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Molecular Diagnostics for Infectious Disease Testing: Testing volume, cost per test, and market potential

Currently, the largest market application segment for molecular diagnostics is that for infectious disease testing. The segment is expected to grow at an annual rate between 7% and 8% over the next few years will present some excellent market opportunites for molecular diagnostic competitors.

This summary report, extracted from Kalorama Information’s U.S. Market for Molecular Diagnostics, (2nd Edition, May 2004), focuses on the technologies and application of molecular diagnostics in the field of infectious disease testing.

The major market effects of new diagnostics—with the potential of a breakthrough product always a possibility—are being seen and are expected to significantly impact the market over the next ten years. The technology trends selected in conjunction with the growing interest in molecular diagnostics and their application to current health priorities (e.g., HIV/AIDS, cancer, sexually transmitted diseases, etc.) present the most informative picture of advances in this field and the markets that result.

Market analysis considers various infectious disease diagnostic applications of molecular testing rather than the markets for specific technologies in the U.S. This report does not consider instrumentation, such as thermocyclers, luminometers, sequencers, etc. and their disposable support products. Some mention is made of such instrumentation, but greater emphasis is placed on applications and the technologies that will address those specific applications. The focus of the report is on molecular diagnostics technologies and products with the potential to become first-line methods for use in the clinical laboratory for infectious disease testing, and not for research or genomic data collection and cataloguing.

The analysis presented in this report is based on data from a combination of company, government, industry, and institutional and private sources. It includes information from extensive literature reviews, as well as interviews and discussions with experts in the field, including molecular biologists, laboratory medicine professionals, pathologists, research scientists, business development managers and marketing managers


Scope and Methodology

Market Context

Exhibit 1: Distribution of Molecular Diagnostics Testing in U.S. 2004

Infectious Disease Testing: Targets and Trends

Chlamydia trachomatis

Neisseria gonorrhoeae


Human Immunodeficiency Virus (HIV)


Hepatitis B Virus (HBV)

Hepatitis C Virus (HCV)

Herpes Simplex Virus (HSV)

West Nile Virus (WNV)

Products and Progress of Note

Exhibit 2: Commercially Available Molecular Diagnostic Tests for Infectious Diseases...........

Recent Research Studies: Prospects and Advances in Testing

Number of Tests

Exhibit 3: Projected Infectious Disease Testing by
Molecular Diagnostics in U.S. 2003-2013

Exhibit 4: Trending in Projected Test Volume for
Molecular Diagnostics in Infectious Disease Testing in U.S. 2003-2013

Exhibit 5: Trending in Projected Test Volume Composition for
Molecular Diagnostics in Infectious Disease Testing in U.S. 2003-2013

Market and Cost per Test Projections, 2003-2013

Exhibit 6: Projected Molecular Diagnostics Infectious Disease Testing
Market Potential in U.S. 2003-2013

Exhibit 7: Trending in Projected Market Potential for
Molecular Diagnostics in Infectious Disease Testing in U.S. 2003-2013

Exhibit 8: Trending in Projected Market Potential Composition for
Molecular Diagnostics in Infectious Disease Testing in U.S. 2003-2013

Exhibit 9: Trending in Projected Estimated Cost Per Test (ECPT) for
Molecular Diagnostics in Infectious Disease Testing in U.S. 2003-2013

Major Competitors

Abbott Diagnostics (Division of Abbott Laboratories)

Affymetrix, Inc.

Ambion RNA Diagnostics (Division of Ambion, Inc.)

Celera Genomics/Celera Diagnostics (Division of Applera Corporation)

Cenetron Diagnostics

Cepheid, Inc.

Chiron Corporation

Dharmacon, Inc.

Digene Corporation

Gen-Probe Incorporated

Innogenetics NV

Nanogen, Inc.

Roche Diagnostics Division/
Roche Molecular Systems F. Hoffmann-LaRoche Ltd.

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