Infectious Diseases: R&D Challenges and Market Drivers

Published by: CHI Insight Pharma Reports

Published: Sep. 1, 2006 - 200 Pages

Table of Contents

CHAPTER 1 NEW MICROBIAL DEMANDS AND MAJOR DRIVERS OF THE ANTI-INFECTIVE MARKETPLACE

1.1. The Emergence, Re-emergence, and Spread of Infectious Diseases

1.2. The Very Serious Problem of Drug Resistance

1.3. Biodefense

1.4. Technological Growth and Increased Knowledge

1.5. Growing Concerns about Food Safety

1.6. Animal Health

1.7. The Infectious Etiology of Chronic Diseases

CHAPTER 2 THERAPEUTIC CHALLENGES: MICROBES AS MOVING TARGETS

2.1. Introduction

2.2. HIV/AIDS Antiretrovirals: Growth in a Mature Market

2.3. Adding to the Antibiotic Arsenal

Phage Therapy: A New Market Niche for Alternative Antibacterials?

2.4. Bird Flu

The Current Avian Influenza A (H5N1) Outbreak

Influenza Therapeutics

Oseltamivir (Tamiflu)

2.5. Retroviruses: A Global Threat More Serious Than Influenza?

2.6. Vaccine Industry Challenges

Infectious Agent Vaccines for the Prevention of Chronic Disease

Human Papilloma Virus Vaccines

Changing Trends in Vaccine Technology and Targets

New Vaccine Targets

The Race To Make a Universal Influenza Vaccine

M2 Vaccines

NP Vaccines

When Will Plant-Based Vaccines Be Ripe for Marketing?

CHAPTER 3 DOING THE DETECTIVE WORK: INFECTIOUS DISEASE DIAGNOSTICS

3.1. Introduction

3.2. Molecular Diagnostics

Advantages of Molecular Versus Culture-Based Detection

Human Papilloma Virus Testing: The Fastest-Growing Molecular Diagnostic Test

HIV and HCV Viral Load Tests

HCV Testing

3.3. Blood Safety: The Emerging Problem of Bacterial Contamination

Other Blood-Borne Pathogens of Concern

The Emerging Problem of Transfusion-Associated Bacterial Contamination

3.4. The 2003 to 2006 Avian Influenza Outbreak: The Importance of Rapid Diagnostic Testing

Prompt Treatment

Surveillance and WHO Notification

Preventing Dissemination and Opportunities for Viral Evolution

The Ideal Influenza Test

Available Avian Influenza Diagnostic Tests

PCR-Based Nucleic Acid Amplification Tests

Commercial Availability of “Rapid” Tests Still Requiring Validation

CHAPTER 4 COMMERCIAL OPPORTUNITIES: COMFORTABLE NICHES EXIST FOR BOTH BIG PHARMA AND SMALL BIOTECHS

4.1. Introduction

4.2. Patent Expiration and Price Drops

4.3. Antimicrobial Resistance and Market Opportunities

Products and Profitability: Major and Small-Company Players

4.4. Biodefense: A Call to Industry

Opportunities and Challenges for Small Companies Seeking Government Biodefense Contracts

Companies on Government Contract

Finding the Funds

Efforts to Strengthen BioShield: Looking to Large Pharma

4.5. The Present and Future Burden of Infectious Disease

4.6. Finding Your Market Niche

4.7. Neglected Infectious Disease Drug Development: Opportunities for All, Big and Small

Major Neglected Infectious Diseases

Malaria

Tuberculosis

Onchocerciasis

Dengue

Visceral Leishmaniasis

Lymphatic Filariasis

4.8. Collaboration and Consolidation

4.9. The Biggest Challenge Is Basic Science: The Red Queen Race

CHAPTER 5 COMPANY PROFILES

5.1. Acambis

5.2. Adlyfe Inc.

5.3. Akonni Biosystems

5.4. Alnylam Pharmaceuticals

5.5. Arbor Vita Corporation

5.6. Biophage Pharma Inc.

5.7. CEL-SCI Corporation

5.8. CombiMatrix Corporation

5.9. Cubist Pharmaceuticals, Inc.

5.10. Gilead Sciences, Inc.

5.11. NanoBio Corporation

5.12. Nanosphere, Inc.

5.13. Obetech, LLC

5.14. Panacos Pharmaceuticals, Inc.

5.15. PowderMed Limited

5.16. Progenics Pharmaceuticals, Inc.

5.17. Ribomed Biotechnologies, Inc.

5.18. Tanox, Inc.

5.19. Targanta Therapeutics, Inc.

5.20. Tm Bioscience Corporation

APPENDIX

CHA ADVANCES INFECTIOUS DISEASE SURVEY - July/August 2006 (n = 83)

References

Glossary

Company Index with Web Sites

LIST OF TABLES AND FIGURES

Figure 2.1. Survey Results: Outlook for the HIV R&D Market

Figure 4.1. Survey Results: Federal Biodefense Incentives and Decision-Making

Figure 4.2. Survey Results: New Legislation and Decision-Making

Figure 4.3. Survey Results: Modes of Collaboration

Table 1.1. Rank Order of Deaths for the 20 Leading Causes Worldwide, Both in 2002 and in the Future (2030)

Table 1.2. Select List of the More than Two Dozen Human Pathogens Newly Recognized in the Past Few Decades

Table 1.3. Chronic Conditions Associated with Infectious Disease Agents

Table 2.1. Brand-Name Drugs Approved by the U.S. FDA for Use in the Treatment of HIV Infection

Table 2.2. HIV Antiretrovirals in Development

Table 2.3. Select List of Companies Involved in Bacteriophage R&D and the Nature of Their Involvement

Table 2.4. Confirmed Avian Influenza A Outbreaks in Humans since 1997

Table 2.5. Major Infectious Diseases without Controllable Vaccines

Table 2.6. New Vaccine Targets

Table 3.1. Targets of the Top-Selling Infectious Disease Molecular Diagnostic Products

Table 3.2. Cumulative Number of Laboratory-Confirmed Human Cases of Avian Influenza A H5N1 Reported to WHO

Table 3.3. Commercially Available Influenza Rapid Diagnostic Tests

Table 4.1. Generic Antiretroviral Manufacturers in the United States

Table 4.2. Prevalence of Drug Resistance among Some of the More Common Bacterial Human Pathogens

Table 4.3. Total U.S. Federal Government R&D Expenditures by Recipient

Table 4.4. Total U.S. Federal Government Development Expenditures by Recipient

Table 4.5. Projected Trends in Global Years of Life Lost (YLL) per 1,000 (Population Size)

Table 4.6. Proportional Contribution to Total Disease Burden for the 20 Leading Causes of DALYs, Both Now and as Projected in 2030

Table 4.7. Ten Leading Causes of Death, by Income Group, 2030

Abstract

• The emergence of pandemics
• Perceived and actual threat of bioterrorism
• Advances in molecular biology and nanotechnology
• Accumulating evidence that many chronic diseases have an infectious etiology

• Recent developments and opportunities in the infectious disease testing market, which accounts for 80% of the estimated $6.5 billion global molecular diagnostics market
• The vaccines market, which has shed its low-margin image and posted 10-fold growth over the past decade driven by new threats, new technologies, and new targets
• Food safety and the food microbiology testing market
• The expanding market for veterinary drugs and diagnostics
• Niche opportunities in antimicrobial resistance
• Opportunities—and a practical guide to capitalizing on them—in Biodefense
• Neglected disease markets both large and small, including Malaria, TB, Onchocerciasis, Dengue, and more.

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