Market Report Source

Overview

The purpose of this TriMark Publications report is to describe the threatening world pandemic caused by avian influenza, also known as bird flu. This report discusses the origins of the disease, the bird-to-human infection risks, the catastrophic health crisis avian flu poses, and the efforts by world governments and international health organizations to mitigate of the impact the threat to humans.

The U.S., Asia and Europe are the focus of this study. Primary attention is paid to the clinical market segment and, separately, to the medical procedures and supplies for the influenza infection control market. An analysis of the technology trends and developing areas of influenza infection science is provided, along with a review of the market for pharmaceutical agents, vaccines and hospital supplies in clinical use. Activity in research-including the factors that influence infection control-are addressed in this review. Also discussed are changes that have stimulated this disease and patterns of information processing in assessing its spread. Several subjects related to the major elements of influenza treatment such as disposable plastic supplies, needles and lancets are discussed only briefly because they are considered entirely different fields or markets.

The goal of this report is to review the potential threat of a human influenza pandemic resulting from the avian flu virus. It defines the responses that are now being undertaken worldwide by governmental authorities to contain the spreading bird flu. Specifically, this study contains:

• A comprehensive overview of the several categories of anti-influenza technology platforms that are or will be revolutionizing flu related healthcare in hospitals.

• Full descriptions of the public health measures involved in controlling the spread of avian influenza and the prevention of cross infection to humans.

• Analysis of the technological approaches undertaken by various world governments, as well as industry and end-user response to these ideas.

• Regulatory issues and legislation affecting use and marketing of influenza prevention and treatment products.

• Forecasts for each category of infection control.

Table of Contents

1. Overview
1.1 Statement of Report
1.2 Scope of Report
1.3 Objectives
1.4 Methodology
1.5 Executive Summary

2. The Basics of Human Influenza
2.1 Influenza, the Disease
2.1.1 Symptoms
2.1.2 Transmission
2.1.3 Public Health Factors
2.1.4 Influenza Diagnosis
2.2 Influenza Viruses
2.2.1 Types, Subtypes and Strains
2.2.1.1 Influenza Type A and its Subtypes
2.2.1.2 Highly Pathogenic versus Lowly Pathogenic Avian Influenza A Viruses
2.2.1.3 Human Influenza Viruses and Avian Influenza A Viruses
2.2.1.3.1 Influenza A H5
2.2.1.3.2 Influenza A H7
2.2.1.3.3 Influenza A H9
2.2.1.4 Influenza Type B
2.2.1.5 Influenza Type C
2.2.2 How Influenza Viruses Change: Drift and Shift
2.2.3 Seasons and Human Influenza
2.2.4 Risk Factors and Human Influenza
2.2.5 Human Influenza Complications, Comorbidities and Dangers
2.2.5.1 Flu complications in children and teenagers
2.2.6 Human Influenza Prognosis
2.3 Pandemic Influenza
2.4 How Influenza Viruses Change

3. The Basics of Avian Influenza
3.1 Avian Influenza in Birds
3.1.1 Avian Influenza Outbreaks in Poultry
3.1.2 More Information About Avian Influenza Viruses
3.2 Transmission of Influenza A Viruses between Animals and People
3.3 Avian Influenza Infection in Humans
3.3.1 Instances of Avian Influenza Infection in Humans
3.3.2 Symptoms of Avian Influenza in Humans
3.3.3 Antiviral Agents for Influenza
3.4 Avian Influenza (H5N1)
3.4.1 Avian Influenza (H5N1) Outbreaks
3.5 All Types of Avian Influenza Worldwide Outside of Asia
3.5.1 Canada
3.5.2 Netherlands
3.5.3 United States
3.5.3.1 Delaware
3.5.3.2 Texas
3.5.3.3 Maryland
3.5.3.4 International Response
3.5.3.5 Available Options

4. Epidemiology of Avian Influenza
4.1 Worldwide Avian Influenza
4.2 H5N1 Avian Influenza: Timeline
4.3 U.S. Avian Influenza

5. Influenza Diagnosis and Laboratory Issues
5.1 “Classic” Methods for Influenza Diagnosis
5.2 Example Lab: Yale New Haven Hospital (YNHH)
5.3 Conventional PCR Assay for Sub-typing Influenza Virus
5.3.1 Gel Analysis
5.4 Real Time TaqMan PCR
5.4.1 From PacMan to TaqMan-A Computer Game Revisited
5.4.2 The Advantages of Real-Time TaqMan PCR Over Conventional Quantitative PCR
5.5 Example Strategy for Avian Influenza
5.6 Laboratory Safety Issues for H5N1 Viruses
5.6.1 Biosafety Level 3
5.6.2 Biosafety Level 3-Ag
5.6.3 CDC Criteria for Testing
5.6.4 What Samples Are Needed?

6. Preparedness
6.1 Education
6.2 Ethical and Legal Issues
6.3 Worldwide
6.3.1 Overarching Goals, Objectives and Actions for WHO and National Authorities, by Phase
6.3.1.1 Interpandemic Period, Phase 1-Overarching Goal
6.3.1.2 Interpandemic Period, Phase 2-Overarching Goal
6.3.1.3 Pandemic Alert Period, Phase 3-Overarching Goal
6.3.1.4 Pandemic Alert Period, Phase 4-Overarching Goal
6.3.1.5 Pandemic Alert Period, Phase 5-Overarching Goal
6.3.1.6 Pandemic Period, Phase 6-Overarching Goal
6.3.2 Recommendations for Non-Pharmaceutical Public Health Interventions
6.4 U.S.
6.4.1 U.S. National Plan
6.4.2 U.S. Locally
6.4.2.1 Community Preparedness Leadership and Networking
6.4.2.2 Surveillance
6.4.2.3 Public Health and Clinical Laboratories
6.4.2.4 Healthcare and Public Health Partners
6.4.2.5 Infection Control and Clinical Guidelines
6.4.2.6 Vaccine Distribution and Use
6.4.2.7 Antiviral Drug Distribution and Use
6.4.2.8 Community Disease Control and Prevention
6.4.2.9 Public Health Communications
6.4.2.10 Workforce Support: Psychosocial Considerations and Information Needs
6.4.2.11 State Plans
6.5 The Hospital Response
6.5.1 Introduction
6.5.2 Key Assumptions
6.5.3 Arrival
6.5.4 Triage
6.5.5 Isolation
6.5.6 Patient Movement
6.5.7 Communication
6.5.8 Medical Evaluation
6.5.9 Diagnosis
6.5.10 Treatment
6.5.11 Potential for Surge
6.6 Business Preparedness
6.7 School Preparedness
6.8 Individual Preparedness

7. Economics of Avian Influenza
7.1 Impact on Governments
7.1.1 Worldwide Economic Impact of Avian Flu
7.1.2 U.S. Nationally
7.2 Impact of a Pandemic
7.2.1 Supply Side Effect
7.2.2 Demand Side Effect

8. Fighting the Flu
8.1 The Worldwide Pharmaceutical Industry
8.1.1 FDA Approved Vaccines: Tamiflu and Relenza
8.1.2 Stockpiling
8.1.3 Total Avian Influenza Drug Market Size and Growth
8.2 Funding
8.3 Antiviral Agents for Influenza: Background Information
8.3.1 Introduction
8.3.1.1 Antiviral Usage Recommendation-2005-06
8.3.2 Neuraminidase Inhibitors (Zanamivir, Oseltamivir)
8.3.3 How do the Neuraminidase Inhibitor Drugs Work?
8.3.4 How Effective are the Neuraminidase Inhibitor Drugs?
8.3.4.1 Treatment
8.3.4.2 Chemoprophylaxis
8.3.4.3 Side Effects of the Neuraminidase Inhibitor Drugs
8.3.4.4 Antiviral Resistance to the Neuraminidase Inhibitor Drugs
8.3.5 Adamantane Derivatives (Amantadine, Rimantadine)
8.3.5.1 Antiviral Activity: How do the Adamantane Drugs Work?
8.3.5.2 How Effective are the Adamantane Drugs?
8.3.5.2.1 Treatment
8.3.5.2.2 Chemoprophylaxis
8.3.5.3 Side Effects of the Adamantane Drugs
8.3.5.4 Antiviral Resistance
8.3.6 Adamantanes Compared with Neuraminidase Inhibitors
8.3.7 Anti-Avian Influenza Drugs, Generics and Patents
8.3.7.1 Taiwan
8.3.7.2 India
8.3.7.3 Other Countries
8.3.8 Regulatory Issues
8.3.9 New Anti-Avian Influenza Therapy
8.3.10 Pharmaceutical Business Perspective
8.3.10.1 A Market Dominated by GSK and Roche
8.3.10.2 Generic Presence
8.3.10.3 Challenging Tamiflu
8.4 Other Treatment Requirements
8.5 Business Opportunities

INDEX OF FIGURES

Figure 2.1: Influenza Subtypes
Figure 2.2: Timeline of Emergence of Influenza A Viruses in Humans
Figure 2.3: Model of the Emergence of a Pandemic Virus
Figure 3.1: Map of H5N1 Instances and Asian Migratory Bird Zones
Figure 3.2: Map of H7N3 in British Columbia
Figure 4.1: Nations with Confirmed Cases of H5N1 Avian Influenza
Figure 4.2: World: Affected Areas with Confirmed Cases of H5N1 Avian Influenza Since 2003
Figure 4.3: World: Affected Areas with Confirmed Cases of H5N1 Avian Influenza Since January 2006
Figure 4.4: World: Areas Reporting Confirmed Occurrence of H5N1 Avian Influenza in Poultry and Wild Birds Since January 2006
Figure 4.5: World: Areas Reporting Confirmed Occurrence of H5N1 Avian Influenza in Poultry and Wild Birds Since 2003
Figure 4.6: Waterfowl Flyways of North America
Figure 5.1: FDA-approved Kit-based Test
Figure 5.2: Immunofluorescence-based Detection
Figure 5.3: Uninfected and Infected Tissue Cultures
Figure 5.4: TEM of Negatively Stained Influenza Virions (from Cultures)
Figure 5.5: PCR Assay Graphic
Figure 5.6: PCR assay
Figure 5.7: “Amplicon” Generation
Figure 5.8: The TaqMan 5’-3’ Nuclease Assay
Figure 5.9: TaqMan Amplification Plot
Figure 5.10: TaqMan Fluorescent Reaction Components
Figure 5.11: Biosafety Level 3-Ag-Full Tyvek Body Suit
Figure 6.1: Signage: Informing Staff
Figure 6.2: Signage: Informing Patients
Figure 6.3: Respiratory Etiquette Kit
Figure 6.4: Isolation
Figure 6.5: Communication Scheme
Figure 6.6: Surge

INDEX OF TABLES

Table 2.1: Probability of Influenza Diagnosis Using Office-Based Testing
Table 2.2: Prescribing Guidelines for Treating Influenza
Table 2.3: Influenza Virus Types
Table 2.4: H5N1 Cases and Deaths, 2003-2005
Table 4.1: Phase 3 is the Current WHO Phase of Alert
Table 4.2: Cumulative Number of Confirmed Human Cases of Avian Influenza A/(H5N1) Reported to WHO, 2003-2006
Table 4.3: Early (Pre Wave I) Events in Asia, 1996, 1997 and 2003
Table 4.4: Wave I
Table 4.5: Wave II
Table 4.6: Wave III
Table 5.1: Methods for Influenza Diagnosis
Table 5.2: Summary of Current Clinical Virology Laboratory Tests for Influenza
Table 6.1: Interpandemic Period, Phase 1-Planning and Coordination
Table 6.2: Interpandemic Period, Phase 1-Prevention and Containment
Table 6.3: Interpandemic Period, Phase 1-Health System Response
Table 6.4: Interpandemic Period, Phase 1-Communications
Table 6.5: Interpandemic Period, Phase 2-Planning and Coordination
Table 6.6: Interpandemic Period, Phase 2-Situation Monitoring and Assessment
Table 6.7: Interpandemic Period, Phase 2-Prevention and Containment
Table 6.8: Interpandemic Period, Phase 2-Health System Response
Table 6.9: Interpandemic Period, Phase 2-Communications
Table 6.10: Pandemic Alert Period, Phase 3 – Planning and Coordination
Table 6.11: Pandemic Alert Period, Phase 3-Situation Monitoring and Assessment
Table 6.12: Pandemic Alert Period, Phase 3-Prevention and Containment
Table 6.13: Pandemic Alert Period, Phase 3-Health System Response
Table 6.14: Pandemic Alert Period, Phase 3-Communications
Table 6.15: Pandemic Alert Period, Phase 4-Planning and Coordination
Table 6.16: Pandemic Alert Period, Phase 4-Situation Monitoring and Assessment
Table 6.17: Pandemic Alert Period, Phase 4-Prevention and Containment
Table 6.18: Pandemic Alert Period, Phase 4-Health System Response
Table 6.19: Pandemic Alert Period, Phase 4-Communications
Table 6.20: Pandemic Alert Period, Phase 5-Planning and Coordination
Table 6.21: Pandemic Alert Period, Phase 5-Situation Monitoring and Assessment
Table 6.22: Pandemic Alert Period, Phase 5-Prevention and Containment
Table 6.23: Pandemic Alert Period, Phase 5-Health System Response
Table 6.24: Pandemic Alert Period, Phase 5-Communications
Table 6.25: Pandemic Period, Phase 6-Planning and Coordination
Table 6.26: Pandemic Period, Phase 6-Situation Monitoring and Assessment
Table 6.27: Pandemic Period, Phase 6-Prevention and Containment
Table 6.28: Pandemic Period, Phase 6-Health System Response
Table 6.29: Pandemic Period, Phase 6-Communications
Table 6.30: National Measures (Living or Traveling Within an Affected Country)
Table 6.31: International Measures (for Entering or Exiting a Country)
Table 6.32: State and Local Planning Checklist-Community Preparedness Leadership and Networking
Table 6.33: State and Local Planning Checklist-Surveillance
Table 6.34: State and Local Planning Checklist-Public Health and Clinical Laboratories
Table 6.35: State and Local Planning Checklist-Healthcare and Public Health Partners
Table 6.36: State and Local Planning Checklist-Healthcare and Public Health Partners
Table 6.37: State and Local Planning Checklist-Vaccine Distribution and Use
Table 6.38: State and Local Planning Checklist-Antiviral Drug Distribution and Use
Table 6.39: State and Local Planning Checklist-Community Disease Control and Prevention
Table 6.40: State and Local Planning Checklist-Public Health Communications
Table 6.41: State and Local Planning Checklist-Workforce Support: Psychosocial Considerations and Information Needs
Table 6.42: Arrival
Table 6.43: Triage
Table 6.44: Isolation
Table 6.45: Patient Movement
Table 6.46: Communication
Table 6.47: Medical Evaluation
Table 6.48: Diagnosis
Table 6.49: Treatment
Table 6.50: Surge
Table 6.51: Plan for the Impact of a Pandemic on Your Business
Table 6.52: Plan for the Impact of a Pandemic on Your Employees and Customers
Table 6.53: Establish Policies to be Implemented During a Pandemic
Table 6.54: Allocate Resources to Protect Your Employees and Customers During a Pandemic
Table 6.55: Communicate to and Educate Your Employees
Table 6.56: Coordinate with External Organizations and Help Your Community
Table 6.57: Planning and Coordination:
Table 6.58: Continuity of Student Learning and Core Operations
Table 6.59: Infection Control Policies and Procedures
Table 6.60: Communications Planning
Table 6.61: Items to have on Hand for an Extended Stay at Home
Table 6.62: Immunizations FAQ
Table 6.63: WHO Global Plan for Pandemic Preparedness
Table 7.1: Assumptions Underlying Estimates of the Supply-Side Impact of an Avian Flu Pandemic
Table 7.2: Assumed Declines in Demand, by Industry, in the Event of an Avian Flu Pandemic
Table 8.1: Top 30 Pharmaceutical and Biotech Companies Ranked by Healthcare Revenue (“Big Pharma”)
Table 8.2: Recommended Daily Dosage of Influenza Antiviral Medications for Treatment and Prophylaxis
Table 8.3: Examples of Preparedness Supplies