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.