Top 10 Molecular Diagnostics Companies: a Closer LookTop 10 Molecular Diagnostics Companies: a Closer Look
Last month we published a list of the top 10 molecular diagnostics companies based on 2012 molecular-related revenues. To refresh your memory, those 10 were:
June 13, 2013
Roche Diagnostics
Qiagen Netherlands (includes Digene)
Becton Dickinson (BD)
Novartis
Abbott
Hologic (includes Gen-Probe)
Agilent/Dako
Cepheid
Siemens Healthcare
bioMérieux
The list was compiled by analysis firm Kalorama Information.
The names on the list are not surprising, but it's worth looking at them, and the molecular diagnostics industry in general, a little more closely to help determine what kind of factors translate to success in this exciting field.
In 2012, 14 companies controlled 85% or more of the market for molecular tests. Most of these companies have product sales of less than $10 million, however, so they are unlikely to give the industry leaders a lot of stiff competition. The crystal-clear market leader is Roche, whose product portfolio 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," points out Bruce Carlson, Kalorama's publisher.
Second on the list is Qiagen, which transformed itself from a molecular sample-prep technology manufacturer to a very successful molecular test company. Nearly half of its revenues are from its molecular assays, Carlson says.
Becton Dickinson can credit its success largely to the GenOhm acquisition and its investment in BD Max.
Novartis, almost exactly one year ago, got the CE mark for its Procleix Panther system and Ultrio Elite assay for screening donated blood for infectious disease, and Agilent's acquisition of Dako (the former's biggest acquisition to date) paid off with an impressive 44% increase in diagnostics and genomics orders over the prior year.
Abbott Diagnostics, at number 5, has continued to release tests for the m2000 system, which has served the company well in the molecular assay market, says Carlson.
Gen-Probe (now part of Hologic) has positioned itself as a leader in the chlamydia and gonorrhea testing market, and Cepheid has done the same in the hospital-acquired-infection testing market.
Siemens and BioMérieux are holding their own in the last two spots of the top 10 but "have not managed to fully exploit their investments in molecular products," Carlson offers. (However, we are now halfway through 2013, and bioMérieux just recently earned FDA approval of its THxID BRAF test, a companion diagnostic test that helps determine whether a patient's melanoma cells have the V600E or V600K mutation in the BRAF gene. The test guides treatment with melanoma drugs.)
As for the industry in general, the past decade has seen molecular-test sales increase five-fold, Carlson says, and the number of companies and tests has grown remarkably. Roughly 350 companies are "actively involved" in molecular diagnostics.
While molecular testing is "making a valuable contribution to clinical diagnostics on many fronts, it is far from the expected panacea," writes analyst Shara Rosen in Kalorama's "The World Market for Molecular Diagnostics, 5th Edition" report, published earlier this year. She points to the important contributions the field has made to cancer diagnosis and therapy, infectious-disease diagnosis, and the analysis of gene mutations, but "the routine and substantial use of molecular tests is yet to be realized," she adds.
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