Digital Imaging for Hematology Coming Into Focus

Digital Imaging for Hematology Coming Into Focus

The leader in differential imaging for hematology can expect a more crowded market space in the coming years. CellaVision AB commands an intriguing, peripheral IVD market sub-segment aimed at eliminating one of the most costly and time-consuming procedures: the manual differential . The company’s products effectively replace manual microscopy and cell counting with automated systems that use neural networking and algorithms to classify blood cell populations based on image-captured and archived morphology. Several companies specializing in laboratory technology and cutting-edging microscopy seek to duplicate the approach, if not the technology, of CellaVision and introduce competitive platforms.

CellaVision introduced its first system for blood cell differential imaging to the European market in 2000 and in the United States in 2001. Since then, the company is estimated by Kalorama Information to have delivered close to 1,500 differential imaging systems worldwide. CellaVision has active distribution agreements with hematology leaders including Sysmex, Beckman Coulter, Siemens, Abbott Diagnostics, and Mindray.

The only current market competitor to CellaVision is U.S. IVD company Medica Corporation.  The first of Medica’s EasyCell digital differential systems was installed in the United States in 2010. The differential menu, throughput and price are all lower on the EasyCell system than CellaVision’s DM96 and DM1200 systems.  Medica sales of digital differential systems are estimated to be less than 10% of CellaVision system sales. Potential competitors to the two vendors - Constitution Medical Inc., Clemex Technologies Inc., Horn Imaging GmbH, and NextSlide Imaging, LLC -  have yet to secure FDA approval for the clinical or diagnostic use of their hematology imaging systems. An image-based analyzer system, 3Gems, has been under joint development by IRIS International and Fujirebio since 2011 with a tenative market introduction in 2015. The 2012 acquisition of IRIS by Danaher is intriguing as the subsidiary hematology platforms of IRIS and Beckman Coulter may prove mutually exclusive in some labs. The United States represents over half of CellaVision’s global sales and installed base.

The push of several developers to introduce digital hematology imaging systems is in recognition of the large potential market left remaining. CellaVision estimates its global market penetration at only 10% after recording average annual revenue growth of 14% through the past five years. Potential competitor Constitution Medical did not escape the notice of IVD giant Roche Diagnostics. Aside from distribution partnerships with hematology companies, Roche had minimal presence in the IVD market segment until its acquisition of Constitution Medical and its Bloodhound instrument for $220 million in July 2013. The Bloodhound represents not only a digital hematology imaging system, but a potential replacement of traditional impedance- and light scatter-based hematology analyzers.

Synonymous with CellaVision, digital hematology imaging and imaging differentials will from the introduction of future systems appealing to smaller and more price-sensitive labs and platforms able to comprehensively address hematology testing in the lab. A relatively static IVD product space, the future hematology market will feature a pervasive instrument platform with a legacy distinct from Coulter counting and flow cytometry.