July 2011 Clinical Laboratory News: News Brief

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July 2011: Volume 37, Number 7

Forecast: Robust Market for Molecular Diagnostics

A new report released by Kalorama Information predicts the world market for molecular diagnostic tests will grow 11% annually, reaching $8.085 billion U.S. dollars in 2015. Back in 1995, the market for these nascent tests was estimated to comprise just 2% of the total in vitro diagnostic (IVD) market or $360 million. Today that number stands at $4.765 billion.

The report, “The World Market for Molecular Diagnostics,” highlights the primary growth drivers for molecular diagnostics, and describes challenges facing the IVD industry in the future. The authors call the track record for molecular diagnostic testing a testament to innovation.

The report attributes the continued growth in the market to the introduction of numerous assays over the past 5 years, as well as publication of the Human Genome Project and advances in functional genomics, bioinformatics, miniaturization, and microelectronics. At the same time, demand for testing has been fueled by an increase in cancer patients, proliferation of infectious diseases and growing interest in parental gene carrier analysis.

Especially notable is the fact that many of these complex tests have been commercialized as proprietary lab-developed tests offered by reference labs and company-sponsored lab services.

But major challenges obstruct use of molecular diagnostic assays, including getting stakeholders, payers, physicians, researchers, and regulators to work together to close the gap between research and clinical applicability. Physician education is also lacking, and reimbursement problems threaten further implementation of these tests.

The report also provides a snapshot of today’s market share. While some 350 companies are actively involved in molecular diagnostics, most hold tiny fractions of the market. The major players are Roche Diagnostics with an estimated 15% market share, followed by Abbott and Gen-Probe with 8% each.

The full report is available for purchase online.

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