Market Overview:
The Fish oil based drugs market size was valued at USD 4825 million in 2024 and is anticipated to reach USD 7690 million by 2032, at a CAGR of 6 % during the forecast period (2024-2032).
| REPORT ATTRIBUTE |
DETAILS |
| Historical Period |
2020-2023 |
| Base Year |
2024 |
| Forecast Period |
2025-2032 |
| Fish Oil Based Drugs Market Size 2024 |
USD 4825 million |
| Fish Oil Based Drugs Market, CAGR |
6% |
| Fish Oil Based Drugs Market Size 2032 |
USD 7690 million |
Key drivers fueling market growth include the rising global burden of cardiovascular diseases, increasing awareness of lifestyle-related disorders, and a growing elderly population prone to chronic health conditions. The expanding base of health-conscious consumers is driving demand for clinically validated fish oil-based pharmaceuticals over general dietary supplements. Moreover, the shift toward prescription-based omega-3 therapies—especially in the U.S., Europe, and Japan—is promoting broader adoption. Strategic collaborations, patent extensions, and reformulation efforts are enabling market players to differentiate offerings in a competitive landscape. Regulatory approvals for newer indications such as dry eye disease and nonalcoholic fatty liver disease (NAFLD) are also opening new growth avenues.
Regionally, North America dominates the fish oil-based drugs market, supported by strong R&D investments, favorable reimbursement policies, and a high prevalence of cardiovascular and metabolic diseases. The U.S. remains the largest contributor, with key players such as Amarin Corporation, AstraZeneca, Solutex GC, Aker Biomarine, and Omega Protein Corporation leading product development. Europe follows closely, driven by regulatory support and increasing physician acceptance of prescription omega-3 therapies. The Asia Pacific market is expected to witness the fastest growth rate due to rising healthcare awareness, improving access to pharmaceutical treatments, and expanding geriatric population, particularly in countries like Japan, China, and South Korea.
Market Insights:
- The fish oil-based drugs market was valued at USD 4,825 million in 2024 and is projected to reach USD 7,690 million by 2032.
- Cardiovascular diseases and metabolic disorders remain the primary drivers for increasing prescription-based omega-3 drug adoption.
- Geriatric population growth continues to expand the patient pool, especially for chronic disease management in developed and emerging markets.
- Pharmaceutical innovations such as high-purity EPA formulations and enteric-coated capsules are improving drug tolerability and adherence.
- Intense competition from OTC omega-3 supplements and generics challenges pricing power and brand retention in the market.
- North America held 41% of global revenue in 2024, with strong physician adoption and companies like Amarin and AstraZeneca leading development.
- Asia Pacific, with 18% share in 2024, is the fastest-growing region, driven by urbanization, regulatory support, and expanding healthcare access.
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Market Drivers:
Rising Prevalence of Cardiovascular and Lifestyle Diseases Fuels Prescription Demand:
The growing incidence of cardiovascular diseases, diabetes, and metabolic syndrome continues to drive the fish oil-based drugs market. Clinical evidence supports the use of omega-3 fatty acids, especially EPA and DHA, in reducing triglyceride levels and improving heart health. Physicians increasingly prescribe fish oil-derived drugs for hypertriglyceridemia and secondary prevention of cardiovascular events. Patients are shifting toward clinically approved pharmaceutical-grade options over standard dietary supplements. Regulatory authorities recognize the therapeutic value of prescription omega-3 products, which strengthens physician confidence. The fish oil-based drugs market benefits directly from this medical endorsement and increasing prescription volume.
- For instance, Amarin Corporations Vascepa (icosapent ethyl) demonstrated a 25% reduction in major adverse cardiovascular events when used alongside statin therapy in patients with elevated triglycerides, as shown in the landmark REDUCE-IT trial involving over 8,179 participants.
Growing Geriatric Population and Chronic Disease Burden Expand Market Base:
Aging populations in developed and emerging economies present a large and expanding patient pool for fish oil-based therapies. Older adults are more susceptible to chronic diseases, including cardiovascular disorders, arthritis, and cognitive decline, where omega-3 fatty acids play a therapeutic role. Healthcare providers recommend fish oil-based drugs to this demographic for their anti-inflammatory and lipid-regulating benefits. It allows pharmaceutical companies to position their products for preventive as well as therapeutic use. Improved life expectancy and focus on long-term disease management support recurring demand. The fish oil-based drugs market captures sustained value from the aging trend across multiple regions.
- For instance, the REDUCE-IT trial with Amarin’s Vascepa showed that among 8,179 statin-treated patients, the risk of death, heart attack, and stroke was reduced by 26% over placebo, with especially strong benefits seen in older patients with persistent cardiovascular risk factors.
Pharmaceutical Innovations and Reformulations Improve Drug Efficacy and Tolerability:
Innovation in drug delivery and formulation enhances the clinical appeal of fish oil-based drugs. Companies are developing high-purity EPA-only formulations and enteric-coated capsules to improve patient adherence. These innovations reduce side effects such as gastrointestinal discomfort and fishy aftertaste, making prescription omega-3s more acceptable. The fish oil-based drugs market benefits from differentiated formulations that align with regulatory and consumer expectations. Patented delivery technologies and extended product lifecycles also contribute to brand retention and profitability. It enables manufacturers to maintain market leadership amid increasing therapeutic competition.
Shifting Consumer Preferences Toward Evidence-Based and Prescribed Omega-3 Therapies:
Consumers increasingly favor evidence-based, regulated pharmaceutical options over unregulated omega-3 supplements. Rising health literacy and physician recommendations play a critical role in this shift. The fish oil-based drugs market captures this trend by offering products with standardized dosages and clinically validated outcomes. It positions prescription fish oil drugs as reliable treatment options for high-risk patients. Marketing strategies now focus on differentiating prescription drugs from over-the-counter alternatives. Regulatory approval for new indications further strengthens the value proposition for patients and physicians alike.
Market Trends:
Rising Adoption of High-Purity EPA Formulations and Single-Ingredient Therapies:
Pharmaceutical companies are focusing on high-purity EPA-based drugs to differentiate their offerings from generic and supplement-grade alternatives. Clinical trials have demonstrated that EPA-only formulations, such as icosapent ethyl, provide significant cardiovascular risk reduction beyond standard statin therapy. This has led to growing physician preference for single-ingredient prescription omega-3 drugs over mixed EPA/DHA formulations. The fish oil-based drugs market is responding with a pipeline of specialized products targeting hypertriglyceridemia and atherosclerotic cardiovascular disease. It allows companies to target niche segments while complying with regulatory expectations for safety and efficacy. Product launches with strong clinical backing are gaining traction in both primary care and specialty settings.
- For instance, Epanova (AstraZeneca), a prescription omega-3-carboxylic acid formulation, contains a high content of EPA and DHA and is approved for use at 2 to 4 capsules per day to treat severe hypertriglyceridemia, delivering up to 3–4 grams of omega-3 fatty acids daily for marked triglyceride reduction.
Expansion of Therapeutic Indications Beyond Cardiovascular Health:
Manufacturers are exploring new therapeutic indications for fish oil-derived drugs beyond lipid management. Areas such as nonalcoholic fatty liver disease (NAFLD), dry eye disease, rheumatoid arthritis, and cognitive decline are attracting investment. The fish oil-based drugs market is evolving with clinical trials aimed at validating efficacy in these chronic and underserved conditions. It opens pathways for product repurposing and lifecycle extension. Companies are pursuing regulatory approvals to expand product labels and gain access to broader patient populations. These emerging applications position fish oil-based drugs as multi-functional therapeutics across various segments of chronic care.
- For instance, a randomized controlled trial demonstrated that fish oil capsules containing 1,245 mg EPA and 540 mg DHA per day for 12 weeks resulted in significantly improved tear film break-up time (BUT) and subjective symptoms of “eye pain” compared with placebo among dry eye patients (p < 0.05)
Market Challenges Analysis:
Intense Competition from OTC Supplements and Generic Alternatives:
The availability of over-the-counter (OTC) omega-3 supplements poses a significant challenge to the prescription drug segment. Many consumers choose lower-cost dietary supplements despite their inconsistent purity and lack of clinical validation. The fish oil-based drugs market must overcome this pricing pressure by emphasizing the therapeutic value and regulatory approval of prescription-grade products. It requires sustained investment in physician education and patient awareness campaigns. Generic versions of older prescription formulations are also eroding market share for established brands. These dynamics limit pricing flexibility and reduce margins for manufacturers.
Regulatory Hurdles and Supply Chain Dependency on Marine Sources:
Securing regulatory approvals for new indications or formulations remains a lengthy and resource-intensive process. Agencies demand extensive clinical data, especially for chronic or non-cardiovascular applications. The fish oil-based drugs market also faces risk from fluctuations in fish oil supply, driven by environmental concerns, overfishing, and seasonal variation. It increases production costs and creates pressure on sourcing sustainability. Companies must invest in alternative sourcing and sustainable marine practices to mitigate long-term risks. Failure to address these concerns may impact public perception and regulatory compliance.
Market Opportunities:
Emerging Therapeutic Applications Across Chronic Disease Segments:
Expanding the clinical use of omega-3 drugs in chronic conditions beyond cardiovascular health presents strong growth potential. Pharmaceutical companies are investing in trials for diseases such as NAFLD, Alzheimer’s, depression, and inflammatory bowel disorders. The fish oil-based drugs market can leverage these therapeutic avenues to diversify revenue streams and reduce reliance on traditional indications. It enables companies to reposition existing molecules or introduce new combinations tailored to specific disease pathways. Healthcare providers are increasingly open to prescribing multi-functional agents for complex chronic care. This shift supports broader adoption of prescription omega-3 formulations in specialty practice.
Expansion in Underserved and Emerging Markets Strengthens Global Reach:
The growing middle-class population and improving healthcare infrastructure in emerging regions offer new commercial opportunities. Countries in Asia Pacific, Latin America, and the Middle East show rising demand for preventive therapies and chronic disease management. The fish oil-based drugs market can benefit by expanding distribution networks, adapting pricing strategies, and aligning with local regulatory frameworks. It allows companies to capture market share in regions where awareness is rising but access to quality omega-3 therapies remains limited. Public health programs and partnerships with local players can enhance reach and credibility. These efforts position the market for long-term global growth.
Market Segmentation Analysis:
By Source:
The fish oil-based drugs market is segmented by source into anchovy, mackerel, sardine, cod, and others. Anchovy dominates the segment due to its high oil yield and EPA/DHA concentration, supporting large-scale pharmaceutical extraction. Companies prefer anchovy for consistent supply and favorable fatty acid profile. Cod liver oil remains relevant in legacy formulations but holds a smaller share. It relies heavily on sustainable fishing practices and certified sourcing standards to maintain long-term viability. Manufacturers are also exploring alternative marine sources to ensure stability in raw material procurement.
- For instance, Mara Renewables Corporation has successfully commercialized microalgae-derived omega-3 oil, with their proprietary microalgae producing oil that represents over 60 percent of the organism’s weight, enabling large-scale production of sustainable EPA and DHA-rich oils without the use of fish.
By Indication:
The market segments by indication into hypertriglyceridemia, cardiovascular diseases, rheumatoid arthritis, and others. Hypertriglyceridemia accounts for the largest share, driven by clinical validation and physician preference for EPA-only formulations. Cardiovascular diseases remain a core segment, supported by extensive clinical trial data and guideline endorsements. It captures consistent demand due to the global burden of heart disease and growing preventive care efforts. Rheumatoid arthritis and emerging indications such as NAFLD are gaining attention, with companies pursuing new clinical programs to expand their therapeutic footprint.
- For instance, the REDUCE-IT trial (sponsored by Amarin) provided compelling evidence for guideline inclusion, enrolling more than 8,000 participants and showing significant cardiovascular risk reduction.
By Distribution Channel:
By distribution channel, the market includes hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies lead the segment due to prescription-driven demand and institutional access. Retail pharmacies maintain a strong presence, especially in regions with broad reimbursement coverage. Online channels are gaining traction with rising consumer convenience and e-prescription adoption. It benefits from increasing digitalization in healthcare and direct-to-consumer models. Distribution efficiency and regulatory compliance remain key to channel success.
Segmentations:
By Source:
- Anchovy
- Mackerel
- Sardine
- Cod
- Others
By Indication:
- Hypertriglyceridemia
- Cardiovascular Diseases
- Rheumatoid Arthritis
- Nonalcoholic Fatty Liver Disease (NAFLD)
- Others
By Distribution Channel:
- Hospital Pharmacies
- Retail Pharmacies
- Online Pharmacies
By Region:
- North America
- Europe
- Germany
- France
- U.K.
- Italy
- Spain
- Rest of Europe
- Asia Pacific
- China
- Japan
- India
- South Korea
- South-east Asia
- Rest of Asia Pacific
- Latin America
- Brazil
- Argentina
- Rest of Latin America
- Middle East & Africa
- GCC Countries
- South Africa
- Rest of the Middle East and Africa
Regional Analysis:
North America :
North America accounted for 41% of the global revenue in the fish oil-based drugs market in 2024. The U.S. contributed the majority of regional demand due to widespread use of prescription omega-3 therapies and a high prevalence of cardiovascular diseases. It benefits from strong physician adoption, advanced healthcare infrastructure, and favorable reimbursement policies. Companies such as Amarin Corporation and AstraZeneca maintain leading positions through continuous clinical innovation and product expansion. Regulatory bodies like the FDA support prescription-based omega-3 products, reinforcing physician and patient trust. Strategic marketing and patient awareness programs have solidified demand across both primary and specialty care.
Europe :
Europe represented 28% of global revenue in the fish oil-based drugs market in 2024. Countries such as Germany, the UK, France, and Italy drive demand through established cardiovascular treatment guidelines that include omega-3 prescription options. It benefits from structured reimbursement models, aging populations, and growing prevalence of chronic conditions. European regulators support clinical trials for new indications, which encourages continued investment. Prescription-based fish oil drugs are gaining preference over dietary supplements, supported by physician recommendations. Manufacturers are expanding regional operations to align with evolving healthcare policies and market needs.
Asia Pacific :
Asia Pacific accounted for 18% of global revenue in the fish oil-based drugs market in 2024 and is expected to register the highest growth through 2032. Countries such as Japan, China, South Korea, and India lead demand due to large aging populations and rising chronic disease incidence. It gains momentum from improved healthcare infrastructure, urbanization, and growing public awareness of cardiovascular health. Regulatory agencies in these countries are increasingly open to approving innovative therapies. Multinational companies are partnering with local firms to strengthen market penetration. Government health programs and preventive care initiatives further support regional expansion.
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Key Player Analysis:
- Solutex GC
- Aker Biomarine
- Omega Protein Corporation
- United Laboratories
- GC Rieber Oil
- Clover Corporation
- Croda International PLC
- Stepan Company
- Pharma Marine
- BASF SE
Competitive Analysis:
The fish oil-based drugs market features a competitive landscape led by pharmaceutical firms and specialized marine ingredient suppliers. Key players such as Solutex GC, Aker Biomarine, and Omega Protein Corporation play a central role in securing high-quality, pharmaceutical-grade omega-3 oils. It emphasizes innovation in formulation, sustainability in sourcing, and strategic partnerships with drug manufacturers to strengthen market presence. Companies focus on clinical differentiation, securing regulatory approvals for new indications, and optimizing supply chains to ensure consistent quality. Branded prescription products continue to dominate, though generic entrants and OTC supplements exert pricing pressure. Leading firms invest in expanding their therapeutic portfolios and global distribution capabilities. Competitive success depends on IP protection, product purity, and the ability to scale production while complying with stringent regulatory standards.
Recent Developments:
- In April 2024, Solutex GC announced that its facility achieved the V-Label VEGAN Certification for Omegatex® Plant-Based algae oils.
- In July 2025, The United Laboratories announced that its investigational new drug (IND) application for UBT37034 Injection, a novel treatment for overweight or obesity, was approved by the U.S. FDA.
- In March 2025, Fiserv, the parent company of Clover, launched its smart Clover point-of-sale (POS) platform in Australia, extending its global reach to 11 countries and powering 3.5 million POS devices.
Market Concentration & Characteristics:
The fish oil-based drugs market is moderately concentrated, with a few global pharmaceutical companies holding significant revenue share due to patented formulations and established brand presence. It features high entry barriers driven by stringent regulatory approvals, clinical trial requirements, and raw material sourcing constraints. Leading players focus on prescription-grade omega-3 products with proven efficacy, differentiating them from over-the-counter supplements. The market exhibits strong brand loyalty, particularly in regions with reimbursement support and physician-driven adoption. Companies invest in R&D for novel delivery formats and new therapeutic indications to sustain competitive advantage. The market structure favors firms with advanced manufacturing capabilities and global distribution networks.
Report Coverage:
The research report offers an in-depth analysis based on Source, Indication, Distribution Channel and Region. It details leading Market players, providing an overview of their business, product offerings, investments, revenue streams, and key applications. Additionally, the report includes insights into the competitive environment, SWOT analysis, current Market trends, as well as the primary drivers and constraints. Furthermore, it discusses various factors that have driven Market expansion in recent years. The report also explores Market dynamics, regulatory scenarios, and technological advancements that are shaping the industry. It assesses the impact of external factors and global economic changes on Market growth. Lastly, it provides strategic recommendations for new entrants and established companies to navigate the complexities of the Market.
Future Outlook:
- Pharmaceutical companies will pursue regulatory approvals for fish oil-based drugs in emerging indications such as NAFLD, dry eye, and cognitive disorders.
- It will integrate novel delivery systems, including nano-emulsions and sustained-release capsules, to enhance bioavailability and patient comfort.
- Manufacturers will invest in genetic markers to personalize omega-3 therapy based on individual risk profiles and metabolic response.
- Market players will seek strategic partnerships with healthcare providers to promote prescription use over dietary supplements.
- It will adopt digital health tools and remote monitoring to track patient adherence and therapeutic outcomes.
- Companies will expand into underserved regions by establishing localized manufacturing and distribution partnerships.
- It will focus on sustainable sourcing, including algae-based omega-3 and certified fish oil, to address environmental concerns and supply stability.
- Firms will differentiate their portfolio through combination therapies pairing omega-3 with lipid-lowering or anti-inflammatory agents.
- It will leverage real-world evidence and post-market studies to support coverage and reimbursement decisions by payers.
- Competitive positioning will depend on lifecycle management strategies, including reformulations, pediatric approvals, and extended-release variants.
