DeciBio Insights

MDx Market Size, Growth and Trends

Clinical Diagnostics

Content of the 3rd Edition of our Molecular Diagnostics (MDx) Report

LOS ANGELES, CA (DeciBio – May 19th, 2011) – Today, DeciBio published the third edition of its “Molecular diagnostics: market size, segmentation, growth and opportunities” report. Molecular diagnostics (MDx) is a class of in vitro diagnostic tests that identify nucleic acids such as DNA or RNA. These nucleic acids vary in nature; they can be genetic material of foreign organisms (e.g., HIV infection) or genetic markers of individual patients (e.g., Her-2 overexpression in breast cancer). In the last 5 years, MDx has experienced double digit growth, driven by these tests high sensitivity, fast turnaround times and relatively low-cost compared to culture-based or immune-based techniques. MDx involves platforms and assays that leverage multiple technologies, including PCR, qPCR, TMA, FISH, hybrid capture, CE sequencing, next generation sequencing and microarrays.

From a market perspective, MDx is the fastest growing segment of the in vitro diagnostics (IVD) industry. With an estimated market size of ~$4.8B in 2010, and growth rate of 10-20% depending on segments, this attractive market continues to be a major contributor in the evolution of the healthcare landscape.

This report reviews the market size, segments, growth and opportunities of the MDx industry from 2007 to 2013. The market is segmented to provide insights on specific growth opportunities by therapeutic areas, analytes tested (i.e., plex level), test rationale, test location and geography. Factors driving growth in each of the segments are reviewed. In addition, this report explores thirteen opportunities and challenges facing the MDx industry. Some emphasis is placed on molecular signature MDx tests (e.g.,Oncotype Dx, Mammaprint, Allomap, CorusCAD, PreDx, Prolaris).

Competitors shaping the industry include BioPharma (e.g., Abbott, Roche), IVD/MDx pure-play companies (e.g., BioMerieux, Cepheid, Gen-probe) or research tool companies (e.g., Illumina, Life Technologies). Major competitors are reviewed along with their key platforms.

This third edition adds a novel 9-pages section on the adoption of next generation sequencing (NGS) in clinical settings. “Many experts expect whole genome and exome diagnostics to become the most universal and cost-effective test for diseases with genetic components in the near future” said Stephane Budel, a managing partner with DeciBio. He added “In this report, we review the NGS tests that are currently available – offered by companies such as GeneDx, Correlagen and Ambry Genetics – and review nine factors that will drive and gate further adoption of this technology.”

Authors: Stephane Budel, Partner at DeciBio, LLC

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