IRIS » Topics » Competition

These excerpts taken from the IRIS 10-K filed Mar 6, 2009.

Competition

 

Competition in the IVD industry is intense. Many of our competitors are substantially larger than we are and have greater financial, research, manufacturing, marketing, sales and other resources than we do. As a result, our competitors may develop technologies or products that could render our products or products under development obsolete or noncompetitive.

 

Competition

 

STYLE="margin-top:0px;margin-bottom:0px; text-indent:4%">Competition in the IVD industry is intense. Many of our competitors are substantially larger than we are and have greater financial, research,
manufacturing, marketing, sales and other resources than we do. As a result, our competitors may develop technologies or products that could render our products or products under development obsolete or noncompetitive.

STYLE="margin-top:0px;margin-bottom:0px"> 

These excerpts taken from the IRIS 10-K filed Mar 14, 2008.

Competition

 

Competition in the IVD industry is intense. Many of our competitors are substantially larger than we are and have greater financial, research, manufacturing, marketing, sales and other resources than we do. As a result, our competitors may develop technologies or products that could render our products or products under development obsolete or noncompetitive.

 

Competition

 

STYLE="margin-top:0px;margin-bottom:0px; text-indent:4%">Competition in the IVD industry is intense. Many of our competitors are substantially larger than we are and have greater financial, research,
manufacturing, marketing, sales and other resources than we do. As a result, our competitors may develop technologies or products that could render our products or products under development obsolete or noncompetitive.

STYLE="margin-top:0px;margin-bottom:0px"> 

This excerpt taken from the IRIS 10-K filed Mar 23, 2007.

Competition

In the urine chemistry segment, Bayer and Roche are our principal competitors selling urine analyzers and test strips used in determining the concentration of various chemical substances found in urine. In the automated urine microscopy segment, Sysmex Corporation markets its automated urine sediment analyzers globally and remains our principal competitor. We believe the Sysmex systems have several significant limitations including the inability to perform particle and cellular imaging, an incomplete testing menu, and are not designed to perform body fluid analysis. These limitations result in repeat testing, requiring the technologist to retrieve the original sample, prepare a slide and conduct a manual microscopic analysis. The principal competitive factors in the urinalysis market are cost-per-test, ease of use and quality of result. We believe our automated systems compete favorably with respect to these factors.

 

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In 2004, however, Bayer and Sysmex formed a distribution alliance in the US market, whereby Bayer markets the ADVIA® Urinalysis WorkCell, comprised of the Bayer Clinitek Atlas® chemistry instrument and Sysmex UF100™ Urine Cell Analyzer. These two instruments are linked with a sample transport and the software to combine results. Despite the fact that these instruments are connected, we believe they have not overcome the limitations described above.

The iQ200 and the iQ200 Sprint Systems are the first instruments to fully integrate urine chemistry and urine microscopy analysis. We believe these systems provide the broadest menu available and are the only systems to provide digital images of urine and body fluids particles, which provides significant competitive advantages over these other systems. We believe the clinical utility and ease of use of our iQ200 product family will result in a better economic return for clinical laboratories and hospitals.

In addition to industry competitors, we are experiencing increased domestic and international pricing pressures in the urinalysis market due to the ongoing consolidation of both hospitals and medical device suppliers. Competitors are attempting to offer one-stop shopping for a variety of laboratory instruments, supplies and service. In the US, competitors typically offer hospitals annual rebates based on the hospital’s total volume of business. We have been successful in preventing this type of “product bundling” by negotiating contracts with the six largest GPOs in the US allowing GPO members to purchase our products and receive comparable product discounts but not rebates.

This excerpt taken from the IRIS 10-K filed Mar 16, 2006.

Competition

 

In the urine chemistry segment, Bayer and Roche are our principal competitors selling urine analyzers and test strips used in determining the concentration of various chemical substances found in urine. In the automated urine microscopy segment, Sysmex Corporation markets its automated urine sediment analyzers globally and remains our principal competitor. We believe the Sysmex systems have several significant limitations including the inability to perform particle and cellular imaging, an incomplete testing menu, and are not designed to

 

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perform body fluid analysis. These limitations result in repeat testing, requiring the technologist to retrieve the original sample, prepare a slide and conduct a manual microscopic analysis. The principal competitive factors in the urinalysis market are cost-per-test, ease of use and quality of result. We believe our automated systems compete favorably with respect to these factors.

 

In 2004, however, Bayer and Sysmex formed a distribution alliance in the US market, whereby Bayer markets the ADVIA® Urinalysis WorkCell, comprised of the Bayer Clinitek Atlas® chemistry instrument and Sysmex UF100 Urine Cell Analyzer. These two instruments are linked with a sample transport and the software to combine results. Despite the fact that these instruments are connected, we believe they have not overcome the limitations described above.

 

The iQ200 and the iQ200 Sprint Systems are the first instruments to fully integrate urine chemistry and urine microscopy analysis. We believe these systems provide the broadest menu available and are the only systems to provide digital images of urine and body fluids particles, which provides significant competitive advantages over these other systems. We believe the clinical utility and ease of use of our iQ200 product family will result in a better economic return for clinical laboratories and hospitals.

 

In addition to industry competitors, we are experiencing increased domestic and international pricing pressures in the urinalysis market due to the ongoing consolidation of both hospitals and medical device suppliers. Competitors are attempting to offer one-stop shopping for a variety of laboratory instruments, supplies and service. In the US, competitors typically offer hospitals annual rebates based on the hospital’s total volume of business. We have been successful in preventing this type of “product bundling” by negotiating contracts with five of the six largest GPOs in the US allowing GPO members to purchase our products and receive comparable product discounts but not rebates.

 

This excerpt taken from the IRIS 10-K filed Mar 16, 2005.

Competition

 

Our primary products are the iQ200 product family. The principal competitive factors in the urinalysis market are cost-per-test, ease of use, and quality of result. We believe our systems compete favorably with regard to these factors in their target markets.

 

Bayer Diagnostics and Roche Diagnostics are the principal competitors selling lines of urine test strips that are used in determining the concentration of various chemical substances found in urine. The iQ200 and the iQSprint Systems are the first to fully integrate the urine chemistry and urine microscopy analysis. Despite the Company obtaining FDA clearance for the fully-integrated and walkway iQ200 System, a substantial portion of the urinalysis market has subscribed to the theory that test strips can be relied upon to reduce the number of microscopic examinations. We believe that this is largely due to laboratories’ reacting to cost-cutting pressures and labor shortages and, has resulted in slower growth in the demand for microscopic examinations at certain hospitals and reference laboratories. We believe the lower price and ease of use of our iQ200 product family will result in a better economic return for clinical laboratories and hospitals utilizing manual microscopy, therefore accelerating the adoption of IRIS automated microscopy technology. As urine chemistry test strips remain a large segment of the urinalysis market and a revenue source for us, the exclusive U.S. distribution agreement with ARKRAY for the Aution Max AX-4280 Automated Urine Chemistry Analyzer offers a competitive alternative in the form of a compact, high-throughput analyzer with a complete test strip menu.

 

Our urinalysis systems currently support automated test strip readers supplied by Roche Diagnostics and Arkray, Inc. Some potential customers who have previously purchased automated test strip readers from Bayer Diagnostics (the dominant company in the urine test strip business) cannot connect those readers to our legacy products. Our ability to modify our legacy products to support a connection to test strip readers from Bayer Diagnostics and other suppliers is presently subject to significant restrictions under our existing agreements with Roche Diagnostics. In 2002, Roche Diagnostics exercised its right to terminate its agreements with us, however, in accordance with the term and conditions contained in these agreements, Roche Diagnostics will continue to supply its test strips through 2009. Our new iQ200 and iQ200 Sprint Automated Microscopy Analyzers can be used as stand-alone systems for those laboratories that continue using Bayer or Roche urine chemistry analyzers.

 

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Sysmex Corporation (Kobe, Japan) markets its automated urine sediment analyzers globally, and remains our principal competitor in the urine microscopy business segment. While the Sysmex systems, are automated and easy to use, we believe they have several limitations. These systems are not designed to perform body fluid analysis and are limited in terms of the number of quantitatively reported analyses. Additionally, when further examination is needed, Sysmex systems, which do not use image analysis, require the technologist to remove the sample, prepare a slide and conduct a manual microscopic analysis.

 

In addition to industry competitors, we are experiencing increased domestic and international pricing pressures in the urinalysis market due to the ongoing consolidation of both hospitals and medical device suppliers. Large hospital chains and groups of affiliated hospitals are negotiating comprehensive supply contracts with the larger medical device suppliers, who can offer one-stop shopping for a variety of laboratory instruments, supplies and service. In the US, they typically offer hospitals annual rebates based on the total volume of business with the suppliers. These rebates create financial incentives against purchasing instruments or supplies from others and act as a barrier to the penetration of hospital laboratories covered by the contract.

 

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