|News> Articles > Brain Health: Unlocking White Space Potential for the OTC Industry|
As of 2014, in the United States Alzheimer's disease kills more people each year than a combination of people who die due to prostate cancer and breast cancer. More than 99.0% of Alzheimer’s drugs tested in clinical trials have failed. Despite an abundance of scientific research, there is no cure for Alzheimer’s disease. Scientists and researchers continue to work on multiple in an effort to make a breakthrough. The only progress made so far is with the FDA approving five prescription drugs to treat different levels of Alzheimer’s disease.
|Table 3: FDA Approved Medications for Alzheimer’s Disease in the United States|
|Drug name||Brand name||Manufacturer||Approved for||FDA approved year|
|Galantamine||Razadyne||Johnson & Johnson||Mild to moderate||2001|
|Memantine||Namenda||Allergan||Moderate to severe||2003|
|Donepezil and memantine||Namzaric||Allergan and Adamas Pharmaceuticals||Moderate to severe||2014|
According to a study published in the journal Neurology(6), consumption of omega-3 fatty acids, commonly found in various types of fish, is likely to benefit individuals with a high risk potential of acquiring Alzheimer’s. Lovaza, a prescription drug marketed by GlaxoSmithKline and developed by Reliant Pharmaceuticals, is an FDA-approved drug for treating patients with high triglyceride levels. The drug is synthesized from fish body oils and is formulated using two main active pharmaceutical ingredients: EPA-ethyl ester and DHA-ethyl ester. In April 2014, Teva Pharmaceutical Industries announces the FDA approval of the generic equivalent to Lovaza in the United States. The drug is not indicated for the treatment of Alzheimer’s disease, but it is possible that such an indication could be added if the drug is found to have efficacy for Alzheimer’s treatment in clinical trials.
Two prescription drugs, solanezumab (Eli Lilly) and aducanumab (Biogen), are at the beginning of research in human trials and would require a minimum of two years to get through the approval process if they prove to be effective. Both drugs intend to clear amyloid plaque buildups from the brain in order to slow cognitive declines caused by Alzheimer’s disease. Initial results of clinical trials for both drugs were released on July 22, 2015, and indicate that solanezumab exhibits consistently better results when the drug is taken for a longer period of time while aducanumab yielded stronger efficacy with a higher dosage.
There are currently no nonprescription medications indicated for the treatment of dementia or Alzheimer’s disease; however, several vitamins and ingredients are suspected in playing a role in delaying dementia and maintaining brain health including ginseng, ginkgo biloba, omega 3s, Huperazine A, amino acids, vitamins A, C, D, and E, B vitamins, and choline.
Data on various OTC brain health market segments in the United States are shown in Table 4. The market for omega 3 is sizable, but brands in this space make mostly heart health claims. The specific brain health segment of the market, while currently small has grown over 300% in the past year. From the growth over the past year it is evident that consumers are interested in taking supplements that are labeled for “brain” or “mind” health as shown by the rapid growth of the “brain health” and “mind blends” market segments.
|Table 4: U.S. Brain Health Nutritional Supplements Sales and Growth by Segment|
|Segment||2015 Retail Sales, $ million||% Change vs prior year|
|IRI MULO sales data 52 weeks ending September 13, 2015.|
The total size of the brain health nutritional supplement market is only a fraction of the overall size of vitamin and mineral supplements category, which is valued at $6.6 billion in retail sales (IRI MULO data 52 weeks ending May 17, 2015) and grew 2.3% from the same time frame in 2014. While these sales estimates include drug, food, mass, club, and dollar stores and exclude the sizeable online and health food channels, they nevertheless help illustrate the relatively nascent nature and strong growth potential of the brain health market.
Companies market supplements that claim to enhance memory and delay age-related cognitive decline. There are several “memory supplements” with claims of being formulated using a combination of vitamins, herbs, amino acids, fats, and other nutrients. However, the two primary ingredients in these memory supplements include acetyl-l-carnitine and phosphatidylserine. Acetyl-l-carnitine is an amino acid with attested brain-boosting and anti-aging properties and is purported to improve alertness, focus, mental clarity, and mood. Studies have documented phosphatidylserine to boost memory, cognition, concentration, and learning as it normalizes the stress hormone cortisol and helps to reduce stress. Some brain health/memory enhancing supplement brands are shown in Table 5.
|Table 5: Select Supplements for Brain Health/Memory Enhancement in the United States|
|Brand name||Manufacturer||Product image||Ingredients||Claims|
|Cebria||Ever-Neuro Pharma||Lactose, glutamic acid, lysine, leucine, arginine, asparatic acid, serine, phenylalanine, valine, threonine, tyrosine, isoleucine, histidine, methionine, and tryptophan.||Formulated with a blend of neuropeptides which claim to improve connections in the brain. Company claims this brand will improve short-term memory within 30 days.|
||Formulated with patented ingredient, apoaequorin, which is a protein found in a specific species of jellyfish known as Aequorea.||Company claims this brand will improve memory within 90 days. Developed by researchers at the University of Wisconsin in Madison, WI.|
|Alpha Brain||Onnit Labs||Formulated with earth-grown ingredients including Bacopa Monniera, Cat’s claw, Huperzia Setrata, and Oat Straw||Claims to improve focus, mental drive, and memory based on the results of two clinical trials. Also claims to improve processing speed and flow state.|
|Focus Factor||Factor Nutrition Labs||Contains a range of vitamins, minerals, herbal extracts and amino acids.||Claims to support brain function and helps the brain function more efficiently.|
|Procera AVH||Procera Health||Contains three super nutrients (Acetyl-l-Carnitine, Huperzine, and Vinpocetine) to support brain and cognitive health.||Patented product developed by cognitive health pioneers; research was conducted at Brain Institute in Australia.|
|Neuro Sonic||Neuro Drinks||Controlled caffeine combined with L-Theanine, choline alphoscerate, and SerinAid, which helps controls jitters and prevent “crash” experienced with other energy drinks.||Energy drink that claims to increase alertness, sustain energy, and support mental performance.|
|SOURCE: IRI MULO sales data 52 weeks ending 9/13/15.|
Sales data and growth rates for select supplements are shown in Table 6. While these brands are small compared to other supplement/OTC brands, the rates of growth for these supplements are significant, which signals that consumers are seeking prevention options for brain health. White space opportunity clearly exists in brain health. OTC or nutritional supplements that claim to prevent dementia/memory loss and help maintain brain health will be increasingly well-received by consumers across multi generations who want to take a proactive approach to helping themselves in this important aspect of their health.
|Table 6: U.S. Sales and Growth of Select Brain Health Nutritional Supplements|
|Brand||2015 Retail sales, $ million||% Change vs prior year|
|SOURCE: IRI MULO sales data 52 weeks ending September 13, 2015.|
Since there is currently no cure for dementia, OTC marketers are advised to focus on developing and marketing preventive solutions that delay or lower the risk of the disease. Several studies have been and are being conducted in an effort to determine if certain natural and supplement ingredients are correlated to a reduction in the risk of developing Alzheimer’s disease. Details on research related to some ingredients are described in Figure 5.
Figure 5: OTC and Nutritional Ingredients and their Link to Reduced Risk of Cognitive Decline |
Scientists and researchers are also in the process of developing tests to detect symptoms of Alzheimer’s disease or related dementia much before memory decline manifests itself. So far, no test can forecast the risk or determine the progression rate of the disease in a precise manner.
Americans of all generations are concerned about cognitive decline and many are adjusting diets, increasing physical activity, and challenging intellectual abilities in an effort to maintain and preserve brain health(10). While the baby boomer population may be the chief target for such products or services, OTC marketers can also effectively tap Generation X and millennials. According to the Census Bureau data analysis, millennials are likely to surpass baby boomers as the largest generation alive by 2028.
Successful marketers will integrate digital media and mobile applications to effectively engage with consumers of all ages by helping them live healthy lifestyles and support their brain health. For example, a brand could offer an app that integrates content about brain health, a cognitive memory game, monitors risk factors like stress and fitness, and information about their product offering. Currently there are many digital offerings addressing brain health such as Fit Brains by Rosetta Stone, shown in Figure 6, CogniFit Brain Fitness app, and InteraXon’s Muse Brain Sensing Headband, but few, if any, are integrated with treatment options.
Figure 6: Digital Brain Health: Fit Brains by Rosetta Stone|
Conclusions and recommendations
There is significant upside market potential in the area of brain health, which remains a largely untapped OTC market with meaningful treatment gaps even in the prescription market as well. Opportunities exist for OTC products that are specifically marketed to preserve, support, and maintain brain health. Many consumers are eager to maintain their own brain health and prevent or delay the onset of dementia or Alzheimer’s disease.
Companies that educate consumers on product ingredients, efficacy, and safety can benefit from this burgeoning category. The most successful brands in this space will make specific claims backed by solid, scientific evidence that can demonstrate tangible results. Companies whose clinical trials produce products or claims that can be patented or gain market exclusivity are likely to enjoy success, although this is not an absolute requirement for success in this category. White space opportunity exists that OTC marketers can fill in brain health because demand is critical with a high number of consumers seeking solutions which are not adequately addressed by currently available OTC or prescription drugs. OTCs/nutritional supplements can bridge the gap with products aimed at prevention of dementia/memory loss and that help maintain brain health. There is ample evidence such products will be increasingly demanded by consumers across multiple generations who want to take a proactive approach to helping themselves in this important aspect of their health.
(1) Alzheimers’ Association.
(2) www.worldlifeexpectancy.com”, WHO Publish Date, May 2014.
(3) “Alzheimer’s Disease Surging In Baltic States” (Gary Chandler), alzheimerdisease.tv, June 2015.
(4) “How chronic stress accelerates Alzheimer's disease” (Sara K. Bengtsson), Umea University, March 2013.
(5) “Depression could be separate risk factor for dementia” (research led by Rush University Medical School), Neurology, July 2014.
(6) “Eating Omega-3s May Help Reduce Alzheimer’s Risk” (researchers from Columbia University Medical Center in New York), Neurology, May 2012.
(7) “Ginkgo biloba for Prevention of Dementia: A Randomized Controlled Trial” (ST DeKosky), The Journal of the American Medical Association, November 2008.
(8) “Effects of Gingko biloba supplementation in Alzheimer's disease patients receiving cholinesterase inhibitors: data from the ICTUS study” (M Canevelli), Phytomedicine, May 2014.
(9) “Major Alzheimer's Risk Factor Linked to Red Wine Target” (researchers from the Buck Institute), The Proceedings of the National Academy of Sciences, October 2013.
(10) “Aging Americans work to keep dementia at bay with healthy eating and brain teasers”(Kelsey Dallas), NEWSOK, July 2015