In its recent report, publisher Kalorama Information (New York, NY, USA) predicts a US$90 million market for pharmacodiagnostics, tests that determine whether a treatment matches the individual patient, by 2014. The information captured from the Human Genome Project and pharmacogenomics research by the drug industry is making possible individualized drug therapy based on the genetic composition of a patient. The concept has been discussed for some time, but Kalorama noted in its biennial review of the cancer testing market that with five U.S. Food and Drug Administration (FDA)-approved test/treatment products, including tests for Herceptin, Gleevec, Erbitux, and Tarceva, and with many others in development, pharmacodiagnostics has moved beyond the concept phase.

"Personalized medicine is not occurring overnight, but it is occurring,” said Shara Rosen, lead diagnostic analyst for Kalorama Information. "More and more physicians are using these tests, and more Pharma companies are getting involved and looking to IVD [in vitro diagnostic] companies for biomarker tools.”

The report noted that while personalized medicine strategies are not new--it has been eight years that Herceptin package inserts have labeled tests for therapy-responsive patients--the increase in drug/test development points towards greater utilization of these products. The market leaders are histopathology IVD companies Dako (Glostrup, Denmark), Ventana Medical (Tucson, AZ, USA), Roche Diagnostics (Basel, Switzerland), and Third Wave Technologies (Madison, WI, USA) with FDA-cleared tests. Oncotype DX was launched in the United States in 2004, where it has since been adopted as the standard of care for treating early-stage breast cancer. Oncotype DX is recommended in the guidelines of the American Society of Clinical Oncology (ASCO) and the U.S. National Comprehensive Cancer Network (NCCN), and is extensively reimbursed in the United States. Physicians use Oncotype DX to predict the likelihood of chemotherapy benefit, as well as the likelihood of recurrence, for patients with early stage breast cancer, in order to make individualized treatment decisions about the addition of chemotherapy to hormonal therapy.

By 2025, one in five new drugs could be labeled with a companion test, many of which will be cancer drugs, according to Kalorama. Many of the new companion tests are being developed as Dx-Rx partnerships. There are scores of Dx-Rx cancer codevelopment projects underway. Companies such as Qiagen/DxS (Manchester, UK), MolecularMD (Portland, OR, USA), and Roche/454 Life Sciences (Branford, CT, USA) launched CE Marked test kits in 2008 and 2009. These tests are performed using blood instead of biopsied tissue.

Kalorama analysts believe better-than-average growth levels will drive more companies to this area. "This trend to personalized medicine is expected to create a huge market for cancer diagnostics in combination with the commercialization of the therapy,” Ms. Rosen said. "We expect pharmacogenomics, predisposition diagnostics, and molecular diagnostics [Pgx] to show 25-30% annual growth over the next 5-10 years.”

Kalorama Information supplies independent market research in the life sciences, as well as provide custom research services.

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