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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

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October 28, 2010 Posted by | Academia & Non-Profit, Corporate, Labwork & Science | , , , , | Leave a comment

Companion diagnostics ready to soar

As I’ve worked with companies putting together the next installment in our Trends in Cancer Research series, I’ve learned that pharma seems to be realizing that it needs to collaborate with diagnostic companies to stratify patients and to make safer, more effective drugs.

The development of companion drugs and diagnostics has the potential to improve treatment outcomes, enhance patient compliance with prescriptions and eliminate the need for insurers to pay for expensive therapies that often prove to be ineffective.

And the available information on biomarkers that indicate whether a therapy could work on a particular individual continues to grow rapidly.

Still, it can be a daunting task to develop drugs and companion diagnostics.

One company—Eli Lilly & Co.—has announced plans to build a diagnostics capability. A big part of the company’s innovation strategy is providing improved outcomes for individual patients—which it says can be achieved through tailored therapies.

Several technologies exist that enable the development of biomarkers into companion diagnostics. PCR, microarrays and expression profiling are being used to improve the sensitivity and selectivity of companion diagnostics. Next-generation sequencing and proteomics are two other growing areas of interest.

Biomarkers that are validated have the ability to lead to safer and more effective products, especially when developed into a companion diagnostic.

There certainly are challenges, such as identifying the right biomarker early in the discovery process; developing a robust biomarker assay in advance in the clinic; developing companion diagnostics well before reaching Phase III trials; and gaining approval of a drug and diagnostic at the same time.

An example of just how far this area has come is the World Companion Diagnostics Summit—to be held Dec. 1-2 in Boston. The summit will be addressing exactly these most crucial challenges, and has been developed in collaboration with the companion diagnostic pioneers from Roche, Genentech, Johnson & Johnson, AstraZeneca, Bristol-Myers Squibb, Novartis, Pfizer, Amgen, Abbott, Qiagen and Dako.

According to the website, the meeting has “evolved from the urgent need for those committed to personalized medicine to come together and share expertise that will underpin the path for making companion diagnostics a reality.”

Workshops will be held Nov. 30 and Dec. 3.

The summit will provide the scientific community an opportunity to have an open discussion of strategies for developing companion diagnostics and making strides in the quality and efficacy of research results. In the end, hopefully, we will all be winners.

(Note: If your company or institution is doing pharma or biotech research and development the oncology arena and would like to serve as a source for the last installment in ddn’s Trend in Cancer Research series, contact David Hutton at hutton@drugdiscoverynews.com.)

September 27, 2010 Posted by | Corporate, Dealmakers | , , | Leave a comment