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Mass Spectrometry in Clinical Applications (MALDI-TOF, Triple Quad, QTRAP, Ion Trap, GCMS, Orbitrap & Ion-Orbitrap, QTOF, Other Mass Spec)

$1,995.00 – $3,990.00

SKU: KLI5235894 Categories: , Pages: 250

Description

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.

The report includes profiles of the following companies:

  • AB Sciex (DANAHER CORPORATION)
  • Agilent Technologies
  • Bruker Corporation
  • Perkin Elmer
  • Thermo Fisher
  • Waters Corporation

Table of Contents

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 & 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 & 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 & 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 & 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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