表紙
市場調查報告書

肺炎球菌疫苗:市場預測及分析 (到2024年)

Pneumococcal Vaccines Market and Forecast Analysis to 2024

出版商 Datamonitor Healthcare 商品編碼 939976
出版日期 內容資訊 英文 45 Pages
商品交期: 最快1-2個工作天內
價格
肺炎球菌疫苗:市場預測及分析 (到2024年) Pneumococcal Vaccines Market and Forecast Analysis to 2024
出版日期: 2020年04月01日內容資訊: 英文 45 Pages
簡介

本報告提供全球肺炎球菌疫苗臨床實驗形勢與市場趨勢預測相關分析,疾病概要和流行病學的預測,目前主要治療藥 (已上市/開發中產品) 和臨床實驗的進展,目前未滿足需求和未來的市場機會,臨床實驗/市場將來相關專家的見解等資訊彙整,為您概述為以下內容。

概要

疾病的背景情況

  • 定義
  • 症狀
  • 診斷
  • 風險要素

疫苗接種指南

  • 主要市場上疫苗接種指南

已上市疫苗

開發平台疫苗

法規上主要的動向

成功的可能性

授權合約/資產收購交易

臨床實驗環境

  • 臨床試驗贊助者的分類:各狀況
  • 臨床試驗贊助者的分類:各相位
  • 目前的趨勢

疫苗的評估模式

  • 非胰島素
  • 非專利口服藥
  • 非胰島素系品牌藥
  • 胰島素
  • 其他開發平台的機制

疫苗的評估

  • Prevnar
  • Pneumovax
  • V114
  • PF-06482077

市場動態

今後的趨勢

共識預測

近幾年的市場趨勢和分析師的見解

  • PF-06482077(肺炎球菌疫苗用,2020年3月18日)
  • V114(肺炎球菌疫苗用,2019年5月8日)

今後的市場主要動向

KOL (專家)的見解

未滿足需求

  • 為了對抗血清型的變化的威脅,血清型的範圍更寬廣的疫苗
  • 其他「有風險」群組的涵蓋範圍低

參考文件

  • 處方藥的資訊

附錄

目錄
Product Code: DMKC0216103

Latest Key Takeaways:

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 Advisory Committee on Immunization Practices (ACIP) recommendation for Prevnar 13's use in the elderly population will hamper Prevnar 13's 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 said 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. Datamonitor Healthcare expects V114 to gain preferential status over Prevnar 13 for the infant population once launched.

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 Q4 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.

Currently, 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 highly recommended Prevnar 13. The overall likelihood of approval of a Phase I pneumococcal vaccine is 9.5%, and the average probability the vaccine advances from Phase III is 50%. Pneumococcal vaccines, on average, take 8.6 years from Phase I to approval, compared to 8.8 years in the overall infectious diseases space.

TABLE OF CONTENTS

OVERVIEW

  • Latest key takeaways

DISEASE BACKGROUND

  • Definition
  • Symptoms
  • Diagnosis
  • Risk factors

VACCINATION GUIDELINES

  • Vaccination guidelines in major markets

MARKETED VACCINES

PIPELINE VACCINES

KEY REGULATORY EVENTS

  • UK Adds Pneumococcal Polysaccharide Vaccine To Export Ban List
  • Prevnar 13 Loses 'Routine' Endorsement For Older Adults in CDC Panel Vote
  • Merck's V114 Earns First Pediatric Pneumococcal Vaccine Breakthrough Therapy Designation

PROBABILITY OF SUCCESS

CLINICAL TRIAL LANDSCAPE

  • Sponsors by status
  • Sponsors by phase
  • Recent events

VACCINE ASSESSMENT

  • Prevnar 13
  • Pneumovax 23

V114

PF-06482077

MARKET DYNAMICS

FUTURE TRENDS

CONSENSUS FORECASTS

RECENT EVENTS AND ANALYST OPINION

  • PF-06482077 for Pneumococcal Vaccines (March 18, 2020)
  • V114 for Pneumococcal Vaccines (May 8, 2019)

KEY UPCOMING EVENTS

KEY OPINION LEADER INSIGHTS

UNMET NEEDS

  • Vaccines with broader serotype coverage to counter the threat of serotype shift
  • Low coverage in miscellaneous 'at-risk' groups

BIBLIOGRAPHY

  • Prescription information

APPENDIX

LIST OF FIGURES

  • Figure 1: Overview of pipeline pneumococcal vaccines in the US
  • Figure 2: Pipeline pneumococcal vaccines, by company
  • Figure 3: Pipeline pneumococcal vaccines, by drug type
  • Figure 4: Pipeline pneumococcal vaccines, by classification
  • Figure 5: Probability of success in the pneumococcal vaccines pipeline
  • Figure 6: Clinical trials in pneumococcal vaccines and therapeutic agents
  • Figure 7: Top 10 drugs for clinical trials in pneumococcal vaccines and therapeutic agents
  • Figure 8: Top 10 companies for clinical trials in pneumococcal vaccines and therapeutic agents
  • Figure 9: Trial locations in pneumococcal vaccines and therapeutic agents
  • Figure 10: Pneumococcal vaccines and therapeutic agents trials status
  • Figure 11: Pneumococcal vaccines and therapeutic agents, by phase
  • Figure 12: Market dynamics in pneumococcal vaccines
  • Figure 13: Future trends in pneumococcal vaccines
  • Figure 14: Key upcoming events in pneumcoccal vaccines

LIST OF TABLES

  • Table 1: Vaccination guidelines in major markets
  • Table 2: Marketed pneumococcal vaccines
  • Table 3: Pipeline pneumococcal vaccines
  • Table 4: Historical global sales, by vaccine ($m), 2015-18
  • Table 5: Forecasted global sales, by vaccine ($m), 2020-24
  • Table 6: PF-06482077 for Pneumococcal Vaccines (March 18, 2020)
  • Table 7: V114 for Pneumococcal Vaccines (May 8, 2019)