Accessibility Statement Skip Navigation
  • Resources
  • Blog
  • Journalists
  • +44 (0)20 7454 5110
  • Client Login
  • Send a Release
Return to PR Newswire homepage
  • News
  • Products
  • Contact
When typing in this field, a list of search results will appear and be automatically updated as you type.

Searching for your content...

No results found. Please change your search terms and try again.
  • News in Focus
      • Browse News Releases

      • All Public Company News
      • All Multimedia News
      • View All News Releases

      • Regulatory News

      • D/A/CH Regulatory News
      • UK Regulatory News
      • View All Regulatory News

  • Business & Money
      • Auto & Transportation

      • Aerospace & Defense
      • Air Freight
      • Airlines & Aviation
      • Automotive
      • Maritime & Shipbuilding
      • Railroads & Intermodal Transportation
      • Supply Chain/Logistics
      • Transportation, Trucking & Railroad
      • Travel
      • Trucking & Road Transportation
      • View All Auto & Transportation

      • Business Technology

      • Blockchain
      • Broadcast Tech
      • Computer & Electronics
      • Computer Hardware
      • Computer Software
      • Data Analytics
      • Electronic Commerce
      • Electronic Components
      • Electronic Design Automation
      • Financial Technology
      • High Tech Security
      • Internet Technology
      • Nanotechnology
      • Networks
      • Peripherals
      • Semiconductors
      • View All Business Technology

      • Entertain­ment & Media

      • Advertising
      • Art
      • Books
      • Entertainment
      • Film & Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • View All Entertain­ment & Media

      • Financial Services & Investing

      • Accounting News & Issues
      • Acquisitions, Mergers & Takeovers
      • Banking & Financial Services
      • Bankruptcy
      • Bond & Stock Ratings
      • Conference Call Announcements
      • Contracts
      • Cryptocurrency
      • Dividends
      • Earnings
      • Earnings Forecasts & Projections
      • Financing Agreements
      • Insurance
      • Investments Opinions
      • Joint Ventures
      • Mutual Funds
      • Private Placement
      • Real Estate
      • Restructuring & Recapitalisation
      • Sales Reports
      • Shareholder Activism
      • Shareholder Meetings
      • Stock Offering
      • Stock Split
      • Venture Capital
      • View All Financial Services & Investing

      • General Business

      • Awards
      • Commercial Real Estate
      • Corporate Expansion
      • Earnings
      • Environmental, Social and Governance (ESG)
      • Human Resource & Workforce Management
      • Licensing
      • New Products & Services
      • Obituaries
      • Outsourcing Businesses
      • Overseas Real Estate (non-US)
      • Personnel Announcements
      • Real Estate Transactions
      • Residential Real Estate
      • Small Business Services
      • Socially Responsible Investing
      • Surveys, Polls & Research
      • Trade Show News
      • View All General Business

  • Science & Tech
      • Consumer Technology

      • Artificial Intelligence
      • Blockchain
      • Cloud Computing/Internet of Things
      • Computer Electronics
      • Computer Hardware
      • Computer Software
      • Consumer Electronics
      • Cryptocurrency
      • Data Analytics
      • Electronic Commerce
      • Electronic Gaming
      • Financial Technology
      • Mobile Entertainment
      • Multimedia & Internet
      • Peripherals
      • Social Media
      • STEM (Science, Tech, Engineering, Math)
      • Supply Chain/Logistics
      • Wireless Communications
      • View All Consumer Technology

      • Energy & Natural Resources

      • Alternative Energies
      • Chemical
      • Electrical Utilities
      • Gas
      • General Manufacturing
      • Mining
      • Mining & Metals
      • Oil & Energy
      • Oil & Gas Discoveries
      • Utilities
      • Water Utilities
      • View All Energy & Natural Resources

      • Environ­ment

      • Conservation & Recycling
      • Environmental Issues
      • Environmental Policy
      • Environmental Products & Services
      • Green Technology
      • Natural Disasters
      • View All Environ­ment

      • Heavy Industry & Manufacturing

      • Aerospace & Defence
      • Agriculture
      • Chemical
      • Construction & Building
      • General Manufacturing
      • HVAC (Heating, Ventilation & Air-Conditioning)
      • Machinery
      • Machine Tools, Metalworking & Metallurgy
      • Mining
      • Mining & Metals
      • Paper, Forest Products & Containers
      • Precious Metals
      • Textiles
      • Tobacco
      • View All Heavy Industry & Manufacturing

      • Telecomm­unications

      • Carriers & Services
      • Mobile Entertainment
      • Networks
      • Peripherals
      • Telecommunications Equipment
      • Telecommunications Industry
      • VoIP (Voice over Internet Protocol)
      • Wireless Communications
      • View All Telecomm­unications

  • Lifestyle & Health
      • Consumer Products & Retail

      • Animals & Pets
      • Beers, Wines & Spirits
      • Beverages
      • Bridal Services
      • Cannabis
      • Cosmetics & Personal Care
      • Fashion
      • Food & Beverages
      • Furniture & Furnishings
      • Home Improvement
      • Household, Consumer & Cosmetics
      • Household Products
      • Jewellery
      • Non-Alcoholic Beverages
      • Office Products
      • Organic Food
      • Product Recalls
      • Restaurants
      • Retail
      • Supermarkets
      • Toys
      • View All Consumer Products & Retail

      • Entertain­ment & Media

      • Advertising
      • Art
      • Books
      • Entertainment
      • Film & Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • View All Entertain­ment & Media

      • Health

      • Biometrics
      • Biotechnology
      • Clinical Trials & Medical Discoveries
      • Dentistry
      • FDA Approval
      • Fitness/Wellness
      • Health Care & Hospitals
      • Health Insurance
      • Infection Control
      • International Medical Approval
      • Medical Equipment
      • Medical Pharmaceuticals
      • Mental Health
      • Pharmaceuticals
      • Supplementary Medicine
      • View All Health

      • Sports

      • General Sports
      • Outdoors, Camping & Hiking
      • Sporting Events
      • Sports Equipment & Accessories
      • View All Sports

      • Travel

      • Amusement Parks & Tourist Attractions
      • Gambling & Casinos
      • Hotels & Resorts
      • Leisure & Tourism
      • Outdoors, Camping & Hiking
      • Passenger Aviation
      • Travel Industry
      • View All Travel

  • Policy & Public Interest
      • Policy & Public Interest

      • Animal Welfare
      • Corporate Social Responsibility
      • Economic News, Trends & Analysis
      • Education
      • Environmental
      • European Government
      • Labour & Union
      • Natural Disasters
      • Not For Profit
      • Public Safety
      • View All Policy & Public Interest

  • People & Culture
      • People & Culture

      • Aboriginal, First Nations & Native American
      • African American
      • Asian American
      • Children
      • Diversity, Equity & Inclusion
      • Hispanic
      • Lesbian, Gay & Bisexual
      • Men's Interest
      • People with Disabilities
      • Religion
      • Senior Citizens
      • Veterans
      • Women
      • View All People & Culture

  • Overview
  • Distribution
  • Paid Placement
  • Multimedia
  • Disclosure Services
  • SocialBoost
  • Rooms
    • MediaRoom
    • ESG Rooms
  • AI Tools
  • General Enquiries
  • Media Enquiries
  • Partnerships
  • Hamburger menu
  • Cision PR Newswire UK provides press release distribution, targeting, monitoring, and marketing services
  • Send a Release
    • Phone

    • +44 (0)20 7454 5110 from 8 AM - 5:30 PM GMT

    • ALL CONTACT INFO
    • Contact Us

      +44 (0)20 7454 5110
      from 8 AM - 5:30 PM GMT

  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • News in Focus
    • Browse News Releases
    • Regulatory News
  • Business & Money
    • Auto & Transportation
    • Business Technology
    • Entertain­ment & Media
    • Financial Services & Investing
    • General Business
  • Science & Tech
    • Consumer Technology
    • Energy & Natural Resources
    • Environ­ment
    • Heavy Industry & Manufacturing
    • Telecomm­unications
  • Lifestyle & Health
    • Consumer Products & Retail
    • Entertain­ment & Media
    • Health
    • Sports
    • Travel
  • Policy & Public Interest
    • Policy & Public Interest
  • People & Culture
    • People & Culture
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • Overview
  • Distribution
  • Paid Placement
  • Multimedia
  • Disclosure Services
  • Cision Communications Cloud®
  • AI Tools
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • General Enquiries
  • Media Enquiries
  • Partnerships
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists

LEQVIO Strengthens Position as Leader in Cholesterol-Lowering Therapies Across Seven Major Markets | DelveInsight

This image opens in the lightbox

News provided by

DelveInsight Business Research, LLP

08 May, 2025, 21:46 GMT

Share this article

Share toX

Share this article

Share toX

LEQVIO marks a significant advancement in hypercholesterolemia management, particularly for patients not achieving target LDL-C levels despite maximally tolerated statin therapy. As the first FDA-approved siRNA therapy for LDL-C reduction, it introduces a novel mechanism of action with sustained efficacy and biannual dosing, enhancing patient adherence.

LAS VEGAS, May 8, 2025 /PRNewswire/ -- DelveInsight's "LEQVIO Market Size, Forecast, and Market Insight Report" highlights the details around LEQVIO, which is a PCSK9 Inhibitor. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of LEQVIO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].

Novartis/Alnylam Pharmaceuticals' LEQVIO (inclisiran) Overview

LEQVIO (inclisiran) is a first-of-its-kind therapy developed by Novartis based on small interfering RNA (siRNA) technology. It targets the mRNA of PCSK9 (proprotein convertase subtilisin/kexin type 9), reducing the production of this protein in the liver. Unlike traditional treatments, LEQVIO lowers LDL-C levels by enhancing the liver's ability to absorb and eliminate it from the bloodstream.

In the US, LEQVIO is approved for use alongside diet and statin therapy in adults with primary hyperlipidemia, including those with heterozygous familial hypercholesterolemia (HeFH), to help reduce low-density lipoprotein cholesterol (LDL-C).

The recommended LEQVIO dosage is 284 mg, given via subcutaneous injection initially, followed by a dose at 3 months, and then every 6 months thereafter, in combination with statins. In 2034, the market size of inclisiran is expected to be USD 2.2 billion in the US.

Drug Name

LEQVIO (inclisiran)

Molecule type

Small interfering Ribonucleic Acid (siRNA)

Developer

Novartis/Alnylam Pharmaceuticals

Primary Indication

Primary hyperlipidemia, clinical ASCVD or HeFH, hypercholesterolemia, and others

Mechanism of action

Proprotein Convertase Subtilisin Kexin 9 (PCSK9) Inhibitor

Route of administration

Subcutaneous

Learn more about LEQVIO projected market size for PCSK9 inhibitors @ LEQVIO Market Potential 

Proprotein convertase subtilisin/kexin type 9 (PCSK9) is a serine protease essential to cholesterol metabolism, primarily by controlling the breakdown of low-density lipoprotein (LDL) receptors. This mechanism decreases the removal of LDL particles from the blood, thereby influencing LDL cholesterol (LDL-C) levels. There is an inverse relationship between PCSK9 activity and LDL-C levels: gain-of-function mutations in the PCSK9 gene lead to increased LDL-C and a higher cardiovascular risk, as seen in familial hypercholesterolemia, while loss-of-function mutations are associated with lower LDL-C levels and reduced atherosclerotic cardiovascular disease (ASCVD) risk. In 2023, approximately 640,000 cases of familial hypercholesterolemia were diagnosed across the 7MM, with homozygous forms being extremely rare.

PCSK9 inhibitors have emerged as a vital therapeutic option for hypercholesterolemia management, especially for patients at elevated cardiovascular risk or those unresponsive to standard treatments like statins. These drugs inhibit PCSK9, a protein that promotes LDL receptor degradation. By blocking PCSK9, these therapies enhance the presence of LDL receptors on liver cells, improving LDL-C clearance from the bloodstream. According to DelveInsight, the PCSK9 inhibitor market in the 7MM was valued at USD 2 billion in 2023.

In summary, the PCSK9 inhibitor market is projected to witness substantial growth, driven by their use in statin-intolerant patients, expanding applications of PCSK9 inhibition, potential in broader therapeutic areas, and their role in preventive strategies to help reduce the overall cardiovascular disease burden.

Discover more about the PCSK9 inhibitors market in detail @ PCSK9 Inhibitors Market Report

Emerging Competitors of LEQVIO

Several drugs are currently under development in the PCSK9 inhibitor pipeline, including Lerodalcibep (LIB Therapeutics), MK-0616 (Merck), VERVE-101 and VERVE-102 (Verve Therapeutics), and CiVi 008 (CiVi Biopharma), among others.

Lerodalcibep is a third-generation PCSK9 inhibitor designed to overcome the limitations of traditional LDL-C-lowering therapies like statins and ezetimibe. It aims to help patients reach the more aggressive LDL-C targets recommended by recent cardiovascular guidelines. The drug is being developed as a once-monthly, low-volume injection with long shelf stability at room temperature. Currently in Phase III clinical trials, LIB Therapeutics intends to file a Biologics License Application (BLA) by year-end, with a potential PDUFA decision expected in the latter half of 2025.

MK-0616, an oral PCSK9 inhibitor from Merck, is a novel macrocyclic peptide that blocks the interaction between PCSK9 and LDL receptors, thus reducing LDL cholesterol. It is currently in Phase III trials and could become the first oral treatment in its class.

Verve Therapeutics is advancing two gene-editing candidates—VERVE-101 and VERVE-102—targeting PCSK9. These one-time treatments are designed to permanently switch off the PCSK9 gene in the liver, thereby lowering LDL-C levels. VERVE-102 is being evaluated in the Heart-2 Phase Ib trial for patients with heterozygous familial hypercholesterolemia (HeFH) or early-onset coronary artery disease. Meanwhile, enrollment in the Heart-1 trial for VERVE-101 has been paused due to lab abnormalities, and an investigation is ongoing. Based on the results, Verve will work with regulators to decide the next steps for VERVE-101. The company plans to initiate a randomized, placebo-controlled Phase II trial based on data from both the Heart-1 and Heart-2 studies.

As these next-generation therapies move closer to approval, they have the potential to significantly disrupt and redefine the PCSK9 inhibitor market, ultimately giving fierce competition to LEQVIO.

To know more about the number of competing drugs in development, visit @ LEQVIO Market Positioning Compared to Other Drugs

Key Milestones of LEQVIO

  • In July 2023, the US FDA approved an expanded indication for Novartis LEQVIO to include treatment of adults with high LDL-C and who are at increased risk of heart disease. The updated indication for primary hyperlipidemia allows for the expanded use of LEQVIO as an adjunct to diet and statin therapy beyond the previously approved ASCVD and HeFH patient populations.
  • In 2023, LEQVIO (inclisiran) was approved by MHLW for familial and non-familial hypercholesterolemia and for patients who are at a high risk of developing cardiovascular events.
  • In August 2022, Novartis selected Soleo Health as a Limited Drug Distribution Partner for the Administration of LEQVIO. Under this partnership, Soleo Health will administer the drug to patients in their homes or at one of the Company's Ambulatory Infusion Centers (AICs) in the US.
  • In 2021, Novartis reached an agreement with the National Health Service (NHS) in England to implement a first-of-its-kind population health management approach designed to provide faster and broader access to LEQVIO for certain high-risk patients with ASCVD.
  • In December 2020, Novartis announced that the European Commission (EC) approved LEQVIO to treat adults with hypercholesterolemia or mixed dyslipidemia, two common forms of elevated cholesterol.

Discover how LEQVIO is shaping the PCSK9 inhibitors treatment landscape @ LEQVIO Injection

LEQVIO Market Dynamics

LEQVIO, as a first-in-class small interfering RNA (siRNA) that helps maintain bad cholesterol levels and improve mortality rates, strengthens its market position with a value-based price per dose and promising market access and reimbursement. Ongoing trials for CVRR and Pediatric Hyperlipidemia expansion pave the way for label expansion, addressing diverse medical needs. The escalating patient population presents a favorable trend for expanding LEQVIO's market reach and driving growth. 

However, its market is currently constrained by its specific indication for HeFH in adults, potentially limiting its reach compared to competitors like REPATHA and PRALUENT, which are approved for both HoHF and HeHF in adults and pediatrics. The market is expected to face heightened competition post-2027, which may impact LEQVIO's market share, and similar annual treatment costs across PCSK9 inhibitors may pose a challenge, affecting LEQVIO's competitive edge despite better reimbursement policies.

Dive deeper to get more insight into LEQVIO's strengths & weaknesses relative to competitors @ LEQVIO Market Drug Report

Table of Contents

1

Report Introduction

2

LEQVIO: Novartis/Alnylam Pharmaceuticals

2.1

Product Overview

2.2

Other Development Activities

2.3

Clinical Development

2.4

Clinical Trials Information

2.5

Safety and Efficacy

2.6

Product Profile

2.7

Market Assessment

2.7.1

The 7MM Analysis

2.7.1.1

Cost Assumptions and Rebate

2.7.1.2

Pricing Trends

2.7.1.3

Analogue Assessment

2.7.1.4

Launch Year and Therapy Uptake

2.7.2

The United States Market Analysis

2.7.3

EU4 and the United Kingdom Market Analysis

2.7.3.1

Germany

2.7.3.2

France

2.7.3.3

Italy

2.7.3.4

Spain

2.7.3.5

UK

2.7.4

Japan Market Analysis

2.8

Market Drivers

2.9

Market Barriers

2.10

SWOT Analysis

3

Key Cross of Marketed Competitors of LEQVIO

4

Key Cross of Emerging Competitors of LEQVIO

Related Reports

PCSK9 Inhibitor Market

PCSK9 Inhibitor Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key PCSK9 inhibitor companies, including LIB Therapeutics, Merck, Verve Therapeutics, CiVi Biopharma, among others.

PCSK9 Inhibitors Pipeline

PCSK9 Inhibitors Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key PCSK9 inhibitors companies, including Ionis Pharmaceuticals, Akeso Biopharma, Amgen, Novo Nordisk, Civi BioPharma, among others.

Hypercholesterolemia Market

Hypercholesterolemia Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key hypercholesterolemia companies, including Novartis Pharmaceuticals, Merck Sharp & Dohme LLC, Esperion Therapeutics, Inc., Arrowhead Pharmaceuticals, LIB Therapeutics LLC, Medpace, Inc., AstraZeneca, NewAmsterdam Pharma, among others.

Homozygous Familial Hypercholesterolemia Market

Homozygous Familial Hypercholesterolemia Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key homozygous familial hypercholesterolemia companies, including Arrowhead Pharmaceuticals, Novartis, Alnylam Pharmaceuticals, LIB Therapeutics, among others.

About DelveInsight

DelveInsight is a leading 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. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve.

Contact Us
Shruti Thakur
info@delveinsight.com
+14699457679

Logo: https://mma.prnewswire.com/media/1082265/3528414/DelveInsight_Logo.jpg

Modal title

Also from this source

LUPKYNIS Strengthens Market Position as Demand for Lupus Nephritis Treatment Grows | DelveInsight

LUPKYNIS Strengthens Market Position as Demand for Lupus Nephritis Treatment Grows | DelveInsight

DelveInsight's "LUPKYNIS Market Size, Forecast, and Market Insight Report" highlights the details around LUPKYNIS, the first oral lupus...

Mucopolysaccharidosis Type I Market to Witness Upsurge in Growth at a CAGR of 8% During the Forecast Period (2025-2034) | DelveInsight

Mucopolysaccharidosis Type I Market to Witness Upsurge in Growth at a CAGR of 8% During the Forecast Period (2025-2034) | DelveInsight

DelveInsight's Mucopolysaccharidosis Type I Market Insights report includes a comprehensive understanding of current treatment practices,...

More Releases From This Source

Explore

Health Care & Hospitals

Health Care & Hospitals

Medical Pharmaceuticals

Medical Pharmaceuticals

Pharmaceuticals

Pharmaceuticals

Biotechnology

Biotechnology

News Releases in Similar Topics

Contact PR Newswire

  • +44 (0)20 7454 5110
    from 8 AM - 5:30 PM GMT
  • General Enquiries
  • Media Enquiries
  • Partnerships

Products

  • Content Distribution
  • Multimedia Services
  • Disclosure Services
  • Cision Communications Cloud®

About

  • About PR Newswire
  • About Cision
  • Partnering Opportunities
  • Careers
  • APAC
  • APAC - Simplified Chinese
  • APAC - Traditional Chinese
  • Brazil
  • Canada
  • Czech
  • Denmark
  • Finland
  • France
  • Germany
  • India
  • Indonesia
  • Israel
  • Japan
  • Korea
  • Mexico
  • Middle East
  • Middle East - Arabic
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Russia
  • Slovakia
  • Spain
  • Sweden
  • United States
  • Vietnam

My Services

  • All News Releases
  • Customer Portal
  • Resources
  • Blog
  • Journalists
  • Data Privacy

Do not sell or share my personal information:

  • Submit via Privacy@cision.com 
  • Call Privacy toll-free: 877-297-8921

Contact PR Newswire

Products

About

My Services
  • All News Releases
  • Customer Portal
  • Resources
  • Blog
  • Journalists
+44 (0)20 7454 5110
from 8 AM - 5:30 PM GMT
  • Terms of Use
  • Privacy Policy
  • Information Security Policy
  • Site Map
  • RSS
  • Cookie Settings
Copyright © 2025 PR Newswire Europe Limited. All Rights Reserved. A Cision company.