Diagnostics for Emerging Infectious Disease Threats Volume II: Viral Disease

 
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Published Dec 1, 2003 | 100 Pages | Pub ID: KLI895748

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Severe Acute Respiratory Syndrome (SARS), which was a new and unidentified disease when it first affected people, ripped through Asia and Toronto from late 2002 into the summer of 2003, before being contained for the season. Taiwan with just 346 reported cases performed 10,000 diagnostic tests. Three years after West Nile Virus (WNV) first appeared in the United States in 1999 with just 62 cases and 7 deaths, the U.S. Center for Disease Control reports thousands of cases and 150 to 250 deaths in 2002 and 2003. In 2003, WNV commercial and public testing is estimated to be a market worth over $100 million. Yellow Fever is the subject of a major vaccine and monitoring program. However, 2002 and 2003 were marked with two severe viral disease epidemic outbreaks.

The need to be able to easily, cheaply, and quickly diagnose these and other potential outbreak viral infections as public health problems in specific geographic regions, in addition to travel and bioterrorism concern, is driving the commercial development of several viral diagnostics.

This report focuses on diagnostic testing for 10 emerging viral infectious diseases:

  • West Nile Virus (WNV)
  • Severe Acute Respiratory Syndrome (SARS)
  • Hantaviruses
  • Ebola Virus
  • Marburg Virus
  • Crimean Congo
  • Lassa Fever
  • Yellow Fever
  • Japanese Encephalitis
  • Dengue

The main objectives of the study were to forecast testing volume and revenues in various regions and various populations, including human and other species. The report identifies the markets with the most potential for revenue, discusses competitors, and reports on available epidemiology.

Sensitivity, specificity, cost, speed, and volume of testing are all factors that regulate and drive the diagnostic technology development. For the diseases where there are large enough testing volumes, there are commercial diagnostic testing options and development, but otherwise home-brew ELISAs and PCR techniques are used. The technologies being used in the United States and worldwide and the technologies being developed are discussed, including

  • ELISA
  • Immunochromatographic Lateral Flow Strip Test
  • Real Time Polymerase Chain Reaction (RT-PCR)
  • Luminex Protein Bead
  • NASBA
  • AEGIS
  • Transcription Mediated Amplification (TMA)

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 found here. 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.

CHAPTER ONE: EXECUTIVE SUMMARY
  • Introduction
  • Scope and Methodology
  • Summary of Major Findings

CHAPTER TWO: EMERGING VIRAL INFECTIONS

  • West Nile Virus
  • Severe Acute Respiratory Syndrome (SARS)
  • Hantaviruses
  • Viral Hemorrhagic Fevers
    • Ebola Virus
    • Marburg Virus
    • Crimean Congo (CCHF)
    • Lassa Fever
    • Yellow Fever

  • Japanese Encephalitis (JE)
  • West Nile Virus (WNV)
  • Dengue (Group B Arbovirus)

CHAPTER THREE: THE MARKETS & TECHNOLOGIES

  • West Nile Virus
    • U.S. West Nile Virus Testing
    • Canada WNV Testing
    • Mexico WNV Testing

  • HantaVirus
    • Human Hantaviral Testing
    • Rodent Hantavirus Testing

  • Dengue
  • SARS
  • Japanese Encephalitis

CHAPTER FOUR: CONCLUSIONS AND STRATEGIC IMPLICATIONS

  • First Conclusion
  • Second Conclusion
  • Third Conclusion
  • Fourth Conclusion
  • Fifth Conclusion
  • Sixth Conclusion

CHAPTER FIVE: COMPANY PROFILES

  • Abbott Laboratories
  • AccuDX
  • Arup Laboratories
  • Bio Merieux
  • Chiron
  • Cypress Diagnostics
  • Eragen Biosciences, Inc.
  • Focus Technologies, Inc.
  • GeneLabs Diagnostics Pte. Ltd.
  • Gen-Probe
  • Hennessy Research Associates
  • InBIOS International
  • LabCorp
  • Medical Analysis Systems, Inc.
  • MCC Medical and Clinical Consortium
  • Mikrogen
  • Ortho-Clinical Diagnostics/Johnson & Johnson
  • PANBIO
  • PROGEN
  • Quest Diagnostics
  • Roche/Roche Molecular Diagnostics
  • Specialty Labs
  • V.I. Technologies, Inc.

APPENDIX: COMPANY DIRECTORY
List of Exhibits

  • Table 2-1: Number of SARS Cases & Deaths
  • Table 2-2: Estimated number of Hanta Pulmonary Syndrome Cases in American Countries in 2003
  • Table 2-3: Number of Ebola Cases by Country 1976-2003
  • Table 2-4: Number of Suspect Yellow Fever Cases by Year and Country
  • Table 2-5: Number of U.S. Human WNV Cases & Deaths
  • Table 2-6: Number of Dengue Cases in the Americas by Region and Year
  • Table 2-7: Number of Dengue Hemorrhagic Fever (DHF) Cases in the Americas by Region and Year
  • Table 2-8: Number of Dengue Hemorrhagic Fever (DHF) Cases in Asia
  • Table 2-9: Number of DHF Cases in Americas by Country 1981-2002
  • Table 2-10: Dengue/DHF Outbreak Cases
  • Table 3-1: Top Emerging Viral Infectious Disease Testing Revenue by Disease 2001-2008
  • Table 3-2: Top Emerging Viral Infectious Disease Testing Volume by Disease 2001-2008
  • Table 3-3: World West Nile Virus Testing Revenue by Region 2001-2008
  • Table 3-4: World West Nile Virus Testing Volume by Region 2001-2008
  • Table 3-5: U.S. West Nile Virus Testing Revenue by Segment 2001-2008
  • Table 3-6: U.S. West Nile Virus Testing Volume by Category 2001-2008
  • Table 3-7: U.S. Commercial West Nile Virus Testing* Revenue 2001-2008
  • Table 3-8: U.S. Commercial West Nile Virus Testing* Volume 2001-2008
  • Table 3-9: U.S. West Nile Virus Commercial Testing Market Share by Competitor 2002 and 2003
  • Table 3-10: U.S. Human West Nile Virus Commercial Testing Volume by Competitor 2002 and 2003
  • Table 3-11: U.S. Public Health West Nile Virus Testing Revenue by Species 2001-2008
  • Table 3-12: U.S. Public Health West Nile Virus Testing Volume by Species 2001-2008
  • Table 3-13: West Nile Virus Human Testing Volume by State 2001-2003
  • Table 3-14: West Nile Virus Human Testing Revenue by State 2001-2003
  • Table 3-15: U.S. West Nile Virus Avian Testing Volume by State, 2001-2003
  • Table 3-16: U.S. WNV Avian Testing Revenue by State 2001-2003
  • Table 3-17: U.S. WNV Mosquito Testing Volume by State 2001-1003
  • Table 3-18: U.S. WNV Mosquito Testing Revenue by State 2001-2003
  • Table 3-19: U.S West Nile Virus Chicken Testing Volume by State, 2001-2003
  • Table 3-20: WNV Chicken Testing Revenue by State 2001-2003
  • Table 3-21: U.S West Nile Virus Equine Testing Volume by State, 2001-2003
  • Table 3-22: WNV Equine Testing Revenue
  • Table 3-23: Health Canada WNV Testing Revenue by Species 2001-2008
  • Table 3-24: Health Canada WNV Testing Volume by Species 2001-2008
  • Table 3-25: Mexican Ministry of Health WNV Testing Revenue by Species 2001-2008
  • Table 3-26: Mexican Ministry of Health WNV Testing Volume by Species 2001-2008
  • Table 3-27: Hantavirus Testing Revenue by Region 2001-2008
  • Table 3-28: HantaVirus Testing Volume by Region 2001-2008
  • Table 3-29: Dengue Test Manufacturers
  • Table 3-30: Sample of Dengue Test List Prices
  • Table 3-31: Taiwan SARS Testing Volume by Technology 2002-2003
  • Table 3-32: SARS Tests for Sale and in Development by Manufacturer