Led by tissue tests to aid drug therapy decisions, the personalized medicine testing market exceeded $28 billion in 2011, according to Kalorama Information. The healthcare market research publisher includes in its analysis all tests that are used to determine the appropriate therapeutic on an individual patient.

This broad scope includes new molecular tests based on proven biomarkers, as well as routine glucose and microbial identification tests. The dynamic part of the market is the new tests, and according to Kalorama's report, "World Market for Personalized Medicine Diagnostics," the tests that have turned personalized medicine from concept to reality are tissue tests that determine therapy for cancer. These will experience better than average IVD industry revenue growth rates in the next five years.

"Tissue-based diagnostic testing continues to serve as one of the gold standards for cancer diagnosis," said Shara Rosen, lead diagnostic analyst for Kalorama Information and author of the report. "There is no other technology that can capture the biological context of the disease and the critical parameters that factor into patient outcomes."

From a biopsy, a pathologist can determine the type of cancer, the stage and the degree to which the cancer has invaded healthy tissue. Personalized tissue-based tests using immunohistochemical stains (IHC) and in situ hybridization (ISH) allow pathologists and researchers to view specific protein and molecular structures in fixed tissues, body fluids, and cells.
 
To improve patient survival rates, therapies in the oncology marketplace are being combined with predictive biomarkers to help select patients who will respond to specific drugs. The report finds that tissue diagnostics will be in high demand and produce a robust market with many high growth opportunities.

Kalorama reports that the market leaders in what is often called pharmacodiagnostic histology are Dako, Abbott Diagnostics and Roche/Ventana Medical. China Medical is dedicated to making locally produced pharmacodiagnostic histology available.

The report notes that the application of pharmacodiagnostic histology is becoming more sophisticated. Many of these tests are used as companion tests for targeted drugs and also in test services. In addition to the standard IHC and ISH staining procedures, DNA and RNA extracted from tissue samples are further analyzed using mass spectroscopy, PCR and sequencing. As more is understood about radiation therapy, tests have also been developed to assess radiosensitivity of tumors.