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市場調查報告書

肺炎球菌疫苗市場與至2024年的預測分析

Pneumococcal Vaccines Market and Forecast Analysis to 2024

出版商 Datamonitor Healthcare 商品編碼 980114
出版日期 內容資訊 英文 47 Pages
商品交期: 最快1-2個工作天內
價格
肺炎球菌疫苗市場與至2024年的預測分析 Pneumococcal Vaccines Market and Forecast Analysis to 2024
出版日期: 2020年12月10日內容資訊: 英文 47 Pages
簡介

肺炎鏈球菌(S. pneumoniae)是一種細菌,可引起多種類型的肺炎球菌疾病,包括血流感染(敗血症),肺炎,腦膜炎與鼻竇炎和中耳炎等其他輕度疾病。 肺炎球菌疾病的嚴重程度以侵入性或非侵入性為特徵,由於可以從通常的無菌部位(例如血液或腦脊液)中分離出細菌,因此侵入性肺炎球菌疾病更為嚴重。

由於法國,西班牙和美國的老年人口增加,同時利潤豐厚的美國市場持續短期價格上漲,肺炎球菌疫苗市場的價值在預測期內將穩定成長。

I期肺炎球菌疫苗的認證的整體可能性是16.7%,疫苗從III期進行的平均概率是75%。肺炎球菌疫苗,在感染疾病的領域全體是8.9年,從I期到核准花費平均8.6年。

本報告提供肺炎球菌疫苗市場相關調查,市場概要,以及至2024年的市場成長預測,未滿足需求,開發平台趨勢等。

目錄

內容

概要

  • 最新重要點

疾病背景

  • 定義
  • 症狀
  • 診斷
  • 危險因素

疫苗接種指南

  • 主要市場上疫苗接種指南

市售的疫苗

開發平台疫苗

主要的法規活動

  • 英國禁止出口清單追加肺炎球菌多糖疫苗

成功的概率

授權及資產取得的交易

  • 鹽野義製藥株式會社取得HanaVax的鼻肺炎球菌疫苗的世界權利

臨床試驗情勢

  • 各狀態臨床試驗贊助者
  • 各階段臨床實驗要求
  • 最近的活動

疫苗評估

  • Prevnar13
  • Pneumovax23

V114

PF-06482077

  • 值得注意的II期疫苗

市場動態

趨勢

共識預測

最近的事件和分析師的見解

  • 肺炎球菌疫苗用V114(2020年9月9日)
  • 肺炎球菌疫苗用V114(2020年6月22日)
  • 肺炎球菌疫苗用PF-06482077(2020年3月18日)
  • 肺炎球菌疫苗用V114(2019年5月8日)

今後主要的活動

主要的小齒輪KOL的洞察

未滿足需求

  • 為了對抗血清型轉移的威脅網羅更寬泛的血清的疫苗
  • 其他 "有風險" 群組的網羅率低

參考文件

  • 處方資訊

附錄

圖表清單

表格清單

目錄
Product Code: DMKC0216103

Disease Overview

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 (eg blood or cerebrospinal fluid), and requires hospital treatment.

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 (from June 2021) and Prevnar 13 in infants (from H1 2023). 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, the 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.

From June 2021, Prevnar 13's market share in adults is expected to be cannibalized by Pfizer's 20-valent successor vaccine, PF-06482077, which could potentially void the need for separate Prevnar 13 and Pneumovax 23 vaccinations. In a Phase III study, the 20-valent vaccine has demonstrated non-inferiority to the 13 strains shared with Prevnar 13, in addition to non-inferior immunogenicity for six out of the seven shared strains with Pneumovax 23, with one serotype (8) narrowly missing non-inferiority criteria. In addition, Prevnar 13 will also face competition in the infant segment for the first time from Merck & Co's 15-valent V114, which has broader serotype coverage and is expected to gain approval in the pediatric setting in mid-2022 (approval in adults is expected in Q4 2021, but PF-06482077 is expected to be preferred due to broader serotype coverage). To protect the company's market share in this lucrative segment, Pfizer is also investigating PF-06482077 in infants, and Datamonitor Healthcare expects US and EU indication expansions to be granted in H1 2023.

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 Q3 2021 due to the increasing elderly population in France, Spain, and the US. However, following PF-06482077's anticipated approval from June 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 six vaccines in clinical development, with Merck & Co's 15-valent V114 and Pfizer's 20-valent PF-06482077 both currently under regulatory review by the FDA for the prevention of pneumococcal disease in adults. Both vaccines possess broader serotype coverage than the currently recommended Prevnar 13, and hope to benefit commercially from serotype shift in pneumococcal disease incidence.

The overall likelihood of approval of a Phase I pneumococcal vaccine is 16.7%, and the average probability the vaccine advances from Phase III is 75%. Pneumococcal vaccines, on average, take 8.6 years from Phase I to approval, compared to 8.9 years in the overall infectious disease space.

TABLE OF CONTENTS

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

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS

  • Shionogi Acquires Global Rights To HanaVax's Nasal Pneumococcal Vaccine

CLINICAL TRIAL LANDSCAPE

  • Sponsors by status
  • Sponsors by phase
  • Recent events

VACCINE ASSESSMENT

  • Prevnar 13
  • Pneumovax 23

V114

PF-06482077

  • Phase II vaccines to watch

MARKET DYNAMICS

FUTURE TRENDS

CONSENSUS FORECASTS

RECENT EVENTS AND ANALYST OPINION

  • V114 for Pneumococcal Vaccines (September 9, 2020)
  • V114 for Pneumococcal Vaccines (June 22, 2020)
  • 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: V114 for Pneumococcal Vaccines (September 9, 2020): Phase III - PNEU-AGE, Phase III - PNEU-TRUE
  • Figure 15: V114 for Pneumococcal Vaccines (June 22, 2020): Phase III - PNEU-WAY / PNEU-FLU
  • Figure 16: 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 in the US
  • Table 4: Historical global sales, by vaccine ($m), 2015-19
  • Table 5: Forecasted global sales, by vaccine ($m), 2020-24
  • Table 6: V114 for Pneumococcal Vaccines (September 9, 2020)
  • Table 7: V114 for Pneumococcal Vaccines (June 22, 2020)
  • Table 8: PF-06482077 for Pneumococcal Vaccines (March 18, 2020)
  • Table 9: V114 for Pneumococcal Vaccines (May 8, 2019)