Adam Ismail, executive director, Global Organization for EPA and DHA Omega-3s (GOED; Salt Lake City, UT), characterizes the omega-3 pharmaceuticals market in particular as “growing overall,” pointing out that omega-3 pharmaceuticals are “extremely effective,” with a good safety profile.
As physicians learn more about these products, Ismail asserts, the drugs’ efficacy and safety provide a strong incentive for practitioners to prescribe them to their patients. He points to GlaxoSmithKline’s Lovaza, Amarin Pharma’s Vascepa, and Trygg Pharma’s OmTryg as leading examples of omega-3 drugs marketed and prescribed for treating hypertriglyceridemia, and says that additional high-concentrate omega-3 pharmaceuticals will continue coming to market.
“There are more than 50 R&D projects in the pipeline containing high-EPA and -DHA concentrates,” he says. He predicts the demand for omega-3 pharmaceuticals will grow and grow—“even if none of those current 50-plus R&D targets reaches the market.”
Likewise, high-concentrate fish oils and high-purity krill oils will continue to increase in popularity with supplement manufacturers, predict the GOED leadership and those who supply the oils, as supplement consumers learn more about high concentrates and demand increased convenience and higher omega-3 dosages.
“The drive toward convenience means we are seeing many more supplement products utilizing high concentrates to deliver smaller pill sizes, and there are also a number of loyal consumers who want to upgrade their usage and start to see and feel differences they attribute to the omega-3s, or learn more about the science,” Ismail explains. Those consumers who are just beginning supplementation with omega-3s, the “entry-level consumers,” don’t typically purchase high-concentrate omega-3 products, he adds, so the potential for the high-concentrate omega-3 supplement market to grow is dependent on existing omega-3 consumers becoming more educated and sophisticated regarding omega-3s and their benefits.
First Things First: Defining High-Concentrate Omega-3 Fish Oil
The generally agreed-on definition of a high-concentrate omega-3 fish oil is also supported by the Codex Alimentarius Commission’s current draft fish-oil standard: Highly concentrated fish oils contain greater than 50% w/w fatty acids as a sum of EPA and DHA. Additionally, highly concentrated fish-oil ethyl esters (the result of processing and refining raw fish oils) are defined by the draft standard as greater than 60% w/w fatty acids as a sum of EPA and DHA.
Commercially available examples of high-concentrate omega-3 oil include products in Organic Technologies’ (Coshocton, OH) AlaskOmega line, which AlaskOmega Ingredients’ global director, Steve Dillingham, says are up to 80%–85% omega-3. “At the highest end of our omega-3 concentrate spectrum,” Dillingham explains, “we produce an 800 mg/g EPA concentrate, a 600 mg/g EPA and 200 mg/g DHA concentrate, and a 570 mg/g EPA and 230 mg/g DHA concentrate.” These concentrated oils are all in ethyl ester form, he adds. In triglyceride form, AlaskOmega offers a 530 mg/g EPA and 200 mg/g DHA concentrate, “with other high-triglyceride concentrates currently in the pipeline,” Dillingham says.
Epax Omega-3, a division of FMC Health and Nutrition (Sandvika, Norway), offers a Core Concentrates high-concentrate omega-3 line, which consists of products containing a minimum of 500 mg/g and a maximum 699 mg/g combined EPA and DHA, and an Ultra Concentrates line whose products contain a minimum of 700 mg/g combined EPA and DHA.
“We do not consider anything less than 500 mg/g EPA and DHA high concentrate,” states Epax Omega-3 associate products manager, FMC Health and Nutrition, Sarah Christianslund.
Safe, Effective, and Gaining in Popularity: High-Concentrate Omega-3s in Pharmaceuticals
Drugs containing therapeutic levels of high-concentrate omega-3 fatty acids have been commercially available in the United States for about a decade. Lovaza, a high-concentrate omega-3 drug for which BASF (Florham Park, NJ) supplies the active ingredient, came to market in the United States in 2005 for treatment of hypertriglyceridemia. BASF is “clearly focused on the high-concentrate omega-3 market in both pharmaceuticals and dietary supplements,” says the company’s Andres-Christian Orthofer, global communications nutrition & health pharma ingredients & services, omega-3s.
“The usual pharmaceutical market dynamics [including competition from generics] impacted Lovaza, but at a lower pace than normally experienced on the market,” Orthofer says. “Nevertheless, driven by generics, we expect the total U.S. market for omega-3 pharmaceuticals to further expand. Currently we see a strong interest in the market, especially from generic players and originators, with a need for next-generation products. This will further drive awareness of the health benefits of omega-3 fatty acids among consumers.”
He adds, “BASF will continue to further shape the global and U.S. markets with our unique knowledge, expertise, and capabilities as a pioneer and leader in pharmaceutical application of omega-3s.”
AlaskOmega’s Dillingham takes a similar view to Orthofer, pointing out that the “major success of Lovaza and Omacor [Lovaza’s brand name outside of the United States] shows the significant market potential for these types of products.”
Dillingham believes that further differentiation in the omega-3 drug space will bode well for further market expansion. “As more and more omega-3 drug candidates come on line,” he says, “the general population will become increasingly aware of the science supporting higher omega-3 dosing for certain health benefits,” which will, presumably, drive demand.
BASF’s Orthofer predicts that differentiation in this market will focus on the “purity” of the omega-3s (i.e., the absence of environmental pollutants).
Not Just for Pharma: High-Concentrate Omega-3s in Supplements
GOED’s Ismail describes the supplement market for high-concentrate omega-3s as having “lots of potential,” in part because “the drive toward convenience means we are seeing many more products utilizing high concentrates to deliver smaller pill sizes,” he says. Likewise, FMC’s Christianslund agrees that high concentrates are “definitely not limited to pharmaceuticals.” She asserts her company’s Epax oils were first to market with high concentrates intended for dietary and food supplements back in the late 1980s, “enabling brand owners to promote omega-3 as a condition-specific supplement through a range of various scientifically proven EPA/DHA ratios and concentrations,” and this application remains relevant.
BASF’s Orthofer points to a “strong underlying trend” toward using higher concentrates in the nutritional supplements market, “particularly in North America, as consumers stepwise become more educated about the benefits of these oils.” He lists “the convenience needs of consumers, an increasing need for solutions to health-specific conditions, and innovative health concepts to differentiate from competition” as the main drivers of this trend.
Supplement manufacturers who purchase AlaskOmega’s high omega-3 concentrates, for instance, are typically looking to stand out in the market through innovation and product differentiation by “delivering a clinically relevant dosage of omega-3 in a smaller capsule size,” Dillingham says. The supplier’s supplement-manufacturer customers are also, in some cases, looking to formulate multiple-ingredient combination products without sacrificing omega-3 potency. “These manufacturers, in turn, are serving an omega-3 consumer base which values ease of use and being able to reduce overall capsule count in their daily supplement regime,” Dillingham says, echoing comments from his industry peers about consumer convenience.
Onward and Upward for High-Concentrate Omega-3s
Industry consensus is that highly concentrated omega-3 oils will continue to grow in demand for both the pharmaceutical and supplement markets.
“As a drug,” BASF’s Orthofer points out, “omega-3 is a well-established treatment for hypertriglyceridemia. Furthermore,” he adds, “the strong growth of lifestyle-related diseases also increases the need for new and affordable treatments with products like omega-3 in all life stages. There is strong clinical evidence for the benefits of omega-3 fats on the cardiovascular system. However, studies indicate that omega-3s have additional beneficial health effects on the brain, the eyes, and the nervous system.” Indeed, in Europe, the EU Register on Nutrition and Health Claims permits food and supplement labeling related to omega-3 fatty acids’ contributions to the maintenance of normal blood pressure, brain function, vision, and heart function, among others.1
BASF, for one, is “significantly investing” in research to further explore and prove the benefits of omega-3 for the human body,” Orthofer concludes, and it appears likely that others will follow its lead.
Krill-Oil Suppliers Have Their Say
The oil contained in krill, an ocean-dwelling crustacean, provides another source of omega-3 fatty acids, and it has recently been touted by those marketing it within the supplements industry as a more bioavailable source of these acids. (According to a 2014 editorial in the journal Lipids in Health and Disease2, this bioavailability claim has yet to be fully substantiated.)
Tina Sampalis, medical science liaison for Neptune Technologies & Bioressources (Laval, QC, Canada), a supplier of krill oil, describes the advantages of the product this way: “Krill oil is concentrated by increasing its purity by removing triglycerides and other less beneficial elements from the crude oil, leaving the bioactive ingredients unaltered in their natural state. High-concentrate krill oil is composed of natural and highly bioavailable omega-3 phospholipids.” Sampalis’s opinion is that fish oil–derived omega-3 ethyl esters “have reached their plateau,” and that the market is “now ready for more innovative, dose-friendly, and better absorbed products” derived from krill oil. “The future looks bright for concentrated krill oils that offer the combined benefits of highly absorbed omega-3 phospholipids and antioxidants,” she concludes.
Similarly, Enzymotec’s (Migdal HaEmeq, Israel) Volkan Eren asserts his company’s K-REAL high-potency krill-oil products consist of a “unique and sophisticated profile that reaches higher levels of phospholipids, EPA, DHA, and astaxanthin” than standard krill oil, “all in an easy-to-consume small softgel size.”
Krill-oil–based prescription-drug update: Pharmaceutical firm Acasti, which has an exclusive license from Neptune Technologies & Bioressources to develop pharmaceutical products customized to manage cardiovascular disease, continues to develop drug candidate CaPre for the prevention and treatment of cardiometabolic disorders, including hypertriglyceridemia. According to documents published on Acasti’s website, Acasti has successfully completed two Phase II clinical trials designed to evaluate the safety and efficacy of its drug candidate for the management of hypertriglyceridemia, and it has also successfully completed a pharmacokinetic trial evaluating the bioavailability and safety of CaPre on healthy individuals taking single and multiple daily oral doses of the product.3
- EU Register on Nutrition and Health Claims. Via the Europa portal at ec.europa.eu/nuhclaims/?event=getLatestVersionOfRegister. Accessed on July 28, 2015.
- Salem N Jr. et al., “A reexamination of krill oil bioavailability studies.” Lipids in Health and Disease. Published online August on 26, 2014.
- “Clinical Trials Strategy.” Acasti’s Research & Innovation Web pages www.acastipharma.com/en/research-innovation/clinical-trials-strategy. Accessed on July 28, 2015.