The following list presents the top molecular diagnostics companies, based on revenue figures from 2003. Molecular diagnostics is continuing to emerge as one of the dominant testing platforms and represents one of the fastest-growing segments of the IVD market. However, the contributions that molecular diagnostics can make to clinical decision making still face significant obstacles, including reimbursement issues, lack of standardization, and difficulties in interpreting test data. 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 Kalorama's Web site at www.kaloramainformation.com.
1. Roche Diagnostics
Since 1991, Roche Diagnostics has invested hundreds of millions of dollars in research and development to accelerate the development of polymerase chain reaction (PCR) technology, with an emphasis on practical applications with direct benefits to healthcare. This commitment has included grants to academic institutions, government laboratories, and nonprofit organizations for PCR-related research, as well as the continuing dedication of more than 250 Roche scientists and engineers to further developing the technology. The company has retained a focus on such areas as virology, blood screening, and oncology.
2. Chiron Corp.
The original basis of Chiron's diagnostic business was its work in HIV and the hepatitis C virus (HCV). In 1989, Chiron and Ortho-Clinical Diagnostics Inc. (Raritan, NJ) established a joint venture that developed and sold immunodiagnostic tests for infectious diseases. The first product was an HCV blood-screening test. Chiron also had a substantial business outside of blood screening in molecular diagnostics, immunodiagnostics, and critical-care blood gas analyzers, which was built through an acquisition from Ciba-Geigy. In 1998, Chiron established its blood testing division by forming a collaboration with Gen-Probe Inc. (San Diego).
3. Gen-Probe Inc.
With more than 20 years of expertise in nucleic acid detection, Gen-Probe develops, manufactures, and markets nucleic acid testing (NAT) products that are used to diagnose human diseases and screen donated human blood. Using its patented NAT technologies, the company has received FDA clearances for a broad portfolio of products that detect infectious microorganisms, including those that cause sexually transmitted diseases, tuberculosis, strep throat, pneumonia, and fungal infections. The company also developed and manufactures the only FDA-approved blood-screening assay that simultaneously detects HIV-1 and the hepatitis C virus.
4. Bayer Diagnostics
Bayer Diagnostics' molecular testing group offers an array of molecular assays and instrumentation. This group has emerged through a series of acquisitions. In 1998, Bayer acquired Chiron Corp.'s diagnostic business for $1.1 billion in cash plus licensing and royalty fees. Included in this agreement were Chiron's immunodiagnostic, critical-care diagnostic, nucleic acid diagnostic, and clinical chemistry businesses. In 2002, Bayer accomplished another milestone in its ongoing strategy to expand its infectious disease portfolio when it acquired Visible Genetics Inc (VGI). Through this agreement, Bayer acquired VGI's Trugene HIV-1 genotyping assay.
5. BD (Becton, Dickinson and Co.)
Franklin Lakes, NJ
Assays for BD's ProbeTec ET system feature homogeneous amplification and real-time detection technology, combining the company's strand displacement amplification (SDA) with an energy transfer detection method. SDA is a patented isothermal amplification technology that can rapidly generate billions of copies of target molecules from a single DNA or RNA template. First marketed in 1998, the ProbeTec ET system is the only commercially available real-time DNA amplification assay for detecting chlamydia and gonorrhea. In 2002, the Viper sample processor became available.
One of the business areas that Innogenetics is building is specialty diagnostics. For Innogenetics, specialty diagnostics is translated into developing and manufacturing tests that can identify which patients are more suited to a particular therapy, and providing feedback on how well a patient is responding to a drug in order to optimize treatment regimens. The company concentrates on three key areas in its specialty diagnostics division: infectious diseases, genetic testing, and neurodegeneration. Founded in 1985, Innogenetics was one of the first biotech companies to be listed on a European stock exchange.
7. Digene Corp.
Digene develops, manufactures, and markets DNA and RNA tests focused on women's cancers and infectious diseases. The company's flagship product, the Digene HPV test, is the only FDA-approved test for the human papillomavirus (HPV). The company's Hybrid Capture screening technology serves as the platform for its signal-amplified nucleic acid tests. The Hybrid Capture platform utilizes specific RNA probes, hybridization, antibody capture, and signal amplification. The company's product portfolio also includes DNA tests for the detection of other sexually transmitted infections, including chlamydia and gonorrhea, as well as tests for blood viruses.
8. bioMérieux SA
Marcy l'Etoile, France
The current trends in molecular diagnostics for bioMérieux include increased automation, widespread adoption of molecular testing technologies for infectious disease diagnostics and screening, and improvements in the ability to diagnose and identify infections rapidly. The company invests a large percentage of its budget in research and development to reinforce its offerings in microbiology based on its expertise and leadership in this field. The allocation of investments in R&D expresses the company's clear determination to develop its activity in the field of infectious diseases, in particular through molecular diagnostics.
9. Qiagen NV
Venlo, The Netherlands
In January 2005, Qiagen initiated a new organization focused completely on the routine clinical molecular diagnostics market segment. While the company has made inroads into this market segment, primarily with the largest laboratories, it is committed to the idea that molecular diagnostics will migrate more broadly into hospital laboratories with the emergence of new menu items. With this factor as a driver, the company has established a dedicated business unit to serve the growing molecular diagnostics market. The company has also created dedicated sales and marketing groups to focus exclusively on this segment.
10. Eurogentec SA
Eurogentec has developed a broad platform of enabling technologies. The activities are organized around two business units. The tools for the genomics and proteomics department, which offers oligonucleotide synthesis with a large range of modifications, oligonucleotides for IVDs, real-time PCR products, DNA microarray services, and a wide range of kits and consumables. The department also gathers know-how in the design of peptides, either for antibody production or bioactive peptide purposes. The company's biologics unit is a full-service contract manufacturing organization that delivers research, development, and production services for clinical batch manufacturing.
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