DUBLIN, Feb. 6, 2024 /PRNewswire/ — The “Global Lipid Nanoparticle Manufacturing Market 2023-2035: Services and Technologies – Distribution by Type of Lipid Nanoparticle, Type of Molecule Delivered, Company Size, Target Therapeutic Area, Type of End-user and Key Geographical Regions” report has been added to ResearchAndMarkets.com’s offering.
The global lipid nanoparticle manufacturing market was 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.
Key Market Insights
The 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.
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.
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.
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.
Key Topics Covered:
1. PREFACE
2. RESEARCH METHODOLOGY
3. ECONOMIC AND OTHER PROJECT SPECIFIC CONSIDERATIONS
4. EXECUTIVE SUMMARY
5. INTRODUCTION
5.1. Chapter Overview
5.2. Overview of Lipids
5.3 Introduction to Lipid Nanoparticles
5.4. Challenges Associated with Lipid Nanoparticle Manufacturing
5.5. Need for Outsourcing Lipid Nanoparticle Manufacturing
5.6. Concluding Remarks
6. LIPID NANOPARTICLES: SERVICE PROVIDERS LANDSCAPE
6.1. Chapter Overview
6.2. Lipid Nanoparticle Manufacturing: List of Service Providers
6.2.1 Analysis by Year of Establishment
6.2.2 Analysis by Company Size
6.2.3 Analysis by Location of Headquarters
6.2.4 Analysis by Company Size and Location of Headquarters
6.2.5 Analysis by Location of Lipid Nanoparticle Manufacturing Facility
6.2.6 Analysis by Scale of Operation
6.2.7 Analysis by Type of Molecule Delivered
6.2.8 Analysis by Therapeutic Area
6.2.9 Analysis by Type of Additional Services Offered
7. LIPID NANOPARTICLES: TECHNOLOGY LANDSCAPE
7.1. Chapter Overview
7.2. Lipid Nanoparticle: Technology Landscape
7.3. Lipid Nanoparticle Technologies: List of Technology Developers
8. OTHER TYPES OF LIPIDS: SERVICE PROVIDERS LANDSCAPE
8.1. Chapter Overview
8.2. Other Types of Lipids: List of Service Providers
9. COMPANY COMPETITIVENESS ANALYSIS
9.1. Chapter Overview
9.2. Assumptions and Key Parameters
9.3. Methodology
9.4. Lipid Nanoparticle Manufacturing Service Providers: Company Competitiveness Analysis
10. TECHNOLOGY COMPETITIVENESS ANALYSIS
10.1. Chapter Overview
10.2. Assumptions and Key Parameters
10.3. Methodology
10.4. Lipid Nanoparticle Technologies: Competitiveness Analysis
11. COMPANY PROFILES: SERVICE PROVIDERS OF LIPID NANOPARTICLES
11.1. Chapter Overview
11.2. Curia
11.3. Emergent BioSolutions
11.4. EUROAPI
11.5. Evonik
11.6. Ardena
11.7. BIOVECTRA
11.8. Precision NanoSystems
12. COMPANY PROFILES: LIPID NANOPARTICLE TECHNOLOGY DEVELOPERS
12.1. Chapter Overview
12.2. Ascendia Pharmaceuticals
12.3. leon-nanodrugs
12.4. Pantherna Therapeutics
12.5. TLC Biosciences
12.6. Acuitas Therapeutics
12.7. Integrated Nanotherapeutics
12.8. Matinas BioPharma
13. COMPANY PROFILES: SERVICE PROVIDERS OF OTHER TYPES OF LIPIDS
13.1. Chapter Overview
13.2. Avanti Polar Lipids
13.3. Corden Pharma
13.4. Fujifilm
13.5. Merck
13.6. FormuMax Scientific
13.7. Creative Biolabs
13.8. Fresenius Kabi
14. PARTNERSHIPS AND COLLABORATIONS
14.1. Chapter Overview
14.2. Partnership Models
14.3. Lipid Nanoparticles Services and Technologies: List of Partnerships and Collaborations
15. LIKELY PARTNER ANALYSIS
15.1. Chapter Overview
15.2. Methodology
15.2. mRNA Drug Developers: Potential Strategic Partners in North America
15.3. mRNA Drug Developers: Potential Strategic Partners in Europe and Asia-Pacific
16. MAKE VERSUS BUY DECISION FRAMEWORK
16.1. Chapter Overview
16.2. Assumptions and Key Parameters
16.3. Lipid Nanoparticle Service Providers: Make versus Buy Decision Making Framework
17. CAPACITY ANALYSIS
18. MARKET IMPACT ANALYSIS: DRIVERS, RESTRAINTS, OPPORTUNITIES AND CHALLENGES
19. GLOBAL LIPID NANOPARTICLE MANUFACTURING MARKET
20. LIPID NANOPARTICLE MANUFACTURING MARKET, BY TYPE OF LIPID NANOPARTICLE
21. LIPID NANOPARTICLE MANUFACTURING MARKET, BY TYPE OF MOLECULE DELIVERED
22. LIPID NANOPARTICLE MANUFACTURING MARKET, BY COMPANY SIZE
23. LIPID NANOPARTICLE MANUFACTURING MARKET, BY TARGET THERAPEUTIC AREA
24. LIPID NANOPARTICLE MANUFACTURING MARKET, BY TYPE OF END-USER
25. LIPID NANOPARTICLE MANUFACTURING MARKET, BY KEY GEOGRAPHICAL REGIONS
Companies Mentioned
- 2seventy bio
- ABITEC
- Acuitas Therapeutics
- ADM
- Afrigen Biologics
- AIM Vaccine
- Aragen Life Sciences
- Arbor Biotechnologies
- Arbutus Biopharma
- Arcturus Therapeutics
- Ardena
- Arranta Bio
- Ascendia Pharmaceuticals
- Ascension Sciences
- AskBio
- Astellas Pharma
- Athebio
- B. Braun
- Baseimmune
- BASF Pharma
- Beam Therapeutics
- BeiGene
- Bio-Serv
- BioNTech
- Biopharma PEG Scientific
- BIOVECTRA
- BOC Sciences
- BSP Pharmaceuticals
- CanSino Biologics
- Carisma Therapeutics
- Catalent
- Cayman Chemical
- CD Bioparticles
- Celonic
- Cone Bioproducts
- ConserV Bioscience
- CordenPharma
- Creative Biolabs
- Creative Biostructure
- Croda
- CSL Seqirus
- Curapath
- CureVac
- Curia
- Cytiva
- Daewoong Pharmaceutical
- Daiichi Sankyo
- Dalton Pharma Services
- Danaher
- DIANT Pharma
- DSM
- Emergent BioSolutions
- Empirical Labs
- Encapsula NanoSciences
- Endo International
- Entos
- Esco Aster
- eTheRNA
- EUROAPI
- Evonik
- ExploRNA Therapeutics
- ForDoz Pharma
- FormuMax Scientific
- Fresenius Kabi
- Fujifilm
- Gattefosse
- GC Biopharma
- Generation Bio
- Genprex
- GP Pharm
- GreenLight Biosciences
- Gritstone bio
- Harro Hofliger
- Helix Biotech
- HTD Biosystems
- IBM
- IMUNON
- InnoRNA
- Integrated Nanotherapeutics
- KD Pharma
- Kernal Biologics
- Korro Bio
- Lead Biotherapeutics
- leon-nanodrugs
- LGC Axolabs
- Lipid Systems Sp.
- Lipidome Lifesciences
- Lipoid
- LIPOSOMA
- Lonza
- Matinas BioPharma
- Merck
- Metagenomi
- Micro-Sphere
- Moderna
- MyBiotech
- Myeloid Therapeutics
- Nabros Pharma
- NanoVation Therapeutics
- National Resilience
- NeoVac
- NextPharma
- Nippon Fine Chemical
- NOF Corporation
- Omega Therapeutics
- Oncorus
- Orna Therapeutics
- OZ Biosciences
- Pantherna Therapeutics
- PCI Pharma Services
- Pfizer
- Phosphorex
- Piramal Pharma Solutions
- Polymun Scientific
- Precigenome
- Precision NanoSystems
- ProMab Biotechnologies
- Providence Therapeutics
- PROVIREX Genome Editing Therapies
- Quay Pharma
- QurCan Therapeutics
- Recipharm
- ReCode Therapeutics
- Replicate Bioscience
- Sanofi
- Sarepta Therapeutics
- SciTech Development
- ST Pharm
- STA Pharmaceutical
- StaniPharm
- Takeda Pharmaceutical
- Tergus Pharma
- TLC Biosciences
- TTY Biopharm Company
- Turn Biotechnologies
- Valimenta Labs
- VAV Life Sciences
- Vaxinano
- Vernal Biosciences
- Vertex Pharmaceuticals
- Verve Therapeutics
- ViiV Healthcare
- VLP Therapeutics
- ZoneOne Pharma
For more information about this report visit https://www.researchandmarkets.com/r/455hgv
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