感染症における研究開発の課題と市場促進要因

Abstract

Global sales of anti-infective drugs reached $44.5 billion in 2005 and will likely double over the next 5 years. Antibiotics led the category at $31 billion. Infectious Diseases: R&D Challenges and Market Drivers, a new CHA Advances report, analyzes the factors driving infectious disease therapeutic and diagnostic markets, the key business and technology trends, targets and drugs in development, companies at the forefront of anti-infective R&D, and the commercial opportunities and challenges of anti-infective drugs and vaccines.

Past hurdles to pursuing anti-infective drug development―including historically low margins, short therapeutic regimens, manufacturing challenges, and regulatory problems associated with developing drugs for "unvalidated" microbial targets―are no longer discouraging entrants. Big Pharma has rediscovered the anti-infectives market and is bolstering its pipelines through licensing agreements and acquisitions. And smaller, less risk-aversive biopharmaceutical companies have discovered the allure of substantial profits while also meeting public health goals. A quantitative survey (commissioned by CHA in July/August 2006, N=83) of individuals involved in infectious disease R&D and business development sheds light on the research priorities and R&D trends in industry, government, and academia.

The evolution of drug resistance is the most powerful driver of anti-infective R&D. Other factors fueling research that are assessed in the report include:

• 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

Infectious Diseases: R&D Challenges and Market Drivers drills down into the emerging commercial opportunities, providing expert insight into:

• 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.

Individuals in R&D, business development, strategic planning, and marketing will benefit from the hundreds of hours of primary and secondary research that went into Infectious Diseases: R&D Challenges and Market Drivers.

About the Author

Leslie A. Pray, PhD, is a science writer and consultant to the Forum on Microbial Threats at the National Academy of Sciences. She has written extensively on a range of genetic, biotechnology, infectious disease, public health policy, and higher education issues for The Scientist, Genomics and Proteomics, The Chronicle of Higher Education, Orion, the American Chemical Society, the American Association for the Advancement of Science, Oak Ridge National Laboratory, and the CBR Institute for Biomedical Research, among others. Dr. Pray received her PhD in population genetics from the University of Vermont and her BA degree from the University of California , Berkeley. An elected member of Sigma Xi, she has been the recipient of numerous scientific research awards, including an American Society of Naturalists Young Investigator Award and a National Science Foundation Environmental Biology Postdoctoral Fellowship. Dr. Pray can be reached at lpray@nasw.org .

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