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Originally Published IVD Technology July/August 2005

Tenth Anniversary

Top 10 High-Growth IVD Manufacturers

The following list presents the top IVD manufacturers with high average annual revenue growth rates, based on revenue figures from 2003. While the average growth rates of the top IVD manufacturers by revenues, profiled in a previous top-10 list (IVD Technology, January/February 2005), are about 4%, these high-growth companies with less than $300 million in revenues have posted average revenue increases of more than 50%. These companies are smaller niche players that tend to specialize in specific business areas. The following figures were provided courtesy of Kalorama Information (New York City) and were taken from its report, “The Worldwide Market for In Vitro Diagnostic Tests.” More information about this report can be accessed via the Kalorama Web site at www.kaloramainformation.com.

1. Inverness Medical Innovations Inc.
Waltham, MA
$296 million
Inverness Medical Innovations is a global developer of advanced diagnostic devices. The company is presently exploring new opportunities for its proprietary electrochemical and other technologies in a variety of professional diagnostic and consumer-oriented applications, including immunodiagnostics with a focus on women’s health and cardiology. The company’s new product development efforts are supported by its intellectual property portfolio.

2. TheraSense Inc.
Alameda, CA
$212 million
TheraSense develops, manufactures, and sells glucose monitoring systems that are designed to reduce the pain of testing for people with diabetes. In June 2000, the company began selling its first product, the FreeStyle blood glucose monitoring system. The FreeStyle system has wide distribution in the United States through a number of national retailers. In April 2004, Abbott Laboratories (Abbott Park, IL) acquired TheraSense for $1.2 billion. With the acquisition of TheraSense, Abbott created Abbott Diabetes Care.

3. Gen-Probe Inc.
San Diego, CA
$189 million
Gen-Probe develops and manufactures rapid nucleic acid tests that are used to diagnose human diseases and screen donated human blood. The company markets a broad portfolio of products that use its patented technologies to detect infectious microorganisms. The company also develops and manufactures the only FDA-approved blood-screening assay for the simultaneous detection of HIV-1 and the hepatitis C virus. In addition, the company’s Tigris instrument is the only fully automated, high-throughput nucleic acid testing system for diagnostics and blood screening.

4. Biosite Inc.
San Diego, CA
$169 million
Biosite is a biomedical company that commercializes proteomics discoveries for the advancement of medical diagnosis. The company has adopted a strategy that encompasses the diagnostic continuum from protein validation to point-of-care diagnostics. The company’s products have contributed to improvements in medical care by aiding physicians in the diagnosis of critical diseases and health conditions. The company’s Triage rapid diagnostics are currently used in approximately 50% of U.S. hospitals and in more than 50 international markets.

5. Horiba ABX
Kyoto, Japan
$139 million
The acquisition of French manufacturer ABX in 1996 took the Horiba Group into the diagnostic equipment industry, in particular by expanding its share of the small-size hematology analyz-er market. Renamed Horiba ABX, the company plans to expand its operations in this segment by targeting the market for large-size hematology analyzers that are used in major hospitals and medical institutions. The company also plans to expand its presence through new product introductions in clinical chemistry analyzers.

6. Ventana Medical Systems Inc.
Tucson, AZ
$132 million
Ventana develops and manufactures instruments and reagent systems that automate slide preparation and staining in clinical histology and drug discovery laboratories. The company’s clinical systems are used in the diagnosis and treatment of cancer and infectious diseases. The company also develops drug discovery systems for accelerating the discovery of new drug targets. The company was founded in 1985 by Thomas M. Grogan, MD, a pathologist at the University of Arizona, who was interested in improving the practice of medicine through automation.

7. Trinity Biotech plc
Bray, Ireland
$66 million
Trinity Biotech develops and manufactures more than 500 diagnostic products for the point-of-care and clinical laboratory segments of the diagnostic market. The company’s test kits are used to detect infectious diseases, sexually transmitted diseases, blood coagulation disorders, and autoimmune diseases. The company sells worldwide in more than 80 countries through its own sales force and a network of international distributors and strategic partners. Formed in 1992, Trinity is a public company with manufacturing facilities in Ireland, New York, California, Germany, and Sweden.

8. Digene Corp.
Gaithersburg, MD
$63 million
Digene develops and manufactures proprietary gene-based testing systems for the screening, monitoring, and diagnosis of human diseases. The company’s primary focus is in women’s cancers and infectious diseases. The company has applied its proprietary Hybrid Capture technology to develop a diagnostic test for human papillomavirus (HPV). In addition to its HPV-test marketing efforts, the company is focusing its commercialization strategy in two areas: diagnostic testing and genomics research.

9. TriPath Imaging Inc.
Burlington, NC
$54 million
TriPath Imaging develops and manufactures solutions for the clinical management of cancer. In September 1999, the company was formed through the merger of AutoCyte Inc. and NeoPath Inc., and the acquisition of Neuromedical Systems’ technology and intellectual property. The company was created to leverage the complementary nature of the products, technologies, and intellectual property developed by the predecessor companies. These companies were early pioneers in the application of computerized image processing and analysis to detect cellular abnormalities associated with cancer and its precursors.

10. Qiagen NV
Venlo, The Netherlands
$41 million
Qiagen is a provider of enabling technologies and products for the separation, purification, and handling of nucleic acids and proteins. The company has developed a portfolio of more than 320 consumable products for numerous applications, such as nucleic acid amplification, as well as automated instrumentation and synthetic nucleic acid products. The company is also positioning its products for sale in developing commercial markets, including applied-testing markets, clinical research, nucleic acid–based molecular diagnostics, genetic vaccination, and gene therapy.

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