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Lipid Contract Manufacturing Market by Type of Lipid , Triglycerides, Sphingolipids, Neutral Lipids, Others), Company Size , Scale of Operation and Key Geographical Regions: Industry Trends and Global Forecasts, 2021-2030

  • ID: 5411393
  • Report
  • June 2021
  • Region: Global
  • 230 Pages
  • Roots Analysis

FEATURED COMPANIES

  • 2-BBB Medicines
  • BioZone Labs
  • Empirical Labs
  • Lantheus Medical Imaging
  • NattoPharma
  • SciTech Development
  • MORE

Overview

Around 90% of the drug candidates in the current development pipeline and close to 40% of marketed pharmacological products, have been associated with concerns related to solubility and/or permeability. In this context, considering modern regulatory standards, a large number of potential therapeutic leads fail to clear the clinical evaluation phase and enter the market, owing to poor bioavailability. Over time, innovators in the biopharmaceutical industry have developed a number of ways to improve/augment physiochemical properties and ultimately, the drug-like behavior of pharmacological substances. Amidst other alternatives, lipid nanoparticles and the use of various lipid-based excipients (which improve permeability across biological membranes), have garnered the attention of drug developers. In fact, the novel mRNA-based COVID-19 vaccines use lipid nanoparticles to deliver the active ingredient of the preventive intervention to the required site of action, which is within target antigen presenting cells in the human body. Moreover, many other companies are using the aforementioned lipid-based solutions to re-formulate existing product candidates in order to improve their bioavailability. As a result, the demand for lipid drug carriers and excipients has grown considerably. However, for some of the lipids that have medical applications, the associated manufacturing processes are highly complex, capital-intensive, and fraught with multiple challenges. Some of the major issues related to the production of GMP grade lipids include the need for specialized expertise (especially in the case of lipid nanoparticles), lack of facilities with the necessary infrastructure and capacity to produce the required quality of substances, as well as concerns related to storage, safety and efficacy. 

Considering the technical and routine operations-related challenges, an increasing number of pharmaceutical companies have demonstrated the preference to outsource their respective lipid production operations to specialized service providers. The benefits of engaging CMOs for lipid manufacturing are numerous; for instance, contracting a supplier for medical grade lipids enables sponsors to leverage new technologies (available with the service provider), access larger capacities and achieve greater operational flexibility. Presently, there are several contract manufacturers and technology providers that claim to have the required capabilities to manufacture lipid-based drug delivery systems (such as liposomes/lipid nanoparticles) and lipid excipients. However, the global expertise and capabilities for producing GMP grade lipids is presently limited. As a result, many of the aforementioned companies are actively trying to consolidate their presence in this field, by entering into strategic alliances to broaden their respective service portfolios and lipid manufacturing capabilities. On the other hand, recently, a number of deals were inked between vaccine developers and CMOs in order to cater to the urgent need for lipid-based solutions for formers’ respective COVID-19 vaccines. Considering the benefits of using lipids to improve drug-like properties, we believe that the demand for high quality lipids is likely to drive commendable growth within the specialty contract manufacturing market in the coming years.

Scope of the Report

The ‘Lipid Contract Manufacturing Market by Type of Lipid (Liposomes/Lipid Nanoparticles, Phospholipids, Pegylated Lipids, Ionizable Lipids (Cationic/Anionic Lipids), Triglycerides, Sphingolipids, Neutral Lipids and Others), Company Size (Small, Mid-Sized and Large/Very Large), Scale Of Operation (Preclinical, Clinical and Commercial) and Key Geographical Regions (North America, Europe, Asia Pacific, MENA and Latin America and Rest Of The World): Industry Trends and Global Forecasts, 2021-2030’ report features an extensive study of the current market landscape and future potential of the lipid contract manufacturing market. The study features an in-depth analysis, highlighting the capabilities of contract service providers engaged in this domain. 

Amongst other elements, the report features:

  • A detailed review of the overall landscape of companies offering contract services for the manufacturing of lipids, along with information on their year of establishment, company size (in terms of employee count), scale of operation (preclinical, clinical and commercial), location of headquarters, location of manufacturing facilities, type of product (lipid-based FDF, lipid-based drug delivery system, lipid excipients and lipid-based API), type of service(s) offered (manufacturing, formulation development, process development/pre-formulation, analytical method development, scale-up, stability studies, regulatory support, fill/finish and packaging and other services) and type of lipid manufactured (liposomes/lipid nanoparticles, phospholipids, PEGylated lipids, ionizable lipids, triglycerides, sphingolipids, neutral lipids and others).
  • A competitiveness analysis of the lipid contract manufacturers, located in North America, Europe and Asia-Pacific, based on various relevant parameters, such as supplier power (based on the experience/expertise of the manufacturer) and service strength (based on number of service(s) offered, type of product(s) manufactured, number of manufacturing facilities, type of lipid manufactured and scale of operation).
  • An analysis of the partnerships that have been inked by stakeholders engaged in this domain, during the period 2016-2021. The various types of partnerships captured in our study include (in alphabetical order) acquisitions, distribution agreements, manufacturing agreements, product development agreements, service alliances, supply agreements, technology licensing agreements and others. 
  • A detailed analysis of the recent expansions undertaken (since 2016) by various service providers for augmenting their respective lipid contract manufacturing service portfolios. The analysis is based on several relevant parameters, including year of expansion, type of expansion (capacity expansion, facility expansion and new facility), scale of operation (n terms of type of expansion), type of product, amount invested, company size, location of headquarters, geographical location of the expanded facility, most active players (in terms of number of recent expansions) and geographical distribution (region-wise and country-wise) of the expansion activity.
  • An estimate of the global installed capacity for lipids, by taking into consideration the capacities of various lipid contract manufacturers. The chapter highlights the distribution of available global lipid production capacity based on various parameters, such as company size (small, mid-sized, large and very large companies), scale of operation (preclinical, clinical and commercial) and key geographical regions (North America, Europe, Asia-Pacific and rest of the world).
  • Elaborate profiles of prominent players (shortlisted based on a proprietary criterion) that offer various lipid manufacturing services, across North America, Europe and Asia-Pacific. Each profile provides an overview of the company, its financial performance (if available), details related to its service portfolio, manufacturing facilities, recent developments, and an informed future outlook. 
  • A qualitative analysis, highlighting the various factors that need to be taken into consideration by lipid developers while deciding whether to manufacture their respective products in-house or engage the services of a CMO.
  • A case study on the wide adoption of lipids as drug delivery systems in mRNA vaccines. It also provides a list of various technology developers for formulating lipid-based formulations and lipid-based/liposomal drugs that are approved by the FDA till date.

One of the key objectives of the report was to evaluate the current opportunity and the future potential of the lipid contract manufacturing market over the coming decade. We have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the period 2021-2030. Our year-wise projections of the current and future opportunity have further been segmented on the basis of [A] type of lipid (liposomes/lipid nanoparticles, phospholipids, PEGylated lipids, ionizable lipids (cationic/anionic lipids), triglycerides, sphingolipids, neutral lipids and others), [B] company size (small, mid-sized and large/very large), [C] scale of operation (preclinical, clinical and commercial) and [D] key geographical regions (North America, Europe, Asia-Pacific, MENA, Latin America and rest of the world). To account for future uncertainties in the market and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution.

The opinions and insights presented in the report were also influenced by discussions held with senior stakeholders in the industry. 

The report features detailed transcripts of interviews held with the following individuals:

  • Asha Van Rooijen (Founder and Chief Executive Officer, Liposoma)
  • Rahul Keswani (Associate Director, Formulation Development, Exelead)
  • John Riley (Director, Process Development-Chemistry, BioVectra) and Clement Mugabe (Acting Manager, Biotech Process Development, BioVectra) 

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

Key Questions Answered

  • Who are the leading lipid contract manufacturers engaged in this domain?
  • Which global regions are considered as key hubs for contract manufacturing of lipid products?
  • What type of partnership models are commonly adopted by stakeholders in this industry?
  • What different expansion initiatives have been undertaken by lipid contract manufacturers? 
  • Which factors are likely to influence the decision of lipid manufacturing being done in-house or outsourced?
  • What is current, global lipid manufacturing capacity (in litres) of contract manufacturers?
  • How is the current and future market opportunity likely to be distributed across key market segments?
Note: Product cover images may vary from those shown

FEATURED COMPANIES

  • 2-BBB Medicines
  • BioZone Labs
  • Empirical Labs
  • Lantheus Medical Imaging
  • NattoPharma
  • SciTech Development
  • MORE

1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Key Questions Answered
1.4. Chapter Outlines

2. EXECUTIVE SUMMARY

3. INTRODUCTION
3.1. Chapter Overview
3.2. Introduction to Lipids
3.2.1. Types of Lipids
3.3. Applications of Lipids in Pharmaceutical Industry
3.4. Challenges Associated with Lipid Manufacturing
3.5. Need for Outsourcing Lipid Manufacturing
3.6. Concluding Remarks

4. COMPETITIVE LANDSCAPE
4.1. Chapter Overview
4.2. Lipid Contract Manufacturers: Overall Market Landscape
4.2.1. Analysis by Year of Establishment
4.2.2. Analysis by Company Size
4.2.3. Analysis by Scale of Operation
4.2.4. Analysis by Location of Headquarters
4.2.5. Analysis by Location of Lipid Manufacturing Facilities
4.2.6. Analysis by Type of Product
4.2.7. Analysis by Service(s) Offered
4.2.8. Analysis by Types of Lipids Manufactured
4.2.8.1. Analysis by Types of Lipids Manufactured and Company Size
4.2.8.2. Analysis by Types of Lipids Manufactured and Scale of Operation
4.2.8.3. Analysis by Types of Lipids Manufactured and Location of Headquarters

5. COMPANY COMPETITIVENESS ANALYSIS
5.1. Chapter Overview
5.2. Assumptions and Key Parameters
5.3. Methodology
5.4 Lipid Contract Manufacturers: Company Competitiveness Analysis
5.4.1. Company Competitiveness Analysis: Lipid Contract Manufacturers in North America
5.4.2. Company Competitiveness Analysis: Lipid Contract Manufacturers in Europe
5.4.3. Company Competitiveness Analysis: Lipid Contract Manufacturers in Asia-Pacific

6. COMPANY PROFILES: LIPID CONTRACT MANUFACTURERS IN NORTH AMERICA
6.1. Chapter Overview
6.2. Avanti Polar Lipids
6.2.1. Company Overview
6.2.2. Lipid Manufacturing Service Offerings
6.2.3. Manufacturing Facilities
6.2.4. Recent Developments and Future Outlook
6.3. Creative Biolabs
6.3.1. Company Overview
6.3.2. Lipid Manufacturing Service Offerings
6.3.3. Manufacturing Facilities
6.3.4. Recent Developments and Future Outlook
6.4. Exelead
6.4.1. Company Overview
6.4.2. Lipid Manufacturing Service Offerings
6.4.3. Manufacturing Facilities
6.4.4. Recent Developments and Future Outlook
6.5. FormuMax Scientific
6.5.1. Company Overview
6.5.2. Lipid Manufacturing Service Offerings
6.5.3. Manufacturing Facilities
6.5.4. Recent Developments and Future Outlook
6.6. T&T Scientific
6.6.1. Company Overview
6.6.2. Lipid Manufacturing Service Offerings
6.6.3. Manufacturing Facilities
6.6.4. Recent Developments and Future Outlook

7. COMPANY PROFILES: LIPID CONTRACT MANUFACTURERS IN EUROPE
7.1. Chapter Overview
7.2. Ardena
7.2.1. Company Overview
7.2.2. Lipid Manufacturing Service Offerings
7.2.3. Manufacturing Facilities
7.2.4. Recent Developments and Future Outlook
7.3. CordenPharma
7.3.1. Company Overview
7.3.2. Lipid Manufacturing Service Offerings
7.3.3. Manufacturing Facilities
7.3.4. Recent Developments and Future Outlook
7.4. Evonik
7.4.1. Company Overview
7.4.2. Lipid Manufacturing Service Offerings
7.4.3. Manufacturing Facilities
7.4.4. Recent Developments and Future Outlook
7.5. Fresenius Kabi
7.5.1. Company Overview
7.5.2. Lipid Manufacturing Service Offerings
7.5.3. Manufacturing Facilities
7.5.4. Recent Developments and Future Outlook
7.6. Merck KGaA
7.6.1. Company Overview
7.6.2. Lipid Manufacturing Service Offerings
7.6.3. Manufacturing Facilities
7.6.4. Recent Developments and Future Outlook

8. COMPANY PROFILES: LIPID CONTRACT MANUFACTURERS IN ASIA-PACIFIC
8.1. Chapter Overview
8.2. Fujifilm
8.2.1. Company Overview
8.2.2. Lipid Manufacturing Service Offerings
8.2.3. Manufacturing Facilities
8.2.4. Recent Developments and Future Outlook
8.3. Nagase Medicals
8.3.1. Company Overview
8.3.2. Lipid Manufacturing Service Offerings
8.3.3. Manufacturing Facilities
8.3.4. Recent Developments and Future Outlook
8.4. Nippon Fine Chemical
8.4.1. Company Overview
8.4.2. Lipid Manufacturing Service Offerings
8.4.3. Manufacturing Facilities
8.4.4. Recent Developments and Future Outlook
8.5. TTY Biopharm
8.5.1. Company Overview
8.5.2. Lipid Manufacturing Service Offerings
8.5.3. Manufacturing Facilities
8.5.4. Recent Developments and Future Outlook
8.6. VCARE Bio Labs
8.6.1. Company Overview
8.6.2. Lipid Manufacturing Service Offerings
8.6.3. Manufacturing Facilities
8.6.4. Recent Developments and Future Outlook

9. PARTNERSHIPS AND COLLABORATIONS
9.1. Chapter Overview
9.2. Partnership Models
9.3. Lipid Contract Manufacturing Market: Partnerships and Collaborations
9.3.1. Analysis by Year of Partnership
9.3.2. Analysis by Type of Partnership
9.3.3. Analysis by Type of Product
9.3.4. Analysis by Type of Focus Area
9.3.5. Most Active Players: Analysis by Number of Partnerships
9.3.6. Geographical Analysis
9.3.6.1. Region-wise Distribution
9.3.6.2. Country-wise Distribution

10. RECENT EXPANSIONS
10.1. Chapter Overview
10.2. Lipid Contract Manufacturing Market: Recent Expansions
10.2.1. Analysis by Year of Expansion
10.2.2. Analysis by Type of Expansion
10.2.3. Analysis by Type of Expansion and Scale of Operation
10.2.4. Analysis by Type of Product
10.2.5. Analysis by Amount Invested
10.2.6. Analysis by Company Size and Location of Headquarters
10.2.7. Analysis by Location of Expanded Facility
10.2.8. Most Active Players: Analysis by Number of Recent Expansions
10.2.9. Geographical Analysis
10.2.9.1. Region-wise Distribution
10.2.9.2. Country-wise Distribution

11. CAPACITY ANALYSIS
11.1. Chapter Overview
11.2. Key Assumptions and Methodology
11.3. Lipid Contract Manufacturing: Installed Global Capacity (Million Liters)
11.3.1. Analysis by Company Size
11.3.2. Analysis by Scale of Operation
11.3.3. Analysis by Location of Manufacturing Facility
11.4. Concluding Remarks

12. MAKE VERSUS BUY DECISION MAKING FRAMEWORK
12.1. Chapter Overview
12.2. Assumptions and Parameter Definitions
12.3. Lipid Contract Manufacturing: Make Versus Buy Decision Making
12.3.1. Scenario 1
12.3.2. Scenario 2
12.3.3. Scenario 3
12.3.4. Scenario 4
12.4. Concluding Remarks

13. MARKET FORECAST AND OPPORTUNITY ANALYSIS
13.1. Chapter Overview
13.2. Forecast Methodology and Key Assumptions
13.3. Global Lipid Contract Manufacturing Market, 2021-2030
13.4. Lipid Contract Manufacturing Market, 2021-2030: Distribution by Type of Lipid
13.5. Lipid Contract Manufacturing Market, 2021-2030: Distribution by Company Size
13.6. Lipid Contract Manufacturing Market, 2021-2030: Distribution by Scale of Operation
13.7. Lipid Contract Manufacturing Market, 2021-2030: Distribution by Region
13.7.1. Lipid Contract Manufacturing Market in North America, 2021-2030
13.7.2. Lipid Contract Manufacturing Market in Europe, 2021-2030
13.7.3. Lipid Contract Manufacturing Market in Asia-Pacific, 2021-2030
13.7.4. Lipid Contract Manufacturing Market in MENA, 2021-2030
13.7.5. Lipid Contract Manufacturing Market in Latin America, 2021-2030
13.7.6. Lipid Contract Manufacturing Market in Rest of the World, 2021-2030

14. CASE STUDY: APPLICATIONS OF LIPIDS AND LIPID FORMULATION TECHNOLOGIES
14.1. Chapter Overview
14.2. Biopharmaceutical Drug Classification System
14.3. Lipid-based Formulations as Drug Delivery Systems
14.3.1. Role of Lipids in mRNA Vaccines
14.3.2. Recent Developments in Lipid Nanoparticles
14.4. Lipid-based Formulation Technology Developers
14.4.1. Analysis by Year of Establishment
14.4.2. Analysis by Company Size
14.4.3. Analysis by Location of Headquarters

15. CONCLUDING REMARKS

16. EXECUTIVE INSIGHTS
16.1. Chapter Overview
16.2. Liposoma
16.2.1. Company Snapshot
16.2.2. Interview Transcript: Asha Van Rooijen, Founder and CEO
16.3. Exelead
16.3.1. Company Snapshot
16.3.2. Interview Transcript: Rahul Keswani, Associate Director, Formulation Development
16.4. BioVectra
16.4.1. Company Snapshot
16.4.2. Interview Transcript: Clement Mugabe, Acting Manager, Biotech Process Development and John Riley, Director, Process Development – Chemistry

17. APPENDIX 1: TABULATED DATA

18. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

Note: Product cover images may vary from those shown
  • 2-BBB Medicines
  • Abbott Laboratories
  • AbbVie Contract Manufacturing
  • ABITEC
  • ADM-SIO
  • Ajinomoto Bio-Pharma Services
  • Alnylam Pharmaceuticals
  • Althea Technologies
  • Altum Pharmaceuticals
  • Amatsigroup
  • AmpTec
  • AMRI
  • Arbro Pharmaceuticals
  • Arbutus Biopharma
  • Arcturus Therapeutics
  • Ardena
  • Aronex Pharmaceuticals (a subsidiary of Agenus)
  • Ascendia Pharmaceuticals
  • Astellas Pharma
  • Avanti Polar Lipids
  • B. Braun
  • BASF
  • Bausch Health (formerly Valeant Pharmaceuticals)
  • Bayer
  • Berna Biotech Pharma
  • Biochempeg
  • BioConnection
  • BioNTech
  • Bioserv 
  • BioVectra
  • BioZone Labs
  • BOC Sciences
  • Boehringer Ingelheim
  • Bristol Myers Squibb
  • Britannia Pharmaceuticals
  • BSP Pharmaceuticals
  • Caisson Biotech
  • Camurus
  • CanSino Biologics
  • Capsugel
  • Catalent
  • Cayman Chemical
  • ChemConnection
  • Cipher Pharmaceuticals
  • Cone Bioproducts
  • CordenPharma
  • Creative Biolabs
  • Creative Biostructure
  • Croda
  • Crucell
  • CuriRx
  • Daiichi Sankyo
  • Dalton Pharma Services
  • Diethelm Keller Siber Hegner (DKSH)
  • DSM
  • Eisai
  • Elan Pharmaceuticals
  • Empirical Labs
  • Encapsula NanoSciences
  • Entos Pharmaceuticals
  • Evonik
  • Exelead
  • ForDoz Pharma
  • FormuMax Scientific
  • Fresenius Kabi
  • Fujifilm
  • Gattefossé
  • Genus Pharmaceuticals (acquired by STADA Arzneimittel)
  • Genzyme
  • GHO Capital
  • GlaxoSmithKline
  • Glenmark Pharmaceuticals
  • GP Pharm
  • Helix BioPharma
  • HTD Biosystems
  • IMCD
  • Intas Pharmaceuticals
  • Jamia Hamdard University
  • Jazz Pharmaceuticals
  • Jina Pharmaceuticals
  • Juniper Pharmaceuticals (acquired by Catalent)
  • KD Pharma
  • Keystone Nano
  • Kowa Pharmaceuticals
  • Kuecept
  • Lantheus Medical Imaging
  • Larodan
  • LATITUDE Pharmaceuticals
  • Leadiant Biosciences
  • Lipid Systems
  • Lipidome Lifesciences
  • Lipoid
  • LipoMedix
  • Lipomize
  • LIPOSOMA
  • lndchem International
  • Lonza
  • LSNE Contract Manufacturing
  • Lubrizol
  • Lupin
  • Lypro Biosciences
  • Marine Ingredients (KD Pharma)
  • Matinas BioPharma
  • Matreya
  • Memory Secret
  • Merck
  • Merrimack Pharmaceuticals
  • Micro-Sphere
  • MIKA PHARMACEUTICALS
  • Moderna
  • Moleculin Biotech
  • Nabros Pharma
  • Nagase Medicals
  • NattoPharma
  • Nemus Bioscience
  • NeXstar Pharmceuticals (acquired by Gilead Sciences)
  • NextPharma
  • Nippon Fine Chemical
  • NOF Europe
  • Novartis
  • Novavax
  • OPKO Health
  • Organon
  • Ozone Pharmaceuticals
  • Pacira Pharmaceuticals
  • Pfizer
  • Phares Drug Delivery
  • Pharmaceutics International
  • Pharmacia
  • PharmaSol
  • Phosphorex
  • Piramal Pharma Solutions
  • Polymun Scientific
  • Precision NanoSystems
  • Quay Pharma
  • Quotient Sciences
  • Regulon
  • Roche
  • Samyang Biopharmaceuticals
  • Sancilio Pharmaceuticals
  • Sanofi-Aventis
  • Schering-Plough
  • SciTech Development
  • Sequus Pharmaceuticals
  • Shochem (Shanghai)
  • Sirnaomics
  • SkyPharma
  • SoluBest
  • STA Pharmaceutical
  • Sucampo Pharmaceuticals
  • Sun Pharma
  • Syntagon
  • T&T Scientific
  • Takeda Pharmaceuticals
  • Talon Therapeutics
  • Tergus Pharma
  • Teva Pharmaceuticals
  • The Liposome Company (acquired by Elan Pharmaceuticals)
  • Transferra Nanosciences (acquired by Evonik)
  • TTY Biopharm
  • Univar Solutions
  • Validus Pharmaceuticals
  • Valimenta
  • Variant Pharmaceuticals
  • VAV Lifesciences
  • VCARE Bio Labs
  • Vesifact
  • Vineland Environmental Laboratories
  • ViralClear Pharmaceuticals (a subsidiary of BioSig)
  • Vitasome
  • VLP Therapeutics
  • Wyeth Pharmaceuticals
  • ZoneOne Pharma
Note: Product cover images may vary from those shown

 

 

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