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R&D Trends: Influenza vaccines - Commoditization limits opportunities in a crowded market

Abstract

Introduction

In the last two post-pandemic years and with a number of seasonal influenza vaccines available, the race for novel influenza vaccine candidates has slowed somewhat. Pipeline candidates try to address further unmet needs, but novel technologies might struggle against the uncertainty regarding the next pandemic influenza strain and the increasing commoditization of the influenza markets.

Features And Benefits

• Discussion of seasonal, pandemic and universal influenza vaccine pipelines
• Analysis of innovative new approaches in influenza vaccine development
• Discussion of clinical trial design and the target product profile (TPP) for influenza vaccines
• Analysis of future strategic opportunities and threats in a competitive influenza vaccine market

Highlights

Novel products will further drive the commoditization of the influenza vaccine market and enhance the already fierce competition. It will also increase the pressure on innovative earlier-stage products such as DNA-based influenza vaccines which will have to show a clear benefit over existing products if they want to compete for market share.

Datamonitor identified 22 compounds in the clinical seasonal influenza vaccine pipeline, with a diminishing number of later-stage products. With 28 candidates in development, the pandemic influenza vaccine pipeline is more robust. However, this also reflects the prevailing uncertainty about which strains are most likely to cause another pandemic.

Pipeline influenza vaccines particularly try to address limitations associated with the amount of available vaccine, vaccine production timelines, strain coverage and vaccine efficacy. While a number of universal influenza vaccine candidates have reached clinical development, none has yet been able to progress beyond Phase II clinical trials.

Your Key Questions Answered

• Get an overview of the pipelines for seasonal, pandemic and universal influenza vaccines
• Recognize development trends in influenza vaccines development and innovative earlier-stage approaches
• Understand opportunities and threats for influenza vaccine manufacturers and identify promising strategies to tackle future challenges

Table of Contents

Executive Summary

   Strategic scoping and focus
   Datamonitor key findings
   Related reports

OVERVIEW

   Catalyst
   Summary

CLINICAL PIPELINE OVERVIEW

   Novel influenza vaccine candidates have to address unmet needs if they want to be commercially attractive
      Adjuvants can enhance immunogenicity and allow "dose-sparing"
      Cell-culture techniques could allow faster and more flexible vaccine production
      Needle-free administration techniques could allow for faster and more convenient vaccination
      Moving on from the split/subunit design: next-generation influenza vaccines
      Novel live-attenuated vaccines promise better immunogenicity balanced with safe attenuation
   Seasonal influenza vaccines
      A crowded market leads to a diminishing pipeline
      Quadrivalent vaccines are being developed to improve protection against influenza B virus
   Pandemic influenza vaccines
   Universal influenza vaccines

TARGET PRODUCT PROFILE

   Fluzone (trivalent inactivated influenza vaccine; Sanofi Pasteur)
      Tougher competition could lead to higher regulatory hurdles for the approval of influenza vaccines

CLINICAL TRIAL DESIGN IN INFLUENZA VACCINES

   Preclinical trials
   Clinical trials for influenza vaccines
      US and EU guidelines offer guidance for the clinical development of influenza vaccines
      Most clinical trials for new influenza vaccines rely on surrogate endpoints as markers of protection
      Other endpoints: pre-licensure trials use surrogate endpoints to prove immunoprotection against influenza
      Adjuvanted influenza vaccines require additional evidence
      There are several opportunities to achieve accelerated regulatory approval for influenza vaccines
      Comparison with marketed vaccines is the norm in influenza vaccine development
   Future developments in clinical trial design

INNOVATIVE APPROACHES IN INFLUENZA VACCINE DEVELOPMENT

   Recombinant protein vaccines
   Virus-like particles, virosomes, and liposomes
   Viral vector vaccines
   DNA-based vaccines

THE FUTURE OF INFLUENZA VACCINES

   Adjuvanted and cell-based vaccines will further drive the commoditization of the influenza market
   The future of quadrivalent influenza vaccines largely depends on a positive cost-benefit profile
   Vaccines based on novel technologies face a highly commoditized and competitive market
   Universal influenza vaccines are theoretically attractive but still far from reaching the market

BIBLIOGRAPHY

   Journal papers
   Websites

Appendix

   Contributing experts
   Conferences attended
   Report methodology
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