U.S. Vaccine Markets: Overview and Four Case Studies

Overview

There is intense interest among scholars and the public about the risks, benefits, and pricing of pharmaceuticals—but relatively little attention has been devoted to vaccine markets and the political, economic, and regulatory factors that influence their development. In this important new study, Ernst R. Berndt, Rena N. Denoncourt, and Anjli C. Warner investigate the key business drivers and challenges of vaccine markets, the complex interactions among their important stakeholders, and the emerging opportunities ...

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Overview

There is intense interest among scholars and the public about the risks, benefits, and pricing of pharmaceuticals—but relatively little attention has been devoted to vaccine markets and the political, economic, and regulatory factors that influence their development. In this important new study, Ernst R. Berndt, Rena N. Denoncourt, and Anjli C. Warner investigate the key business drivers and challenges of vaccine markets, the complex interactions among their important stakeholders, and the emerging opportunities for growth. U.S. Markets for Vaccines: Characteristics, Case Studies, and Controversies examines several case studies—including vaccines for diphtheria, tetanus, pertussis, seasonal influenza, chicken pox, and shingles—that demonstrate the diverse dynamics of vaccine markets. The authors consider the role of intellectual property protection in the discovery process, preclinical and clinical development issues, manufacturing and cost characteristics, and the challenges of marketing, product differentiation, pricing, and distribution. They also explore the process of obtaining regulatory approval from the U.S. Food and Drug Administration and earning a spot on the Centers for Disease Control and Prevention's vaccination schedules for pediatric and adult populations. Finally, the authors address the controversial debate over an alleged link between childhood vaccinations and autism. Drawing upon extensive interviews with representatives from industry, insurance providers, government agencies, health-care providers, and academia, U.S. Markets for Vaccines offers a balanced and comprehensive snapshot of the changing landscape for vaccine markets.

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Product Details

  • ISBN-13: 9780844742809
  • Publisher: Aei Press
  • Publication date: 5/15/2009
  • Pages: 250
  • Product dimensions: 6.30 (w) x 8.90 (h) x 0.80 (d)

Meet the Author

Ernst R. Berndt is the Louis E. Seley Professor in Applied Economics at the MIT Sloan School of Management, and a member of the affiliated faculty of the Harvard-MIT Division of Health Sciences and Technology. Rena N. Denoncourt is program manager at Alnylam Pharmaceuticals in Cambridge, Massachusetts. Anjli C. Warner, MBA, is senior associate, Business Analysis and Information, Amgen, Thousand Oaks, California.

Ernst R. Berndt is the Louis E. Seley Professor in Applied Economics at the MIT Sloan School of Management, and a member of the affiliated faculty of the Harvard-MIT Division of Health Sciences and Technology.

Rena N. Denoncourt is program manager at Alnylam Pharmaceuticals in Cambridge, Massachusetts.

Anjli C. Warner, MBA, is senior associate, Business Analysis and Information, Amgen, Thousand Oaks, California.

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Table of Contents

List of Illustrations ix

Acknowledgments xi

Introduction 1

Part I Differentiating Characteristics of Vaccines 5

Introduction to Part I 7

1 Envisaging and Developing a Vaccine 12

Intellectual Property Protection and Other Barriers to Market Entry 12

Preclinical and Clinical Development 14

2 Planning For Vaccine Launch 26

Manufacturing Facility Complexity, Scale Economies, and Costs 26

Coordination with Public Health Officials and Payers 30

Distribution and Delivery Channels and Payers 32

3 Rolling Out the New Vaccine 39

Product Liability Issues 39

Pricing, Product Differentiation, and Marketing 42

Post-Launch Surveillance 52

Industry Structure, Concentration, and Shortages 54

Part II Four Case Studies 61

Introduction to Part II 63

4 Diphtheria, Tetanus, and Pertussis and Related Combination Vaccines 66

Disease Overviews and Treatments 66

Historical Background and Currently Available Formulations 68

Evolution of More Convenient Combination Formulations 72

Rationalizing the Bundled-Product Landscape 73

Manufacturing Issues 75

Pricing and Marketing 76

Post-Launch Surveillance 76

The Long-Term Outlook for the DTP Vaccine Segment 77

5 Seasonal Influenza Vaccines 79

Influenza Disease and Its Treatments 79

Vaccine Development Timelines 80

Thimerosal Preservative Issues 84

Clinical Development: Testing for Safety and Efficacy 86

Manufacturing Developments: Egg-Based versus Cell-Based Production 87

Influenza Vaccine Distribution Issues 94

Extensive Role of Government in Flu Vaccine Supply and Demand 95

Pricing, Marketing, and Nonprice Competition 97

Post-Launch Surveillance 99

Pandemic Issues 101

Future Issues andChallenges 102

6 Prevnar-The Seven-Valent Pneumococcal Conjugate Vaccine 104

Disease Background 104

Preclinical Research and Development 105

Clinical Development: Testing for Safety and Efficacy 106

Manufacturing Issues 107

Securing a Listing on the ACIP Recommended Schedule 109

Pricing and Marketing 110

Post-Launch Surveillance 111

The Evolving Competitive Landscape 112

Emerging Challenges: Replacement Phenomena 114

Implications for the Developing World 115

Conclusion 117

7 Varicella Zoster Vaccines 118

Preclinical Research and Development 120

Clinical Development: Testing for Safety and Efficacy 121

Manufacturing Issues 123

Pricing and Marketing 124

Post-Launch Surveillance 125

Emerging Challenges and Issues 126

Part III Ongoing and Future Issues in Vaccine Policies and R&D 129

Introduction to Part III 131

8 Challenges in Maintaining Public Trust in Vaccine Safety 132

The Autism "Epidemic" 132

The MMR Three-in-One-Jab Panic in the United Kingdom 135

Mercury, Vaccines, and Autism 143

Conclusion: Beyond The Turning Point-The Expanding Focus of Vaccine R&D 156

Appendix A Organizations (and Number of Individuals) Interviewed, February-August 2007 161

Appendix B The Three Traditional Phases of Clinical Development for Vaccines: A Summary 162

Appendix C Advisory Committee on Immunization Practices Recommended Immunization Schedules, 2009 165

Appendix D CDC Pediatric, Adult, and Influenza Vaccine Price Lists, 2008 176

Notes 183

References 205

About the Authors 227

Index 229

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