Molecular diagnostics (MDx) is a class of diagnostic tests that identify nucleic acids such as DNA. These nucleic acids 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 recent years, MDx has experienced fast growth, given 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 to identify genetic variations in individual patients. These technologies include qPCR, TMA, FISH, hybrid capture, 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 a double digit growth rate, this attractive segment continues to be a major contributor in the evolution of the healthcare landscape. The major factors driving growth include increased availability of various tests, increased incidence of chronic diseases due to an aging population and Pharmacogenomics/personalized medicine.
This report reviews the market size, growth, segments and trends 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.
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.
MDx is a highly regulated space. IVD instruments/assays are treated as medical devices and often require 510(k)/IVD clearance to gain full adoption in the marketplace. We briefly review the various level of clearance for MDx tests.
Finally, this report explores thirteen opportunities and challenges in the MDx industry. In this third edition, we place an emphasis on next generation sequencing and its emerging adoption in clinical settings.
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