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For capacity, accuracy, and specificity of analysis, the use of mass spectrometry in clinical diagnostics and clinical research has grown dramatically in recent years. This Kalorama Information report, Mass Spectrometry for Clinical Applications: Market Analysis and End User Survey, looks at the growth of Mass Spec systems being used in diagnostics and other clinical applications this year.

A Detailed Examination of the Market Opportunity for MS in Clinical Applications

Prior to the explosion in the last several years, GC-MS, LC-MS, and LC-MS/MS were being used in diagnostics primarily only for newborn screening of metabolic diseases. Clinical research applications related mainly to pharmaceutical development. But the situation has changed dramatically as a number of applications have seen particularly rapid adoption in the last few years, including testing for microbial identification, steroids/ endocrinology, vitamin D, and therapeutic drug monitoring (TDM). A large range of diagnostic tests are being researched for both small molecules and proteins. Depending on the application, MS can have many advantages over the immunoassays typically used for most diagnostics. In some cases, there is simply no alternative testing method available.

Clinical MS Market and Revenues Forecast
Market Share of Clinical MS Systems by Product (MALDI-TOF, triple quad, QTRAP, ion trap, GCMS, Orbitrap & ion-Orbitrap, QTOF, Other)
Clinical MS Market Share by Supplier
Overview of Types of MS and Clinical Use
Challenges
Strategic Recommendations
Company Profiles

INCLUDES: An End User Survey on Applications, Brand Ownership, Handling of Regulated Samples, Future Plans

A survey of 50 labs was conducted to get a better picture of the usage and trends with MS in clinical labs. Labs included in the survey are those running regulated patient samples for routine diagnostics, or unregulated patient samples for diagnostics/prognostics/ theranostics-oriented research. A wide breadth of labs was targeted in order to obtain a richer picture of the market. Results provided by the survey respondents include:

Brands of MS Systems Used by Regulated/Not Regulated
Types of MS Systems (triple quad, Q-trap, ion trap, MALDI TOF, GCMS, Q-TOF, Orbitrap, ion trap-Orbitrap, MALDI-TOF/TOF, triple TOF, isotope ratio MS, ICP-MS, N/D, Other) Used in Labs
Labs’ Certification/ Accreditation for Diagnostic MS
Future Purchase Time Frame
Brands of Systems Considered Most Appealing by Regulated/Not Regulated
Most Important Trends in Clinical MS

Several MS systems and kits have now received regulatory approval for diagnostic use. These enable labs to run the tests without the extra work and expense involved with laboratory developed tests (LDTs), also referred to as “homebrew” tests. The area of LDTs has also been evolving in recent years as the FDA and other related agencies determine how best to regulate an area that has been somewhat of a grey area.

The use of MALDI-TOF MS for microbiology testing is a somewhat distinct application which appears poised for explosive growth over the next several years. The major advantages over alternatives are its ability to identify microbes in a much shorter time, with less work, and with greater accuracy. From a culture or colony, the system can identify the microbes in minutes rather than many hours required with older techniques. In a clinical diagnostic setting, the time savings can equate to a major benefit in terms of treatment and economics. The patient receives a more accurate diagnosis and/or earlier treatment, and these result in significant savings.

While MS has grown rapidly and holds great promise, there are several challenges relating to its use in clinical applications, including its complexity, high upfront cost, lack of user-friendliness, low throughput (except MALDI) as well as the complexity of the science and the associated regulatory process. These will need to be addressed in order to penetrate further into more routine testing settings. These are also presented in the report and are part of the analysis.

Table Of Contents

Mass Spectrometry for Clinical Applications: Market Analysis and End User Survey
CHAPTER ONE: EXECUTIVE SUMMARY
Scope and Methodology
Main Conclusions of the Report
CHAPTER TWO: INTRODUCTION
Advantages of Mass Spectrometry
CHAPTER THREE: MARKET TRENDS
MALDI-TOF Revolutionizing Microbiology Testing
Rapid Technological Advances in Mass Spectrometry Systems
Regulatory Hurdles Being Addressed, Overcome
Clinical Labs Increasingly Driven Towards Mass Spectrometry
Increase in Therapeutic Drug Monitoring and Drugs of Abuse
Gradual Expansion of Newborn Screening
Recent Product Introductions
CHAPTER FOUR: CONSORTIA / ALLIANCES
The Biomarkers Consortium
Biomarkers Research Initiatives in Mass Spectrometry (BRIMS)
CDC Vitamin D and Hormone Standardization Programs
Clinical Proteomic Tumor Analysis Consortium
Early Detection Research Network (EDRN)
New Biomarker Development Alliance
Key Deals in Recent Years Related to Mass Spectrometry Technology
in Clinical Applications
CHAPTER FIVE: REVENUES FORECAST and COMPETITIVE ANALYSIS
Clinical Mass Spectrometry Revenues Forecast
Clinical Mass Spectrometry Revenue Forecast
Clinical Mass Spectrometry Revenue Forecast Growth Rate
Clinical Mass Spectrometry Market Share by Supplier
Clinical Mass Spectrometry Market Share by Supplier
Market Share of Clinical Mass Spectrometry Systems by Product (MALDI-TOF, triple quad,
QTRAP, ion trap, GCMS, Orbitrap and ion-Orbitrap, QTOF, Other)
CHAPTER SIX: END-USER SURVEY
Lab's Main Specialization(s)/ Discipline(s)
Labs' Mass Spectrometry Usage for Regulated Diagnostics
Labs' Distribution of Industry/ Segment
Distribution of Lab Function(s)
Lab Personnel
Regional Distribution (United States, Europe, Canada, Australia)
Brands of Mass Spectrometry Systems Used in Labs
Types of Mass Spectrometry Systems Used in Labs
Labs' Certification/ Accreditation for Diagnostic Mass Spectrometry
Labs' Certification/ Accreditation for Diagnostic Mass Spectrometry
Lab Use of Samples
Challenges for Adoption/ Growth of Diagnostic Mass Spectrometry
Improvements/ Changes Wanted by Labs
Most Important Trends in Clinical Mass Spectrometry
Future Purchases
CHAPTER SEVEN: CORPORATE PROFILES
AB Sciex (DANAHER CORPORATION)
Agilent Technolgies
Bruker Corporation
Perkin Elmer
Thermo Fisher
Waters Corporation
CHAPTER EIGHT: CHALLENGES
CHAPTER NINE: STRATEGIC RECOMMENDATIONS

LIST OF EXHIBITS

CHAPTER FOUR: CONSORTIA / ALLIANCES
Table 4-1: Key Deals in Recent Years Related to MS Technology in Clinical Applications
CHAPTER FIVE: REVENUES FORECAST and COMPETITIVE ANALYSIS
Table 5-1: Clinical MS Revenues Forecast
Figure 5-1: Clinical MS Revenue Forecast ($M)
Figure 5-2: Clinical MS Revenue Forecast Growth Rate
Table 5-2: Clinical MS Market Share by Supplier
Figure 5-3: Clinical MS Market Share by Supplier
Table 5-3: Market Share of Clinical MS Systems by Product (MALDI-TOF, triple quad, QTRAP, ion trap, GCMS, Orbitrap and ion-Orbitrap, QTOF, Other)
Figure 5-4: Market Share of Clinical MS Systems (2013)
CHAPTER SIX: END-USER SURVEY
Table 6-1: Lab's Main Specialization(s)/ Discipline(s)
Figure 6-1: Lab's Main Specialization(s)/ Discipline(s) (% of Labs)
Table 6-2: Lab's Main Specialization(s)/Discipline(s) by Regulated/Not Regulated
Table 6-3: Lab's Main Specialization(s)/Discipline(s) by Regulated/Not Regulated (% of Systems)
Figure 6-2: Lab's Main Specialization(s)/Discipline(s) by Regulated/Not Regulated
Table 6-4: Labs' MS Usage for Regulated Diagnostics
Figure 6-3: Labs' MS Usage for Regulated Diagnostics (% of Labs)
Table 6-5: Distribution of Industry/ Segment
Figure 6-4: Distribution of Industry/ Segment (% of Labs)
Table 6-6: Distribution of Industry/ Segment by Regulated/Not Regulated
Table 6-7: Distribution of Industry/ Segment by Regulated/Not Regulated (% of Labs)
Figure 6-5: Industry/Segment Distribution by Regulated/Not Regulated (% of Labs)
Table 6-8: Distribution of Lab Function(s)
Figure 6-6: Distribution of Lab Function(s) (% of Labs)
Table 6-9: Lab's Function(s) by Regulated/Not Regulated
Table 6-10: Lab's Function(s) by Regulated/Not Regulated (% of Labs)
Figure 6-7: Lab's Function(s) by Regulated/Not Regulated (% of Labs)
Table 6-11: Number of Personnel Working in Lab
Figure 6-8: Number of Personnel Working in Lab (% of Labs)
Table 6-12: Position/ Role in Laboratory
Figure 6-9: Position/ Role in Laboratory (% of Labs)
Table 6-13: Overall Regional Distribution (United States, Europe, Canada, Australia)
Figure 6-10: Overall Regional Distribution (United States, Europe, Canada, Australia)
Table 6-14: United States Regional Distribution
Figure 6-11: United States Regional Distribution
Table 6-15: Brands of MS Systems Used in Labs
Figure 6-12: Brands of MS Systems Used in Labs (% of Systems)
Table 6-16: Brands of MS Systems Used by Regulated/Not Regulated
Table 6-17: Brands of MS Systems Used by Regulated/Not Regulated (% of Systems)
Table 6-18: Types of MS Systems (triple quad, Q-trap, ion trap, MALDI TOF, GCMS, Q-TOF, Orbitrap, ion trap-Orbitrap, MALDI-TOF/TOF, triple TOF, isotope ratio MS, ICP-MS, N/D, Other) Used in Labs
Figure 6-13: Types of MS Systems (triple quad, Q-trap, ion trap, MALDI TOF, GCMS, Q-TOF, Orbitrap, ion trap-Orbitrap, MALDI-TOF/TOF, triple TOF, isotope ratio MS, ICP-MS, N/D, Other) Used in Labs (% of Systems)
Table 6-19: Types of Systems (triple quad, Q-trap, ion trap, MALDI TOF, GCMS, Q-TOF, Orbitrap, ion trap-Orbitrap, MALDI-TOF/TOF, triple TOF, ICP-MS, isotope ratio MS, N/D, Other) Used by Regulated/Not Regulated
Table 6-20: Types of Systems (triple quad, Q-trap, ion trap, MALDI TOF, GCMS, Q-TOF, Orbitrap, ion trap-Orbitrap, MALDI-TOF/TOF, triple TOF, ICP-MS, isotope ratio MS, N/D, Other) Used by Regulated/Not Regulated (% of Systems)
Table 6-21: Triple Quad Systems by Brand (% of Systems)
Figure 6-14: Triple Quad Systems by Brand (% of Systems)
Table 6-22: Ion Trap Systems by Brand
Figure 6-15: Ion Trap Systems by Brand (% of Systems)
Table 6-23: MALDI-TOF Systems by Brand
Figure 6-16: MALDI-TOF Systems by Brand (% of Systems)
Table 6-24: GC-MS Systems by Brand
Figure 6-17: GC-MS Systems by Brand (% of Systems)
Table 6-25: Q-TOF Systems by Brand
Figure 6-18: Q-TOF Systems by Brand (% of Systems)
Table 6-26: Types of AB Sciex Systems (QTRAP, triple quad, triple TOF, MALDI-TOF/TOF, MALDI TOF, QTOF, N/D) Used in Labs
Figure 6-19: Types of AB Sciex Systems (QTRAP, triple quad, triple TOF, MALDI-TOF/TOF, MALDI TOF, QTOF, N/D) Used in Labs (% of Systems)
Table 6-27: Types of AB Sciex Systems (QTRAP, triple quad, triple TOF, MALDI TOF, QTOF, MALDI-TOF/TOF, N/D) by Regulated/Not Regulated
Table 6-28: Types of AB Sciex Systems (QTRAP, triple quad, triple TOF, MALDI TOF, QTOF, MALDI-TOF/TOF, N/D) by Regulated/Not Regulated (% of Systems)
Table 6-29: Types of Agilent Systems (GC/MS, triple quad, ion trap, QTOF, ICP-MS) Used in Labs
Figure 6-20: Types of Agilent Systems (GC/MS, triple quad, ion trap, QTOF, ICP-MS) Used in Labs (% of Systems)
Table 6-30: Types of Agilent Systems (GCMS, triple quad, ion trap, QTOF, ICP-MS) by Regulated/Not Regulated
Table 6-31: Types of Agilent Systems (GCMS, triple quad, ion trap, QTOF, ICP-MS) by Regulated/Not Regulated (% of Systems)
Table 6-32: Types of Bruker Systems (MALDI TOF, ion trap, MALDI-TOF/TOF, FTICR, QTOF, MALDI-TOF) Used in Labs
Figure 6-21: Types of Bruker Systems (MALDI TOF, ion trap, MALDI-TOF/TOF, FTICR, QTOF, MALDI-TOF) Used in Labs (% of Systems)
Table 6-33: Types of Bruker Systems (MALDI TOF, ion trap, MALDI-TOF/TOF, FTICR, QTOF) by Regulated/Not Regulated
Table 6-34: Types of Bruker Systems (MALDI TOF, ion trap, MALDI-TOF/TOF, FTICR, QTOF) by Regulated/Not Regulated (% of Systems)
Table 6-35: Types of Thermo Systems (triple quad, Orbitrap, ion trap, ion trap-Orbitrap, ICP-MS, GCMS, quadrupole-Orbitrap-ion trap, quadrupole-Orbitrap, N/D) Used in Labs
Figure 6-22: Types of Thermo Systems (triple quad, Orbitrap, ion trap, ion trap-Orbitrap, ICP-MS, GCMS, quadrupole-Orbitrap-ion trap, quadrupole-Orbitrap, N/D) Used in Labs (% of Systems)
Table 6-36: Types of Thermo Systems (triple quad, ion trap, Orbitrap, GCMS, ion trap-Orbitrap, ICP-MS, quadrupole-Orbitrap-ion trap, quadrupole-Orbitrap, N/D) by Regulated/Not Regulated
Table 6-37: Types of Thermo Systems (triple quad, ion trap, Orbitrap, GCMS, ion trap-Orbitrap, ICP-MS, quadrupole-Orbitrap-ion trap, quadrupole-Orbitrap, N/D) by Regulated/Not Regulated (% of Systems)
Table 6-38: Types of Waters Systems (triple quad, QTOF, ion mobility, N/D, isotope ratio MS, GC-TOF) Used in Labs
Figure 6-23: Types of Waters Systems (triple quad, QTOF, ion mobility, N/D, isotope ratio MS, GC-TOF) Used in Labs (% of Systems)
Table 6-39: Types of Waters Systems by Regulated/Not Regulated (No. of Systems) and by Type (triple quad, QTOF, ion mobility, isotope ratio, GC-TOF, N/D)
Table 6-40: Types of Waters Systems by Regulated/Not Regulated (% of Systems) and by Type (triple quad, QTOF, ion mobility, isotope ratio, GC-TOF, N/D)
Table 6-41: Models of AB Sciex Systems Used in Labs
Figure 6-24: Models of AB Sciex Systems Used in Labs (% of Systems)
Table 6-42: Models of Agilent Systems Used in Labs
Figure 6-25: Models of Agilent Systems Used in Labs (% of Systems)
Table 6-43: Models of Bruker Systems Used in Labs
Figure 6-26: Models of Bruker Systems Used in Labs (% of Systems)
Table 6-44: Models of Thermo Systems Used in Labs
Table 6-45: Models of Waters Systems Used in Labs
Table 6-46: Labs' Certification/ Accreditation for Diagnostic MS
Figure 6-27: Labs' Certification/ Accreditation for Diagnostic MS
Table 6-47: Areas Using MS (Neonatal/ pediatrics/ metabolic diseases, Steroids/ endocrinology, Therapeutic drug monitoring, Vitamin D, Toxicology, Microbiology/ infectious diseases, Amino acids, Cancer/ oncology, Cardiovascular, Vitamin B12, Nephrology, Genetic testing) for Regulated Patient Samples
Figure 6-28: Areas Using MS (Neonatal/ pediatrics/ metabolic diseases, Steroids/ endocrinology, Therapeutic drug monitoring, Vitamin D, Toxicology, Microbiology/ infectious diseases, Other) for Regulated Patient Samples (% of Labs)
Table 6-48: Areas Using MS (Cancer/ oncology, Diabetes/ nephrology, Microbiology/ infectious diseases, Cardiovascular, Therapeutic drug monitoring, Immunology/ autoimmune, Neurology, Pediatrics/ metabolic diseases, Steroids/ endocrinology, Toxicology, Multiple sclerosis, Vitamin D, Aging, Environmental health, Forensic toxicology, Gastrointestinal, Genetic testing, Hepatology, Pharmacokinetics, Preeclampsia, Sickle cell) for Non-Regulated Patient Samples
Figure 6-29: Areas Using MS (Cancer/ oncology, Diabetes/ nephrology, Microbiology/ infectious diseases, Cardiovascular, Therapeutic drug monitoring, Immunology/ autoimmune, Neurology, Pediatrics/ metabolic diseases, Steroids/ endocrinology, Toxicology, Multiple sclerosis, Vitamin D, Other) for Non-Regulated Patient Samples
Table 6-49: Number of MS Samples per Month
Figure 6-30: Number of MS Samples per Month
Table 6-50: Non-Patient Samples, Out of Total (2013)
Figure 6-31: Non-Patient Samples, Out of Total (2013)
Table 6-51: Non-Patient Samples, Out of Total (2014 est.)
Figure 6-32: Non-Patient Samples, Out of Total (2014 est.)
Table 6-52: Non-Regulated Patient Samples, Out of Total (2013)
Figure 6-33: Non-Regulated Patient Samples, Out of Total (2013)
Table 6-53: Non-Regulated Patient Samples, Out of Total (2014 est.)
Figure 6-34: Non-Regulated Patient Samples, Out of Total (2014 est.)
Table 6-54: Regulated Patient Samples, Out of Total (2013)
Figure 6-35: Regulated Patient Samples, Out of Total (2013)
Table 6-55: Regulated Patient Samples, Out of Total (2014 est.)
Figure 6-36: Regulated Patient Samples, Out of Total (2014 est.)
Table 6-56: Challenges for Adoption/ Growth of Diagnostic MS
Figure 6-37: Challenges for Adoption/ Growth of Diagnstic MS (% of Labs)
Table 6-57: Improvements/ Changes Wanted by Labs
Figure 6-38: Improvements/ Changes Wanted by Labs (% of Labs)
Table 6-58: Most Important Trends in Clinical MS
Figure 6-39: Most Important Trends in Clinical MS
Table 6-59: MS Systems Considered Most Appealing (% of Responses)
Table 6-60: Brands of Systems Considered Most Appealing
Figure 6-40: Brands of Systems Considered Most Appealing (% of Responses)
Table 6-61: Brands of Systems Considered Most Appealing by Regulated/Not Regulated
Table 6-62: Brands of Systems Considered Most Appealing by Regulated/Not Regulated (% of Responses)
Table 6-63: Future Purchase Time Frame
Figure 6-41: Future Purchase Time Frame (% of Labs)

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