Lipid Nanoparticles Market Size, Share & Industry Analysis, By Type (Solid Lipid Nanoparticles (SLNs), Nanostructured Lipid Carriers (NLCs), and Others), By Application (Therapeutics, Research), By End-user (Pharmaceutical & Biotechnology Companies, Academic & Research Institutes, and Others), and Regional Forecast, 2024-2032

The global lipid nanoparticles market size was valued at USD 880.0 million in 2023. The market is projected to grow from USD 997.2 million in 2024 to USD 2,823.4 million by 2032, exhibiting a CAGR of 13.9% during the forecast period. North America dominated the lipid nanoparticles market with a market share of 65.65% in 2023. Moreover, the U.S. lipid nanoparticles market size is projected to grow significantly, reaching an estimated value of USD 1.84 billion by 2032, driven by presence of major players and their focus on developing novel products.

Lipid nanoparticles are clinically advanced gene delivery systems. Generally, they are used to deliver nucleic acids, becoming promising vectors for several therapeutic options in the pharmaceutical industry. Many pharmaceutical and biotechnology companies are focusing on manufacturing LNP-based drugs to deliver a variety of therapeutic agents. The nanoparticles are being utilized in the treatment of diseases such as cancer.

• For instance, in June 2020, the U.S. FDA granted to fast-track designation to Ipsen Pharma for using liposomal irinotecan (ONIVYDE) to treat patients with metastatic pancreatic cancer.

Hence, rising applications as a drug carrier will boost the market. Moreover, researchers are using lipid-based nanoparticles with a particle size of approximately 100 nm as a drug carrier that can be prepared from different lipid & chemical components to overcome biological barriers. This is increasing its applications in therapeutics & vaccines.

• In May 2021, Merck KGaA launched synthetic cholesterol products to meet the demand for lipids to develop mRNA-based vaccines and therapeutics.

This increasing focus on personalized medicine is projected to propel the market. Combined with this, the latest innovations are estimated to boost the overall market.

The market witnessed high growth in terms of revenues in 2020, owing to the increasing adoption of these products as a carrier for vaccine delivery. Fragile m-RNA used in COVID-19 vaccines cannot enter the cells, and thus lipid nanoparticles are essential for the delivery of m-RNA into the cells as they perform transportation of gene-based vaccines to the right target site in the human body, which has increased the usage of LNP’s in COVID-19 vaccines. For instance, Pfizer Inc. and Moderna, Inc. use LNP’s to produce mRNA COVID-19 vaccines.

The market players witnessed significant growth in revenue generated during 2020. For instance, Merck KGaA registered an increase of around 9.5% in revenue generated from the sales of lipid nanoparticles in 2020 compared to 2019.

Moreover, revoking lockdown restrictions and stay-home orders in many countries, along with launches of lipid nanoparticle-based drugs, has been instrumental for further lipid nanoparticles market growth during 2021. Therefore, the resumption of medical facilities & new product launches had a positive impact on the demand in 2021.

Lipid Nanoparticles Market Trends

Market Value Driven by Growing Adoption of Nanoparticles in Gene Therapy as Vector

Lipid nanoparticles are deployed as vectors in gene therapy to treat genetic disorders. These are safer than viral proteins. They can deliver various sizes of nuclei acids to cells. Also, they can be quickly produced by the combination of targeting ligands.

• For instance, in hemophilia A & B therapy, a lipid nanoparticle is being used to deliver CRISPR-Cas9 for antithrombin gene editing.

Moreover, the strong emphasis of key players on mergers and acquisitions for expanding their product portfolio and setting up new manufacturing facilities is further propelling the applications of LNP products.

• For instance, in January 2022, Acuitas Therapeutics partnered with Pfizer Inc. to develop lipid nanoparticle (LNP) delivery systems facilitating mRNA-based therapeutics.


• Similarly, in June 2021, Danaher Corporation acquired Precision NanoSystems. Precision NanoSystems is involved in the development of technologies & solutions of lipid nanoparticles and genetic medicine, including therapeutics and mRNA vaccines.

In addition, several biotechnological companies are emphasizing the development of AI-based lipid nanoparticle delivery platforms to increase the development of novel therapeutics.

• In October 2023, Mana.bio unveiled a lipid nanoparticle (LNP) delivery platform powered by artificial intelligence aimed at expanding the advancement of nucleic acid-based therapeutics and vaccines.

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Lipid Nanoparticles Market Growth Factors

Market Growth to be Driven by Increasing Focus on Innovative and Personalized Medicine

Personalized medicines are essential for delivering drugs at specifically targeted sites. Liposomes, niosomes, nanoparticles, and nanotechnology-based drug delivery systems are helpful in several therapeutic areas. Lipid nanoparticles are used as a carrier in delivering oncology and neurology-related drugs.

Key players in the market collaborated with other biotechnology companies to develop and manufacture lipid nanoparticle-based drugs to treat inflammatory disorders and cardiovascular diseases.

• In July 2022, Precision NanoSystems collaborated with Replicate Bioscience to manufacture genomic medicines to treat inflammatory and autoimmune disorders and other diseases.


• Similarly, in January 2022, Beam Therapeutics Inc. and Pfizer Inc. entered a four-year research collaboration agreement. This partnership merges Pfizer’s extensive expertise in global drug development, encompassing programs employing messenger RNA (mRNA), lipid nanoparticles (LNP), and gene therapy, with Beam’s leadership in base editing and mRNA/LNP delivery technologies.

Strong Focus on R&D by Market Players for Development of Distinct Products to Stimulate Market Growth

The key manufacturing companies in the market are focusing on developing lipid nanoparticle (LNP) based drugs to address certain medical challenges. Also, they are focusing on collaborations with government organizations to establish new lipid production facilities. This has led to a rise in demand for nanomaterials and lipid-based carriers globally.

• In June 2022, Evonik Industries AG partnered with the U.S. government to build a new lipid-based production center to develop mRNA-based products, and the U.S. government funded the facility with up to USD 150.0 million through its Biomedical Advanced Research and Development Authority (BARDA).


• In August 2020, Croda International Plc acquired Avanti Polar Lipids, which focuses on developing innovative lipid-based products. This acquisition helped the company to improve its R&D capability in drug delivery.

Also, pharmaceutical scientists and biologists are collaborating to develop the next generation of lipid nanoparticles (LNPs) for drug delivery. By integrating structural biology with advanced pharmaceutical science, the team aims to create LNPs capable of precisely delivering vaccines and therapeutics to targeted tissues while enhancing the product's shelf life and duration of action.

RESTRAINING FACTORS

Stringent Regulations and Side Effects Associated with the Use of Lipid Nanoparticles to Restrict Growth in Emerging Countries

As the pharmaceutical industry is growing globally, several laws have been introduced to monitor the quality and effectiveness of medicines. Regulatory authorities have emerged to accomplish the requirements of legal procedures for drug development in several countries. Moreover, stringent regulations issued by several governments restricted the inflow of R&D investments for developing and marketing complex drugs using nanoparticles.

• According to the article published by Frontiers Media S.A., in 2022, it was reported that European Medicines Agency (EMA) and FDA issued distinct regulatory decisions for lipid-based generic drugs.

The clinical trials and research on these nanoparticles have depicted side effects, which are one of the major factors limiting the market growth.

• According to the article published by Elsevier B.V., in 2021, it was observed that the side effects might rise due to the high inflammatory nature of these nanoparticles.

Furthermore, lipid nanoparticles hold significant promise in reshaping the future of mRNA delivery. However, being a relatively novel substance, lipid nanoparticles exhibit certain drawbacks in mRNA delivery.

• For instance, as per an article published by Single Use Support in June 2023, lipid nanoparticles in mRNA delivery have several disadvantages, including low drug load efficiency, instability under in vivo conditions, toxicity issues, and short blood circulation time.

Thus, strict regulatory guidelines, disadvantages with lipid nanoparticle drug delivery, and toxicity concerns restrict market growth.

Lipid Nanoparticles Market Segmentation Analysis

By Type Analysis

Solid Lipid Nanoparticles Segment to Dominate Backed by Associated Benefits

The solid lipid nanoparticles (SLNs) segment held a major market share globally in 2023. This is due to increasing associated advantages:

• These nanoparticles provide high loading capacity and bioavailability compared to traditional liposomes.


• Moreover, solid lipid nanoparticle-based drugs are extensively used in cancer treatment and drug discovery. This, along with the numerous ongoing clinical trials on these drugs in cancer treatment, is responsible for the dominance of the segment. For instance, according to an article published in MDPI (Multidisciplinary Digital Publishing Institute), Celecoxib-loaded solid lipid nanoparticles are being studied for colon delivery.

In addition, several research studies are going on to develop effective cancer treatment with the help of solid lipid nanoparticles.

• For instance, as per the data published by ACS Omega in May 2022, a research study was conducted to enhance the drug's oral bioavailability and anticancer activity with the help of solid lipid nanoparticles. The study result revealed that the solid lipid nanoparticles (SLNs) improved the drug's oral bioavailability and anticancer activity in treating prostate cancer.

The nanostructured lipid carriers segment is estimated to grow at a higher CAGR owing to the introduction of advanced nanostructured lipid carriers based drugs by pharmaceutical companies.

• In April 2022, IOI Oleo GmbH designed Azithromycin (AM)-loaded nano lipid carriers for the purpose of ocular delivery, which is further converted into a sol-gel system characterized for histopathology, hydration, permeation, drug release, irritation, and antibacterial activity.

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By Application Analysis

Therapeutics Segment Share to Rise Due to Increasing Use of Lipid Nanoparticles as Carriers

The therapeutics segment is anticipated to grow at a faster CAGR in terms of share by application. The increasing use in manufacturing drugs to treat various chronic diseases such as cancer is responsible for the growth of this segment. Also, the major players in the market focus on launching innovative products.

• In May 2021, Merck KGaA launched synthetic cholesterol to develop mRNA-based vaccines and therapeutics.

The growth of the research segment is owing to the increasing number of clinical trials conducted by leading players to establish the efficiency of these products as therapeutic options for the treatment of various conditions and the use of LNP- mRNA-based vaccines for COVID-19.

By End-user Analysis

Pharmaceutical & Biotechnology Companies Segment to Record Substantial Growth Due to Increasing Demand for Lipid Nanoparticle-based Drugs

The pharmaceutical & biotechnology companies segment is anticipated to generate the highest market revenue during the projected period. The increasing demand for LNPs by pharmaceutical companies in manufacturing and marketing various drugs based on LNP formulation technology to deliver mRNA is responsible for the growth of this segment. For instance, in April 2021, VAV Lifesciences agreed with CDMO to supply nanoparticles used in vaccine manufacturing.

The growth of the academic & research institutes segment during the forecast period is due to the ongoing research studies on LNPs to develop innovative and advanced products in the market to treat complex diseases like cancer. For instance, according to a study published in the Multidisciplinary Digital Publishing Institute (MDPI), researchers have developed a lipid-based micelle encapsulated with docetaxel (M-DOC) effective in breast cancer treatment.  

REGIONAL INSIGHTS

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On the basis of region, North America generated a revenue of USD 577.7 million in 2023 and is expected to dominate the global lipid nanoparticles market share throughout the forecast period. The robust presence of the major players and wide portfolio range are some of the major factors driving the regional market. Moreover, the intense focus of key players on geographical expansion to increase their international presence is responsible for the growth in this region.

• In May 2022, Gattefossé established a new manufacturing facility in Texas, U.S. to manufacture lipid-based specialty ingredients for pharmaceutical and cosmetic industries.

On the other hand, Europe is anticipated to emerge as the second-most dominant region by 2032. The growth in this region is attributed to the focus on receiving product approvals and R&D investments of key players to launch new products. For instance, EUROAPI collaborated with Sanofi to support its mRNA vaccine platform by developing lipid nanoparticles.

Asia Pacific is projected to record slow growth during the forecast period. This is attributed to the companies' lack of direct presence and stringent government regulations on these drugs. For instance, India-based VAV Lifesciences is the only major player in the region.

The market in the rest of the world, including Latin America and the Middle East & Africa, is estimated to grow slower than Asia Pacific due to the absence of key market players and lack of awareness. Furthermore, increased demand for LNP-mRNA-based COVID-19 vaccines has increased the demand for LNPs based drugs in the region. For instance, in February 2022, Moderna, Inc. partnered with Adium Pharma S.A. to distribute SpikeVax in 18 countries across Latin America.

List of Key Companies in Lipid Nanoparticles Market

Key Players Adopt Various Strategies to Consolidate Market Position

Merck KGaA is the leading player in the global market. Its focus on strategies such as mergers and acquisitions, collaborations, and new product developments strengthened its market position globally. Combined with this, the growing investment of the company in research activities to develop a portfolio of superior treatment solutions has enabled the company to hold a leading position in the market.

• For instance, in February 2022, Merck KGaA acquired Exelead for lipid nanoparticle drug delivery technology to improve the company’s contract development and manufacturing organization (CDMO).

Other players operating in the market, such as Evonik Industries AG, Gattefossé, and IOI Oleo GmbH, are focusing on establishing new manufacturing facilities to expand their geographic footprint to meet the growing demand for LNP-mRNA-based drugs in the market.

LIST OF KEY COMPANIES PROFILED:

• Merck KGaA (Germany)


• Evonik Industries AG (Germany)


• Gattefossé (France)


• Precision NanoSystems (Canada)


• IOI Oleo GmbH (Germany)

KEY INDUSTRY DEVELOPMENTS:

• July 2023: Cytiva introduced NanoAssemblr, a specialized commercial formulation system designed specifically for lipid nanoparticle medicines' clinical and commercial production.


• October 2022: Polypeptide Therapeutic Solutions (PTS), a key player in manufacturing and developing polyamino-acid-based delivery systems, expanded its drug delivery capabilities, including novel nanoparticle formulation and functional lipid excipients.


• September 2022: The National Institute of Allergy and Infectious Diseases awarded a USD 13.8 million contract to the University of California for conducting immune profiling of lipid nanoparticles to study their role in increasing vaccine protective responses.


• May 2022: Gattefossé established a new manufacturing facility in the U.S. to manufacture lipid-based specialty ingredients for the cosmetic and pharmaceutical industries.


• October 2021: Gattefossé launched three new lipid excipients, including Labrafac MC60, Gelucire, and Emulfree Duo, to expand the product portfolio and deliver unique customer solutions.


• June 2021: Danaher acquired Precision NanoSystems (PNI). This acquisition helped the PNI mRNA technology to develop vaccines to treat unmet conditions such as cancer and genetic diseases.

REPORT COVERAGE

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The global market research report provides an elaborative analysis of the global industry dynamics and competitive landscape. Key sights presented in the report are new product launches by key players, advances in drug delivery, key mergers, acquisitions, partnerships, and company profiles.

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