Molecular Diagnostics: Market Size, Segmentation, Growth and Opportunities

Molecular Diagnostics: Market Size, Segmentation, Growth and Opportunities


February 15, 2012
116 Pages - SKU: DCB3790026
License type:
Online Download      US $3,150.00
Global Site License      US $4,200.00
Molecular diagnostics (MDx) are a class of in vitro diagnostic (IVD) tests that identify nucleic acids, such as DNA. MDx tests may identify nucleic acids that are the genetic material of foreign organisms (e.g., HIV genotyping, MRSA screening) or the genetic markers of an individual patient (e.g., Her-2 overexpression for breast cancer, Factor V Leiden for coagulation). MDx tests continue to be the fastest growing segment within the IVD space, driven by high sensitivity, fast turnaround time, easy workflow and relatively low-cost compared to other techniques, such as culture-based or immune-based tests.

MDx involves platforms and assays that leverage multiple technologies to identify genetic variations. Technologies utilized include; PCR (e.g., HBV qualitative screening; Roche) qPCR (e.g., MRSA screening; Cepheid), TMA (CT/GC screening; Gen-Probe), FISH (PathVysion Her-2; Abbott), capillary electrophoresis (CE) sequencing (e.g., BRAC 1/2 testing; Myriad Genetics), next generation sequencing (Trisomy21 test; Sequenom), microarrays (Amplichip, Roche) and a host of other methods (e.g., pyrosequencing, bDNA, hybrid capture, hybridization beads, kPCR, electrochemical detection).

Analysis from this report indicates that the ~$5.9B MDx market (2011E) is expected to grow at >15% p.a. over the next 4 years, reaching $10.9B by 2015. MDx growth is expected to continue to be driven by increased incidence of chronic diseases due to an aging population, increased availability of various tests, and the further adoption of Pharmacogenomics / personalized medicine.

This report reviews the market size, growth, segments and trends of the MDx industry from 2007 through 2015. The market is segmented to provide insights on specific growth opportunities by therapeutic area (infectious diseases, oncology, HPV, others), technology (PCR, qPCR, TMA, hybrid capture, CE Sequencing, NGS, FISH, other), analytes tested (low and high plex level), test rationale (predisposition, screening, diagnosis, therapy selection, monitoring), test location (reference labs, academic hospitals, blood banks, other) and geography (U.S., Europe, Japan, rest of the world). Growth and growth drivers for each segment are quantified and reviewed.

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

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 opportunities and challenges in the MDx industry. In this fourth edition, we place an emphasis on NGS and its emerging adoption in clinical settings, as well as other emerging technologies (e.g., dPCR, CGH).

The report contains 116 pages and 33 figures.

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



More Diagnostics reports by DeciBio

Fluidigm Due Diligence: Company Profile and Market Opportunity by DeciBio
Fluidigm is a life science company that develops and distributes instruments, chips and reagents primarily for genomic analysis. The company owns a disruptive and scalable ...
Molecular Diagnostics: Market Segmentation and Opportunities by DeciBio
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 ...
Life Sciences Research Tools Market by DeciBio
This report provides an overview of the life sciences research tools market from 2005 to 2015. Life sciences research tools companies offer instruments and reagents ...
Qiagen Due Diligence: Company Profile, SWOT Analysis and Market Opportunity by DeciBio
Qiagen (NASDAQ: QGEN) develops and markets biological sample preparation and analysis products for academic, biopharmaceutical and molecular diagnostics companies. These products are considered gold standards ...
See all reports like this >>