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Mass Spectroscopy for Clinical Laboratory Analysis

TriMark Publications
November 1, 2011
165 Pages - SKU: TRI6655653

Abstract Table of Contents Related Reports

Mass Spectroscopy for Clinical Laboratory Analysis

Mass spectroscopy is a clinical laboratory analysis technique used in determining the basic composition and structure of a sample or molecule. The process involves bending a charged beam of vaporized material using an electric and/or magnetic field and then plotting a spectrum of how the sample's ions are deflected. Mass spectroscopy assays based on well-documented techniques such as time-of-flight, liquid chromatography/tandem, liquid chromatography, gas chromatography-quadrupole and others have gained wide acceptance in the clinical laboratory due to their accuracy, speed and sensitivity compared to traditional analytical drug detection techniques. This TriMark Publications report provides a detailed analysis of the mass spectroscopy drug testing market, including size, growth, technology platforms, clinical applications, new instrumentation, industry trends and the internal structure of the sector.

The mass spectroscopy market remains the fastest-growing segment of the diagnostics analytical instruments market. Highly-attractive clinical growth areas covered in this study include: disease markers; molecular diagnostics; infectious disease; toxicology; inborn errors in metabolism; metabolomics; proteins and peptides; small molecule analytes (vitamins, steroids, thyroid, etc.); tobacco exposure; chemical warfare agents; tissue analysis by MALDI; clinical chemistry/toxicology; microbiology/virology; proteomic, metabolomic and tissue histology laboratories; high-end MS; and food testing. Also provided in this review is a thorough analysis of the companies known to be marketing, manufacturing or developing mass spectroscopy products in the U.S. and worldwide, as well as detailed tables, charts and figures with past and projected data analyzed by geographic region with a focus on the U.S., Europe and Japan, the world's three largest mass spectroscopy markets.

1. Overview: 1.1 Statement of Report; 1.2 About This Report; 1.3 Scope of the Report; 1.4 Objectives; 1.5 Methodology
2. Introduction to Mass Spectroscopy for Clinical Laboratory Testing: 2.1 Mass Spectroscopy Testing and Opportunities in the Clinical Laboratory; Sector; 2.2 Overview of Laboratory Mass Spectroscopy Instrumentation; 2.3 Opportunities in Mass Spectroscopy and Clinical Diagnostics; 2.4 Development of Mass Spectroscopy Testing Markets; 2.5 Mass Spectrometry; 2.6 Advances in Mass Spectroscopy Technologies
3. Mass Spectroscopy Diagnostics Testing Market: 3.1 Market Overview; 3.2 Mass Spectroscopy Diagnostics Market; 3.3 Mass Spectroscopy Clinical Testing Platforms
4. Mass Spectrometry Diagnostic Testing in the Clinical Laboratory: 4.1 Clinical Laboratory Molecular Tests Using Mass Spectroscopy; 4.2 Top Mass Spectroscopy Assays; 4.3 Challenges in Mass Spectrometry Clinical Diagnostic Technologies; 4.4 Mass Spectroscopy Develops Novel Applications; 4.5 Paradigm Shift within the Mass Spectrometry Market; 4.6 Metabolomics; 4.7 Proteomics; 4.8 Automated Workstations; 4.9 Biomarkers; 4.10 Multiplexing; 4.11 Use of Mass Spectrometry in Biomarker Discovery; 4.12 Technological Breakthroughs/Innovations
5. Business Landscape for Mass Spectroscopy for Clinical Labs: 5.1 Technology and Market Trends; 5.2 M&A Activity; 5.3 Partnerships; 5.4 Competitive Analysis; 5.5 The Success Achieved by the Mass Spectroscopy Clinical Products; 5.6 Intellectual Property Rights; 5.7 Opportunities and Strategic Recommendations; 5.8 Business Models in Mass Spectroscopy Clinical Products
6. Product Developments/Competitive Landscape: 6.1 Manufacturers Decisions in the Global Analytical Instrument Industry; 6.2 Instrument Introductions
7. Business Decisions, Strategic Outlook and Recommendations Using Mass Spectroscopy Technology Platforms in the Clinical Laboratory Testing Space: 7.1 What are the Key Opportunities for Mass Spectroscopy in Clinical Laboratory Testing Development and Commercialization?; 7.2 What are the Current Obstacles for Mass Spectroscopy in Clinical Laboratory Testing Implementation?; 7.3 How Do Business Strategies, Such as those Relating to Acquisition, Drive Mass Spectroscopy Strategies?; 7.4 How Might Novel Clinical Laboratory MS Test Development Lead to Acquisition or Partnering Strategies and their Implications for Deal Making?; 7.5 How can Mass Spectroscopy Tests Increase Value in an Associated Drug Marketing Plan?; 7.6 Which Types of Clinical Laboratory Testing Should be Developed by Mass Spectroscopy Companies?; 7.7 How can Regulatory Oversight Drive Approval and Adoption of New Technologies?; 7.8 What are the Noteworthy Deals?; 7.9 Who are the Acquirers?; 7.10 Who are the Target Companies?; 7.11 How will Platform Technology Companies Enter the Space?; 7.12 Will Pharma Integrate with Diagnostics?; 7.13 How Do Platform Technology Companies Position Themselves for Diagnostic and Pharma Development?; 7.14 Evaluate How Partnering and M&As will Alter the Competitive Landscape; 7.15 Predict How FDA Regs will Impact New Diagnostic Tests; 7.16 How can Big Pharma and Mass Spectroscopy Companies Co-develop Biomarkers in a Model for Regulatory Acceptance?; 7.17 How to Maximize Business Development through Biomarker Strategies?; 7.18 What is the Best Type of Business Model for Developing Genetic Biomarkers for Clinical Laboratory?; 7.19 How Best can Mass Spectroscopy Provide the Most Benefit in Clinical Laboratory Testing?; 7.20 What are the Most Innovative Methods in Development of Mass Spectroscopy Diagnostic Testing?
8. Company Profiles: 8.1 AB SCIEX; 8.2 Agilent Technologies; 8.3 Applied Biosystems/Sciex; 8.4 bioMérieux; 8.5 Bruker; 8.6 Danaher Corporation; 8.7 Hiden Analytical; 8.8 JEOL; 8.9 Konica Minolta; 8.10 MDS Analytical Technologies; 8.11 PerkinElmer; 8.12 Shimadzu Corporation; 8.13 Spectro; 8.14 Thermo Fisher Scientific; 8.15 Varian; 8.16 Waters Corporation
INDEX OF FIGURES: Figure 2.1: Relationship of Mass Spectrometry Testing to Key Areas of Clinical Diagnosis; Figure 2.2: Magnetic or Electrostatic Sector in Mass Spectroscopy; Figure 2.3: Triple Quadrupole (Tandem) Mass Spectroscopy; Figure 2.4: Time-of-flight Mass Spectroscopy; Figure 2.5: Diagram of a Quadrupole MS Analyzer; Figure 2.6: Diagram of an Ion Trap MS Analyzer; Figure 3.1: Mass Spectroscopy by Testing Type, 2010; Figure 3.2: Key Players Market Share in Global Mass Spectroscopy Testing Market; Figure 3.3: Mass Spectroscopy World Market and Global Testing for Forensic and Drug Testing, 2007-2010; Figure 3.4: Global Revenue Forecast for Mass Spectroscopy, 2009-2016; Figure 3.5: Global Market Revenue Share Forecast for Mass Spectroscopy Testing Markets by Region, 2010 and 2016; Figure 3.6: U.S. Market Revenue Forecast for Mass Spectroscopy, 2009-2016; Figure 3.7: European Market Revenue Forecast for Mass Spectroscopy, 2009-2016; Figure 3.8: Japanese Market Revenue Forecast for Mass Spectroscopy, 2009-2016; Figure 3.9: Global Revenue Forecast for Mass Spectroscopy Forensic and Drug; Testing Market, 2009-2016; Figure 3.10: Global Market Revenue Share Forecast for Mass Spectroscopy Forensic and Drug Testing Markets by Region, 2010 and 2016; Figure 3.11: U.S. Market Revenue Forecast for Mass Spectroscopy Forensic and; Drug Testing Market, 2009-2016; Figure 3.12: European Market Revenue Forecast for Mass Spectroscopy Forensic and Drug Testing Market, 2009-2015; Figure 3.13: Japanese Market Revenue Forecast for Mass Spectroscopy Forensic and Drug Testing Market, 2009-2016; Figure 3.14: Mass Spectrometry Supplier Market Shares; Figure 5.1: Market Growth of MS Clinical Laboratory Tests; Figure 8.1: Agilent’s Well Distributed Worldwide Business; Figure 8.2: Bruker’s Revenue Stream; Figure 8.3: Bruker’s Geographic Distribution; Figure 8.4: Thermo Fisher Laboratory Products Revenue Share; Figure 8.5: Thermo Fisher Biosciences Revenue Shares
INDEX OF TABLES: Table 2.1: Mass Spectrometry Utilization in the Clinical and Life Science Space; Table 2.2: Mass Spectrometry Tests for Clinical Applications; Table 2.3: Emerging Mass Spectrometric Technologies; Table 2.4: Advantages of Electrospray Ionization (ESI); Table 2.5: Disadvantages of Electrospray Ionization (ESI); Table 2.6: Advantages of Matrix-Assisted Laser Desorption/Ionization (MALDI); Table 2.7: Disadvantages of Matrix-Assisted Laser Desorption/Ionization (MALDI); Table 2.8: Mass Analyzers Event; Table 2.9: Automated Mass Spectroscopy Platforms for Clinical Laboratory Testing; Table 2.10: Companies Marketing Products Using MS Technology Platforms; Table 2.11: Mass Spectroscopy Market: Market Drivers Ranked in Order of Impact; Table 2.12: Mass Spectroscopy Market: Market Restraints Ranked in Order of Impact; Table 2.13: A Timeline of Mass Spectrometry; Table 2.14: Attractive Growth Areas for Mass Spectroscopy Testing; Table 3.1: Mass Spectroscopy World Market, 2007-2010; Table 3.2: Mass Spectroscopy U.S. Market, 2007-2010; Table 3.3: Mass Spectroscopy European Market, 2007-2010; Table 3.4: Mass Spectroscopy Japan Market, 2007-2010; Table 3.5: Mass Spectroscopy Global Testing Sectors for Forensic and Drug Testing Market, 2007-2010; Table 3.6: Mass Spectroscopy U.S. Testing Sectors for Forensic and Drug Testing Market, 2007-2010; Table 3.7: Mass Spectroscopy European Testing Sectors for Forensic and Drug Testing Market, 2007-2010; Table 3.8: Mass Spectroscopy Japanese Testing Sectors for Forensic and Drug; Testing Market, 2007-2010; Table 3.9: Share of Mass Spectroscopy Testing for Life Science, Pharma, and Clinical by Testing Type, 2010; Table 3.10: Key Players and Market Share in Global Mass Spectroscopy Testing Market; Table 3.11: Revenue Model for Mass Spectrometry Testing; Table 3.12: Mass Spectroscopy in the Clinical Market: Market Drivers Ranked in Order of Impact; Table 3.13: Mass Spectroscopy in the Clinical Market: Market Restraints Ranked in Order of Impact; Table 3.14: Global Revenue Forecast for Mass Spectroscopy, 2009-2016; Table 3.15: U.S. Market Revenue Forecast for Mass Spectroscopy, 2009-2016; Table 3.16: European Market Revenue Forecast for Mass Spectroscopy, 2009-2016; Table 3.17: Japanese Market Revenue Forecast for Mass Spectroscopy, 2009-2016; Table 3.18: Global Revenue Forecast for Mass Spectroscopy Forensic and Drug Testing Market, 2009-2016; Table 3.19: U.S. Market Revenue Forecast for Mass Spectroscopy Forensic and Drug Testing Market, 2009-2016; Table 3.20: European Market Revenue Forecast for Mass Spectroscopy Forensic and Drug Testing Market, 2009-2015; Table 3.21: Japanese Market Revenue Forecast for Mass Spectroscopy Forensic and Drug Testing Market, 2009-2016; Table 3.22: Business Factors Influencing Advanced Mass Spectroscopy Testing Services; Table 3.23: Companies Marketing Multiple Products in Mass Spectroscopy Sector; Table 3.24: Commercially Available GC/MS Spectrophotometers; Table 3.25: GC/MS Market: Market Drivers Ranked in Order of Impact; Table 3.26: GC/MS Market: Market Restraints Ranked in Order of Impact; Table 3.27: Commercially Available Ion Trap MS; Table 3.28: Commercially Available Liquid Chromatography/MS Systems; Table 3.29: Commercially Available Orbitrap MS; Table 3.30: Commercially Available MALDI MS; Table 3.31: Commercially Available ICP MS; Table 4.1: Immunoassays vs. Liquid Chromatography/Mass Spectrometry for Clinical Analysis; Table 4.2: Drugs-of-Abuse and Pain Management; Table 4.3: Fastest-Growing Lab Tests, 2006-2009; Table 4.4: Therapeutic Drugs; Table 4.5: Utilization of Mass Spectrometry for Hormone Analysis; Table 4.6: Steroids Commonly Measured Using MS Technology Platforms; Table 4.7: Mass Spectroscopy Newborn Screening Program; Table 4.8: Prevalence of Metabolic Disorders Analyzed by MS/MS; Table 4.9: Principal Cost Factors in the Mass Spectroscopy Clinical Laboratory Testing Market; Table 4.10: Priorities for Vendors; Table 4.11: Key Drivers of the Mass Spectroscopy Market in Life Sciences; Table 4.12: Proteins Measured in Clinically-available MS Tests in the U.S.; Table 4.13: Concentration of Some Abundant Proteins, New Cancer Biomarkers; Identified by SELDI-TOF, and Classical Cancer Biomarkers in Serum; Table 4.14: Strengths and Limitations of MRM Assays; Table 4.15: Software Methods for Mass Spectroscopy for Clinical Analysis; Table 4.16: Software Methods for Mass Spectroscopy for Drugs of Abuse Analysis; Table 5.1: Technology Trends in Mass Spectroscopy for Clinical Laboratory Testing; Table 5.2: Clinical Testing Trends in Mass Spectroscopy for Clinical Laboratory Testing; Table 5.3: Business Market Trends in Mass Spectroscopy Clinical Laboratory Testing; Table 5.4: Expected Changes in Healthcare; Table 5.5: Customer Feedback for Automated Mass Spectroscopy Instruments; Table 5.6: Mass Spectroscopy Clinical Laboratory Market: Market Drivers Ranked in Order of Impact; Table 5.7: Mass Spectroscopy Clinical Laboratory Market: Market Restraints; Ranked in Order of Impact; Table 5.8: Advantages of European Markets for Mass Spectroscopy Testing; Table 5.9: Disadvantages of European Markets for Mass Spectroscopy Testing; Table 5.10: Summary of Recent M&A Activity in the Mass Spectroscopy Sector; Table 5.11: High Value Opportunities in Collaborative and Strategic Partnerships Using MS; Table 5.12: Principal Competitive Factors in the Mass Spectroscopy Clinical; Laboratory Testing Market; Table 5.13: Mass Spectroscopy Clinical Laboratory Testing Market: Strategic; Recommendations on Mass spectroscopy Sector Business Functions; Table 5.14: Mass Spectroscopy Clinical Laboratory Market: Impact of Top Industry Challenges (U.S.); Table 5.15: Documents for Protecting Intellectual Property Rights; Table 5.16: Specific Opportunities for Automated Instrumentation and Reagent Systems in Mass Spectroscopy for Clinical Laboratory Testing; Table 5.17: Strategies and POA for Marketing Clinical Laboratory Diagnostic Products; Table 7.1: Effect of Regulation on Molecular Diagnostics Clinical Laboratory Market Technology Platforms, 2007-2015; Table 7.2: Companies Utilizing New, Cutting-Edge Technologies to Develop, Validate and Market Mass Spectroscopy Tests for Clinical Use; Table 7.3: Impediments to Incorporating Promising Mass Spectroscopy Tests into Clinical Practice; Table 7.4: Alliances Showing the Greatest Synergy in Bringing Mass Spectroscopy’s Tests to Market

Mass Spectroscopy for Clinical Laboratory Analysis

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