脂質異常症市場：主要市場別-市場規模、動向、薬剤予測（2032年までの疫学、疾患管理、競合評価、アンメットニーズ、臨床試験戦略、パイプライン分析）

脂質異常症市場における薬剤売上は2022年から2032年にかけて大きく成長し、全体の年間平均成長率（CAGR）は10.8%になると予測されています。2022年、脂質異常症市場全体の規模は主要7ヶ国全体で55億6,000万米ドルと推定されています。2022年には、米国が41億2,000万米ドル（74%）で世界総売上高の大半を占めました。EU5ヶ国は11億8,000万米ドルと推定され、世界の脂質異常症市場売上の21%を占め、日本の脂質異常症市場売上は2022年に2億5,290万米ドルと推定され、市場の5%を占めています。

予測期間終了の2032年には、155億3,000万米ドルに達すると予測されており、米国は世界市場の78%を占め、市場価値は120億6,000万米ドルです。これは、米国における脂質異常症の有病率が高いこと、EU5ヶ国や日本と比較して薬剤の価格が全体的に高いことに起因すると考えられます。さらに、米国では予測期間中に脂質異常症市場に参入するパイプライン薬剤の数が、EUや日本に比べて多くなっています。EU諸国はCAGR 8.3%で成長し、売上高は26億3,000万米ドルに達すると予想されます。日本は総売上高の5%を占め、予測期間終了時のCAGRは12.8%です。

脂質異常症パイプラインの中でもPCSK9クラスの成長は、脂質異常症市場における生物学的製剤の現在の拡大を浮き彫りにしています。しかし、その高価格のため、規制当局の承認に基づく治療の対象となる患者と治療を受ける患者の間には大きな乖離があります。これに対し、より一般的な脂質異常症市場をターゲットとした、より費用対効果の高い治療薬には十分なチャンスがあります。メルク初の経口PCSK9阻害剤MK-0616のようなパイプライン薬剤が、このアンメット・ニーズに対応することになります。

当レポートでは、脂質異常症市場について調査し、2032年までの疫学動向、アンメットニーズ、臨床試験戦略、パイプライン分析、競合情勢などを提供しています。

目次

第1章 脂質異常症：エグゼクティブサマリー

第2章 イントロダクション

第3章 病気の概要

• 病因学と病態生理学

第4章 疫学

• 病気の背景
• 危険因子と併存疾患
• 世界的および歴史的動向
• 予測調査手法
• 脂質異常症の疫学予測（2022年～2032年）
• 議論

第5章 疾病管理

• 診断と治療の概要
• 疾病管理に関するKOLの洞察

第6章 競争力の評価

• 概要

第7章 アンメットニーズと機会の評価

• 概要
• リポタンパク質を標的とする治療法
• 効果的な中性脂肪低下療法
• 脂質異常症に対する費用対効果の高い治療法
• 個別の治療
• 診断、患者教育、長期的なコンプライアンスの改善

第8章 研究開発戦略

• 概要
• 臨床試験の設計

第9章 パイプラインの評価

• 概要
• 臨床開発中の有望な薬剤

第10章 パイプラインの評価分析

• 概要
• 競争力評価

第11章 現在および将来の市場参入企業

• 概要
• 取引成立の動向

第12章 市場の見通し

• 世界市場
• 米国
• EU5ヶ国
• 日本

第13章 付録

Abstract

This report covers the 7MM (US, France, Germany, Italy, Spain, UK, Japan) and provides an Excel-based forecast model for the dyslipidemia market through 2032.

Examples of key findings from this report include the following -

• 2022 base year sales within the dyslipidemia market are approximately $5.6 billion across the 7MM detailed in this report. GlobalData estimates that this market will grow at a compound annual growth rate (CAGR) of 10.8% to reach $15.5 billion by the end of the forecast period.
• The growth of the PCSK9 class, among others in the dyslipidemia pipeline, highlights the current expansion of biologics into the dyslipidemia market. However, due to their high prices, there is a significant disconnect between patients who are eligible for treatment based on regulatory approval and those who receive treatment. In response to this, there is ample opportunity for more cost-effective therapies targeting the more general dyslipidemia market. This is where pipeline drugs such as Merck's first oral PCSK9 inhibitor, MK-0616, will address this unmet need.

Key Highlights

According to GlobalData, the drug sales in the dyslipidemia market are expected to grow significantly between 2022 and 2032, with an overall compound annual growth rate (CAGR) of 10.8%. In 2022, GlobalData estimated the total dyslipidemia market to be valued at $5.56 billion across the 7MM. In 2022, the US made up the majority of total global sales, with $4.12 billion (74%). The 5EU accounted for 21% of the global dyslipidemia market sales with an estimated value of $1.18 billion million and Japan's dyslipidemia market sales were estimated to be $252.9 million in 2022, accounting for 5% of the market.

By the end of the forecast period in 2032, GlobalData expects the dyslipidemia market to grow at a CAGR of 10.8%, reaching sales of $15.53 billion, with the US accounting for 78% of the global market with a market value of $12.06 billion. This could be due to the large prevalence of dyslipidemia in the US, as well as the higher overall price of drugs as compared to the 5EU and Japan. Moreover, the US has more pipeline drugs entering the dyslipidemia market during the forecast period compared to the 5EU and Japan. The 5EU is anticipated to grow with a CAGR of 8.3%, reaching sales of $2.63 billion. Japan accounts for 5% of the total sales with a CAGR of 12.8% by the end of the forecast period.

Major drivers of the dyslipidemia market growth during the forecast period are -

• The increasing global prevalence of dyslipidemia due to an increase in obesity, sedentary lifestyles, and unhealthy dietary habits. As the global population continues to age, the prevalence of dyslipidemia is likely to increase.
• Improved awareness about the health risks associated with dyslipidemia and increased efforts in screening and diagnosis are expected to lead to more people being diagnosed with the condition.
• Therapies with new targets will enter the market, which will significantly boost market growth.
• The launch of the first oral PCSK9 inhibitor, Merck's MK-0616, as well as other promising pipeline therapies, including NewAmsterdam's oral CETP inhibitor, obicetrapib, and Akcea Therapeutics's apoC-III, olezarsen.

Major barriers that will restrict the growth of the dyslipidemia market during the forecast period are:

• The price of novel launched drugs for dyslipidemia and the restriction of access to highly priced new therapies.
• Widespread use of cheap, generic drugs making it difficult for high-priced branded therapies to penetrate the market.
• Continued generic erosion of Pfizer's Lipitor, AstraZeneca's Crestor (rosuvastatin), as well as Merck's Zetia (ezetimibe) across the 7MM.

Scope

• Overview of dyslipidemia, including epidemiology, symptoms, diagnosis, and disease management.
• Annualized dyslipidemia therapeutics market revenue, cost of therapy per patient, and treatment usage patterns forecast from 2022 to 2032.
• Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping, and implications of these factors for the dyslipidemia therapeutics market.
• Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for dyslipidemia treatment. The most promising candidates in late-stage development are profiled.
• Analysis of the current and future market competition in the global dyslipidemia therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

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 7MM dyslipidemia therapeutics market.
• Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the 7MM dyslipidemia therapeutics market in the future.
• Formulate effective sales and marketing strategies by understanding the competitive landscape and by 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 and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Table of Contents

Table of Contents

1 Dyslipidemia: Executive Summary

• 1.1 Dyslipidemia market will exhibit strong growth during the forecast period, reaching sales of $15.53 billion in 2032
• 1.2 Key players will continue their competitive position in the dyslipidemia market over the forecast period
• 1.3 Patient compliance, the availability of cost-effective drugs, and therapies that target lipoprotein (a) are the greatest unmet needs in the dyslipidemia space
• 1.4 Late-stage pipeline therapies are anticipated to drive growth in the dyslipidemia market
• 1.5 What do physicians think?

2 Introduction

• 2.1 Catalyst
• 2.2 Related reports
• 2.3 Upcoming reports

3 Disease Overview

• 3.1 Etiology and pathophysiology

4 Epidemiology

• 4.1 Disease background
• 4.2 Risk factors and comorbidities
• 4.3 Global and historical trends
• 4.4 Forecast methodology
• 4.5 Epidemiological forecast for dyslipidemia (2022-32)
• 4.6 Discussion

5 Disease Management

• 5.1 Diagnosis and treatment overview
• 5.2 KOL insights on disease management

6 Competitive Assessment

• 6.1 Overview

7 Unmet Needs and Opportunity Assessment

• 7.1 Overview
• 7.2 Therapies that target lipoprotein (a)
• 7.3 Efficacious triglyceride-lowering therapies
• 7.4 Cost-effective therapies for dyslipidemia
• 7.5 Personalized treatment
• 7.6 Improving diagnosis, patient education, and long-term compliance

8 R&D Strategies

• 8.1 Overview
• 8.2 Clinical trials design

9 Pipeline Assessment

• 9.1 Overview
• 9.2 Promising drugs in clinical development

10 Pipeline Valuation Analysis

• 10.1 Overview
• 10.2 Competitive assessment

11 Current and Future Players

• 11.1 Overview
• 11.2 Deal-making trends

12 Market Outlook

• 12.1 Global markets
• 12.2 US
• 12.3 5EU
• 12.4 Japan

13 Appendix

• 13.1 Bibliography
• 13.2 Abbreviations
• 13.3 Methodology
• 13.4 Primary research - KOLs interviewed for this report
• 13.5 Primary research - prescriber survey
• 13.6 About the authors
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