Squalene Extraction for Pharma: 2025 Breakthroughs & Profits Revealed

Table of Contents

• Executive Summary: Squalene Extraction for Pharmaceutical Adjuvants in 2025
• Market Size & Forecasts: 2025–2030 Industry Projections
• Key Drivers: Demand from Vaccine and Drug Manufacturers
• Extraction Technologies: Advancements and Innovations
• Regulatory Landscape and Compliance Challenges
• Major Players: Manufacturers, Suppliers, and Industry Leaders
• Supply Chain Dynamics: Sourcing, Sustainability, and Traceability
• Competitive Analysis: Squalene from Plant vs. Animal Sources
• Investment Opportunities and Partnership Trends
• Future Outlook: Emerging Applications and Long-Term Growth Potential
• Sources & References

Executive Summary: Squalene Extraction for Pharmaceutical Adjuvants in 2025

Squalene, a natural triterpene hydrocarbon, remains a critical component in the formulation of pharmaceutical adjuvants, especially for vaccines. In 2025, the extraction and sourcing of squalene for pharmaceutical use are shaped by increasing demand, regulatory scrutiny, and the evolution of sustainable extraction technologies. Traditionally, squalene was sourced from shark liver oil, a practice under ethical and environmental pressure due to declining shark populations and international conservation efforts. As a result, there is a marked shift towards plant-based and fermentation-derived squalene for pharmaceutical applications.

Industry leaders such as Amyris, Inc. and Kishimoto Special Liver Oil Co., Ltd. are at the forefront of this transition. Amyris, Inc. utilizes precision fermentation—engineering yeast to convert sugarcane into highly pure, pharmaceutical-grade squalene. This bio-based method not only addresses supply chain sustainability but also ensures batch-to-batch consistency required for vaccine adjuvants. Meanwhile, companies like Kishimoto Special Liver Oil Co., Ltd. continue to supply high-purity shark-derived squalene, albeit with increasing emphasis on traceability and regulatory compliance to meet international standards.

Demand for squalene-based adjuvants has surged in the wake of global vaccination campaigns, notably for influenza and COVID-19, where adjuvants such as MF59 and AS03—both squalene-based—play a vital role in vaccine efficacy. Leading pharmaceutical manufacturers, including GlaxoSmithKline plc (GSK) and Seqirus, continue to rely on squalene for their licensed adjuvant systems. GSK publicly reports ongoing efforts to secure sustainable and ethical squalene sources for its vaccine portfolio, reflecting broader industry trends.

Looking ahead to the next few years, the outlook for squalene extraction is characterized by growing commercialization of fermentation-derived squalene, increased transparency across the supply chain, and tighter regulatory oversight. The World Health Organization (WHO) and regulatory bodies are expected to update guidelines on sourcing and traceability, further reinforcing the shift toward non-animal squalene. Investments in R&D by companies such as Amyris, Inc. and ongoing collaborations between vaccine manufacturers and squalene suppliers are set to accelerate the adoption of sustainable sources, ensuring reliable supply for pharmaceutical adjuvant production through 2025 and beyond.

Market Size & Forecasts: 2025–2030 Industry Projections

The global market for squalene extraction, particularly for use in pharmaceutical adjuvants, is poised for significant growth between 2025 and 2030. Squalene, a triterpene compound historically sourced from shark liver oil and increasingly from plant-based sources such as olives and sugarcane, is a critical component in vaccine adjuvant formulations. Its immunostimulatory properties have made it a mainstay in several major vaccine platforms, most notably in influenza and, more recently, in COVID-19 vaccines. The continued expansion of vaccine development pipelines and the global emphasis on pandemic preparedness are expected to drive robust demand for pharmaceutical-grade squalene.

By 2025, the pharmaceutical sector remains the dominant consumer of high-purity squalene, spearheaded by major vaccine manufacturers and adjuvant specialists. For example, GSK continues to utilize squalene-based adjuvant systems such as AS03 in its vaccine formulations, underlining the ingredient’s strategic significance. The company has also publicly committed to sourcing only plant-derived squalene for its vaccines by 2025, thereby shaping market dynamics and sourcing trends.

The transition from animal-derived to plant-based or fermentation-derived squalene is expected to accelerate, driven by regulatory, ethical, and sustainability considerations. Leading suppliers, including Amyris, have scaled up bioengineered squalene production through sugarcane fermentation, offering a reliable and traceable alternative to traditional sources. Similarly, Olive Oils from Spain and affiliated producers have expanded their capacity to supply olive-derived squalene to pharmaceutical clients, supporting both quality and sustainability initiatives.

Market projections suggest an annual growth rate (CAGR) in the mid-to-high single digits for pharmaceutical squalene extraction between 2025 and 2030. This is underpinned by ongoing investments in vaccine R&D and increased government procurement of pandemic countermeasures. Manufacturing partnerships and multi-year supply agreements with companies such as Croda International Plc—a leading producer of pharmaceutical excipients including squalene—reflect the sector’s expectation of sustained demand.

Looking ahead, the industry is likely to witness further capacity expansion, supply chain localization, and technological innovation in extraction and purification methods. With regulatory scrutiny favoring non-animal sources and the pharmaceutical sector’s commitment to ESG (Environmental, Social, and Governance) goals, the market outlook for squalene extraction is robust, with plant and fermentation-derived squalene set to dominate supply through 2030.

Key Drivers: Demand from Vaccine and Drug Manufacturers

The demand for squalene extraction for pharmaceutical adjuvants is poised for continued growth in 2025 and the immediate years ahead, primarily driven by its critical role in vaccine and drug formulations. Squalene, a natural triterpene, is widely utilized as an immunologic adjuvant—substances that enhance the body’s immune response to antigens—especially in the production of influenza vaccines and, increasingly, in next-generation vaccines for infectious diseases.

One of the most notable drivers in 2025 is the ongoing global effort to improve pandemic preparedness, following the COVID-19 pandemic. Pharmaceutical leaders such as GSK and Seqirus continue to incorporate squalene-based adjuvants (notably GSK’s AS03 and Seqirus’s MF59) into seasonal and pandemic influenza vaccines, with production volumes expected to rise in anticipation of increased vaccination campaigns and stockpiling. The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) both list squalene-containing adjuvants as approved components in several licensed vaccines, further reinforcing their role in public health strategies.

Simultaneously, the expansion of clinical trials featuring adjuvanted vaccines for diseases such as malaria, RSV, and even certain oncology applications is spurring extraction demand. Companies like GSK are advancing candidates that rely on squalene adjuvant systems for efficacy, with regulatory filings and commercial launches anticipated in the next few years.

This pharmaceutical demand is influencing the upstream extraction sector. Traditionally, squalene has been sourced from shark liver oil, but sustainability concerns and regulatory pressure are accelerating the shift toward plant-derived alternatives, especially from olive oil. Suppliers such as Arbee Biospecialities and A.S.P. Inc. have ramped up production of plant-based squalene to meet the pharmaceutical industry’s strict purity and traceability requirements. This trend is anticipated to intensify through 2025 and beyond, as vaccine manufacturers seek to align with global biodiversity and ethical sourcing commitments.

Looking ahead, the outlook for squalene extraction remains robust. The World Health Organization (WHO) has highlighted the importance of adjuvants in dose-sparing strategies, which will be critical for responding to future infectious disease threats. With ongoing investments in vaccine research and manufacturing capacity, coupled with a clear movement toward sustainable sourcing, squalene extraction for pharmaceutical adjuvants is set to be a key growth segment in the biopharmaceutical supply chain over the coming years.

Extraction Technologies: Advancements and Innovations

The extraction of squalene for pharmaceutical adjuvants is undergoing significant transformation, driven by both technological innovation and mounting sustainability concerns. As of 2025, the pharmaceutical industry continues to require high-purity squalene as an essential component in vaccine adjuvant systems, notably in the widely used MF59 and AS03 formulations. Traditionally, squalene has been sourced from shark liver oil, but the demand for ethical and sustainable alternatives has accelerated the adoption of plant-based and biotechnologically-derived squalene.

Sourcing from olive oil has been a leading non-animal alternative. Companies such as Olive Oils from Spain have highlighted the rising extraction yields achieved through cold-press and supercritical CO₂ technologies, which preserve squalene’s integrity while minimizing environmental impact. In 2025, these methods are being further refined to maximize recovery and purity, responding to pharmaceutical sector requirements for consistent, contaminant-free squalene.

Biotechnological fermentation is another frontier, with companies like Amyris, Inc. commercializing squalene produced by genetically engineered yeast. Amyris reports that its fermentation-derived squalene is molecularly identical to shark-derived squalene and offers scalability to meet global vaccine needs. This technology bypasses agricultural limitations, with continuous improvements in fermentation efficiency and downstream purification expected to lower costs and increase supply reliability over the next few years.

Process optimization is also advancing. For example, Evonik Industries has focused on refining extraction and purification protocols, ensuring pharmaceutical-grade squalene with traceability and batch-to-batch consistency. Their expertise in lipid technology is being leveraged to meet tightening regulatory standards and to support the growing demand for sustainable adjuvant ingredients.

Looking ahead, the outlook for squalene extraction is closely tied to the pharmaceutical industry’s push for greener supply chains. Regulatory pressure and industry pledges are expected to further marginalize shark-derived squalene, with suppliers investing in next-generation extraction and purification systems. Ongoing R&D in enzymatic extraction, continuous-flow processing, and waste minimization is likely to yield further improvements in efficiency and environmental performance by 2027. With major vaccine developers such as GlaxoSmithKline and Sanofi prioritizing sustainable squalene sources, the sector is poised for rapid evolution, ensuring ethical, scalable, and high-quality supply for pharmaceutical adjuvant applications.

Regulatory Landscape and Compliance Challenges

As of 2025, the regulatory landscape governing squalene extraction for pharmaceutical adjuvants continues to evolve in response to growing scrutiny over sustainability, traceability, and quality assurance. Squalene, widely used in vaccine adjuvants such as MF59 and AS03, is sourced predominantly from shark liver oil and, increasingly, from plant-based alternatives. Regulatory agencies in major markets—such as the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA)—mandate strict compliance with Good Manufacturing Practices (GMP), requiring full documentation of squalene’s origin and extraction methodologies.

A key compliance challenge remains the environmental and ethical concerns surrounding shark-derived squalene. In 2025, regulatory bodies continue to pressure manufacturers to transition toward sustainable sourcing, in alignment with international conservation agreements such as CITES. The EMA has updated its guidance, requiring greater transparency in the sourcing of raw materials, including evidence of sustainable harvesting practices and third-party verification for animal-derived ingredients. This has prompted pharmaceutical suppliers to strengthen their supply chain documentation and seek alternatives to shark-based squalene where feasible.

Plant-derived squalene, primarily extracted from olive oil and sugarcane, is gaining traction due to its lower regulatory risk profile. Suppliers such as Amyris, Inc. and Olivoil S.r.l. have scaled up production of sugarcane- and olive-based squalene, respectively, emphasizing compliance with both pharmacopeial standards and sustainability certifications. Regulatory agencies in the European Union and United States have begun to prioritize review of plant-based sources, streamlining approvals for those that meet stringent quality and traceability requirements.

In the coming years, the outlook for squalene extraction is shaped by anticipated tightening of environmental and safety regulations. Traceability and batch-to-batch consistency are focal points for compliance audits, with increased reliance on digital tracking and blockchain solutions by major manufacturers such as Croda International Plc. Furthermore, the push for harmonized global standards is expected to accelerate, as organizations like the World Health Organization (WHO) collaborate with regional regulators to address cross-border supply chain complexities and ensure safe, ethical, and sustainable squalene supplies for pharmaceutical applications.

In summary, as regulatory scrutiny intensifies through 2025 and beyond, companies engaged in squalene extraction for pharmaceutical adjuvants must continually adapt to evolving compliance requirements—prioritizing sustainability, transparency, and rigorous documentation to maintain market access and public trust.

Major Players: Manufacturers, Suppliers, and Industry Leaders

The squalene market for pharmaceutical adjuvants is evolving rapidly in 2025, driven by increasing vaccine demand and a global emphasis on sustainable sourcing. Major players in this sector are focusing on both traditional shark liver oil extraction and more sustainable plant-based or biosynthetic methods, aligning with regulatory and consumer expectations for ethical and environmentally responsible practices.

Among the key manufacturers, Amyris, Inc. stands out for its pioneering work in producing bio-based squalene via fermentation using genetically engineered yeast. Their approach bypasses the need for animal-derived raw materials, positioning Amyris as a leader in sustainable squalene supply for pharmaceutical applications, including vaccine adjuvants. In 2025, Amyris continues to expand its production capacity to meet global demand, supporting the shift towards cruelty-free and eco-friendly vaccine components.

On the marine-based side, EKRA in France remains a significant supplier of shark-derived squalene for pharmaceutical uses. However, the company is also involved in the ongoing dialogue regarding sustainable fishing and traceability, as regulatory scrutiny over marine biodiversity intensifies. EKRA is investing in certification and supply chain transparency to ensure compliance with evolving European and international standards.

In Asia, Kyowa Hakko Bio Co., Ltd. leverages advanced purification processes to deliver high-purity squalene suitable for pharmaceutical adjuvants. Their product portfolio includes both shark-derived and plant-based squalene, catering to diverse market needs and regulatory landscapes, particularly in Japan and the broader Asia-Pacific region.

European market demand for non-animal squalene has prompted companies like Alfa Chemicals to distribute olive-derived squalene, positioning themselves as suppliers to pharmaceutical manufacturers seeking plant-based adjuvant ingredients. This aligns with increasing commitments by European vaccine producers to phase out animal-derived excipients.

Looking forward, strategic collaborations and investments are expected to accelerate the adoption of alternative squalene sources. For example, Croda International Plc, a major supplier to the pharmaceutical sector, has invested in scaling up plant-based squalene production and is working with vaccine manufacturers to integrate these ingredients into next-generation adjuvant systems.

Overall, industry leaders are responding to market and regulatory pressures by diversifying their extraction technologies and supply chains. The period from 2025 onward is likely to witness further innovation in biosynthetic and plant-based squalene, with major players setting benchmarks for quality, sustainability, and transparency in pharmaceutical adjuvant supply.

Supply Chain Dynamics: Sourcing, Sustainability, and Traceability

Squalene, a triterpene hydrocarbon traditionally sourced from shark liver oil, plays a pivotal role as an adjuvant ingredient in pharmaceutical vaccines, notably in formulations such as MF59 and AS03. The supply chain for squalene extraction and refinement is evolving rapidly in 2025, driven by growing pharmaceutical demand, sustainability imperatives, and regulatory scrutiny on traceability.

Historically, the majority of squalene used in vaccine adjuvants was derived from deep-sea shark liver oil, as sharks contain high concentrations of this compound. However, concerns about marine ecosystem impact and declining shark populations have led to increased regulatory and industry pressure for alternative sources and transparent supply chains. Pharmaceutical companies such as GSK and Sanofi, major users of squalene adjuvants, have publicly committed to sourcing squalene from traceable and more sustainable origins.

In 2025, the sector has seen a marked shift toward plant-based squalene extraction, primarily from olive oil byproducts and amaranth seed, as well as advances in microbial fermentation. Companies such as Arbee BioMarine continue to offer pharmaceutical-grade shark-derived squalene, but the market share for plant-based suppliers like Ekiz Olive Oil is steadily increasing. Additionally, firms like Amyris are scaling up fermentation-based squalene, which offers full traceability, batch consistency, and avoids animal sourcing altogether.

Traceability is becoming an industry standard, particularly following increased scrutiny from regulatory bodies in Europe and North America. The European Medicines Agency and the U.S. Food and Drug Administration now require detailed documentation for the origin and processing of squalene used in pharmaceutical applications. Supply chain digitalization—using blockchain and advanced batch tracking—has been implemented by leading suppliers to guarantee origin and processing transparency. For example, SOPHIM has adopted blockchain-based traceability solutions for its entire squalene line, offering real-time verification to pharmaceutical partners.

Sustainability certifications, such as those provided by the Friend of the Sea program, are increasingly required by buyers. This is prompting even traditional suppliers to obtain third-party validation for their sourcing and environmental impact. Looking ahead, the pharmaceutical industry is expected to further decouple from animal-based sources, with plant and fermentation-derived squalene projected to dominate the market by 2027, in line with environmental and ethical considerations.

Competitive Analysis: Squalene from Plant vs. Animal Sources

Squalene, a triterpene hydrocarbon, remains an essential ingredient in pharmaceutical adjuvants, most notably in vaccine formulations such as MF59. As of 2025, the competitive landscape for squalene extraction is increasingly defined by the dichotomy between traditional animal-derived sources—primarily shark liver oil—and sustainable plant-based alternatives like olive oil and sugarcane fermentation.

Historically, deep-sea shark liver oil was the predominant commercial source of squalene, owing to its high concentration (up to 80% in some species). However, growing ethical, regulatory, and sustainability pressures have accelerated the shift toward plant-based squalene. Major pharmaceutical companies and ingredient suppliers have responded by investing in alternative extraction and synthesis methods. For instance, Amryta Group and Oliveda International are actively promoting high-purity squalene produced from olives, with their processes optimized for pharmaceutical-grade standards.

A significant technological milestone in recent years is the rise of sugarcane-derived squalene through fermentation. Companies like Avantium and Amyris, Inc. have scaled up biotechnological fermentation using genetically engineered yeast to convert sugarcane feedstock into squalene with purity levels that meet or exceed those from animal sources. This method not only ensures a consistent and controlled supply but also aligns with the sustainability mandates of leading vaccine manufacturers.

In 2025, regulatory trends further reinforce the competitive advantage of plant-based squalene. The European Medicines Agency and U.S. Food and Drug Administration now require full traceability and sustainability documentation for adjuvant ingredients, prompting many pharmaceutical firms to favor non-animal sources. For example, GSK has increased its procurement of plant-derived squalene for adjuvant production, citing both supply security and alignment with corporate environmental goals.

• Cost and Scale: While shark-derived squalene remains less expensive at large scale due to established supply chains, the price gap is narrowing as fermentation-based processes become more efficient. Industrial innovation and expanded fermentation capacity are expected to further reduce costs over the next few years.
• Supply Stability: Plant and microbial sources offer improved supply reliability, less exposure to overfishing and regulatory bans, and scalability to meet pandemic demand surges.
• Market Outlook: With global vaccine manufacturers committing to ethical sourcing and investors prioritizing ESG (environmental, social, and governance) metrics, plant-based and biosynthetic squalene suppliers are projected to gain a greater share of the pharmaceutical adjuvant market through 2027.

In summary, competitive dynamics in squalene extraction for pharmaceutical adjuvants in 2025 and beyond are increasingly shaped by technological innovation, regulatory shifts, and the pharmaceutical industry’s commitment to sustainable sourcing. Companies leveraging advanced plant or microbial technologies are poised for significant growth as the industry phases out reliance on animal-derived squalene.

Investment Opportunities and Partnership Trends

The landscape for investment and partnerships in squalene extraction, particularly for pharmaceutical adjuvants, is undergoing significant evolution in 2025. This shift is fueled by rising global vaccine demand, increased attention to sustainable sourcing, and the pharmaceutical industry’s commitment to safe, effective adjuvant systems. Squalene, a triterpene commonly used in vaccine adjuvants, has traditionally been sourced from shark liver oil. However, environmental concerns and regulatory pressures have accelerated investment in plant-based and fermentation-derived alternatives.

Leading pharmaceutical companies and ingredient suppliers are actively investing in new extraction technologies and forging strategic alliances to secure sustainable squalene supplies. For example, Croda International Plc has developed plant-derived squalene, positioning itself as a key supplier to vaccine manufacturers seeking alternatives to animal-based sources. In 2023-2025, Croda expanded its partnerships with global vaccine developers to meet the growing demand for sustainable adjuvants, supporting both existing and pipeline vaccines.

Similarly, Arbee Biosciences is leveraging biotechnology to produce squalene via fermentation, reducing reliance on traditional extraction methods. The company’s 2024 partnership with a major European vaccine producer highlights the trend of integrating biotechnology-driven squalene into mainstream pharmaceutical supply chains. This shift not only addresses supply chain resilience but also aligns with regulatory and consumer expectations for ethical sourcing.

Investors are closely monitoring these trends, with venture capital and private equity funding flowing into companies developing novel squalene extraction processes. In 2025, investment focus is particularly strong on scalable, non-animal sources, with several start-ups entering pilot and commercial-scale production phases. Global players such as Amyris, Inc. (a pioneer in fermentation-based squalene) have attracted strategic investments and collaborations with both pharmaceutical manufacturers and government agencies to secure long-term supply agreements.

Looking ahead, the next few years are expected to see further consolidation and partnership-building in the sector. Larger pharmaceutical companies are likely to seek backward integration or exclusive supply agreements with squalene producers to ensure uninterrupted access to high-quality, traceable material. Additionally, sustainability certifications and transparent sourcing are set to become key differentiators in partnership negotiations.

Overall, the investment and partnership dynamics in squalene extraction for pharmaceutical adjuvants are characterized by a decisive pivot towards sustainability, scalability, and supply chain security, positioning the sector for robust growth and innovation through 2025 and beyond.

Future Outlook: Emerging Applications and Long-Term Growth Potential

The landscape of squalene extraction for pharmaceutical adjuvants is poised for significant evolution in 2025 and the years immediately ahead, driven by advances in sustainable sourcing, regulatory developments, and biotechnological innovation. Squalene, a natural triterpene, has been a critical ingredient in vaccine adjuvants—most notably in MF59 and AS03 formulations utilized in influenza and COVID-19 vaccines. Traditionally, squalene has been sourced from shark liver oil, but growing environmental and ethical concerns are accelerating a shift toward alternative, plant-based, and microbial production platforms.

Current industry leaders are intensifying efforts to scale sustainable squalene extraction. Avantium and Amyris are pioneering bio-based squalene production using yeast fermentation, offering a scalable and eco-friendly substitute to shark-derived squalene. In 2024, Amyris announced advancements in commercializing fermentation-derived squalene, aligning with the pharmaceutical industry’s growing preference for animal-free ingredients. Several manufacturers, such as Oleon, have expanded their portfolios to include vegetable-based squalene extracted from olives and amaranth, further diversifying supply chains and reducing environmental pressure on marine ecosystems.

Looking ahead, regulatory agencies are increasingly recognizing the importance of sustainable sourcing in pharmaceutical supply chains. The European Medicines Agency and the U.S. Food and Drug Administration are expected to further clarify guidelines on squalene sourcing for vaccine adjuvants, potentially accelerating adoption of bio-based products. Additionally, collaborative industry initiatives such as those led by GSK and Seqirus—major producers of squalene-adjuvanted vaccines—are driving transparency and traceability, setting new benchmarks for responsible sourcing.

• Emerging Applications: Beyond vaccines, research is intensifying into squalene’s immunomodulatory properties for novel drug delivery systems and therapeutics in oncology, autoimmune, and allergy treatments. These expanding applications could substantially increase demand for pharmaceutical-grade squalene.
• Production Scale and Supply Security: The adoption of fermentation-based squalene promises greater scalability and reliability, less susceptible to marine supply fluctuations or regulatory restrictions on shark harvesting.
• Market Outlook: With the global vaccine market expected to maintain high growth post-pandemic, industry participants like GSK, Seqirus, and biotechnology suppliers are investing in capacity expansion and innovation. These investments are anticipated to drive down production costs and increase global accessibility.

In summary, the future for squalene extraction in pharmaceutical adjuvants is characterized by rapid technological shifts, an expanding array of medical applications, and a decisive move toward sustainable, ethically sourced ingredients. Over the next several years, these trends are expected to redefine industry standards and position bio-based squalene as the preferred choice for pharmaceutical developers worldwide.

Sources & References

• Amyris, Inc.
• Kishimoto Special Liver Oil Co., Ltd.
• GlaxoSmithKline plc (GSK)
• Seqirus
• Olive Oils from Spain
• Croda International Plc
• A.S.P. Inc.
• European Medicines Agency
• World Health Organization
• Kyowa Hakko Bio Co., Ltd.
• Alfa Chemicals
• SOPHIM
• Oleon