Probiotics the main CHC growth driver in Europe

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As part of our series of blogs on the 10 Infinity Zones for future CHC growth outlined by Nicholas Hall, this week we take a closer look at the fast-growing probiotics category. As Nicholas mentioned in his keynote speech at this year’s Vienna conference, probiotics is a category that has moved from adjacency to mainstream, producing more value growth in Europe in the past 5 years (additional US$364mn in sales) than any other OTC category.

In 2018, global sales of probiotics totalled US$4.2bn, representing 10.8% growth. This was a slightly better performance than the previous year (sales of probiotics were up 10.4% in 2017) but still marks a deceleration compared to the recent peak in 2016 of 13.6% growth. Looking at global product innovation trends, thanks to our OTC New Products Tracker tool covering 20 key markets, there are also indications that probiotics expansion may have hit a temporary plateau, with roughly the same number of innovations in this category in 2017 (277) and 2018 (270).

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However, the appearance of new probiotics niches looks set to energise further growth and innovation going forward. As highlighted in our recently published Lower GIs report, the development of probiotics with novel positioning (IBS, hangover, etc) and for specific life stages (infancy, pregnancy, etc) are expanding the category’s appeal even further. Recent examples of new probiotics for kids include Zarbee’s Naturals Baby Daily Probiotic Drops (J&J) and Biocodex’s launch of Florastor Baby.

Personalisation will also be an important future growth driver for probiotics. Despite the increasing number of proprietary bacterial strains, the probiotics category is still largely characterised by a one-size-fits-all approach. As scientific understanding of the microbiome advances, however, we may soon reach a stage where tailored probiotic strains are recommended for people with specific host microbiomes or diets. This sort of precision therapy could also eventually see a growing number of probiotics regulated as medicines rather than dietary supplements.

How is regulation of consumer healthcare products set to evolve in future? Find out in the chapter dedicated to regulation in Nicholas Hall’s New Paradigms for CHC 2019: Over the Horizon, written by Nicholas himself. Other chapters will look at issues surrounding the CHC market including digital engagement, M&A, healthcare trends and much more! You also have the option to upgrade your purchase to include a customised in-house presentation or webinar with Nicholas for an additional GB£10,000. To find out more or to place your order, please contact melissa.lee@NicholasHall.com.

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CBD rollout gathers pace

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2019 looks to be the “breakout year” for US cannabidiol-based products. Changing legislation – hemp’s removal from the Controlled Substances Act in December 2018 – along with growing retailer support, marketer innovation and high consumer demand have combined to make CBD the hottest property in the consumer healthcare market. CVS Pharmacy has announced plans to sell topical CBD products such as creams, sprays, roll-ons and salves in 800 selected stores across eight US states, including Alabama, California, Colorado, Illinois, Indiana, Kentucky, Maryland and Tennessee.

More recently, Walgreens announced it was following suit, with plans to sell CBD creams, sprays and patches in almost 1,500 stores across nine states – Oregon, Colorado, New Mexico, Kentucky, Tennessee, Vermont, South Carolina, Illinois and Indiana. “This is in line with our efforts to provide a wider range of accessible health & wellbeing products and services to best meet the needs and preferences of our customers”, said a Walgreens spokesman. Between CVS and Walgreens, CBD-infused topical products will be sold in at least 12 US states, including five where both retailers will be active – see our map below.

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Regulatory uncertainty is still an issue though, with the FDA insisting that marketers should not add CBD to food or sell it as a dietary supplement. The American Herbal Products Association has adopted a new Guidance Policy for dietary supplement and food products that contain hemp and hemp-derived cannabidiols to help ensure the industry complies with existing regulations. The policy was developed to encourage industry to be mindful of the federal regulations that apply to these product categories, notwithstanding the FDA’s ongoing review of the status of CBD and potential pathways for its lawful addition to food and dietary supplements.

This uncertainty isn’t completely holding back the market, however, with SPINS data showing that CBD functional ingredient sales in the US natural channel grew to US$40.4mn in the 52 weeks ending 4th November 2018, up from just US$1.2mn two years previously. Given that CBD is now moving out of the natural channel into mainstream retail, the potential for CBD is huge, with the Brightfield Group estimating the US market could be worth US$22bn by 2022.

Review 18,000+ new launches and innovations, including the latest medical cannabis developments, with OTC New Products Tracker, the ultimate competitive intelligence tool! Products are given a star rating, with “me too” items ranked 1*; launches / line extensions in a new category / adjacency 2*; major launches / line extensions with strong new benefits / positioning 3*, and 1st Rx-to-OTC switches in a category, creation of a new OTC class or other major leaps in innovation 4*. With a recently-released major update including eye-catching new graphics and powerful search filters that help you visualise and explore the vast archive according to your exact specifications, now is the perfect time to set up your free trial. For a demo or more information, contact waisan.lee-gabell@NicholasHall.com.

AESGP meeting 2018: Key learnings

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OTC INSIGHT Europe Editor Sarah Carter reports back from this year’s 54th AESGP Annual Meeting, which was held in Amsterdam and served as a farewell to Dr Hubertus Cranz, who retired as Director General after 30 years in the role.

Below are 8 key learnings from the meeting:

  1. Representatives from Pfizer and Hexal / Sandoz demonstrated how Rx-to-OTC switch can act as a growth driver for the consumer healthcare industry, with Nexium Control (EU Centralised Switch) and MometaHexal (Germany) given as case studies. Both asserted that the Rx heritage of the brands was instrumental in their successful switch, with both market leaders in their respective Rx spheres.
  2. However, while switch offers growth opportunities, several speakers stressed that the limited 1-year data exclusivity available with a switched product in the EU can deter marketers from making the timely and costly investment needed to switch their product.
  3. Digitalisation has transformed the rules of the healthcare industry and education. According to Google, search engines and online videos are the most important touch points for OTC purchasers, with one in 20 searches on Google related to health. In 2017, there were 40bn healthcare queries in EMEA alone.
  4. The global volume of healthcare data doubles every 18 months. It is crucial that we build trust with consumers regarding Big Data, ensuring that our industry uses this in a responsible manner, particularly salient given the introduction of the EU’s General Data Protection Regulation on 25 May 2018.
  5. Low levels of health literacy act as a barrier to self-care. We must empower consumers with the tools and knowledge necessary to play an active role in their health management, healthy ageing and prevention. Healthcare systems need conscious individuals who actively pursue a healthy lifestyle, and seek HCP advice where necessary.
  6. Technology such as wearables and apps has helped to raise health awareness and engagement among consumers, driving the trend for wellness and encouraging people to become key actors in their health management. In the industry, we see increasing purchases of long-term preventive products, rather than OTC treatments.
  7. It is vital that we understand the consumer at a much deeper level than we have done historically, as they no longer want to be sold to, but engaged with. The advent of Big Data and AI deliver us new tools to generate insights and ultimately create more meaningful connections and stronger relationships.
  8. There is little to report on regulations — still no decision on botanicals, and no real update on medical device regulations.

Only two weeks to go until the annual North American OTC Conference! Hosted by Nicholas Hall and Everything Health in Morristown, New Jersey, 20-21 June, this highly-anticipated meeting will review crucial topics impacting the competitive landscape around the central theme of The Future of Consumer Self-care: New OTC Solutions. With topics on the agenda including the e-commerce revolution, a presentation on “Magical Marketing in Healthcare” from Google and a look at the industry’s ‘Switch wish list’, this promises to be an event you can’t afford to miss. To receive a copy of the full meeting agenda or to reserve your place now, contact lianne.hill@NicholasHall.com

Self-care in Canada: Meandering Path to New Regulations

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Mathematically, the shortest distance between two points is a straight line. However, in public policy it is rare to chart such a clear direction. Reading through the “What was Heard” report from Health Canada’s public consultation on self-care regulation, which was conducted online in late 2016, there does not appear to be any real consensus over new proposals for an overhaul of all the regulations for non-prescription medicines, Natural Health Products (NHPs) and cosmetics.

Although the report was completed months ago, it was only released in late March this year, as a backgrounder to a series of town hall style discussions on a more detailed set of changes starting 4th April. While the government has developed a more detailed set of proposals that address some of the concerns set out in the report from last year’s consultation, it would appear that those attending the provincial feedback forums will not have the opportunity to digest these details prior to giving their advice. In fact, one of the key findings of the report was that all stakeholders felt that the original outline lacks enough specificity to make cogent comment.

Reading the report, it is interesting how what was heard may not actually be fully representative of what was said. For example, the report concludes that “many participants in the consultation see considerable value in the clarity that would be provided by a single regulatory approach to all three affected areas” (i.e. cosmetics, NHPs and OTCs). What the data show is that in virtually all stakeholder categories, the support across several key measures was only around 30%. Taken another way, roughly 70% or more of the stakeholders would not be more confident in these proposals.

The report notes that most of the concerns came from the NHP segment. This should not be a surprise since all previous consultations were only about moving OTCs out of the prescription drug regulations. For non-prescription medicines, this was round two of the discussions but for the NHP and cosmetics sectors this was novel territory. The visceral reaction was clear given that the NHP community spent years developing a set of regulations independent from drug classification and achieved it through a parliamentary process. They perceived that rolling all OTCs and NHPs into one single regulation was a step back in time, especially given the tone of the documents about claims-based barriers to market access.

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There weren’t many points where all stakeholders agreed. However, it seems there was a strong consensus that self-care products (OTCs, NHPs and cosmetics) “should not be regulated in the same manner as prescription drugs”. Far from an epiphany, this was the basis for the idea that OTCs should be granted their own regulations outside the prescription regulations, just as NHPs were granted such regulatory status. Cosmetics have never been in the prescription drug framework.

There was no consensus on the specific elements of the new framework. The risk-based approach was supported to the degree that most agreed that “products which pose a greater risk of harm should receive greater scrutiny and be subject to significant requirements”. Where the consensus fell into disarray was around the confusion between evaluating products for their individual risk and categorising products broadly into risk levels. The proposal seemed to set out a lower-risk category where claims would be limited and as such the government would not review and license them for sale. This type of product would be supported by pre-cleared information such as monographs.

The logic suffered in some stakeholders’ view since the model would seem to require lower-risk products to move into higher risk categorisation when clinical data would be provided to create greater confidence in the claims. The report notes that “there is no consensus that the proposed risk-based approach would create more confidence when purchasing self-care products”. In fact, 82% of consumers and healthcare professionals and 93% of cosmetics manufacturers said it would not give them more confidence.

The thought of requiring only “scientific” proof to justify health claims met with resistance from most stakeholders (except the five OTC drug companies). Only 30% of all respondents agreed with this notion and that was not highly differentiated across several segments. The support for stricter reliance on “science” (not defined but often assumed to be clinical trial data) was low with consumers (30%), healthcare professionals (33%), NHP companies (21%) and cosmetics manufacturers (30%). On the other side of the argument, academics and researchers were more supportive (60%).

A concept floated by government was that they would not evaluate and license certain types of products based on the types of claims being made. This was suggested to be accompanied by a disclaimer that Health Canada did not assess the claim. While cosmetics already enjoy a similar notification system, most stakeholders didn’t appear to support adopting a cosmetic-like system for OTCs and NHPs. The report notes that “participants are somewhat divided on the use of a disclaimer on products whose efficacy would not be reviewed”.

Despite the lack of consensus on a disclaimer, there would appear to be acceptance that changes could be made that would “facilitate informed consumer choice”. Some stakeholders have proposed adding labelling statements that would make it clearer when traditional evidence was used to support the claim. This, they feel, would add information that enhances consumer choice.

This consultation elicited a very strong response relative to most government consultations. Perhaps this was influenced by the fact that during the consultation period, Health Canada put out a very strong social media campaign and used traditional media stories to “clarify” some aspects of their proposals. With the communications efforts to ensure that the consultation garnered significant and reasoned responses, it should give some confidence in the results.

Perhaps one of the most telling observations related to the confidence stakeholders would have in the newly designed system. Consumers (78%), healthcare professionals (75%), NHP companies (80%) and cosmetics firms (63%) did not feel more confident with the new proposals. In a similar vein, 82% of consumers didn’t feel that the proposals adequately addressed their needs. The numbers were similar for healthcare professionals (78%), NHP companies (81%) and cosmetics businesses (74%). Only two OTC companies felt that their concerns were addressed.

The report concludes that “there is clearly a need for further detail on the proposed approach so that stakeholders may provide more specific feedback to Health Canada as the framework continues to be developed”. No doubt this is true and, as the government heads into the next phase of face-to face discussions, it would have been helpful to have that kind of detail available before asking stakeholders to respond.

Trump To Roll Back E-cig Rules?

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As vaping has escalated in popularity over the past year, tobacco companies are focusing on new smoking products, which are potentially less harmful. With Trump now in his full role of presidency, the industry sees an opening for rolling back rules on these products.

In November, Trump’s surprise election victory, and his pledges to reduce federal regulations on business, led tobacco lobby groups to create a new plan of action. The immediate objective is to delay the implementation of new regulations on the current generation of e-cigarettes and other vaping devices. These devices produce a vapour from liquid nicotine rather than burning tobacco.

Longer-term, they are setting their sights on repealing the 2016 law that treats these devices like cigarettes. Lobbyists have described a wary optimism as they approach lawmakers with their plans for products that they say can help traditional smokers quit and avoid the well-known health threats caused by tobacco.

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With US sales of conventional cigarettes decreasing, Big Tobacco has made a major gamble in the past few years, flying the flag for the e-cigarette industry. Last week, British American Tobacco Plc announced a US$49bn deal to take over competitor Reynolds American, uniting two of the largest e-cigarette players in the United States and United Kingdom and becoming a huge rival to Philip Morris International and US partner Altria Group.

“Suddenly things that were not conceivable became something we thought we could do,” said Cynthia Cabrera, former president and executive director for the Smoke-Free Alternatives Trade Association (SFATA).

While the potential health risks and benefits of e-cigarettes are still being studied and debated, with regulators in different countries interpreting the evidence in different ways, some industry voices are saying that a change in US regulations could hurt the smaller companies there and cripple development and innovation in the country’s e-cigarette industry.

OTC Vending Machines in USA IN 2017?

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Vending machines are commonly used for distributing fizzy pop or a sugary / savoury snack to perhaps curb a period of waiting, quench thirst or eat on the go. Now that self-service is so available to us, why not use vending machines to offer other products?

In the US, a bill seeking to revise the current Pharmaceutical Affairs Law to allow OTC vending machines is currently under final review by the Ministry of Government Legislation, before being submitted to the National Congress for approval.

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Of course machines selling OTCs such as condoms, feminine hygiene products and tights are already a common feature in pubs, restaurants, clubs and cinemas but there are many possibilities to extend the product range beyond these common items.

The amendments are expected to be passed without difficulty and will come into effect on 1st January 2017. They will allow pharmacists to sell OTCs through vending machines located outside their premises after conducting a consultation with consumers via video call through the machine.

Jacksonville are already one step ahead as Jacksonville Memorial Hospital recently started offering prescription medicines through an “Rx-to-go” kiosk in its emergency room. At the start of this month, three Jacksonville pharmacists also launched medical vending machines of their own which provide OTC medicines and personal hygiene products.

OTCs in Action Episode 32: ED in NZ, not .com

OTCinActionheaderIllegal internet sales of Rx and OTC drugs, as well as adulterated dietary supplements, put consumers at great risk. “Tainted Sexual Enhancement Products”, published on the FDA’s website, warns consumers:

“The FDA has identified an emerging trend where over-the-counter products, frequently represented as dietary supplements, contain hidden active ingredients that could be harmful. Consumers may unknowingly take products laced with varying quantities of approved prescription drug ingredients, controlled substances, and untested and unstudied pharmaceutically active ingredients. These deceptive products can harm you! Hidden ingredients are increasingly becoming a problem in products promoted for sexual enhancement. Remember, FDA cannot test all products on the market that contain potentially harmful hidden ingredients. Enforcement actions and consumer advisories for tainted products only cover a small fraction of the tainted over-the-counter products on the market.”

Last week, this blog’s sister publication, OTC.NewDirections, reported that an international crackdown on  illegal internet trade of medical products yielded $81.8mn worth of items from 115 different countries, and 156 arrests. In the UK, a record $25.1mn worth of counterfeit and unlicensed medicines and 15,000 devices was seized, including potentially harmful slimming pills, erectile dysfunction, anaemia and narcolepsy tablets. The US FDA took action against 1,050+ websites that illegally sell potentially dangerous, unapproved Rx medicines and medical devices.

In fact, regulators around the world are playing a high stakes game of Whack-a-Mole, a popular arcade game in which players hit cheeky little moles with mallets, but as soon as one is knocked out another appears elsewhere.

WHACK A MOLE_0However, the risky business is driven by consumer demand, and now OTCs are in Action in New Zealand to satisfy those needs safely and legally. One of the more common unapproved ingredients in the FDA’s list of adulterated products is sildenafil, more commonly known by its legal Rx brand name, Viagra. The Rx-to-OTC switch of Silvasta (sildenafil) erectile dysfunction treatment in New Zealand was approved in late 2014. Men aged 35-70 years can purchase Silvasta without an Rx following a screening process with a trained pharmacist. This spring Nicholas Hall & Company awarded Douglas Pharma its top marketing award for the launch of Silvasta. A consumer campaign includes TV ads featuring an “everyday” man explaining that help is at hand from pharmacies without the need to see a doctor, while a pharmacy finder website directs men to the nearest outlet.

Another interesting development that will ensure consumer access to safer drugs is the UK’s new requirement that online medicine sellers must be registered with the Medicines & Healthcare products Regulatory Agency. They must display on every page of their website the new European common logo, which will be linked to their entry in the MHRA’s list of registered online sellers. The medicine being offered online must be licensed in the member state where the purchaser is based, and the seller must be legally entitled to sell medicine in accordance with UK legislation. Registered pharmacies can sell general sales list and pharmacy medicines or supply Rx-only medicines that they have dispensed against a prescription. Other retailers can only sell GSL (self-selection OTC) products. The penalty for disobeying the registration and logo rules is up to two years in prison, a fine or both.

In an somewhat related matter, as it affects consumer safety and appropriate use of OTC medicines by reducing illicit methamphetamine manufacture, Acura Pharmaceuticals has entered into an agreement with OTC cold remedy giant Bayer to license its IMPEDE technology. IMPEDE technology, which is available in the US in Acura’s Nexafed, has demonstrated significantly reduced yields of methamphetamine compared to traditional formulations in lab tests and has been associated with a reduction in meth labs in local markets of up to 90%. OTCs in Action covered the launch of Acura’s Nexafed Sinus Pressure + Pain (pseudoephedrine and acetaminophen) in February.

Episode 17: Outwitting meth manufacturers