U.S. Markets for Breast Cancer Detection and Diagnostic Technologies

Breast cancer is the second leading cause of death by cancer in women (surpassed only by lung cancer). According the American Cancer Society (ACS), approximately 192,370 women in the United States (U.S.) will be diagnosed with breast cancer and approximately 40,170 will die of the disease in 2009. According to the National Cancer Institute, in 2006 there were more than 2.5 million women in the U.S. with a family history of breast cancer. Over the next 25 years, it is projected that there will be more than 25 million new breast cancer cases diagnosed worldwide. The high number of women with breast cancer is noteworthy due to the fact that, while the disease is not always preventable, early detection may substantially increase the chances for survival, as nearly all breast cancers are treatable when detected early. Commonly, when symptoms of breast cancer appear, the tumor tends to be larger and more likely to have spread or metastasized. In contrast, early-stage breast tumors detected during screening examinations are more likely to be smaller and confined to the breast. Due to the fact that the size of a malignant lesion and how far it has metastasized are the most important factors in predicting the prognosis of breast cancer, early detection is critical and has the potential to save many thousands of lives each year.

In the U.S., more than $8 billion is spent to diagnose and treat breast cancer annually; however, not all women are able to afford, or have access to, early detection technologies recommended by ACS guidelines. The ubiquity of mammography units in clinics, hospitals, and physician offices as well as the growing availability of novel breast cancer imaging and testing technologies are driving the market for early-stage breast cancer detection and diagnostic technologies and products.

Increased mammography screening rates and funding to improve breast cancer detection methods are pivotal in increasing survival rates. Research has demonstrated that women who have not been screened one to three years prior to diagnosis were more than twice as likely to have late-stage breast cancer. However, despite the effectiveness of mammography in detecting early-stage disease, better screening methods need to be devised due to the rate of false-negative readings (it is estimated that nearly 40% of women with late-stage breast cancer had a negative screening 1 to 3 years prior to their diagnosis).

Early diagnosis is critical, as stage 0 (noninvasive) and stage I (early invasive) breast cancers are highly curable, posting average 5-year survival rates of 100%. In stage 0 breast cancer, malignant cells are present in the lining of a lobule or duct but have not spread to the surrounding fatty tissue. In stage I cancer, the malignancy has spread from the lobules or ducts to nearby tissue in the breast, the tumor generally is 2cm or less in diameter; and there has been no metastasis to the lymph nodes. In stage II cancer, in which the tumor is larger than 2cm but no larger than 5cm and has metastasized to the axillary lymph nodes, the 5-year survival rate is approximately 86%; however, for later-stage invasive cancers in which the disease has metastasized to the lymph nodes, the chest wall, or other sites such as the bones, brain, liver, or lungs, the 5-year survival rate drops to 57% for stage III cancer and 20% for stage IV disease.

Breast cancer survival rates continue to decline after 5 years from the time of diagnosis; however, over time, these rates tend to stabilize due in part to the availability in the U.S. of improved detection and treatment methods. Survival rates after 15 years from the time of diagnosis, however, remain the lowest and depend on the stage of the disease.