Lipid-based Nanoparticles for the Pharmaceutical Industry: Pre-clinical and Clinical Advancements

Description

Varied Lipid Composition, Improved Temperature Stability, and Efficient Manufacturing Drive Product Commercialization

In the last decade, nanomedicine and nanotechnology have helped unlock revolutionary therapeutic potential that has positively impacted healthcare. Among the different nanotechnology-based innovations, lipid-based nanoparticles such as liposomes and lipid nanoparticles (LNPs) show great promise across multiple therapies. Although the Food and Drug Administration (FDA) approved the use of liposomes for the delivery of cancer drug therapeutics in the early 90s, the recent breakthrough in use of LNPs for mRNA vaccine delivery for COVID-19 has created high interest in LNPs from pharmaceutical companies worldwide. Contract manufacturing of LNPs with diverse phospholipids of different surface charge and effective methods of stabilizing the lipid-based carriers using stabilizers such as cholesterols and emulsifiers to maintain size and drug-loading efficiency are the key focus areas in industrial R&D.

LNPs are chosen widely for drug/vaccine delivery due to their ease in formulation and high biocompatibility in comparison with other polymeric nanocarriers. LNPs have brough a radical change in the treatment of cancer therapy, ensuring improved drug delivery to the target site with minimal side effects. Importantly, LNPs can cross the blood-brain barrier (BBB) to improve drug delivery in treating brain tumors or neurodegenerative diseases. Apart from therapeutics, use of LNPs for the delivery of nucleic acids, such as pDNA, mRNA, and siRNA, has gained profound interest and potential in demonstrating high capabilities in viral vaccine delivery. The LNPs offer stability and protection to the mRNA, ensuring better efficacy and enhanced immune response. The last decade witnessed progress in LNPs used for treating complex diseases and as preventative vaccines; however, regulations of LNPs and their large-scale production for uniform size, shape, and product stability limit wide-scale adoption. The commercialization of LNPs for therapeutic and vaccine delivery holds major promise in transforming global health issues when supported by good manufacturing practices, regulations, and quality control analysis for better clinical translation.

This study offers an in-depth analysis of the current research and industrial developments in use of lipid-based nanoparticles. Focus areas include key advancements in R&D for the pre-clinical and clinical stages of LNP development for use in therapeutic delivery for different diseases such as cancer, cardiovascular, and neurodegenerative disorders. The use of LNPs as an mRNA carrier for vaccine delivery is discussed, providing insights on industrial adoption and future perspective. In addition, the research highlights the challenges and the drivers; important policies; innovations; and key market participants in LNP production and utilization.

This research answers the following questions:

What are the current research advancements in use of LNPs for therapeutic and vaccine delivery?

What is the current scenario and progress made in industrial manufacturing and adoption of LNPs?

What are the advancements in optimizing stability, targeting ability, formulation, manufacturing, and storage of LNP-based therapeutics?

What initiatives are industry participants undertaking to accelerate adoption?

What are the expected outcomes in use of LNPs in the pharmaceutical sector, and how does it help to resolve global health challenges?

Product Code: DA6E

Strategic Imperatives

Why Is It Increasingly Difficult to Grow?The Strategic Imperative 8™: Factors Creating Pressure on Growth
The Strategic Imperative 8™
The Impact of the Top 3 Strategic Imperatives on the R&D Advances for Lipid Nanoparticles in the Pharmaceutical Industry
Growth Opportunities Fuel the Growth Pipeline Engine™
Research Methodology

Growth Opportunity Analysis

Lipid-Based Nanoparticles: Overview and Significance
LNPs Are Better Suited than Liposomes for Nucleic Acid Delivery
Next-generation Lipid-based Nanocarriers Display Promising Attributes in Encapsulation and Large-scale Production
Second-generation LNPs Offer Better Design Flexibility and Improved Stability
Second-generation LNPs Offer Better Design Flexibility and Improved Stability (continued)
First-generation Lipid-based Nanoparticles Are Used Widely in the Cosmetics, Food & Beverage, and Nutraceuticals Industries
Research Scope
Segmentation
Growth Drivers
Growth Restraints

LNPs: Formulation, Manufacturing, and Therapeutics Delivery

LNPs Constitute a Mix of Lipids and Stabilizers
Approved LNP Formulations Encapsulate Diverse Cargo of Different Chemical & Physical Properties
Mixing Ratio of Lipids and Aqueous Phase Critically Determine the Size of LNPs and their Entrapment Efficiency
High Pressure Homogenization Is the Preferred Choice for Large-scale Manufacturing of LNPs
Microfluidics and Super Critical Fluid Technology Offer Improved Control over Particle Size and Distribution
Formulation Techniques Play a Critical Role in Determining Size, Solvent Residue, and Distribution
Active and Passive Targeting of LNPs Exhibit Improved Cellular Penetration of Therapeutics with Minimal Systemic Toxicity
Rational Design of Lipids for Improved In Vivo Stability of mRNA Vaccines and Therapeutics Drives Commercialization
Lipid-based Nanocarriers Increasingly Used in the Treatment of Various Diseases

LNP: Emerging Areas of R&D

LNPs Conjugated with Antibody/Ligands Exhibit High Specificity for Cancer Targeting
Design and Use of New Phospholipid Combinations, Linkers, and Cholesterol Alternatives Improve In Vivo Stability, Safety, and Transfection of LNPs
Lipid and Polymer Hybrid LNPs offer Synergistic Benefits with Improved Stability and Targeting
In-line Detection and Tracking of LNPs Formulation Minimizes Production Time and Enables Process Feedback Control
Intramuscular and Intravenous Routes of Delivery Are Most Preferred for LNP-based Therapeutics
Surface Modification of LNPs and Lyophilization of Lipids and Cargo Exhibit Improved Stability for Long-term Storage

Clinical, Financial, and Innovation Landscape of LNPs Therapeutics and Vaccines

North America Secures High Funding for Commercial Development of LNP-based Therapeutics
Private Funding Focuses on Improved LNP Formulations for Vaccines and Immunotherapeutics
Entry of Thermostable and Targeted LNPs-based Therapeutics into Clinical Trials
Pharmaceutical Companies Innovate in the Stability, Biodegradation, Formulation, and Cost-Effectiveness of LNPs
Lipid Manufacturers Collaborate with API Developers to Leverage LNP-based Therapeutics
Therapeutic and Vaccine Formulations Using LNPs Are in Different Phases of Clinical Trial

Intellectual Property Analysis

North America Holds Highest Share of Patent Filings for LNPs
Leading LNPs and mRNA Players Battle on Patent Infringement

Growth Opportunity Universe

Growth Opportunity 1: In-silico and AI-based Lipid Composition Prediction
Growth Opportunity 1: In-silico and AI-based Lipid Composition Prediction (continued)
Growth Opportunity 2: Formulation of Stable LNPs with Improved Functionality
Growth Opportunity 2: Formulation of Stable LNPs with Improved Functionality (continued)
Growth Opportunity 3: Automated and Microfluidics-based LNP Manufacturing Platform
Growth Opportunity 3: Automated and Microfluidics-based LNP Manufacturing Platform (continued)
Growth Opportunity 4: Directed Development of LNPs for Tissue-targeted Delivery
Growth Opportunity 4: Directed Development of LNPs for Tissue-targeted Delivery (continued)

Appendix

Technology Readiness Levels (TRL): Explanation

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