MAT Q1 2018: Global OTC growth steady at 4.1%

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According to Nicholas Hall’s global OTC database, DB6, the OTC market maintained 4.1% growth in the 12 months to end-March 2018. This steady but slower rate of global OTC growth compares to a faster pace during the first three quarters of 2017, when growth peaked at 4.6%.

The key factor in the persistent slowdown in Q1 2018 was lower OTC growth in the USA (+2.5% vs +2.8% for calendar 2017), with faster development held back by a weak allergy season. As highlighted in our OTC DASHBOARD market summary for North America, the impact of recent Rx-to-OTC switch activity in the US market has also been minimal.

Some positives emerged in the MAT Q1 2018 data. OTC growth in Western Europe improved to 1.8%, boosted by a high incidence of cough & cold in the first quarter of this year, while Latin America’s OTC market continued to increase strongly (+11.8%), with leading country Brazil up by 9.8%.

The OTC performance in Asia-Pacific (+4.7%) was mixed, with China (+6.3%) and India (+7.9%) improving upon their 2017 growth, however Japan and Australia remained flat in Q1 2018. Growth in the Middle East & Africa remained stable at 6.7%, while Central & Eastern Europe decelerated further to 5.5%, with weakening growth in both Russia (+3.5%) and Poland (+3.3%).

If you are not a subscriber and would like to find out more about what DB6 covers, please contact kayleigh.griffinhooper@NicholasHall.com for a free demo.

 

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Further FDA delays to NSURE guidance on Rx-to-OTC switch

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One of the key topics at our North American OTC Conference to be held in Morristown, New Jersey this week (20-21 June) is Rx-to-OTC switch, and opportunities for marketers in the dynamic US regulatory climate. Hopes that the FDA would publish guidance this year on the Nonprescription Safe Use Regulatory Expansion (NSURE) were recently dashed after the Notice of Proposed Rulemaking date was changed to February 2019.

NSURE was introduced in 2012 to encourage utilisation of technology to “ensure” the safe use and self-selection of innovative Rx-to-OTC switches, but the programme has been stalled for several years.

At the Consumer Healthcare Product Association’s recent Regulatory, Science & Quality meeting, FDA Deputy Director for Regulatory Programs, Dr Doug Throckmorton, assured attendees that the 5-year delay had “nothing to do with our interest and support”, but was a result of administrative priorities. He encouraged sponsors to bring ideas to the FDA. This request has been voiced for several years, but manufacturers appear to be waiting for the draft guidance.

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For those that can’t make this week’s meeting, Nicholas Hall’s Opening Address will be live-streamed here at 8.30-9.10 on Wednesday 20 June.

Following this, you can also view these live presentations:

Dave Wendland, Hamacher Resource Group, will be presenting on Independent Pharmacy Opportunity: Myth or Reality? on Wednesday 20 June 09:40-10:10 here 

Join the CHC Institute Launch with Steve Sowerby and Ed Rowland on Wednesday 20 June 14:15-15:15 here 

See Joseph McGovern, Everything Health, review the Key Issues of Switch on Thursday 21 June 09:00-09:30 here 

Plus, join Everything Health’s Mary Alice Lawless & Joseph McGovern to review how you can Change the Words to Change the World in the move from OTC to Non-Prescription, followed by Nicholas Hall’s Summary & Close of the meeting on Thursday 21 June 12:40-13:30 here 

All timings EST. To ensure you enjoy the event in full (download the brochure here), including panel sessions and networking opportunities, reserve your place now by contacting lianne.hill@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

Q3 2017: Global OTC growth stays at 4.7%

According to the latest figures published by Nicholas Hall’s global OTC sales database DB6, the OTC market maintained 4.6% growth in MAT Q3 2017. Commenting on the results, DB6 VP Celine Waller said: “Russia remained the fastest-growing leading market, though its growth slowed slightly compared to MAT Q2 2017 (+17.3%). Brazil and Turkey (+13.1%) also both achieved double-digit growth. Growth in the US increased marginally, with an improved performance in cough & cold offset by continued weakness in gastrointestinals and dermatologicals. France and Australia (-0.7%) remained in decline – France owing to the poor performance of the large OTx sector and reverse switch of some cough ingredients, and Australia driven by a slowdown in demand from Chinese consumers buying VMS products for resale in China (daigou or ‘suitcase entrepreneurs’).”

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Though OTC growth remains high in many of the Emerging Markets, the established markets of North America, Japan (+0.6%) and western Europe – notably Germany (+1.8%), France (-1.2%), Italy (+2.0) and UK (+1.7%) – remain relatively flat. Innovative Rx-to-OTC switches, such as the UK MHRA’s recent approval of the POM-to-P reclassification of Viagra Connect, or the emergence of new OTC categories, such as e-cigarettes or medical cannabis, offer the most promising route back to growth for many of these established OTC markets.

Nicholas Hall said: “Q3 data confirms 4.6% as the baseline for CHC growth, and frankly it’s not good enough!! Only the sleepiest or most risk-averse companies will accept competing in a market where growth is only modestly ahead of inflation + higher population. That is why the first serious step by Pfizer to switch Viagra is so important. Since we made our first detailed review of the ED category for a Big Pharma client exactly 5 years ago, we have been convinced that Viagra is potentially the world’s largest consumer health brand. Some might say that it already is, although that would be true only for the use of the Viagra brand name on the internet as most of the blue pills sold in that channel are not from Pfizer. As a legitimate CHC category, and with recreational use included — which Big Pharma companies dislike as they see ED brands as treatments — the overall CHC reproductive health category, including ED brands, condoms, oral contraceptives, EHC and conception products and diagnostics, could easily reach sales of US$20bn at MSP in all channels of distribution.”

World first digital pill gets FDA green light

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Otsuka (in association with Proteus Digital Health) has been granted approval by the US FDA for Abilify MyCite, the world’s first digital pill, which contains a sensor that tracks when the medicine has been ingested by the patient. Though Abilify is an Rx medicine for schizophrenia and bipolar disorder, its approval has far-reaching implications for both prescription drugs and consumer healthcare.

How it works: Containing a sensor the size of a grain of sand, Abilify MyCite emits an electrical signal when it comes into contact with stomach acid, and this signal is received by a patch on the patient’s rib cage. In turn, this patch communicates with a smartphone app via Bluetooth, providing data such as time of ingestion and dosage. As well as the doctor and patient, up to 4 other people (including family members) can have access to the app’s data – though, importantly, the patient has control and can revoke access.

 

Mitchell Mathis, Director of the Division of Psychiatry Products at the FDA’s Center for Drug Evaluation & Research, said: “The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers.” Inevitably, during the initial phase, the digital pill will be incorporated solely into Rx medicines – to allow the FDA to monitor its impact on safety and adherence – however, at a later date, there is nothing to stop this new technology being part of innovative Rx-to-OTC switches.

Patients, doctors and insurers are increasingly coming to appreciate the ability to access objective data about the whole range of our medical consumption – from Rx drugs to OTCs and supplements. Once the price of these new sensors is reduced to a certain level of affordability, we could see a much wider rollout of the technology.

That said, a major stumbling block could be the issue of privacy. Some are concerned that patients who fail to take their medicines on a regular basis may be punished by their health insurers, while others have worries that the technology could be used as a coercive tool against certain types of patients. However, those concerns aside, the future for healthcare looks increasingly digital and the FDA is already hiring more staff in anticipation of a raft of new applications for digital pills.

OTC hearing aids: Awaiting US Senate vote

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Cheaply priced reading glasses have long been available to buy without prescription in supermarkets and pharmacies. While there is an available OTC product for some living with farsightedness, there is still yet to be an approved inexpensive over-the-counter equivalent for those living with mild-to-moderate hearing loss.

Medicare and most private insurance plans in the US do not cover prescription hearing aids, which cost around $2,400 for one device. Owing to this, it is thought that many people with hearing loss go without hearing aids because they cannot afford the devices.

This could be changing soon, as the House of Representatives has passed legislation that would create a new class of hearing aids that could be sold OTC.

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“We get inquiries every day from people who cannot afford hearing aids,” said Nancy Macklin, a spokeswoman for the Hearing Loss Association of America. According to a 2016 study from the National Academies of Sciences, Engineering & Medicine, just 14% of those with hearing loss use a hearing aid.

While there are several types of less expensive non-prescription personal sound amplification devices on the market, the devices are not regulated by any government entity for safety or quality standards and are used to aid people with normal hearing but wish to amplify sound.

Recent advances in technology have made the concept of less-expensive, OTC hearing aids very possible. The potential switch is part of the FDA Reauthorization Act of 2017, which the House passed Wednesday with a voice vote. The bill received widespread bipartisan support, but the Senate has yet to announce a timeline for holding a vote on the bill.

The arrival of OTC hearing aids can’t come soon enough for an ageing population that is continually growing. As Baby Boomers age and Generation X hits middle age, the number of people with mild to moderate hearing loss is increasing rapidly.

NHC North America Conference: Day 2

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Here’s the second and final blog review of our recent regional North American OTC Conference, which took place last week at The Westin Governor Morris hotel in Morristown, New Jersey.

Our first speaker on Day 2, Bernie Simone, Head of Rx-to-OTC Switches NA, Sanofi, discussed the growth engine for consumer healthcare and improved consumer self-care relating to Rx-to-OTC Switch, and highlighted how 43% of OTC industry sales are associated with a Switch, with almost half of proposed Switches failing. Bernie also explained the concern that Switch will no longer be possible if the medical community does not approve, and so it is imperative that we as an industry think of new initiatives to involve communities in the earlier stages of the Switch process in order to identify viable and novel Switch candidates.

Following Bernie on stage was Chuck Jolly from Baker Donelsen, who reviewed legal risk amelioration strategies that can be adopted by marketers to safeguard their practices, leading us into our first networking hour of the day.

Vidhu Dev, VP, Rx-to-OTC Switch & R&D, GSK, then gave us an informative outlook on Switch overseas and the likely future challenges and successes, before focusing back on the local US market – for example, the US OTC allergy market has continued Switch activity, is highly competitive and dominant. Vidhu also identified possible categories for OTC switch candidates, such as antifungals, anti-diabetics and cough & cold, and the evolving role of the pharmacist will be integral in making this possible.

Our panel then took to the stage, debating the establishment of collaborative relationships with payer, retail and CPG entities to put the consumer first and deliver superior outcomes.

Shannon Huneke of UHC, Colleen Lindholz of Kroger & Chris Jobes of J&J came together to discuss their collaboration in the healthcare ecosystem. Together they discussed their marriage of information on consumer insight and their segmentation of this, and how this equips them in the battle against industry challenges, and transforms the behavioural science behind consumer healthcare. The panel also mapped the patient’s journey through their condition, with each journey presenting an opportunity to translate individual patient requirements. They concluded by asserting that we can’t get where we want to be in healthcare without partnerships – and if we can create a healthier population, we all win!

Our unplugged panel session continued as Christina Speck, Head of Brand Partnerships & Sponsorships, Aetna, and Brian Doherty, Executive VP, Managing Director, Ogilvy CommonHealth, joined forces to discuss partnerships, technology and engaging healthcare consumers in the real world. Together Christina and Brian discussed consumers living in a digital age, with Christina mainly focusing on Aetna’s partnership with Apple products and apps. Christina highlighted how healthcare and well-care are not exactly fun (but they should be!), which is where the combination of technology creates a vision for this, connecting clinical and well-care, and demystifying healthcare communications.

Our panel discussions certainly gave some food for thought in time for lunch, with many delegates taking the time to discuss and debate the key learnings with industry peers. Returning from lunch, we saw Walmart executives Alex Hurd, Senior Director of Health & Wellness Transformation, and Jamie Grace, Senior Director & Merchandise Manager, explore the role of retail in providing access to high quality care at lower costs.

John Delfs from The Foundation for Health Smart Consumers shared with the audience the need to empower consumers through motivation and collaboration with HCPs, and was followed by Randy Vogenberg from the National Institute of Collaborative Healthcare, who gave us an insight into access trends for OTCs, delving into innovation, incubation and implementation.

Mary Alice Lawless, from our conference partners, EverythingHEALTH, then took to the stage to identify and analyse new strategies for unlocking the next generation of Rx-to-OTC Switch, before an esteemed panel of moderators debated the next steps in consumer healthcare transformation. Panellists included Joseph McGovern of EverythingHEALTH, Andrea Leondard-Segal, former FDA Director of the Division of Nonprescription Clinical Evaluation, Helmut Albrecht, President of H2A-Associates, and Dennis Tze, Biograph Inc. Together they asked whether we should provide case studies for the Switch industry, questioning how we can enhance changes in Switch through branding and digital.

Overall our first North American conference was a real success, with a fantastic turn out, excellent insights, a riveting display of speakers and plenty of industry knowledge. We certainly hope to see you next year and thank you all for joining us in this first time North American conference experience!