特集 : 国別レポートが13,000件から検索可能になりました!

特集 : 海外市場の委託調査がセミカスタムベースでお手軽にできます

株式会社グローバルインフォメーション
表紙
市場調査レポート
商品コード
927052

疾患分析:C型肝炎

Disease Analysis: Hepatitis C

出版日: | 発行: Datamonitor Healthcare | ページ情報: 英文 46 Pages | 納期: 即日から翌営業日

価格
価格表記: USDを日本円(税抜)に換算
本日の銀行送金レート: 1USD=105.60円
疾患分析:C型肝炎
出版日: 2020年06月18日
発行: Datamonitor Healthcare
ページ情報: 英文 46 Pages
納期: 即日から翌営業日
  • 全表示
  • 概要
  • 目次
概要

最新の重要ポイント

2018年現在、世界全体で7220万人のC型肝炎患者が存在していると推測されています。

当レポートでは、世界のC型肝炎向け治療薬の治験情勢と市場動向見通しについて分析し、疾患の概要や疫学的予測、現在の主な治療薬 (上市済み/パイプライン製品) や治験の進行状況、現在のアンメットニーズと将来的な市場機会、治験/市場の先行きに関する専門家の見解、といった情報を取りまとめてお届けいたします。

概要

疾患の背景事情

  • 定義
  • 症状
  • 危険因子
  • 患者の分類

治療法

  • 治療ガイドライン:疾患の重症度とは無関係の、DAAの使用の推奨
  • 主な薬物クラス
  • 推奨事項の要約:治療を受けていない患者向け
  • 推奨事項の要約:治療経験のある患者向け

疫学

  • 有病率の調査手法
  • 高リスク集団の有病率
  • WHOの目標:C型肝炎ウイルスの排除

市販薬

パイプライン医薬品

主な規制イベント

  • 米国保健福祉省 (HHS) の輸入計画:認証済みジェネリック医薬品を用いた、国内の約価引き下げ構想

成功の可能性

治験情勢

医薬品の評価モデル

市場のダイナミクス

将来の動向

コンセンサス予測

近年の市場動向とアナリストの見解

  • C型肝炎 (HCV) 向けCC-31244 (抗ウイルス薬) (2019年1月22日)

参考文献

  • 処方薬の情報

付録

目次
Product Code: DMKC0210688

Latest key takeaways

Datamonitor Healthcare estimates that in 2018, there were 72.2 million prevalent cases of hepatitis C worldwide.

Therapeutic strategies for chronic hepatitis C have evolved rapidly over the last six years. Following the debut of Sovaldi in 2013, direct-acting antiviral (DAA) combination regimens containing at least two modes of action (nucleotide NS5B inhibitors, NS5A inhibitors, and NS3/4A protease inhibitors) have rapidly become the standard of care, replacing older interferon-based regimens. The drastic shift to DAA regimens is due to their significant advances in cure rates (≥95%), greatly improved tolerability profiles, and shortened treatment durations (down from 48 weeks to 8-12 weeks for most patients).

Since peaking in 2015, the sales value of the hepatitis C market has entered a protracted decline as intensifying competition has slashed treatment costs, and patient numbers have fallen sharply in the US, Japan, and five major European markets (France, Germany, Italy, Spain, and the UK). Despite significant improvements in patient access to treatment as payers lifted treatment restrictions in response to lower treatment costs, the patient pool is expected to continue to shrink as the influx of newly diagnosed patients fails to offset the high number of patients exiting the treatment algorithm due to cure. Thus, investment in initiatives to improve screening uptake and linkage to care will be critical in softening the pace of this decline.

The launch of AbbVie's Mavyret in 2017 shook up the hepatitis C market and led to AbbVie capturing market-leader status from Gilead, which had previously dominated the field with rival regimens Harvoni (mainly genotype 1 [GT-1]) and Epclusa (all genotypes). Both Mavyret and Epclusa possess pan-genotypic activity, which positions them as one-size-fits-all regimens and provides a strategic advantage in payer negotiations versus Merck & Co's Zepatier, which is only efficacious in GT-1/4 patients. However, Mavyret possesses the advantage of a shorter eight-week duration in most treatment-naive patients versus Epclusa's 12-week dosing, and AbbVie also priced Mavyret at an aggressive discount to Epclusa to rapidly capture market share. Datamonitor Healthcare believes that market dynamics in the hepatitis C space will remain relatively stable, with Mavyret expected to continue to command the majority of market share and Epclusa continuing to hold out in second place.

The 2017 launch of Gilead's Vosevi has addressed the final clinical unmet need for an effective treatment option in the small minority of patients who fail treatment with first-line DAA regimens. Such patients commonly develop resistance-associated substitutions (RASs), particularly to NS5A inhibitors, which render them less likely to respond to repeated treatment. Notably, Vosevi displayed comparable cure rates in patients with RASs to those without RASs in the POLARIS-1 study, positioning it as an ideal therapy for prior treatment failures. While Vosevi faces minimal competition in this niche, its sales potential is limited by the small (and decreasing) size of the salvage population. With no major clinical unmet needs remaining and the value of the hepatitis C market continuing to decline, there is a scarcity of agents in the late-phase development pipeline. Indeed, while there are 18 drugs in the pipeline, only one has reached Phase III, and the continued development of early-phase compounds is unlikely given their ever-diminishing commercial potential and very limited ability to show clinical differentiation from currently available options.

The overall likelihood of approval of a Phase I hepatitis C drug is 8.4%, and the average probability a drug advances from Phase III is 69.6%. Hepatitis C drugs, on average, take 6.7 years from Phase I to approval, substantially shorter than the average of 9.1 years in the overall infectious disease space.

TABLE OF CONTENTS

CONTENTS

OVERVIEW

  • Latest key takeaways

DISEASE BACKGROUND

  • Definition
  • Patient segmentation
  • Symptoms
  • Risk factors
  • Diagnosis

TREATMENT

  • Treatment guidelines recommend the use of DAAs irrespective of disease severity
  • Main drug classes
  • Summary of recommendations for treatment-naive patients
  • Summary of recommendations for treatment-experienced patients

EPIDEMIOLOGY

  • Prevalence methodology
  • Prevalence in high-risk groups
  • WHO targets to eliminate hepatitis C virus

MARKETED DRUGS

PIPELINE DRUGS

KEY REGULATORY EVENTS

  • Keeping Track: J&J Submits Ponesimod NDA For MS; US FDA Clears Epclusa For Pediatric HCV
  • HHS Importation Plan Builds On Use Of Authorized Generics To Lower US List Prices

PROBABILITY OF SUCCESS

CLINICAL TRIAL LANDSCAPE

  • Sponsors by status
  • Sponsors by phase

DRUG ASSESSMENT MODEL

MARKET DYNAMICS

FUTURE TRENDS

CONSENSUS FORECASTS

RECENT EVENTS AND ANALYST OPINION

  • CC-31244 for Hepatitis C (HCV) (Antiviral) (January 22, 2019)

KEY UPCOMING EVENTS

BIBLIOGRAPHY

  • Prescription information

APPENDIX

LIST OF FIGURES

  • Figure 1: Test outcomes and interpretations
  • Figure 2: Main drug classes
  • Figure 3: Overview of pipeline drugs for hepatitis C in the US
  • Figure 4: Pipeline drugs for hepatitis C, by company
  • Figure 5: Pipeline drugs for hepatitis C, by drug type
  • Figure 6: Pipeline drugs for hepatitis C, by classification
  • Figure 7: Probability of success in the hepatitis C pipeline
  • Figure 8: Clinical trials in hepatitis C
  • Figure 9: Top 10 drugs for clinical trials in hepatitis C
  • Figure 10: Top 10 companies for clinical trials in hepatitis C
  • Figure 11: Trial locations in hepatitis C
  • Figure 12: Hepatitis C trials status
  • Figure 13: Hepatitis C trials sponsors, by phase
  • Figure 14: Datamonitor Healthcare's drug assessment summary for hepatitis C
  • Figure 15: Market dynamics in hepatitis C
  • Figure 16: Future trends in hepatitis C
  • Figure 17: CC-31244 for Hepatitis C (HCV) (Antiviral) (January 22, 2019): Phase IIa - with Epclusa (Maryland)
  • Figure 18: Key Upcoming Events in Hepatitis C

LIST OF TABLES

  • Table 1: Summary of recommended treatment regimens for newly diagnosed patients in the 2018 AASLD and EASL treatment guidelines
  • Table 2: Prevalent cases of hepatitis C, 2018
  • Table 3: Marketed drugs for hepatitis C
  • Table 4: Pipeline drugs for hepatitis C
  • Table 5: Historical global sales, by drug ($m), 2015-19
  • Table 6: Forecasted global sales, by drug ($m), 2020-24
  • Table 7: CC-31244 for Hepatitis C (HCV) (Antiviral) (January 22, 2019)
株式会社グローバルインフォメーション
© Copyright 1996-2020, Global Information, Inc. All rights reserved.