Key Insights• According to the research report, "Italy EPA & DHA Market Outlook, 2031," published by Actual Market Research, the Italy EPA & DHA Market is expected to reach a market size of more than USD 103.26 Million by 2031. The Italian EPA & DHA market is steadily expanding as the country faces the most advanced demographic aging profile in the European Union and a substantial burden of circulatory disease, supported by Europe's largest food supplement market. According to ISTAT, Italy's resident population stood at approximately 58.9 million on January 1, 2026, with people aged 65 and older numbering 14.8 million, or 25.1% of the population, and the mean age reaching 47.1 years, making Italy the oldest country in the EU. ISTAT data show that diseases of the circulatory system caused 206,119 deaths in 2023, roughly 31% of the 666,131 deaths recorded that year, representing 33% of female deaths and 28% of male deaths. Italy recorded approximately 355,000 births in 2025, down 3.9% from 2024. The growing clinical burden is placing additional pressure on the National Health Service (Servizio Sanitario Nazionale, SSN) and the consumer health sector to strengthen access to EPA and DHA through supplements, prescription omega-3 medicines, infant nutrition, and clinical nutrition.• Italy's EPA & DHA market is characterized by a highly developed pharmacy-centered ecosystem comprising Italian pharmaceutical companies, supplement laboratories, multinational consumer health groups, infant nutrition producers, and a large pet care industry. Italy is the largest food supplement market in Europe, accounting for around 26% of European revenue, ahead of Germany at 19% and France at 15%.

The Italian supplement market was valued at about EUR 5 billion in 2025 and is estimated to reach EUR 5.4 billion in 2026, with more than 30 million Italians having taken at least one supplement in the past 12 months and over 200 million packs sold annually in pharmacies. Italy also has a long tradition of prescription omega-3 medicines, and is home to Recordati, which in June 2025 signed an exclusive license and supply agreement with Amarin to commercialize Vazkepa (icosapent ethyl) across 59 countries focused on Europe. In infant nutrition, Kraft Heinz agreed in July 2025 to sell its Italian baby and specialty food business, including the Plasmon brand, to NewPrinces Group.• Regulatory oversight for EPA and DHA products in Italy is shaped by European Union legislation implemented through national rules administered by the Ministry of Health. Food supplements are regulated under Directive 2002/46/EC, transposed through Legislative Decree No. 169/2004, and must be notified to the Ministry of Health before marketing, after which they are included in the Ministry's public register of notified supplements. The Ministry also publishes guidelines on the use of specific nutrients and substances, including omega-3 fatty acids, in supplements. Health claims are governed by Regulation (EC) No. 1924/2006 and Regulation (EU) No. 432/2012, infant formula must contain DHA under Delegated Regulation (EU) 2016/127, and prescription omega-3 medicines are authorized by the Italian Medicines Agency (AIFA), which also determines reimbursement through the SSN.

The Italian EPA & DHA market is supplied through a mix of imported refined oils and domestic encapsulation, formulation, and pharmaceutical manufacturing capacity.Market Outlook• A defining characteristic of Italy's EPA & DHA market is the central role of the pharmacy and the close integration between supplements and medical recommendation. Italian physicians, cardiologists, and pharmacists frequently recommend omega-3 for cardiovascular, cognitive, eye, and joint health, while Italian laboratories offer a wide range of high-concentration fish oils, krill oil, and combination products. The prescription segment is also gaining momentum. Amarin identified Italy as a key market for Vazkepa in its fourth-quarter 2025 results, and Recordati, headquartered in Milan, now leads the product's commercialization across Europe, with the first milestone payment to Amarin tied to Recordati reaching USD 100 million in annual net sales. Recordati's established relationships with cardiologists and its European commercial network are expected to accelerate the uptake of prescription EPA for cardiovascular risk reduction in Italy and neighboring markets.• The market also reflects Italy's growing emphasis on healthy aging and chronic disease prevention. With more than one in four Italians aged 65 or older and the mean age at 47.1 years, demand for products that support cardiovascular and cognitive health is expected to remain robust.

The Mediterranean diet, which includes fish consumption, provides a supportive cultural backdrop for omega-3 messaging, although intake of oily fish varies widely across regions and age groups. In infant nutrition, births fell to approximately 355,000 in 2025, constraining formula volumes, while the mandatory DHA requirement ensures stable demand for high-purity fish and algal DHA among formula producers. The change in ownership of Plasmon, one of Italy's leading baby food brands, is expected to reshape competitive dynamics in the domestic infant nutrition segment.Market DynamicsDriver: Europe's oldest population and high circulatory disease burden supported by the largest supplement marketItaly's EPA & DHA market is primarily driven by demographic aging and the high prevalence of circulatory disease. People aged 65 and older numbered 14.8 million, or 25.1% of the population, on January 1, 2026, according to ISTAT. Diseases of the circulatory system caused 206,119 deaths in 2023, the leading cause of death among women. Italy's supplement culture is the strongest in Europe, with more than 30 million Italians using supplements and over 200 million packs sold annually through pharmacies.

EU-authorized health claims enable EPA and DHA products to communicate benefits for normal heart function, blood triglyceride levels, and, for DHA, normal brain function and vision. Prescription omega-3 medicines also have a long-established role in Italy for hypertriglyceridemia and cardiovascular risk management. As awareness of prevention and healthy aging continues to grow, pharmacies are witnessing sustained demand for high-quality EPA and DHA products.Challenge: Reimbursement constraints, raw material volatility, and regulatory scrutinyOne of the principal challenges facing Italy's EPA & DHA market is the constrained reimbursement environment for prescription omega-3 medicines, with AIFA applying specific prescribing criteria and regional health authorities managing pharmaceutical budgets tightly. At the same time, raw material costs remain volatile. Peru's first 2026 north-central anchovy quota was set at 1,914,049 tonnes, approximately 36% lower than in 2025, following a coastal El Niño event, while the Antarctic krill fishery closed early on August 1, 2025, and again on August 12, 2026. Additionally, the Ministry of Health's notification system and guidelines on permitted ingredients and levels require continuous regulatory monitoring, and the absence of harmonized EU maximum levels for EPA and DHA creates divergence between national approaches.

Declining births are also reducing the addressable market for infant formula. Together, these factors require continuous investment in compliance, scientific substantiation, and supply chain resilience.Trend: Expansion of prescription EPA, premium formats, and algal omega-3Italy is experiencing a significant shift toward evidence-based and premium omega-3 solutions supported by the expansion of prescription EPA and consumer interest in purity and sustainability. Recordati's commercialization of Vazkepa from 2025 is expected to strengthen cardiologist engagement with high-purity EPA. In the supplement segment, Italian laboratories are expanding high-concentration triglyceride oils, liquid omega-3s, and combination products for cognitive and eye health, while algal DHA is gaining traction in prenatal and vegetarian ranges, supported by ingredient innovation such as dsm-firmenich's life'sDHA B54-0100, launched in October 2024 with 545 mg DHA and 80 mg EPA per gram. The continued expansion of EU-authorized algal oils, including Schizochytrium sp. (CABIO-A-2) oil authorized in July 2024, is broadening supply options. The growth of online pharmacies and e-commerce is also expanding consumer access to specialty formats.Policies• Food Supplement Notification (Legislative Decree No. 169/2004): Food supplements containing EPA and DHA are regulated under Directive 2002/46/EC and Legislative Decree No. 169/2004.

Products must be notified to the Ministry of Health before marketing and are included in the Ministry's public register of notified supplements, with labelling and composition subject to national guidelines.• Ministry of Health Guidelines on Nutrients and Substances: The Ministry of Health publishes guidelines on the use of nutrients and other substances in food supplements, including omega-3 fatty acids, specifying conditions of use and labelling recommendations that inform product formulation and enforcement.• EU Nutrition and Health Claims Regulation: Health claims for EPA and DHA are governed by Regulation (EC) No. 1924/2006 and Regulation (EU) No. 432/2012, authorizing claims for normal heart function, blood triglyceride levels, blood pressure, and DHA contributions to normal brain function, vision, and maternal and infant development.• Infant Formula DHA Requirement: Under Delegated Regulation (EU) 2016/127, infant formula and follow-on formula must contain DHA at 20–50 mg per 100 kcal, ensuring stable demand for high-purity fish and algal DHA.• AIFA Medicine Authorization and Reimbursement: Prescription omega-3 medicines are authorized at the EU level through the European Medicines Agency or nationally by AIFA, which determines pricing, reimbursement class, and prescribing conditions within the SSN, influencing access to prescription EPA and omega-3-acid ethyl esters.Segment AnalysisItaly EPA & DHA Market By Product Type• Docosahexaenoic Acid (DHA) maintains an important position within Italy, particularly in infant formula, prenatal supplements, and cognitive and eye health products for seniors. DHA is mandatory in infant formula, and algal DHA is increasingly used in prenatal ranges.• Eicosapentaenoic Acid (EPA) represents the fastest-growing product type segment in Italy, driven by Recordati's commercialization of Vazkepa from 2025 and increasing interest in high-EPA concentrates for cardiovascular health and inflammation-related wellness.Italy EPA & DHA Market By Source• Fish Oil represents the leading revenue-generating source category in Italy due to its cost-effectiveness, use in prescription omega-3 medicines, and broad consumer familiarity.• Algae Oil represents the fastest-growing source category in Italy, driven by infant formula use, prenatal supplements, and demand for sustainable and contaminant-free omega-3.• Krill Oil is a premium source category positioned for absorption and smaller capsule size, sold primarily through pharmacies and online channels.• Other Marine Sources hold a niche position in the Italian market, including cod liver oil, salmon oil, and calamari oil, primarily used in specialty supplements and pet nutrition.Italy EPA & DHA Market By Application• Dietary Supplements represent the largest application segment in Italy, within Europe's largest supplement market, valued at about EUR 5 billion in 2025, distributed primarily through pharmacies, parapharmacies, and online channels.• Pharmaceuticals represent a significant application segment in Italy, reflecting the country's long tradition of prescription omega-3 medicines and the expansion of prescription EPA under Recordati from 2025.• Infant Formula represents a strategically important application segment, with DHA mandatory in all infant and follow-on formulas. Births fell to approximately 355,000 in 2025, constraining volumes.• Food & Beverages encompasses omega-3-enriched dairy, eggs, bread, and functional foods, with growth supported by healthy aging and Mediterranean diet positioning.• Clinical Nutrition & Medical Foods includes fish oil-based lipid emulsions for parenteral nutrition and enteral formulas used in hospitals and home care for elderly and critically ill patients.• Pet Nutrition represents the fastest-growing application segment in Italy, supported by a pet care market of EUR 5.3 billion in 2025, of which dog and cat food accounted for EUR 4.2 billion, and a pet population including 11 million cats and 9.1 million dogs, according to Assalco and Zoomark.Major EPA & DHA Manufacturers Operating in Italy• Recordati, Amarin, SPA (Società Prodotti Antibiotici), Pierre Fabre, Menarini, Angelini, Named, dsm-firmenich, KD Pharma Group, NewPrinces (Plasmon), Nestlé, Danone, Humana Italia, and Aker BioMarine are leading players in the Italian EPA & DHA market, offering prescription omega-3 medicines, finished supplements, DHA-fortified infant formula, and refined omega-3 ingredients. Recordati signed an exclusive license and supply agreement with Amarin for Vazkepa in Europe in June 2025. Their strong presence, pharmacy partnerships, medical promotion networks, and scientific support programs have driven adoption across the Italian market.• The market is also supported by contract manufacturers, private-label producers, ingredient distributors, and testing laboratories that provide formulation, encapsulation, and quality assurance support. With Europe's largest supplement market and strong pharmaceutical capabilities, Italy remains a leading European market for omega-3.Italy EPA & DHA Supply and Pricing Economics• EPA and DHA products in Italy represent value-added nutritional and pharmaceutical products whose pricing depends on source, concentration, chemical form, certification, and channel.

Pricing varies considerably between pharmacy supplements, prescription medicines, krill oil, and algal oil.• Refined fish oil prices normalized by late 2024 after the El Niño-related disruption, according to GOED, but the reduced 2026 Peruvian anchovy quota is expected to place renewed upward pressure on raw material prices.• Supplements are paid out-of-pocket, with pharmacy promotions and online pharmacies shaping consumer pricing. Prescription omega-3 medicines are reimbursed by the SSN only under AIFA-defined conditions, with pricing negotiated nationally.• Algal oil and krill oil command a premium over standard fish oil, while online pharmacies are intensifying price competition for mass-market products.Market Outlook by Consumer Health Spending and Supply Infrastructure• Italy's EPA & DHA market growth is strongly linked to demographic aging, consumer health spending, and the strength of the pharmacy channel, although reimbursement constraints and raw material volatility remain significant factors influencing growth.• Private consumer spending drives the supplement and pet nutrition segments, while the SSN and AIFA shape access to prescription omega-3. Recordati's leadership of Vazkepa in Europe positions Italy as a hub for prescription EPA commercialization.• The future growth opportunity for EPA and DHA in Italy depends on expanding prescription EPA access, sustaining innovation in pharmacy supplements, consumer education on cardiovascular and cognitive health, and continued growth of algal and sustainable omega-3. Greater integration of omega-3 within healthy aging programs and cardiovascular prevention will likely become key strategies for long-term market development.Global EPA & DHA MarketConsidered in this report• Historic Year: 2020• Base Year: 2025• Estimated Year: 2026• Forecast Year: 2031Aspects covered in this report• EPA & DHA Market with its value and forecast along with its segments• Various drivers and challenges• Ongoing trends and developments• Top profiled companies• Strategic recommendationsBy Product Type• Eicosapentaenoic Acid (EPA)• Docosahexaenoic Acid (DHA)By Application• Dietary Supplements• Infant Formula• Pharmaceuticals• Food & Beverages• Clinical Nutrition & Medical Foods• Pet NutritionBy Source• Fish Oil• Algae Oil• Krill Oil• Other Marine Sources.