Since Kalorama Information last updated our comprehensive market report on cancer testing, changes in the industry abound. Developments that were novel two years ago such as the commercialization of service products , PGx testing and tissue microarrays are showing an increased presence. Some companies who promised much in the past have not produced results. And new entrants have entered the field.
These changes and more are addressed in Kalorama Information's Worldwide Market for Cancer Diagnostics, 4th. Edition. This report authored by Kalorama Diagnostic Analyst Shara Rosen, contains detailed market data on the following IVD segments for their use in cancer diagnostics:
Given the unfortunate statistics of cancer in the developed world, innovation is a must. Growth rates in cancer testing tends to be higher than in other IVD fields. Diagnostic tests for effective cancer screening are obviously needed more than ever. As cancer becomes more treatable, diagnostics are finding multiple expanded roles, including pharmacodiagnostics for matching the targeted treatment to the patient and ongoing disease monitoring as treatable cancer enters the realm of the chronic disease. Often these tests are commercialized as test services, a trend explored in the report.
Kalorama Information reports are always based on primary research of the market with particular attention to important market trends that are more important to understand than today's numbers. Shara Rosen not only defines the marketplace and provides market numbers, but her report also examines trends that are driving cancer testing now and determining where it will go in the future. Some of the trends examined in this report include:
Kalorama Information's Worldwide Market for Cancer Diagnostics, 4th Edition represents the fourth time Kalorama has engaged in an exhaustive study on the status of this important diagnostic market. The report contains scores of tables with data points that can be useful for marketing strategy, product development or business forecasting. Here are a sampling of the data points readers could find in this report:
This latest edition of Kalorama Information’s study takes a fresh look at all of these developments both qualitatively and quantitatively. The report provides revenue and growth forecasts through 2014 and, as in the previous edition, analyzes the market in two ways:
In addition to extensive reviews of products on the market and in development in each segment, the report provides detailed company profiles in three sections. The activities of the top IVD companies in cancer testing are presented in full, as are the activites of those 'status quo' companies who are leading in at least one segment. There is also coverage of the possible leaders of the future, the novel companies who have entered the market or developed a new approach. Companies profiled include the following:
All market data is based on factory sales to the end user and not retail pricing or reimbursement payments. For cancer testing, this means that the actual dollar market - that is what manufacturers earn from the sale of their products is undervalued. Market data is presented in dollar market size for categories of tests, and for specific analytes where possible.
The report discusses tests and technologies that are currently available and those that are expected to take their place. Generally, current products and technologies establish the standard of care and its value to payers. Many of the assays and imaging techniques presented in the report are expected to replace the standard of care in 2010, but with healthcare systems' emphasis on cost/benefit analysis for new technologies adoption, the market value and thus penetration capabilities of newer approaches may be limited.
The information presented in this report is derived on publicly available information sources such as company, government, and medical organization reports. The analysis is based on the author's industry knowledge combined with literature searches and interviews with industry professionals and experts in the areas of in vitro diagnostics, imaging industries and cancer specialists.
Biomarkers Seeing Increased, But Not Routine, use in Cancer Diagnostics
New biomarkers for cancer detection are emerging using several different approaches, and many of these technologies are still in the early phases of development. Protein and genetic biomarkers have long been celebrated as the future of personalized diagnostic medicine. They play an important role in detecting early forms of disease, in monitoring a patient’s disease and in response to therapy. However, biomarkers have a long way to go before they are routinely applied in clinical settings. The biomarkers below are the latest attempts:
In April 2007, the American Association for Cancer Research (AACR), the Food and Drug Administration (FDA), and the National Cancer Institute (NCI) formed a collaboration aimed at creating a regulatory pathway for biomarkers that establishes guidelines for taking biomarkers from the research phase through the FDA approval process and then on to use in clinical laboratories.
The Cancer Biomarkers Collaborative (CBC) is focused on developing recommendations on assay validation and bioinformatics that would integrate biomarkers into drug development and clinical trials. This initiative is expected to provide the standardization needed for the use of new biomarkers in the clinical lab.
Personalized Medicine and Cancer Diagnostics
New York, April 27, 2010 — 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.
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 make-up 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 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 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/test development points towards greater utilization of these products. The market leaders are histopathology IVD companies Dako, Ventana Medical, Roche Diagnostics and Third Wave Technologies 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 Dx-Rx partnerships. There are scores of Dx-Rx cancer co-development projects underway. Companies such as Qiagen/DxS (UK), MolecularMD (Portland, OR) and Roche/454 Life Sciences (Branford, CT) 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 said. “We expect pharmacogenomics, predisposition diagnostics and molecular diagnostics (PGx) to show 25 - 30% annual growth over the next 5-10 years.”
The report includes forecasts of several cancer testing market segments, detailed company profiles, trends and other information.
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