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Extent of digestive problems is food for thought.

NEW YORK -- The digestive health category is the third largest in consumer packaged goods sales, according to Stacey Harris, senior brand manager for Turns at GlaxoSmithKline PLC (GSK), as more and more consumers become aware of the link between digestive health and overall health.

Eating the wrong food, eating on the run, stress and an aging population are factors contributing to the increase in digestive issues, such as indigestion, heartburn and acid reflux, and remedies for these conditions represent one of the largest retail categories. Nearly 32% of adults in the United States have mild, moderate or severe allergies to food, Harris says, that contribute to many of these digestive ailments.

According to Mintel's "Digestive Health Report for 2017," a large number of adults, 83%, have experienced some kind of digestive health issue in the last year, and these adults are looking not only to control their digestive health issues quickly but to get long-lasting relief from them as well.

According to Mintel, 57% of consumers say quick relief is a top priority when picking an over-the-counter digestive remedy, and 47% list long-lasting relief as the other.

Heartburn, one of the most common digestive ailments, according to WebMD, can start when there is a problem with the muscular valve called the lower esophageal sphincter (LES), which is located where the esophagus meets the stomach.

Normally, with the help of gravity, the LES keeps stomach acid in the stomach, where it's supposed to be. When working properly, the LES opens to allow food into the stomach or to produce a belch, then it closes again. But if the LES opens too often or doesn't close tightly enough, stomach acid can seep into the esophagus, causing a burning sensation.

If the LES doesn't tighten as it should, there are often two things that contribute to the problem--overeating, which puts too much food in the stomach, and too much pressure on the stomach, which is often due to obesity, pregnancy or constipation.

With the prevalence of digestive issues, it's not surprising that the global antacids category is so lucrative, with Transparency Market Research estimating the market will top $18 billion by 2025, achieving a CAGR (compound annual growth rate) of 3.7% between 2017 and 2025.

Despite the frequency of heartburn, however, the heartburn remedy category experienced some declines in sales, as more consumers expressed worry about the safety of long-term use of one of the common remedies, proton pump inhibitors (PPIs). According to Jordana Barish, associate director of marketing for upper GI at Sanofi Consumer Healthcare, H2 blockers, such as Rolaids antacids and Zantac, offer additional heartburn treatment options that have helped to bring consumers back to the category with a desire for a product that has the flexibility to prevent heartburn as well as to relieve it. Zantac provides that flexibility, combating symptoms in as little as 30 minutes and controlling acid for up to 12 hours.

Harris points out that GSK offers the most products to address the myriad digestive health needs--Benefiber, Turns, Alii, Prevacid, Citrucel, Ex-Lax, Gaviscon and Gas-X.

Nexium 24HR from Pfizer Consumer Healthcare is another top O-T-C remedy. It comes in three forms, allowing consumers to get the same complete protection from frequent heartburn in capsules, easy-to-swallow tablets or new clear minis with a 38% smaller pill. Nexium 24HR ClearMini is a transparent pill that allows consumers to see the medicine inside the capsule. All Nexium 24HR products offer the same effective protection against frequent heartburn, according to Pfizer.

An alternative to Nexium, from Aurobindo Pharma Ltd., which is based in India, was recently granted approval by the Food and Drug Administration to manufacture O-T-C 20 mg esomeprazole magnesium delayed-release capsules, a generic antacid version of Pfizer's Nexium 24HR capsules.

As with Nexium 24HR capsules, Aurobindo's generic product is indicated for the treatment of frequent heartburn, which is defined as heartburn occurring two or more days a week.

The way the medication works is by stopping acid production at the source by blocking the pumps that release acid into the stomach. PPIs, such as Nexium 24HR, are the only FDA-approved medications for the nonprescription treatment of frequent heartburn.

It's important to note that there can be long-term effects from chronic heartburn, acid reflux and GERD (gastroesophageal reflux disease). According to information provided by Pfizer, the continual backwash of stomach acid can cause chronic injury and inflammation in the esophagus, which can potentially lead to the narrowing of the esophagus, making it difficult to swallow or causing an ulcer to develop there.

Acid reflux may also cause respiratory problems, such as asthma symptoms or chronic cough, and it can lead to dental problems, as acid tends to erode tooth enamel.

In very rare instances, acid reflux and GERD can lead to cancer of the esophagus. Those dealing with chronic digestive issues are advised to consult their physicians about their risks for developing these potential complications.

Pfizer rolled out Nexium 24HR in the spring of 2014, shortly after receiving FDA approval that granted the company three-year market exclusivity for the product. Annual U.S. sales of Nexium 24HR have topped more than $300 million, according to IRI data.

Pfizer had acquired global O-T-C rights to Nexium from AstraZeneca in August 2012. Nexium 24HR, however, could be going on the block after Pfizer announced earlier this month that it was exploring strategic alternatives for its Consumer Health unit, including a potential sale of the business.

A range of options will be considered, according to Pfizer, including a full or partial separation of the Consumer Healthcare unit from Pfizer through a spin-off, sale or other transaction, and Pfizer may ultimately decide to retain the business. Pfizer Consumer Healthcare is one of the largest O-T-C health care products businesses in the world, with 2016 revenues of approximately $3.4 billion, operating in more than 90 countries globally.
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Publication:Chain Drug Review
Date:Feb 12, 2018
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