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
- 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