • Breath
  • Hair
  • Serum
• Mechanisms of Gene Modification, Regulation and Expression
  • Methylated Gene (meDNA) Patterns
  • RNA - Ribonucleic Acid
  • Transcription Factors
  • Circulating Cell-free Nucleic Acids
• Sample Preparation and System Automation
• Homebrew Reagents
• DNA Test Sample Preparation Market
• PCR Patent Update

CHAPTER FIVE: PLATFORMS AT THE FOREFRONT OF MOLECULAR ASSAYS

• Background
• Components of DNA tests
• Molecular Test Platforms Market Overview
  • Polymerase Chain Reaction (PCR)
  • Non-PCR Amplification Technologies
  • Miniaturized Platforms - Arrays and Biochips
  • Mass Spectroscopy
  • Laser Capture Microdissection (LCM) and Tissue Arrays
  • TMAs

CHAPTER SIX: MARKET ANALYSIS

• Worldwide Opportunities for Molecular Tests
  • The United States
  • Europe
  • China
• Molecular Diagnostics And Target Markets
• The Market for Molecular Assays in Cancer Management
  • CUP/TUO
  • Herceptin
• The Market for Molecular Assays In Hematology
  • Towards Routine Hematology Testing
• The Market For Molecular Assays in Coagulation
  • Procoagulation and Thrmobolytic Markers
  • Warfarin
• The Market For Molecular Assays in Histopathology/Cytology
  • Overview
  • The Future of the Pap Smear & HPV Testing
  • In Situ Hybridization and Digital Cytometry
  • Microscopy
• The Market for Molecular Assays in Microbiology/Virology
  • HIV
  • STDs
  • Hospital Acquired Infections (HAIs)
  • Respiratory Viruses
• The Market for Molecular Assays in Blood Transfusion Medicine
  • Transfusion Statistics
  • Trends in Transfusion Medicine
  • Blood Screening Markets
  • PROCLEIX
• The Market for Molecular Assays in Tissue Transplant Management
• The Market for Molecular Assays in Prenatal and Neonatal Testing
  • Prental Carrier and Fetus Screening Market
  • FISH Assays
  • PAP Assays
  • IVF Fertilization Procedure Testing
• The Market for Molecular Assays for Inherited Diseases
• Pharmacodiagnostic Test Applications

CHAPTER SEVEN: MAJOR VENDORS AND COMPANIES TO WATCH

• Company Triage
• The Majors
• The Stars
• Participants
• Newcomers
• 2012 and Beyond
• Acquisitions, Alliances and Collaborations in Molecular Diagnostics

CHAPTER EIGHT: CONCLUSIONS AND STRATEGIC IMPLICATIONS

• Conclusion One
  • Implication
• Conclusion Two
  • Implication
• Conclusion Three
  • Implication
• Conclusion Four
  • Implication
• Conclusion Five
  • Implication
• Conclusion Six
  • Implication

CHAPTER NINE: MAJOR VENDORS AND COMPANIES TO WATCH

Top Companies

• Abbott Diagnostics
  • Revenues
  • Key Comment
  • Details
• Becton, Dickinson and Company (BD)
  • Revenues
  • Key Comment
  • Details
• Beckman Coulter Inc.
  • Revenues
  • Key Comment
  • Details
• bioMerieux Inc.
  • Revenues
  • Key Comment
  • Details
• Celera
  • Revenues
  • Key Comment
  • Details
• Cepheid
  • Revenues
  • Key Comment
  • Details
• Dako A/S
  • Revenues
  • Key Comment
  • Details
• Digene Corporation
  • Revenues
  • Key Comment
  • Details
• Genomic Health
  • Revenues
  • Key Comment
  • Details
• Gen-Probe Inc.
  • Revenues
  • Key Comment
  • Details
• Genzyme Corporation
  • Revenues
  • Key Comment
  • Details
• Ortho Clinical Diagnostics (OCD)
  • Revenues
  • Key Comment
  • Details
• Qiagen N.V.
  • Revenues
  • Key Comment
  • Details
• Roche Diagnostics
  • Revenues
  • Key Comment
  • Details
• Siemens Medical Solutions Diagnostics
  • Revenues
  • Key Comment
  • Details
• Sysmex Corporation
  • Revenues
  • Key Comment
  • Details
• Ventana Medical Systems. Inc.
  • Revenues
  • Key Comment
  • Details

Other Companies

• 23andMe, Inc.
  • Revenues
  • Key Comment
  • Details
• 454 Life Sciences Corporation
  • Revenues
  • Key Comment
  • Details
• AdnaGen AG
  • Revenues
  • Key Comment
  • Details
• Adnavance Technologies Inc.
  • Revenues
  • Key Comment
  • Details
• Advanced Analytical Technologies, Inc. (AATI)
  • Revenues
  • Key Comment
  • Details
• AdvanDx, Inc.
  • Revenues
  • Key Comment
  • Details
• Affymetrix
  • Revenues
  • Key Comment
  • Details
• Agendia B.V.
  • Revenues
  • Key Comment
  • Details
• Agilent Technologies Inc.
  • Revenues
  • Key Comment
  • Details
• Almac Diagnostics (formerly ArraDx)
  • Revenues
  • Key Comment
  • Details
• Althea Technologies, Inc.
  • Revenues
  • Key Comment
  • Details
• Ambry Genetics Corporation
  • Revenues
  • Key Comment
  • Details
• Arcxis Biotechnologies
  • Revenues
  • Key Comment
  • Details
• Asuragen, Inc.
  • Revenues
  • Key Comment
  • Details
• Athena Diagnostics, Inc.
  • Revenues
  • Key Comment
  • Details
• Atlas Genetics Limited
  • Revenues
  • Key Comment
  • Details
• AutoGenomics, Inc.
  • Revenues
  • Key Comment
  • Details
• AviaraDx (formerly Arcturus Biosciences)
  • Revenues
  • Key Comment
  • Details
• bcs BIOTECH S.p.A.
  • Revenues
  • Key Comment
  • Details
• BG Medicine
  • Revenues
  • Key Comment
  • Details
• Biocept, Inc.
  • Revenues
  • Key Comment
  • Details
• BioHelix Corporation
  • Revenues
  • Key Comment
  • Details
• BioNanomatrix
  • Revenues
  • Key Comment
  • Details
• Bio-Reference Laboratories, Inc. (BRLI)
  • Revenues
  • Key Comment
  • Details
• Biotage AB (formerly Pyrosequencing Technologies)
  • Revenues
  • Key Comment
  • Details
• Biotools, B & M Labs, S.A.
  • Revenues
  • Key Comment
  • Details
• BioTrove, Inc.
  • Revenues
  • Key Comment
  • Details
• China Medical Technologies, Inc.
  • Revenues
  • Key Comment
  • Details
• Clarient Inc. (formerly ChromaVision)
  • Revenues
  • Key Comment
  • Details
• Clinical Data, Inc.
  • Revenues
  • Key Comment
  • Details
• CLONDIAG chip technologies GmbH
  • Revenues
  • Key Comment
  • Details
• CombiMatrix Molecular Diagnostics (CMDX)
  • Revenues
  • Key Comment
  • Details
• Consumer Genetics
  • Revenues
  • Key Comment
  • Details
• Correlogic Systems, Inc.
  • Revenues
  • Key Comment
  • Details
• Curidium Medica Plc
  • Revenues
  • Key Comment
  • Details
• deCode Genetics Inc.
  • Revenues
  • Key Comment
  • Details
• DiaGenic ASA
  • Revenues
  • Key Comment
  • Details
• Diatherix Laboratories Inc.
  • Revenues
  • Key Comment
  • Details
• DNAFORM
  • Revenues
  • Key Comment
  • Details
• DNA Direct, Inc.
  • Revenues
  • Key Comment
  • Details
• The DNA Repair Company (DNAR)
  • Revenues
  • Key Comment
  • Details
• DxS Ltd.
  • Revenues
  • Key Comment
  • Details
• eGene Inc.
  • Revenues
  • Key Comment
  • Details
• eGenomics, Inc.
  • Revenues
  • Key Comment
  • Details
• Eiken Chemical Co., Ltd
  • Revenues
  • Key Comment
  • Details
• Enigma Diagnostics Limited
  • Revenues
  • Key Comment
  • Details
• Epigenomics AG
  • Revenues
  • Key Comment
  • Details
• Epistem Ltd.
  • Revenues
  • Key Comment
  • Details
• Eppendorf Biochip Systems GmbH
  • Revenues
  • Key Comment
  • Details
• EraGen Biosciences Inc.
  • Revenues
  • Key Comment
  • Details
• EXACT Sciences Corporation
  • Revenues
  • Key Comment
  • Details
• Exiqon A/S
  • Revenues
  • Key Comment
  • Details
• Fluidigm Corporation
  • Revenues
  • Key Comment
  • Details
• Focus Diagnostics, Inc.
  • Revenues
  • Key Comment
  • Details
• Fujifilm Diagnostics (Fujifilm GmbH)
  • Revenues
  • Key Comment
  • Details
• Gene Express, Inc.
  • Revenues
  • Key Comment
  • Details
• GeneNews Limited
  • Revenues
  • Key Comment
  • Details
• GenoID Ltd.
  • Revenues
  • Key Comment
  • Details
• Genomas
  • Revenues
  • Key Comment
  • Details
• Genoptix, Inc.
  • Revenues
  • Key Comment
  • Details
• GENPOINT AS
  • Revenues
  • Key Comment
  • Details
• Greiner Bio-One International AG
  • Revenues
  • Key Comment
  • Details
• Hain Lifescience GmbH
  • Revenues
  • Key Comment
  • Details
• Hamilton Thorne Biosciences, Inc.
  • Revenues
  • Key Comment
  • Details
• HandyLab, Inc.
  • Revenues
  • Key Comment
  • Details
• Health Discovery Corporation
  • Revenues
  • Key Comment
  • Details
• HiFi DNA Tech, LLC
  • Revenues
  • Key Comment
  • Details
• Ikonisys Inc.
  • Revenues
  • Key Comment
  • Details
• Illumina
  • Revenues
  • Key Comment
  • Details
• Immunicon Corporation
  • Revenues
  • Key Comment
  • Details
• Innogenetics NV
  • Revenues
  • Key Comment
  • Details
• InterGenetics, Inc.
  • Revenues
  • Key Comment
  • Details
• Interleukin Genetics, Inc.
  • Revenues
  • Key Comment
  • Details
• IntegraGen SA
  • Revenues
  • Key Comment
  • Details
• Invitrogen Corporation
  • Revenues
  • Key Comment
  • Details
• Ipsogen
  • Revenues
  • Key Comment
  • Details
• Iris BioTechnologies Inc.
  • Revenues
  • Key Comment
  • Details
• KREATECH Biotechnology B.V.
  • Revenues
  • Key Comment
  • Details
• Lab21 Healthcare
  • Revenues
  • Key Comment
  • Details
• Laboratory Corporation of America Holdings (LabCorp)
  • Revenues
  • Key Comment
  • Details
• Med BioGene, Inc. (MBI)
  • Revenues
  • Key Comment
  • Details
• Microchip Biotechnologies, Inc. (MBI)
  • Revenues
  • Key Comment
  • Details
• Microgen Bioproducts Ltd.
  • Revenues
  • Key Comment
  • Details
• Mobidiag Oy
  • Revenues
  • Key Comment
  • Details
• Molzym GmbH & Co. KG
  • Revenues
  • Key Comment
  • Details
• Monogram Biosciences, Inc. (formerly ViroLogic)
  • Revenues
  • Key Comment
  • Details
• Myconostica, Ltd.
  • Revenues
  • Key Comment
  • Details
• Myriad Genetics, Inc.
  • Revenues
  • Key Comment
  • Details
• Nanogen
  • Revenues
  • Key Comment
  • Details
• Nanosphere, Inc.
  • Revenues
  • Key Comment
  • Details
• Navigenics
  • Revenues
  • Key Comment
  • Details
• NeuroMark
  • Revenues
  • Key Comment
  • Details
• NorDiag ASA
  • Revenues
  • Key Comment
  • Details
• Novartis Vaccines and Diagnostics/Chiron
  • Revenues
  • Key Comment
  • Details
• Nuvera Biosciences
  • Revenues
  • Key Comment
  • Details
• OncoMethylome Sciences S.A.
  • Revenues
  • Key Comment
  • Details
• Orchid Cellmark
  • Revenues
  • Key Comment
  • Details
• Orion Genomics
  • Revenues
  • Key Comment
  • Details
• Osmetech plc
  • Revenues
  • Key Comment
  • Details
• Pacific Biosciences of California, Inc. (PacBio)
  • Revenues
  • Key Comment
  • Details
• ParagonDx LLC
  • Revenues
  • Key Comment
  • Details
• Pathwork Diagnostics (formerly Predicant Biosciences)
  • Revenues
  • Key Comment
  • Details
• Perceptronix Medical Inc.
  • Revenues
  • Key Comment
  • Details
• PerkinElmer, Inc.
  • Revenues
  • Key Comment
  • Details
• Prediction Sciences
  • Revenues
  • Key Comment
  • Details
• Prodesse, Inc.
  • Revenues
  • Key Comment
  • Details
• Progenika Biopharma
  • Revenues
  • Key Comment
  • Details
• Psynomics Incorporated
  • Revenues
  • Key Comment
  • Details
• Q Chip Ltd.
  • Revenues
  • Key Comment
  • Details
• Quest Diagnostics Incorporated
  • Revenues
  • Key Comment
  • Details
• Rosetta Genomics Ltd.
  • Revenues
  • Key Comment
  • Details
• Seegene, Inc.
  • Revenues
  • Key Comment
  • Details
• SensiGen LLC
  • Revenues
  • Key Comment
  • Details
• Sequenom, Inc.
  • Revenues
  • Key Comment
  • Details
• SIRS-Lab
  • Revenues
  • Key Comment
  • Details
• Smart Genetics
  • Revenues
  • Key Comment
  • Details
• Tepnel Life Sciences
  • Revenues
  • Key Comment
  • Details
• TessArae, LLC
  • Revenues
  • Key Comment
  • Details
• TheraGenetics, Limited
  • Revenues
  • Key Comment
  • Details
• Third Wave Technologies Inc.
  • Revenues
  • Key Comment
  • Details
• Transgenomic Inc.
  • Revenues
  • Key Comment
  • Details
• TrimGen Corporation
  • Revenues
  • Key Comment
  • Details
• Veredus Laboratories Pte Ltd.
  • Revenues
  • Key Comment
  • Details
• Veridex, LLC
  • Revenues
  • Key Comment
  • Details
• Vita Genomics
  • Revenues
  • Key Comment
  • Details
• Xceed Molecular
  • Revenues
  • Key Comment
  • Details
• XDx Inc.
  • Revenues
  • Key Comment
  • Details
• Xenomics, Inc.
  • Revenues
  • Key Comment
  • Details
• Zila, Inc.
  • Revenues
  • Key Comment
  • Details

Other Participants

TABLE OF EXHIBITS

CHAPTER ONE: EXECUTIVE SUMMARY

• Table 1-1: Exchange Rate Fluctuations, 2003-2007
• Table 1-2: Worldwide Molecular Test Sales, 2007-2012
• Table 1-3: Market Penetration Of Clinical Molecular Diagnostics, by Geographic Area (North America, EU Europe, Japan, ROW)

CHAPTER TWO: INTRODUCTION

• Table 2-1: Selected Events in the Evolution of DNA Testing

CHAPTER THREE: TECHNOLOGY PLATFORMS

• Table 3-1: Selected Platforms for Multiplexed Nucleic Acids and Proteins
• Table 3-2: Selected SNP - Drug Interactions
• Table 3-3: Selected Molecular Test Services Available in 2008

CHAPTER FOUR: TECHNOLOGICAL TRENDS THAT ENABLE THE FUTURE OF MOLECULAR DIAGNOSTICS

• Table 4-1: Selected Multiplexed Molecular Assays, 2008
• Table 4-2: Selected Multiplexed Molecular Assays, 2008
• Table 4-3: Selected Methylated DNA Tests
• Table 4-4: Selected RNA-based Cancer Tests
• Table 4-5: Selected Nucleic Acid Sample Preparation Products

CHAPTER FIVE: TECHNOLOGY PLATFORMS AT THE FOREFRONT OF MOLECULAR ASSAYS

• Table 5-1: Market Potential Of Key Clinical Molecular Platforms, 2008
• Table 5-2: Molecular Test Product Sales, Worldwide, by Platform, 2007
• Table 5-3: Selected Companies With PCR-Based Products
• Table 5-4: Non-PCR Molecular Tests Sales, Worldwide, by Platform, 2007(bDNA, TMA, SDA, LIPA, NASBA, Invader, Others)
• Table 5-5: Selected Non-PCR Molecular Platforms (Company, Location, Platform/Technology)
• Table 5-6: Selected New Molecular Test Platforms
• Table 5-7: Major Microfluidics Companies
• Table 5-8: Major Molecular Markers For Tissue Staining
• Table 5-9: Selected In Situ Hybridization Innovation
• Table 5-10: Selected LCM Systems on the Market, 2008

CHAPTER SIX: MARKET ANALYSIS

• Table 6-1: Worldwide Molecular Test Sales, 2007-2012
• Table 6-2: Breakdown Of Home-Brew Molecular Diagnostic Tests, 2007 (Test Type, % Number of Tests)
• Table 6-3: Market Penetration Of Clinical Molecular Diagnostics, by Geographic Area (North America, EU Europe, Japan, ROW)
• Table 6-4: Average Cost Of Selected Genetic Test Services, U.S.
• Table 6-5: Selected Reference Lab and IVD Company Collaborations
• Table 6-6: Selected IVD Cancer Markers used in Tissue Analysis
• Table 6-7: Selected Molecular Tests for Coagulation Testing (Company, Location, Details, Test, Status)
• Table 6-8: Selected Advanced HPV Tests, 2006-2008 (Company, Location, Test, Status)
• Table 6-9: Selected Microscopy and Image Analysis Products
• Table 6-10: Molecular Test Sales, Infectious Diseases, 2007-2012 (Company, Location, Details, Status)
• Table 6-11: Selected Infectious Disease Molecular Test Products, 2006-2008 (Company, Location, Details, Status)
• Table 6-13: Most Frequently Requested Genetic Tests
• Table 6-14: Selected Molecular Tests for Inherited Diseases (Company, Location, Details, Status)

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