Cancer, with its high prevalence and mortality rate, continues to rank among the world’s deadliest and most costly diseases. According to the WHO, in 2003, about 25 million people live with cancer and nearly 11 million new cases are diagnosed each year.
With advances in protein and cell chemistry, genetics and molecular biology researchers are making continued progress in understanding the disease. Further, cancer drug research is moving from traditional cytotoxic chemotherapies toward higher specificity immunological and biological approaches that target unique biochemical receptors and signaling pathways. These new drugs will be more cancer- and patient-specific and will have the potential for slowing cancer growth and inhibiting disease progression, with fewer adverse effects on the patient. As these drugs come to market, in vitro diagnostics will become critical to matching drug to cancer and to patient and then the monitoring of the drug’s action on the disease.
It is anticipated that many of the newer test modalities such as microarrays (chips), mass spectroscopy protein patterns, amplification of tumor cell DNA and RNA, and others will piggyback onto these trends in cancer diagnosis and treatment. There is the expectation that they will make a huge difference in the diagnosis, prognosis, and monitoring of cancer patients. On account of these developments, cancer testing has brought new life to the diagnostics industry in the form of new tests, technologies, new companies and renewed investor interest.
However, there are obstacles to the successful commercialization of these tests. First, they carry a hefty price tag—anywhere from $350.00 to $3500.00. There is considerable skepticism over the ability of health care systems, worldwide, to pay for these new tests, which so far have shown little effect on patient outcomes. Second, the 1990s tremendous strides were made in cancer management using more traditional tests including tissue biopsies and serum assays, which means that penetrating the existing clinical market will be challenging.
Our research indicates that in the next few years some 50 immunoassays for new tumor markers, 20 or so biochip systems, 25 tests for genes and proteins in peripheral blood are near market. Not to be left behind, at least 25 new immunohistochemical and in situ hybridization assays will be introduced in the near future. There are even several point-of-care DNA analysis systems in development, and just about every major cancer treatment center and research group is working on gene and protein patterns for the early detection of cancer.
This report, written from the point of view of in vitro diagnostic modalities for the early detection of cancer and in particular solid tumors, thoroughly reports the demographics and epidemiology of cancer, reviews emerging technologies and products, quantifies existing markets (in terms of both cancer tests in traditional IVD segments AND IVD tests in different cancer segments), and forecasts likely clinical and business scenarios in this rapidly changing industry.
The crucial question the report endeavors to answer are: How will the market for this mix of new and older technologies evolve over the next 5 to 10 years? What forces will ultimately shape the cancer management practice of the future? And who will succeed in the marketplace?