World Market for Molecular Diagnostics Growing Rapidly

The molecular diagnostics segment is growing fast but not at the rate expected in 2007. Today around 350 companies are actively involved in the field but recently growth has been somewhat slower than originally anticipated due in part to the economic recession, a lack of trained lab technicians, and increasing costs.

The primary growth drivers in the molecular diagnostics market 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. Advances in cancer therapies and personalized medicine provide another reason for growth in the market for molecular tests and technologies.

In 1995, the molecular tests constituted 2% of the in vitro diagnostics (IVD) world market and that increased to approximately 10% in 2009.

The healthcare market research publisher Kalorama Information (New York, NY, USA) published a report that provides revenues and market forecasts, but also looks deeply at some of the trends in the market and what might impact results in the future. Kalorama forecasts an annual growth of about 11% in the molecular diagnostics segment through 2015. That is healthy growth, according to the report, but somewhat less than some of the extreme predictions in the media and among industry analysts of 20% or more.

"Molecular diagnostics—one of the fastest growing segments in diagnostics—is becoming the dominant platform in clinical medicine and it has made rapid and timely information about infectious diseases and bacterial infections a reality," noted Shara Rosen, RT, MBA, Kalorama Information's senior diagnostics analyst, and author of the report. "New molecular tests are being launched all the time, many of which are CE Marked and the US Food and Drug Administration (FDA; Silver Springs, MD, USA)-cleared."

However, the contribution that these tests can make to patient outcomes faces some barriers including reimbursement programs that still lag behind the speed of innovation, competition from test services in some segments, complexity, and limited quality control products and programs.

"One of the major challenges facing molecular diagnostics is getting stakeholders—including payers, physicians, researchers, and regulators—to work together to close the gap between research and clinical applicability," added Shari Rosen.

Related Links:
Kalorama Information
US Food and Drug Administration