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질환 분석 : 만성 심부전

Disease Analysis: Chronic Heart Failure

리서치사 Datamonitor Healthcare
발행일 2020년 06월 상품 코드 939972
페이지 정보 영문 82 Pages
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US $ 22,000 ₩ 25,933,000 PDF (Single User License)


질환 분석 : 만성 심부전 Disease Analysis: Chronic Heart Failure
발행일 : 2020년 06월 페이지 정보 : 영문 82 Pages

만성 심부전에 대해 조사했으며, 질환의 배경, 치료법, 역학, 출시되고 있는 의약품, 파이프라인상 의약품, 약사 규제면의 중요한 동향, 임상시험의 상황, 약제 평가 모델, 시장 역학, 향후 동향 등의 정보를 제공하고 애널리스트 및 업계 리더의 견해도 정리하여 전해드립니다.

목차

개요

질환의 배경

  • 정의
  • 진단법
  • 위험인자
  • 증상
  • 환자 세분화

치료법

  • 앤지오텐신 전환 효소 저해제
  • 앤지오텐신 수용체 길항제
  • 베타 차단제
  • 알도스테론 길항제
  • 과분극 활성화 환형 뉴클레오티드 작동성 채널 차단제
  • 앤지오텐신 수용체 네프릴리신 저해제
  • 기타 약물 클래스

역학

  • 유병률의 조사 방법

출시되고 있는 의약품

파이프라인상 의약품

규제면의 주요 동향

  • SGLT-2 저해제로서는 처음으로 AstraZeneca의 Farxiga가 승인된다.
  • Mesoblast, Revascor의 출시를 향한 개발을 가속
  • 미 FDA가 심부전 치료제 개발의 가이던스를 발표

성공의 가능성

임상시험의 상황

  • 각 단계의 임상시험 의뢰자
  • 각 상의 임상시험 의뢰자
  • 최근 이벤트

약물 평가 모델

시장 역학

향후 동향

  • 유력 브랜드의 치료제 이용 확대에 의한 매출 확대
  • Entresto의 HFpEF 치료제 임상시험 실패로 매출 확대의 가능성이 대폭 하락
  • SGLT-2 저해제와의 경쟁에 직면하는 Entresto
  • 제네릭 의약품과의 경쟁에 의한 성장의 둔화

최근 이벤트와 애널리스트의 견해

향후 주요 동향

주요 업계 리더의 견해

  • 출시되고 있는 의약품
  • 파이프라인상 의약품
  • 미충족 요구

미충족 요구

  • HFpEF 환자의 치료
  • HFrEF 환자의 심장 수축성을 개선하는 치료법
  • 기타 요구
  • 미충족 요구에 관한 심장 전문의의 순위

참고 문헌

  • 처방약에 관한 정보

부록

KSA 20.06.17

Latest key takeaways

Chronic heart failure (CHF) is a progressive condition in which the heart muscle is unable to pump enough blood to meet the needs of the body. Datamonitor Healthcare estimates that in 2018, there were approximately 80.5 million cases in Asia, Europe, Latin America and the Caribbean, Northern America, and Oceania combined.

Datamonitor Healthcare forecasts the number of prevalent cases of CHF to increase by 9.1% between 2018 and 2027. These trends are driven by population demographics, as prevalence proportions were held constant throughout the forecast period.

The CHF market is expected to grow significantly over the next 10 years across the US, Japan, and five major European markets (France, Germany, Italy, Spain, and the UK). The CHF market has predominantly been saturated with generics, which has limited the market revenue. Angiotensin-converting enzyme inhibitors remain the current standard-of-care therapy, and are used in every line of treatment except when using Entresto. However, there are a growing number of late-stage pipeline therapies, which, combined with the rising disease prevalence, will be the major drivers of market growth.

Despite initially encountering reimbursement challenges which led to a slower than expected uptake, Entresto reached blockbuster status in 2018 and maintained solid growth in 2019. Continued uptake of Entresto in the CHF market due to favorable recommendations in treatment guidelines and its proven ability to reduce mortality will be a key driver of market growth.

High prices of branded therapies will translate into high revenues, despite the large number of generics on the market. The SGLT-2 inhibitors, Jardiance and Farxiga, will be major market growth drivers, as they are expected to experience strong uptake in both diabetic and non-diabetic patients. SGLT-2 inhibitors are expected to capture the greatest market share in diabetic patients due to the convenience and cost-saving benefit of using one medication for two indications.

Generic entry of dapagliflozin, ivabradine, and sacubitril/valsartan will attenuate market growth towards the end of the forecast period.

The CHF market is becoming an increasingly active space, with 11 drug candidates currently in Phase III. Therapies in mid-to-late-stage development for CHF focus on a wide variety of targets, and include subcutaneous, oral, and injectable drug candidates.

The overall likelihood of approval of a Phase I CHF asset is 5.1%, and the average probability that a CHF drug advances from Phase III is 40%. CHF drugs, on average, take 10.5 years from Phase I to approval, compared to 10.0 years in the overall cardiovascular space.

Numerous high-impact upcoming events for drugs in the CHF space are expected in 2020, including Phase III trial results for a number of different drug candidates, such as data from SGLT-2 inhibitor Jardiance's Phase III EMPEROR-Reduced and -Preserved trials.

TABLE OF CONTENTS

CONTENTS

OVERVIEW

  • Latest key takeaways

DISEASE BACKGROUND

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

TREATMENT

  • Angiotensin-converting enzyme inhibitors
  • Angiotensin receptor blockers
  • Beta blockers
  • Aldosterone antagonists
  • Hyperpolarization-activated cyclic nucleotide-gated channel blockers
  • Angiotensin receptor-neprilysin inhibitors
  • Other drug classes

EPIDEMIOLOGY

  • Prevalence methodology

MARKETED DRUGS

PIPELINE DRUGS

KEY REGULATORY EVENTS

  • AZ To Adopt Indication-Based Pricing For Farxiga In Heart Failure
  • Novartis Seeks Entresto HFpEF Indication With Readjudicated PARAGON-HF Data
  • AstraZeneca's Farxiga Approval In Heart Failure A First For SGLT-2 Inhibitors
  • Mesoblast Sees Accelerated Path To Market For Revascor In Sickest Heart Failure Patients
  • Heart Failure Drug Development Might Need A Good Lawyer After US FDA Guidance

PROBABILITY OF SUCCESS

CLINICAL TRIAL LANDSCAPE

  • Sponsors by status
  • Sponsors by phase
  • Recent events

DRUG ASSESSMENT MODEL

MARKET DYNAMICS

FUTURE TRENDS

  • The high value of the CHF market will be driven by increased use of branded therapies
  • Entresto's failure in HFpEF patients will significantly limit revenue potential
  • Entresto faces competition from SGLT-2 inhibitors
  • Generic competition will offset growth in the CHF market

CONSENSUS FORECASTS

RECENT EVENTS AND ANALYST OPINION

  • Mavacamten for CHF and Cardiomyopathies (May 11, 2020)
  • Mavacamten for CHF and Cardiomyopathies (March 30, 2020)
  • Vericiguat for CHF and Cardiomyopathies (March 28, 2020)
  • Elamipretide (Systemic Delivery) for CHF and Cardiomyopathies (February 18, 2020)
  • Jardiance for CHF and Cardiomyopathies (December 13, 2019)
  • Vericiguat for CHF and Cardiomyopathies (November 18, 2019)
  • Entresto for CHF and Cardiomyopathies (November 17, 2019)
  • Mavacamten for CHF and Cardiomyopathies (November 11, 2019)
  • Entresto for CHF and Cardiomyopathies (September 1, 2019)
  • Farxiga for CHF and Cardiomyopathies (September 1, 2019)
  • Mavacamten for CHF and Cardiomyopathies (August 31, 2019)
  • Farxiga for CHF and Cardiomyopathies (August 20, 2019)
  • Entresto for CHF and Cardiomyopathies (July 29, 2019)

KEY UPCOMING EVENTS

KEY OPINION LEADER INSIGHTS

  • Marketed drugs
  • Pipeline drugs
  • Unmet needs

UNMET NEEDS

  • Treatment for HFpEF patients
  • Therapies that improve cardiac contractility in patients with HFrEF
  • Other unmet needs
  • Cardiologist rankings of unmet needs in CHF

BIBLIOGRAPHY

  • Prescription information

APPENDIX

LIST OF FIGURES

  • Figure 1: Summary of treatment guidelines in CHF
  • Figure 2: Trends in prevalent cases of CHF, 2018-27
  • Figure 3: Overview of pipeline drugs for CHF in the US
  • Figure 4: Pipeline drugs for CHF, by company
  • Figure 5: Pipeline drugs for CHF, by drug type
  • Figure 6: Pipeline drugs for CHF, by classification
  • Figure 7: Probability of success in the CHF pipeline
  • Figure 8: Clinical trials in CHF
  • Figure 9: Top 10 drugs for clinical trials in CHF
  • Figure 10: Top 10 companies for clinical trials in CHF
  • Figure 11: Trial locations in CHF
  • Figure 12: CHF trials status
  • Figure 13: CHF trials sponsors, by phase
  • Figure 14: Datamonitor Healthcare's drug assessment summary for CHF
  • Figure 15: Market dynamics in CHF
  • Figure 16: Future trends in CHF
  • Figure 17: Mavacamten for CHF and Cardiomyopathies (May 11, 2020): Phase III - EXPLORER-HCM
  • Figure 18: Mavacamten for CHF and Cardiomyopathies (March 30, 2020): Phase II - MAVERICK-HCM
  • Figure 19: Vericiguat for CHF (March 28, 2020): Phase III - VICTORIA
  • Figure 20: Elamipretide (systemic delivery) for CHF (February 18, 2020): Natural History Study
  • Figure 21: Jardiance for CHF (December 13, 2019): Phase III - EMPERIAL-Preserved, Phase III - EMPERIAL-Reduced
  • Figure 22: Vericiguat for CHF (November 18, 2019): Phase III - VICTORIA
  • Figure 23: Mavacamten for CHF and Cardiomyopathies (November 11, 2019): Phase II - MAVERICK-HCM
  • Figure 24: Entresto for CHF (September 1, 2019): Phase III - PARAGON-HF
  • Figure 25: Farxiga for CHF (September 1, 2019): Phase III - DAPA-HF
  • Figure 26: Mavacamten for CHF and Cardiomyopathies (August 31, 2019): Phase II - PIONEER-OLE
  • Figure 27: Farxiga for CHF (August 20, 2019): Phase III - DAPA-HF
  • Figure 28: Entresto for CHF (July 29, 2019): Phase III - PARAGON-HF
  • Figure 29: Key upcoming events in CHF
  • Figure 30: Average scores of unmet needs in CHF in the US (n=40)
  • Figure 31: Average scores of unmet needs in CHF in Europe (n=41)

LIST OF TABLES

  • Table 1: Definition of HFrEF and HFpEF
  • Table 2: New York Heart Association functional classification based on severity of symptoms and physical activity
  • Table 3: Prevalent cases of CHF, 2018-27
  • Table 4: Marketed drugs for CHF
  • Table 5: Pipeline drugs for CHF in the US
  • Table 6: Historical global sales, by drug ($m), 2015-19
  • Table 7: Forecasted global sales, by drug ($m), 2020-24
  • Table 8: Mavacamten for CHF and Cardiomyopathies (May 11, 2020)
  • Table 9: Mavacamten for CHF and Cardiomyopathies (March 30, 2020)
  • Table 10: Vericiguat for CHF and Cardiomyopathies (March 28, 2020)
  • Table 11: Elamipretide (Systemic Delivery) for CHF and Cardiomyopathies (February 18, 2020)
  • Table 12: Jardiance for CHF and Cardiomyopathies (December 13, 2019)
  • Table 13: Vericiguat for CHF and Cardiomyopathies (November 18, 2019)
  • Table 14: Entresto for CHF and Cardiomyopathies (November 17, 2019)
  • Table 15: Mavacamten for CHF and Cardiomyopathies (November 11, 2019)
  • Table 16: Entresto for CHF and Cardiomyopathies (September 1, 2019)
  • Table 17: Farxiga for CHF and Cardiomyopathies (September 1, 2019)
  • Table 18: Mavacamten for CHF and Cardiomyopathies (August 31, 2019)
  • Table 19: Farxiga for CHF and Cardiomyopathies (August 20, 2019)
  • Table 20: Entresto for CHF and Cardiomyopathies (July 29, 2019)
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