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PCSK9 억제제 : 시장 인사이트, 역학, 시장 예측(2032년)

PCSK9 Inhibitors - Market Insight, Epidemiology and Market Forecast - 2032

리서치사 DelveInsight Business Research LLP
발행일 2022년 09월 상품코드 1126002
페이지 정보 영문 286 Pages 배송안내 1-2일 (영업일 기준)
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PCSK9 억제제 : 시장 인사이트, 역학, 시장 예측(2032년) PCSK9 Inhibitors - Market Insight, Epidemiology and Market Forecast - 2032
발행일 : 2022년 09월 페이지 정보 : 영문 286 Pages

본 상품은 영문 자료로 한글과 영문 목차에 불일치하는 내용이 있을 경우 영문을 우선합니다. 정확한 검토를 위해 영문목차를 참고해주시기 바랍니다.

세계 주요 7개국의 PCSK9 억제제 시장 규모는 2021년에 약 13억 900만 달러에 달하고, 조사기간 중(2019-2032년)에도 확대 경향이 계속될 전망입니다.

국가별로 보면 미국의 PCSK9 억제제 시장 규모는 2021년에 7억 2,900만 달러에 달하고, 유럽 5개국은 2021년에 5억 2,700만 달러, 일본은 5,300만 달러에 달할 것으로 예측됩니다.

세계 주요 7개국 - 미국, 유럽 주요 5개국(EU5 : 프랑스·독일·이탈리아·스페인·영국), 일본 - 의 PCSK9 억제제 역학적 동향과 향후 시장 전망에 대해 분석했으며, 질환 개요와 시장의 기본 구조, 현재 치료법과 미충족 수요, 유병자수 동향 전망, 출시된/임상시험중인 치료제 프로파일, 세계 전체/각국의 시장 규모(2019-2032년), 주요 시장 성장 촉진·억제요인 등의 정보를 정리하여 전해드립니다.

목차

제1장 주요 인사이트

제2장 보고서 서론

제3장 목차

제3장 PCSK9 억제제 : 시장 개요

  • PCSK9 억제제 시장 점유율(2019년)
  • PCSK9 억제제 시장 점유율(2032년)

제5장 PCSK9 억제제(PCSK9i) : 주요 요약

제6장 역학과 시장 조사 방법

제7장 PCSK9 억제제(PCSK9i) : 배경과 개요

  • 서론
  • PCSK9 유전자 생물학
  • PCSK9 기능 역학
  • PCSK9 억제제
  • PCSK9 억제 전략
  • PCSK9 억제제 승인 상황
  • PCSK9 억제제 질환 영역
    • 원발성 고지혈증
    • 입원을 필요로 하는 심근경색, 뇌졸중, 불안정협심증 예방

제8장 가이드라인

  • 이상지질혈증 관리를 위한 ESC/EAS 가이드라인
  • 미국심장병학회/미국심장협회 임상 진료 가이드라인에 관한 태스크 포스
  • 전미지질협회의 전문가 패널로부터 추천사항
  • 스페인동맥경화학회(SEA)의 추천사항
  • NICE 가이드라인
  • 일본동맥경화학회(JAS)의 동맥경화성 심혈관질환 예방 가이드라인
  • 가이드라인 비교

제9장 역학과 환자수

  • 주요 조사 결과
  • 가정과 근거 : 주요 7개국
  • 주요 7개국의 역학 시나리오
    • 가족성 고콜레스테롤혈증(FH) 총유병자수
    • 가족성 고콜레스테롤혈증 진단된 총발증건수
    • 가족성 고콜레스테롤혈증 총발증건수 : 종류별
    • 가족성 고콜레스테롤혈증 총발증건수 : 연령별
    • 가족성 고콜레스테롤혈증 총발증건수 : 돌연변이 특이적
    • 예방적 설정에서의 PCSK9 억제제 총발증건수 : 위험인자별
    • PCSK9 억제제 총치료 증례수
  • 미국의 역학 시나리오
    • 가족성 고콜레스테롤혈증(FH) 총유병자수
  • 유럽 5개국의 역학 시나리오
  • 일본의 역학 시나리오

제10장 환자 여정

제11장 PCSK9 억제제 임상시험 : 중요한 엔드포인트

제12장 출시된 치료제

  • 키 크로스
  • PRALUENT(Alirocumab) : Sanofi/Regeneron Pharmaceuticals
    • 약제 설명
    • 규제 마일스톤
    • 기타 개발 활동
    • 중요한 임상시험
    • 현재 진행중인 파이프라인 활동
  • REPATHA(Evolocumab/AMG 145) : Amgen
  • LEQVIO(Inclisiran) : Novartis/Alnylam Pharmaceuticals

제13장 새로운 치료제

  • 키 크로스 경쟁
  • AZD8233(ION449) : AstraZeneca and Ionis Pharmaceuticals
    • 약제 설명
    • 기타 개발 활동
    • 임상 개발
    • 안전성과 유효성
  • Cepadacursen sodium(CIVI-007) : CiVi Biopharma
  • LIB003(Lerodalcibep) : LIB Therapeutics
  • MK-0616 : Merck Sharp & Dohme

제14장 PCSK9 억제제 속성 해석

제15장 PCSK9 억제제 : 주요 7개국의 시장 분석

  • 주요 조사 결과
  • 시장 전망
  • PCSK9 억제제(PCSK9i) 시장
  • 주요 7개국의 PCSK9 억제제 시장 규모
    • PCSK9 억제제 전체 시장 규모
    • PCSK9 억제제 시장 규모 : 치료제별(치료·2차 예방)
  • 미국의 PCSK9 억제제 시장 규모
  • 유럽 5개국의 PCSK9 억제제 시장 규모
  • 일본의 PCSK9 억제제 시장 규모

제16장 시장 접근과 상환

  • PCSK9i에 관한 HTA의 중요한 결정 사항
  • 상환
  • 환자 액세스 프로그램

제17장 KOL의 견해

제18장 SWOT 분석

제19장 미충족 수요

제20장 부록

제21장 DelveInsight 서비스 내용

제22장 면책사항

제23장 DelveInsight 소개

KSM 22.09.23

List of Tables

  • Table 1: Summary of PCSK9 inhibitors, Market, Epidemiology, and Key Events (2019-2032)
  • Table 2: Molecular Genetic Testing Used in FH
  • Table 3: The Dutch Lipid Clinics Network Criteria Score (DLCNS)
  • Table 4: Recommendations for Pharmacological Low-density Lipoprotein Cholesterol-lowering
  • Table 5: Recommendations for the Detection and Treatment of Patients With Heterozygous Familial Hypercholesterolemia
  • Table 6: Recommendations for Lipid-lowering Drugs in Patients With Peripheral Arterial Disease (Including Carotid Artery Disease)
  • Table 7: Recommendations for Lipid-lowering Therapy in Very High-risk Patients With Acute Coronary Syndromes
  • Table 8: Recommendations for Statin Therapy Use in Patients With ASCVD
  • Table 9: Recommendations for Primary Severe Hypercholesterolemia (LDL-C ?190 mg/dL [?4.9 mmol/L])
  • Table 10: Recommendations for Primary Severe Hypercholesterolemia (LDL-C ?190 mg/dL [?4.9 mmol/L])
  • Table 11: Recommendations and Level of Evidence for the Prescription of a PCSK9 inhibitor Concerning the Patient's Clinical Situation and LDL-C Levels
  • Table 12: LDL-C concentrations above which PCSK9s are recommended by NICE
  • Table 13: Comparison of Recommendations for PCSK9-mAb Use
  • Table 14: Total Prevalent Cases of Familial Hypercholestrolemia (in Thousands) (2019-2032)
  • Table 15: Total Diagnosed Cases of Familial Hypercholesterolemia (in Thousands) (2019-2032)
  • Table 16: Total Type-specific Cases of Familial Hypercholesterolemia (in Thousands) (2019-2032)
  • Table 17: Total Age-specific Cases of Familial Hypercholesterolemia (in Thousands) (2019-2032)
  • Table 18: Total Mutation-specific Cases of Familial Hypercholesterolemia (in Thousands) (2019-2032)
  • Table 19: Total Risk factor-specific Cases of PCSK9 Inhibitors in Prophylactic/Preventive setting (in Thousands) (2019-2032)
  • Table 20: Total Treated Cases of PCSK9 Inhibitors (in Thousands) (2019-2032)
  • Table 21: Total Prevalent Cases of Familial Hypercholestrolemia (in Thousands) (2019-2032)
  • Table 22: Total Diagnosed Cases of Familial Hypercholesterolemia (in Thousands) (2019-2032)
  • Table 23: Total Type-specific Cases of Familial Hypercholesterolemia (in Thousands) (2019-2032)
  • Table 24: Total Age-specific Cases of Familial Hypercholesterolemia (in Thousands) (2019-2032)
  • Table 25: Total Mutation-specific Cases of Familial Hypercholesterolemia (in Thousands) (2019-2032)
  • Table 26: Total Risk factor-specific Cases of PCSK9 Inhibitors in Prophylactic/Preventive setting (in Thousands) (2019-2032)
  • Table 27: Total Treated Cases of PCSK9 Inhibitors (in Thousands) (2019-2032)
  • Table 28: Total Prevalent Cases of Familial Hypercholestrolemia (in Thousands) (2019-2032)
  • Table 29: Total Diagnosed Cases of Familial Hypercholesterolemia in EU5 (in Thousands) (2019-2032)
  • Table 30: Total Type-specific Cases of Familial Hypercholesterolemia (in Thousands) (2019-2032)
  • Table 31: Total Age-specific Cases of Familial Hypercholesterolemia (in Thousands) (2019-2032)
  • Table 32: Total Mutation-specific Cases of Familial Hypercholesterolemia (in Thousands) (2019-2032)
  • Table 33: Total Risk factor-specific Cases of PCSK9 Inhibitors in Prophylactic/Preventive setting (in Thousands) (2019-2032)
  • Table 34: Total Treated Cases of PCSK9 Inhibitors (in Thousands) (2019-2032)
  • Table 35: Total Prevalent Cases of Familial Hypercholestrolemia in Japan (in Thousands) (2019-2032)
  • Table 36: Total Diagnosed Cases of Familial Hypercholesterolemia in Japan (In thousands) (2019-2032)
  • Table 37: Total Type-specific Cases of Familial Hypercholesterolemia in Japan (in Thousands) (2019-2032)
  • Table 38: Total Age-specific Cases of Familial Hypercholesterolemia in Japan (in Thousands) (2019-2032)
  • Table 39: Total Mutation-specific Cases of Familial Hypercholesterolemia in Japan (in Thousands) (2019-2032)
  • Table 40: Total Risk factor-specific Cases of PCSK9 Inhibitors in Prophylactic/Preventive setting in Japan (in Thousands) (2019-2032)
  • Table 41: Total Treated Cases of PCSK9 Inhibitors in Japan (in Thousands) (2019-2032)
  • Table 42: Key cross competition - Marketed drugs
  • Table 43: PRALUENT (Alirocumab), Clinical Trial Description, 2022
  • Table 44: REPATHA (Evolocumab/AMG 145), Clinical Trial Description, 2022
  • Table 45: Changes in Lipid Parameters in Patients with HeFH on Maximally Tolerated Statin Therapy
  • Table 46: LEQVIO (Inclisiran), Clinical Trial Description, 2022
  • Table 47: Comparison of emerging drugs under development
  • Table 48: AZD8233 (ION449), Clinical Trial Description, 2022
  • Table 49: CIVI-007 (Cepadacursen Sodium), Clinical Trial Description, 2022
  • Table 50: LIB003 (Lerodalcibep), Clinical Trial Description, 2022
  • Table 51: MK-0616; Clinical Trial Description, 2022
  • Table 52: 7MM Market Size of PCSK9 inhibitors in USD Million (2019-2032)
  • Table 53: 7MM Market Size of PCSK9 inhibitors by Therapies in USD Million (2019-2032)
  • Table 54: Therapywise Market Size of PCSK9 inhibitors by Treatment Setting in the 7MM, USD Million
  • Table 55: Therapywise Market Size of PCSK9 inhibitors in Secondary Prevention in the 7MM, USD Million
  • Table 56: Market Size of PCSK9 inhibitors in the US, in USD Million (2019-2032)
  • Table 57: US Market Size of PCSK9 inhibitors by Therapies in the US, in USD Million (2019-2032)
  • Table 58: Therapywise Market Size of PCSK9 inhibitors by Treatment Setting in the US, USD Million (2019-2032)
  • Table 59: Therapywise Market Size of PCSK9 inhibitors in Secondary Prevention in the US, in USD Million (2019-2032)
  • Table 60: EU5 Market Size of PCSK9 inhibitors in USD Million (2019-2032)
  • Table 61: EU5 Market Size of PCSK9 inhibitors by Therapies in USD Million (2019-2032)
  • Table 62: EU5 Market Size of PCSK9 inhibitors by Treatment Setting in USD Million (2019-2032)
  • Table 63: EU5 Market Size of PCSK9 inhibitors by Therapies in secondary inhibition in USD Million (2019-2032)
  • Table 64: Japan Market Size of PCSK9 inhibitors in USD Million (2019-2032)
  • Table 65: Japan Market Size of PCSK9 inhibitors by Therapies in USD Million (2019-2032)
  • Table 66: Therapywise Market Size of PCSK9 inhibitors by Treatment Setting in Japn, USD Million
  • Table 67: Therapywise Market Size of PCSK9 inhibitors in Secondary Prevention in Japan, USD Million
  • Table 68: Inclisiran - Probability and Extent of Added Benefit
  • Table 69: Key HTA Decisions
  • Table 70: Average costs for REPATHA with Medicare drug coverage

List of Figures

  • Figure 1: Epidemiology and Market Methodology
  • Figure 2: Intracellular and Extracellular Pathways of PCSK9
  • Figure 3: Mechanism and Role of PCK9 in Low-density Lipoprotein-Cholesterol Metabolism
  • Figure 4: Pharmacologic approaches to lower LDL cholesterol
  • Figure 5: Mechanism of Action for PCSK9-mAb and siRNA
  • Figure 6: Timeline of PCSK9 Inhibitors
  • Figure 7: Timeline of ICER's Evaluation of PCSK9 Inhibitors
  • Figure 8: Difference Between HeFH and HoFH
  • Figure 9: Diagnostic Considerations by the American Heart Association
  • Figure 10: Algorithm for Consideration of PCSK9 Treatment in Severe FH Patients Without ASCVD
  • Figure 11: Secondary Prevention in Patients With Clinical ASCVD
  • Figure 12: Algorithm for Consideration of PCSK9 Inhibitor Treatment in Very High-risk Patients, i.e., With Atherosclerotic Cardiovascular Disease (ASCVD) or Diabetes Mellitus
  • Figure 13: Treatment Flow Chart for Adult (15 years or over) Heterozygous FH
  • Figure 14: Treatment Flow Chart for Adult (15 Years or Over) Homozygous FH
  • Figure 15: Total Prevalent Cases of Familial Hypercholestrolemia in the 7MM (2019-2032)
  • Figure 16: Total Diagnosed Cases of Familial Hypercholesterolemia in the 7MM (2019-2032)
  • Figure 17: Total Type-specific Cases of Familial Hypercholesterolemia in the 7MM (2019-2032)
  • Figure 18: Total Age-specific Cases of Familial Hypercholesterolemia in the 7MM (2019-2032)
  • Figure 19: Total Mutation-specific Cases of Familial Hypercholesterolemia in the 7MM (2019-2032)
  • Figure 20: Total Risk factor-specific Cases of PCSK9 Inhibitors in Prophylactic/Preventive setting in the 7MM (2019-2032)
  • Figure 21: Total Treated Cases of PCSK9 Inhibitors in the 7MM (2019-2032)
  • Figure 22: Total Prevalent Cases of Familial Hypercholestrolemia in the US (2019-2032)
  • Figure 23: Total Diagnosed Cases of Familial Hypercholesterolemia in the US (2019-2032)
  • Figure 24: Total Type-specific Cases of Familial Hypercholesterolemia in the US (2019-2032)
  • Figure 25: Total Age-specific Cases of Familial Hypercholesterolemia in the US (2019-2032)
  • Figure 26: Total Mutation-specific Cases of Familial Hypercholesterolemia in the US (2019-2032)
  • Figure 27: Total Risk factor-specific Cases of PCSK9 Inhibitors in Prophylactic/Preventive setting in the US (2019-2032)
  • Figure 28: Total Treated Cases of PCSK9 Inhibitors in the US (2019-2032)
  • Figure 29: Total Prevalent Cases of Familial Hypercholestrolemia in EU5 (2019-2032)
  • Figure 30: Total Diagnosed Cases of Familial Hypercholesterolemia in EU5 (2019-2032)
  • Figure 31: Total Type-specific Cases of Familial Hypercholesterolemia in EU5 (2019-2032)
  • Figure 32: Total Age-specific Cases of Familial Hypercholesterolemia in EU5 (2019-2032)
  • Figure 33: Total Mutation-specific Cases of Familial Hypercholesterolemia in EU5 (2019-2032)
  • Figure 34: Total Risk factor-specific Cases of PCSK9 Inhibitors in Prophylactic/Preventive setting in EU5 (2019-2032)
  • Figure 35: Total Treated Cases of PCSK9 Inhibitors in EU5 (2019-2032)
  • Figure 36: Total Prevalent Cases of Familial Hypercholestrolemia in Japan (2019-2032)
  • Figure 37: Total Diagnosed Cases of Familial Hypercholesterolemia in Japan (2019-2032)
  • Figure 38: Total Type-specific Cases of Familial Hypercholesterolemia in Japan (2019-2032)
  • Figure 39: Total Age-specific Cases of Familial Hypercholesterolemia in Japan (2019-2032)
  • Figure 40: Total Mutation-specific Cases of Familial Hypercholesterolemia in Japan (2019-2032)
  • Figure 41: Total Risk factor-specific Cases of PCSK9 Inhibitors in Prophylactic/Preventive setting in Japan (2019-2032)
  • Figure 42: Total Treated Cases of PCSK9 Inhibitors in Japan (2019-2032)
  • Figure 43: CiVi-007 MOA: Comparison to approved Anti-PCSK9 MAB'S
  • Figure 44: Market Size of PCSK9 inhibitors in the 7MM, USD Million (2019-2032)
  • Figure 45: 7MM Market Size of PCSK9 inhibitors by Therapies in USD Million (2019-2032)
  • Figure 46: Therapywise Market Size of PCSK9 inhibitors by Treatment Setting in the 7MM, USD Million (2019-2032)
  • Figure 47: Therapywise Market Size of PCSK9 inhibitors in Secondary Prevention in the 7MM, USD Million (2019-2032)
  • Figure 48: Market Size of PCSK9 inhibitors in the US, USD Million (2019-2032)
  • Figure 49: US Market Size of PCSK9 inhibitors by Therapies in the US, in USD Million (2019-2032)
  • Figure 50: Therapywise Market Size of PCSK9 inhibitors by Treatment Setting in the US, in USD Million (2019-2032)
  • Figure 51: Therapywise Market Size of PCSK9 inhibitors in Secondary Prevention in the US, in USD Million (2019-2032)
  • Figure 52: Market Size of PCSK9 inhibitors in EU5, USD Million (2019-2032)
  • Figure 53: EU5 Market Size of PCSK9 inhibitors by Therapies in USD Million (2019-2032)
  • Figure 54: Therapywise Market Size of PCSK9 inhibitors by Treatment Setting in EU5, USD Million (2019-2032)
  • Figure 55: Therapywise Market Size of PCSK9 inhibitors in Secondary Prevention in EU5, USD Million (2019-2032)
  • Figure 56: Market Size of PCSK9 inhibitors in Japan, USD Million (2019-2032)
  • Figure 57: Japan Market Size of PCSK9 inhibitors by Therapies in USD Million (2019-2032)
  • Figure 58: Therapy wise Market Size of PCSK9 inhibitors by Treatment Setting in Japan, USD Million
  • Figure 59: Therapy wise Market Size of PCSK9 inhibitors in Secondary Prevention in Japan, USD Million (2019-2032)

DelveInsight's " PCSK9 Inhibitors (PCSK9i)- Market Insight, Epidemiology and Market Forecast-2032" report delivers an in-depth understanding of PCSK9i, historical and forecasted epidemiology as well as the PCSK9i trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan.

The PCSK9i market report provides emerging drugs, PCSK9i market share of the individual cancer types, current and forecasted PCSK9i market size from 2019 to 2032 segmented by seven major markets. The Report also covers current PCSK9i unmet medical needs to curate best of the opportunities and assesses underlying potential of the market.

Geography Covered:

  • The United States
  • EU5 (Germany, France, Italy, Spain, and the United Kingdom)
  • Japan

Study Period: 2019-2032.

PCSK9 Inhibitors Understanding and Treatment Algorithm

The DelveInsight's PCSK9i epidemiology report gives a thorough understanding of PCSK9 Inhibitors by including details such as overview of PCSK9 inhibitors, advantages, disadvantages and available therapies. Comprehensive epidemiology insight of the tumors targeted by PCSK9 inhibitors. Proprotein convertase subtilisin/Kexin type 9 serine protease (PCSK9) plays a vital role in cholesterol metabolism by regulating low-density lipoprotein (LDL) receptor degradation, which reduces the clearance of circulating LDL particles. PCSK9 activity is inversely related to LDL cholesterol (LDL-C) level: Gain-of-function PCSK9 gene mutations are one cause of elevated LDL-C and cardiovascular risk in familial hypercholesterolemia (FH), whereas loss-of-function mutations cause low LDL-C and reduced risk of atherosclerotic cardiovascular disease (ASCVD).

PCSK9 inhibitors, in combination with other LDL lowering drugs, have been demonstrated to be highly effective for some people. Studies have shown that these drugs reduce LDL-C by 40-65% beyond the effect of other lipid-lowering drugs. The use of a PCSK9 inhibitor can reduce the chance of heart attack and stroke. New PCSK9 inhibitors are in development and are currently in clinical trials. The development of PCSK9 inhibitors, which are monoclonal antibodies directed against PCSK9, led to a significant enhancement of the lipid-lowering armamentarium, as PCSK9 inhibitors result in a consistent and robust reduction in LDL-C serum concentrations, substantially improving CV outcomes.

PCSK9 binds to the LDL receptor. After internalizing the LDL receptor bound to PCSK9 (and an LDL particle), the LDL receptor is degraded. PCSK9 can be inhibited pharmacologically by using monoclonal antibodies that bind and neutralize PCSK9 or by RNA-targeting drugs which contain an RNA strand complementary to PCSK9 mRNA and lead to the assembly of an RNA-induced silencing complex (RISC) which degrades PCSK9 mRNA for a prolonged period of time and thereby inhibits the production of PCSK9. The consequence of both approaches is a lower concentration of PCSK9 that can bind the LDL receptor, which after internalization, more often cycles back to the cell surface and can take up further LDL particles, leading to lower LDL cholesterol serum concentrations.

PCSK9 Inhibitors Epidemiology

The epidemiology section provides the insights about historical and current indication wise eligible patient pool and forecasted trend for each seven major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the DelveInsight report also provides the diagnosed patient pool and their trends along with assumptions undertaken.

Key Findings

The disease epidemiology covered in the report provides historical as well as forecasted PCSK9 inhibitor epidemiology scenario in the 7MM covering the United States, EU5 countries (Germany, Spain, Italy, France, and the United Kingdom), and Japan from 2019 to 2032.

In the year 2021, the total prevalent cases of Familial Hypercholestrolemia was 3,129.5 K cases in the 7MM which are expected to grow during the study period, i.e., 2019-2032.

The disease epidemiology covered in the report provides historical as well as forecasted PCSK9 Inhibitors epidemiology [segmented as Total prevalent cases of Familial Hypercholesterolemia, Total diagnosed cases of Familial Hypercholesterolemia, Total type-specific cases of Familial Hypercholesterolemia, Total age group-specific cases of Familial Hypercholesterolemia, Total mutation-specific cases of Familial Hypercholesterolemia, Total risk factor-specific cases of PCSK9 Inhibitors in Prophylactic/Preventive setting, and Total Treated cases of PCSK9 Inhibitors] in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2019 to 2032.

Country Wise- PCSK9 Inhibitors Epidemiology

The epidemiology segment also provides the PCSK9 Inhibitors epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.

PCSK9 Inhibitors Drug Chapters

The drug chapter segment of the PCSK9 Inhibitors report encloses the detailed analysis of PCSK9 Inhibitors marketed drugs and late stage (Phase III and Phase II) pipeline drugs. It also helps to understand the PCSK9 Inhibitors clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.

Emerging Drugs

The report provides the details of the emerging PCSK9 Inhibitors under the late and mid-stage of development for selected indications treatment.

PCSK9 Inhibitors Market Outlook

The PCSK9 Inhibitors market outlook of the report helps to build the detailed comprehension of the historic, current, and forecasted PCSK9 Inhibitors market trends by analyzing the impact of current therapies on the market, unmet needs, and demand of better technology.

This segment gives a thorough detail of PCSK9 Inhibitors market trend of each marketed drug and late-stage pipeline therapy by evaluating their impact based on the annual cost of therapy, inclusion and exclusion criteria's, mechanism of action, compliance rate, growing need of the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market and view of the key opinion leaders. The calculated market data are presented with relevant tables and graphs to give a clear view of the market at first sight.

According to DelveInsight, the PCSK9 Inhibitors market in 7MM is expected to witness a major change in the study period 2019-2032.

Key Findings

The PCSK9 Inhibitors market size in the 7MM is expected to change during the study period 2019-2032. The PCSK9 Inhibitors therapeutic market in the seven major markets is expected to increase during the study period (2019-2032). In 2021, the total market size of PCSK9 Inhibitors was approximately USD 1,309 million which is expected to rise during the study period (2019-2032).

The United States Market Outlook

The total market size of PCSK9 Inhibitors in the United States accounted for USD 729 million in 2021 which is expected to rise during the study period (2019-2032).

EU-5 Countries: Market Outlook

In EU5, the total market size of PCSK9 Inhibitors was USD 527 million in 2021, which is expected to rise during the study period (2019-2032).

Japan Market Outlook

In Japan, the total market size of PCSK9 Inhibitors was USD 53 million in 2021, which is expected to rise during the study period (2019-2032).

PCSK9 Inhibitors Uptake

This section focuses on the rate of uptake of the potential drugs recently launched in the PCSK9 Inhibitors market or expected to get launched in the market during the study period 2019-2032. The analysis covers PCSK9 Inhibitors market uptake by drugs; patient uptake by therapies; and sales of each drug.

This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs, and allows the comparison of the drugs based on market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

PCSK9 Inhibitors Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase II, and Phase III stages. It also analyses key players involved in developing PCSK9 Inhibitors.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition, and merger, licensing patent details, and other information for emerging PCSK9 Inhibitors.

Reimbursement Scenario in PCSK9 Inhibitors

Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In a report, we consider reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.

KOL- Views

To keep up with current market trends, we take KOLs and SMEs ' opinions working in the PCSK9 Inhibitors domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps to understand and validate current and emerging therapies treatment patterns or PCSK9 Inhibitors market trends. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.

Competitive Intelligence Analysis

We perform Competitively and Market Intelligence analysis of the PCSK9 Inhibitors Market by using various Competitive Intelligence tools that include - SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the Report:

  • The report covers a detailed overview of the development of PCSK9 Inhibitors across the several selected indications, explaining its various classes, benefits, and challenges for future.
  • Comprehensive insight has been provided into the PCSK9 Inhibitors epidemiology and treatment in the 7MM.
  • Additionally, an all-inclusive account of both the current and emerging therapies for PCSK9 Inhibitors is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
  • A detailed review of PCSK9 Inhibitors market; historical and forecasted is included in the report, covering drug outreach in the 7MM.
  • The report provides an edge while developing business strategies, by understanding trends shaping and driving the global PCSK9 Inhibitors market.

Report Highlights:

  • In the coming years, PCSK9 Inhibitors market is set to change due to improved patient outcomes, treatment of cold tumors, rich emerging pipeline and convenient production and administration; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
  • The companies and academics are working to assess challenges and seek opportunities that could influence PCSK9 Inhibitors R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
  • Major players are involved in developing therapies for PCSK9 Inhibitors. Launch of emerging therapies, will significantly impact the PCSK9 Inhibitors market.
  • Our in-depth analysis of the pipeline assets across different stages of development (Phase III and Phase II), different emerging trends and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.

PCSK9 Inhibitors Report Insights

  • Patient Population
  • Therapeutic Approaches
  • PCSK9 Inhibitors Pipeline Analysis
  • PCSK9 Inhibitors Market Size and Trends
  • Market Opportunities
  • Impact of upcoming Therapies

PCSK9 Inhibitors Report Key Strengths

  • 11 Years Forecast
  • 7MM Coverage
  • PCSK9 Inhibitors Epidemiology Segmentation
  • Key Cross Competition
  • Highly Analyzed Market
  • Drugs Uptake

PCSK9 Inhibitors Report Assessment

  • Current Treatment Practices
  • Unmet Needs
  • Pipeline Product Profiles
  • Market Attractiveness

Key Questions

Market Insights:

  • What was the PCSK9 Inhibitors Market share (%) distribution in 2019 and how it would look like in 2032?
  • What would be the PCSK9 Inhibitors total market size as well as market size by therapies across the 7MM during the study period (2019-2032)?
  • What are the key findings pertaining to the market across the 7MM and which country will have the largest PCSK9 Inhibitors market size during the study period (2019-2032)?
  • At what CAGR, the PCSK9 Inhibitors market is expected to grow in the 7MM during the study period (2019-2032)?
  • What would be the PCSK9 Inhibitors market outlook across the 7MM during the study period (2019-2032)?
  • What would be the PCSK9 Inhibitors market growth till 2032 and what will be the resultant market size in the year 2032?
  • PCSK9 Inhibitors patient types/pool where unmet need is more and whether emerging therapies will be able to address the residual unmet need?

Epidemiology Insights:

  • What is the challenges and unmet needs of the PCSK9 Inhibitors?
  • What are the key factors driving the epidemiology trend for seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
  • What is the historical PCSK9 Inhibitors patient pool in the seven major markets covering the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan?
  • What would be the forecasted patient pool of PCSK9 Inhibitors in the 7 major markets covering the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan?
  • What will be the growth opportunities in the 7MM with respect to the patient population pertaining to PCSK9 Inhibitors?
  • Out of all the 7MM countries, which country would have the highest incident population of PCSK9 Inhibitors during the study period (2019-2032)?
  • At what CAGR the population is expected to grow by 7MM during the study period (2019-2032)?
  • What are the various recent and upcoming events which are expected to improve the uptake of PCSK9 Inhibitors?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:

  • What are the marketed PCSK9 Inhibitors and their respective MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, efficacy, etc.?
  • How many companies are developing PCSK9 Inhibitors for the treatment of selected cancers?
  • How many PCSK9 Inhibitors are in-development by each company for selected cancer treatment?
  • How many are emerging PCSK9 Inhibitors in mid-stage, and late stage of development for selected cancers treatment?
  • What are the key collaborations (Industry - Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the PCSK9 Inhibitors?
  • What are the recent novel therapies, targets, mechanisms of action, and technologies being developed to overcome the limitation of existing therapies?
  • What are the clinical studies going on for PCSK9 Inhibitors and its status?
  • What are the current challenges faced in drug development?
  • What are the key designations that have been granted for the emerging PCSK9 Inhibitors?
  • What are the global historical and forecasted markets of PCSK9 Inhibitors?

Reasons to buy:

  • The report will help in developing business strategies by understanding trends shaping and driving the PCSK9 Inhibitors market
  • To understand the future market competition in the PCSK9 Inhibitors market and Insightful review of the key unmet needs
  • Organize sales and marketing efforts by identifying the best opportunities for PCSK9 Inhibitors in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom), and Japan
  • Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors
  • Organize sales and marketing efforts by identifying the best opportunities for the PCSK9 Inhibitors market
  • To understand the future market competition in the PCSK9 Inhibitors market

Table of Contents

1. Key Insights

2. Report Introduction

3. Table of Contents

4. PCSK9 Inhibitors Market Overview at a Glance

  • 4.1. Market Share (%) Distribution of PCSK9 Inhibitors in 2019
  • 4.2. Market Share (%) Distribution of PCSK9 Inhibitors in 2032

5. Executive Summary of PCSK9 Inhibitors (PCSK9i)

  • 5.1. Key Events

6. Epidemiology and Market Methodology

7. PCSK9 Inhibitors (PCSK9i) Background and Overview

  • 7.1. Introduction
  • 7.2. PCSK9 gene biology
  • 7.3. Functional mechanics of PCSK9
  • 7.4. PCSK9 Inhibitors
  • 7.5. PCSK9 Inhibition Strategies
  • 7.6. The Approval Status of PCSK9 Inhibitors
  • 7.7. Disease Areas of PCSK9 Inhibitors
    • 7.7.1. Primary Hyperlipidemia
    • 7.7.2. Prevention of Myocardial Infarction, Stroke, and Unstable Angina Requiring Hospitalization

8. Guidelines

  • 8.1. ESC/EAS Guidelines for the Management of Dyslipidemias
  • 8.2. American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines
  • 8.3. Recommendations From an Expert Panel of the National Lipid Association
  • 8.4. Recommendations of the Spanish Society of Arteriosclerosis (SEA)
  • 8.5. NICE guidelines
  • 8.6. Japan Atherosclerosis Society (JAS) Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases
  • 8.7. Comparison of guidelines

9. Epidemiology and Patient Population

  • 9.1. Key Findings
  • 9.2. Assumptions and Rationale 7MM
  • 9.3. Epidemiology Scenario in the 7MM
    • 9.3.1. Total Prevalent Cases of FH
    • 9.3.2. Total Diagnosed Cases of Familial Hypercholesterolemia
    • 9.3.3. Total Type-specific Cases of Familial Hypercholesterolemia
    • 9.3.4. Total Age-specific Cases of Familial Hypercholesterolemia
    • 9.3.5. Total Mutation-specific Cases of Familial Hypercholesterolemia
    • 9.3.6. Total Risk factor-specific Cases of PCSK9 Inhibitors in Prophylactic/Preventive setting
    • 9.3.7. Total Treated Cases of PCSK9 Inhibitors
  • 9.4. Epidemiology Scenario in the US
    • 9.4.1. Total Prevalent Cases of Familial Hypercholestrolemia
    • 9.4.2. Total Diagnosed Cases of Familial Hypercholesterolemia
    • 9.4.3. Total Type-specific Cases of Familial Hypercholesterolemia
    • 9.4.4. Total Age-specific Cases of Familial Hypercholesterolemia
    • 9.4.5. Total Mutation-specific Cases of Familial Hypercholesterolemia
    • 9.4.6. Total Risk factor-specific Cases of PCSK9 Inhibitors in Prophylactic/Preventive setting
    • 9.4.7. Total Treated Cases of PCSK9 Inhibitors
  • 9.5. Epidemiology Scenario in EU5
    • 9.5.1. Total Prevalent Cases of Familial Hypercholestrolemia
    • 9.5.2. Total Diagnosed Cases of FH
    • 9.5.3. Total Type-specific Cases of Familial Hypercholesterolemia
    • 9.5.4. Total Age-specific Cases of Familial Hypercholesterolemia
    • 9.5.5. Total Mutation-specific Cases of Familial Hypercholesterolemia
    • 9.5.6. Total Risk factor-specific Cases of PCSK9 Inhibitors in Prophylactic/Preventive setting
    • 9.5.7. Total Treated Cases of PCSK9 Inhibitors
  • 9.6. Epidemiology Scenario in Japan
    • 9.6.1. Total Prevalent Cases of Familial Hypercholestrolemia
    • 9.6.2. Total Diagnosed Cases of Familial Hypercholesterolemia
    • 9.6.3. Total Type-specific Cases of Familial Hypercholesterolemia
    • 9.6.4. Total Age-specific Cases of Familial Hypercholesterolemia
    • 9.6.5. Total Mutation-specific Cases of Familial Hypercholesterolemia in Japan
    • 9.6.6. Total Risk factor-specific Cases of PCSK9 Inhibitors in Prophylactic/Preventive setting
    • 9.6.7. Total Treated Cases of PCSK9 Inhibitors

10. Patient Journey

11. Key Endpoints in PCSK9 inhibitor Clinical Trials

12. Marketed drugs

  • 12.1. Key-cross
  • 12.2. PRALUENT (Alirocumab): Sanofi/Regeneron Pharmaceuticals
    • 12.2.1. Drug description
    • 12.2.2. Regulatory milestones
    • 12.2.3. Other developmental activities
    • 12.2.4. Pivotal clinical trial
    • 12.2.5. Ongoing current pipeline activity
  • 12.3. REPATHA (Evolocumab/AMG 145): Amgen
    • 12.3.1. Drug description
    • 12.3.2. Regulatory milestones
    • 12.3.3. Other developmental activities
    • 12.3.4. Pivotal clinical trial
    • 12.3.5. Ongoing current pipeline activity
  • 12.4. LEQVIO (Inclisiran): Novartis/Alnylam Pharmaceuticals
    • 12.4.1. Drug description
    • 12.4.2. Regulatory milestones
    • 12.4.3. Other developmental activities
    • 12.4.4. Pivotal clinical trial
    • 12.4.5. Ongoing current pipeline activity

13. Emerging Therapies

  • 13.1. Key Cross Competition
  • 13.2. AZD8233 (ION449): AstraZeneca and Ionis Pharmaceuticals
    • 13.2.1. Drug description
    • 13.2.2. Other developmental activities
    • 13.2.3. Clinical development
    • 13.2.4. Safety and Efficacy
  • 13.3. Cepadacursen sodium (CIVI-007): CiVi Biopharma
    • 13.3.1. Product Description
    • 13.3.2. Other developmental activities
    • 13.3.3. Clinical development
    • 13.3.4. Safety and efficacy
  • 13.4. LIB003 (Lerodalcibep): LIB Therapeutics
    • 13.4.1. Drug description
    • 13.4.2. Clinical development
    • 13.4.3. Safety and efficacy
  • 13.5. MK-0616: Merck Sharp & Dohme
    • 13.5.1. Product description
    • 13.5.2. Clinical development
    • 13.5.3. Safety and Efficacy

14. Attribute Analysis of PCSK9 Inhibitors

15. PCSK9 inhibitors: 7 Major Market Analysis

  • 15.1. Key Findings
  • 15.2. Market Outlook
  • 15.3. Market of PCSK9 Inhibitors (PCSK9i)
  • 15.4. 7MM Market Size of PCSK9 inhibitors
    • 15.4.1. Total Market Size of PCSK9 inhibitors
    • 15.4.2. Market Size of PCSK9 inhibitors by Therapies (Treatment and Secondary Prevention)
  • 15.5. Market Size of PCSK9 inhibitorsin the US
    • 15.5.1. Total Market Size of PCSK9 inhibitors
    • 15.5.2. Market Size of PCSK9 inhibitors by Therapies (Treatment and Secondary Prevention)
  • 15.6. Market Size of PCSK9 inhibitors in EU5
    • 15.6.1. Total Market Size of PCSK9 inhibitors
    • 15.6.2. Market Size of PCSK9 inhibitors by Therapies (Treatment and Secondary Prevention)
  • 15.7. Market Size of PCSK9 inhibitors in Japan
    • 15.7.1. Total Market Size of PCSK9 inhibitors
    • 15.7.2. Market Size of PCSK9 inhibitors by Therapies

16. Market Access and Reimbursement

  • 16.1. Key HTA decisions for PCSK9i
  • 16.2. Reimbursement
  • 16.3. Patient Access Programs

17. KOL Views

18. SWOT analysis

19. Unmet Needs

20. Appendix

  • 20.1. Acronyms and Abbreviations
  • 20.2. Bibliography
  • 20.3. Report Methodology

21. DelveInsight Capabilities

22. Disclaimer

23. About DelveInsight

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