The good, bad and ugly of the probiotics category
The good: Probiotics as a category already is hot and is about to become hotter as Bayer reaches national distribution with its Phillips Colon Health, and Procter & Gamble rolls out its Align probiotic to full distribution in mid-March. Both Bayer and P&G will be supporting their respective brands with both consumer messaging and pharmacist education.
The bad: There is some confusion as to how to best merchandise the category. Do new probiotic SKUs, which are regulated as supplements, get cut into digestives or supplements? Will increasing awareness around probiotics justify a probiotic destination center?
The ugly: Good manufacturing practices are important in any category, but potentially more so in probiotics. The key to efficacy is delivering on the number of live bacteria to a shelf-stable product—live bacteria that needs to survive both the manufacturing process and a consumer’s own digestive system in enough numbers that it makes a beneficial difference on the gut’s flora. To do less is to risk efficacy, and any lack of efficacy in such a burgeoning category as probiotics could turn into one-off trials, where consumers try the product, don’t realize the benefit and then spurn not only that ineffective product, but the entire category.
Sales of supplements of acidophilus/probiotics were up 32.7% for the 52 weeks ended Jan. 25, according to Information Resources Inc., reaching a dollar volume of $47.6 million across food, drug and mass (minus Walmart) outlets. Sales of Amerifit Brands’ antacid Culturelle were up 40.9% to $10.2 million, and sales of Dannon Activia, the probiotic-rich yogurt credited by many suppliers for educating consumers on probiotic benefits, were up 15.2% to $215.2 million; Dannon Activia Light sales were up 69.6% to $115.4 million.
Even with all of that growth, “there’s a lot of confusion about probiotics,” noted Mary Berry, marketing manager for Biocodex, which markets Florastor.
“It’s very difficult for a consumer to know they’re getting a good [probiotic], and it’s just as difficult for a pharmacist to know they’re recommending the right one,” Berry said. “The market is flooded with various forms of bacterial probiotics,” which makes professional communication all the more crucial in this category, especially as probiotics are recommended more often alongside the use of antibiotics.
Walgreens set to expand distribution capacity
WOBORN, Mass. Walgreens is expanding the distribution capacity at its Mt. Vernon, Ill.-based distribution center by adding more portable robotic picking devices and upgrading many of its traditional conveyor-based systems into automated zones for sortation and movement of items to be shipped.
Walgreens uses the Kiva Mobile Fulfillment System from Kiva Systems in Mt. Vernon to store inventory and pick replenishment orders for its 6,700 stores and specialty pharmacies. Expanding the system in that distribution center puts nearly 1,000 mobile robots under a single roof, according to Kiva.
The upgrade marks the third expansion of the robotic picking system at the center since its initial deployment in 2007, Kiva noted. It also heralds a doubling of the throughput capacity at the center, the company reports.
“Productivity metrics from previous rollouts far exceeded Walgreens’ specifications for pick rate, accuracy, cycle time, tote utilization and installation time,” said Kiva CEO Mick Mountz. “By doubling capacity we expect Walgreens to quickly achieve an extraordinary new level of strategic competitive advantage and productivity.”
Congress takes up follow-on biologics bill
The long-awaited breakthrough for follow-on biologics may be close at hand.
Prompted by a far more supportive President and the growing crisis in healthcare funding, Congress has again taken up the call for a bill that would create a regulatory pathway for FDA approval of generic versions of biologically-engineered drugs. And with the strong affirmation of President Obama, who has campaigned for such an approval pathway, the newest iteration of the bill stands a far better chance of passage than previous attempts in the House and Senate.
The Promoting Innovation and Access to Life-Saving Medicine Act could mark the most significant change to the delicate balance of power between the branded and generic drug industries since passage of the landmark Hatch/Waxman compromise bill in 1984, which ushered in the modern era of me-too medicines. Tellingly, one of the new bill’s sponsors is an architect of that 1984 legislation, Democratic Rep. Henry Waxman of California.
The push for follow-on biologics augers well for both health plan payers and patients coping with the sometimes staggering costs of critically important but expensive pioneer biologics, and for the generic drug industry itself as it faces a critical shortage of new marketing opportunities as the number of blockbuster drugs facing patent expirations dries up. A new pipeline of me-too biologics could help fill the gap.
“With countless patients struggling to pay the high costs of brand biopharmaceuticals, an approval pathway for safe, effective and affordable biogeneric medicines that provides access sooner rather than later is desperately needed,” stated Kathleen Jaeger, president and CEO, Generic Pharmaceutical Association.
Cost-saving considerations aside, there’s no disputing the business potential follow-on biologics represent. Bio-engineered pharmaceuticals and specialized, highly targeted medications aimed at serious chronic or life-threatening diseases represent the only major bright spot right now in the global pharmaceutical market, with growth rates that far outpace the sluggish market for mainline meds. Indeed, most of the drugs that have reached blockbuster status in recent years have been biologically engineered specialty meds.