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感染疾病

市場調查報告書

商品編碼

973487

疾病分析:C型肝炎

Disease Analysis: Hepatitis C

出版日期: 2021年06月24日 | 出版商:

Datamonitor Healthcare | 英文 43 Pages | 商品交期: 最快1-2個工作天內

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簡介
目錄

簡介

截至2018年，據估計全球有7220萬丙型肝炎。自2013年Sovaldi推出以來，已經開發並推出了許多DAA（直接作用抗病毒藥物），從而更新了傳統療法。儘管治療效果已顯著改善並且許多患者已經治愈，未滿足的需求也有所減少，但這預計也將導致管道產品的下降和未來市場增長的下降。

本報告提供全球C型肝炎治療藥臨床實驗形勢與市場趨勢預測相關分析，彙整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，為您概述為以下內容。

Disease Overview

Hepatitis C is a liver disease caused by chronic infection with hepatitis C virus (HCV), a hepacivirus belonging to the Flaviviridae family. HCV infects hepatocytes and is the leading cause of cirrhosis and hepatocellular cancer (HCC). Approximately 15-45% of people infected with HCV will spontaneously clear the virus, but the remaining 55-85% will develop chronic HCV infection. For those chronically infected with HCV, the risk of cirrhosis increases by 15-30% within 20 years.

Latest key takeaways

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

The current treatment paradigm is dominated by two competing pan-genotypic regimens, Epclusa and Mavyret, which possess excellent efficacy (cure rates of ≥95%), strong tolerability profiles (≤1% of patients discontinue due to adverse events), and convenient once-daily dosing schedules with treatment durations of 8-12 weeks.

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 have 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 COVID-19 pandemic led to a steep, transient decline in market value in 2020 (sales of $4,061m versus $6,202m in 2019) as new patient initiations dropped due to disrupted screening initiatives and difficulty in accessing physician care, particularly in patients with less advanced fibrosis where treatment can be delayed without risking negative outcomes. Sales are expected to partially recover in 2021, but will fall in a stepwise fashion thereafter due to gradual exhaustion of the pool of diagnosed patients available for treatment.

The launch of AbbVie's Mavyret in 2017 shook up the hepatitis C market and led to AbbVie severely eroding the market share of Gilead, which had previously dominated the field with rival regimens Harvoni (mainly 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.

Harvoni and Zepatier's commercial prospects will continue to suffer from their limited genotypic potency (GT-1/4) and competition from pan-genotypic regimens. Indeed, Harvoni's global sales declined from $4,370m in 2017 to just $272m in 2020 due to a combination of competition from Mavyret and cannibalization of its patient share from Gilead's own Epclusa (as well as the impact of the COVID-19 pandemic), while Zepatier's 2020 global sales totaled just $167m, down from a peak of $1,660m in 2017. This trend is expected to continue now that simplified US and European treatment guidelines promote the use of pan-genotypic regimens.

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 declining size of the salvage population due to both reductions in overall patient numbers and the excellent efficacy and tolerability of first-line regimens.

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 pipeline. There are three drugs presently in clinical development, but a lack of clear differentiation from currently marketed agents and ever-diminishing chances of gaining a return on investment mean their continued development is unlikely.

The overall likelihood of approval of a Phase I hepatitis C drug is 6.8%, and the average probability a drug advances from Phase III is 66.7%. Hepatitis C drugs, on average, take 6.7 years from Phase I to approval, substantially shorter than the average of 9.0 years in the overall infectious disease space.

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 DAA-experienced patients

EPIDEMIOLOGY

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

MARKETED DRUGS

PIPELINE DRUGS

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

AT-527 for Hepatitis C (October 9, 2020)

BIBLIOGRAPHY

APPENDIX

LIST OF FIGURES

Figure 1: Main drug classes for hepatitis C
Figure 2: Overview of pipeline drugs for hepatitis C in the US
Figure 3: Pipeline drugs for hepatitis C, by company
Figure 4: Pipeline drugs for hepatitis C, by drug type
Figure 5: Pipeline drugs for hepatitis C, by classification
Figure 6: Probability of success in the hepatitis C pipeline
Figure 7: Clinical trials in hepatitis C
Figure 8: Top 10 drugs for clinical trials in hepatitis C
Figure 9: Top 10 companies for clinical trials in hepatitis C
Figure 10: Trial locations in hepatitis C
Figure 11: Hepatitis C trials status
Figure 12: Hepatitis C trials sponsors, by phase
Figure 13: Datamonitor Healthcare's drug assessment summary for hepatitis C
Figure 14: Market dynamics in hepatitis C
Figure 15: Future trends in hepatitis C
Figure 16: AT-527 for Hepatitis C (October 9, 2020): Phase II - w/daclatasvir

LIST OF TABLES

Table 1: Hepatitis C test outcomes and interpretations
Table 2: Summary of recommended treatment regimens for newly diagnosed hepatitis C patients in AASLD and EASL treatment guidelines
Table 3: Prevalent cases of hepatitis C, 2018
Table 4: Marketed drugs for hepatitis C
Table 5: Pipeline drugs for hepatitis C in the US
Table 6: Historical global sales, by drug ($m), 2016-20
Table 7: Forecasted global sales, by drug ($m), 2021-25
Table 8: AT-527 for Hepatitis C (October 9, 2020)

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