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ポイントオブケア (POC) 分子診断市場と潜在性

The Market and Potential for Molecular Point of Care Diagnostic Tests

発行 Kalorama Information 商品コード 296895
出版日 ページ情報 英文 299 Pages
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ポイントオブケア (POC) 分子診断市場と潜在性 The Market and Potential for Molecular Point of Care Diagnostic Tests
出版日: 2018年01月25日 ページ情報: 英文 299 Pages
概要

当レポートでは、ポイントオブケア (POC) 分子診断市場について調査分析し、主要セグメントに焦点を当てて、現在の売上高、市場の機会など、体系的な情報を提供しています。

第1章 エグゼクティブサマリー

第2章 ポイントオブケア (POC) 分子診断とは

  • 利点と欠点
  • 共通の検査と分析
  • 分子診断
  • 概要

第3章 市場と発展

  • イントロダクション
  • 検出
  • 分子プラットフォームと製品
  • 応用と潜在用途
  • 救急クリニック
  • リテールクリニック

第4章 市場分析

  • 市場の規模と成長率
  • 市場リーダー
  • 市場:地域別
  • 市場推計と潜在性:疾患タイプ別

第5章 企業プロファイル

  • Ahram Biosystems
  • Akonni Biosystems
  • Alere (Abbott)
  • Analytik Jena
  • Atlas Genetics
  • Axxin
  • Becton, Dickinson and Company
  • Biocartis
  • bioMerieux
  • Canon Biomedical
  • Cepheid
  • Curetis
  • DestiNA Genomics
  • Diagnostics for All
  • Diagnostics for the Real World
  • Diasorin
  • Diassess
  • 栄研化学
  • Entopsis
  • ERBA Molecular
  • genedrive plc (旧:EPISTEM)
  • GeneFluidics
  • GenePOC
  • GeneReach Biotechnology
  • Greiner Bio-One
  • Hai Kang Life
  • Hain Lifescience
  • Illumina
  • Immunexpress
  • Insilixa
  • Lucigen
  • Mast Group
  • Mbio Diagnostics
  • Meridian Bioscience
  • Mesa Biotech
  • Metaara Medical Technologies
  • Micronics (ソニー)
  • Molbio
  • MP Biomedicals
  • Nanodetection Technology
  • NanoIVD
  • Nanomix
  • Nanosphere (Luminex)
  • Optigene
  • Orion Diagnostica
  • PositiveID
  • Pretect
  • Qiagen
  • QuantumDX
  • Quidel
  • Rheonix
  • Roche Diagnostics
  • Scanogen
  • Seegene
  • Spartan Bioscience
  • Stat-DX
  • T2 Biosystems
  • Thermal Gradient
  • Ubiquitome
  • Ustar Biotechnologies
  • Veredus Laboratories
  • Wave 80 Bioscience
目次
Product Code: KLI15582179

Among the various technologies and products of the global in vitro diagnostics (IVD) market, molecular diagnostics performed at the point of care or near the patient are regarded as a leading expansion market. Molecular point-of-care (POC) diagnostics are able to improve the sensitivity and specificity of existing near-patient and rapid tests and also expand the diagnostic capabilities at points of care such as hospital critical care units, physician offices, outpatient clinics, and community health posts in the developing world. Existing POC diagnostics range from urinalysis dipsticks performed in physician office laboratories (POLs) through rapid infectious disease tests used to quickly diagnose admitted patients.

Real-World Estimates and Reliable Forecasts

There have been many projections made about molecular point care. This report provides consensus market views and realistic estimates for this novel field, incorporating primary and secondary research, feedback from end users and reports from vendors. It also factors in tests already being used by laboratories at this time and how molecular POC has fared in displacing those markets.

Kalorama Information, with two decades of experience in IVD markets - the publishers of The Worldwide Market for In Vitro Diagnostics in ten editions - produced two definitive market studies of this market in 2013, prior to significant product development, and 2016 as the first products - Alere i, BioFire Film Array, Gene Expert Omni and cobas Liat appeared on the scene. Now, with more market track records and approvals, mPOC products competing with traditional systems, Kalorama has updated its findings with the latest information. Who is leading? Where is investment in mPOC systems? Who has products in development? What companies are lagging? What can we expect in the future. This report answers these questions and more.

The Market and Potential for Molecular Point of Care Diagnostic Tests examines the major segments of molecular POC diagnostics, exploring in-depth current sales and market opportunity and providing the following market information:

  • Molecular POC Systems on the Market
  • Molecular POC Systems in Development
  • Advantages and Disadvantages of Molecular POC
  • Molecular POC Market for Influenza Testing (2017-2023)
  • Molecular POC Market for Strep A Testing (2017-2023)
  • Molecular POC Market for RSV and Other Respiratory
  • Molecular POC Market for STD Testing [CT/NG, GBS, HSV, Others] (2017-2023)
  • Molecular POC Market for HIV (2017-2023)
  • Molecular POC Market for GI Pathogens (2017-2023)
  • Molecular POC Market for HAIs (2017-2023)
  • Other Molecular POC (2017-2023)
  • Investments in Decentralized Molecular Diagnostics Companies (2014-2017)
  • Potential Entrants, Platforms, Menus and Other Industry Trends
  • Retail Clinics and Other Walk-ins: Game Changers in Healthcare
  • Extensive Company Profiling

Profiled companies include those with clinical molecular diagnostic systems applicable to POC testing markets; molecular diagnostic systems applicable to hospital lab molecular testing; development-stage molecular diagnostic systems for decentralized testing; molecular diagnostic products for use primarily in emerging markets of the developing world and for field testing; companies with original equipment manufacturer (OEM) platforms and component technologies that could be featured in the molecular POC diagnostics market; and other companies that have been involved in molecular POC diagnostics through investment, collaborative research or technology development that could allow them to enter the market. Companies profiled include:

The market introduction of POC diagnostics or tests (POCTs) often follows a period of technological maturation or refinement of an existing laboratory diagnostic modality or platform. One of the major enabling technologies for POC testing with molecular diagnostics is real-time polymerase chain reaction (qPCR) testing that eliminated the need for post-amplification electrophoresis and integrated detection within the same instrument that performed amplification. Advances and innovations in microfluidics; isothermal and other alternative amplification chemistries; test automation; primers and probes; and next-generation sequencing (NGS) methods have been the most significant to the development of decentralized molecular diagnostics. In many cases, these technologies work together to facilitate clinical molecular testing in an automated manner within a smaller device.

Who is Who in Molecular POC? - Company Coverage

Companies profiled in this report include:

  • Ahram Biosystems
  • Akonni Biosystems
  • Alere (Abbott)
  • Analytik Jena
  • Atlas Genetics
  • Axxin
  • Becton, Dickinson And Company
  • Biocartis
  • Biomerieux
  • Canon Biomedical
  • Cepheid
  • Curetis
  • Destina Genomics
  • Diagnostics For All
  • Diagnostics For The Real World
  • Diasorin
  • Diassess
  • Eiken Chemical
  • Entopsis
  • Erba Molecular
  • Genedrive (Formerly Epistem)
  • Genefluidics
  • Genepoc
  • Genereach Biotechnology
  • Greiner Bio-One
  • Hai Kang Life
  • Hain Lifescience
  • Illumina
  • Immunexpress
  • Insilixa
  • Lucigen
  • Mast Group
  • Mbio Diagnostics
  • Meridian Bioscience
  • Mesa Biotech
  • Metaara Medical Technologies
  • Micronics (Sony)
  • MolBio
  • MP Biomedicals
  • Nanoivd 235
  • Nanodetection Technology
  • Nanōmix
  • Nanosphere (Luminex)
  • Optigene
  • Orion Diagnostica
  • Positive Id
  • Pretect
  • Qiagen
  • HPV
  • Quantumdx
  • Quidel
  • Rheonix
  • Roche Diagnostics
  • Scanogen
  • Seegene
  • Spartan Bioscience
  • Stat-Dx
  • T2 Biosystems
  • Thermal Gradient
  • Ubiquitome
  • Ustar Biotechnologies
  • Veredus Laboratories
  • Wave 80 Bioscience

Table of Contents

ONE: EXECUTIVE SUMMARY

  • MOLECULAR POINT-OF-CARE DIAGNOSTICS DEFINED
  • STRENGTHS AND WEAKNESS OF MOLECULAR POINT-OF-CARE TESTING
    • Table 1-1 Advantages of Molecular Point-of-care by Setting
    • Table 1-2: Disadvantages of Point-of-Care Diagnostics by Setting - Hospital POC, POL/Outpatient, Low-Resource and Developing Areas
  • COMPONENT TECHNOLOGIES OF MOLECULAR POINT-OF-CARE DIAGNOSTICS
  • Microfluidics
  • qPCR
  • Microarrays
  • Isothermal Amplification
  • Test Automation
  • Primers and Probes
  • Detection
  • Next-Generation Sequencing
    • Table 1-3: Molecular POC Products on the Market
  • SCOPE AND METHODOLOGY
  • SIZE AND GROWTH OF THE MARKET
    • Figure 1-1: Molecular Point of Care Market, 2017-2023 ($ millions)
  • Conclusions
    • Table 1-4: Growth Areas for Molecular POC and Rapid Tests

TWO: WHAT IS MOLECULAR POINT-OF-CARE DIAGNOSTICS?

  • ADVANTAGES AND DISADVANTAGES OF MOLECULAR POINT-OF-CARE
  • COMMON TESTS AND ANALYTES IN POC DIAGNOSTICS
  • MOLECULAR DIAGNOSTICS
  • Real-Time PCR (qPCR)
  • Isothermal Amplification Methods
  • Microarrays
  • Sequencing
  • Common Tests and Analytes in Molecular Diagnostics
    • Table 2-1: Selected POCTs for the diagnosis of illnesses covered by Emergency Use Authorizations (EUAs) currently in effect
  • POINT-OF-CARE DIAGNOSTICS IN BRIEF
  • Examples of POCT settings

THREE: MOLECULAR POC SYSTEMS ON THE MARKET AND IN DEVELOPMENT

  • INTRODUCTION
  • Advances in Molecular Diagnostics
  • Microfluidics
  • Isothermal Amplification
    • Table 3-1: Selected Isothermal Amplification Methods and Platform Examples
  • Test Automation
  • Primers and Probes
  • DETECTION
    • Table 3-2: Selected Analyzer Platforms for Decentralized and POC Molecular Testing with Image Sensor Detectors (CCD, CMOS)
    • Table 3-3: Selected Analyzer Platforms for Decentralized and POC Molcular Testing with Photodiode Detectors
    • Table 3-4: Selected Analyzer Platforms for Decentralized and POC Molecular Testing with Electrochemical Detectors
    • Table 3-5: Selected Analyzer Platforms for Decentralized and POC Molecular Testing with Immunochromatographic Detection
  • Next-Generation Sequencing
    • Table 3-6: Selected NGS Platforms for Decentralized and POC Sequencing
  • MOLECULAR PLATFORMS AND PRODUCTS FOR DECENTRALIZED TESTING
    • Table 3-7: Market-Available Molecular POC Diagnostic Platforms (Vendor, Assay Menu, Planned Assays, Regulatory Status, Procedure Integration, Test Principles)
    • Table 3-8: Market-Available Hospital Molecular Diagnostic Platforms (Vendor, Assay Menu, Planned Assays, Regulatory Status, Procedure Integration, Test Principles)
    • Table 3-9: Hospital and POC Molecular Diagnostic Platforms in Development (Vendor, Assay Menu, Procedure Integration, Test Principles)
    • Table 3-10: Menu Expansions for Hospital and POC Molecular Platforms (Vendor, Platform, Menu Addition, Time to Results, CLIA-waiver, US/EU Availability)
    • Table 3-11: Market-Available Molecular Diagnostic Platforms for Emerging Markets and the Developing World (Vendor, Assay Menu, Planned Assays, Regulatory Status, Procedure Integration, Test Principles) .. 71
    • Table 3-12: Molecular Diagnostic Platforms in Development for Emerging Markets and the Developing World (Vendor, Assay Menu, Procedure Integration, Test Principles)
    • Table 3-13: Line Probe Assays and Other Molecular Lateral Flow Test Strips (Vendor, Assay Menu, Planned Assays, Regulatory Status)
    • Table 3-14: Potential Entrants into Molecular POC Diagnostics (Vendor, Current Platform[s], Primary Market for Platform, Assay Menu, Applicable Tech)
    • Table 3-15: Selected Developmental Molecular POC-Enabling Technologies and Platforms by Vendor
  • APPLICATIONS AND POTENTIAL APPLICATIONS FOR MOLECULAR POINT-OF-CARE
  • Major Testing Applications for Molecular POC Diagnostics
  • Hospital-Acquired Infections (HAIs)
  • Strep A
  • Respiratory Syncytial Virus (RSV)
  • Influenza
  • Other Respiratory Infections
  • Group B Streptococcus
  • Human Papillomavirus
  • Chlamydia and Gonorrhea
  • Herpes Simplex Virus
  • Vaginitis
  • Human Immunodeficiency Virus (HIV)
  • Tuberculosis
  • Hepatitis
  • Malaria
  • Other Tropical and Neglected Diseases
  • Gastrointestinal Infections
  • Bloodstream Infections (BSIs)
  • Pharmacogenetics
  • Hereditary Disease
  • Cancer
  • URGENT CARE CLINICS
    • Table 3-16: Urgent Care Centers vs. Retail Clinics and Physician Practices
  • RETAIL CLINICS

FOUR: MARKET ANALYSIS

  • SIZE AND GROWTH OF THE MARKET
    • Figure 4-1: Market Analysis, Molecular Point of Care - 2017-2023 ($ millions)
  • Challenges for Molecular POC
  • MARKET LEADERS
  • Abbott / Alere i
  • Biocartis: An Ascendant Player
  • Cepheid Gene Xpert and, Xpert Xpress and Xpert Omni
  • Roche cobas Liat
  • Biomerieux BioFire Film Array
  • MARKET BY GEOGRAPHY
    • Figure 4-2: Molecular Point of Care Market by Geography
  • MARKET ESTIMATE AND MARKET POTENTIAL BY TYPE OF DISEASE
    • Table 4-1: Market for Molecular POC by Test (Influenza, Strep A, RSV, Other Resp., CT/NG, GBS, HPV, HSV, TV, TB, HIV, Hep, Malaria, Tropical/Other Neglected, HAIs, Other Molecular POC)
    • Figure 4-3: Molecular POC Market by Category, 2017 (Flu/Resp. Vs. All Other)
  • Influenza
  • Strep A, RSV and Other Respiratory
  • CT/NG
  • HPV
  • HSV
  • HIV
  • Hepatitis
  • Malaria
  • Other Molecular POC Testing

FIVE: COMPANY PROFILES

  • AHRAM BIOSYSTEMS
  • AKONNI BIOSYSTEMS
  • ALERE (ABBOTT)
    • Table 5-1: Alere Revenue (2014-H1 2017)
  • ANALYTIK JENA
  • ATLAS GENETICS
  • AXXIN
  • BECTON, DICKINSON AND COMPANY
    • Table 5-2: Becton, Dickinson & Co. (BD) Revenue (2014-2017)
  • BIOCARTIS
    • Table 5-3: Biocartis NV Revenue (2014-2017)
  • BIOMERIEUX
    • Table 5-4: bioMérieux Revenue (2014-2017)
  • CANON BIOMEDICAL
  • CEPHEID
    • Table 5-5: Cepheid Revenue (2013-2016)
  • Molecular Healthcare-Acquired Infection (HAI) Testing
  • Molecular Sexual Health and Women's Health Testing
  • Molecular Critical Infectious Disease Testing
  • Molecular Oncology/Genetics Testing
  • CURETIS
  • DESTINA GENOMICS
  • DIAGNOSTICS FOR ALL
  • DIAGNOSTICS FOR THE REAL WORLD
  • DIASORIN
    • Table 5-6: DiaSorin Revenue (2014-Q3 2017)
  • DIASSESS
  • EIKEN CHEMICAL
    • Table 5-7: Eiken Chemical Revenue (FY 2014-2017)
  • ENTOPSIS
  • ERBA MOLECULAR
  • GENEDRIVE PLC (FORMERLY EPISTEM)
    • Table 5-8: genedrive Revenue (FY 2014-2017)
  • GENEFLUIDICS
  • GENEPOC
  • GENEREACH BIOTECHNOLOGY
  • GREINER BIO-ONE
  • HAI KANG LIFE
  • HAIN LIFESCIENCE
  • ILLUMINA
    • Table 5-9: Illumina Revenue (FY 2014-2017)
  • IMMUNEXPRESS
  • INSILIXA
  • LUCIGEN
  • MAST GROUP
  • MBIO DIAGNOSTICS
  • MERIDIAN BIOSCIENCE
    • Table 5-10: Meridian Bioscience Revenue (FY 2014-2017)
  • MESA BIOTECH
  • METAARA MEDICAL TECHNOLOGIES
  • MICRONICS (SONY)
  • MOLBIO
  • MP BIOMEDICALS
  • NANODETECTION TECHNOLOGY
  • NANOIVD
  • NANŌMIX
  • NANOSPHERE (LUMINEX)
    • Table 5-11: Nanosphere Revenue (2013-2016)
  • OPTIGENE
  • ORION DIAGNOSTICA
    • Table 5-12: Orion Diagnostica Revenue (2014-Q3 2017)
  • POSITIVEID
    • Table 5-13: PositiveID Revenue (2014-Q3 2017)
  • PRETECT
  • QIAGEN
    • Table 5-14: QIAGEN Revenue (2014-Q3 2017)
  • HPV
  • Other Activities (Development, Licensing, Investment)
  • QUANTUMDX
  • QUIDEL
    • Table 5-15: Quidel Corporation Revenue (2013-2016)
  • RHEONIX
  • ROCHE DIAGNOSTICS
    • Table 5-16: Roche Diagnostics Revenue (2014-2017)
  • SCANOGEN
  • SEEGENE
    • Table 5-17: Seegene Revenue (2014-Q3 2017)
  • SPARTAN BIOSCIENCE
  • STAT-DX
  • T2 BIOSYSTEMS
    • Table 5-18: T2 Biosystems Revenue (2014-Q3 2017)
  • THERMAL GRADIENT
  • UBIQUITOME
  • USTAR BIOTECHNOLOGIES
  • VEREDUS LABORATORIES
  • WAVE 80 BIOSCIENCE
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