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.
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?
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?
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