FiercePharma Marketing

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Introduction

Industry Outlook

Common Usage Categories for Older Adults

OTC Innovation Trends

OTC Innovation Case Studies: Fostering Healthy Aging

Conclusion

share:

October 2016

Healthy Aging: Improved Dose Forms for Aging Population

Healthy Aging: Improved Dose Forms for Aging Population // October 2016 //

FiercePharma Marketingshare:

Introduction

Industry Outlook

Common Usage Categories for Older Adults

OTC Innovation Trends

OTC Innovation Case Studies: Fostering Healthy Aging

Conclusion

IntroductionToday’s aging consumer is more concerned than ever about healthy living. While life expectancy for most countries has increased by 60% since 1900, living longer is no guarantee for living healthier.1

“Consumers want to own their health,” said Matt Petterson, research director of consumer health industry teams at Euromonitor International. “Self-care is becoming a critical aspect of healthy aging based on individual health and needs, but more importantly by individuals’ choices. In the past, people would consult first and rely heavily on the recommendation and guidance of their healthcare practitioners. But now, the push for responsible self-care has transformed how people take ownership of their health.”

In the United States, the average age of life expectancy has risen to 82. However, an average of 9 of those later years will be spent dealing with poor health, according to Euromonitor. Americans aged 50 and older want more years of vibrancy and are taking charge of their health and wellbeing to ensure that increased lifespan equates to a more robust health span.

The Gen X generation, just now beginning to hit their 50s, is leading

the self-management and care charge. They, along with the Baby Boomers, are devoting significant time and resources to actively managing and ensuring a healthy second half of life.

The self-care trend among consumers has attracted growing interest among companies looking to address key category needs and provide safe, effective and fast-acting over-the-counter treatments to fulfill the demands of the aging population. These needs within OTC treatments range from safety and convenience to cost and effectiveness and are becoming increasingly important to both consumers and manufacturers, creating new opportunities for the industry while also improving health outcomes for aging consumers around the world.

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Healthy Aging: Improved Dose Forms for Aging Population // October 2016 //

FiercePharma Marketingshare:

Introduction

Industry Outlook

Common Usage Categories for Older Adults

OTC Innovation Trends

OTC Innovation Case Studies: Fostering Healthy Aging

Conclusion

Industry OutlookOver-the-counter therapies are big business globally. The global OTC industry will represent an estimated $98.5 billion in sales in 2016. North America makes up 29% of the market at $28 billion, while Europe accounts for 28% of the global market. The global OTC numbers are expected to increase at a 5-year compound annual growth rate (CAGR) of 6.6%.4

The key driver of this growth is the aging population. In the U.S., people aged 65 and up make up about 13% of the population, but account for 30% of OTC medication use, including supplements and vitamins, according to a summary report from the Gerontological Society of America and Consumer Healthcare Products Association.

However, aging consumers are different from typical OTC consumers. Pill fatigue is a very real problem for older consumers who can be taking upto 10 pills a day. A 30% decrease in size from a regular-sized softgel, for instance, can make a big difference to individuals in those cases.

Other physiological changes for aging adults include the slowing of blood circulation, which may affect the amount of time it takes for the medicine to reach the liver and kidneys. Declining liver and kidney function can also affect the way medication is metabolized and eliminated from the body.

Older people also tend to have lower health-literacy levels, are more likely to rely on a healthcare provider or pharmacist recommendation than friends or family for

suggestions, and more often have assistance from a family caregiver, according to Consumer Healthcare Products Association (CHPA).

OTC drug companies need to take those differences into account and consider solutions, such as improving OTC communication and patient education through the better use of electronic health records, and encouraging wider adoption of adherence-helping smartphone applications.

Another growth driver in OTC is the switching of drugs from prescription to over-the-counter status.

Sue Peschin, CEO at the Alliance for Aging Research, said, “We know older adults use non-prescription OTC products for pain relief, GI disturbances, to help them sleep and for oral health. As more of those types of products become OTC, you’ll have an increase in use among older adults….Today, more and more pharmaceutical companies have Rx to OTC business units where before it was pretty separate.”

The switch brings new market expansion opportunities, especially in the areas of respiratory and digestive health. “The market prospects for the consumer health industry reveal an optimistic outlook that will support future growth in spite of recent turbulence in the economics and politics of many countries. After all, people still need to take medicines when unwell, or in any case, take supplements for preventive health no matter the state of the economy,” said Matt Petterson, research director of consumer health industry teams at Euromonitor International.

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Healthy Aging: Improved Dose Forms for Aging Population // October 2016 //

FiercePharma Marketingshare:

Introduction

Industry Outlook

Common Usage Categories for Older Adults

OTC Innovation Trends

OTC Innovation Case Studies: Fostering Healthy Aging

Conclusion

Common Usage Categories for Older Adults While it is true that older people are bigger consumers of OTC therapies than the general population, their usage of the drugs tends to be concentrated around chronic or recurring issues.

Approximately 92% of older adults have at least one chronic disease, and 77% have at least two conditions, according to the National Council on Aging.

From pain management and digestive issues to cardiovascular and sleep problems, aging consumers can face a wide range of health problems related to the aging process. In the following section, we look at the current and projected market in several of these categories, the key trends in each, and possible areas of opportunity.

Cough, Cold and AllergyWorldwide market 2016: $33 billionProjected market 2020: $43 billion2016 – 20 CAGR: 6.5% Most people today head to the drugstore before visiting their doctor when they come down with a cough or cold. For older people, common colds and coughs can become more serious problems, which means it’s especially important to make sure OTC remedies encourage adherence. Older adults’ diminished cough reflexes and weaker immune systems can more quickly lead to respiratory complications.

The very young and older people are often targets of campaigns to get flu shots, and there is evidence in the U.S. that more individuals are getting the flu vaccine and using immune-boosting supplements during the traditional season. Yet, many will still get sick. And not only are they turning to the pharmacy first, they’re also turning to combination products that claim to treat a variety of cold, cough and allergy symptoms. Multi- symptom products will contribute the greatest category growth over the next five years.4 That’s because when individuals do become sick, they are increasingly tending to turn to combination products which claim to treat a variety of symptoms.

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Healthy Aging: Improved Dose Forms for Aging Population // October 2016 //

FiercePharma Marketingshare:

Introduction

Industry Outlook

Common Usage Categories for Older Adults

OTC Innovation Trends

OTC Innovation Case Studies: Fostering Healthy Aging

Conclusion

The pills, dissolvables and liquid combo products are perceived as providing the greatest benefits with the least risk, however drug interactions are of particular concern to older adults, for whom the likelihood of harmful drug interactions is higher due to greater use of prescription drugs, OTC remedies and vitamins and dietary supplements.

Pain ManagementWorldwide market 2016: $22 billionProjected market 2020: $30 billion2016 – 20 CAGR: 7.9%More than 100 million Americans live with persistent pain, according to the Alliance for Aging Research, and pain management is the largest category of drugs most often used by older people. The most commonly used oral medicine for pain is acetaminophen, which accounts for $5.3 billion of worldwide revenue. However, other popular remedies include ibuprofen ($4.3 billion), combination products ($3.4 billion), aspirin ($2.4 billion), naproxen ($690 million), and diclofenac ($353 million). Topical analgesics make up another $5.7 billion in sales.4

Pain medications, even over-the-counter ones, are a current hot-button issue in politics and healthcare with a variety of plans floated that would restrict access to avoid medication mistakes. However, an AAR study found that most Americans are against restrictions on OTC pain relievers, with 68% of people over age 60 preferring education instead of restrictions as the best way to protect from possible overdose.

“We are supportive of the combination of prescription and over-the-counter products for seniors as long as there is communication between healthcare providers and patients about everything that they’re taking,” Alliance for Aging Research’s Peschin said. “There are valid concerns about interactions with medicines, supplements, foods and drinks along with prescription medications, so it’s just really important that there is open communication, and that healthcare providers are proactive.”

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Healthy Aging: Improved Dose Forms for Aging Population // October 2016 //

FiercePharma Marketingshare:

Introduction

Industry Outlook

Common Usage Categories for Older Adults

OTC Innovation Trends

OTC Innovation Case Studies: Fostering Healthy Aging

Conclusion

Digestive HealthWorldwide market 2016: $15 billionProjected market 2020: $20 billion 2016 – 20 CAGR: 6.7%OTC digestive health remedies are booming, thanks to the move from prescription treatments for gastroesophageal reflux disease (GERD) to over the counter. The changeover of proton pump inhibitors (PPI) such as Prilosec® and Nexium® from prescription to OTC has had an impact on aging people as GERD is the most common upper gastrointestinal disorder seen in the later years, and can be more severe than it is in younger people.2

The switch from prescription to OTC contributed to a 10% increase in PPI category revenues from 2015-2020.4

Still, GERD isn’t the only problem for which older adults seek OTC help. About 40% of older adults have one or more age-related digestive symptoms every year. Other popular forms of digestive OTC products for older adults include antacids, laxatives, antiflatulents, H2 blockers and irritable bowel syndrome treatments.

Probiotics are another growth category for older adults as they look to not only treat age-related problems, but proactively take care of their digestive health.

Sleep Aids Worldwide market 2016: $2.2 billionProjected market 2020: $2.8 billion2016 – 20 CAGR: 6.4%There is a yin and yang opposing force at work in the OTC sleep market for older adults, with one side focused on the difficulty in achieving good sleep while the other tackles getting the energy to be awake. In the case of sleep aids, chronic conditions and pain can interfere with good sleep and often older adults turn to OTC sleep aids. The National Health and Wellness Survey found that out of 41 million people in the U.S. aged 65 and older, more than 6.3 million (15%) reported sleeplessness with insomnia or sleep difficulties. Of those, 1.1 million reported the use of an OTC sleep aid, according to a recent article in Today’s Geriatric Medicine.3 They also found differences between the way younger and older people take sleep aids in that older people were about twice as likely to take OTC sleep aids for 15 or more days per month, even though label instructions for most advise seeking medical attention if sleeplessness continues for two weeks.

Sales of sleep aids overall have grown more than 15% in the past five years, with a similar rate expected in the next five years.

On the energy side of the sleep equation, sales of energy drinks and supplements are also robust, along with coffee and ginseng, amounting to $114.4 billion in the retail value of energy with growth of 20% by 2020.4

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Healthy Aging: Improved Dose Forms for Aging Population // October 2016 //

FiercePharma Marketingshare:

Introduction

Industry Outlook

Common Usage Categories for Older Adults

OTC Innovation Trends

OTC Innovation Case Studies: Fostering Healthy Aging

Conclusion

OTC Innovation Trends Many OTC products are particularly appropriate for these older consumers in this expanding market, as the products address conditions that become more prevalent with age. The range of available products is expanding too, with more prescription medicines that are aimed at conditions affecting older people making the switch to OTC.

Yet the consumer healthcare market is an intensely competitive one. The top 10 companies account for more than 38% of market share in 2016.4 It is important for manufacturers to create differentiated products, with consumer benefits that will encourage people to choose their brands over the competition on the shelf.

As people age, physiological changes demand tailored innovation in OTC treatments. For example, the tendency for dysphagia, or difficulty swallowing, to settle in during the later years, has spurred a trend in “enjoyable form” medicines, said Mark Gardella, Catalent Pharma Solutions global research and development platform leader for consumer softgels. That includes not only smaller form factors, but also chewables and innovations in coatings.

Other consumer preferences for aging consumers for OTC medications include performance, convenience, reduced pill burden, ease of swallowing, ease of identification, and environmental and cultural concerns.

Catalent works with 19 of the 20 top consumer health companies worldwide to research and develop the form factors and product attributes that consumers want and request. Consumers are looking for products that are efficacious and offered in dosage forms that are compatible with their busy lifestyles. OTC products that are easy to take are likely to win over those that are less convenient. And with convenience, comes improved compliance. For instance, painkillers that act more rapidly may well be considered worth the premium price over a standard formulation.

The softgel category appeals to consumers who perceive the drugs to be faster acting, as well as effective and easy to take. In a global consumer study from Catalent Pharma Solutions, consumers rated softgel capsules as highly desirable. Eighty-two percent of the study participants rated softgels as fast acting and effective, while 89% found them easy to digest.

Catalent’s specific innovative dosage forms can help companies address aging consumer preferences and need, and include:

OptiGel™ Mini: This small form factor delivers the same full-size dosage in a softgel reduced in size by 30% to 50%. It allows higher concentrations of the active pharmaceutical ingredients and improves

The Consumer healthcare market is an intensely competitive one. The top 10 companies account for more than 38% of market share in 2016.

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Healthy Aging: Improved Dose Forms for Aging Population // October 2016 //

FiercePharma Marketingshare:

Introduction

Industry Outlook

Common Usage Categories for Older Adults

OTC Innovation Trends

OTC Innovation Case Studies: Fostering Healthy Aging

Conclusion

absorption of those APIs in consumer-preferred smaller sizes.

EasyBurst™ Chewable: Another product type likely to be particularly suitable for aging consumers – and also for children – is the chewable softgel. The easy rupture and dissolvable form releases the active ingredient in the mouth and does not need to be swallowed. When combined with advanced taste-masking technologies, EasyBurst™ chewables can provide significant product differentiation at the retail shelf.

OptiShell™ plant-based capsule: Delivers complex formulations in a plant based delivery system. The plant-based format appeals to consumers with environmental or dietary concerns.

Graphicaps™ Technology: Personalization brought to the medicine bottle. With inline printing directly onto the softgel, companies can brand products down to the individual dose while clearly marking OTC pills for older consumers to help them avoid mix-ups when taking several medications.

Other innovations in OTC medicines include self-emulsifying drug delivery systems, which could be especially advantageous for aging people. The technology works by allowing the medicine to break down on contact with water or digestive fluids to form a microemulsion. That kind of delivery can help increase the amount and absorption of active ingredients in the capsule. Self-emulsifying drug delivery can reduce the differences in patient medication experiences across

ages. However, it’s especially problematic for older people whose systems may react differently than they did in earlier years, likely as a consequence of aging organ function and body composition, a declining metabolic rate and the higher likelihood of co-morbid conditions.

Also in the works are advances in softgel coating applications that would allow the coating itself to contain active ingredients. That means two different active ingredients could be contained in one softgel: one on the outside and one on the inside. This two-for-one idea is particularly attractive to aging consumers who could then swallow fewer pills daily.

Technology and digital adherence helpers are another area of advances in OTC for aging consumers. Apps like Mango Health’s Medication Manager, Drugs.com’s Pill Reminder, Pill Identifier and Medication Guide and even CVS’ mobile app which includes an OTC interaction checker make taking meds and managing health easier.

Alternate treatments, with OTC products that include fish oil, vitamin D, natural immunity products with vitamin C, zinc and echinacea, are outpacing the overall vitamin and dietary supplement market as consumers look to put those treatments to use in healthy aging.

Cost is an ongoing concern for older adults that is also being addressed by OTC drug makers. More private-label medicines, the switch from branded drugs to OTC, and future innovations like 3D printing have

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Healthy Aging: Improved Dose Forms for Aging Population // October 2016 //

FiercePharma Marketingshare:

Introduction

Industry Outlook

Common Usage Categories for Older Adults

OTC Innovation Trends

OTC Innovation Case Studies: Fostering Healthy Aging

Conclusion

the potential to help address expense as the aging population’s income tends to decrease with passing years. In March, the first FDA approved 3D printed drug, Aprecia Pharmaceutical’s epilepsy treatment Spritam®, was born, while a month later MIT announced its own solution of an on-demand pharmacy that can print four different drugs, although no word on when that might be ready for commercial release.

The previously discussed trend of drugs moving from prescription to OTC will also continue to contribute to the cost-savings trend.

“Not only does greater access to OTC medicines improve public health and provide greater options, convenience, and access to care for consumers, these products have proven economic benefits as well.

The use of OTC medicines yields significant savings to both consumers and the health care system by reducing unnecessary physician visits for otherwise self-treatable conditions,” according to a Pfizer paper on the value of OTC medicines.5

The goal in OTC innovation for older adults is improving the quality of life and comfort, which, at the end of the day, means making meaningful contributions that foster healthy aging and longer happier healthspans.

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Healthy Aging: Improved Dose Forms for Aging Population // October 2016 //

FiercePharma Marketingshare:

Introduction

Industry Outlook

Common Usage Categories for Older Adults

OTC Innovation Trends

OTC Innovation Case Studies: Fostering Healthy Aging

Conclusion

OTC Innovation Case Studies: Fostering Healthy Aging

“Fun” Medicine Not Just for Kids Anymore While the creation of the so-called enjoyable form of OTC medicines originated in the service of children, the expansion and growth of the adult market has been explosive. Swallowing pills becomes more difficult with age, and taking multiple pills for different things can get repetitive, making fun and easier-to-take OTC medicines more desirable.

Enter chewables and softgels. Over 70% of OTC products today are in tablet form, with the remaining split up as 13% softgels, 12% liquids, 3% powders and 2% capsules.6 There is a huge market opportunity to trade up consumers to preferred dose forms such as chewables and softgels.

“The idea is to improve the ability to take the medicines that people need. Whether that’s by reducing the size of the capsules people take, which can have a psychological as well as physiological effect, or making the product more enjoyable to take. Consumer preference is a big influence in what people pick off the shelf,” Catalent’s Gardella said.

Softgel Analgesics: Taking the Pain Out of Taking Pain PillsWhen a global healthcare OTC maker found that one of its 50-year-old haymaker analgesic brands was losing market share among loyal customers, the company challenged Catalent to come up with an innovative solution.

Catalent went to work quickly to identify the problem with customers, the OTC’s in-house team and its own R&D leaders. They looked at brand strategy and market dynamics for the medicine, and used key consumer insights to come up with new product ideas.

The winning concept was RP Scherer softgels. The softgels offered the best solution to revitalize the brand by following consumer preferences of fast acting, easy to swallow and on-the-go convenience. A highly successful launch led to halo growth for the whole brand with the new softgel line extension pumping up overall brand market share.

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Healthy Aging: Improved Dose Forms for Aging Population // October 2016 //

FiercePharma Marketingshare:

Introduction

Industry Outlook

Common Usage Categories for Older Adults

OTC Innovation Trends

OTC Innovation Case Studies: Fostering Healthy Aging

Conclusion

ConclusionHealthy aging is a growing concern for 35% of the U.S. population now aged 50 or older. As they seek to manage their health and wellbeing into old age, they will increasingly turn to OTC treatments that are more straightforward, convenient, accessible and less expensive. A successful partnership between OTC brands and manufacturing companies can cater to the needs and demands of this new audience of empowered seniors and enable them to manage their individual healthy aging plans. n

1 https://www.nia.nih.gov/research/publication/global-health-and-aging/living-longer2 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3010469/3 http://www.todaysgeriatricmedicine.com/archive/MA16p20.shtml4 Market research provider, Euromonitor International (2016) current prices fixed 2016 rates5 http://www.pfizer.com/files/health/VOM_OTC.pdf6 Market research provider, IRI Worldwide (2016)

Prilosec and Nexium are registered trademarks of AstraZeneca AB

Spritam is a registered trademark of Aprecia Pharmaceuticals Co.

OptiGel, OptiShell, Easyburst, and Graphicaps are trademarks of Catalent Pharma

Solutions

Catalent is a global leader in innovative oral and topical softgel technologies for the Consumer Health and Beauty markets. With consumer-preferred formats, and its advanced development formulation expertise, Catalent can help brands grow with unique, tailored solutions for OTC, nutritional supplement, and skincare challenges.

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