Medical Device Link.

Originally Published IVD Technology January/February 2005

Tenth Anniversary

The following list presents the top IVD manufacturers based on revenue figures from 2003, which were provided by Kalorama Information (New York City). The revenues from these companies totaled more than $17 billion, which accounted for more than 60% of the entire IVD market. The manufacturers on this list have different backgrounds and origins. Some of these companies are affiliated with larger healthcare conglomerates that are involved in pharmaceuticals and other medical devices. Other firms are pure diagnostics companies that only manufacture IVDs. In addition, while most of these manufacturers are based in the United States, some of them are located outside the United States, which demonstrates the global nature of the IVD market.

1. Roche Diagnostics
Basel, Switzerland
$4.06 billion
Roche Diagnostics was founded in 1968. However, with the acquisition of Boehringer Mannheim in 1998, the company’s diagnostic roots go back to 1859. The early years were marked by the development of the first reagent kits (e.g., test combinations, multipurpose reagents) and instruments (e.g., photospectrometers) for the semiquantitative and quantitative determination of parameters in clinical chemistry and coagulation. Such developments laid the foundation for the contribution of diagnostics to therapeutic processes.

2. Abbott Diagnostics
Abbott Park, IL
$3.04 billion
Abbott Diagnostics’ first hepatitis test, the Ausria-125, was introduced in 1972. At that time in the United States, approximately 30,000 people per year contracted serum hepatitis; in 1500–3000 of these cases, the infections were fatal. Although there were hepatitis tests available, none of them had the sensitivity to detect infection with enough certainty. The Ausria test offered that sensitivity, and soon more than 70% of all blood drawn in the United States was tested with this assay.

3. Ortho Clinical Diagnostics Inc.
Raritan, NJ
$2.6 billion
Ortho-Clinical Diagnostics grew from a merger in 1997 of two Johnson & Johnson companies: Ortho Diagnostic Systems, which handled diagnostic reagents and instrument systems, and Johnson & Johnson Clinical Diagnostics, formerly a division of Eastman Kodak that was acquired by J&J in 1994 and handled clinical laboratory systems. The company’s roots date back to 1937, when Johnson & Johnson established the Ortho Products Division. That division became a full and separate member of the Johnson & Johnson family of companies in 1974.

4. Bayer Diagnostics
Tarrytown, NY
$1.8 billion
An important event in Bayer Diagnostics’ history occurred in 1989 when Miles Inc. acquired Technicon to expand its existing range of diagnostics systems. Even though Miles had been a member of the Bayer family since 1978, it was unable to use the parent company name in North America due to legal restrictions. The 1994 acquisition by Miles Inc. of Sterling Winthrop’s North American over-the-counter drug business returned to Bayer the rights to the Bayer cross and name in North America.

5. Beckman Coulter Inc.
Fullerton, CA
$1.73 billion
From its first small steps as a tiny operation in the rear of a shed in Pasadena, CA, to its recognition today as a world leader in life science research and clinical diagnostics, Beckman Coulter owes its success to three entrepreneurs who made it all possible: Arnold O. Beckman, PhD, and the late brothers, Wallace and Joseph Coulter. Together, these three men of vision revolutionized science and medicine, saving countless lives and improving the quality of daily life.

6. Dade Behring Inc.
Deerfield, IL
$1.44 billion
Dade Behring traces its roots back to Dr. Emil von Behring, who received the first Nobel Prize for medicine and physiology for the discovery of passive immunity in 1901. He has been called the founder of immunotherapy because of his discovery of the biological principles behind the development of specific antibodies to fight disease. In 1904, Von Behring founded Behringwerke in Marburg, Germany, to develop and produce a range of vaccines and serums. Behringwerke introduced the first commercial diagnostics products in 1935.

7. BD (Becton, Dickinson & Co.)
Franklin Lakes, NJ
$1.1 billion
Maxwell W. Becton and Fairleigh S. Dickinson met on a sales trip in 1897. Months later, they decided to go into business together, sealing their partnership with a handshake. They named their medical device import company Becton, Dickinson and Co. In 1955, BD acquired Baltimore Biological Laboratories, which provided a crucial impetus for BD’s emergence in diagnostic medicine. Through licensing arrangements with Stanford University, BD manufactured its first fluorescence-activated cell sorting (FACS) instrument in 1973, pioneering the company’s involvement in cytology.

8. bioMérieux SA
Marcy l’Etoile, France
$969 million
Institut Mérieux was founded in 1897 by Marcel Mérieux, Louis Pasteur’s assistant, and began operations as a medical analysis laboratory. Under the leadership of Dr. Charles Mérieux, this institute, dedicated to vaccines, set up a reagents division that was later to become BD Mérieux. In 1963, Alain Mérieux took over the management of BD Mérieux, in which Institut Mérieux and Becton Dickinson held a 50-50 ownership interest. The company took on the new name of bioMérieux and acquired its independence internationally in 1974.

9. Bio-Rad Laboratories Inc.
Hercules, CA
$515 million
For more than 50 years, Bio-Rad Laboratories has provided a range of tools and services to the clinical diagnostics and life science research markets. The company is committed to advancing research and development efforts and supporting the commercialization of new technology, especially in genomics, proteomics, biopharmaceutical discovery, food safety, and biotechnology education. Bio-Rad manufactures and distributes products that incorporate a range of technologies, including electrophoresis, imaging, immunoassay, chromatography, microbiology, bioinformatics, and transfection.

Arkray Inc.
Kyoto, Japan
$500 million
In 1960, Tadashi Doi, the late chairman, established KDK Corp. as a private company to develop and manufacture various precision parts for Shimadzu Corp. To commemorate its 40th anniversary, the company changed its name to Arkray Inc. in 2000. Originally a corporate brand name, Arkray comes from two words: “ark” which means life, and “ray” which means “brightness.” This new company name encapsulates the corporate philosophy of creating health science with love.

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