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市場調查報告書

疾病分析:人類乳突病毒 (HPV) 疫苗

Disease Analysis: Human Papillomavirus (HPV) Vaccines

出版商 Datamonitor Healthcare 商品編碼 923385
出版日期 內容資訊 英文 31 Pages
商品交期: 最快1-2個工作天內
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疾病分析:人類乳突病毒 (HPV) 疫苗 Disease Analysis: Human Papillomavirus (HPV) Vaccines
出版日期: 2020年01月17日內容資訊: 英文 31 Pages
簡介

2006年發售最初的人類乳突病毒(HPV)疫苗以來,市場踏實成長,全球銷售額從2006年的2億3,500萬美元,到2016年增加了到23億美元。這個成長,起因於以9歲∼14歲的少女的治療及對15歲∼26歲的女性的疫苗接種catch up為中心,許多主要市場上疫苗接種計劃的開始。

本報告提供全球人類乳突病毒 (HPV) 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、篩檢
  • 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

近來的法規上的主要動向

成功確立

  • 臨床實驗環境

疫苗的評估模式

市場動態

未來趨勢

近幾年的市場趨勢

關鍵意見領袖 (KOL)的見解

未滿足需求

  • 人類乳突病毒(HPV)疫苗的單劑量計劃
  • 提供寬廣的預防的人類乳突病毒(HPV)疫苗
  • 已經感染了HPV的患者用疫苗

參考文獻

  • 處方藥的資訊

附錄

目錄
Product Code: DMKC0211529

Key Takeaways:

Worldwide vaccination programs for human papillomavirus (HPV) have evolved substantially over the last decade. There are currently three approved vaccines for HPV: Cervarix, Gardasil, and Gardasil 9. Merck & Co's Gardasil, a quadrivalent vaccine, was first-to-market with its debut in 2006, narrowly ahead of the 2007 release of GlaxoSmithKline's rival bivalent vaccine, Cervarix. Both vaccines are based on the recombinant expression of major capsid antigen L1 from different HPV serotypes, which self-assemble into virus-like particles (VLPs). In 2014, Gardasil 9, a nine-valent vaccine capable of protecting from an additional 20% of HPV-related cancers, superseded Gardasil.

Since the launch of the first HPV vaccine in 2006, the market has seen steady growth, with global sales rising from $235m in 2006 to $2.3bn in 2016. This growth was attributed to the launch of vaccination programs in most major markets, centered on the treatment of girls aged 9-14 years and catch-up vaccinations for females aged 15-26 years. In the last two years, the HPV market has experienced unprecedented growth, and it looks set to continue this upwards trajectory. Key growth drivers include the expansion of vaccination programs to include males aged 9-26 years in major markets such as the US, UK, and Germany, rising pressure to increase coverage rates for HPV vaccination globally, and the introduction of national programs in new markets such as China. Indeed, Merck & Co attributed its $850m sales boost in 2018 to a successful launch in the Chinese market. The introduction of additional national HPV vaccination programs is projected to sustain considerable growth in the HPV market, so much so that Merck & Co has invested $1.68bn into two manufacturing plants to meet global demand for the HPV vaccine.

There remain significant factors that will limit growth of the HPV market over the next five years. One such factor is that vaccine manufacture is currently lagging behind global demand. To combat this, Merck & Co recently announced plans to establish two new manufacturing plants that should be completed by 2023. The Gardasil franchise has always held market-leader status because of its wider serotype coverage and preferential reimbursement from payers, and with little competition from Cervarix or any major threats from pipeline candidates, it will maintain its lead for the foreseeable future.

Cervarix was the second-to-market vaccine and has experienced a sharp decline in sales from a peak of $800m in 2011, triggered by direct competition with Gardasil over market share. The global sales gap between the Gardasil franchise and Cervarix has continued to widen from $398m in 2011 to $2,964m in 2018, driven largely by preference for Gardasil 9 in major and emerging markets, and this trend is expected to continue as Gardasil 9 continues to gain uptake in the lucrative Chinese market. Sales of Cervarix have now stabilized at approximately $180m, and while the vaccine will continue to lose share in major markets, the rise of emerging markets presents opportunities for Cervarix to achieve sales growth in the near future. In particular, a shortage of supply of Gardasil 9 in emerging markets has presented GlaxoSmithKline with a small window of opportunity to drive use of Cervarix until Merck & Co can increase its supply of Gardasil 9 to meet growing demand.

Currently, there is only a single clinical pipeline candidate (in Phase I) in the HPV market, being developed by 2A Pharma outside of the US. This vaccine is based on the L2 protein, which is more conserved across different strains of HPV; the company aims to utilize this feature to generate a pan-protective vaccine. It is highly unlikely that this vaccine will gain approval during the five-year forecast period.

At the start of 2020, China's regulator approved Cecolin, a generic HPV bivalent vaccine produced by the Chinese firm Innovax. The generic vaccine is set to be the first of a series of vaccines developed by the company, including generics for the quadrivalent and nonavalent HPV vaccines. Datamonitor Healthcare's discussions with KOLs indicated that there are several companies generating HPV vaccines in China and India, but their approvals in the US and EU are unlikely. There are no pipeline candidates in the US for HPV, however, there is a single pipeline candidate being developed in Europe by 2A Pharma. 2A Pharma is developing an L2 vaccine which it hypothesizes will be pan-protective based on the higher conservation of the L2 capsid protein between HPV strains. The company claims the vaccine will have broader coverage, will not require adjuvants, and will have a low production cost.

TABLE OF CONTENTS

OVERVIEW

  • Latest key takeaways

DISEASE BACKGROUND

  • Definition
  • Symptoms
  • Diagnostics and screening
  • Risk factors

VACCINATION GUIDELINES

  • Vaccination guidelines in major markets

MARKETED VACCINES

PIPELINE VACCINES

KEY REGULATORY EVENTS

  • Merck & Co.'s Gardasil 9 Gets US CDC Panel Backing For Broader Age Group

PROBABILITY OF SUCCESS

CLINICAL TRIAL LANDSCAPE

VACCINE ASSESSMENT MODEL

MARKET DYNAMICS

FUTURE TRENDS

CONSENSUS FORECASTS

KEY UPCOMING EVENTS

KEY OPINION LEADER INSIGHTS

UNMET NEEDS

  • Single-dose schedules for HPV vaccines
  • HPV vaccine that provides pan-protection
  • Vaccine for patients already infected with HPV

BIBLIOGRAPHY

  • Prescription information

APPENDIX

LIST OF FIGURES

  • Figure 1: Probability of success in the HPV vaccines pipeline
  • Figure 2: Clinical trials in HPV vaccines and antivirals
  • Figure 3: Top 10 drugs for clinical trials in HPV vaccines and antivirals
  • Figure 4: Top 10 companies for clinical trials in HPV vaccines and antivirals
  • Figure 5: Trial locations in HPV vaccines and antivirals
  • Figure 6: HPV vaccine and antiviral trials status
  • Figure 7: HPV vaccine and antiviral trials sponsors, by phase
  • Figure 8: Datamonitor Healthcare's vaccine assessment summary for HPV
  • Figure 9: Market dynamics in HPV vaccines
  • Figure 10: Future trends in HPV vaccines
  • Figure 11: Key upcoming events in HPV vaccines

LIST OF TABLES

  • Table 1: Vaccination programs in major markets
  • Table 2: Marketed vaccines for HPV
  • Table 3: Historical global sales, by vaccine ($m), 2014-18
  • Table 4: Forecasted global sales, by vaccine ($m), 2019-23