高脂血症市場 - 競合情勢

2024年の高トリグリセリド（TG）を伴う高比重リポ蛋白C（LDL-C）の総有病者数は128,720,003人とされておりし、2029年には総有病者数が133,846,798人に増加すると予測されています。

上市済み高脂血症治療薬の大半は酵素阻害薬であり、イノベーター分子とジェネリック分子を含みます。

高脂血症治療薬として開発中の分子は合計207品目あり、うち15品目が登録前段階、28品目が第III相、23品目が第II相にあります。

過去10年間に高脂血症を対象とした臨床試験は合計1,637件開始されました。高脂血症の臨床試験が最も多く実施された年は2023年の227試験、次いで2022年の178試験でした。

高脂血症治療薬の開発では、南米ではライセンス契約が主流でしたが、アフリカでは提携が、アジア太平洋地域では買収がより広がりました。

当レポートでは、世界の高脂血症市場について調査し、疾患の概要とともに、治験動向、パイプライン概要、将来の見通しなどを提供しています。

目次

第1章 目次

第1章 序文

第2章 主な調査結果

第3章 病気の情勢

• 疾患の概要
• 疫学概要
• 治療の概要

第4章 上市済み薬剤の評価

• 主な上市済み薬剤
• 作用機序別概要
• 分子タイプ別概要
• 製品プロファイルと売上予測

第5章 価格設定と償還評価

• 年間治療費
• 価格設定と償還までの時間

第6章 パイプライン薬剤の評価

• 中期から後期段階のパイプライン薬剤
• 開発段階別概要
• 作用機序別概要
• 分子タイプ別概要
• 薬剤固有の相転移成功率（PTSR）と承認可能性（LoA）
• 治療領域と適応症別のPTSRとLoA

第7章 臨床試験の評価

• 歴史的概要
• 相別概要
• ステータス別概要
• 進行中および計画中の試験の相別概要
• 仮想コンポーネントの試験
• 地域別の試験概要
• 地域別の単一国および多国間試験
• 相別のスポンサー上位20社
• ステータス別のスポンサー上位20社
• エンドポイントステータス別概要
• 人種と民族別概要
• 登録データ
• 治験実施施設上位20カ国
• 世界のトップ20サイト
• 実現可能性分析- 地理的概要
• 実現可能性分析- ベンチマークモデル

第8章 取引の情勢

• 地域別の合併、買収、戦略的提携
• 最近の合併、買収、戦略的提携

第9章 商業的評価

第10章 将来の市場促進要因

第11章 付録

This reports provides a data-driven overview of the current and future competitive landscape in Hyperlipidemia therapeutics.

GlobalData epidemiologists estimate 128,720,003 total prevalent cases of high low-density lipoprotein C (LDL-C) with high triglycerides (TG) in 2024, which is expected to increase to 133,846,798 total prevalent cases in 2029.

Most of the marketed hyperlipidemia assets, including both innovator molecules and generic molecules, are enzyme inhibitors,

A total of 207 molecules are in development for hyperlipidemia, including 15 drugs in the pre-registration stage, 28 in Phase III, and 23 in Phase II.

A total of 1,637 clinical trials were initiated for hyperlipidemia in the last 10 years. The year with the most trials conducted for hyperlipidemia was 2023, with 227 trials, followed by 2022 with 178 trials.

In the development of hyperlipidemia assets, licensing agreements were the dominant deal type in South America, while partnerships prevailed in Africa and acquisitions were more common in the Asia-Pacific region.

Scope

GlobalData's Hyperlipidemia: Competitive Landscape combines data from the Pharma Intelligence Center with in-house analyst expertise to provide a competitive assessment of the disease marketplace.

Components of the report include -

• Disease Landscape
• Disease Overview
• Epidemiology Overview
• Treatment Overview
• Marketed Products Assessment
• Breakdown by Mechanism of Action, Route of Administration
• Product Profiles with Sales Forecast
• Pricing and Reimbursement Assessment
• Annual Therapy Cost
• Time to Pricing and Time to Reimbursement
• Pipeline Assessment
• Breakdown by Development Stage, Mechanism of Action, Molecule Type, Route of Administration
• Product Profiles with Sales Forecast
• Late-to-mid-stage Pipeline Drugs
• Phase Transition Success Rate and Likelihood of Approval
• Clinical Trials Assessment
• Breakdown of Trials by Phase, Status, Virtual Components, Sponsors, Geography, and Endpoint Status
• Enrolment Analytics, Site Analytics, Feasibility Analysis
• Deals Landscape
• Mergers, Acquisitions, and Strategic Alliances by Region
• Overview of Recent Deals
• Commercial Assessment
• Key Market Players
• Future Market Catalysts

Reasons to Buy

• Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
• Develop business strategies by understanding the trends shaping and driving the Hyperlipidemia market.
• Drive revenues by understanding the key trends, innovative products and technologies, and companies likely to impact the global Hyperlipidemia market in the future.
• Formulate effective sales and marketing strategies by understanding the competitive landscape and analyzing the performance of various competitors.
• Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
• Organize your sales and marketing efforts by identifying the market categories that present the maximum opportunities for consolidations, investments, and strategic partnerships.

Table of Contents

1 Table of Contents

1 Preface

• 1.1 Contents
• 1.2 Report Scope
• 1.3 List of Tables and Figures
• 1.4 Abbreviations

2 Key Findings

3 Disease Landscape

• 3.1 Disease Overview
• 3.2 Epidemiology Overview
• 3.3 Treatment Overview

4 Marketed Drugs Assessment

• 4.1 Leading Marketed Drugs
• 4.2 Overview by Mechanism of Action
• 4.3 Overview by Molecule Type
• 4.4 Product Profiles and Sales Forecast

5 Pricing and Reimbursement Assessment

• 5.1 Annual Cost of Therapy
• 5.2 Time to Pricing and Reimbursement

6 Pipeline Drugs Assessment

• 6.1 Mid-to-late-stage Pipeline Drugs
• 6.2 Overview by Development Stage
• 6.3 Overview by Mechanism of Action
• 6.4 Overview by Molecule Type
• 6.5 Drug Specific Phase Transition Success Rate (PTSR) and Likelihood of Approval (LoA)
• 6.6 Therapy Area and Indication-specific PTSR and LoA

7 Clinical Trials Assessment

• 7.1 Historical Overview
• 7.2 Overview by Phase
• 7.3 Overview by Status
• 7.4 Overview by Phase for Ongoing and Planned Trials
• 7.5 Trials with Virtual Components
• 7.6 Overview of Trials by Geography
• 7.7 Single-Country and Multinational Trials by Region
• 7.8 Top 20 Sponsors with Breakdown by Phase
• 7.9 Top 20 Sponsors with Breakdown by Status
• 7.10 Overview by Endpoint Status
• 7.11 Overview by Race and Ethnicity
• 7.12 Enrollment Data
• 7.13 Top 20 countries for Trial Sites
• 7.14 Top 20 Sites Globally
• 7.15 Feasibility Analysis - Geographic Overview
• 7.16 Feasibility Analysis - Benchmark Models

8 Deals Landscape

• 8.1 Mergers, Acquisitions, and Strategic Alliances by Region
• 8.2 Recent Mergers, Acquisitions, and Strategic Alliances

9 Commercial Assessment

• 9.1 Key Market Players

10 Future Market Catalysts

11 Appendix

• 11.1 Methodology
• 11.2 Methodology - Sales Forecast
• 11.3 Methodology - Pricing and Reimbursement
• 11.4 Methodology - PTSR and LoA Analysis
• 11.5 About the Authors
• 11.6 Contact Us
• 11.7 Disclaimer