DUBLIN--(BUSINESS WIRE)--The "Pneumococcal Vaccines Market and Forecast Analysis to 2024" report has been added to ResearchAndMarkets.com's offering.
Streptococcus pneumoniae (S. pneumoniae) is a bacterium that can cause multiple types of pneumococcal disease, including bloodstream infections (sepsis), pneumonia, meningitis, and other milder diseases such as sinusitis and otitis media. The severity of pneumococcal disease is characterized as invasive or non-invasive, with invasive pneumococcal disease being more severe as the bacterium can be isolated from ordinarily sterile sites (e.g. blood or cerebrospinal fluid), and requires hospital treatment.
- The value of the pneumococcal vaccines market will steadily grow over the forecast period due to increasing elderly populations across France, Spain, and the US, alongside continued short-term price increases in the lucrative US market. A brief period of increased growth is expected with the anticipated launch of the 20-valent vaccine, PF-06482077, which may replace Prevnar 13 and Pneumovax 23 in adults due to its broader serotype coverage, but its Phase III program is yet to include infants. Overall, the biggest opportunity for short-term growth within the pneumococcal vaccines market is associated with increasing vaccination rates within the elderly in the US and Italian markets; however, the 2019 reversal of the original 2014 ACIP recommendation for Prevnar 13's use in the elderly population will hamper its growth in the US.
- As the only vaccine routinely recommended for use in infants in the US, Japan, and five major European markets (France, Germany, Italy, Spain, and the UK), Prevnar 13 generates blockbuster revenues from this segment on account of large annual birth cohorts, high vaccination coverage rates, and its multi-dose schedule (2-4 doses are recommended depending on the market). However, Prevnar 13's high price point has resulted in very limited uptake in the elderly outside of the US, as the more affordable Pneumovax 23 is generally recommended for the elderly population, with the exception of Italy, where both vaccines are recommended.
- The changing epidemiology of pneumococcal disease has begun to influence vaccine and dosing recommendations in the US and UK. Within the US, ACIP has updated its vaccination guidance to remove its previous 2014 recommendation for the routine administration of a single dose of Prevnar 13 for all adults aged 65 years. This change in stance was because the use of Prevnar 13 has caused a decline in invasive pneumococcal disease (IPD) incidence among adults and children (due to both direct and indirect herd protection effects), thus reducing the socioeconomic rationale for the vaccine's routine use in the elderly. Indeed, since the initial 2014 recommendation for Prevnar 13's use in the elderly, the incidence of IPD in the elderly has remained unchanged at five per 100,000 individuals, implying no clear population benefit of the previous recommendation. Additionally, within the UK, Public Health England has reduced the number of recommended doses of Prevnar 13 in infants from three to two based on the very low incidence of IPD caused by the 13 serotypes included in the vaccine, and the low carriage of the serotypes in the general population. While the decision was not directly motivated by cost savings in the UK, it could serve as a model for other markets with low IPD incidence, as well as low-income markets where the high cost of Prevnar 13 acts as a major hurdle for the implementation of national vaccination programs.
- Prevnar 13's sales will be threatened by anticipated competition from Merck & Co's V114, which has broader serotype coverage. However, if no serotype shift occurs, V114 will need to be priced comparably or lower than Prevnar 13 to gain payer favor, as in the absence of serotype shift, the inclusion of two additional serotypes would provide little real-world value. The publisher expects V114 to gain preferential status over Prevnar 13 for the infant population once launched. In addition, sales in China and lower-income markets are expected to be adversely affected by the 2020 launches of Walvax's 13-valent conjugate vaccine and the Serum Institute of India's Pneumosil (10-valent conjugate vaccine), which represent lower-cost alternatives to Prevnar 13.
- Pneumovax 23 will face direct competition from Pfizer's successor product PF-06482077 in the elderly population, due to its broad serotype coverage. PF-06482077 could become the go-to vaccine for the elderly as it voids the need for separate administration of Prevnar 13 and Pneumovax 23. Pfizer plans to investigate the infant population after its initial approval in the elderly population.
- As a pneumococcal polysaccharide vaccine, Pneumovax 23 is not recommended for routine use in infants as it does not stimulate protective immunity in this age range, which is thought to be due to the inability of individuals aged < 24 months to mount T-cell independent humoral responses. The lack of an independent humoral response has resulted in Pneumovax 23's use being limited to the elderly, where its broad serotype coverage is attractive. Pneumovax 23 sales are expected to grow through to 2021 due to the increasing elderly population in France, Spain, and the US. However, following PF-06482077's anticipated approval from Q3 2021, Pneumovax 23's sales could plummet if PF-06482077 gains recommendations for preferential use from national immunization advisory groups.
- Strong adherence to immunization guidelines has resulted in high infant pneumococcal vaccination rates across the US, Japan, and five major European markets. However, key opinion leaders have stated that there is a significant unmet need to increase vaccination coverage rates in the at-risk populations, which are currently limited by lack of awareness of vaccination recommendations and patient eligibility among primary care physicians and patients. In addition, adolescents and younger adults tend to have less frequent contact with physicians than infants and the elderly, which limits opportunities to refer patients for vaccination.
- Presently, there are five products in Phase I-III development in the clinical pipeline. Merck & Co and Pfizer are currently evaluating their 15-valent and 20-valent pneumococcal vaccines, respectively, in Phase III studies. Both companies are hoping to commercially benefit from serotype shift in pneumococcal disease incidence, given that both vaccines possess broader serotype coverage than the currently recommended Prevnar 13.
- The overall likelihood of approval of a Phase I pneumococcal vaccine is 11.1%, and the average probability the vaccine advances from Phase III is 50%. Pneumococcal vaccines, on average, take 8.8 years from Phase I to approval, compared to 9.1 years in the overall infectious disease space.
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