Lipid CMO Market

Lipid CMO Market Overview

The lipid CMO market is estimated to be worth $2.4 billion in 2021 and is expected to grow at CAGR of 10.8% during the forecast period. 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 liposome 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 nanoparticle manufacturing), 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 manufacturers. 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 lipid 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 liposome 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 market growth within the specialty contract manufacturing market during the forecast period.

Key Companies in Lipid CMO Market

Examples of key companies engaged in lipid CMO market (which have also been profiled in this market report; the complete list of companies is available in the full report) include Avanti Polar Lipids, Creative Biolabs, Exelead, FormuMax Scientific, T&T Scientific, Ardena, Corden Pharma, Evonik, Fresenius Kabi, Merck KGaA, Fujifilm, Nagase Medicals, Nippon Fine Chemical, TTY Biopharm and VCARE Bio Labs. This market report includes an easily searchable excel database of all the companies providing lipid CMO services, worldwide.

Recent Developments in Lipid CMO Market:

Several recent developments have taken place in the field of lipid CMO market. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that have been outlined in our analysis.

• In September 2023, GenScript Biotech expanded its IVT mRNA synthesis portfolio by adding services for customized circular RNA (circRNA) and lipid nanoparticles (LNPs) formulation. 
• In March 2023, Evonik expanded its portfolio with the addition of new lipid manufacturing facility in Hanau, Germany with an aim to grow its presence in the contract manufacturing and development industry.

Scope of the Report

The ‘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’ market report features an extensive study of the current market landscape, market size, market share, market forecast, market outlook and future opportunities of the lipid CMO market. The market research report features an in-depth analysis, highlighting the capabilities of contract service providers engaged in lipid CMO market.

Amongst other elements, the market research 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 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 lipid CMO market, 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 expansiosince) 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 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.

The key objective of lipid CMO market report is to provide a detailed market analysis in order to estimate the existing market size, market value, statistics and future opportunity for lipid CMO market during the forecast period. We have provided an informed estimate of the likely evolution of the market in the short to mid-term and long term, for the forecast 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 market forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution.

The opinions and insights presented in the market report were also influenced by discussions held with senior stakeholders in the industry. The market research 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 market report are in USD, unless otherwise specified.

Frequently Asked Questions

Question 1: What is a lipid CMO?

Answer: A lipid CMO is a special kind of an organization, offering contract manufacturing services to pharmaceutical companies for various kinds of drug components involving lipid molecules, including small molecules, APIs and excipients.

Question 2: How big is the lipid CMO market?

Answer: The lipid CMO market size is estimated to be worth $2.4 billion in 2021.

Question 3: What is the projected market growth of the lipid CMO market?

Answer: The lipid CMO market is expected to grow at compounded annual growth rate (CAGR) of 10.8% during the forecast period 2021 – 2030.

Question 4: Who are the leading players in the lipid CMO market?

Answer: Examples of key companies engaged in lipid CMO market (which have also been profiled in this market report; the complete list of companies is available in the full report) include Avanti Polar Lipids, Creative Biolabs, Exelead, FormuMax Scientific, T&T Scientific, Ardena, Corden Pharma, Evonik, Fresenius Kabi, Merck KGaA, Fujifilm, Nagase Medicals, Nippon Fine Chemical, TTY Biopharm and VCARE Bio Labs.

Question 5: How many companies are currently engaged in the lipid CMO market?

Answer: Over 55 companies are currently engaged in the lipid CMO market providing contract manufacturing services for lipid based products.

Question 6: How many lipid based drugs have been approved by the FDA till date?

Answer: Close to 70 lipid based drugs have been approved by the FDA till date.

Question 7: How many partnership deals have been inked between the stakeholders engaged in lipid CMO market?

Answer: Since 2016, more than 60 partnership deals have been inked between the stakeholders engaged in lipid CMO market, highlighting the consolidation efforts of the players in this field.