Dec 16, 2020   SOURCE: PR NewsWire

Global Seasonal Influenza Vaccines Market Report 2020 - FDA Clears CDC Diagnostic For COVID-19 And Influenza

DUBLIN, Dec. 16, 2020 /PRNewswire/ -- The "Seasonal Influenza Vaccines" report has been added to ResearchAndMarkets.com's offering.

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The seasonal influenza vaccines market in the US, Japan, and five major European markets (France, Germany, Italy, Spain, and the UK) is expected to continue to expand over the next 10 years, largely due to the continued uptake of premium-priced vaccines in the elderly subgroup, including quadrivalent forms of Fluzone High-Dose (HD) and Fluad, as well as the launch of the first-in-class adjuvanted nanoparticle vaccine, NanoFlu.

Further to this, an aging population in the US, Japan, five major European markets, and other developed countries will increase the number of patients in the 65 years age group, where coverage rates are higher. Additionally, the COVID-19 pandemic has prompted an unexpected surge in demand for influenza vaccines due to heightened public awareness of the threat posed by respiratory viruses to the elderly and those with co-morbidities, as well as the potential burden on healthcare services of coinciding COVID and influenza waves.

Three major manufacturers dominate the seasonal influenza vaccines market, namely GlaxoSmithKline, Seqirus, and Sanofi, with 2019 vaccines sales of $684m, $799m, and $2,144m, respectively. Each company saw increased sales in 2018 and 2019, with GlaxoSmithKline (Fluarix and Flulaval), Sanofi (Fluzone, Fluzone HD, Vaxigrip, and Flublok), and Seqirus (Afluria, Agrippal, Fluad, and Flucelvax) growing by 3%, 7%, and 19%, respectively. Additionally, AstraZeneca is a minor player in the market with only one marketed vaccine, FluMist QIV, which has struggled since negative CHMP recommendations in the 2016/17 and 2017/18 seasons, as well as manufacturing issues in the 2019/20 season.

Vaccines produced by the traditional egg-based method including Afluria/Agrippal (CSL), Fluarix/Flulaval (GlaxoSmithKline), and Fluzone/Vaxigrip (Sanofi) collectively hold the greatest share of the seasonal influenza market and are primarily used outside of the lucrative elderly subgroup, where other vaccines that have demonstrated superior effectiveness to standard dose inactivated vaccines (Fluzone HD, Fluad, Flucelvax, and Flublok) have been gaining increasing uptake in recent years. As there is no differentiation between the standard dose inactivated vaccines with regard to effectiveness or safety, uptake is primarily based on marketing and manufacturing capabilities, as well as competitive tendering processes. Egg-based vaccines have the disadvantage of long production timelines, and the viral HA antigens are prone to mutations during the egg-based replication process. On the other hand, recombinant or cell-based vaccines have faster production timelines and a reduced risk of HA mutations, leading to potentially superior protection.

There are two non-egg-based vaccines on the market, Sanofi's recombinant HA protein vaccine Flublok QIV, and Seqirus's cell-based vaccine Flucelvax QIV, with the latter having the benefit of a broader label in the US (individuals aged 4 years versus aged 18 years for Flublok). There is growing evidence that Flublok's and Flucelvax's egg-free production process (and subsequent lack of egg-based mutations that can lead to the produced HA antigens differing from those of circulating strains) results in superior real-world effectiveness compared to inactivated egg-based vaccines, particularly in the elderly where vaccine effectiveness is suboptimal. Both Flucelvax QIV and Flublok QIV are expected to experience sales growth following anticipated regulatory approvals in the EU in Q4 2020. Approval of Flublok QIV in the EU will allow the vaccine to compete against Flucelvax QIV, Fluad QIV, and Sanofi's own Efluelda QIV in the elderly segment from the 2021/22 season, where all vaccines have shown evidence of increased effectiveness compared to standard dose inactivated vaccines.

The 2020 EU approvals of CSL's Fluad QIV and Sanofi's Fluzone HD QIV mark significant opportunities for both manufacturers. Within Europe, Fluad possesses first-to-market advantage and benefits from a preferential recommendation for use in the elderly in the UK. Historical manufacturing capacity issues prevented Sanofi from marketing Fluzone HD outside of the US, but after investing in increasing its manufacturing capacity, Sanofi has now decided to market the vaccine in additional regions including Europe, posing a significant threat to Fluad's European dominance of the elderly segment. Given the lack of head-to-head trials comparing Fluad and Fluzone HD, competitive pricing will be paramount for Fluad to maintain its market share.

NanoFlu, a first-in-class nanoparticle vaccine, is the most advanced asset in the influenza pipeline. Novavax expects to file a BLA in Q4 2020, with subsequent approval in mid-2021 (due to fast track status), and a probable launch in the 2022/23 influenza season. The vaccine will be approved based on a Phase III trial showing superior immunogenicity in the elderly compared to standard dose Fluzone; however, a confirmatory efficacy study post-approval will be required, most probably against Fluzone HD. Based on promising immunogenicity against both vaccine homologous and historically drifted strains, the publisher expects NanoFlu will be a strong competitor for Fluzone HD, Flublok, and Fluad in the elderly segment, but much will depend on the outcome of the confirmatory efficacy study as some physicians/payers will not be willing to infer that improved immunogenicity necessarily results in improved real-world protection.

There is a high unmet need in the influenza space for a universal influenza vaccine which offers protection against a broader variety of strains, ideally over several seasons, though at this stage it is unclear how long any protective effect would last. Additionally, universal vaccines should be able to provide protection against new pandemic strains that may arise, which the seasonal influenza vaccine is unable to do.

Despite positive immunogenicity data from Phase I and Phase II clinical trials, in October 2020 BiondVax reported that its universal vaccine candidate M-001 had failed to demonstrate efficacy in its pivotal Phase III trial. Based on these negative data and the company's lack of funding to initiate a new trial, the publisher expects that BiondVax will discontinue the vaccine shortly. Although Imutex's FLU-v is now the most advanced universal vaccine in development, progress is currently stalled while the company seeks a partner to fund a pivotal trial, and therefore it seems that the earliest a universal vaccine will reach the market is 2024.

Key Topics Covered:

OVERVIEW

    --  Latest key takeaways

DISEASE BACKGROUND

    --  Definition
    --  Symptoms
    --  Risk groups

RECOMMENDED VACCINES

US

    --  Five major European markets
    --  Seasonal influenza vaccination recommendations, by country

MARKETED VACCINES

PIPELINE VACCINES

KEY REGULATORY EVENTS

    --  Sanofi Seeks Double Vaccine Approval Nod In EU
    --  FDA Clears CDC Diagnostic For COVID-19 And Influenza
    --  Audenz Brings Cell-Based Manufacturing To Pandemic Influenza

PROBABILITY OF SUCCESS

CLINICAL TRIAL LANDSCAPE

    --  Sponsors by status
    --  Sponsors by phase
    --  Recent events

VACCINE ASSESSMENT

    --  Overview
    --  Standard dose, egg-based inactivated vaccines
    --  Live-attenuated vaccine
    --  Vaccines for the elderly
    --  Pipeline vaccines
    --  Universal influenza vaccine
    --  Pipeline live-attenuated vaccine

MARKET DYNAMICS

FUTURE TRENDS

    --  Completion of conversion to QIVs will drive incremental growth
    --  Retrospective analysis showing superior effectiveness of Fluzone HD to
        Fluad in the elderly will help Sanofi retain US market share
    --  NanoFlu is expected to achieve high uptake due to its superior efficacy
        over standard influenza vaccines
    --  Universal vaccines could begin to replace the current standard of care

CONSENSUS FORECASTS

RECENT EVENTS AND ANALYST OPINION

    --  NanoFlu for Seasonal Influenza Vaccines (March 24, 2020)

KEY UPCOMING EVENTS

UNMET NEEDS

BIBLIOGRAPHY

    --  Prescription information

APPENDIX

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