DUBLIN–(BUSINESS WIRE)–The “Meningococcal Vaccines Disease Coverage Forecast and Market Analysis to 2024” report has been added to ResearchAndMarkets.com’s offering.
Market growth will be driven by the uptake of pentavalent vaccines, which could significantly boost coverage for the MenB component by linking the higher coverage rates observed with the booster dose of MenACWY in adolescents (53.7% in 2019) to the suboptimal coverage rates with MenB vaccines (21.8% of 17-year-olds received at least one MenB dose in 2019). The pentavalent vaccines would also be more convenient for physicians and patients as they would reduce the total number of doses required during adolescence from four (two MenACWY + two MenB) to three.
The five major European markets (France, Germany, Italy, Spain, and the UK) are expected to experience anemic growth over the forecast period because pentavalent vaccines have much lesser appeal within the EU. Indeed, unlike the US market, none of the five major European markets routinely recommend both MenACWY and MenB vaccines in adolescents, meaning that the introduction of pentavalent vaccines would necessitate increased costs and add further complexity to immunization schedules, which would therefore be unlikely to be routinely reimbursed if approved.
While new Spanish recommendations for routine use of MenACWY vaccines in adolescents aged 12 years and one-off catch-up vaccination for adolescents aged 13-18 years will drive a short-term increase in sales, weak growth in other markets will be dependent on incremental increases in vaccination coverage rates (primarily for Bexsero and MenACWY in Italy).
Menactra currently dominates the lucrative MenACWY US market on account of its first-to-market status and more convenient presentation (ready-to-inject liquid) compared to Menveo (lyophilized MenA component that must be reconstituted with liquid MenCWY components before injection). Within the five major European markets, where Menactra is not approved, Nimenrix dominates over Menveo, but the sales potential of the class is limited as France and Germany restrict MenACWY reimbursement to niche groups considered at risk of invasive meningococcal disease (IMD).
MenQuadfi is Sanofi’s successor vaccine to Menactra and will act to broaden the company’s target markets to include the EU following its anticipated EU launch in 2021 (approval occurred in November 2020). MenQuadfi has demonstrated superior immunogenicity for all four serogroups compared to Menveo when administered as a primary dose in adolescents aged 10-17 years, as well as superior immunogenicity compared to Menactra for serogroups A, C, and W-135 when administered as a booster dose in adolescents and adults. Thus, with compelling immunogenicity data in both of the key market segments for MenACWY vaccines, MenQuadfi is expected to erode the market shares of both incumbents. However, a concerted marketing effort will be required given physician inertia and the lack of data showing that the improved immune response translates into superior protection (such a trial would not be feasible due to the low incidence of IMD necessitating an impractically large sample size).
Within the US, GlaxoSmithKline’s Bexsero competes against Pfizer’s Trumenba in individuals aged 10-25 years and has captured the majority of MenB market share because of its more convenient dosing schedule. Bexsero is recommended in a two-dose schedule where the doses only have to be separated by one month, while Trumenba must be administered in a two-dose schedule separated by six months (for adolescents aged 16-23 years), or in a three-dose schedule (at 0, 1, and 6 months) if patients are considered at high risk of IMD.
GlaxoSmithKline hopes to increase Bexsero’s sales with a US indication expansion for use in infants, though an ongoing Phase III trial in this group is not expected to reach primary completion until July 2024. If approved for infants, positive real-world effectiveness data from the UK market could be presented to convince the ACIP to make a Category A recommendation for routine use of Bexsero (a lack of efficacy data was a key driver of the weaker Category B recommendation in adolescents), which would be very lucrative for GlaxoSmithKline as a multi-dose schedule is required and high coverage rates are typically achieved in infants.
There is very limited activity in the meningococcal vaccines pipeline, with only three candidates in clinical-stage development in the US, Japan, and five major European markets. GlaxoSmithKline and Pfizer are both developing pentavalent vaccines, MenABCWY and PF-06886992, respectively, which aim to partially or completely replace separate MenACWY and MenB vaccines for adolescents in the lucrative US market.
The overall likelihood of approval of a Phase I antibacterial, mycobacterial, or fungal asset is 19.1%, and the average probability an asset advances from Phase III is 60.8%. Antibacterial, mycobacterial, or fungal assets take 9.5 years on average from Phase I to approval, slightly longer than the 9.0 years in the overall infectious disease space.
Key Topics Covered:
- Latest key takeaways
- Diagnostics and screening
- Risk factors
- Vaccination guidelines in major markets
PROBABILITY OF SUCCESS
CLINICAL TRIAL LANDSCAPE
- Sponsors by status
- Sponsors by phase
- Meningococcal ACWY vaccines
- Meningococcal B vaccines
- Pipeline pentavalent vaccines
KEY OPINION LEADER INSIGHTS
- MenACWY vaccines
- Pentavalent vaccines
- MenB vaccines
- Improvements in meningococcal vaccination coverage rates in at-risk populations
- Vaccines with more durable humoral responses
- Improvements in MenB vaccination coverage rates in US adolescents and young adults
- Prescription information
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Laura Wood, Senior Press Manager
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