An Array of Diagnostic Information at Your Fingertips
Diagnostics companies sell instruments and tests for the analysis of the diagnosis of a disease or condition. At roughly 6%, spending on diagnostics is still a small part of overall health care expenditure, though it has a disproportionate impact as the results of testing inform roughly 75% of health care decisions. It is therefore a high value-add activity.
Diagnostics (Dx) is a roughly $50 billion annual industry growing in the mid-single digits annually. Dx has numerous sub-segments with differing rates of growth. In vitro diagnostics, a roughly $33 billion sub-market of Dx, are tests performed outside of the body. Within the in vitro diagnostics market, molecular diagnostics (MDx) is the fastest growing Dx segment, at a roughly 16% compound annual growth rate (CAGR), and it is estimated that it will reach more than $5 billion by 2010. Molecular–based testing has potential for significantly improved clinical sensitivity and specificity by detecting microorganisms, cancer cells, bacteria, and viruses based nucleic acid sequences.
Key sub-markets within molecular diagnostics include infectious disease, pharmacogenomics and oncology testing. Akonni is currently developing new assays on using its TruDiagnosis System approach to address market needs in these areas.
Detection and screening for infectious diseases is the largest and one of the most established sub-markets within molecular diagnostics, growing at 15% CAGR and expected to reach $2,590 million in 2010. Across the board there is an increasing desire to use molecular methods to screen, detect and study infectious diseases, like drug resistant Tuberculosis, MRSA, Influenza and Encephalitis.
One of the great promises of molecular diagnostics is that it will enable an era of “personalized medicine,” and nearly everyone’s definition of that term includes therapy chosen tailored to an individual’s genetic makeup. This is also known as “pharmacogenomics,” and has been a fast-growing area as the cost of testing has decreased and the knowledge of gene–disease associations has increased. Pharmacogenomic testing is already in use for some expensive cancer drugs, the best well known of which is Herceptin. In individuals with a certain mutation, EGFR inhibitors are ineffective, meaning those patients will not benefit from treatment with drugs like Erbitux (cetuximab). The use of genetic markers for prescribing and dosing not only aids patient outcomes, but also payers are in favor because it reduces the wasteful use of expensive medicines.
Diagnosis of and screening for cancer is one of the fastest growing areas of MDx, growing at a projected 27% CAGR and expected to reach $600 million annually by 2010. As cancer is a common yet dangerous condition, screening and early diagnosis are very important. Older cancer screening techniques, like pap smears for cervical cancer, film mammography for breast cancer, and PSA testing for prostate cancer, are all less sensitive and specific than newer techniques like HPV screening, tomosynthesis, and PCA3.
Screening and early diagnosis for diseases like Alzheimer’s and cardiovascular disease is becoming increasingly important in managing patients and health care costs. Through molecular–based testing, there is potential for significantly improved clinical sensitivity and specificity in the early detection of such diseases based on nucleic acid or protein markers.