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Brain Health: Unlocking White Space Potential for the OTC Industry Introduction www.klinegroup.com © 2015 Kline TABLE OF CONTENTS Brain Health: The Issue ................................. Available Treatments ........................................ 2 Introduction .................................................. 1 8 Looking Ahead ............................................. 11 15 Conclusion and Recommendations ................ Currently, in the nonprescripon spectrum of the market, there are a handful of nutrional supplement brands aimed at brain health, but this area remains largely underserved by the OTC industry. There are OTC brands that make claims for heart health, joint health, and even prevenon of heart aack, so why not claims for brain health? This paper examines the current landscape of brain health and fleshes out opportunies for OTC marketers to consider. There are significant opportunies for OTC marketers in the area of brain health. This is an area of serious concern for many individuals who either have the disease or wish to avoid succumbing to it. Current prescripon drugs offer treatment for individuals with advanced levels of demena and Alzheimer’s disease, with mixed results. However, many consumers, seeing first-hand results of brain disease in elderly parents and relaves, are eager to maintain their own brain health and prevent or delay the onset of demen- a or Alzheimer’s disease.

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Page 1: IRI BRAIN HEALTH kline... · healthcare costs of their own in 2014 due to the toll of caregiving to Alzheimer’s disease patients. 1 2 3 5.1 million people are aged 65 and above

Brain Health:Unlocking White Space Potential for the OTC Industry

Introduction

www.klinegroup.com © 2015 Kline

TABLE OF CONTENTS

Brain Health: The Issue .................................

Available Treatments ........................................

2

Introduction .................................................. 1

8

Looking Ahead ............................................. 11

15Conclusion and Recommendations ................

Currently, in the nonprescription spectrum of the market, there are a handful of nutritional supplement brands aimed at brain health, but this area remains largely underserved by the OTC industry. There are OTC brands that make claims for heart health, joint

health, and even prevention of heart attack, so why not claims for brain health? This paper examines the current landscape of brain health and fleshes out opportunities for OTC marketers to consider.

There are significant opportunities for OTC marketers in the area of brain health. This is an area of serious concern for many individuals who either have the disease or wish to avoid succumbing to it. Current prescription drugs offer treatment for individuals with advanced levels of dementia and Alzheimer’s disease, with mixed results. However, many consumers, seeing first-hand results of brain disease in elderly parents and relatives, are eager to maintain their own brain health and prevent or delay the onset of demen-tia or Alzheimer’s disease.

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As individuals age, the size of the brain gradually decreases and blood flow within the brain also decel-erates. As a part of the normal aging process, individu-als are less flexible, both physically and mentally. Occasional memory lapses are common as certain nerve cells shrink or lose connections with other nerve cells. However, significant memory loss and other cognitive symptoms that affect everyday activities are not considered normal.

Dementia is an umbrella term that describes the symptoms that take place when the brain is affected by certain diseases or conditions, as described in Figure 1. The mental decline in dementia is severe enough to disrupt routine activities and affects one of the four core brain functions: recent memory, language, visual/spatial function, and executive func-tion, which includes memory, reasoning, problem solving, and other cognitive processes.

As the baby boomer population continues to age in the United States, the number of people with Alzhei-mer’s disease is likely to increase. According to April 2014 data from the U.S. Census Bureau, there are currently 76.4 million baby boomers in the United States. The Census Bureau estimates that individuals above the age of 65 will total 98.2 million by 2060.

Alzheimer’s disease is the sixth leading cause of death in the United States. As shown in Figure 2, an astonish-ing 82.9% of deaths in the 85+ age group are from

Alzheimer’s disease. Among the top 10 diseases lead-ing to death, Alzheimer’s disease is the only cause of death that cannot be forestalled, cured, or delayed. Several researchers are employing imaging technolo-gies to indicate that the disease progressively destructs personalities and yet it remains irreversible. Available Alzheimer's disease treatments cannot halt the disease from progressing and can only temporarily slow progression of symptoms. As of 2015, approxi-mately 5.3 million Americans of all ages have Alzhei-mer's disease, and of this total 96.2% or roughly

Brain Health: The Issue

Dementia

Figure 1: Types of Dementia

DEMENTIA

Alzheimer's Disease

60-80% of cases

Vascular Dementia20-30% of

cases

Fronto Temporal Dementia5-10% of

cases

Dementia with Lewy

Bodies<5% of cases

Younger Onset

Dementia

Other Dementias (include Korsakoff

Syndrome, Parkinson's Disease, Huntington's

Disease, HIV Dementia, and Mixed Dementia)

SOURCE: Alzheimer's Association

Alzheimer’s disease

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Figure 2: Alzheimer’s Death Rate per 100,000 by Age in the United States, 2013

According to the Alzheimer’s Foundation of America in 2014, friends and family of patients suffering from Alzheimer's disease and other dementia rendered approximately 17.9 billion hours of unpaid care. Providing care for family members with Alzheimer’s disease takes a toll on the caregivers’ health and well-being. Nearly 60.0% of Alzheimer’s disease and

dementia caregivers rate the emotional stress of care-giving as high or very high and around 40.0% of care-givers suffer from depression. Alzheimer’s disease and dementia caregivers had $9.7 billion in additional healthcare costs of their own in 2014 due to the toll of caregiving to Alzheimer’s disease patients.

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2

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5.1 million people are aged 65 and above. Of the people aged 65 and older with Alzheimer's disease in the United States, 3.2 million diagnosed or 62.8% are women. African American and Hispanic Americans are more likely to develop Alzheimer’s disease than Caucasian Americans.

According to the Centers for Disease Control and Prevention, the number of people living with Alzhei-mer’s disease is likely to triple during the next 35 years due to the aging population. Figure 3 illustrates the rapid expected growth of the aged 65+ population. Current prescription medications for Alzheimer’s disease or dementia are expensive and provide support only for a limited period of time. Cognitive decline is a major concern of the aging baby boomer

population. Studies indicate women's brains to be more vulnerable to Alzheimer's disease and other problems with memory and thinking in comparison to men. Women with mild cognitive impairment, which can lead to Alzheimer's disease, are likely to decline faster than men.

Projections for Alzheimer’s disease and dementia incidence inthe United States and globally

Among the top 10 diseases leading to death, Alzheimer’s disease is the only cause of death that cannot be fore-stalled, cured, or delayed.

15.3%

82.9%

1.6%0.2%a

75-84

65-74

85+

55-64

45-54

SOURCE: National Center for Health Statistics.a- Negligible percentage.

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In 2015, the direct costs to American society of caring for those with Alzheimer's will total an estimated $226 billion, with half of the costs borne by Medicare. Unless something is done, in 2050, Alzheimer's is projected to cost over $1.1 trillion (in 2015 dollars). There is a sizable opportunity to shift the costs of care to treatments that prevent or cure cognitive decline.

Globally, approximately 44 million people have Alzhei-mer’s disease or related dementia. According to Alzheimer’s Disease International, approximately only one-in-four individuals experiencing Alzheimer’s disease have been diagnosed. The global distribution of dementia varies according to the cultural and the socioeconomic differences among nations. The preva-lence of dementia is higher in the developed nations in comparison to the developing nations. The differ-ence in the risk prevalence can be attributed to the level of exposure to cerebrovascular risk factors, such as hypertension, smoking, obesity, and diabetes. A greater availability of accessible health care in devel-oped nations may also contribute to the higher incidence rate, as a larger proportion of the popula-tion would be under a doctor’s care and therefore

more likely to receive a diagnosis, compared to devel-oping nations where a disease is more likely to go undetected. Given the longer life spans of residents of developed nations, the risks of developing dementia are also higher compared to residents of developing nations where residents may not live as long.

According to 2014 World Health Organization (WHO) data , 172 countries are ranked according to death rates due to Alzheimer’s disease per 100,000. North America (excluding Mexico), Western Europe, and Australia demonstrate the highest death rates due to Alzheimer’s disease while select regions in Africa and Brazil indicate a moderately high death rate due to the disease. Countries such as Slovakia, Zimbabwe, Kenya, Greece, Brunei, Oman, Mauritius, and Russia are cate-gorized as having moderately low death rates due to Alzheimer’s disease. Of the 172 countries, 21 coun-tries register less than 1 death rates due to Alzhei-mer’s disease or dementia, outlined in Table 2.

Several Nordic countries, including Finland, Iceland, and Sweden, have high mortality rates due to Alzhei-mer’s disease or dementia, as noted in Table 1. Envi-

4

Figure 3: Number of Persons 65+, 1900 to 2060 (Number in Millions)

SOURCE: U.S. Census Bureau, Population Estimates and Projections.

0

20

40

60

80

100

1

2

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ronmental pollutants are the principal factor that result in a high incidence of the disease in these regions. The Baltic Sea, which is enclosed by Scandina-via, Finland, the Baltic countries, and the northern European plains, is one of the most polluted bodies of water on the planet, the microbes of which affect most Nordic countries. Alzheimer’s disease is a member of an aggressive family of neurodegenerative diseases known as Transmissible Spongiform Enceph-

alopathy (TSE). TSEs are caused by a deadly protein called prion which is found in the Baltic Sea and else-where . Prions spread in an uncontrolled manner within victims and within the environment. Neurologi-cal diseases caused by prions include Alzheimer’s, Parkinson’s, Huntington’s, amyotrophic lateral sclero-sis (Lou Gehrig’s disease), and other disorders known as frontotemporal dementias.

Table 1: Highest Death Rates by Country due to Alzheimer’s/Dementia

Death rate per 100,000

123456789

10

Rank Country

3

FinlandUnited StatesCanadaIcelandSwedenSwitzerlandNorwayDenmarkChile/NetherlandsBelgium

53.845.635.534.132.432.330.229.529.327.2

Table 2: Least Death Rates by Country due to Alzheimer’s/Dementia

Death rate per 100,000

123456789

10

Rank Country

SurinameSingaporeGeorgiaUzbekistanKyrgyzstanTajikistanCambodiaIndiaAzerbaijanKuwait

-0.20.30.40.40.40.50.50.50.6

SOURCE: WHO 2014

SOURCE: WHO 2014

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Amyloid precursor protein (APP)

Presenilin-1 (PS-1)

Presenilin-2 (PS-2)

6

The largest risk factor associated with Alzheimer’s disease is age. The risk of developing the disease doubles every five years after the age of 65 years. The risk of contracting the disease reaches 50.0% after the age of 85 years.

There are two types of genes that play a role in deter-mining whether a person develops a disease: risk genes and deterministic genes. Alzheimer's disease genes have been found in both categories. Below is the list of chromosomes containing one of the three genes that cause hereditary Alzheimer's disease and the gene with the greatest impact on Alzheimer's disease risk:

Risk Factors

Age

Genetics

Apolipoprotein E-e4 (APOE4)

The risk factors associated with dementia are high for consumers who opt for unhealthful choices, such as smoking, an unhealthy diet, and a sedentary lifestyle.

In 2014, the World Health Organization (WHO) issued a report titled “Tobacco Use & Dementia" which finds that smokers have a 45.0% higher risk of acquiring dementia in comparison to non-smokers. The report states that roughly 14.0% of all global Alzheimer's disease cases may be attributed to smoking. Accord-ing to the study, smokers with dementia die sooner than non-smokers with dementia.

A few studies have analyzed the link between chronic stress and dementia and indicate a positive correla-tion between the two factors. Some research indicates yoga and meditation can forestall and/or

heal symptoms of mild cognitive impairment (MCI) and dementia and improve the quality of life for both patients and their caregivers.

There are several studies that suggest a link between depression and dementia and scientists are working to uncover the reasons for a probable connection between the two. A few top theories include a link between depression which may directly impair brain cells leading to dementia and that depression may alter the size of the hippocampus, an area of your brain involved in forming emotions and memory, thereby placing such individuals at a higher risk of dementia. According to the Alzheimer’s Association, approximately 40.0% of patients suffering from Alzheimer’s disease also suffer from significant depression.

Lifestyle

Figure 4: Risk Factors for Brain Disease

Lifestyle

Brain disease

Age

Genetics

Lifestyle

4

5

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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.

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Challenges

There are several prescription medications indicated for the treatment of Alzheimer’s disease. Drugs that make up the class of medications known as cholines-terase inhibitors include:

Available Treatments

Prescription medications

Drug name Brand name Manufacturer Approved for FDA approved year

Donepezil Aricept Pfizer All stages 1996 Rivastigmine Exelon Novartis All stages 2000 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

Exelon (rivastigmine) by Novartis indicated for treatment of mild to moderate Alzheimer’s disease.

Razadyne (galantamine) by Johnson & Johnson indicated for treatment of mild to moderate dementia of Alzheimer’s type.

Aricept (donepezil) by Pfizer for treatment of all stages of Alzheimer’s disease.

Additionally, Allergan markets Namenda (memantine HCl) for the treatment of moderate to severe Alzhei-mer’s and this drug treats memory loss, confusion, and problems with thinking and reasoning. Allergan co-markets Namzaric with Adamas Pharmaceuticals which combines memantine with donepezil for the

treatment of moderate to severe Alzheimer’s disease and was recently approved in 2014 by the U.S. FDA.

As of 2014, the FDA approved select drugs for treating various stages of Alzheimer’s disease, as listed in Table 3.

Table 3: FDA Approved Medications for Alzheimer’s Disease in the United States

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According to a study published in the journal Neurolo-gy , 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 Pharma-ceuticals, 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 treat-ment 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 mini-mum 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 solane-zumab exhibits consistently better results when the drug is taken for a longer period of time while aducanumab yielded stronger efficacy with a higher dosage.

Over-the-counter options

There are currently no nonprescription medications indicated for the treatment of dementia or Alzhei-mer’s disease; however, several vitamins and ingredi-ents 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.

Segment 2015 Retail Sales, $ million

Omega 3 327.5 1.0 Brain health 33.9 308.0 Ginkgo 12.0 13.0 Mind blends 9.9 34.0 Reservatrol 0.8 (56.0) All other 5.1 (1.0) Total 389.2 8.0

SOURCE: IRI MULO sales data 52 weeks ending September 13, 2015.

Table 4: U.S. Brain Health Nutritional Supplements Sales and Growth by Segment

% Change vs prior year There are currently no

nonprescription medi-cations indicated for the treatment of dementia.

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The total size of the brain health nutritional supple-ment 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 nutri-ents. 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 phos-phatidylserine to boost memory, cognition, concen-tration, 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.

Prevagen Quincy Bioscience

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.

(Continued)

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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

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.

Neuro Drinks

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-re-ceived by consumers across multi generations who want to take a proactive approach to helping them-selves 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

Prevagen 31.0 +496.0 Neuro Sonic 8.9 +33.0 Procera AVH 1.2 +300.0

SOURCE: IRI MULO sales data 52 weeks ending September 13, 2015.

Brand name Manufacturer Product image Ingredients Claims

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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

Looking Ahead

Some early studies find a loose association between Acetyl-L-carnitine and possible delayed onset of cognitive decline by clearing the mitochondria of toxic fatty-acid metabolites and regenerating neurons damaged by free radicals. However, other more recent studies on the same ingredient suggest it is unlikely to improve cognitive behavior among dementia or Alzheimer’s disease patients.

Some studies hint curcumin, a chemical found in turmeric, have a positive effect on patients with Alzheimer’s or related dementia. Curcumin helps sustain healthy brain cellular metabo-lism, aids brain cells mending themselves, and keeps cells connected to each other. Studies support this point by stating the lower rate of developing Alzheimer’s disease or dementia in Asian countries, where turmeric is abundantly used in Asian cuisine.

Ginkgo biloba, a tree native to China, is available in herbal supplements such as Ginkgold (Nature’s Way) and Ginsana (Alan James Group). Studies done by Stefan Weinmann, Christoph Vauth, and Stefan N Willich which was funded by Dr. Willmar Schwabe GmbH & Co indicate that ginkgo biloba may improve memory in individuals with cognitive impairment or dementia. However, studies from the School of Medicine at the University of Virginia suggest that ginkgo biloba does not improve cognitive function in healthy people.

Some studies hint Huperzine A, a dietary supplement derived from the Chinese club moss Huperzia serrata, which functions as a cholinesterase inhibitor improves memory and protects nerve cells and slows cognitive decline associated with Alzheimer's disease. The Alzheimer's Association recommends not taking Huperzine A with a prescribed cholines-terase inhibitor such as donepezil (Aricept), rivastigmine (Exelon), or galantamine (Razadyne) since taking both could increase the risk of serious side effects.

Scientists from the Stanford University School of Medicine state that a protein fragment known as beta-amyloid, strongly entailed in Alzheimer’s disease, commences destructing synapses before it clumps into plaques that lead to nerve cell death.According to a study published in the Federation of American Societies for Experimental Biology journal in July 2015, omega-3 fish oil supplements might be beneficial for certain individuals experiencing Alzheimer’s disease. Participants in the study had MCI and witnessed reduced inflammation in neurological tissues and elimination of amyloid-beta protein.

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Acetyl-L-carnitine

Curcumin

Ginkgo biloba

Huperzine A

Omega-3

(Continued)

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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 intellectu-al abilities in an effort to maintain and preserve brain health . 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 boom-

ers 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, moni-tors 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 treat-ment options.

Findings of a preclinical study published in the Journal of Alzheimer's Disease, indicate very small amounts of tetrahydrocannabinol (THC), a chemical found in marijuana, to reduce the produc-tion of thebeta-amyloid protein, a known hallmark of Alzheimer's disease.

In 2014, findings of a study published in the Journal of the American Medical Association demonstrated individuals, with mild-to-moderate Alzheimer’s disease, who received high doses of vitamin E, showed a 19.0% slower rate of functional decline. However, the study also indicates the need for more research before using the supplement as a preventive measure.

Observational studies conducted by the Buck Institute for Age Research which was led by Dr. Rammohan Rao indicate that resveratrol, a compound commonly found in grapes, berries, chocolate, peanuts, and red wine can reduce beta-amyloid deposits in the brain and reduce the risk of Alzheimer’s disease. “Major Alzheimer's Risk Factor Linked to Red Wine Target”, The Proceedings of the National Academy of Sciences, October 2013. The possible claims are made based on limited evidence and further research needs to done to deterimine the effectiveness of resveratrol to reduce the risk of developing cognitive decline.

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10

Vitamin E

Tetrahydrocannabinol (THC)

Resveratrol

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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 ingre-dients, 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 prod-

ucts 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 cate-gory. White space opportunity exists that OTC market-ers 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 proac-tive approach to helping themselves in this important aspect of their health.

Figure 6: Digital Brain Health: Fit Brains by Rosetta Stone

Conclusions and recommendations

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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 inhibi-tors: 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

References

OTC Brain Health

Opportunities

Scientific claims

Tangible results

Educate

Target younger

generations

Go digital

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About the IRI/Kline Alliance

About IRI:

About Kline:

About the IRI Partner Ecosystem:

For more information on this white paper or the IRI/Kline alliance please contact Lisa C. Buono, Client Insights Principal, Health Care Vertical at IRI [email protected] or Laura A. Mahecha, Industry Manager, Healthcare at Kline & Company [email protected].

Information Resources, Inc. (IRI) the global leader in innovative solutions and services for consumer, retail and over-the-counter healthcare companies, and Kline & Company, a global market research and management consulting firm, have established an exclusive alliance to serve the worldwide, over-the-counter (OTC) drug and overall consumer healthcare industries. This powerful alliance will provide a higher level of data accuracy and an unparalleled, global range of thought leadership on stimulating topics in the consumer healthcare space.

As part of this collaborative relationship, IRI will contribute its granular, widely recognized, point-of-sale (POS) market data, related insights, and thought leadership. Meanwhile, Kline will provide its unmatched historical data-base, global network, and 360-degree view of the complex OTC drug market, including its comprehensive channel coverage and vast expertise in the area of Rx-to-OTC switches.

The collaborative thought leadership will manifest through white papers like this one on such topics as Rx-to-OTC switch, merger and acquisition activity, new product innovation, as well as trends and issues in international and emerging markets within the OTC drugs industry.

IRI is a leader in delivering powerful market, consumer and media exposure information, predictive analytics and the foresight that leads to action. We go beyond the data to ignite extraordinary growth for our clients in the CPG, retail and over-the-counter health care industries by pinpointing what matters and illuminating how it can impact their businesses. Move your business forward at www.iriworldwide.com.

IRI fundamentally believes that delivering differentiated growth for clients requires deep, highly integrated part-nering with a variety of best-of-breed companies. As such, IRI works closely with a broad range of industry lead-ers to create innovative joint solutions, services and access to capabilities to help its clients more effectively compete in their various markets and exceed their growth objectives. IRI is committed to its partnership philoso-phy and continues to actively enhance its ecosystem of partners through alliances, joint ventures, acquisitions and affiliations. The IRI Partner Ecosystem includes such companies as BlueKai (an Oracle Co.), The Boston Consulting Group, comScore, Datalogix (an Oracle Co.), Experian, GfK, Ipsos, Kantar, Kline, MaxPoint, Millward Brown Digital, Rentrak, SPINS, Univision, MasterCard Advisors and others.

Kline is a worldwide consulting and research firm dedicated to providing the kind of insight and knowledge that helps companies find a clear path to success. The firm has served the management consulting and market research needs of organizations in the agrochemicals, chemicals, materials, energy, life sciences, and consumer products industries for over 50 years. For more information, visit www.KlineGroup.com.

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