Molecular diagnostics is one of those areas of healthcare where such bold predictions have been made that the resulting performance of test products and companies, which on their own could be considered revolutionary, have not always equaled the market’s imagination. Truth is, molecular products have met expectations and become dominant in some areas of medicine. In other areas, adoption is sluggish.
There are myriad challenges presented to companies operating in this market, as seen by the market share. While over 350 companies compete in the market, only a handful are dominant. The names that dominate molecular diagnostics in 2010 are not upstarts but familiar names: Roche, Abbott, Gen-Probe, Qiagen, BD, Siemens, and Cepheid.
Almost every day the discovery of new molecular markers for cancer, cardiac disease, diabetes, arthritis, neurological diseases, and psychiatric conditions are announced. More and more laboratories offer complex panels of tests that help physicians evaluate disease risk and make therapeutic decisions. Government and private healthcare payers have recognized the value of new molecular tools and have agreed to pay for them.
This renewed interest in IVDs in general and more particularly in molecular diagnostics has lead to the commercialization of a number of technological tools that make more sensitive and specific tests possible. Some of these technological innovations include: cost-effective, multiplexed testing platforms coupled with high-powered software capabilities. In addition analyses using saliva, urine, and blood instead of biopsied tissue make for more patient-friendly test systems.
Molecular diagnostics is becoming the dominant platform in clinical medicine and represents one of the fastest growing segments of the diagnostics market. It has emerged fully from research into clinical practice. Instrumentation now automates many of the sample-preparation and assay steps that were formerly labor intensive. New tests are being launched all the time.
Many molecular tests are CE Marked and FDA-cleared and many more are in development. The result is that molecular testing is indicated in many areas of healthcare including: cardiology, oncology, infectious diseases, inherited diseases, and disorders. Molecular assays have made rapid and timely information about infectious diseases and bacterial infections a reality.
On the business environment side, healthcare delivery trends and novel therapeutics help refocus the role of laboratory medicine in disease management to the patient by helping individualize diagnoses and treatments.
The primary growth drivers in the molecular diagnostics market overall, are the continued discovery of genetic markers with proven clinical utility, the increasing adoption of genetic based diagnostic tests, and the expansion of reimbursement programs to include a greater number of approved diagnostic tests. The most attractive growth areas are molecular tests for women’s health, infectious diseases, organ transplant testing, and oncology.
Molecular diagnostics is on an upswing. For the past five years the number of assays introduced has been growing at a remarkable clip. The track record for molecular testing is outstanding and a testament to the spirit of innovation in the IVD industry. In 1995 the world market for molecular tests was estimated at $360 million (2% of the market); this had grown to $940 million by 2000, $2,700 million by 2005, and $3,650 million in 2009 (10% of the market).
Kalorama Information estimates that the 2010 market for molecular (DNA) assays worldwide is estimated at $4,765 million. The market will grow 11% annually and will reach $8,085 million in 2015. That kind of growth is healthy and much faster than most of IVD. Yet, a few years ago there were predictions of twenty-something percent growth.