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世界の分子診断市場:第6版

The World Market for Molecular Diagnostics, 6th Edition

発行 Kalorama Information 商品コード 172533
出版日 ページ情報 英文 1032 Pages
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世界の分子診断市場:第6版 The World Market for Molecular Diagnostics, 6th Edition
出版日: 2015年09月30日 ページ情報: 英文 1032 Pages
概要

当レポートでは、世界の分子診断市場の現状と見通しを調査分析し、分子IVD市場の市場規模実績・予測(7種の診断区分別)、分子診断市場の地域別内訳、主要関連事業者のプロファイルなどをまとめています。

第1章 エグゼクティブサマリー

第2章 イントロダクション

第3章 分子検査の外来診療所への供給

  • 背景
  • 医療費償還環境
  • 医師の採用
  • 米国の経験
  • オーダーメイド精密医療の進歩と障壁
  • サービス産業の普及

第4章 シーケンシング:どこまでやれるか?

  • 背景
  • 企業・技術
  • 市場分析
  • シーケンシング研究プロジェクト
  • よりパーソナライズした癌
  • 病原菌シーケンシング

第5章 市場分析:世界市場

  • 背景
  • 世界における分子検査の機会
  • 米国
  • カナダ
  • 欧州
  • 中国

第6章 癌における血液マーカー市場

  • イントロダクション
  • 適確医療および新しい分子の認識
  • 現状へ戻る

第7章 血液学における分子アッセイ市場:細胞ベースの分子検査

  • フローサイトメトリー
  • 市場分析

第8章 凝固における分子アッセイ市場

  • 血栓性素因SNP
  • 薬理診断 (Pharmacodiagnostics)

第9章 組織学と細胞学

  • 背景
  • 先進分析ツール
  • サンプル調製
  • ISH (in situ ハイブリダイゼーション)
  • HPV検査
  • 循環腫瘍細胞 (CTC)
  • 薬理診断の組織学

第10章 微生物学とウイルス学

  • イントロダクション
  • 市場概要
  • POCおよび分散型検査
  • サンプル調製
  • 検査サービス
  • 抗菌薬耐性
  • 微生物学における次世代シーケンシング
  • ヒトマイクロバイオーム
  • 新しい病気の脅威
  • 血液培養 & HAI (院内感染)
  • HIV
  • 肝炎
  • 性感染症 (STD)
  • 呼吸器感染症
  • 結核
  • 真菌感染症

第11章 輸血療法における分子アッセイ市場

  • 血液由来病原体のスクリーニング
  • 血液型検査

第12章 臓器移植管理における分子アッセイ市場

  • 技術進歩
  • 市場分析

第13章 出生前診断・新生児検査における分子アッセイ市場

  • イントロダクション・市場データ
  • 無侵襲的出生前遺伝学的検 (NITP)
  • キャリアスクリーニング
  • 親のキャリアスクリーニンぐ
  • DNAの市場拡大
  • 新生児検査

第14章 遺伝性疾患における分子アッセイ市場

  • 自閉症
  • アルツハイマー病
  • 心血管疾患
  • 糖尿病
  • 精神疾患
  • 胃腸の状態
  • 奇病

第15章 総論・戦略的影響

  • 将来の展望
  • 戦略的見通し

第16章 主要ベンダー・注目企業

第17章 企業プロファイル:トップティア

第18章 企業プロファイル:主要分子検査企業

第19章 市場参入企業

第20章 有望企業

第21章 新規参入企業

第22章 企業プロファイル:検査サービスプロバイダー

第23章 企業プロファイル:POC検査専門企業

第24章 企業プロファイル:サンプル調製

第25章 企業プロファイル:IT専門企業

第26章 企業プロファイル:組織病理専門企業

第27章 企業プロファイル:微生物の専門企業

第28章 企業プロファイル:血液バンクの専門企業

第29章 企業プロファイル:出生前診断サービスプロバイダー

第30章 企業プロファイル:CTC (循環腫瘍細胞) & 液体生検検査プロバイダー

図表リスト

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目次
Product Code: KLI5695907

Molecular tests are used in just about every facet of laboratory medicine: infectious diseases, inherited diseases, coagulation, transplant medicine, prenatal and postnatal screening and cancer. In ‘The World Market for Molecular Diagnostics, 6th Edition’, Kalorama IVD market analyst Shara Rosen, R.T., MBA provides authoritative and complete analysis of the molecular testing industry.

In this report, exclusive market sizing and forecasts are provided for the following diagnostic segments:

  • Cancer Markers & PGx
  • Histology (In situ hybridization, HPV)
  • Microbiology/Virology (HAI; HIV; Hepatitis; GC/Chlamydia; Respiratory; Organism ID; Mycobacteria, TB; Others)
  • Blood Screening
  • Coagulation & PGx
  • Prenatal Testing
  • Inherited Diseases Testing
  • Tissue Typing
  • Organ Transplant Testing (HLA Typing)
  • Circulating Tumor Cells (CTCs)
  • Clinical Sequencing
  • Flow Cytometry

The amount of activity over the last few years is short of phenomenal with a continuous stream of new platforms, tests and quality control materials for test standardization coming to market. There is intense competition but also opportunities for entrants in some areas. Comprehensive Coverage of the Molecular Diagnostics Industry

Molecular diagnostics is one of the fastest growth segments in clinical diagnostics, and for the past five years there's been a considerable rate of growth in the number of assays introduced. Moreover, growth of this segment is fuelled by rising incidence of chronic disorders, an increasing geriatric population and adoption of personalized medicines.

This report not only contains current market data for business planning, it goes beyond the numbers to fully assess what is going on in the market and why. Since the last edition of this report, a lot has changed, and a lot has stayed the same.

As part of its coverage, the report includes the following:

  • Over 1,000 Pages of Detailed Market Coverage
  • Over 70 Tables and Figures Makes Market Analysis More Accessible
  • Current Market Size and Forecast 2014-2019 for Several Specific Molecular IVD Segments
  • Exome Sequencing, Metabolic Profiling, Hospital Acquired Infections, LDTs, Information Technology,

Status of China and Emerging Markets and Other Trends

  • Infectious Disease Molecular Sales by Disease
  • Over 190 Profiles of Molecular Diagnostic Competitors
  • Recent Mergers and Acquisitions
  • Revenues of Test Service Companies
  • Geographic Breakout of the Molecular Diagnostics Market by Region
  • Sample Preparation Trends
  • Breakout of Molecular Histology/Cytology Market
  • Mergers, Partnerships, Distribution Agreements in Molecular IVD

More and more laboratories offer complex panels of tests that help physicians evaluate disease risk and make therapeutic decisions. Government and private healthcare payers have recognized the value of new molecular tools and have agreed to pay for them. A desire for better and faster test results, a preference for tests that are aimed at the patent, renewed interest in IVD in general and more particularly in molecular IVD has led to the commercialization of a number of technological tools that make more sensitive and specific tests possible. Some of these technological innovations include cost-effective, multiplexed testing platforms coupled with high-powered software capabilities.

Who to Watch: Top Leaders and Rising Innovators

Kalorama provides profiles of over 200 companies participating in the market. All of these companies have different strategies and compete in different areas, and Kalorama acknowledges this by separating the companies in a triage system based on where they stand in the molecular in vitro diagnostics market.

  • "IVD Leaders" - The top IVD companies participating in molecular diagnostics as well as dominating the rest of testing. Their activities in molecular testing and their results.
  • "Major Molecular Diagnostics Leaders" -The top companies focused on molecular testing.
  • "Molecular Diagnostics Participants"- Molecular diagnostic companies that are by now established in the market
  • "Great Expectation Companies"- Those companies that have potential with an innovative approach
  • "Molecular Diagnostics Newcomers"- IVD Companies that have novel or interesting approaches to keep an eye on
  • “CTC and Liquid Biopsy Test Providers” Biocept, Veridex, Qiagen and other companies in this high-interest molecular testing segment.
  • "Platform Innovators"- Companies that have developed new platform technologies
  • "Information Technology Companies" - Molecular testing relies on strong information systems to handle data. These companies are in the forefront.
  • "Sample Prep Leaders" - Companies focused on sample preparation for molecular diagnostics
  • "Segment Specialist Companies" - In various areas (microbiology, histology, blood banking, etc)

Molecular diagnostics tests are rapidly being developed for genetic testing, infectious diseases testing, blood screening, oncology testing, cardiovascular testing and others. The report looks in detail at market segments, evaluating them in terms of selected tests, test innovations, advanced techniques, and companies in the segment, providing where possible segment revenue and company sales information.

A Global Focus

The various tests, technologies, and trends are discussed from the point of view of their present and potential market impact. The report focuses on developments at work in both mature markets and in emerging nations, providing market penetration of clinical molecular diagnostics by geographic area for 2014 and 2019. ‘The World Market for Molecular Diagnostics’ looks at how social and economic events in selected countries may affect the evolution of molecular testing worldwide.

Regions covered include:

  • North America
  • Western Europe
  • Japan
  • China
  • India
  • Rest of World

The report covers trends and issues concerning: globalization of markets and diseases, reimbursement of new technologies , Novel test platforms diagnostic biomarkers and genetic indicators. The application of molecular technologies to clinical analyses has received widespread attention around the world and has made a significant mark in diagnostic systems, and will continue to do so. The report looks at what can be expected in the coming 5 to 10 years, presenting conclusions and strategic implications.

In 2015 the technologies that were used for the Human Genome Project have become tools that molecular pathologists routinely use to diagnose diseases in patients that had remained a mystery for a long time. This is good for patient care but the evolution of sequencing and next generation sequencing-based tests have gone so quickly that government agencies and payers are scurrying to cope with the regulatory, reimbursement and ethical issues that accompany this new generation of tests. Only five years ago it would have been almost inconceivable that hospital and government funded programs would provide whole genome and whole exome sequencing for thousands and even millions of people.

Information technology (IT) is an important tool that plays three essential roles, as detailed in this report: 1) data sharing to develop well-curated gene variations, 2) interpretation of gene variants to develop testing guidelines and 3) distribution of this information to clinicians for use in patient care. A discussion of developments in information technology and molecular diagnostics merits a report all to itself. Here Kalorama presents a bird's eye view of the programs and initiatives that suggest how the IT-molecular diagnostics mix is evolving. Hundreds of genome studies are underway, worldwide, involving sometimes hundreds of thousands of patient test results.

Companies profiled include:

  • Abbott Diagnostics
  • Alere Inc.
  • Beckman Coulter, Inc. / Danaher
  • Becton, Dickinson and Company (BD)
  • Bio-Rad Laboratories, Inc.
  • bioMérieux Inc.
  • Danaher Corporation
  • General Electric - GE Healthcare
  • Hologic, Inc.
  • QIAGEN N.V.
  • Roche Diagnostics
  • Siemens Healthcare Diagnostics
  • Sysmex Corporation
  • Thermo Fisher Scientific Inc.
  • Affymetrix Inc.
  • Agilent Technologies
  • Asuragen Inc.
  • BGI
  • Cepheid
  • Eiken Chemical Co., Ltd
  • Enzo Biochem Inc.
  • Illumina
  • Life Technologies Corporation
  • PerkinElmer, Inc. (PE)
  • RainDance Technologies, Inc.
  • AutoGenomics Inc.
  • Biocartis SA
  • DiaSorin S.p.A
  • EKF Diagnostics Holdings Plc
  • ELITech Group
  • Epigenomics
  • Exosome Diagnostics, Inc.
  • Fluidigm Corporation
  • Fujirebio Diagnostics, Inc.
  • GenMark Diagnostics
  • Genome Diagnostics BV (GenDx)
  • Luminex Corporation
  • Menarini Diagnostics
  • Nanostring Technologies, Inc.
  • Pacific Biosciences of California, Inc. (PacBio)
  • Quidel Corporation
  • Rubicon Genomics, Inc.
  • Transgenomic, Inc.
  • TrovaGene, Inc.
  • WaferGen Bio-systems, Inc.
  • Genomic Vision
  • GENOMICA S.A.U.
  • IncellDx, Inc.
  • Inivata
  • IntegenX Inc.
  • Linkage Biosciences, Inc.
  • Savyon Diagnostics
  • Selventa
  • VolitionRx Limited
  • B Braun CeGaT, LLC
  • Canon BioMedical, Inc.
  • DestiNA Genomics Ltd.
  • DiamiR, LLC
  • Randox Laboratories Ltd.
  • 23andMe
  • Adaptive Biotechnologies Corporation
  • Agendia BV
  • AltheaDx Diagnostics, Inc.
  • Ambry Genetics
  • ARUP Laboratories
  • Assurex Health
  • Athena Diagnostics
  • Bio-Reference Laboratories, Inc. (BRLI)
  • bioTheranostics
  • Cancer Genetics, Inc. (CGI)
  • CareDx, Inc.
  • Caris Life Sciences
  • Centogene AG
  • Complete Genomics
  • Counsyl
  • Exact Sciences Corp.
  • Foundation Medicine Inc.
  • Genomic Health, Inc.
  • Helomics Corporation
  • IntegraGen
  • Invitae Corporation
  • LabCorp, Laboratory Corporation of America
  • Mayo Medical Laboratories
  • MDxHealth SA
  • Myriad Genetics
  • Pathway Genomics Corporation
  • Quest Diagnostics
  • Rosetta Genomics Ltd.
  • Veracyte, Inc.
  • Atlas Genetics Ltd.
  • Biomeme, Inc.
  • DiAssess Inc.
  • DNA Electronics Ltd (DNAe)
  • Enigma Diagnostics Limited
  • Entopsis
  • Epistem Holdings plc
  • InSilixa Inc.
  • Lucigen
  • PositiveID Corporation
  • QuantuMDx Group Limited
  • Rheonix, Inc.
  • Scanogen Inc.
  • Ubiquitome
  • Veredus Laboratories Pte Ltd
  • Xagenic
  • Horizon Discovery Group plc
  • MO BIO Laboratories, Inc.
  • PreAnalytiX GmbH
  • QIAGEN N.V.
  • SeraCare Life Sciences, Inc.
  • Advaita Bioinformatics
  • Apple Inc.
  • Cartagenia
  • Cerner Corp.
  • CLC bio
  • CollabRx Inc.
  • DNAnexus
  • GENALICE
  • GenomOncology
  • Google Genomics
  • IBM Healthcare
  • Intel Corporation
  • Knome Inc.
  • N-of-One
  • PierianDx
  • Sophia Genetics
  • Advanced Cell Diagnostics (ACD)
  • Amoy Diagnostics Co. Ltd.
  • Applied Spectral Imaging Inc. (ASI)
  • BioView Ltd.
  • Circulomics Inc.
  • Covaris Inc.
  • Cymogen Dx, LLC
  • Dako A/S
  • Definiens
  • DxTerity Diagnostics Inc.
  • HTG Molecular Diagnostics
  • Leica Biosystems
  • PreTect AS (formerly Norchip)
  • Kapa Biosystems Inc.
  • Ventana Medical Systems Inc.
  • Accelerate Diagnostics, Inc.
  • Advanced Biological Laboratories, S.A. (ABL)
  • AdvanDx, Inc.
  • altona Diagnostics
  • Aperiomics
  • Co-Diagnostics HBDC
  • Curetis AG
  • DxNA, LLC
  • Fast-Track Diagnostics
  • Focus Diagnostics, Inc.
  • Genetic Analysis AS
  • Great Basin Scientific, Inc.
  • Greiner Bio-One International GmbH
  • Hain Lifescience GmbH
  • Hutman Diagnostics AG
  • Intelligent Medical Devices, Inc. (IMDx)
  • Meridian Bioscience, Inc.
  • Mobidiag Ltd
  • Molbio Diagnostics Pvt Ltd.
  • Nanosphere, Inc.
  • PathoGenetix, Inc.
  • Pathogenica
  • Reference Genomics Inc.
  • Seegene, Inc.
  • Specific Technologies
  • T2 Biosystems
  • AXO Science
  • Grifols
  • Immucor, Inc.
  • Ariosa Diagnostics, Inc.
  • Berry Genomics Co. Ltd
  • Combimatrix Corp.
  • Good Start Genetics, Inc.
  • Illumina
  • LifeCodexx AG
  • Multiplicom N.V.
  • Natera
  • Premaitha Health plc
  • Sequenom Inc.
  • Angle plc
  • ApoCell, Inc.
  • Biocept, Inc.
  • Clearbridge BioMedics
  • Cynvenio Biosystems, Inc.
  • Epic
  • Fluxion Biosciences, Inc.
  • Genyo - Centre for Genomics
  • Qiagen Hanover (formerly AdnaGen GmbH)
  • ScreenCell
  • Veridex, LLC
  • WaveSense LLC

The world market for molecular diagnostics is provided in U.S. dollars for the years 2014 to 2019. The report discusses tests and technologies that are currently available and those that are expected to take their place. 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 information presented in this report is derived on 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 pathology.

Table of Contents

ONE: EXECUTIVE SUMMARY

  • Introduction
  • Scope and Methodology
  • Report Design
  • Size and Growth of the Market
  • Market Trends

TWO: INTRODUCTION

  • Background
  • The Buzz Is On
  • DTC in 2015 - Building Evidence
  • Sequencing Enters the Clinic
  • Exome Sequencing
  • Metabolomic Profiling
  • Liquid Biopsy
  • Information Technology Brings Clarity
  • Forensic Studies - An Emerging Opportunity
  • Multi-omic IT
  • Molecular Test Expansion Supported by Quality Measures
  • Test Platforms
  • Tests and Technologies in 2014
  • Molecular Diagnostics and Target Markets

THREE: DELIVERING MOLECULAR TESTS TO THE CLINIC

  • Background
  • The Reimbursement Environment
  • Physician Uptake
  • The U.S. Experience
  • Personalized Precision Medicine Advances and Barriers
  • The Service Industry Is Here to Stay

FOUR: SEQUENCING - HOW FAR CAN WE GO?

  • Background
  • Companies and Technologies
  • Market Analysis
  • Sequencing Research Projects
  • Cancer More Personalized
  • Pathogen Sequencing

FIVE: MARKET ANALYSIS: WORLD MARKETS

  • Background
  • Worldwide Opportunities for Molecular Tests
  • The United States of America
  • Canada
  • Europe
  • China

SIX: THE MARKET FOR BLOOD MARKERS IN CANCER

  • Introduction
  • Precision Medicine and a New Molecular Perception
  • Back to the Status Quo

SEVEN: THE MARKET FOR MOLECULAR ASSAYS IN HEMATOLOGY: CELL-BASED MOLECULAR TESTS

  • Flow Cytometry
  • Market Analysis

EIGHT: THE MARKET FOR MOLECULAR ASSAYS IN COAGULATION

  • Thrombophilia SNPs
  • Pharmacodiagnostics

NINE: HISTOLOGY AND CYTOLOGY

  • Background
  • Advanced Analysis Tools
  • Sample Preparation
  • In Situ Hybridization
  • HPV Testing
  • Circulating Tumor Cells
  • Pharmacodiagnostic Histology

TEN: MICROBIOLOGY AND VIROLOGY

  • Introduction
  • Market Overview
  • POC and Decentralized Testing
  • Sample Preparation
  • Test Services
  • Antimicrobial Drug Resistance
  • Next Generation Sequencing in Microbiology
  • The Human Microbiome
  • Emerging Disease Threats
  • Blood Culture & Hospital Acquired Infections
  • HIV
  • Hepatitis
  • Sexually Transmitted Diseases (STDs)
  • Respiratory Tract Infections
  • Tuberculosis
  • Fungal Infections
  • Miscellaneous Tests

ELEVEN: THE MARKET FOR MOLECULAR ASSAYS IN BLOOD TRANSFUSION MEDICINE

  • Blood Pathogen Screening
  • Blood Typing

TWELVE: THE MARKET FOR MOLECULAR ASSAYS IN ORGAN TRANSPLANT MANAGEMENT

  • Technological Advancements
  • Market Analysis

THIRTEEN: THE MARKET FOR MOLECULAR ASSAYS IN PRENATAL AND NEWBORN SCREENING

  • Introduction and Market Data
  • cfNIPT - Perception, Perception, Perception
  • Parental Carrier Screening
  • In Vitro Fertilization
  • cfDNA Market Expansion
  • Newborn Screening

FOURTEEN: THE MARKET FOR MOLECULAR ASSAYS FOR INHERITED DISEASES

  • Autism
  • Alzheimer's Disease
  • Cardiovascular Disease
  • Diabetes
  • Psychiatric Disorders
  • Gastrointestinal Conditions
  • Rare Diseases

FIFTEEN: CONCLUSIONS AND STRATEGIC IMPLICATIONS

  • LDTs to Market Cleared Tests
  • Esoteric Testing Scenario in Europe
  • Future Outlook
  • Strategic Implications

SIXTEEN: MAJOR VENDORS AND COMPANIES TO WATCH

  • Market Drivers and Leaders
  • Review of Top Companies
  • Acquisitions, Alliances and Collaborations
  • Looking Beyond Borders

SEVENTEEN: COMPANY PROFILES: THE TOP TIER

  • Abbott Diagnostics
  • IntelligentMDx Alliance
  • PLEX-ID
  • Iridica
  • Histology
  • Alere Inc.
  • Beckman Coulter, Inc. / Danaher
  • Lab Services
  • Sequencing
  • Genomics
  • Information Technology
  • Becton, Dickinson and Company (BD)
  • The BD MAX Enterprise
  • Oncology
  • HPV
  • Sequencing
  • Initiatives
  • Mass Spectrometry
  • Flow Spectrometry
  • Bio-Rad Laboratories, Inc.
  • Controls
  • Digital PCR
  • bioMérieux Inc
  • Expansion
  • Oncology
  • Molecular Strategy
  • Sequencing Service
  • Danaher Corporation
  • General Electric - GE Healthcare
  • Clarient Diagnostic Services, Inc.
  • Hologic, Inc.
  • Product News
  • The Gen-Probe Business
  • Panther System
  • Blood Bank
  • Quest Contract
  • QIAGEN N.V.
  • Personalized Healthcare
  • Infectious Disease Testing
  • Transplant Medicine and HAIs
  • HPV
  • Companion Diagnostics
  • Liquid Biopsy/CTC
  • Instrumentation Base
  • Rotor-Gene Q - Clinical Diagnostics
  • Sequencing
  • Exosomes
  • Information Technology
  • Collaborations
  • Forensics
  • Roche Diagnostics
  • New Enterprises
  • Global Access Program for HIV
  • Core Molecular Tests
  • STDs
  • A POC Enterprise - Liat
  • Prenatal and cfDNA
  • HPV
  • Blood Bank
  • Liquid Biopsy
  • Sequencing - Putting the Pieces Together
  • Siemens Healthcare Diagnostics
  • Histology
  • Molecular
  • Companion Diagnostics
  • Sequencing
  • China
  • Sysmex Corporation
  • Inostics GmbH
  • Intraoperative Test
  • Flow Cytometry
  • Thermo Fisher Scientific Inc.
  • Molecular Microbiology
  • Microbiology IT
  • Transplant
  • Quality Control
  • Mass Spectrometry

EIGHTEEN: COMPANY PROFILES: MAJOR MOLECULAR COMPANIES

  • Affymetrix Inc.
  • Agilent Technologies
  • Agilent in Genomics
  • PCR
  • Sequencing
  • Arrays
  • Sample Management
  • Mass Spectrometry
  • Expansion
  • Asuragen Inc.
  • Controls
  • Sample Collection
  • Sequencing
  • BGI
  • With Complete Genomics
  • BGI Projects
  • Cepheid
  • Hospital Acquired Infections (HAI)
  • TB
  • Infectious Diseases
  • Virology
  • Oncology
  • Eiken Chemical Co., Ltd
  • Enzo Biochem Inc.
  • IP Situation
  • Illumina
  • Sequencing
  • Sequencing Kits
  • Sample Prep
  • IVD Business
  • Oncology
  • HLA Typing
  • IT
  • Forensics
  • CLIA Lab Service
  • Nanopore Sequencing
  • Sample to Insight
  • Making a Market
  • IP Situation
  • Life Technologies Corporation
  • Instrumentation and Applications
  • Liquid Biopsy
  • Sequencing
  • Life Technologies an IVD Company
  • Partnerships Worldwide
  • Life and Quidel Develop Diagnostics on the 7500 Fast Dx
  • Sepsis
  • HIV
  • Emerging Pathogens
  • Bacterial Typing
  • Personalized Medicine
  • Forensic
  • PerkinElmer, Inc. (PE)
  • Newborn Testing
  • Prenatal Testing
  • Sequencing
  • Mass Spectrometry
  • Information Technology
  • China
  • RainDance Technologies, Inc.
  • Market Expansion

NINETEEN: COMPANY PROFILES: PARTICIPANTS

  • AutoGenomics Inc.
  • Biocartis SA
  • Connectivity
  • Instrumentation
  • Collaborations
  • Idylla News
  • DiaSorin S.p.A
  • EKF Diagnostics Holdings Plc
  • ELITech Group
  • Epigenomics
  • Exosome Diagnostics, Inc.
  • Fluidigm Corporation
  • Fujirebio Diagnostics, Inc.
  • GenMark Diagnostics
  • Genome Diagnostics BV (GenDx)
  • Luminex Corporation
  • Business Expansion
  • MAGPIX Multiplexing
  • Next Generation NxTag
  • Product News
  • Menarini Diagnostics
  • Nanostring Technologies, Inc.
  • Alliances
  • LDTs
  • Pacific Biosciences of California, Inc. (PacBio)
  • Quidel Corporation
  • Lyra Product Line
  • Solana Molecular System
  • AmpliVue Product Line
  • Savanna (formerly Wildcat)
  • Acquisitions
  • Rubicon Genomics, Inc.
  • Transgenomic, Inc.
  • Alliances
  • Lab Services
  • Diagnostic Tools Division
  • TrovaGene, Inc.
  • WaferGen Bio-systems, Inc.

TWENTY: COMPANY PROFILES: GREAT EXPECTATIONS

  • Genomic Vision
  • GENOMICA S.A.U.
  • IncellDx, Inc.
  • Inivata
  • IntegenX Inc
  • Linkage Biosciences, Inc.
  • Savyon Diagnostics
  • Selventa
  • VolitionRx Limited

TWENTY-ONE: COMPANY PROFILES: NEWCOMERS

  • B Braun CeGaT, LLC
  • Canon BioMedical, Inc.
  • DestiNA Genomics Ltd
  • DiamiR, LLC
  • Randox Laboratories Ltd.

TWENTY-TWO: COMPANY PROFILES: TEST SERVICE PROVIDERS

  • 23andMe
  • What a Difference a Few Years Makes
  • The Move to Building a Research Company
  • Therapeutics Group
  • Ancestry
  • Outside the U.S.
  • Adaptive Biotechnologies Corporation
  • Agendia BV
  • AltheaDx Diagnostics, Inc.
  • Ambry Genetics
  • Oncology
  • Cardiac
  • Prenatal
  • Information Technology
  • ARUP Laboratories
  • Assurex Health
  • Athena Diagnostics
  • Bio-Reference Laboratories, Inc. (BRLI)
  • bioTheranostics
  • Cancer Genetics, Inc. (CGI)
  • The Response Genetics Acquisition
  • CareDx, Inc.
  • Caris Life Sciences
  • Centogene AG
  • Complete Genomics
  • Counsyl
  • Exact Sciences Corp.
  • Foundation Medicine Inc.
  • Genomic Health, Inc.
  • Market Uptake
  • Sequencing
  • Liquid Biopsy
  • Service Spin Off
  • Helomics Corporation
  • IntegraGen
  • Invitae Corporation
  • LabCorp, Laboratory Corporation of America
  • Infectious Diseases
  • Prenatal
  • Sequencing
  • Oncology
  • BRCA Saga
  • Information Technology
  • Forensic
  • Collaborations
  • Mayo Medical Laboratories
  • Information Technology
  • MDxHealth SA
  • Myriad Genetics
  • Product News
  • Companion Tests
  • Beyond Cancer
  • The U.S. Market
  • IP Update
  • Pathway Genomics Corporation
  • Quest Diagnostics
  • Oncology
  • Toxicology
  • Prenatal and Women's Health
  • Market Expansion
  • Quest Partners for Market Accessibility
  • Rosetta Genomics Ltd.
  • Expansion
  • Veracyte, Inc.

TWENTY-THREE: COMPANY PROFILES: POINT OF CARE TEST SPECIALISTS

  • Atlas Genetics Ltd.
  • Biomeme, Inc.
  • DiAssess Inc
  • DNA Electronics Ltd (DNAe)
  • Enigma Diagnostics Limited
  • Entopsis
  • Epistem Holdings plc
  • InSilixa Inc.
  • Lucigen
  • PositiveID Corporation
  • QuantuMDx Group Limited
  • Rheonix, Inc.
  • Scanogen Inc.
  • Ubiquitome
  • Veredus Laboratories Pte Ltd
  • Xagenic

TWENTY-FOUR: COMPANY PROFILES: SAMPLE PREPARATION

  • Horizon Discovery Group plc
  • MO BIO Laboratories, Inc.
  • PreAnalytiX GmbH
  • QIAGEN N.V.
  • SeraCare Life Sciences, Inc.

TWENTY-FIVE: COMPANY PROFILES: INFORMATION TECHNOLOGY SPECIALISTS

  • Advaita Bioinformatics
  • Apple Inc.
  • Cartagenia
  • Cerner Corp.
  • CLC bio
  • CollabRx Inc.
  • DNAnexus
  • GENALICE
  • GenomOncology
  • Google Genomics
  • IBM Healthcare
  • Intel Corporation
  • Knome Inc.
  • Collaborations
  • N-of-One
  • PierianDx
  • Sophia Genetics

TWENTY-SIX: COMPANY PROFILES: HISTOPATHOLOGY SPECIALISTS

  • Advanced Cell Diagnostics (ACD)
  • Amoy Diagnostics Co. Ltd.
  • Applied Spectral Imaging Inc. (ASI)
  • BioView Ltd.
  • Circulomics Inc.
  • Covaris Inc.
  • Cymogen Dx, LLC
  • Dako A/S
  • Companion Diagnostics
  • Digital Imaging
  • Flow Cytometry
  • Automation
  • Alliances
  • Definiens
  • DxTerity Diagnostics Inc.
  • HTG Molecular Diagnostics
  • Leica Biosystems
  • Companion Diagnostics
  • PreTect AS (formerly Norchip)
  • Kapa Biosystems Inc.
  • Ventana Medical Systems Inc.
  • Digital Pathology
  • Virtuoso Software Update
  • Product News
  • Automation
  • China
  • Partnerships

TWENTY-SEVEN: COMPANY PROFILES: MICROBIOLOGY SPECIALISTS

  • Accelerate Diagnostics, Inc.
  • Advanced Biological Laboratories, S.A. (ABL)
  • AdvanDx, Inc.
  • altona Diagnostics
  • Aperiomics
  • Co-Diagnostics HBDC
  • Curetis AG
  • DxNA, LLC
  • Fast-Track Diagnostics
  • Focus Diagnostics, Inc.
  • Genetic Analysis AS
  • Great Basin Scientific, Inc.
  • Greiner Bio-One International GmbH
  • Hain Lifescience GmbH
  • Hutman Diagnostics AG
  • Intelligent Medical Devices, Inc. (IMDx)
  • Abbott Diagnostics Partnership
  • Qiagen Partnership
  • Meridian Bioscience, Inc.
  • illumigene
  • Meridian Life Science
  • Mobidiag Ltd
  • Molbio Diagnostics Pvt Ltd.
  • Nanosphere, Inc.
  • Market Expansion
  • PathoGenetix, Inc.
  • Pathogenica
  • Reference Genomics Inc.
  • Seegene, Inc.
  • Instrumentation
  • Collaborations
  • Specific Technologies
  • T2 Biosystems

TWENTY-EIGHT: COMPANY PROFILES: BLOOD BANK SPECIALISTS

  • AXO Science
  • Grifols
  • Blood Transfusion Novartis Business
  • International Programs
  • Immucor, Inc.

TWENTY-NINE: COMPANY PROFILES: PRENATAL TEST SERVICE PROVIDERS

  • Ariosa Diagnostics, Inc.
  • IP Status
  • Berry Genomics Co. Ltd
  • Combimatrix Corp.
  • Oncology
  • Good Start Genetics, Inc.
  • Illumina
  • IP Issues
  • Cytogenetics
  • LifeCodexx AG
  • Multiplicom N.V.
  • Natera
  • Premaitha Health plc
  • Sequenom Inc
  • Market Expansion
  • Product Expansion
  • IP Issues
  • Coagulation

THIRTY: COMPANY PROFILES: CTC & LIQUID BIOPSY TEST PROVIDERS

  • Angle plc
  • ApoCell, Inc.
  • Biocept, Inc.
  • Menu Expansion
  • Reimbursement
  • Clearbridge BioMedics
  • Cynvenio Biosystems, Inc.
  • Epic
  • Fluxion Biosciences, Inc.
  • Genyo - Centre for Genomics
  • Qiagen Hanover (formerly AdnaGen GmbH)
  • ScreenCell
  • Veridex, LLC
  • WaveSense LLC

LIST OF EXHIBITS

ONE: EXECUTIVE SUMMARY

  • Table 1-1: Common Next Generation Molecular Test Traits
  • Table 1-2: Selected Salient Developments for Now and the Future
  • Table 1-3: Exchange Rate Fluctuations, 2009-2014 (Europe, Switzerland, UK, Denmark, Sweden, Norway, Japan, Hungary, Singapore, India)
  • Table 1-4: Worldwide Molecular Test Sales, 2014 and 2019 (Microbiology/Virology Histology, Blood Screening, Coagulation & PGx, Inherited Diseases & PGx, Tissue Typing, Cancer Markers & PGx, CTCs, Total)
  • Figure 1-1: Worldwide Molecular Test Sales, 2014-2019 (CTCs, Cancer Markers & PGx,Tissue Typing, Inherited Diseases & PGx, Coagulation & PGx, Blood Screening, Histology, Microbiology/Virology)
  • Table 1-5: Market Penetration of Clinical Molecular Diagnostics by Geographic Area,2014 and 2019 (N. America, W. Europe [EU5], Japan, China, India, ROW, Total)

TWO: INTRODUCTION

  • Table 2-1: Common Next Generation Molecular Test Traits
  • Table 2-2: Selected Salient Developments for Now and the Future
  • Table 2-3: Selected Exosome Sequencing Tests and Services
  • Table 2-4: Selected Liquid Biopsy Innovations
  • Table 2-5: Selected IT Innovations in Molecular Diagnostics
  • Table 2-6: Selected Innovations in Forensic DNA Testing
  • Table 2-7: Selected Multi-omic Test Innovations
  • Table 2-8: Selected Sample Preparation Tools, 2015
  • Table 2-9: Selected Molecular Test Quality Control Standards
  • Table 2-10: Key Molecular Technologies
  • Table 2-11: Selected Molecular Test Platform Innovations
  • Table 2-12: Worldwide Molecular Test Sales, 2014 and 2019 (Microbiology/Virology, Histology, Blood Screening, Coagulation & PGx, Inherited Diseases & PGx, Tissue Typing, Cancer Markers & PGx, CTCs, Total)
  • Table 2-13: Key Molecular Test Applications and Technologies
  • Table 2-14: Selected Rapid Molecular Test Innovations, 2013-2015

THREE: DELIVERING MOLECULAR TESTS TO THE CLINIC

  • Table 3-1: Diseases with Drug Labels
  • Table 3-2: Selected Drug/Biomarker Targets in the U.S.
  • Table 3-3: Selected Drugs That Recommend PGx Testing in Europe
  • Table 3-4: Selected Personalized Medicine Tests, 2013-2015
  • Table 3-5: Revenues for a Selection of Molecular Test Service Labs Worldwide, 2010-2014
  • Table 3-6: Selected New Lab Services, 2015

FOUR: SEQUENCING - HOW FAR CAN WE GO?

  • Figure 4-1: Flatley's Law
  • Table 4-1: Major Sequencing Platforms
  • Table 4-2: Selected Sequencing-Based Test Services

FIVE: MARKET ANALYSIS: WORLD MARKETS

  • Table 5-1: Selected International Agreements
  • Table 5-2: Market Penetration of Clinical Molecular Diagnostics, by Geographic Area, 2014 and 2019 (N. America, W. Europe [EU5], Japan, China, India, ROW, Total)

SIX: THE MARKET FOR BLOOD MARKERS IN CANCER

  • Table 6-1: Selected Sample Preparation Reagents
  • Table 6-2: Selected Cancer Test Innovations, 2015

SEVEN: THE MARKET FOR MOLECULAR ASSAYS IN HEMATOLOGY: CELL-BASED MOLECULAR TESTS

  • Table 7-1: Selected Innovations in Molecular Cell-Based Tests

EIGHT: THE MARKET FOR MOLECULAR ASSAYS IN COAGULATION

  • Table 8-1: Selected Molecular Pharmacodiagnostics for Anticoagulant Drug Testing, 2014

NINE: HISTOLOGY AND CYTOLOGY

  • Table 9-1: Worldwide Molecular Histology Sales, by Type, 2014 and 2019 (In situ hybridization, HPV, Histology Total)
  • Table 9-2: Selected Molecular Histology Innovations, 2015
  • Table 9-3: Selected FFPE DNA/RNA Sample Preparation Innovations
  • Table 9-4: Selected HPV Test Innovations
  • Table 9-5: Selected Innovations in CTC Technology
  • Table 9-6: Major Pharmacodiagnostic Markers
  • Table 9-7: Selected Pharmacodiagnostic Histology Tests

TEN: MICROBIOLOGY AND VIROLOGY

  • Table 10-1: Molecular Test Sales, Microbiology/Virology, 2014 and 2019 (HAI; HIV; Hepatitis; GC/Chlamydia; Respiratory; Organism ID; Mycobacteria, TB; Others; Total)
  • Table 10-2: Molecular Infectious Disease Company Sales, 2014
  • Table 10-3: Selected New Instruments for Molecular Infectious Disease Testing,2015
  • Table 10-4: Selected Molecular Test Innovations for Decentralized Use
  • Table 10-5: Selected Molecular Infectious Diseases Sample Treatment Products
  • Table 10-6: Selected Molecular Infectious Disease Test Services
  • Table 10-7: Selected Tests for Antibiotic Resistance
  • Table 10-8: Selected Microbiology Sequencing Innovations
  • Table 10-9: Selected Microbiome-Based Diagnostics
  • Table 10-10: Tests with Emergency Use Designation
  • Table 10-11: Selected Innovations in Emerging Pathogen Testing
  • Table 10-12: Selected Advanced Techniques for Hospital Acquired Infections
  • Table 10-13: Selected Recent Molecular HIV Test Innovations
  • Table 10-14: Selected Molecular Hepatitis Test Innovations
  • Table 10-15: Selected Molecular STD Test Innovations
  • Table 10-16: Selected Molecular Tests for Respiratory Tract Infections
  • Table 10-17: Selected Molecular Tests for TB
  • Table 10-18: Selected Molecular Tests for Fungal Infections
  • Table 10-19: Miscellaneous Molecular Infectious Disease Tests, 2013-2015

ELEVEN: THE MARKET FOR MOLECULAR ASSAYS IN BLOOD TRANSFUSION MEDICINE

  • Table 11-1: Pathogen Commonly Tested in Donated Blood Units
  • Table 11-2: Selected Pathogen Screening Innovations
  • Table 11-3: Selected Blood Typing Innovations

TWELVE: THE MARKET FOR MOLECULAR ASSAYS IN ORGAN TRANSPLANT MANAGEMENT

  • Table 12-1: Selected HLA Typing Test Innovations, 2015
  • Table 12-2: Selected cfDNA Innovations in Transplant Medicine

THIRTEEN: THE MARKET FOR MOLECULAR ASSAYS IN PRENATAL AND NEWBORN SCREENING

  • Table 13-1: Revenue Stream of Selected NIPT Service Companies, 2010-2015
  • Table 13-2: Selected New IVF Services
  • Table 13-3: Selected Genomic Newborn Screening Services

FOURTEEN: THE MARKET FOR MOLECULAR ASSAYS FOR INHERITED DISEASES

  • Table 14-1: Most Frequently Requested Genetic Tests
  • Table 14-2: Selected Autism Test Innovations
  • Table 14-3: Selected Innovations in Genetic Tests for CVD, 2015
  • Table 14-4: Selected Molecular Diabetes Tests, 2015
  • Table 14-5: Selected Innovations in Personalized Tests for Psychiatric Disorders
  • Table 14-6: Selected Tests for Irritable Bowel Diseases
  • Table 14-7: Selected Molecular Tests for Inherited Diseases, 2015

SIXTEEN: MAJOR VENDORS AND COMPANIES TO WATCH

  • Table 16-1: Estimated Revenues of the Top Ten Molecular Test Vendors, 2010-2014
  • Table 16-2: Estimated Revenues of Selected Molecular Test Vendors, 2010-2014
  • Table 16-3: Selected Acquisitions in Molecular Diagnostics, 2013-2015
  • Table 16-4: Selected Collaborations and Licensing Agreements, 2013-2015
  • Table 16-5: Selected Distribution Agreements, 2013-2015
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