Report: Cancer diagnostics market could hit $90 million by 2014

In our October issue, we’re continuing our special report series on trends in cancer research. This month, which is the third installment of a five-part series, discusses the challenges and rewards of developing companion diagnostics for cancer treatment.

To view the story, see “Two are better than one.” We also take a look at recent developments in the field of biomarker research in our story, “Biomarkers: How Good a Test Are They?”

Cancer treatment is one area where the era of personalized medicine is arriving, according to market research publisher Kalorama Information. In its recent report, “The Worldwide Market for Cancer Diagnostics,” Kalorama predicts a $90 million market for pharmacodiagnostics, tests that determine whether a treatment matches the individual patient, by 2014.

According to the report, the information gleaned from the Human Genome Project and pharmacogenomics research by the drug industry is making possible individualized drug therapy based on the genetic makeup of a patient. The concept has been talked about for some time, but Kalorama notes in its biennial review of the cancer testing market that with five U.S. Food and Drug Administration (FDA)-approved test and 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,” says 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 in-vitro diagnostic (IVD) companies for biomarker tools.”

The report says that while personalized medicine strategies are not new—it’s been eight years that Herceptin package inserts have labeled tests for therapy-responsive patients—the increase in drug and test development points towards greater utilization of these products.

According to Kalorama, histopathology IVD companies Dako, Ventana Medical, Roche Diagnostics and Third Wave Technologies (acquired by Hologic in 2008) lead the market 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 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 diagnostic/prescription partnerships. There are scores of these cancer co-development projects underway. Companies such as Qiagen/DxS, MolecularMD and Roche/454 Life Sciences launched CE Marked test kits in 2008 and 2009. These tests are performed using blood instead of biopsied tissue.

Kalorama believes 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,” Rosen says. “We expect pharmacogenomics, predisposition diagnostics and molecular diagnostics to show 25 to 30 percent annual growth over the next five to 10 years.”

In our November issue, we’ll examine the role of academic research in oncology. You can also view our previous reports:

Getting down to basics

Pharmacogenomics harnesses power of prediction, personalization

The big picture

Let’s work together

Alzheimer’s prevention: A call to arms

As our managing editor, Jeffrey Bouley, discussed last week, in our November issue we detail one group’s effort to develop to “launch the era of Alzheimer’s disease prevention research”—before another generation of patients is lost (see “An ounce of prevention”).

That effort, the Alzheimer’s Prevention Initiative, is a project launched by the Banner Alzheimer’s Institute, a nonprofit, collaborative research center in Phoenix.

Led by reknowned Alzheimer’s researchers Drs. Eric Reiman and Pierre Tariot, the API aims to test potential Alzheimer’s treatments and identify new biomarkers that could lead to earlier and more accurate diagnoses for Alzheimer’s patients.

Reiman and Tariot have been carrying the torch for Alzheimer’s disease prevention for many years. In the course of reporting on their work, Reiman shared with me an article they penned this year with colleague Jessica Langbaum that they consider “a call to arms.” The article, “Alzheimer’s Prevention Initiative: a proposal to evaluate presymptomatic treatments as quickly as possible,” was published in the Future Medicine journal, Biomarkers in Medicine.

The article contends that the evaluation of presymptomatic Alzheimer’s treatments must become an urgent priority, identifies what is holding us back and proposes new public policies and scientific strategies to overcome these roadblocks.

Here’s an excerpt from the piece:

“Alzheimer’s disease (AD) is an unacceptable problem. It takes a catastrophic toll on patients and family caregivers, and it is projected to have a financially overwhelming effect around the world in our children’s lifetime. In our opinion, the greatest roadblock in the scientific fight against AD is not necessarily the discovery of new treatments, but the means to evaluate them presymptomatically, when they may have their greatest impact, in a sufficiently rapid and rigorous way. It currently takes too many cognitively normal research subjects, too many years and too much money to evaluate more than a few presymptomatic AD treatments using clinical end points. Brain imaging and other biomarkers of AD progression and pathology have the potential to accelerate the evaluation of presymptomatic AD treatments. However, regulatory agencies are unlikely to provide accelerated approval for a presymptomatic AD treatment based solely on biomarker end points, without additional evidence from randomized clinical trials (RCTs) to conclude that a treatment’s biomarker effects are reasonably likely to predict a clinical benefit. In the meantime, sponsors are reluctant to conduct presymptomatic AD trials without a regulatory approval pathway. This dilemma may at first seem like an insurmountable ‘catch-22,’ leading to a sense of nihilism and a lack of urgency, but inaction is not an option.”

The article makes a compelling case for a sea change in the way scientists, researchers and pharmaceutical companies approach treating this devastating disease. To view the entire piece, please click here to download this PDF file: Reiman.