DelveInsight’s “PCSK9 Inhibitors – Market Insight, Epidemiology, And Market Forecast – 2034″ report offers an in-depth understanding of the PCSK9 Inhibitors, historical and forecasted epidemiology as well as the PCSK9 Inhibitors market trends in the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom) and Japan.
Some of the key facts of the PCSK9 Inhibitors Market Report:
• The PCSK9 Inhibitors Market in the 7MM was valued at approximately USD 2 billion in 2023, with the United States leading the market at around USD 900 million.
• In 2023, approximately 640K diagnosed cases of Familial Hypercholesterolemia were reported across the 7MM, with homozygous cases being extremely rare.
• Peripheral Artery Disease accounted for the highest number of risk factor-specific cases for PCSK9 inhibitors in prophylactic settings within the 7MM.
• Currently, two FDA-approved monoclonal antibodies inhibit PCSK9: PRALUENT (alirocumab) and REPATHA (evolocumab).
• Recently, the European Union and FDA approved LEQVIO (Inclisiran), a small interfering mRNA therapy that blocks intracellular PCSK9 synthesis.
• In December 2024, LIB Therapeutics submitted a Biologics License Application (BLA) to the FDA for Lerodalcibep, seeking approval to lower LDL-C in patients with ASCVD, high ASCVD risk, and primary hyperlipidemia, including HeFH and HoFH.
• Emerging therapies in the PCSK9 Inhibitors pipeline include MK-0616, LIB003 (Lerodalcibep), and others.
• Leading companies in the PCSK9 Inhibitors market include Sanofi, Regeneron Pharmaceuticals, Amgen, Novartis, Alnylam Pharmaceuticals, LIB Therapeutics, AstraZeneca, Ionis Pharmaceuticals, CiVi Biopharma, and others.
To know in detail about the PCSK9 Inhibitors market outlook, drug uptake, treatment scenario, and epidemiology trends, click here: PCSK9 Inhibitors Market Forecast
PCSK9 Inhibitors Overview
The Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) enzyme plays a crucial role in cholesterol metabolism by controlling the degradation of low-density lipoprotein (LDL) receptors, thereby affecting the clearance of circulating LDL particles. PCSK9 activity is inversely linked to LDL cholesterol (LDL-C) levels—gain-of-function mutations in the PCSK9 gene contribute to elevated LDL-C and increased cardiovascular risk in familial hypercholesterolemia (FH), while loss-of-function mutations result in lower LDL-C levels and a reduced risk of atherosclerotic cardiovascular disease (ASCVD).
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PCSK9 Inhibitors Epidemiology
The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2020 to 2034. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends.
PCSK9 Inhibitors Epidemiology Segmentation
The PCSK9 Inhibitors epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by:
• Total Prevalent Cases of Familial Hypercholesterolemia in the 7MM
• Total Diagnosed Prevalent Cases of Familial Hypercholesterolemia in the 7MM
• Type-specific Diagnosed Prevalent Cases of Familial Hypercholesterolemia in the 7MM
• Age-specific Diagnosed Prevalent Cases of Familial Hypercholesterolemia in the 7MM
• Mutation-specific Diagnosed Prevalent Cases of Familial Hypercholesterolemia in the 7MM
• Risk factor-specific Cases of PCSK9 inhibitors in Prophylactic/Preventive setting in the 7MM
• Total Treated Cases of PCSK9 inhibitors in the 7MM
Download the report to understand which factors are driving PCSK9 Inhibitors epidemiology trends @ PCSK9 Inhibitors Epidemiology Forecast
PCSK9 Inhibitor Drugs Uptake and Pipeline Development Activities
The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the PCSK9 Inhibitors market or expected to be launched during the study period. The analysis covers the PCSK9 inhibitors’ market uptake by drugs, patient uptake by therapies, and sales of each drug.
Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share.
The report also covers the PCSK9 Inhibitors Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.
PCSK9 Inhibitors Market Strengths
• PCSK9 inhibitors have demonstrated significant effectiveness in reducing LDL cholesterol levels, making them a preferred treatment option for patients with familial hypercholesterolemia (FH) and those at high cardiovascular risk. Their ability to lower LDL-C beyond traditional statins enhances their clinical utility.
• With increasing regulatory approvals and expanding indications, including for primary hyperlipidemia and atherosclerotic cardiovascular disease (ASCVD), PCSK9 inhibitors are gaining traction in both preventive and therapeutic settings, driving market growth.
PCSK9 Inhibitors Market Weaknesses
• The high price of PCSK9 inhibitors poses a significant barrier to widespread adoption, limiting access for many patients, particularly in regions with cost-sensitive healthcare systems or inadequate insurance coverage.
• Unlike oral lipid-lowering therapies, PCSK9 inhibitors require subcutaneous administration, which can affect patient adherence and preference, potentially hindering long-term treatment compliance and market penetration.
Scope of the PCSK9 Inhibitors Market Report
• Study Period: 2020–2034
• Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
• Key PCSK9 Inhibitors drugs: MK-0616, LIB003 (Lerodalcibep), and others.
• Key PCSK9 Inhibitors Companies: Sanofi, Regeneron Pharmaceuticals, Amgen, Novartis, Alnylam Pharmaceuticals, LIB Therapeutics, AstraZeneca, Ionis Pharmaceuticals, CiVi Biopharma, and others.
• PCSK9 Inhibitors Therapeutic Assessment: PCSK9 Inhibitors currently marketed, and PCSK9 Inhibitors emerging therapies
• PCSK9 Inhibitors Market Dynamics: PCSK9 Inhibitors market drivers and PCSK9 Inhibitors market barriers
• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies
• PCSK9 Inhibitors Unmet Needs, KOL’s views, Analyst’s views, PCSK9 Inhibitors Market Access and Reimbursement
To learn more about the key players and advancements in the PCSK9 Inhibitors Treatment Landscape, visit the PCSK9 Inhibitors Market Analysis Report
Table of Contents
1. PCSK9 Inhibitors Market Report Introduction
2. Executive Summary for PCSK9 Inhibitors
3. SWOT analysis of PCSK9 Inhibitors
4. PCSK9 Inhibitors Patient Share (%) Overview at a Glance
5. PCSK9 Inhibitors Market Overview at a Glance
6. PCSK9 Inhibitors Disease Background and Overview
7. PCSK9 Inhibitors Epidemiology and Patient Population
8. Country-Specific Patient Population of PCSK9 Inhibitors
9. PCSK9 Inhibitors Current Treatment and Medical Practices
10. PCSK9 Inhibitors Unmet Needs
11. PCSK9 Inhibitors Emerging Therapies
12. PCSK9 Inhibitors Market Outlook
13. Country-Wise PCSK9 Inhibitors Market Analysis (2020–2034)
14. PCSK9 Inhibitors Market Access and Reimbursement of Therapies
15. PCSK9 Inhibitors Market Drivers
16. PCSK9 Inhibitors Market Barriers
17. PCSK9 Inhibitors Appendix
18. PCSK9 Inhibitors Report Methodology
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight
About DelveInsight DelveInsight is a leading Healthcare Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.
It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.
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