IVD relies on a number of technologies to test for certain conditions, diseases and infections. Molecular diagnostic (MDx) tests use genomic and proteomic technologies for such analyses. The February 2014 Strategic Directions International report, “The Coveted Molecular Diagnostics Market: From Clinical Research to Diagnosis and Personalized Medicine—Innovative Technologies Break Through,” covers the use of nucleic acid amplification, DNA sequencing, MS and HPLC, among other techniques, as MDx technologies.

According to the report, the IVD market for instruments, consumables and services was valued at $50 billion in 2013, and new technologies and increased access to health care are expected to stimulate its growth. The MDx market is growing quickly, with clinical research applications contributing substantially to MDx growth via test, assay and instrument development. Instruments used in clinical research often make their way into the MDx market. Including clinical research, the total MDx market in 2013 was approximately $6 billion.

The use of HPLC in the MDx market is expanding rapidly. Detectors for HPLC include fixed- and multiple-wavelength spectrophotometric systems, fluorescence detectors and voltammetric systems. Although in MDx, MS is commonly used as the detector for HPLC, LC/MS is classified separately from HPLC in the report.

In 2013, the demand for HPLC in MDx and clinical research applications was about $130 million and $250 million, respectively. Although demand is expected to increase steadily in both segments over the next five years, with overall growth in the high-single to low-double digits, growth for MDx IVD applications is expected to outpace that of clinical research. This is driven in large part by the increase in technologies pairing HPLC with MS, for which the MDx market is expanding even more rapidly.

The aftermarket segment of HPLC, which includes columns, pumps, chemicals and other accessories, makes up the largest product share of the HPLC MDx market, followed by initial systems, at 47% and 44%, respectively. The report indicates that, although currently representing only a small portion of the market, service is projected to grow the most rapidly of the three segments over the next five years.

By region, the US and Canada constituted approximately 40% of the demand for HPLC in 2013 for combined clinical research and MDx, with Europe just a few percentage points smaller. According to the report, those regions will maintain roughly the same relative shares of the HPLC market and expand at similar rates over the next five years. However, over the same time period, China is predicted to lead Asia Pacific to the highest growth rate among regions.

The top two HPLC vendors, Waters and Agilent Technologies, together make up almost 50% of the HPLC MDx market. The companies also lead the HPLC market overall, including markets outside of MDx. The top four companies in the MDx HPLC market, of which Shimadzu and Thermo Fisher Scientific rank third and fourth, respectively, cover almost 75% of the MDx HPLC market. At positions five and six, Sigma-Aldrich and Merck KGaA, which together constitute approximately 10% of the HPLC MDx market, are primarily aftermarket companies.

Demand for HPLC comprises almost one-third of the over $1 billion market for MDx of metabolic disorders. An application of HPLC in MDx not specifically mentioned in the report is for testing levels of the A1c subtype of hemoglobin (HbA1c). HbA1c tests indicate blood glucose levels and are thus used in diabetes management and research. In this application, HPLC is used to separate hemoglobins from a patient’s blood.

As MDx applications for MS continue to grow and gain regulatory approval, the demand for HPLC will similarly grow. In addition, lab-developed tests (LDTs), which are for use only in the labs where they are developed and do not have FDA approval, are important in driving the market for HPLC in LC/MS systems. Triple-quadrupole LC/MS is currently the preferred method in clinical diagnostics for vitamin D testing. LC/MS systems are also used to detect amino acids, hormones and pain-management drugs in biological fluids such as plasma and urine. In addition, LC/MS analysis can detect metabolic diseases in newborns.

An example of such a test for clinical use is Quest Diagnostics‘ LC/MS test for detecting reoccurrence of cancer following surgery based on thyroglobulin levels. Further examples include ARUP Laboratories’ LC/MS tests detecting pain-management and other drugs in urine, serum or plasma and LabCorp’s tests to detect testosterone in saliva.