Description
The recent terrorism events, in addition to the ease of travel that allows infectious diseases to spread, and technology developments drive the renewed interest in clinical and environmental infectious disease diagnostics. The combined public health and bio-terrorism markets of several bacterial and protozoan diseases are estimated to be nearly $100 million.
This report, the final volume of the Diagnostics for Emerging Infectious Disease Threats series, focuses on diagnostic testing for 11 bacterial and protozoal diseases in clinical and environmental testing:
- Anthrax
- Brucella spp – Brucellosis
- Clostridium botulinim – Botulism
- Clostridium perfringens
- Coxiella burnetti – Q Fever
- Staphyloccoccal Enterotoxin B
- Tuberculosis
- Vibrio cholerae
- Yersinia pestis – Plague
- Malaria
- Chagas disease (trypanosomiasis, South American)
The technologies being used and developed in the United States and worldwide are discussed. Information has been collected from numerous industry, government, and academic sources. Sensitivity, specificity, cost, speed, and volume of testing are all factors that regulate and drive the diagnostic technology development. For many of the bacterial diseases, the availability as well as use of a diagnostic that is faster than culture, which will be defined as rapid, is new. The definition of a rapid test in this report includes dipsticks, immunoassay, and PCR methods.
For this discussion about diagnostics, infectious disease testing is classified into 2 economic segments: 1) environmental and 2) clinical. Within the clinical testing category, Brucella, Q fever, chagas, malaria, and tuberculosis are considered significant economic parts. Anthrax and plague are classified as emerging. Botulism, perfringens, cholerae, and staphyloccocal enterotoxin B (SEB) clinical testing exists.
More than 70 companies with a diagnostic or developing a diagnostic in these areas with a diverse range of technological approaches, including ELISAs, lateral flow immunoassays (dipsticks), PCR, nucleic acid sequence based assays (NASBAs), DNA hybridization, ECL, indirect hemagglutination, complement fixation, and DNA Chips.
Information for this report has been collected from various industry, government, and academic sources. Interviews with numerous industry, government, and clinical participants form the core of the information. In addition, searches of the trade, business, and clinical literature were conducted to validate conclusions and fill in background, product, and company financial data where possible.
Table of Contents
CHAPTER ONE: EXECUTIVE SUMMARY
- Introduction
- Scope and Methodology
- Summary of Major Findings
CHAPTER TWO: BACTERIA AND PROTOZOA INFECTIOUS DISEASES
- Anthrax – Bacillus anthracis
- Brucella SPP
- Clostridium Botulinim
- Clostridium Perfringens
- Q Fever
- Staphyloccoccal Enterotoxin B
- Tuberculosis
- Vibrio cholerae
- Malaria
- Chagas Disease – Trypanosomiasis, T. cruzi
CHAPTER THREE: THE MARKETS & TECHNOLOGIES
- Introduction
- Environmental
- Clinical
- Clinical Anthrax Diagnostics
- Brucella
- Clostridium botulinim
- Clostridium perfringens
- Q Fever
- Staphylococcal Enterotoxin B
- Tuberculosis
- Vibrio cholerae
- Yersinia pestis
- Malaria
- Chagas Disease
CHAPTER FOUR: CONCLUSIONS AND STRATEGIC IMPLICATIONS
- First Conclusion
- Second Conclusion
- Third Conclusion
CHAPTER FIVE: COMPANY PROFILES
- Alexeter Technologies
- Becton, Dickinson, And Co.
- BioMerieux, Inc.
- Bio-Quant
- Diffchamb AB
- Gen-Probe
- Immuno-Biological Laboratories (IBL)
- Microgen Bioproducts
- New Horizon Diagnostics
- PANBIO
- r-Biopharm AG
- SA Scientific
- TechLab
- Teco Diagnostics
- TECRA International Pty Ltd.
- TetraCore Technologies
- V.I. Technologies, Inc.
APPENDIX A: COMPANY DIRECTORY
LIST OF EXHIBITS
CHAPTER ONE: EXECUTIVE SUMMARY
- Table 1-1: Summary of Emerging Infectious Disease Testing Market, 2001-2008
CHAPTER TWO: THE MARKETS AND TECHNOLOGIES
- Table 2-1: Number of TB Cases (All Forms) per WHO Region in 2000
- Table 2-2: Number of TB Cases (All Form) for 22 High-Burden Countries
- Table 2-3: Eastern Mediterranean Region Number of Notified Tuberculosis Cases, 1998-2002
- Table 2-4: Eastern Mediterranean Region Number of Notified Tuberculosis Cases by Country 2000-2002
- Table 2-5: Cholera Cases in the Americas 1991-2000
- Table 2-6: Cholera Outbreak Cases by Country 1996-2003
- Table 2-7: Confirmed Malaria Cases in 2001
- Table 2-8: WHO European Region Malaria Confirmed Cases 1991-2002
- Table 2-9: WHO European Region Malaria Confirmed Cases by Country, 2000-2002
- Table 2-10: Confirmed Malaria Cases in Top Nine European Regions & Countries 2000-2002
- Table 2-11: Eastern Mediterranean Region Severe Malaria Countries Estimate of Cases
- Table 2-12: WHO Roll Back Malaria Eastern Mediterranean Region Number of Confirmed Cases 2000-2002
- Table 2-13: Number of Laboratory Confirmed Malaria Cases Southeast Asia 1996-2001
CHAPTER THREE: CONCLUSIONS AND STRETEGIC IMPLICATIONS
- Table 3-1: Emerging Infectious Disease Testing Market Revenue by Testing Type 2001-2008
- Table 3-2: Environmental Bio-Threat Diagnostic Revenues by Method 2001-2008
- Table 3-3: Environmental Bio-Defense Lateral Flow Immunoassay Systems
- Table 3-4: Commercial HHA Anthrax Tests – Survey 1
- Table 3-5: Commercial HHA Anthrax Tests – Survey 2
- Table 3-7: Number of Counties, Parishes, or Independent Cities in the United States by State
- Table 3-8: Relative Limits of Detection of Selected Identification Technologies for Bacillus anthracis
- Table 3-9: Environmental Bio-Defense DNA Systems
- Table 3-10: Clinical Emerging Infectious Disease Testing Revenue by Disease 2001-2008
- Table 3-11: Antrax Test Manufacturers
- Table 3-12: Brucella Test Kits and Manufacturers by Geographic Region
- Table 3-13: SEB Antibody Tests
- Table 3-14: Tuberculosis Antibody Rapid Diagnostics
- Table 3-15: Tuberculosis Nucleic Acid Diagnostic Methods
- Table 3-16: Clinical Vibrio cholerae Diagnostics
- Table 3-17: Number of Laboratory Confirmed Malaria Cases by Region, 1999-2002
- Table 3-18: Number of Laboratory Confirmed Malaria Cases Southeast Asia, 1996-2001
- Table 3-19: Southeast Asia Malaria Estimate vs. Laboratory Confirmed Cases
- Table 3-20: Eastern Mediterranean Region Estimated Cases vs. Laboratory Confirmed Cases
- Table 3-21: Available Malaria Antigen & Antibody RDTs
- Table 3-22: Developing Malaria RDTs
- Table 3-23: Number of Latin America Blood Bank Samples Screened for T. cruzi 1994-2002
- Table 3-24: Percentage of Latin America Blood Bank Samples Screened for T. cruzi 1994-2002
- Table 3-25: Number of Blood Bank Donations in Latin America 1994-2000
- Table 3-26: Chagas Diagnostic Tests
- Table 3-27: Developing Chagas Diagnostics
