Molecular diagnostics primarily refers to a class of diagnostic test that analyzes nucleic acids or proteins at a molecular level. This class of diagnostics is identified as rapidly evolving and fastest growing segment of in-vitro diagnostics industry. Moreover, it is also considered as the most attractive and well established market for clinical applications. Traditionally, usage of molecular diagnostics was limited due to requirement of highly skilled professionals and high cost of tests. But reduction in cost per sample analysis and labor cost, improvements in automation and introduction of advanced technologies has expanded the usage of molecular diagnostics in wide range of applications. The market for molecular diagnostics has expanded since 1990’s with the introduction of PCR test for HIV and Chlamydia Trachomatis/Neisseria Gonorrhoeae (CT/NG). It is estimated that in the U.S. over 600 laboratories and 200 independent laboratories perform molecular diagnostics test to simplify and accelerate the testing process.
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Nowadays, molecular diagnostics tests are widely being adopted for testing infectious diseases (HIV, HCV, HPV HAI and others), genetic diseases, cancer testing and HLA testing. Similarly, molecular diagnostic kits are being used for blood donor screening and pharmacogenetics testing. Growth of this market in various segments is fuelled by the rise in incidence of chronic infections, growing geriatric population, increasing investments in R&D and increasing demand for personalized medicines. Currently, molecular diagnostics revenue is dominated by infectious diseases, capturing more 50% of the market share. Furthermore, growth of this segment will be triggered by rising incidences of hospital acquired infections (HAI) and thus HAI testing market is expected to witness a fastest growth rate in near future. This market is poised to grow at a CAGR of 15.1% from 2013-2019. HAI is being identified as a major cause of death and morbidity among hospitalized patients. It is estimated that each year approximately 14,000 Americans are diagnosed with C.difficile hospital acquired infection each year. Therefore, hospitals continue to adopt HAI testing as more virulent strains of these infections continue to surge. Similarly, rising cancer incidence is expected to drive the market for oncology testing and HPV testing during the analysis period.
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Next generation sequencing is growing rapidly and is estimated to emerge as the fastest growing segment. The technique is gaining importance owing to its rapid turnaround time, sensitivity and reduction in cost of sequencing. PCR market that accounted for a maximum share of the total molecular diagnostics market in 2012 is estimated to decline due to evolution of high throughput sequencing techniques.
Geographically, North America and Europe are most advanced markets in terms of adoption of molecular diagnostic testing and hence account for the majority of the market share. Growth in these regions is driven due to presence of large pool of research laboratories and increased level of public awareness. Moreover, growth in these regions in near future will be driven by growing demand for point of care testing. However, Asian region is expected foresee a high growth during the forecast period of 2013 to 2019. The growth in this region is expected to be fueled by rise in cancer incidence, expanding population base, rising public awareness, and economic developments. Additionally, increased demand for personalized medicines and increasing investments in genomics and proteomics are some other key factors that are likely to propel the market growth in this region. Suppliers therefore can venture into these emerging nations to harness the potential growth opportunities in molecular diagnostics tests.
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Key players of this market include Abbott Laboratories, Roche Diagnostics, Novartis Diagnostics, Hologic Gen-Probe, Qiagen, and Cepheid among others.
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