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市場調查報告書
商品編碼
999262

乙肝病毒感染-全球藥物預測和市場分析(至2029年)

Hepatitis B Virus Infection - Global Drug Forecast and Market Analysis to 2029

出版日期: | 出版商: GlobalData | 英文 132 Pages | 訂單完成後即時交付

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  • 全貌
  • 簡介
  • 目錄
簡介

慢性乙型肝炎(CHB)是一種嚴重的肝臟疾病,由急性乙型肝炎病毒(HBV)感染後病毒清除失敗引起。全球九個主要市場(美國,法國,德國,意大利,西班牙,英國,日本,巴西和中國)的疾病負擔很高,尤其是在中國。

對於大多數患者,CHB是一種無法治癒的終生疾病,每年只有很少的患者進入緩解期。患有慢性乙型肝炎的患者因其狀況而罹患威脅生命的肝臟疾病(如肝硬化和肝細胞癌(HCC))的風險為20%。美國肝病研究協會(AASLD)和歐洲肝病研究協會(EASL)的指南建議用核甘酸類似物(NAs)治療CHB。

管道產品將在2029年預測期的下半年提供。預計到2029年,反義核甘酸將獲得14.7%的市場份額,並在九個主要市場實現7.61億美元的銷售額。吉利德的Toll樣受體8激動劑有望在預測期結束時與反義核甘酸競爭九個主要市場份額。

本報告調查了九個主要市場(美國,法國,德國,意大利,西班牙,英國,日本,巴西,中國)的乙肝病毒感染市場,流行病學,市場預測,機遇,它提供了有關競爭狀況的信息,策略,以及按國家/地區進行市場分析。

目錄

第1章慢性乙型肝炎:執行摘要

  • 預計在2019年至2029年的預測期內市場增長的慢性乙型肝炎的治療
  • 用新的MOA治療肝炎,補充現有的NA治療
  • 旨在提高CHB治癒率的新型MOA管道療法
  • 目前使用新的MOA藥物進行CHB治療的渠道
  • 醫生的觀點

第2章簡介

  • 簡介
  • 相關報告
  • 未來報告

第3章疾病概述

  • 發病機理與病理生理學
    • 發病機理
    • 病理生理學

第4章流行病學

  • 疾病背景
  • 危險因素和合併症
  • 世界和過去的趨勢
  • 預測調查方法
    • 來源
    • 預測的前提條件和方法
  • CHB流行病學預測(2019-2029)
    • 確診為CHB的常見病例
    • 年齡:確診為CHB的常見病例
    • 性別:診斷為CHB的常見病例
    • 通過HBeAg狀態:診斷為CHB的常見病例
    • 通過HBV DNA水平:診斷為CHB的常見病例
    • 按ALT水平分類:診斷為CHB的常見病例
    • 肝硬化類型:診斷為CHB的常見病例
  • 討論
    • 流行病學預測見解
    • COVID-19的影響
    • 分析的局限性
    • 分析優勢

第5章疾病管理

  • 診斷和治療概述
    • 治療指南和主要處方藥
    • 臨床實踐
  • KOL對疾病管理的見解

第6章競爭性評估

  • 概述

第7章未滿足的需求和機會的評估

  • 概述
  • 需要功能治療
  • 減少用藥
  • 縮短治療時間
  • 生物標誌物的發現
  • 改進了對診斷的訪問

第8章研發策略

  • 概述
    • 研發策略1-行動機制
    • 研發策略2組合療法
    • R&D Strategy 3-Corporate Alliance
  • 臨床試驗設計
    • 臨床試驗設計-關鍵終點
    • 臨床試驗設計-聯合治療
    • 第二階段的臨床試驗設計

第9章管道評估

  • 概述
  • 臨床開發中有希望的藥物

第10章管道評估分析

  • 概述
  • 競爭評估

第11章,當前和未來的企業

  • 概述
  • 企業戰略趨勢
  • 交易趨勢

第12章市場前景

  • 世界市場
    • 預測
    • 增長因素和壁壘-世界問題
  • 美國
    • 預測
    • 主要事件
    • 增長因素和障礙
  • 5EU
    • 預測
    • 主要事件
    • 增長因素和障礙
  • 日本
    • 預測
    • 主要事件
    • 增長因素和障礙
  • 巴西
    • 預測
    • 主要事件
    • 增長因素和障礙
  • 中國
    • 預測
    • 主要事件
    • 增長因素和障礙

第13章附錄

目錄
Product Code: GDHC217PIDR

Chronic hepatitis B (CHB) is a serious liver disease caused by the failure of viral clearance following acute hepatitis B virus (HBV) infection. The global disease burden is high in the nine major markets (9MM: US, France, Germany, Italy, Spain, UK, Japan, Brazil, and China); it is especially high in China. For most patients, CHB is a lifelong disease that cannot be cured, with only a very small number of patients entering remission each year. Patients with CHB have a 20% risk of developing life-threatening liver disease, such as cirrhosis and hepatocellular carcinoma (HCC) as a result of their condition. Guidelines by the American Association of the Study of Liver Diseases (AASLD) and the European Association for the Study of Liver (EASL) have recommended CHB to be treated with nucleotide analogs (NA).

Gilead Sciences and Bristol Myers Squibb (BMS) are the major players within the CHB market with their nucleotide analogs Viread (TDF, Gilead), Vemlidy (TAF, Gilead) and Baraclude (entecavir, BMS). However, generic versions of TDF and entecavir dominate the 9MM. The CHB treatment pipeline is predominantly in early stages. Gilead's TLR-8 agonist selgantolimod, J&J's capsid assembly modulator JNJ-6379, and antisense nucleotide JNJ-3898 could significantly impact the CHB market across the 9MM. Also Replicor, Assembly Biosciences, and Ionis Pharmaceuticals are developing CHB therapies. A major unmet for CHB treatment remains the potential to achieve functional cure.

Key Highlights

  • During the 10-year forecast period, there are six major pipeline products that are on track to launch, driving a forecast growth in the 9MM from $3.8B in 2019 to $5.2B in 2029, which represents a CAGR of 3.1%.
  • To combat the unmet need of a functional cure, companies such as Gilead, J&J, Replicor, Ionis, and Assembly Biosciences are developing pipeline products with novel mechanism of action, with the potential of being used as a combination therapy either with current nucleotide analogs or with emerging products.
  • The pipeline products are expected to launch in the second half of the forecast period in 2029. Antisense nucleotides are expected to gain a market share of 14.7% and sales of $761M in the 9MM by 2029. However, capsid assembly modulators from J&J and a toll-like receptor 8 agonist from Gilead are expected to compete with antisense nucleotides for market shares in the 9MM by the end of the forecast period.

Key Questions Answered

  • How will the CHB market landscape in the 9MM (US, France, Germany, Italy, Spain, UK, Japan, Brazil, China) change from 2019-2029?
  • What are the most promising late-stage pipeline products for CHB treatment?
  • How do the clinical and commercial attributes of late-stage pipeline products compare with one another, and against existing CHB treatment options?
  • What are the remaining unmet needs in CHB treatment?
  • What drivers and barriers will affect CHB treatment sales in the 9MM over the forecast period?

Scope

  • Overview of CHB, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current management strategies.
  • Topline CHB treatment market revenue from 2019-2029. Annual cost of therapy and major pipeline product sales in this forecast period are included.
  • Key topics covered include current CHB treatment, unmet needs and opportunities, and the drivers and barriers affecting CHB treatment sales in the 9MM.
  • Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and detailed analysis of late-stage pipeline products.
  • Analysis of the current and future market competition in the global CHB treatment market. Insightful review of the key industry drivers, constraints, and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to Buy

The report will enable you to -

  • Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
  • Develop business strategies by understanding the trends shaping and driving the global Hepatitis B Virus Infection market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the Hepatitis B Virus Infection market in the future.
  • Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
  • Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments, and strategic partnerships.

Table of Contents

Table of Contents

1 Chronic Hepatitis B: Executive Summary

  • 1.1 Chronic Hepatitis B Treatment to Experience Modest Market Growth over the Forecast Period from 2019-2029
  • 1.2 Hepatitis B Therapies with Novel MOAs Will Supplement Existing NA Treatment
  • 1.3 Pipeline Therapies with Novel MOAs Are Aiming to Increase CHB Cure Rates
  • 1.4 Current CHB Treatment Pipeline Includes Agents with Novel MOAs
  • 1.5 What Do Physicians Think?

2 Introduction

  • 2.1 Catalyst
  • 2.2 Related Reports
  • 2.3 Upcoming Reports

3 Disease Overview

  • 3.1 Etiology and Pathophysiology
    • 3.1.1 Etiology
    • 3.1.2 Pathophysiology

4 Epidemiology

  • 4.1 Disease Background
  • 4.2 Risk Factors and Comorbidities
  • 4.3 Global and Historical Trends
  • 4.4 Forecast Methodology
    • 4.4.1 Sources
    • 4.4.2 Forecast Assumptions and Methods
  • 4.5 Epidemiological Forecast for CHB (2019-2029)
    • 4.5.1 Diagnosed Prevalent Cases of CHB
    • 4.5.2 Age-Specific Diagnosed Prevalent Cases of CHB
    • 4.5.3 Sex-Specific Diagnosed Prevalent Cases of CHB
    • 4.5.4 Diagnosed Prevalent Cases of CHB by HBeAg Status
    • 4.5.5 Diagnosed Prevalent Cases of CHB by HBV DNA Level
    • 4.5.6 Diagnosed Prevalent Cases of CHB by ALT Level
    • 4.5.7 Diagnosed Prevalent Cases of CHB by Type of Liver Cirrhosis
  • 4.6 Discussion
    • 4.6.1 Epidemiological Forecast Insight
    • 4.6.2 COVID-19 Impacts
    • 4.6.3 Limitations of Analysis
    • 4.6.4 Strengths of Analysis

5 Disease Management

  • 5.1 Diagnosis and Treatment Overview
    • 5.1.1 Treatment Guidelines and Leading Prescribed Drugs
    • 5.1.2 Clinical Practice
  • 5.2 KOL Insights on Disease Management

6 Competitive Assessment

  • 6.1 Overview

7 Unmet Needs and Opportunity Assessment

  • 7.1 Overview
  • 7.2 The Need for a Functional Cure
  • 7.3 Reduction in Drug Administration
  • 7.4 Reduction in Treatment Time Frame
  • 7.5 Discovery of Biomarkers
  • 7.6 Improve Access to Diagnostics

8 R&D Strategies

  • 8.1 Overview
    • 8.1.1 R&D Strategy 1 - Mechanism of Action
    • 8.1.2 R&D Strategy 2 - Combination Therapy
    • 8.1.3 R&D Strategy 3 - Company Partnerships
  • 8.2 Clinical Trials Design
    • 8.2.1 Clinical Trials Design - Primary Endpoints
    • 8.2.2 Clinical Trials Design - Combination Therapies
    • 8.2.3 Clinical Trials Design - Focused on Phase II

9 Pipeline Assessment

  • 9.1 Overview
  • 9.2 Promising Drugs in Clinical Development

10 Pipeline Valuation Analysis

  • 10.1 Overview
  • 10.2 Competitive Assessment

11 Current and Future Players

  • 11.1 Overview
  • 11.2 Trends in Corporate Strategy
  • 11.3 Deal-Making Trends

12 Market Outlook

  • 12.1 Global Markets
    • 12.1.1 Forecast
    • 12.1.2 Drivers and Barriers - Global Issues
  • 12.2 US
    • 12.2.1 Forecast
    • 12.2.2 Key Events
    • 12.2.3 Drivers and Barriers
  • 12.3 5EU
    • 12.3.1 Forecast
    • 12.3.2 Key Events
    • 12.3.3 Drivers and Barriers
  • 12.4 Japan
    • 12.4.1 Forecast
    • 12.4.2 Key Events
    • 12.4.3 Drivers and Barriers
  • 12.5 Brazil
    • 12.5.1 Forecast
    • 12.5.2 Key Events
    • 12.5.3 Drivers and Barriers
  • 12.6 China
    • 12.6.1 Forecast
    • 12.6.2 Key Events
    • 12.6.3 Drivers and Barriers

13 Appendix

List of Tables

List of Tables

  • Table 1: Key Metrics for CHB in the 9MM
  • Table 2: Phases of CHB Infection
  • Table 3: Risk Factors and Comorbidities for Chronic Hepatitis B
  • Table 4: Treatment Guidelines for CHB
  • Table 5: Country Profile - US
  • Table 6: Country Profile - 5EU
  • Table 7: Country Profile - Japan
  • Table 8: Country Profile - Brazil
  • Table 9: Country Profile - China
  • Table 10: Chronic Hepatitis B Market - Global Drivers and Barriers, 2019-2029
  • Table 11: Key Events Impacting Sales for Chronic Hepatitis B Treatment in the US, 2019-2029
  • Table 12: Chronic Hepatitis B Market - Drivers and Barriers in the US, 2019-2029
  • Table 13: Key Events Impacting Sales for Chronic Hepatitis B Treatment in the 5EU, 2019-2029
  • Table 14: Chronic Hepatitis B Market - Drivers and Barriers in the 5EU, 2019-2029
  • Table 15: Key Events Impacting Sales for Chronic Hepatitis B Treatment in Japan, 2019-2029
  • Table 16: Chronic Hepatitis B Market - Drivers and Barriers in Japan, 2019-2029
  • Table 17: Key Events Impacting Sales for Chronic Hepatitis B Treatment in Brazil, 2019-2029
  • Table 18: Chronic Hepatitis B Market - Drivers and Barriers in Brazil, 2019-2029
  • Table 19: Key Events Impacting Sales for Chronic Hepatitis B Treatment in China, 2019-2029
  • Table 20: Chronic Hepatitis B Market - Drivers and Barriers in China, 2019-2029
  • Table 21: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

List of Figures

List of Figures

  • Figure 1: Global Sales Forecast by Country for CHB in 2019 and 2029
  • Figure 2: Analysis of the Company Portfolio Gap in CHB During the Forecast Period
  • Figure 3: Competitive Assessment of the Late-Stage Pipeline Agents that GlobalData Expects to Be Licensed for the Treatment of CHB During the Forecast Period
  • Figure 4: Hepatitis B Virus Structure
  • Figure 5: Key Steps in HBV Replication and Potential Therapeutic Targets
  • Figure 6: 9MM, Diagnosed Prevalence of CHB (%), Both Sexes, All Ages, 2009-2019.
  • Figure 7: 9MM, Sources Used and Not Used for Diagnosed Prevalence of CHB (%)
  • Figure 8: 9MM, Sources Used for Diagnosed Prevalent Cases of CHB by HBeAg Status (N)
  • Figure 9: 9MM, Sources Used and Not Used for Diagnosed Prevalent Cases of CHB by HBV DNA Level (N)
  • Figure 10: 9MM, Sources Used for Diagnosed Prevalent Cases of CHB by ALT Level (N)
  • Figure 11: 9MM, Sources Used for Diagnosed Prevalent Cases of CHB by Type of Liver Cirrhosis (N)
  • Figure 12: 9MM, Diagnosed Prevalent Cases of CHB, Men and Women, All Ages, N, 2019
  • Figure 13: 9MM, Age-Specific Diagnosed Prevalent Cases of CHB, 9MM, Men and Women, All Ages, N, 2019
  • Figure 14: 9MM, Sex-Specific Diagnosed Prevalent Cases of CHB, All Ages, N, 2019
  • Figure 15: 9MM, Diagnosed Prevalent Cases of CHB by HBeAg Status, Men and Women, All Ages, N, 2019
  • Figure 16: 9MM, Diagnosed Prevalent Cases of CHB by HBV DNA Level, Men and Women, All Ages, N, 2019
  • Figure 17: 9MM, Diagnosed Prevalent Cases of CHB by ALT Level, Men and Women, All Ages, N, 2019
  • Figure 18: 9MM, Diagnosed Prevalent Cases of CHB by Type of Liver Cirrhosis, Men and Women, All Ages, N, 2019
  • Figure 19: Unmet Needs and Opportunities in CHB
  • Figure 20: Overview of the Development Pipeline in Chronic Hepatitis B
  • Figure 21: Key Late-Stage Trials for the Promising Pipeline Agents that GlobalData Expects be Licensed for CHB in the 9MM During the Forecast Period
  • Figure 22: Competitive Assessment of the Late-Stage Pipeline Agents that GlobalData Expects to be Licensed for the Treatment of CHB During the Forecast Period
  • Figure 23: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the Standard of Care (SOC), entecavir, TDF, and TAF
  • Figure 24: Analysis of the Company Portfolio Gap in CHB During the Forecast Period
  • Figure 25: Global (9MM) Sales Forecast by Country for Chronic Hepatitis B in 2019 and 2029
  • Figure 26: Sales Forecast by Class for Chronic Hepatitis B in the US in 2019 and 2029
  • Figure 27: Sales Forecast by Class for Chronic Hepatitis B in the 5EU in 2019 and 2029
  • Figure 28: Sales Forecast by Class for Chronic Hepatitis B in Japan in 2019 and 2029
  • Figure 29: Sales Forecast by Class for Chronic Hepatitis B in Brazil in 2019 and 2029
  • Figure 30: Sales Forecast by Class for Chronic Hepatitis B in China in 2019 and 2029