The 2007 worldwide market for molecular assays was estimated at $3.7 billion by Kalorama. The market will grow 11% annually and should reach $6.2 billion in 2012. This segment includes routine areas such as blood screening and also newer areas of testing such as pharmacogenomics and inherited disease testing, which will experience far greater growth rates—35% and 25%, respectively, during this period.
The market estimate also covers market-authorized assays and reagents. In-lab developed tests, so called home-brew tests, which account for a large portion of this IVD segment, are not included. The increased market penetration of molecular assays should decrease the cost of commercialized kits, which, combined with the need for standardization, will make commercial kits more attractive, especially for small labs.
Microorganism testing continues to comprise a large part of the IVD market, and molecular testing accounts for most of the growth in this segment. In 2007, molecular tests were in the growth mode, however by 2012, because of advances in technology, these tests may begin to mature, and therefore, test prices will decrease.
For the major test segments—infectious diseases and oncology—where traditional immunoassays dominate, molecular assays have captured less than 20–30% of market share. It is expected that by 2015 molecular assays will have increased market penetration at the expense of incumbent techniques.
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.