Boston, MA -- (SBWire) -- 11/19/2012 --Molecular diagnostics (MDx) is a new class of diagnostic tests that identify nucleic acids or proteins to test the status of a disease. These nucleic acids or proteins, which belong to individual patients or foreign organisms, help determine a specific therapy, or risk of developing a specific disease, or other health conditions. MDx is the fastest growing segment within the in-vitro diagnostic (IVD) space, driven by accuracy, high sensitivity, fast turnaround time, easy workflow, and cost-effective testing. Owing to these factors, the molecular diagnostics market crossed $4.8 billion in 2011, and is poised to grow at a CAGR of 9.1% in the next five years.
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MDx involves instruments and reagents that leverage multiple technologies to identify genetic variations. The technologies utilized in molecular diagnostics include polymerase chain reaction (PCR), transcription mediated amplification (TMA), hybridization (In-situ Hybridization & fluorescence in situ hybridization (FISH)), DNA Sequencing, next generation sequencing (NGS), microarrays, and others.
Molecular diagnostics has applications in infectious disease molecular testing, oncology, blood screening, genetic testing, DNA fingerprinting (e.g., paternity testing, forensic testing), microbiology, tissue typing, and food pathogen detection testing. The booming MDx areas are molecular tests for women's health, oncology, and organ transplant testing.
North America dominated the molecular diagnostics market in 2011; the U.S. is the prime market for molecular diagnostics companies due to the availability of government funds, rising incidence of chronic diseases related to the aging population, and high awareness of pharmacogenomics/personalized medicine. In addition, major local companies have easy access to this market, which makes the U.S. the largest and most significant market for suppliers. Europe is still suffering from the economic downturn and the Eurozone crisis and it is predicted that customers will delay purchases of capital equipments; this is expected to hamper the growth of this market, albeit for a short term. The Asian market, however, shows greater opportunities with the highest CAGR due to increased purchasing power, an emerging mindset toward wellness, preventive medicine, and increased access to cutting-edge products and services.
Factors like increase in awareness and acceptance of personalized medicine, advancements in molecular techniques, and increasing investments in genomics & proteomics research will spur the molecular diagnostics market in the future. Yet, reimbursement issues for non-coded tests and complex regulatory framework will restrict the growth of this market.
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