Table of Contents
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 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
2.2.1. Clinical Applications of Mass Spectrometry
2.2.1.1. Therapeutic Drug Monitoring
2.2.1.2. Metabolic Diseases
2.2.1.3. Endocrinology
2.2.1.4. Clinical Toxicology
2.2.1.5. Proteomics
2.2.1.6. Biomarkers
2.3. Opportunities in Mass Spectroscopy and Clinical Diagnostics
2.4. Development of Mass Spectroscopy Testing Markets
2.5. Mass Spectrometry
2.5.1. Overview of Mass Spectrometry
2.5.2. Sample Introduction Techniques
2.5.3. Ionization Source
2.5.3.1. Electrospray Ionization
2.5.3.2. Electron Ionization
2.5.3.3. Matrix-Assisted Laser Desorption/Ionization (MALDI)
2.5.4. Mass Analyzers
2.5.4.1. Quadrupoles
2.5.4.2. Quadrupole Ion Trap
2.5.4.3. Linear Ion Trap
2.5.4.4. Quadrupole Time-of-Flight Tandem MS (TOF)
2.5.4.5. MALDI with Time-of-Flight Analysis (MALDI-TOF)
2.5.4.6. Quadrupole Time-of-Flight MS
2.5.4.7. Fourier Transform Mass Spectrometry (FTMS)
2.5.5. Ion Detectors
2.6. Advances in Mass Spectroscopy Technologies
2.6.1. Market Drivers and Restraints
2.6.1.1. Market Drivers
2.6.1.2. Market Restraints
2.6.2. Market and Technology Trends
2.6.2.1. Market Trends
2.6.2 2. Technology Trends
2.6.3. Strategic Recommendations
3. Mass Spectroscopy Diagnostics Testing Market
3.1. Market Overview
3.1.1. Overall Mass Spectroscopy Clinical Laboratory Market Analysis
3.2. Mass Spectroscopy Diagnostics Market
3.3. Mass Spectroscopy Clinical Testing Platforms
3.3.1. Gas Chromatography/Mass Spectrometry (GC/MS)
3.3.1.1. Background
3.3.1.2. Instruments
3.3.1.3. Method Comparisons
3.3.1.4. Market Drivers and Restraints
3.3.1.4.1. Market Drivers
3.3.1.4.2. Market Restraints
3.3.1.5. Market and Technology Trends
3.3.1.5.1. Market Trends
3.3.1.5.2. Technology Trends
3.3.1.5.3. Strategic Recommendations
3.3.2. Ion Trap and Quadrupole Mass Spectrometers
3.3.2.1. Background
3.3.2.1.1. Instruments
3.3.2.1.2. Method Comparisons
3.3.2.1.3. Market Challenges and Strategic Recommendations
3.3.2.1.3.1. Market Drivers and Restraints
3.3.2.1.3.1.1. Market Drivers
3.3.2.1.3.1.2. Market Restraints
3.3.2.1.4. Market and Technology Trends
3.3.2.1.4.1. Market Trends
3.3.2.1.4.2. Technology Trends
3.3.2.1.5. Strategic Recommendations
3.3.3. Liquid Chromatography/Mass Spectrometry
3.3.3.1. Background
3.3.3.2. Instruments
3.3.3.3. Method Comparisons
3.3.3.4. Market Size
3.3.3.4.1. Liquid Chromatography/Mass Spectroscopy (LC/MS) Market Size
3.3.3.4.1.1. Market Share
3.3.3.4.2. Market Challenges and Strategic Recommendations
3.3.3.4.2.1. Market Drivers and Restraints
3.3.3.4.2.1.1. Market Drivers
3.3.3.4.2.1.2. Market Restraints
3.3.3.4.3. Market and Technology Trends
3.3.3.4.3.1. Market Trends
3.3.3.4.3.2. Technology Trends
3.3.3.4.4. Strategic Recommendations
3.3.4. Ion Mobility and High Definition Mass Spectrometry
3.3.4.1. Background
3.3.5. Liquid Chromatography Tandem Mass Spectrometry
3.3.5.1. Background
3.3.6. Time-of-Flight Mass Spectrometry
3.3.6.1. Background
3.3.7. Orbitrap
3.3.7.1. Background
3.3.7.2. Instruments
3.3.7.3. Method Comparisons
3.3.7.4. Market and Technology Trends
3.3.7.4.1. Market Trends
3.3.7.4.2. Technology Trends
3.3.7.4.3. Strategic Recommendations
3.3.8. Matrix-Assisted Laser Desorption/Ionization (MALDI) Time-of-Flight Mass Spectrometry
3.3.8.1. Background
3.3.9. Inductively coupled Plasma Mass Spectrometry (ICP)
3.3.9.1. Background
3.3.9.2. Instruments
3.3.9.3. Method Comparisons
3.3.10. FTMS
4. Mass Spectrometry Diagnostic Testing in the Clinical Laboratory
4.1. Clinical Laboratory Molecular Tests Using Mass Spectroscopy
4.2. Top Mass Spectroscopy Assays
4.2.1. Drugs of Abuse
4.2.2. Therapeutic Drugs
4.2.3. Hormone Analysis
4.2.3.1. Vitamin D
4.2.3.2. Testosterone and Estradiol
4.2.3.3. Other Hormones
4.2.4. Newborn Screening
4.3. Challenges in Mass Spectrometry Clinical Diagnostic Technologies
4.3.1. Market Drivers and Restraints
4.3.1.1. Market Drivers
4.3.1.2. Market Restraints
4.3.2. Market and Technology Trends
4.3.2.1. Market Trends
4.3.2.2. Technology Trends
4.3.3. Strategic Recommendations
4.3.4. Cost of Mass Spectroscopy Testing
4.3.5. Priorities for Vendors
4.3.6. Mass Spectrometers Market Continues to Grow
4.4. Mass Spectroscopy Develops Novel Applications
4.4.1. Microbiology
4.4.2. Metabolomics
4.4.3. Cancer Therapy
4.4.4. Immunosuppressant Drugs
4.4.5. Pain Management Drugs
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
4.11.1. Multiple Reaction Monitoring Assays (MRMs)
4.11.2. Gel-based Approaches
4.11.3. Non-Gel-based Approaches
4.11.4. SELDI-TOF MS
4.11.5. SELDI and Prognosis
4.11.6. SELDI and Treatment Monitoring
4.11.7. Limitations of Mass Spectroscopy
4.12. Technological Breakthroughs/Innovations
4.12.1. Hybrids
4.12.2. Integrated and Hybrid-based MS systems
4.12.3. LTQ-Velos
4.12.4. Applied Biosystems Integrates Two MS technologies
4.12.5. Q-TOF-MS Leads
4.12.6 Agilent
4.12.6 Agilent?s Chip LC/MS Systems
4.12.7 New Virus Detection System Based on Mass Spectrometry
4.12.8 Orbitrap MS System
4.12.9 Qual-Quan Mass Spectroscopy
4.12.10 SISCAPA
4.12.11 SRM/MRM
4.12.12 AB Sciex?s iMethod and Cliquid Software
4.12.13 Microsaic Mini Mass Specs
5. Business Landscape for Mass Spectroscopy for Clinical Labs
5.1. Technology and Market Trends
5.1.1. Market Trends
5.1.2. Technology Trends
5.2. M&A Activity
5.3. Partnerships
5.4. Competitive Analysis
5.4.1. Primary Competitors
5.4.2. Industry Challenges and Strategic Recommendations
5.4.3. Commercialization of Mass Spectroscopy Products
5.5. The Success Achieved by the Mass Spectroscopy Clinical Products
5.6. Intellectual Property Rights
5.6.1. New Patents
5.6.2. Current Patent Disputes
5.7. Opportunities and Strategic Recommendations
5.7.1. Key Technical Opportunities with Significant Market Appeal in the Mass Spectroscopy Space in the Next Five Years
5.7.2. Developments for Mass Spectroscopy Instrumentation Products
5.7.3. Market Penetration Strategies for Clinical Laboratory Testing
5.8. Business Models in Mass Spectroscopy Clinical Products
5.8.1. Scope of This Section
5.8.2. Business Models for Clinical Mass Spectroscopy Markets
5.8.2.1. SWOT Comparison of Business Models for Mass Spectrometry Diagnostic Testing
5.8.3. Sales and Marketing Strategies for Clinical Laboratory Tests
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. bioMerieux
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
LIST 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
LIST 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