Lipid Nanoparticle Manufacturing Market

Lipid Nanoparticle Market Overview

The global lipid nanoparticle manufacturing market is estimated to be worth USD 0.66 billion in 2023 and is expected to grow at compounded annual growth rate (CAGR) of 11.8% during the forecast period 2023-2035.

Over the past few years, there has been a substantial growth in the pharmaceutical industry; this  is evident from the growing pipeline of drugs that are either approved or being investigated in different preclinical studies/clinical trials. However, poor water solubility and bioavailability are longstanding challenges in the drug development process. Around 90% of the drug candidates in the current development pipeline and close to 40% of the marketed pharmacological products are associated with concerns related to solubility and / or permeability. These poorly soluble drugs tend to get eliminated from the body (before their absorption into the systemic circulation), impacting their therapeutic effectiveness. Therefore, pharmaceutical companies are actively looking for strategies to overcome this challenge. Amongst the various approaches for enhancing solubility / bioavailability of therapeutic agents, lipid nanoparticles (LNPs) and other lipidic excipients have garnered significant interest of drug developers. In addition, LNPs are known to be a versatile nanomedicine delivery platform owing to their ability to encapsulate a wide range of molecules and provide controlled drug release. Given the extensive research activity in this industry, the intellectual capital related to the use of LNPs in drug delivery has also grown over time. 

However, lipid nanoparticle manufacturing is a cost-intensive and complex process that requires multidisciplinary expertise. Consequently, drug developers are increasingly relying on contract manufacturing organizations (CMOs) with specialized equipment and expertise to deal with the technical and routine operations-related challenges. Further, contracting a service provider enables sponsors to leverage innovative and advanced LNP technology (available with the service provider) and achieve greater operational flexibility. Owing to the inherent properties of LNPs, such as small size, multifunctional behavior and surface functionalization, the market for LNP-based therapeutics is likely to grow, in the foreseen future. This in turn will drive the market growth of lipid nanoparticle manufacturing market during the forecast period.

Tap or click on the images for smart insights on Lipid Nanoparticle Manufacturing Market

Key Market Insights

The Lipid Nanoparticle Manufacturing Market: Services and Technologies, 2023-2035 - Distribution by Type of Lipid Nanoparticle (Solid Lipid Nanoparticles and Nanostructured Lipid Carriers), Type of Molecule Delivered (Nucleic Acids, Small Molecules, Proteins/Peptides and Others), Company Size (Very Large and Large, Mid-sized and Small), Target Therapeutic Area (Infectious Diseases, Oncological Disorders, Blood Disorders, Rare Diseases and Other Disorders), Type of End-user (Pharmaceutical and Biotechnology Companies, Academic and Research Institutes, and Other End-users) and Key Geographical Regions (North America, Europe, Asia-Pacific and Rest of the World): Industry Trends and Global Forecasts report features an extensive study of the current market landscape, market size and future opportunities within the lipid nanoparticle manufacturing market, during the given forecast period. Further, the market report highlights the efforts of several stakeholders engaged in this rapidly emerging segment of the pharmaceutical industry. Key takeaways of the lipid nanoparticle manufacturing (services and technologies) market report are briefly discussed below. 

Multifaceted Benefits of Lipid Nanoparticles 

LNPs are transforming the field of nanomedicines with their ability to encapsulate and effectively deliver promising therapeutics (including small molecules and biologics) and vaccines into the body. In August 2018, the US Food and Drug Administration (US FDA) approved the first LNP based genomic medicine, Onpattro (developed by Alnylam) for the treatment of peripheral nerve disease caused by hereditary transthyretin-mediated amyloidosis in adult patients. These delivery systems protect the encapsulated (fragile) materials from degradation, maintain their integrity during transport and facilitate targeted release in specific areas. Notably, in the past few years, the clinical trials evaluating lipid nanoparticle mRNA-based therapeutics have increased due to their enhanced therapeutic effectiveness and low toxicity.

Use of Lipid Nanoparticles for mRNA Vaccine Delivery during the COVID19 Pandemic

Lipid nanoparticles played a significant role during the COVID vaccine development by serving as a delivery platform for mRNA vaccines. Some examples of companies that used LNPs in the development of COVID vaccines include (arranged in alphabetical order) AstraZeneca-Oxford University (ChAdOx1 nCoV-19), CanSino Biologicals (Ad5-nCoV), Moderna (mRNA-1273) and Pfizer-BioNTech (BNT162b2/COMIRNATY). It is worth mentioning that the COVID vaccine developed by BioNTech-Pfizer and Moderna demonstrated a preventive efficiency of about 95%, and were the first mRNA vaccines to receive Emergency Use Authorization by the US FDA as well as European Medicines Agency (EMA), in December 2020 and January 2020, respectively.

Competitive Landscape of Lipid Nanoparticles Manufacturer

The current market landscape features the presence of around 45 lipid nanoparticle contract manufacturers, spread across the globe. Overall, the market seems to be well-fragmented, featuring the presence of very large, large, mid-sized and small companies, which have the required expertise to offer LNP manufacturing services (across different scales of operation). Majority (60%) of the facilities manufacture LNPs for encapsulating and delivering different types of nucleic acids, such as messenger RNA (mRNA), small interfering RNA (siRNA), deoxyribonucleic acid (DNA), self-amplifying RNA (saRNA) and micro-RNA (miRNA). Examples of some key lipid nanoparticle manufacturers include (which have been profiled in the report) BIOVECTRA, Curapath, Curia, Emergent BioSolutions, EUROAPI, Evonik and Precision NanoSystems.  

LNP Technology Developers Landscape

Presently, more than 30 companies are engaged in the development of LNP technology; these companies operate through different business models, including fee-for-service / collaborative research, in-house product catalog and technology / product licensing. It is worth mentioning that most (93%) of the LNP technologies support the delivery of formulations through injectable route; some examples of such technologies include GalNAc-LNP (developed by Verve Therapeutics), ONCOPREX Nanoparticle Delivery System (developed by Genprex) and ScaffoLD Lipid Technology (developed by Integrated Nanotherapeutics). Further, the companies engaged in developing LNP technology include (which have been profiled in the market report) Acuitas Therapeutics, Ascendia Pharmaceuticals, Integrated Nanotherapeutics, leon-nanodrugs, Matinas BioPharma, Pantherna Therapeutics and TLC Biosciences.

Competitive Landscape of Lipid CMO

The current market landscape features the presence of over 55 companies involved in other types of lipid manufacturing, including ionizable lipids, liposomes, neural lipids, PEGylated lipids, phospholipids, sphingolipids and triglycerides. Further, over 80% of the facilities manufacturing other types of lipids offer formulation development services, followed by those providing process development / pre-formulation services (65%) and analytical method development (60%). Some examples of prominent players engaged in manufacturing other types of lipids include (which have been profiled in the market report) Avanti Polar Lipids, CordenPharma, Creative Biolabs, Formumax Scientific, Fresenius Kabi, Fujifilm and Merck. 

Market Trends: Partnerships and Collaborations on the Rise for Lipid Nanoparticle Manufacturing

In recent years, several partnerships have been established by industry stakeholders, in order to consolidate their presence in this field, and enhance their capabilities and product portfolio to meet the growing demand for LNP-based drugs. It is worth highlighting that over 50% of these partnerships have been inked in the past two years. Interestingly, most of the agreements were research and development agreements, followed by product / technology licensing agreements and product development agreements. In April 2023, Moderna entered into an agreement with IBM in order to explore cutting-edge technologies, including quantum computing and artificial intelligence model (MoLFormer) to optimize LNPs and propel mRNA therapeutics research. In March 2023, Acuitas Therapeutics signed a licensing agreement with Athebio for the latter company’s Athebody® DARPin technology. The partnership aims to combine this technology with Acuitas’ LNP technology to enable targeted delivery of nucleic acid therapeutics. Such partnerships will foster the increase in application of LNP technology to support the delivery of novel drugs, increasing the demand for lipid nanoparticle manufacturing during the forecast period of this market report.

Tap or click on the images for smart insights on Lipid Nanoparticle Manufacturing Market

Market Analysis: Global Lipid Nanoparticle Manufacturing Market Size

The global lipid nanoparticle manufacturing market is estimated to be worth USD 0.66 billion in 2023. Driven by the increasing need for novel LNP formulation, along with the ongoing advancements in the LNP technology, the lipid nanoparticle manufacturing market is anticipated to grow at a CAGR of 11.8% during the forecast period. Additionally, in terms of type of LNP, the LNP manufacturing market is currently dominated by the revenues generated by solid lipid nanoparticles. 

Regional Analysis: North America to Hold the Largest Share in Lipid Nanoparticles Market

Majority of the companies offering lipid nanoparticle manufacturing services are headquartered in North America, followed by companies based in Europe. Consequently, more than 40% of the global market for lipid nanoparticle manufacturing is anticipated to be captured by companies based in North America, in 2035. 

Market Segment Analysis: Within Nucleic Acids Segment, mRNA Vaccines to Drive Market Growth

The research and development efforts being undertaken in the mRNA vaccines domain have evolved substantially over time, owing to their various advantages, including higher biological efficacy, enhanced immunogenicity and versatile vaccine delivery platforms, over other therapeutic modalities. Recent reports highlight the potential benefits of mRNA; for instance, no undesirable risk of inadvertent infection and insertional mutagenesis. In February 2022, Merck acquired Exelead, a CDMO capable of lipid nanoparticle manufacturing; through the acquisition, the company aims to enhance its capabilities and accelerate innovation in the mRNA vaccine domain. Further, in the same month, Curia acquired LakePharma and Integrity Bio to offer comprehensive mRNA based solutions to its clients.

In addition to linear mRNA, circular RNA (circRNA) and self-amplifying RNA (saRNA) vaccine platforms are now being acknowledged by the researchers. Owing to its closed-ring structure, circRNA demonstrates enhanced biostability and resistance towards exonuclease-mediated degradation, when compared to linear RNA. Further, saRNA facilitate large production of antigens (at low doses) and triggers an extensive immune response. As such, mRNA vaccines and mRNA therapeutics, along with other novel RNA therapeutics like circRNA and saRNA will drive the market growth for lipid nanoparticle manufacturing market during the forecast period. 

Technological Development Analysis: Continuous Manufacturing and Adoption of Single Use Technology

The production of mRNA-LNP based drugs using the conventional batch processes is associated with certain challenges, due to the sensitive nature of mRNA and requirement of strict control over nanoparticle formation. As a result, drug developers are slowly transitioning from batch processing to continuous manufacturing. The continuous manufacturing process for such drugs offers various benefits, including consistent product quality, enhanced process efficiency, reduced production time, and real-time monitoring of the process parameters. As a result, DIANT Pharma has developed LNP encapsulated oligonucleotides using the continuous manufacturing process. 

Further, single use technology has garnered the interest of various companies for both small scale and large scale production of LNP-based formulations; for instance, in July 2023 Precision NanoSystems (a part of Cytiva) launched single use NanoAssemblr® system that supports clinical and commercial manufacturing of lipid nanoparticles. The single use fluid path offers controlled mixing conditions, decreases the chances of cross-contamination and enables smooth changeover between batches.

Recent Developments in Lipid Nanoparticle Manufacturing Market

Several recent developments have taken place in the field of lipid nanoparticle manufacturing to advance efficient drug delivery, some of which have been outlined below. These developments, even if they took place after the release of this report, reflect the overall market trends that we’ve outlined in our analysis. 

• In October 2023, BIOVECTRA entered into a technology transfer service agreement with Acuitas Therapeutics to use the latter company’s LNP technology in manufacturing mRNA-based therapeutics.
• In August 2023, Avanti Polar Lipids entered into a partnership with Bioz to identify relevant knowledge of products and techniques, in order to drive efficient research and development of novel lipid-based products.
• In August 2023, a research study involving mRNA loaded LNPs showed promising results in reprogramming cells and editing the genes, in sickle cell disease.
• In June 2023, Cardiff University in collaboration with Astra Zeneca used artificial intelligence generated LNPs to accurately target the diseased cells.
• In July 2023, McGill University entered into a partnership with ModernaTX to evaluate the characteristics (including size and payload distribution) of LNPs; the outcome of the project is likely to support in the optimization of LNP manufacturing process and serve as a quality check during the manufacturing of mRNA-based therapeutics.
• In March 2023, Moderna and Generation Bio signed an agreement to combine the former company’s biological and technical expertise with the latter company’s proprietary stealth cell-targeted lipid nanoparticle (ctLNP) delivery system.
• In March 2023, the researchers at Hokkaido University encapsulated CRISPR-Cas9 with LNPs to evaluate its efficiency in preclinical models.
• In February 2023, CordenPharma claimed to start operations in its newly set up GMP LNP suite, in Caponago, Italy facility by the third quarter of 2023; the expansion aims to support the rising demand of LNP-based therapeutics (clinical and commercial manufacturing).
• In September 2022, WuXi STA, a China-based CRDMO, opened a new LNP formulation development and manufacturing facility to expand its end-to-end parenteral formulation capabilities for the development of complex injectables.

Scope of the Report

The market report presents an in-depth analysis of the various firms / organizations that are engaged in lipid nanoparticle manufacturing market, across different segments as defined in the table below:

Key Report Attributes	Details
Base Year	2023
Forecast Period	2024 – 2035
Market Size 2023	$ 0.66 billion
CAGR	11.8%
Type of Lipid Nanoparticle	Solid Lipid Nanoparticles Nanostructured Lipid Carriers
Type of Molecule Delivered	Nucleic Acids Small Molecules Peptides/ Proteins Others
Company Size	Very Large and Large Mid-sized Small
Therapeutic Area	Infectious Diseases Oncological Disorders Blood Disorders Rare Diseases Other Disorders
Type of End-user	Pharmaceutical and Biotechnology Companies Academic and Research Institutes Other End-users
Key Geographical Regions	North America Europe Asia-Pacific Rest of the World
Key Companies Profiled	Acuitas Therapeutics Ascendia Pharmaceuticals Avanti Polar Lipids BIOVECTRA CordenPharma Creative Biolabs Curapath Curia Emergent Biosolutions EUROAPI Evonik Formumax Scientific Fresinius Kabi Fujifilm Integrated Nanotherapeutics leon-nanodrugs Matinas BioPharma Merck Pantherna Therapeutics Precision NanoSystems TLC Biosciences (Full list of more than 70 companies captured is available in the report)
Customization Scope	15% Free Customization Option
Excel Data Packs (Complimentary)	Market Landscape Analysis Partnerships and Collaborations Likely Partner Analysis Capacity Analysis Market Forecast and Opportunity Analysis

The market report presents an in-depth analysis, highlighting the capabilities of various companies engaged in lipid nanoparticle manufacturing, across different geographies. Amongst other elements, the market report includes:

• A preface providing an introduction to the full report, Lipid Nanoparticle Manufacturing Market: Services and Technologies, 2023-2035.
• An outline of the systematic research methodology adopted to conduct the study on lipid nanoparticle manufacturing market, providing insights on the various assumptions, methodologies, and quality control measures employed to ensure accuracy and reliability of our findings.
• An overview of economic factors that impact the overall lipid nanoparticle manufacturing market, including historical trends, currency fluctuation, foreign exchange impact, recession, and inflation measurement.
• An executive summary of the insights captured during our research. It offers a high-level view on the current state of lipid nanoparticle manufacturing market and its likely evolution in the mid-long term.
• A general overview of lipids and its different types. The chapter also provides information on LNP / lipid nanoparticles, highlighting its different types, advantages and applications in the pharmaceutical domain. Further, it discusses the various challenges associated with formulation of LNPs, as well as the growing need for outsourcing the manufacturing operations of such products.
• A detailed assessment of the lipid nanoparticles manufacturer, based on several relevant parameters, including year of establishment, company size (in terms of employee count), location of headquarters (North America, Europe and Asia-Pacific), location of manufacturing facility, scale of operation (preclinical, clinical and commercial), type of molecule delivered (nucleic acids, proteins/peptides, small molecules and others), therapeutic area (infectious diseases, oncological disorders, rare diseases and others) and type of additional services offered (process development/pre-formulation, formulation development, analytical testing, stability studies, scale-up, regulatory support, fill/finish and packaging). 
• A detailed assessment of the lipid nanoparticle technology developers, based on several relevant parameters, such as type of formulation method (microfluidization, homogenization and others), type of molecule delivered (nucleic acids, proteins / peptides, small molecules and others), compatible dosage form (solid and liquid), route of administration (injectable, nasal, oral, topical and others), therapeutic area (oncological disorders, infectious diseases, genetic disorders, cardiovascular disorders, neurological disorders, metabolic disorders, ophthalmological disorders, autoimmune disorders and others). Further, the chapter provides information on the  lipid nanoparticle technology developers, including year of establishment, company size (in terms of employee count), location of headquarters (North America, Europe and Asia-Pacific), business model (in-house product catalog/pipeline, technology / product licensing, and fee-for-service / collaborative research) and most active players (in terms of number of technologies developed).
• A detailed review of the lipid contract manufacturing companies, based on several relevant parameters, including year of establishment, company size (in terms of employee count), location of headquarters (North America, Europe and Asia-Pacific), location of manufacturing facilities, scale of operation (preclinical, clinical and commercial), type of lipid manufactured (liposomes, phospholipids, PEGylated lipids, ionizable lipids, triglycerides, sphingolipids, neutral lipids and others), type of product (lipid-based FDF, lipid-based drug delivery system, lipid excipients and lipid-based API) and type of additional services offered (formulation development, process development/pre-formulation, analytical method development, scale-up, stability studies, regulatory support, fill/finish and packaging and other services).
• A detailed competitiveness analysis of lipid nanoparticle contract manufacturing organizations based on company strength (in terms of years of experience), service strength (in terms of scale of operation, number of type of molecule delivered and number of additional services offered) and number of LNP manufacturing facilities.
• An insightful competitiveness analysis of LNP technology based on developer strength (in terms of the experience, company size and business model of the developer), technology strength (in terms of number of route of administration, number of type of molecule delivered and number of compatible dosage form) and technology applicability (in terms of therapeutic area). 
• Elaborate profiles of prominent players (shortlisted based on our proprietary criterion) engaged in offering LNP manufacturing services and LNP technology. Each profile features a brief overview of the company (including information on year of establishment, location of headquarters, number of employees and leadership team), details related to its LNP service / technology portfolio, recent developments and an informed future outlook. In addition, the report also includes detailed profiles of other types of lipid CMO.
• A detailed analysis of the partnerships inked between stakeholders engaged in this industry, since 2019, based on several parameters, such as year of partnership, type of partnership, type of molecule, therapeutic area, type of partner and the most active players (in terms of the number of partnerships signed). It also provides the regional distribution of the companies involved in these agreements.
• An in-depth analysis of mRNA vaccines and therapeutics developers that are likely to partner with lipid nanoparticle manufacturer. These players have been shortlisted based on several relevant parameters, such as developer score (which takes into account a company’s size and experience in this field), pipeline strength (which takes into account the number of mRNA drugs in pipeline), as well as other mRNA drug related capabilities (which takes into account the target therapeutic area, route of administration and type of candidate). 
• An insightful make versus buy framework, highlighting the key indicators / factors that influence the decision of companies (referred to as sponsors in subsequent sections), whether to outsource the LNP manufacturing operations or develop the means to carry it in-house.
• An estimate of the current global installed capacity available with various LNP contract manufacturers. The study further highlights the distribution of the global installed LNP contract manufacturing capacity, based on company size (small, mid-sized, and large and very large companies), scale of operation (preclinical, clinical and commercial) and geography (North America, Europe and Asia-Pacific).
• An in-depth analysis of the factors that can impact the growth of lipid nanoparticle manufacturing market. It also features identification and analysis of key drivers, potential restraints, emerging opportunities, and existing challenges.

The key objectives of this market report is to provide a detailed market forecast in order to estimate the existing market size and future opportunity in lipid nanoparticle manufacturing market, over the forecast period. We have provided informed estimates on the likely evolution of the market size for the forecast period, 2023-2035. Our year-wise projections of the current and future opportunity have further been segmented based on relevant parameters, such as type of lipid nanoparticle (solid lipid nanoparticles and nanostructured lipid carriers), type of molecule delivered (nucleic acids, small molecules, proteins/peptides and others), company size (very large and large, mid-sized and small), target therapeutic area (infectious diseases, oncological disorders, blood disorders, rare diseases and other disorders), type of end-user (pharmaceutical and biotechnology companies, academic and research institutes, and other end-users) and key geographical regions (North America, Europe, Asia-Pacific and Rest of the World). In order to account for future uncertainties associated with some of the key parameters and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base, and optimistic scenarios, representing different tracks of the industry’s evolution.

The opinions and insights presented in the market report were influenced by our discussions with senior stakeholders in the industry. The report features detailed transcripts of interviews held with some of the key industry stakeholders. 

Further, all actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this market report are in USD, unless otherwise specified.

Tap or click on the images for smart insights on Lipid Nanoparticle Manufacturing Market

Frequently Asked Questions

Question 1: What are lipid nanoparticles?

Answer: Lipid nanoparticles are spherical, nanoscale vesicles that comprise of ionizable lipids that are neutral (at physiological pH) and positively charged (at low pH).

Question 2: What are the two types of lipid nanoparticles?

Answer: Lipid nanoparticles can be primary categorized into two types, namely Solid Lipid Nanoparticles (first generation) and Nanostructured Lipid Carriers (second generation).

Question 3: How are lipid nanoparticles used in drug delivery?

Answer: Owing to their unique size and physicochemical properties (surface area, surface energy, crystal structure and shape), lipid nanoparticles serve as carriers for antibiotics, antigens, chemotherapeutic agents, drugs, genetic materials, proteins and vaccines.

Question 4: What are the advantages of lipid nanoparticles?

Answer: Lipid nanoparticles have the ability to modify solubility, bioavailability and release kinetics of the encapsulated drug. In addition, they protect the sensitive materials from enzymatic degradation in the body, and allow targeted and controlled drug delivery.

Question 5: What are the drawbacks of lipid nanoparticles?

Answer: Some of the limitations of LNPs include complex and cost-intensive formulation process, in-vivo instability (due to clearance by immune system), low drug loading capacity, proneness to contamination and stability concerns during long storage periods.

Question 6: Who manufactures LNPs?

Answer: LNPs are developed and manufactured in-house by various pharmaceutical companies, and research institutes. However, for organizations lacking the required technical expertise and infrastructure, contract manufacturing organizations perform the manufacturing process.

Question 7: What are the most common types of agreement signed by the LNP contract manufacturers?

Answer: Most of the companies offering LNP manufacturing services are entering into research and development agreements, followed by product/technology licensing agreements.

Question 8: How big is the global lipid nanoparticle manufacturing market?

Answer: The lipid nanoparticle manufacturing market size is anticipated to be worth USD 0.66 billion in 2023.

Question 9: What is the likely growth rate (CAGR) of lipid nanoparticles manufacturing market?

Answer: The global lipid nanoparticle manufacturing market is expected to grow at a CAGR of 11.8% during the forecast period 2023 to 2035.

Question 10: What are the key factors driving the lipid nanoparticle manufacturing market?

Answer: The increasing prevalence of chronic diseases that require innovative treatment approaches, advancement in gene therapy (and mRNA) domain, and the ongoing innovations in LNP technology are the factors that foster progress in lipid nanoparticles manufacturing market.