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Report: Hologic, Abbott, Roche and Qiagen Lead Molecular Testing
Date:11/19/2015

NEW YORK, Nov. 19, 2015 /PRNewswire/ -- Although some 350 companies are actively involved in molecular diagnostics, the market is dominated by a few companies, according to Kalorama Information. These include Roche Diagnostics, Hologic, Abbott and Qiagen. These companies own 51% of the market share of the 6.1 billion-dollar molecular testing market, according to Kalorama's report, The World Market for Molecular Diagnostics.   

"The market is still controlled by one company and only a handful of companies can boast significant success," said Shara Rosen, RT, M.B.A., a Kalorama IVD analyst and the author of the report.      

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Kalorama Information Logo

The major player in the 2014 market is Roche Diagnostics with a fifth of the market and with double the share of its nearest competitor. The company has a broad product portfolio, which includes molecular diagnostic tests for oncology, virology, microbiology, and blood screening. The company's molecular test revenues are bolstered by the continued dominance of its Ventana Medical histology business. 

Molecular testing is a very small part of Abbott's IVD business, but the company is making an effort to increase its market presence. Abbott Molecular's portfolio of products includes products for histology, PCR assays and tests designed for the m2000, an automated system developed by Applied Biosystems (now Life Technologies).

In 2005, Qiagen began its transition to an IVD test company with the purchase of artus GmbH (Germany), an established leader in PCR-based molecular diagnostic tests for pathogenenic, genotyping and pharmacogenomic testing, for $39 million. Qiagen has added a number of other companies and is now developing a portfolio of tests in infectious diseases, cancer, transplant medicine, TB, liquid biopsy, sequencing, exosomes, information technology for test data interpretation and multiple collaborations.

In 2012 Hologic acquired Gen-Probe. Gen-Probe is a pioneer in molecular testing and has received over 40 FDA clearances for nucleic acid probe tests to detect a wide range of microorganisms, including those causing sexually transmitted diseases, tuberculosis, strep throat, pneumonia and fungal infections. Gen-Probe's revenues have been invigorated with the launch of its APTIMA line of reagents on the fully automated Tigris instrument. The company's molecular enterprise is focused primarily in infectious diseases and HPV. Hologic reported that the increase in its 2014 product sales was primarily due to an increase in the company's molecular diagnostic franchise and blood screening franchise primarily from Hologic's agreement with Grifols (March 2014) to provide blood screening products to the Japanese Red Cross Society.

Yet there could be a shake up in the market, as fast-moving companies such as Cepheid, Luminex and Fluidigm outpace growth of molecular testing giants. New technologies are also a factor.  Alere (Waltham, MA) is now making a mark in POC molecular testing with a CLIA waived and CE Marked test for influenza as well as market cleared POC tests for other infectious diseases.   Illumina's HiSeq and MiSeq systems are ubiquitous in clinical molecular labs and the release of market cleared test kits adds to the contribution.

The report, The World Market for Molecular Diagnostics, 6th Edition, includes market sizing and forecasts for eight categories of molecular tests as well as several segments. In addition the report contains trend analysis, strategic recommendations, analyst conclusions and company profiles of over 190 companies. The report can be found at: http://www.kaloramainformation.com/redirect.asp?progid=88032&productid=9314088.

About Kalorama Information
Kalorama Information, a division of MarketResearch.com, supplies the latest in independent medical market research in diagnostics, biotech, pharmaceuticals, medical devices and healthcare; as well as a full range of custom research services. Reports can be purchased through Kalorama's website and are also available on www.marketresearch.com and www.profound.com.

We routinely assist the media with healthcare topics. Follow us on Twitter, LinkedIn and our blog at www.kaloramainformation.com.  

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