NEW YORK—Cancer treatment is one area where the era ofpersonalized medicine is arriving, according to market research publisherKalorama Information. In its recent report, "The Worldwide Market for CancerDiagnostics,"Kalorama predicts a $90 million market for pharmacodiagnostics,tests that determine whether a treatment matches the individual patient, by2014.
According to the report, the information gleaned from theHuman Genome Project and pharmacogenomics research by the drug industry ismaking possible individualized drug therapy based on the genetic makeup of apatient.
The concept has been talked about for some time, but Kalorama notes inits biennial review of the cancer testing market that with five U.S. Food andDrug Administration (FDA)-approved test and treatment products, including testsfor Herceptin, Gleevec, Erbitux and Tarceva, and with many others indevelopment, pharmacodiagnostics has moved beyond the concept phase.
"Personalized medicine is not occurring overnight, but it isoccurring," says Shara Rosen, lead diagnostic analyst for Kalorama Information."More and more physicians are using these tests, and more pharma companies aregetting involved and looking to in vitro diagnostic (IVD) companies forbiomarker tools."
The report says that while personalized medicine strategiesare not new—it's been eight years that Herceptin package inserts have labeledtests for therapy-responsive patients—the increase in drug and test developmentpoints towards greater utilization of these products.
According to Kalorama, histopathology IVD companies Dako,Ventana Medical, Roche Diagnostics and Third Wave Technologies lead the marketwith 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 treatingearly-stage breast cancer.Oncotype DX is recommended in the guidelines of theAmerican Society of Clinical Oncology (ASCO) and the National ComprehensiveCancer 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 breastcancer, in order to make individualized treatment decisions about the additionof chemotherapy to hormonal therapy.
By 2025, one in five new drugs could be labeled with acompanion test, many of which will be cancer drugs, according to Kalorama. Manyof the new companion tests are being developed as diagnostic/prescriptionpartnerships.
There are scores of these cancer co-development projectsunderway. Companies such as Qiagen/DxS, MolecularMD and Roche/454 Life Scienceslaunched CE Marked test kits in 2008 and 2009. These tests are performed usingblood instead of biopsied tissue.
Kalorama believes better-than-average growth levels willdrive more companies to this area.
"This trend to personalized medicine is expected to create a huge marketfor cancer diagnostics in combination with the commercialization of thetherapy," Rosen says. "We expect pharmacogenomics, predisposition diagnosticsand molecular diagnostics to show 25 to 30 percent annual growth over the nextfive to 10 years."