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

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, Latin America and Rest of the World): Industry Trends and Global Forecasts, 2021-2030

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.

1.1. 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.

1.2. RESEARCH METHODOLOGY
The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews / surveys with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Wherever possible, the available data has been checked for accuracy from multiple sources of information.
The secondary sources of information include
 Annual reports
 Investor presentations
 SEC filings
 Industry databases
 News releases from company websites
 Government policy documents
 Industry analysts’ views

While the focus has been on forecasting the market over the coming 10 years, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

1.3. 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?
1.4. CHAPTER OUTLINES
Chapter 2 is an executive summary of the key insights captured during our research. It offers a high-level view on the likely evolution of the lipid contract manufacturing market in the short to mid-term, and long term.

Chapter 3 provides a general overview of the lipids, featuring information on the various types and applications of lipids in the pharmaceutical industry. Additionally, it includes information on the challenges related to manufacturing of lipid-based formulations. It also features a discussion on the growing need for outsourcing the manufacturing of such products.

Chapter 4 provides an overview of the overall lipid contract manufacturing landscape. It includes information on close to 60 contract manufacturers currently engaged in this domain. Additionally, it features an in-depth analysis of service providers, based on a number of relevant parameters, such as year of establishment, company size, scale of operation (preclinical, clinical and commercial), location of headquarters, location of lipid manufacturing facilities, type of product (lipid-based FDF, lipid-based drug delivery system, lipid excipients and lipid-based API), type of lipids manufactured (liposomes / lipid nanoparticles, phospholipids, PEGylated lipids, ionizable lipids, triglycerides, sphingolipids, neutral lipids and others) and include details on type of services offered (manufacturing, formulation development, process development / pre-formulation, analytical method development, scale-up, stability studies, regulatory support, fill / finish and packaging and other services).

Chapter 5 features a detailed 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 lipids manufactured and scale of operation).

Chapter 6 provides detailed profiles of the prominent players (shortlisted based on a proprietary criterion) that are active in the lipid contract manufacturing market in North America. Each profile provides an overview of the company, its financial performance (if available), information related to its service portfolio, manufacturing facilities, and details on recent developments, as well as an informed future outlook.

Chapter 7 provides detailed profiles of the prominent players (shortlisted based on a proprietary criterion) that are active in the lipid contract manufacturing market in Europe. Each profile provides an overview of the company, its financial performance (if available), information related to its service portfolio, manufacturing facilities, and details on recent developments, as well as an informed future outlook.

Chapter 8 provides detailed profiles of the prominent players (shortlisted based on a proprietary criterion) that are active in the lipid contract manufacturing market in Asia-Pacific. Each profile provides an overview of the company, its financial performance (if available), information related to its service portfolio, manufacturing facilities, and details on recent developments, as well as an informed future outlook.

Chapter 9 features an analysis of the various collaborations and partnerships that have been inked by stakeholders engaged in this domain, during the period 2016-2021. It includes a brief description of the partnership models (including acquisitions, distribution agreements, manufacturing agreements, product development agreements, service alliances, supply agreements, technology licensing agreements and others) adopted by stakeholders in this domain. Further, it comprises of analysis based on year of agreement, type of agreement, type of product, focus area and most active player(s) (in terms of number of partnerships inked). Further, the chapter includes a world map representation of all the deals inked in this field in the period 2016-2021, highlighting both intercontinental and intracontinental partnership activity.

LIST OF COMPANIES AND ORGANIZATIONS

The following companies and organizations have been mentioned in the report.
1. 2-BBB Medicines
2. Abbott Laboratories
3. AbbVie Contract Manufacturing
4. ABITEC
5. ADM-SIO
6. Ajinomoto Bio-Pharma Services
7. Alnylam Pharmaceuticals
8. Althea Technologies
9. Altum Pharmaceuticals
10. Amatsigroup
11. AmpTec
12. AMRI
13. Arbro Pharmaceuticals
14. Arbutus Biopharma
15. Arcturus Therapeutics
16. Ardena
17. Aronex Pharmaceuticals (a subsidiary of Agenus)
18. Ascendia Pharmaceuticals
19. Astellas Pharma
20. Avanti Polar Lipids
21. B. Braun
22. BASF
23. Bausch Health (formerly Valeant Pharmaceuticals)
24. Bayer
25. Berna Biotech Pharma
26. Biochempeg
27. BioConnection
28. BioNTech
29. Bioserv
30. BioVectra
31. BioZone Labs
32. BOC Sciences
33. Boehringer Ingelheim
34. Bristol Myers Squibb
35. Britannia Pharmaceuticals
36. BSP Pharmaceuticals
37. Caisson Biotech
38. Camurus
39. CanSino Biologics
40. Capsugel
41. Catalent
42. Cayman Chemical
43. ChemConnection
44. Cipher Pharmaceuticals
45. Cone Bioproducts
46. CordenPharma
47. Creative Biolabs
48. Creative Biostructure
49. Croda
50. Crucell
51. CuriRx
52. Daiichi Sankyo
53. Dalton Pharma Services
54. Diethelm Keller Siber Hegner (DKSH)
55. DSM
56. Eisai
57. Elan Pharmaceuticals
58. Empirical Labs
59. Encapsula NanoSciences
60. Entos Pharmaceuticals
61. Evonik
62. Exelead
63. ForDoz Pharma
64. FormuMax Scientific
65. Fresenius Kabi
66. Fujifilm
67. Gattefossé
68. Genus Pharmaceuticals (acquired by STADA Arzneimittel)
69. Genzyme
70. GHO Capital
71. GlaxoSmithKline
72. Glenmark Pharmaceuticals
73. GP Pharm
74. Helix BioPharma
75. HTD Biosystems
76. IMCD
77. Intas Pharmaceuticals
78. Jamia Hamdard University
79. Jazz Pharmaceuticals
80. Jina Pharmaceuticals
81. Juniper Pharmaceuticals (acquired by Catalent)
82. KD Pharma
83. Keystone Nano
84. Kowa Pharmaceuticals
85. Kuecept
86. Lantheus Medical Imaging
87. Larodan
88. LATITUDE Pharmaceuticals
89. Leadiant Biosciences
90. Lipid Systems
91. Lipidome Lifesciences
92. Lipoid
93. LipoMedix
94. Lipomize
95. LIPOSOMA
96. lndchem International
97. Lonza
98. LSNE Contract Manufacturing
99. Lubrizol
100. Lupin
101. Lypro Biosciences
102. Marine Ingredients (KD Pharma)
103. Matinas BioPharma
104. Matreya
105. Memory Secret
106. Merck
107. Merrimack Pharmaceuticals
108. Micro-Sphere
109. MIKA PHARMACEUTICALS
110. Moderna
111. Moleculin Biotech
112. Nabros Pharma
113. Nagase Medicals
114. NattoPharma
115. Nemus Bioscience
116. NeXstar Pharmceuticals (acquired by Gilead Sciences)
117. NextPharma
118. Nippon Fine Chemical
119. NOF Europe
120. Novartis
121. Novavax
122. OPKO Health
123. Organon
124. Ozone Pharmaceuticals
125. Pacira Pharmaceuticals
126. Pfizer
127. Phares Drug Delivery
128. Pharmaceutics International
129. Pharmacia
130. PharmaSol
131. Phosphorex
132. Piramal Pharma Solutions
133. Polymun Scientific
134. Precision NanoSystems
135. Quay Pharma
136. Quotient Sciences
137. Regulon
138. Roche
139. Samyang Biopharmaceuticals
140. Sancilio Pharmaceuticals
141. Sanofi-Aventis
142. Schering-Plough
143. SciTech Development
144. Sequus Pharmaceuticals
145. Shochem (Shanghai)
146. Sirnaomics
147. SkyPharma
148. SoluBest
149. STA Pharmaceutical
150. Sucampo Pharmaceuticals
151. Sun Pharma
152. Syntagon
153. T&T Scientific
154. Takeda Pharmaceuticals
155. Talon Therapeutics
156. Tergus Pharma
157. Teva Pharmaceuticals
158. The Liposome Company (acquired by Elan Pharmaceuticals)
159. Transferra Nanosciences (acquired by Evonik)
160. TTY Biopharm
161. Univar Solutions
162. Validus Pharmaceuticals
163. Valimenta
164. Variant Pharmaceuticals
165. VAV Lifesciences
166. VCARE Bio Labs
167. Vesifact
168. Vineland Environmental Laboratories
169. ViralClear Pharmaceuticals (a subsidiary of BioSig)
170. Vitasome
171. VLP Therapeutics
172. Wyeth Pharmaceuticals
173. ZoneOne Pharma

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