Molecular Diagnostics: Market Segmentation and Opportunities

DeciBio
May 19, 2011
56 Pages - SKU: DCB6358885


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.

Please note: the online download version of this report is for a Site License.


Additional Information

Exhibit 1: WW IVD market size (2007-13F)
Exhibit 2: WW IVD market by test type (2010E)
Exhibit 3: WW MDx market by therapeutic area (2007-13F)
Exhibit 4: MDx market drivers and moderators
Exhibit 5: Multiplex ability and sample throughput of current genomic technologies
Exhibit 6: WW MDx market by therapeutic area (2010E)
Exhibit 7: Infectious disease market segment size and growth
Exhibit 8: WW MDx market by number of analytes (2010E)
Exhibit 9: WW MDx market by test rationale (2010E)
Exhibit 10: MDx test rationales and examples
Exhibit 11: WW MDx market by test location (2010E)
Exhibit 12: WW MDx market by geography (2010E)
Exhibit 13: MDx revenue growth of selected MDx players
Exhibit 14: Advantages and disadvantages of partnerships
Exhibit 15: Selected MDx players
Exhibit 16: Selected MDx platform workflow capabilities
Exhibit 17: Key MDx opportunities and challenges for suppliers
Exhibit 18: Example companion diagnostic tests
Exhibit 19: Selected molecular signature MDx tests
Exhibit 20: Next generation sequencing methodologies
Exhibit 21: Past, current and projected sequencing cost per million base pair
Exhibit 22: Forecasted number of genome sequenced (2009-15)
Exhibit 23: Drivers and moderators of NGS use in clinic settings
Exhibit 24: Selected current and future NGS tests
Exhibit 25: Roche MDx platforms
Exhibit 26: Roche MDx assays

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