Clinical analysis has become a major segment of the tandem quadrupole LC/MS, as known as triple quadrupole LC/MS, market. While the majority of demand is from clinical research applications, tandem quadrupole LC/MS for clinical diagnostic use is beginning to overcome some of the barriers to widespread adoption. Clinical research applications are defined as those tests performed in a clinical or hospital lab setting. All of the major vendors are taking steps that will help expand demand.

Tandem LC/MS competes against techniques such as stand-alone HPLC and immunoassays for clinical analysis applications. Although modern LC/MS systems provide faster and more accurate analyses and require less reagents and other consumables, the up-front capital costs are high and the complexity of the technique can be intimidating to clinical chemists. In addition, in the diagnostic segment, the cost per assay is high compared with standard techniques. Such factors have presented barriers to adoption in clinical labs, particularly diagnostic labs.

Research applications have accounted for most of the clinical applications for tandem quadrupole LC/MS, as regulatory barriers have limited the use for diagnostic applications. One of the first major diagnostic applications for the technique was newborn screening, which developed in the mid-1990s. The application is now widespread for any one of dozens of potential disorders, although the potential demand is much larger, and continues to grow quite rapidly. Other clinical applications of tandem LC/MS include the analysis of vitamin D deficiency and endocrinology.

The demand for tandem quadrupole LC/MS for clinical applications, including research and diagnostics, has grown to a nearly $80 million market. Although clinical research accounts for the largest portion of the market, diagnostics is becoming a higher percentage due to regulated tests as well as lab developed tests.

Tandem LC/MS vendors have been gaining regulatory registration and approval of their manufacturing facilities, systems and related products for diagnostic applications, which will help contribute to future market growth. Although research applications will continue to see solid growth in demand, it is the diagnostic side of the clinical market that is poised to be a major driver of the tandem LC/MS market.

AB SCIEX is the largest supplier of tandem LC/MS systems. It was the last of the three largest vendors to gain ISO 13485 certification of its MS manufacturing facilities. Waters is the largest competitor on the diagnostics side of the clinical market, with its triple quadrupole LC/MS systems sold by PerkinElmer for newborn-screening applications. Waters also directly sells its systems for a variety of other clinical research and diagnostic applications. In January, Agilent announced that it registered all of its 6000 Series LC/MS systems as Class I medical devices with the FDA (see IBO 3/31/12).

Clinical Analysis Tandem

Quadrupole LC/MS at a Glance:

Leading Suppliers

• AB SCIEX

• Waters

• Agilent Technologies

Largest Markets

• Drug/Toxicology

• Endocrinology

• Newborn Screening

Instrument Cost

• $200,000–$500,000