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Market Research Report

Vaccines for Emerging Infectious Diseases: Funding, R&D, and Global Partnership Strategies

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Vaccines for Emerging Infectious Diseases: Funding, R&D, and Global Partnership Strategies
Published: December 11, 2018 Content info: 125 Pages
Description

Although development of interventions for emerging infectious diseases (EIDs) has traditionally been limited by a lack of market incentives, novel funding mechanisms and global partnerships for outbreak preparedness are expanding the commercial prospects for vaccine developers.

EIDs are uniquely challenging for vaccine development due to unpredictable clinical incidence or geographical patterns. In response to recent global outbreaks, such as the 2013-2016 West African Ebola epidemic, global partnerships have been formed to stimulate vaccine development with a blend of push and pull market incentives. Chief among these are advanced market commitments (AMCs) from health organizations to subsidize vaccine development by purchasing a vaccine before licensure.

The report also finds that 90.2% of marketed or experimental vaccines for major EIDs are still in preclinical or clinical development, leaving significant opportunity for drug developers to enter relatively open disease landscapes for numerous indications.

There is a wide gap in the stage of vaccine development for different EIDs. For instance, there have been 57 planned, ongoing, or completed clinical trials for vaccines to prevent Ebola virus disease, and Merck's Phase III product, V920, is expected to receive FDA approval in 2019. However, the majority of EIDs do not have any licensed vaccine products. Some EIDs including Middle East Respiratory Syndrome (MERS) and Crimean-Congo Hemorrhagic Fever (CCHF) have had experimental vaccines tested in fewer than six clinical trials. Adaptive clinical trial design will play a major role in the pivotal studies of pipeline vaccines for EIDs.

KOLs believe that regulators and vaccine developers are moving towards adaptive clinical trials that factor in rapid surges and declines in disease incidence. Instead of requiring a single large, randomized Phase III trial for vaccine approval, new strategies include collecting and combining data across multiple outbreaks, and expanding avenues for post-marketing studies to evaluate safety and clinical benefit.

The latest report "Vaccines for Emerging Infectious Diseases: Funding, R&D, and Global Partnership Strategies", finds that philanthropic organizations and public-private partnerships like the Coalition for Epidemic Preparedness Innovations (CEPI) are filling a niche for funding translational and clinical vaccine research, allowing development of vaccines for diseases such as Lassa fever to occur even in the absence of an ongoing epidemic. As of November 2018, there were 235 vaccines in preclinical investigation, clinical development, or marketed for twelve major EIDs*.

major EIDs include Zika, Ebola, MERS, Lassa, Marburg, Severe Acute Respiratory Syndrome (SARS), Chikungunya, CCHF, West Nile, Dengue, Yellow Fever, H5N1.

This report covers current and future challenges for the development and deployment of vaccines for EIDs, focusing on vaccine platform technology and research, funding mechanisms, and collaborative global partnerships.

Scope

This report combines key opinion leader insight with in-house analyst expertise and research to provide an insight-rich look at vaccines for emerging infectious diseases in the US, Europe, Asia, and Africa. Components of the report include -

  • Overview of EIDs: Background, drivers of transmission, and overview of key EIDs.
  • Clinical Trial Design: How vaccine for EIDs clinical trials are being designed and what regulatory strategies are being explored.
  • Vaccine Platform Technologies: How the current platform technologies for vaccines compare.
  • Pipeline Assessment for Key EIDs: What are the pipeline vaccine products in development for key EIDs.
  • Funding and Market Incentives: How vaccine development is being incentivized in the public and private spaces.
  • Global Collaborations: How global and public-private partnership organizations are supporting vaccine development.
  • Vaccine Preparedness: The current and future challenges face vaccine preparedness from a surveillance and infrastructure perspective.

Reasons to buy

  • Develop business strategies by understanding the global trends shaping and driving the vaccines for EIDs market
  • Formulate effective sales and marketing strategies by understanding the competitive landscape of various competitors in a niche therapeutic space.
  • Identify areas of unmet need within the vaccines for EIDs market to help drive research and development towards future market opportunities.
  • Gain insights to help plan and design your clinical trials.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments, and strategic partnerships.
  • Identify key funding and partnership strategies.
Table of Contents
Product Code: GDHCHT018

Table of Contents

1. Preface

  • 1.1 Table of Contents 2
  • 1.2 Abbreviations 4
  • 1.3 Related Reports 6
  • 1.4 Upcoming Related Reports 7

2. Executive Summary 8

  • 2.1 Key Findings 9
  • 2.2 KOL Insights on Vaccines for Emerging Infectious Diseases 10

3. Overview of Emerging Infectious Diseases 11

  • 3.1 Defining Emerging Infectious Diseases (EIDs) 13
  • 3.2 Drivers of Emerging Infections & Routes of Transmission 15
  • 3.3 Key EIDs 21
  • 3.4 Ebola Virus Disease 22
  • 3.5 Zika Virus Disease 25
  • 3.6 Middle East Respiratory Syndrome (MERS) and Other EIDs 28

4. Clinical Trial Design 32

  • 4.1 Clinical Trial Design Challenges 34
  • 4.2 Randomization Units 35
  • 4.3 Selection of Clinical Trial Population and Comparator 37
  • 4.4 Additional Strategies for Vaccine Approvals 43
  • 4.5 Unmet Needs in Clinical Trial Design 49

5. Vaccine Platform Technologies 50

  • 5.1 Overview of Vaccine Platform Technologies 52
  • 5.2 Vaccine Platforms By Stage of Development 55
  • 5.3 Live-attenuated Vaccines 56
  • 5.4 Viral Vector-Based Vaccines 57
  • 5.5 DNA Vaccines 58
  • 5.6 Whole-Inactivated Vaccines, Subunit Vaccines, and VLPs 60

6. Funding and Market Incentives 62

  • 6.1 Funding Sources for Vaccines for EIDs 64
  • 6.2 Push and Pull Incentives 65
  • 6.3 Challenges for Funding of Vaccine Development 67
  • 6.4 Lessons from the Ebola and Zika Outbreaks 70

7. Global Collaborations for Vaccine Development 73

  • 7.1 Global Vaccine Development Fund and Priority Diseases 75
  • 7.2 Coalition for Epidemic Preparedness Innovations (CEPI) 78
  • 7.3 Vaccine Preparedness 82
  • 7.4 Global Virome Project (GVP) and Other Public-Private Partnerships 84

8. Pipeline Vaccines for Key Emerging Infectious Diseases 87

  • 8.1 Clinical Development of Vaccines for EIDs 89
  • 8.2 Ebola Vaccine Pipeline 90
  • 8.3 Zika Vaccine Pipeline 94
  • 8.4 MERS-CoV Vaccine Pipeline 98

9. Surveillance and Healthcare Infrastructures 101

  • 9.1 Disease Surveillance for EIDs 103
  • 9.2 Logistical Challenges for Vaccine Delivery 107
  • 9.3 Vaccine Preparedness 109
  • 9.4 Unmet Needs in Basic Vaccine Research 111

10. Appendix 115

  • 10.1 Sources 116
  • 10.2 Methodology 119
  • 10.3 Primary Research 120
  • 10.4 About the Authors 121
  • 10.5 About GlobalData 123
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