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Molecular Diagnostics Markets

TriMark Publications
July 1, 2011
335 Pages - SKU: TRI6444430

Abstract Table of Contents Related Reports

The technologies that constitute molecular diagnostics--like first-generation amplification, DNA probes, fluorescent in situ hybridization (FISH), second-generation biochips and microfluidics, next-generation signal detection, biosensors, and molecular labels--are influencing the discovery of therapeutic molecules, the screening and diagnosis of patients, and the optimization of drug therapy. In the past few years, this rapidly evolving field has seen several fascinating developments. This TriMark Publications report describes the specific market segment of the in vitro diagnostics market known as molecular diagnostics and includes all of the generally accepted clinical analytical activities in use today. It examines the prevalent clinical-measurement devices, as well as their reagents and supplies as utilized in hospitals, clinics, large reference laboratories and doctor’s offices. Diagnostic tests marketed primarily as over-the-counter are generally not included in this report, although there is inevitably some overlap. The main objectives of this analysis are: 1) identifying viable technology drivers through a comprehensive look at platform technologies for molecular diagnostics, including probe-based nucleic acid assays, microarrays and sequencing; 2) obtaining a complete understanding of the chief molecular diagnostics tests--i.e., predictive, screening, prognostic, monitoring, pharmacogenomic and theranostic--from their basic principles to their applications; 3) discovering feasible market opportunities by identifying high-growth applications in different clinical diagnostic areas and by focusing on expanding markets, such as communicable diseases, cardiology and oncology; and 4) focusing on global industry development through an in-depth analysis of the major world markets for molecular diagnostics, including growth forecasts.

1. Overview: 1.1 Statement of Report; 1.2 About This Report; 1.3 Scope of the Report; 1.4 Objectives; 1.5 Methodology; 1.6 Executive Summary
2. Introduction to Molecular Diagnostics and PCR Technology: 2.1 Introduction to Genomics and Its Opportunity; 2.2 Impact of the Human Genome Project on Molecular Diagnostics; 2.3 Key Considerations for Molecular Diagnostics; 2.4 Molecular Diagnostics in the Post-Genomic Era; 2.5 Advances in Molecular Diagnostics Technologies; 2.6 Genetic Variability and Disease; 2.7 Major Technology Platforms; 2.8 PCR Reagents for Clinical Diagnostics
3. Nucleic Acid Test Applications: 3.1 Molecular Diagnostic Testing and Infectious Diseases; 3.2 Infectious Disease Testing Using Molecular Diagnostics; 3.3 Genetics Testing in Molecular Diagnostics; 3.4 Molecular Diagnostics Uses in Industrial Testing and Food Diagnostics; 3.5 Molecular Diagnostics Forensics Testing Market; 3.6 Bioterrorism and Molecular Diagnostics; 3.7 Cystic Fibrosis Testing; 3.8 Human Leukocyte Antigen (HLA) Sequencing-based Typing Kits; 3.9 Molecular Cytogenetic Testing; 3.10 Developments in DNA Biochips for Clinical Applications; 3.11 Personalized Medicine, Pharmacogenomics and Molecular Diagnostics Testing; 3.12 Thrombic Disorders; 3.13 Respiratory Virus Panel; 3.14 HFE (Hemochromatosis); 3.15 Lupus; 3.16 Down's Syndrome and Prenatal Screening; 3.17 Molecular Diagnostics Technology Platforms and their Impact on Personalized Medicine
4. Trends in Molecular Diagnostics: 4.1 Pharmacogenomics; 4.2 DNA Microarrays; 4.3 Emerging Markets of DNA Arrays; 4.4 Drivers and Restraints; 4.5 Market Forecast; 4.6 Business Trends in the Industry; 4.7 Patent Protection and Intellectual Property Rights; 4.8 Micoarray Quality Control (MAQC)
5. Molecular Diagnostics Automated Instrumentation Approved for Market by the FDA: 5.1 Gene Expression Profiling; 5.2 Proteomic Multiplex Assays; 5.3 Solution-Phase Multiplexing; 5.4 RNA Interference (RNAi); 5.5 DNA Tags; 5.6 Follow-on Optical Technologies
6. Market Trends and Forecasts: 6.1 Market Dynamics; 6.2 Future Considerations for Molecular Diagnosis; 6.3 Role of Genomics in Transforming Pharmaceutical R&D; 6.4 Cancer Markers; 6.5 Cytology Markers; 6.6 RNA Detection; 6.7 Diagnosis of Inherited Disease; 6.8 Ethical Considerations; 6.9 NAT and Personalized Medicine; 6.10 Five Molecular Diagnostics Growth Areas; 6.11 Specific Commercial Nucleic Acid Probes; 6.12 Novel Amplification Techniques in the Market; 6.13 Ramification Amplification Method (RAM); 6.14 Invader Assays/Third Wave Technologies (Hologic); 6.15 Molecular Beacons; 6.16 Human Leukocyte Antigen (HLA) Sequencing-based Typing Kits; 6.17 Prenatal Diagnosis; 6.18 Newborn Screening; 6.19 NAT and Preventive Medicine: NAT-based Assays; 6.20 Prenatal and Pre-Implantation Diagnosis; 6.21 FISH-based Tests on Fetal Cells; 6.22 Companion Therapeutic/Diagnostic Approach; 6.23 Sample Preparation Market; 6.24 Emerging Amplification Techniques; 6.24.1 Gold Nanoparticle Molecular Probes; 6.24.2 Real-Time Microfluidic PCR Using Magnetic Affinity Beads; 6.25 ASRs (Analyte-Specific Reagents)
7. Company Profiles: 7.1 Abbott Laboratories; 7.2 Adnavance Technologies, Inc.; 7.3 AdvanDx; 7.4 Agendia; 7.5 Agilent Technologies; 7.6 Asuragen; 7.7 Ambry Genetics; 7.8 American Diagnostica; 7.9 Applied Biosystems, Inc. (now Life Technologies); 7.10 ARCA biopharma; 7.11 ArcticDx, Inc.; 7.12 Arcxis Biotechnologies; 7.13 Atlas Genetics; 7.14 Aureon Laboratories; 7.15 AutoGenomics, Inc.; 7.16 Beckman Coulter, Inc.; 7.17 Becton, Dickinson and Company; 7.18 BG Medicine; 7.19 Biocartis; 7.20 BioGenex Laboratories, Inc.; 7.21 Biohelix Corporation; 7.22 bioMerieux; 7.23 Bio-Rad Laboratories; 7.24 Biotage AB; 7.25 Biotest AG; 7.26 Caliper Life Sciences, Inc.; 7.27 Celera; 7.28 Cepheid; 7.29 CombiMatrix Corporation; 7.30 Cytocell Technologies Ltd.; 7.31 CytoCore, Inc.; 7.32 DiagnoCure, Inc.; 7.33 DxS (Acquired by QIAGEN); 7.34 Enzo Biochem; 7.35 Epigenomics; 7.36 EraGen Biosciences; 7.37 Eurogentec; 7.38 EXACT Sciences Corporation; 7.39 Exiqon A/S; 7.40 GeneOhm Sciences; 7.41 Genera Biosystems; 7.42 Genzyme Corporation; 7.43 GenMark Diagnostics, Inc.; 7.44 Genomix Biotech; 7.45 Gen-Probe; 7.46 Gene Express; 7.47 Genomica; 7.48 Hologic; 7.49 Illumina, Inc.; 7.50 Innogenetics NV; 7.51 Invitrogen (Life Technologies); 7.52 Life Technologies; 7.53 Luminex; 7.54 Inverness Medical Innovations; 7.55 Monogram Biosciences, Inc.; 7.56 Myconostica; 7.57 Nanogen; 7.58 Nanosphere; 7.59 NorDiag ASA; 7.60 PharMingen; 7.61 QIAGEN N.V.; 7.62 Roche Diagnostics; 7.63 SABiosciences Corporation; 7.64 Seegene; 7.65 Siemens Healthcare Diagnostics (Siemens); 7.66 SIRS-Lab; 7.67 Source MDx; 7.68 Targeted Molecular Diagnostics; 7.69 Thermo Fisher Scientific; 7.70 Thorne Diagnostics; 7.71 TrimGen; 7.72 TrovaGene; 7.73 U.S. Genomics, Inc.; 7.74 Veredus Laboratories; 7.75 Veridex
8. Market Overview: 8.1 Snapshot of Molecular Diagnostics Industry Structure; 8.2 Global Molecular Diagnostics Testing Market; 8.3 U.S. Molecular Diagnostics Testing Market; 8.4 European Molecular Diagnostics Market; 8.5 Japanese Molecular Diagnostics Testing Market; 8.6 Overview of the European Molecular Diagnostics Country Markets; 8.7 Strategic Assessment and Business Development in the Molecular Diagnostics Sector
INDEX OF FIGURES: Figure 2.1: Segment of Double-stranded DNA Showing the Base-Pair Relationship; Figure 3.1: Overall Structure of Nucleic Acid Testing Market; Figure 3.2: Global Market for Molecular Diagnostics Testing, 2010; Figure 3.3: Share of Molecular Diagnostics Testing by Testing Type, 2009; Figure 3.4: Key Players Market Share in Global Molecular Diagnostics Testing Markets; Figure 3.5: Revenue Mix from BioChips; Figure 3.6: Global Revenue Forecast for Molecular Diagnostics Testing for Infectious Disease, 2009-2016; Figure 3.7: Global Market Revenue Share Forecasts for Molecular Diagnostics Infectious Disease Testing Markets by Region, 2009 and 2016; Figure 3.8: Forecast for Total Global Infectious Disease Molecular Diagnostics Markets, 2016; Figure 3.9: Forecast for Total U.S. Infectious Disease Molecular Diagnostics Markets, 2016; Figure 3.10: Key Players Market Share in Global Molecular Diagnostics Infectious Disease Testing Markets; Figure 3.11: Estimated Market Forecast for Global HIV Molecular Diagnostic Testing, 2011-2016; Figure 3.12: Markers of Acute HBV Infection as a Function of Time after Exposure to Infection; Figure 3.13: Primary Causes of Chronic Liver Disease; Figure 3.14: Markers of Acute HCV Infection as a Function of Time after Exposure to Infection; Figure 3.15: U.S. Market Share for Molecular Diagnostic HPV Testing, 2010; Figure 3.16: Analysis of Cancer Tissue by Microarray; Figure 3.17: Number of Genomic Health Oncotype DX Tests Performed, 1991-2006; Figure 3.18: U.S. Total Infectious Disease Molecular Diagnostics Markets, 2009; Figure 3.19: Estimated Market for Global Blood Screening Product Sales, 2007-2016; Figure 3.20: Blood Screening Market Share, 2010; Figure 3.21: Bacillus anthracis; Figure 4.1: Reimbursement for Diagnostics in Healthcare Decision Making; Figure 7.1: Gen-Probe Projected R&D Expenditures; Figure 8.1: Molecular Diagnostics Market Segmentation by Testing Type; Figure 8.2: Molecular Diagnostics Market Segmentation by Technology; Figure 8.3: Global Market for Molecular Diagnostics, 2002-2016; Figure 8.4: Global Distribution of Molecular Diagnostics Testing by Geographic Region, 2010
INDEX OF TABLES: Table 2.1: Key Assay Technologies for Molecular Diagnostics; Table 2.2: Emerging Molecular Diagnostic Technologies; Table 2.3: Companies involved in Next Generation Sequencing Technology; Table 3.1: Applications of Molecular Diagnostics Technology Platforms; Table 3.2: Global Market for Molecular Diagnostics Testing, 2000-2016; Table 3.3: U.S. Market for Molecular Diagnostics Testing, 2004-2016; Table 3.4: Summary of Molecular Diagnostics Testing Clinical Focus and Detection; Table 3.5: Share of Molecular Diagnostics Testing by Testing Type, 2009; Table 3.6: Key Players and Market Share in Global Molecular Diagnostics Testing Market; Table 3.7: Revenue Model for Molecular Diagnostics Testing; Table 3.8: Annual U.S. Market for DNA Probe Diagnostics, 1998-2012; Table 3.9: Annual Global Market for DNA Probe Diagnostics, 1998-2010; Table 3.10: Roche PCR Licenses; Table 3.11: Companies Marketing Products Using DNA Probes; Table 3.12: Companies Marketing Multiple Products in Molecular Diagnostics Sector; Table 3.13: Global Sales of DNA Probe Kits, 1998-2009; Table 3.14: Companies Marketing DNA Detection Platforms; Table 3.15: Companies Marketing Genotyping Technologies; Table 3.16: Companies Marketing Clinical Genotyping Technologies; Table 3.17: Global Revenues and Forecast for Molecular Diagnostics Testing for Infectious Disease, 2009-2016; Table 3.18: Molecular Diagnostic Markets for Infectious Disease Testing, 2010; Table 3.19: Molecular Diagnostic Markets for Infectious Disease Testing, 2016; Table 3.20: Key Players and Market Share in Global Molecular Diagnostics Infectious Disease Testing Market; Table 3.21: Commercially Available Molecular Diagnostic Products for HIV Assay; Table 3.22: Summary of Assays for HIV Viral Load Testing; Table 3.23: Global Market for Molecular Diagnostic HIV Testing, 2007-2010; Table 3.24: U.S. Market for HIV Molecular Diagnostic Testing, 2007-2010; Table 3.25: Global Market Forecast for Molecular Diagnostic HIV Diagnostic Testing, 2011-2016; Table 3.26: U.S. Market Forecast for Molecular Diagnostic HIV Diagnostic Testing, 2011-2016; Table 3.27: Markers for Diagnosis of HBV Infections; Table 3.28: Recommendations for HBV Diagnostic Testing; Table 3.29: Lower Detection Limits of HBV DNA Assays; Table 3.30: Summary of Molecular Diagnostic Assays for Testing HBV; Table 3.31: Global Market for HBV Diagnostic Testing, 2000-2010; Table 3.32: U.S. Market for HBV Diagnostic Testing, 2000-2010; Table 3.33: Global Market Forecast for HBV Diagnostic Testing, 2011-2016; Table 3.34: U.S. Market Forecast for HBV Diagnostic Testing, 2011-2016; Table 3.35: Recommendations for HCV Diagnostic Testing; Table 3.36: Important HCV Statistics; Table 3.37: Commercially Available Molecular Diagnostic Products for HCV Assay; Table 3.38: Global Market for DNA HCV Diagnostic Testing, 2005-2010; Table 3.39: U.S. Market for DNA HCV Diagnostic Testing, 2005-2010; Table 3.40: Global Market Forecast for NAT HCV Diagnostic Testing, 2011-2016; Table 3.41: U.S. Market Forecast for NAT HCV Diagnostic Testing, 2011-2016; Table 3.42: Global Market for DNA HAV Diagnostic Testing, 2000-2008; Table 3.43: U.S. Market for DNA HAV Diagnostic Testing, 2000-2008; Table 3.44: Global Market for DNA HBV Diagnostic Testing, 2000-2008; Table 3.45: U.S. Market for DNA HBV Diagnostic Testing, 2000-2008; Table 3.46: Global Market for DNA HCV Diagnostic Testing, 2000-2008; Table 3.47: U.S. Market for DNA HCV Diagnostic Testing, 2000-2008; Table 3.48: Commercially Available Molecular Diagnostic Products for HPV Assay; Table 3.49: Major Companies Marketing HPV Molecular Diagnostic Tests: Market Size and Share, 2010; Table 3.50: Global Market for HPV Molecular Diagnostic Testing, 2007-2010; Table 3.51: U.S. Market for HPV Diagnostic Testing, 2007-2010; Table 3.52: Global Market Forecast for HPV Molecular Diagnostic Testing, 2011-2016; Table 3.53: U.S. Market Forecast for HPV Diagnostic Testing, 2011-2016; Table 3.54: Commercially Available Molecular Diagnostic Products for Influenza Assay; Table 3.55: Global Market for Molecular Influenza Diagnostic Testing, 2007-2010; Table 3.56: U.S. Market for DNA Influenza Diagnostic Testing, 2007-2010; Table 3.57: Global Market Forecast for Influenza Molecular Diagnostic Testing, 2010-2016; Table 3.58: U.S. Market Forecast for Influenza Molecular Diagnostic Testing, 2010-2016; Table 3.59: Global Market for Molecular Diagnostics Cancer Testing, 2008-2016; Table 3.60: Leading Segments of the Molecular Diagnostic Testing Market; Table 3.61: KRAS Assays by Analytical Type; Table 3.62: KRAS Mutation Assay from Exiqon Diagnostics; Table 3.63: Players in the Breast Cancer Molecular Diagnostic Space; Table 3.64: U.S. Molecular Diagnostic Markets for Infectious Disease Testing, 2009; Table 3.65: Commercially Available Molecular Diagnostic Products for Chlamydia Assay; Table 3.66: Global Market for Molecular Diagnostic Chlamydia/Gonorrhea Diagnostic Testing, 2000-2010; Table 3.67: U.S. Market for Chlamydia/Gonorrhea Diagnostic Testing, 2000-2010; Table 3.68: Global Market Forecast for Chlamydia/Gonorrhea Diagnostic Testing, 2011-2016; Table 3.69: U.S. Market Forecast for Chlamydia/Gonorrhea Diagnostic Testing, 2010-2016; Table 3.70: CPT Code1 Description National Limitation Amount; Table 3.71: Global Market for MD TB Diagnostic Testing, 2005-2010; Table 3.72: U.S. Market for MD TB Diagnostic Testing, 2005-2010; Table 3.73: Global Market for DNA Group B Streptococcus Diagnostic Testing, 2000-2009; Table 3.74: U.S. Market for DNA Group B Streptococcus Diagnostic Testing, 2000-2009; Table 3.75: Gen-Probe Clinical Diagnostic Products for the Detection of Non-Viral Micro-Organisms; Table 3.76: Commercially Available Molecular Diagnostic Products for MRSA Assay; Table 3.77: Global Market for MRSA Diagnostic Testing, 2005-2010; Table 3.78: U.S. Market for MRSA Diagnostic Testing, 2005-2010; Table 3.79: Global Market Forecast for MD MRSA Diagnostic Testing, 2011-2016; Table 3.80: U.S. Market Forecast for MD MRSA Diagnostic Testing, 2011-2016; Table 3.81: Commercially Available Molecular Diagnostic Products for VRE Assay; Table 3.82: Global Market for VRE Diagnostic Testing, 2005-2010; Table 3.83: U.S. Market for VRE Diagnostic Testing, 2005-2010; Table 3.84: Global Market Forecast for MD VRE Diagnostic Testing, 2011-2016; Table 3.85: U.S. Market for MD VRE Diagnostic Testing, 2011-2016; Table 3.86: Global Market for Blood Screening Product Sales, 2007-2016; Table 3.87: Blood Screening Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact; Table 3.88: Blood Screening Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact; Table 3.89: Drivers of the Genetic Analysis Market; Table 3.90: Leading Players in the SNP Genotyping Space; Table 3.91: Global Market for SNP and Genotyping, 2009-2015; Table 3.92: Instrumentation; Table 3.93: Consumables; Table 3.94: DNA Analysis Market Competitors; Table 3.95: Leading Companies in Medical Utility of SNPs; Table 3.96: Competitors in the Field of Identity, Family and Paternity Testing; Table 3.97: Competitors in the Field of Forensic Testing; Table 3.98: U.S. Market for Food-Screening Diagnostic Testing Using MD Techniques, 2000-2016; Table 3.99: Molecular Diagnostics Methods for Detection of Salmonella in Food; Table 3.100: U.S. Market for Forensic Diagnostics Testing, 2000-2016; Table 3.101: Barriers for Biologics Warfare Monitoring Systems; Table 3.102: U.S. Market for Biological Threat Detection Testing, 2000-2010; Table 3.103: Technical Problems for PCR Assays for Pathogen Genotyping and Detection; Table 3.104: Biological Warfare Agents Identified by PCR Methods; Table 3.105: Companies Developing Detection Devices for Biological Warfare Agents; Table 3.106: Variation of CF Carrier Risks by Ethnic Group; Table 3.107: Reasons for CF Testing; Table 3.108: Variation of CF Detection Rates by Ethnic Background; Table 3.109: Global Market for CF Diagnostic Testing, 2000-2008; Table 3.110: U.S. Market for CF Diagnostic Testing, 2000-2008; Table 3.111: Projected Global Market for CF Diagnostic Testing, 2009-2013; Table 3.112: Projected U.S. Market for CF Diagnostic Testing, 2009-2013; Table 3.113: Commercial CF-Screening Products; Table 3.114: CF Screening Technology Summary; Table 3.115: U.S. Market for HLA Type Testing, 2000-2009; Table 3.116: Competitors in HLA Testing; Table 3.117: Carrier Rates of Common HFE Mutations in Caucasians; Table 3.118: Results and Diagnosis for Fragile X Syndrome; Table 3.119: Other Genetic Testing Procedures by Molecular Diagnostics; Table 3.120: DNA Chip Market Drivers and Restraints; Table 3.121: DNA Chip Major Players; Table 3.122: Applications of DNA Biochips; Table 3.123: Technology Trends in the DNA Microarray Market; Table 3.124: Molecular Diagnostic Personalized Medicine Tests; Table 3.125: Global Revenue Forecasts for Prenatal and Newborn Testing Segment, 2007-2015; Table 3.126: Various Molecular Diagnostics Technologies: Timeline for Impact; Table 3.127: Various Molecular Diagnostics Technologies: Impact on Different Therapeutic Areas in Personalized Medicine; Table 3.128: Various Molecular Diagnostics Technologies: Technical Challenges in the Deployment for Personalized Medicine; Table 4.1: DNA-Sequencing Molecular Diagnostics Market Players; Table 4.2: U.S. Market for DNA Chips, 2000-2015; Table 4.3: Affymetrix DNA Analysis Products; Table 4.4: PCR Segmentation by Sector; Table 4.5: Impediments to Incorporating Promising Molecular Tests into Clinical Practice; Table 4.6: Largest Market Opportunities in PCR Testing; Table 4.7: PCR Real-Time Applications; Table 4.8: Advantages of Using Real-Time PCR; Table 4.9: Pharmaceutical Company Challenges; Table 4.10: Molecular Diagnostic Sector Acquisitions, Agreements and Partnerships; Table 4.11: Regulatory Rules that Affect the Ability of a Diagnostic Testing Reagent Company to Conduct Business; Table 4.12: Strengths of the 510k Process; Table 4.13.: Focus Areas for the FDA Critical Path Initiative; Table 4.14: Medicare Pricing Methods; Table 4.15: Factors Affecting Third-Party Reimbursement for Molecular Diagnostic Tests; Table 4.16: Documents for Protecting Intellectual Property Rights; Table 4.17: Recent Patents Related to PCR, Nucleic Acid Amplification, and Sample Prep; Table 5.1: Molecular Diagnostic High-throughput Automated Testing Systems; Table 6.1: Five Molecular Diagnostics Growth Areas; Table 6.2: Limitations of Nucleic Acid Chip Probes; Table 6.3: Companies Licensed to Sell Custom Molecular Beacon Probes; Table 6.4: U.S. Sample Preparation Market, 2005-2012; Table 7.1: Products Marketed by Abbott in the Diagnostics Market; Table 7.2: Gen-Probe Key Acquisitions; Table 7.3: Roche Diagnostics Key Products; Table 7.4: Sales by Region; Table 7.5: Sales by Business Area; Table 7.6: Product Line Sales; Table 7.7: Growth Drivers; Table 8.1: Number of Molecular Diagnostics Tests in the U.S., 2008-2015; Table 8.2: Global Molecular Diagnostics Testing Revenues, 2000-2016; Table 8.3: Global Distribution of Molecular Diagnostics Testing by Geographic Region, 2010; Table 8.4: U.S. Molecular Diagnostics Testing Market, 2004-2016; Table 8.5: European Molecular Diagnostics Testing Market, 2005-2016; Table 8.6: Japanese Molecular Diagnostics Testing Market, 2005-2016; Table 8.7: Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact; Table 8.8: Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact; Table 8.9: Large General Diagnostic Lab Services; Table 8.10: Small Specialized Diagnostic Lab Services; Table 8.11: MDx Sector Leaders; Table 8.12: Point-of-Care MDx Leaders; Table 8.13: Pure Play MDx Companies; Table 8.14: Array Platforms; Table 8.15: Molecular Diagnostic Testing Market Trends; Table 8.16: Molecular Diagnostic Testing Technology Trends; Table 8.17: Molecular Diagnostics Market: Strategic Recommendations on MD Sector Business Functions

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