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질환 분석 : C형 간염

Disease Analysis: Hepatitis C

리서치사 Datamonitor Healthcare
발행일 2020년 06월 상품 코드 927052
페이지 정보 영문 46 Pages
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질환 분석 : C형 간염 Disease Analysis: Hepatitis C
발행일 : 2020년 06월 페이지 정보 : 영문 46 Pages

최신 주요 포인트 :

2018년 세계 전체에서 7220만 명의 C형 간염(Hepatitis C) 환자가 존재하는 것으로 추측됩니다.

세계 C형 간염용 치료제의 임상시험 상황과 시장 동향 전망에 대해 분석했으며, 질환의 개요 및 역학적 예측, 현재 주요 치료제(출시/파이프라인 제품) 및 임상시험의 진행 상황, 현재의 미충족 요구와 향후 시장 기회, 임상시험/시장의 미래에 관한 전문가의 견해 등의 정보를 정리하여 전해드립니다.

개요

질환 배경

  • 정의
  • 증상
  • 위험인자
  • 환자 분류

치료법

  • 치료 가이드라인 : 질환 중증도와는 무관하게 DAA의 사용이 권장된다.
  • 주요 약물 클래스
  • 권장사항의 요약 : 치료를 받지 않은 환자용
  • 권장사항의 요약 : 치료 경험이 있는 환자용

역학

  • 유병률 조사 방법
  • 고위험집단의 유병률
  • WHO의 목표 : C형 간염 바이러스의 배제

시판약

파이프라인 의약품

주요 규제 이벤트

  • 미국 보건복지부(HHS)의 수입 계획 : 인증 제네릭 의약품을 이용한 자국내 약가인하 구상

성공 가능성

임상시험 상황

의약품 평가 모델

시장 역학

향후 동향

콘센서스 예측

최근 시장 동향과 애널리스트의 견해

  • C형 간염(HCV)용 CC-31244(항바이러스제)(2019년 1월 22일)

참고 문헌

  • 처방약 정보

부록

KSA 20.03.24

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)
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