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

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?