Because of its high incidence and mortality rate, cancer ranks high on the list of the world's deadliest and costliest diseases. Around the world, only cardiovascular disease ranks higher than cancer as a cause of death. The World Health Organization (WHO) estimates that 25 million people have cancer in Japan, Europe and North America with an additional 10.1 million cases diagnosed worldwide each year. By 2020, the WHO estimates that number will grow to 15 million new cases every year.
The patterns of cancer incidence around the world vary in the economic developing versus developed world. In developing countries, cancers of the mouth, pharynx, larynx and esophagus, and of the stomach, liver and cervix are most prevalent. Developed countries tend to have higher rates of colon and rectal cancer, as well as hormone-related cancers including of the female breast, the endometrium and the prostate. Lung cancer, whose primary cause is tobacco, is the leading cause of cancer worldwide.
With such an increasingly prevalent disease, it is not surprising that the overall market for cancer in vitro diagnostics (IVDs) is growing at an annual rate of 13 percent according to a recent market report "The Worldwide Market for Cancer Diagnostics" from Kalorama Information. In 2004, the worldwide market for IVDs used on a routine basis was $4.1 billion. But an aging population, along with advancements in technology, will fuel growth in the diagnostics sector to an estimated $7.4 billion by 2009, the report states.
Fewer than half of new cancer cases—4.7 million per year—are diagnosed in the seven leading countries: France, Germany, Italy, Japan, Spain, the United Kingdom and the United States. Yet these countries account for 85 percent of sales, showing that the market for cancer testing is focused in the developed world. North America, with only 5 percent of new cancer patients worldwide, accounts for nearly 44 percent of the worldwide cancer diagnostics market.
The more traditional diagnostic methods for detecting cancer—histology/cytology and immunoassays—comprised 75 percent of total sales of IVDs in 2004. With the cancer rate growing, these methodologies will continue to grow at 11 percent and 13 annually through 2009. But these methodologies will see an erosion of market share as newer, emerging technologies slowly gain a diagnostic foothold.
Molecular assays, tissue assays and pharmacodiagnostics will lead the way among new diagnostic techniques. Totaling sales of just $11 million in 2004, less than 2.5 percent of the total market, Kalorama forecasts these methods will boast sales of $480 million by 2009.
The report does point out, however, that many of the newer test modalities are not yet used in routine testing. It also points out, however, that "most cancer diagnosis and treatment activities can still be considered in the realm of research because investigators have just touched the tip of the iceberg in understanding how cancer develops."
Development of these new diagnostic methods, according to Kalorama, are related to two significant scientific and research advancements of the 20th century: the Human Genome Project and bioinformatics. These "are providing the building blocks of a medical revolution in the diagnosis, treatment and monitoring of cancer."
Some trends anticipated to impact the market in the coming years include healthcare organizations bringing early diagnostics to the community rather than waiting for people to seek help and a resultant response by the industry to develop point-of-care lab tests and imaging equipment designed for use outside the hospital. Research derived from the Human Genome Project should lead to new therapeutics that will further cut the morbidity and mortality rate of cancer. But the use of genetics in the evaluation of patients at risk for cancer is still developing.
Potential negative impacts to the cancer diagnostics market come primarily in the form of who will pay. Kalorama refers to the commercialization of newer, more sophisticated cancer tests as a "two edged sword" since many of these new devices and technologies will carry a hefty price tag that the payment systems might not choose to cover. That means the responsibility will fall on the manufacturers to prove not only that their intervention methods are effective, but that they also can help supply a cost-effective alternative.