表紙:PCSK9阻害剤:市場分析、疫学、市場予測 (2032年)
市場調査レポート
商品コード
1126002

PCSK9阻害剤:市場分析、疫学、市場予測 (2032年)

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

出版日: | 発行: DelveInsight | ページ情報: 英文 286 Pages | 納期: 1~3営業日

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PCSK9阻害剤:市場分析、疫学、市場予測 (2032年)
出版日: 2022年09月01日
発行: DelveInsight
ページ情報: 英文 286 Pages
納期: 1~3営業日
  • 全表示
  • 概要
  • 図表
  • 目次
概要

世界の主要7ヶ国におけるPCSK9阻害剤の市場規模は、2021年に約13億900万米ドルに達し、調査期間中 (2019年~2032年) も拡大傾向が続く見通しです。

国別にみると、米国におけるPCSK9阻害剤の市場規模は2021年に7億2,900万米ドルに達し、欧州5ヶ国は2021年に5億2,700万米ドル、日本は5,300万米ドルに達すると予測されています。

当レポートでは、世界の主要7カ国 - 米国、欧州主要5ヶ国 (EU5:フランス・ドイツ・イタリア・スペイン・英国)、日本 - におけるPCSK9阻害剤の疫学的動向と今後の市場見通しについて分析し、疾患の概要や市場の基本構造、現在の治療法とアンメットニーズ、有病者数の動向見通し、上市済み/治験中の治療薬のプロファイル、世界全体/各国の市場規模 (2019年~2032年)、主な市場促進・抑制要因、といった情報を取りまとめてお届けいたします。

目次

第1章 主な洞察

第2章 レポートのイントロダクション

第3章 目次

第3章 PCSK9阻害剤:市場概要

  • PCSK9阻害剤の市場シェア (2019年)
  • PCSK9阻害剤の市場シェア (2032年)

第5章 PCSK9阻害剤 (PCSK9i):エグゼクティブサマリー

第6章 疫学と市場調査手法

第7章 PCSK9阻害剤 (PCSK9i):背景と概要

  • イントロダクション
  • PCSK9の遺伝子生物学
  • PCSK9の機能力学
  • PCSK9阻害剤
  • PCSK9の阻害戦略
  • PCSK9阻害剤の承認状況
  • PCSK9阻害剤の疾患領域
    • 原発性高脂血症
    • 入院を要する心筋梗塞、脳卒中、不安定狭心症の予防

第8章 ガイドライン

  • 脂質異常症の管理のためのESC/EASガイドライン
  • アメリカ心臓病学会/アメリカ心臓協会臨床診療ガイドラインに関するタスクフォース
  • 全米脂質協会の専門家パネルからの推奨事項
  • スペイン動脈硬化学会 (SEA) の推奨事項
  • NICEガイドライン
  • 日本動脈硬化学会 (JAS) の動脈硬化性心血管疾患予防ガイドライン
  • ガイドラインの比較

第9章 疫学と患者数

  • 主な調査結果
  • 仮定と根拠:主要7ヶ国
  • 主要7ヶ国の疫学シナリオ
    • 家族性高コレステロール血症 (FH) の総有病者数
    • 家族性高コレステロール血症の受診済み総発症件数
    • 家族性高コレステロール血症の総発症件数:種類別
    • 家族性高コレステロール血症の総発症件数:年齢別
    • 家族性高コレステロール血症の総発症件数:突然変異特異的
    • 予防的設定におけるPCSK9阻害剤の総発症件数:危険因子別
    • PCSK9阻害剤の総治療症例数
  • 米国における疫学シナリオ
    • 家族性高コレステロール血症 (FH) の総有病者数
  • 欧州5ヶ国における疫学シナリオ
  • 日本の疫学シナリオ

第10章 ペイシェントジャーニー

第11章 PCSK9阻害剤の治験:重要なエンドポイント

第12章 上市済み治療薬

  • キークロス
  • PRALUENT (アリロクマブ):Sanofi/Regeneron Pharmaceuticals
    • 薬剤の説明
    • 規制のマイルストーン
    • その他の開発活動
    • 重要な治験
    • 現在進行中のパイプライン活動
  • REPATHA (エボロクマブ/AMG 145):Amgen
  • LEQVIO (Inclisiran):Novartis/Alnylam Pharmaceuticals

第13章 新たな治療薬

  • キークロス競合
  • AZD8233 (ION449):AstraZeneca and Ionis Pharmaceuticals
    • 薬の説明
    • その他の開発活動
    • 臨床開発
    • 安全性と有効性
  • セパダクルセンナトリウム (CIVI-007):CiVi Biopharma
  • LIB003 (Lerodalcibep):LIB Therapeutics
  • MK-0616:Merck Sharp & Dohme

第14章 PCSK9阻害剤の属性解析

第15章 PCSK9阻害剤:主要7ヶ国の市場分析

  • 主な調査結果
  • 市場の見通し
  • PCSK9阻害剤 (PCSK9i) の市場
  • 主要7ヶ国のPCSK9阻害剤の市場規模
    • PCSK9阻害剤の総市場規模
    • PCSK9阻害剤の市場規模:治療薬別 (治療・二次予防)
  • 米国のPCSK9阻害剤の市場規模
  • 欧州5ヶ国のPCSK9阻害剤の市場規模
  • 日本のPCSK9阻害剤の市場規模

第16章 市場アクセスと償還

  • PCSK9iに関するHTAの重要な決定事項
  • 償還
  • 患者アクセスプログラム

第17章 業界の有識者 (KOL) の見解

第18章 SWOT分析

第19章 アンメットニーズ

第20章 付録

第21章 DelveInsightのサービス内容

第22章 免責事項

第23章 DelveInsightについて

図表

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)
目次
Product Code: DIMI1082

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

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