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Lipid CMO 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

June 2021 | 230 pages | ID: LB9330AA443EEN
Roots Analysis

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The lipid CMO market is expected to reach USD 2.4 billion in 2021 and anticipated to grow at a CAGR of 10.8% during the forecast period 2021-2030.

Approximately 90% of existing drug candidates in development and nearly 40% of marketed pharmacological products face concerns regarding their solubility and permeability. These issues pose obstacles in their progression through clinical evaluations and eventual market entry due to poor bioavailability, aligning with current regulatory standards. As a result, researchers in the biopharmaceutical industry have focused on various strategies to enhance the physicochemical properties and overall efficacy of pharmaceutical substances.

Among these strategies, significant attention has been devoted to lipid nanoparticles and various lipid-based additives known for their ability to enhance permeability across biological membranes. Notably, the revolutionary mRNA-based COVID-19 vaccines utilize lipid nanoparticles to efficiently deliver active components to specific cells in the human body. Additionally, numerous companies are exploring the use of lipid-based solutions to reformulate existing pharmaceutical candidates, aiming to improve their bioavailability. Consequently, there has been a notable increase in demand for lipid-based drug carriers and additives.

However, the production processes associated with certain medically applicable lipids are complex, require substantial capital investment, and face multiple challenges. Major issues in manufacturing lipids meeting Good Manufacturing Practice (GMP) standards include the need for specialized expertise, particularly in lipid nanoparticle production, a lack of facilities equipped with necessary infrastructure and capacity for producing high-quality substances, and concerns related to storage, safety, and efficacy.

In view of these technical and operational challenges, an increasing number of pharmaceutical firms are choosing to outsource their lipid manufacturing. Engaging Contract Manufacturing Organizations (CMOs) provides several advantages; it enables sponsors to leverage novel technologies offered by service providers, access larger production capacities, and achieve improved operational flexibility. Currently, several lipid manufacturers and technology providers claim to possess the required capabilities for manufacturing lipid-based drug delivery systems such as liposomes and lipid nanoparticles, as well as lipid additives. However, global expertise and capacities for producing GMP-grade lipids are presently limited.

Consequently, many of these companies are actively working to strengthen their position in this domain by forming strategic alliances to expand their service portfolios and liposome manufacturing capabilities. Notably, recent agreements have been established between vaccine developers and CMOs to address the urgent need for lipid-based solutions for COVID-19 vaccines. Considering the benefits of using lipids to enhance drug properties, it is expected that the demand for high-quality lipids will significantly drive market growth within the specialty contract manufacturing sector in the forecasted future.

Report Coverage
  • The report comprehensively examines the lipid CMO market, categorizing it by lipid type, company size, operational scale, and key geographical regions.
  • It analyzes the market's growth influencers such as drivers, restraints, opportunities, and challenges.
  • Assessment of potential advantages and obstacles within the market is provided, along with information on the competitive landscape for leading market players.
  • Revenue forecasts are outlined for market segments across five major regions.
  • A thorough overview of companies involved in contract services for lipid manufacturing involves analyzing their establishment year, workforce size, operational scale across preclinical, clinical, and commercial stages, headquarters and manufacturing facility locations, product types, services offered, and specific lipid varieties produced.
  • The competitiveness analysis evaluates lipid manufacturers in North America, Europe, and Asia-Pacific based on supplier expertise, service range, manufacturing facilities, and operational scale.
  • Examination of partnerships within the lipid CMO market encompasses acquisitions, distribution agreements, alliances, collaborations, licensing deals, and other engagements between stakeholders.
  • Analysis of recent expansions considers parameters like expansion year, type, operational scale, investment amount, company size, locations, key players, and geographical distribution.
  • Estimation of global installed lipid production capacity evaluates capacities of manufacturers based on company size, operational scale, and geographical distribution across regions.
  • Detailed profiles of significant players in North America, Europe, and Asia-Pacific involve analyzing their overview, financial performance (if available), service portfolio, manufacturing facilities, recent developments, and future prospects.
  • Qualitative analysis aids lipid developers in deciding between in-house manufacturing and engaging CMO services by considering various influencing factors.
  • Insights are offered into the extensive use of lipids in mRNA vaccine delivery systems, including technology developers and FDA-approved lipid-based formulations and drugs.
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
  12.3.2. Scenario
  12.3.3. Scenario
  12.3.4. Scenario
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


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