Overall, clinical molecular testing remains a phenomenon of the developed world. Some industrialized second-tier countries such as Australia, Israel, Brazil, China, and India have strong molecular test industries. At least 80% of the molecular assays performed are concentrated in the developed world.
The European process of product regulation allows for easier entry of new technologies. Thus, in the short term—five years—more innovative molecular tests for cancer, cardiac disease, and pharmacogenomics and test platforms (arrays and biochips) come to the European market before North America.
Most of the research activity and innovation in molecular testing is focused on diagnosing, treating, and monitoring cancer. As more is known about disease processes, however, these tests are increasingly focused on chronic diseases such as neurological conditions, autoimmune diseases, diabetes, and cardiovascular diseases. A range of tests is now on the horizon.
The market for molecular tests is currently limited more by their utility than on the technology required to perform them. Almost daily, medical researchers announce their findings linking genes and gene sets to diseases, however, as yet these research findings have not been translated into many new useful diagnostic tests. Innovation is often stymied by utility and reimbursement, which go hand in hand.
Should this change, growth rates could eclipse what we’ve outlined. For the short term, however, growth of the market for molecular tests is driven by their potential in drug and medical research and the clinical market segment which will only increase as the value of nucleic acid diagnostic markers are developed.