Market Research Logo

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


Attention: There is an updated edition available for this report.

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


  • Executive Summary
    • MAIN CONCLUSIONS OF THE REPORT
  • Introduction
    • ADVANTAGES OF MASS SPECTROMETRY
  • Market Trends
    • MALDI-TOFREVOLUTIONIZING MICROBIOLOGY TESTING
    • RAPID TECHNOLOGICAL ADVANCES IN MS SYSTEMS
    • REGULATORY HURDLES BEING ADDRESSED, OVERCOME
    • CLINICAL LABS INCREASINGLY DRIVEN TOWARDS MS
    • INCREASE IN THERAPEUTIC DRUGMONITORING AND DRUGS OF ABUSE
    • GRADUAL EXPANSION OF NEWBORN SCREENING
    • RECENT PRODUCT INTRODUCTIONS
  • 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
    • DEALS
      • Table Key Deals in Recent Years Related to MS Technology in Clinical Applications
  • Revenues Forecast & Competitive Analysis
    • Table Clinical MS Revenues Forecast
    • COMPETITIVE ANALYSIS
    • MARKET SHARE BY VENDOR
      • Table Clinical MS Market Share by Supplier
    • MARKET SHARE BY PRODUCT
      • Table Market Share of Clinical MS Systems by Product (MALDI-TOF, triple quad, QTRAP, ion trap, GCMS, Orbitrap & ion-Orbitrap, QTOF, Other)
  • End-User Survey
    • DEMOGRAPHICS
      • Table Lab's Main Specialization(s)/ Discipline(s)
      • Table Lab's Main Specialization(s)/Discipline(s) by Regulated/Not Regulated
      • Table Lab's Main Specialization(s)/Discipline(s) by Regulated/Not Regulated (% of Systems)
      • Table Labs' MS Usage for Regulated Diagnostics
      • Table Distribution of Industry/ Segment
      • Table Distribution of Industry/ Segment by Regulated/Not Regulated
      • Table Distribution of Industry/ Segment by Regulated/Not Regulated (% of Labs)
      • Table Distribution of Lab Function(s)
      • Table Lab's Function(s) by Regulated/Not Regulated
      • Table Lab's Function(s) by Regulated/Not Regulated (% of Labs)
      • Table Number of Personnel Working in Lab
      • Table Position/ Role in Laboratory
      • Table Overall Regional Distribution (United States, Europe, Canada, Australia)
      • Table United States Regional Distribution
    • SYSTEMS
      • Table Brands of MS Systems Used in Labs
      • Table Brands of MS Systems Used by Regulated/Not Regulated
      • Table Brands of MS Systems Used by Regulated/Not Regulated (% of Systems)
      • Table 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
      • Table 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 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 Triple Quad Systems by Brand (% of Systems)
      • Table Ion Trap Systems by Brand
      • Table MALDI-TOF Systems by Brand
      • Table GC-MS Systems by Brand
      • Table Q-TOF Systems by Brand
      • Table Types of AB Sciex Systems (QTRAP, triple quad, triple TOF, MALDI-TOF/TOF, MALDI TOF, QTOF, N/D) Used in Labs
      • Table Types of AB Sciex Systems (QTRAP, triple quad, triple TOF, MALDI TOF, QTOF, MALDI-TOF/TOF, N/D) by Regulated/Not Regulated
      • Table 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 Types of Agilent Systems (GC/MS, triple quad, ion trap, QTOF, ICPMS) Used in Labs
      • Table Types of Agilent Systems (GCMS, triple quad, ion trap, QTOF, ICPMS) by Regulated/Not Regulated
      • Table Types of Agilent Systems (GCMS, triple quad, ion trap, QTOF, ICPMS) by Regulated/Not Regulated (% of Systems)
      • Table Types of Bruker Systems (MALDI TOF, ion trap, MALDI-TOF/TOF, FTICR, QTOF, MALDI-TOF) Used in Labs
      • Table Types of Bruker Systems (MALDI TOF, ion trap, MALDI-TOF/TOF, FTICR, QTOF) by Regulated/Not Regulated
      • Table Types of Bruker Systems (MALDI TOF, ion trap, MALDI-TOF/TOF, FTICR, QTOF) by Regulated/Not Regulated (% of Systems)
      • Table 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
      • Table 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 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 Types of Waters Systems (triple quad, QTOF, ion mobility, N/D, isotope ratio MS, GC-TOF) Used in Labs
      • Table 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 Types of Waters Systems by Regulated/Not Regulated (% of Systems) and by Type (triple quad, QTOF, ion mobility, isotope ratio, GCTOF, N/D)
      • Table Models of AB Sciex Systems Used in Labs
      • Table Models of Agilent Systems Used in Labs
      • Table Models of Bruker Systems Used in Labs
      • Table Models of Thermo Systems Used in Labs
      • Table Models of Waters Systems Used in Labs
    • CLINICAL DIAGNOSTICS USAGE
      • Table Labs' Certification/ Accreditation for Diagnostic MS
      • Table 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
      • Table 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
      • Table Number of MS Samples per Month
      • Table Non-Patient Samples, Out of Total (2013)
      • Table Non-Patient Samples, Out of Total (2014 est.)
      • Table Non-Regulated Patient Samples, Out of Total (2013)
      • Table Non-Regulated Patient Samples, Out of Total (2014 est.)
      • Table Regulated Patient Samples, Out of Total (2013)
      • Table Regulated Patient Samples, Out of Total (2014 est.)
    • CHALLENGES FOR CLINICAL MS APPLICATIONS
      • Table Challenges for Adoption/ Growth of Diagnostic MS
    • IMPROVEMENTS/ CHANGES WANTED BY LABS
      • Table Improvements/ Changes Wanted by Labs
    • TRENDS
      • Table Most Important Trends in Clinical MS
    • FUTURE PURCHASES
      • Table MS Systems Considered Most Appealing (% of Responses)
      • Table Brands of Systems Considered Most Appealing
      • Table Brands of Systems Considered Most Appealing by Regulated/Not Regulated
      • Table Brands of Systems Considered Most Appealing by Regulated/Not Regulated (% of Responses)
      • Table Future Purchase Time Frame
  • Corporate Profiles
    • AB SCIEX (DANAHER CORPORATION)
    • AGILENT TECHNOLOGIES
    • BRUKER CORPORATION
    • PERKINELMER, INC.
    • THERMO FISHER SCIENTIFIC
    • WATERS CORPORATION
  • Challenges
    • EXPERTISE REQUIRED TO OPERATE SYSTEMS
    • AUTOMATION AND WORKFLOWS INSUFFICIENT FOR CLINICAL TESTING
    • NEED FOR ROBUSTNESS, RELIABILITY, REPRODUCIBILITY
    • HIGH SYSTEM COST CREATESMAJOR HURDLE
    • DIFFICULTY OF SCIENTIFIC AND REGULATORY PROCESSES, FUNDING
    • NGS BOTH A DRIVER AND COMPETITOR OF MS
    • BIOMARKERS PROGRESSING SLOWLY TO DIAGNOSTICS
    • UNCERTAINTY REGARDING REGULATION OF LDTS
  • Strategic Recommendations
    • IMPROVE AUTOMATION CAPABILITIES AND EASE-OF-USE
    • EXPAND INTO REAGENTS AND OTHER CONSUMABLES
    • POSITION FOR MORE RAPID INTERNATIONAL GROWTH
    • IDENTIFY AND TARGET NICHE APPLICATIONS
    • PROVIDE GUIDANCE ON BIOMARKER VALIDATION/ VERIFICATION
    • SACRIFICE FEATURES IN ORDER TO DROP PRICE
    • OFFER SOFTWARE FOR DIFFERENT SKILL LEVELS

Download our eBook: How to Succeed Using Market Research

Learn how to effectively navigate the market research process to help guide your organization on the journey to success.

Download eBook

Share this report