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Jul 10, 2024

The Lipid Nanoparticles (LNPs) CDMO Market Potential is unvieled by InsightAce Analytic Pvt. Ltd. in it's New Report.

InsightAce Analytic Pvt. Ltd. announces the release of a market assessment report on the "Global The Lipid Nanoparticles (LNPs) CDMO Market Size, Share & Trends Analysis Report By Product (mRNA, Plasmid DNA (pDNA), siRNA, saRNA, microRNA), Scale Of Operation (Preclinical, Clinical, and Commercial), End-Users (Pharmaceutical Companies, Academic Research Institute, Diagnostic Laboratories)- Market Outlook And Industry Analysis 2031"

 

The Global Lipid Nanoparticles (LNPs) CDMO Market is valued at US$ 182.0 Mn in 2023, and it is expected to reach US$ 518.2 Mn by 2031, with a CAGR of 14.10% during the forecast period of 2024-2031.

 

Request for Sample Pages: https://www.insightaceanalytic.com/request-sample/1432

 

Lipid nanoparticles (LNPs) have revolutionized drug delivery by serving as effective carriers for fragile genetic materials like mRNA and gene therapies. LNPs protect these materials from degradation and facilitate their safe delivery into cells, crucially enhancing the efficacy of vaccines, cancer treatments, gene therapies, and various other therapeutics. The success of mRNA vaccines, notably against COVID-19, has propelled the demand for LNPs, with over 2,000 LNP-related pipeline drugs currently in development globally.

 

As the complexity and cost of LNP manufacturing require specialized expertise and infrastructure, pharmaceutical companies increasingly turn to contract development and manufacturing organizations (CDMOs) for support. These CDMOs offer comprehensive services from initial drug development through to large-scale manufacturing, leveraging their technical capabilities to navigate the challenges of LNP production. With the global LNP CDMO market poised for robust growth, driven by expanding applications and strategic investments by key players, these organizations are well-positioned to meet the burgeoning demand and drive innovation in drug delivery technologies.

 

List of Prominent Players in The Lipid Nanoparticles (LNPs) CDMO Market:

  • Genevant Sciences
  • Lonza Group AG
  • Rentschler Biopharma
  • Nitto Denko Avecia
  • Evonik
  • Laboratorios Farmacéuticos Rovi, S.A.
  • Samsung Biologics
  • Thermo Fisher Scientific
  • Sartorius AG (BIA Separations)
  • AGC Biologics
  • Hanmi Pharmaceutical
  • BioCina Pty Ltd.
  • Catalent, Inc
  • Corden Pharma GmbH,
  • eTheRNA,
  • Polypeptide Therapeutic Solutions (PTS),
  • FUJIFILM Corporation,
  • ST Pharm Co Ltd,
  • Exalead (Merck KGaA),
  • Avanti Polar Lipids, Inc. (Croda International Plc.),
  • Emergent CDMO,
  • Esco Aster Pte Ltd,
  • ernal Biosciences,
  • Recipharm AB,
  • Phosphorex Inc,
  • Polymun Scientific Immunbiologische Forschung GmbH,
  • BIOVECTRA
  • Vernal Biosciences
  • Helix Biotech

  

Market Dynamics:

 

Drivers-

The effectiveness of mRNA vaccines against COVID-19 has sparked a surge in demand for lipid nanoparticle (LNP)-mediated drug delivery systems, highlighting LNPs as crucial for RNA-based therapeutics. With over 15,000 patents related to mRNA vaccines granted worldwide as of June 2023, pharmaceutical companies are increasingly turning to contract development and manufacturing organizations (CDMOs) specializing in LNPs. These CDMOs offer essential expertise and infrastructure to support the expanding pipeline of nucleic acid therapeutics, including mRNA vaccines, gene editing therapies, and RNA interference (RNAi) drugs. As pharmaceutical firms outsource more drug development and manufacturing activities, LNPs are poised to play a pivotal role in meeting the growing global demand for advanced, targeted therapies.

 

Challenges:

Lipid nanoparticle (LNP) formulation and manufacturing are complex, requiring specialized expertise and infrastructure, which can pose challenges for market growth. Cost pressures drive the need for competitive pricing strategies from CDMOs, balancing profitability and sustainability. Additionally, stringent regulatory guidelines must be navigated particularly, emphasizing the importance of adherence to safety and efficacy standards in LNP-based pharmaceutical applications.

 

Regional Trends:

North America, particularly the United States, is witnessing robust growth in the lipid nanoparticles (LNPs) CDMO market due to several key factors. The region benefits from high awareness and significant government investments in nanoparticle research and development, fostering innovation and market expansion. The prevalence of chronic diseases drives demand for advanced drug delivery systems, supported by a well-established healthcare infrastructure and a network of contract manufacturing organizations (CMOs). Additionally, the increasing number of clinical trials and advancements in the biopharmaceutical sector underscore North America's pivotal role in driving growth and innovation within the LNPs CDMO market.

 

Recent Developments:

  • In Jan 2024, Thermo Fisher Scientific's Monza, Italy site secured GMP approval from AIFA for RNA-based product manufacturing, enhancing access to advanced therapies for patients with complex conditions and bolstering Italy's biopharmaceutical capabilities.
  • In May 2022, Hanmi Fine Chemical (Hanmi FC), a subsidiary of Hanmi Pharmaceutical Group, known for APIs development and manufacturing, is now expanding into high-tech CDMO services. This strategic shift aims to broaden their business scope beyond APIs, enhancing their capabilities in contract development and manufacturing for advanced pharmaceutical products.
  • In June 2022, Evonik is investing US$220 million in partnership with the U.S. Government to construct a new lipid production facility in the U.S., dedicated to manufacturing mRNA-based therapies.

 

Segmentation of The Lipid Nanoparticles (LNPs) CDMO Market-

 

By Product:

  • mRNA
  • Plasmid DNA (pDNA)
  • siRNA
  • saRNA
  • microRNA
  • Others

By Scale of Operation:

  • Preclinical Scale Operations
  • Clinical Scale Operations
  • Commercial Scale Operations

By End-Users:

  • Pharmaceutical Companies
  • Academic Research Institute
  • Diagnostic Laboratories

 

By Region-

North America-

  • The US
  • Canada
  • Mexico

Europe-

  • Germany
  • The UK
  • France
  • Italy
  • Spain
  • Rest of Europe

Asia-Pacific-

  • China
  • Japan
  • India
  • South Korea
  • Southeast Asia
  • Rest of Asia Pacific

Latin America-

  • Brazil
  • Argentina
  • Rest of Latin America

 Middle East & Africa-

  • GCC Countries
  • South Africa
  • Rest of Middle East and Africa