Sexual health OTC revolution

Building on the news covered in last week’s blog that Sanofi is planning to implement the US Rx-to-OTC switch of erectile dysfunction treatment Cialis by end-2024, this week we look at another major development in the OTC sexual health & fertility category – the announcement by the UK’s MHRA that it has launched a public consultation on the reclassification of two progestogen-only contraceptive pills containing desogestrel, marking the first time the agency has considered such a change.

MHRA is asking the public and stakeholders for their views on whether two continuous-use oral contraceptives – HRA Pharma’s Hana and Maxwellia’s Lovima, both as 75mcg film-coated tablets in 28-count packs – should become pharmacy medicines and available OTC, without a medical prescription (although, in parallel, desogestrel 75mcg will also remain available on prescription, with women potentially able to switch between prescription or pharmacy supply at different times). The agency notes that if the products are reclassified, pharmacists will have access to training materials and a checklist to help them to identify women who can receive the two medicines safely. Two separate consultations are open until 5th March (Hana link; Lovima link).

Following the switch of Adamed’s Maxon Forte (sildenafil 50mg) in Poland in early 2020, the rollout of OTC Viagra (Viatris) to Norway and Ireland in 2020, plus the EU centralised Rx-to-OTC switch of Fortacin (Recordati for Plethora Solutions) for premature ejaculation – formulated with lidocaine 150mg + prilocaine 50mg – in September 2020, the past year has seen a rapid expansion in the availability of OTC sexual health & fertility medicines. With OTC ED on the near horizon in the US market, the UK approval of the daily contraceptive pill as an OTC medicine could lead to a wave of similar approvals worldwide, and inject substantial growth into the global CHC market over the coming years.

CHC.NewDirections Consulting Editor, Nina Stimson adds: This really is an exciting proposal – not only a first for the UK, but also the first significant bid to offer oral contraceptives without prescription outside the Asia Pacific region – China and South East Asian markets lead the way, although sales in most markets are relatively small. If the proposal is approved, will UK pharmacists actively support the switch and help build OTC supply (and will the pharmacy protocol be sufficiently user-friendly not to push women back to the doctor)? And will any price differential between Rx or OTC supply be a factor? Not all ambitious switches in the UK have succeeded in the past, but we have high hopes for this one. Time will tell …

You can save up to GB£1,350 when you pre-order our forthcoming report from CHC New Products Tracker, Innovation in CHC: 2020’s NPD & Launch activity under the spotlight before 31st March! As well as looking in more depth at the latest OTC sexual health & fertility developments, the report also showcases the top 100 innovations in 2020 and features major ingredient trends, delivery format trends and much more. For more information, or to pre-order your copy, please contact melissa.lee@NicholasHall.com.

Sanofi CHC on track to be standalone unit by end-2022

At Sanofi’s Capital Markets Day 2021, the company’s Head of Consumer Healthcare, Julie Van Ongevalle, shared her vision for the business: “With the ongoing implementation of our fully integrated standalone model, we look forward to being more agile and reducing the complexity of our portfolio to drive growth with our consumer-centric, data-driven marketing approach.” The aim is to divest around 150 brands (from the current 250) in the next two years to focus on “priority categories”, such as allergy, body pain, general pain and mental wellness – particularly sleep aids – via a “granular approach”.

Rx-to-OTC switch has already been a key factor in driving growth in one of Sanofi’s priority categories, allergy remedies, thanks to the successful global OTC rollout of Allegra (first available in the USA in 2011) and launch of Xyzal Allergy 24HR (USA, 2017). Josephine Fubara, Chief Science Officer at Sanofi CHC, noted that Sanofi continues to make progress in bringing two potential OTC switches to the market in the coming years, erectile dysfunction treatment Cialis and flu antiviral Tamiflu, presenting a blockbuster opportunity with a combined sales potential of €1bn in the US market alone.

Source: Sanofi Capital Markets Day 2021 presentation

Sanofi also stated that it is on track with its plans to be a standalone CHC business by end-2022. The company said that the overall planning for the transition was complete, and that the majority of its standalone CHC legal entities would be operational by end-2021. Among the benefits that Sanofi believes this transition will bring include the agility to reignite its innovation engine and reduce time-to-market by around 20%.

Looking ahead, Sanofi is targeting above average market growth, driven by its focus on priority categories and Rx-to-OTC switch, with a view to becoming the best-in-market CHC performer by 2024-25. Supporting this objective will be a focus on consumer insights, an emphasis on e-Commerce and digital channels and the operational independence provided by Sanofi’s standalone model.

Save up to GB£1,350 when you pre-order our forthcoming report from CHC New Products Tracker, Innovation in CHC: 2020’s NPD & Launch activity under the spotlight before 31 March. The report showcases the Top 100 innovations in 2020 and features major ingredient trends, delivery format trends, and much more. For further details, or to pre-order your copy, please contact melissa.lee@NicholasHall.com.

Innovation: CES 2021 Health & Wellness Roundup

As our infographic this week indicates, health & wellness led the way in terms of high-quality innovation at this year’s CES (Consumer Electronics Show). Here, we highlight some of the new health & wellness products that were rewarded by judges for the key criteria of excellence in engineering, aesthetics and design, uniqueness, and the innovation they bring to the consumer market.

The winner of the Best of Innovation award in the health & wellness category was Epsy Health, a leading digital health platform for the management of epilepsy that “empowers patients, caregivers and healthcare professionals”. The Epsy app is free to download on both Apple and Android platforms, currently in the USA only, and helps in managing epilepsy by “creating a data rich diary to track seizures, medication compliance and triggers”.

The other level of recognition in each CES category is “Honorees”, i.e. products that score above the threshold in terms of innovation criteria for any given category, and there were several digital healthcare tools here, including Algocare, an IoT (Internet of Things) solution that provides personalised nutrition management at home and at work. Algocare Labs, based in South Korea, claims that the health questionnaires on the Algocare app and its unique algorithm, which analyses thousands of scientific journals, combine to deliver a tailored VMS mix to be dispensed via Algocare’s innovative device. Another CES Honoree was Oova, a high-tech home diagnostic fertility test, which measures luteinising hormone and progesterone in the urine, thanks to its cutting-edge test pads and supporting smartphone app.

Other notable consumer health & wellness innovations at CES 2021 included Flō, a handheld device for managing allergic rhinitis (or hayfever). When placed in the nose and activated, the company says the product projects lights to trigger reactions in the body which limit uncomfortable allergy symptoms. Marketer Fluo Health said it is seeking OTC approval from the FDA, and expects the device to be available to consumers later this year. Another medical device of note was Temp Pal, a smart thermometer from Taiwan-based iWEECARE, which is designed to be placed under the armpit of small children and transmits its readings wirelessly for remote monitoring – according to the company, it measures a child’s temperature within an accuracy of 0.05 degrees Celsius.

Explore the latest cutting-edge consumer healthcare devices, as well as major delivery format and ingredient trends, in our upcoming report from Nicholas Hall’s CHC New Products Tracker, Innovation in CHC: 2020’s NPD & Launch activity under the spotlight! Pre-order your copy before 31 March to save with a generous pre-publication discount. To find out more, please contact melissa.lee@NicholasHall.com.

Innovation powers Genomma OTC growth in LatAm, USA

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Ranking among the Top 50 globally and the No.5 CHC marketer in Latin America, Genomma continues to produce double-digit OTC growth. In its recently published Q2 2020 results, Genomma announced a 10.9% rise in net revenue in Q2 to Ps3.6bn (US$160mn). Adjusted EBITDA grew by 13.1% to Ps754.9mn (US$34mn; 20.8% margin). Mexican sales reached Ps1.5bn (US$67mn; +5.0%), while revenue from LatAm markets was up 8.8% to Ps1.6bn (US$71mn). Reversing the downward trend of recent quarters, sales from Genomma’s US operation grew by 47.8% to Ps478.4mn (US$21mn), attributed to a renewed focus on innovation, POS (point-of-sale) presence and A+P.

Overall, Genomma generates 54% of its revenue from OTC products, with personal care accounting for the remainder. Genomma now has a presence in 18 markets, and international expansion has fuelled the fast quarterly growth in its OTC portfolio (+32.2% in Q2 2020 vs Q2 2019), which offset a 6.5% decline its personal care sales. Mexico accounted for 38% of Genomma’s OTC turnover in Q2 2020, and quarterly sales in its home market fell 2.7%, however this was more than offset by 49.8% growth in LatAm sales (excluding Mexico), which accounted for 42% of its OTC portfolio in Q2, and 128.5% growth in USA sales, which now claim a 20% OTC share.

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Source: Genomma’s Q2 2020 Earnings Release

CHC Insight Latin America Assistant Editor, Jen Jones, commented: “Innovation was the buzzword in Genomma’s Q2 statement to investors. In Mexico, new categories include infant nutrition, sanitisers and shaving products, while in Brazil Genomma recently introduced the region’s first at-home HIV test kit. CCA was central to NPD in LatAm, including launches under the Next banner in Brazil, Argentina and Colombia, as well as the rollout of Tukol cough remedy to new regional markets.”

According to our CHC New Products Tracker service, after a quiet year in 2017, Genomma significantly ramped up NPD activity in 2018 and 2019, and this investment is now being reflected in strong organic OTC growth. While Brazil and Argentina were the main sources of launch activity in that period, the US market has also been a growing focus, with line extensions to skin care brands Lagicam (antifungal), Asepxia (acne remedy) and Cicatricure (aesthetic treatment), as well as additions to the Next systemic cold & flu range (Daytime Relief and Nighttime Relief).

Thousands of innovations are launched every year in the global consumer healthcare market, but relatively few offer notable new benefits for consumers in terms of delivery format or formulation. Which new products are breaking through and offering a unique proposition? Where will new product development take the CHC market in future? Contact Melissa Lee (melissa.lee@nicholashall.com) today to pick up your copy of the Innovation in CHC report.

Immunity sales & NPD activity on the rise

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One of the newer CHC subcategories that appeared in the Top 10 biggest contributors to global consumer healthcare growth in the MAT Q1 2010 period was immune supplements, with the subcategory producing a 28.5% global upturn in the year to end-March 2020. Along with vitamin C products, probiotics and multivitamins, immune supplements were among several major VMS contributors to growth in the first quarter.

For 2019, our CHC New Products Tracker service recorded 95 new product developments in the herbal & natural immune stimulants subcategory, making it the 14th most active subcategory overall in the consumer healthcare market. So far in 2020, immune supplements are already in the Top 10 most active subcategories – a sign of the rapid increase in new product development in response to the Covid-19 pandemic – and we fully expect this growth in NPD activity to accelerate over the remainder of the year.

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There has been a wide array of immunity NPD activity across all regions, notably Europe, North America and Asia-Pacific. In certain markets, such as India and China, there is also likely to be a rise in sales of country-specific natural remedies (Ayurvedic medicine and TCM) positioned for immunity support, though marketers will have to be wary of government clampdowns on products that are claimed to prevent or cure Covid-19.

Notable immunity supplement launches in the USA so far in 2020 include GSK’s Emergen-C Turmeric & Ginger and Emergen-C Elderberry, available in fizzy drink mixes, and RB’s Airborne Immune + Natural Energy Ready To Drink Shot. In Europe, Neuraxpharm unveiled Preventan Clasic in Spain and Italy, while Sambcol Immuno Forte and Sambucol Kids + Vitamin C were rolled out in Germany. As for Asia-Pacific, Grandma’s Kadha effervescent tablets were launched in India and Sanofi’s Cenovis line was relaunched in Australia.

Thousands of innovations are launched every year in the global consumer healthcare market, but relatively few offer notable new benefits for consumers in terms of delivery format or formulation. Which new products are breaking through and offering a unique proposition? Where will new product development take the CHC market in future? Contact Melissa Lee (melissa.lee@nicholashall.com) today to pick up your copy of the Innovation in CHC report.

NPD activity in CHC in Q1 2020

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At the same time as our DB6 division publishes data on the sales performance of the global CHC market in the first quarter of 2020, it’s also a good time to reflect on headline new product development trends in the period from January to March 2020, using our CHC New Products Tracker tool which covers 20 key markets. The major development that stands out this year is the dramatic fall in the volume of new product development (NPD) in March 2020, compared to the same month in the three previous years.

March is traditionally the month we see a sharp rise in NPD activity after the quieter month of February, but this year Covid-19 halted that trend. So far for March 2020, we only have 271 entries – including launches, Rx-to-OTC switches, line extensions, rollouts and relaunches – recorded in our Tracker archive, compared to much higher totals in March 2019 (464 entries), March 2018 (434) and March 2017 (397).

This sharp fall in global NPD activity in March 2020 is likely the result of CHC marketers shelving plans to launch new products in response to the uncertainty caused by the Covid-19 pandemic. The question is whether these plans have been postponed or abandoned altogether? We know that several CHC companies have streamlined their portfolios during the pandemic to ensure continued production of core SKUs, so it’s possible portfolio innovation has fallen down the priority list. Alternatively, we may see a surge in NPD activity in the remainder of 2020. Only time will tell.

What will also be interesting to see play out is how NPD activity in 2020 differs in terms of its focus on fast-growing subcategories, fuelled by the Covid-driven spike in demand. For example, we saw an increasing number of antiseptics & disinfectants launched in March 2020, compared to the same month in previous years. This trend will likely be replicated in other subcategories, such as herbal & natural immune stimulants, when we come to analyse NPD activity in Q2 2020 and later quarters.

Thousands of innovations are launched every year in the global consumer healthcare market, but relatively few offer notable new benefits for consumers in terms of delivery format or formulation. Which new products are breaking through and offering a unique proposition? Contact melissa.lee@nicholashall.com to secure your copy of Innovation in CHC, a report showcasing many of the “wow brands” launched in 2019 and highlighting ingredient and delivery format trends that continue to characterise the market in 2020.

 

Time’s 100 Best Inventions of 2019

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Time magazine has just published its annual round-up of the 100 best innovations – based on key factors such as originality, creativity, influence, ambition and effectiveness – and healthcare was the best represented category with 10 innovations in 2019. Most have been designed for use in primary care settings, such as GE Healthcare’s new Senographe Pristina with Dueta mammogram, but there were several innovations designed for consumer use.

One of these is Tivic Health’s ClearUp, which was added to our OTC New Products Tracker database following its launch in September 2019. Positioned as a drug-free handheld device to treat sinus pain owing to allergic rhinitis, ClearUp delivers microcurrent waveforms to sinus nerves under the cheek, nose and brow bone. The medical device provides three intensity levels for personalised usage, and each treatment takes five minutes to perform and lasts for up to six hours.

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Tivic Health’s ClearUp for sinus pain

Also on the Time Best 100 Innovations of 2019 list were portable ultrasound device Butterfly iQ, Theranica’s drug-free migraine treatment Nerivio and handheld doctor examination kit TytoCare. The latter retails for US$299 and has been designed to eliminate the need for a doctor visit by examining the lungs, ears, skin and throat with special adapters and then video­conferencing a doctor to monitor the metrics in real time. According to TytoCare CEO Dedi Gilad: “It transforms primary care by putting health in the hands of consumers.”

As for Nerivio, it was described as the “first smartphone-controlled acute migraine-relief wearable device” when it gained de novo FDA approval in May 2019. The medical device, which is not suitable for people with chronic migraine, is placed on the upper arm and uses smartphone-controlled electronic pulses to create a Conditioned Pain Modulation (CPM) response. Alon Ironi, CEO and co-founder of Theranica, has said the product will be launched at an “affordable price” when it comes to market in 2020.

Don’t miss out on the chance to save 30% on a subscription to the ultimate tool for tracking consumer healthcare innovation, OTC New Products Tracker! We’ve recently hit over 20K entries and made some innovative improvements within the past year, including powerful new graphs, additional filter options, PowerPoint export, Save & Search options and monthly customised innovations reports. Until the end of 2019 we are offering an exclusive 30% discount off list price — please contact waisan.lee-gabell@nicholashall.com to find out more!

New technology and innovation to revive acne sales?

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For several years, the OTC acne remedies category has been in the doldrums. Global sales grew by just 1.9% in 2018, and the CAGR for the subcategory over the 2014-18 period is a lowly 1.6%. This poor performance is largely related to the US market, where sales of acne remedies fell by 1.4% to US$514mn in 2018.

That’s why the recent news that L’Oréal’s skin care brand, La Roche Posay, has introduced Effaclar Adapalene Gel 0.1% Acne Treatment, is very timely. Retailing for US$29.99 for a 45g tube, the topical retinoid once-daily medication is indicated for the treatment of acne in people aged 12+. The brand has also launched La Roche-Posay My Skin Track PoreScan, an AI-powered skin analysis tool (similar to Effaclar Spotscan, launched earlier in 2019) that can make personalised skincare recommendations for those concerned with clogged pores, raised imperfections and residual marks. 

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OTC.NewDirection‘s Consulting Editor, Nina Stimson, commented: “This is a major step for La Roche Posay and parent, L’Oréal, known worldwide primarily as a cosmetics player. Adapalene’s switch to OTC (at 0.1% Rx strength) as Differin Gel (Galderma / Nestlé) was approved in the USA in July 2016 as the first retinoid drug for the OTC treatment of acne, with adapalene acknowledged as the first new active ingredient for that OTC indication since the 1980s. This launch comes exactly three years later, as Differin’s exclusivity ends, and sees La Roche Posay / L’Oréal move right to the front line of registered OTC acne treatment. Differin Gel OTC sales have probably disappointed against expectations (although Nestlé’s Proactiv has also added an adapalene option to its DTC lineup) and other adapalene gels will undoubtedly also appear on US store shelves. Full marks to L’Oréal for prompt action.

There are also signs of renewed dynamism in Latin America thanks to strong investment in NPD from key marketers like Genomma. In June 2019, the company unveiled an innovative new acne remedy, Asepxia Maquiagem Liquida Autoajustavel, which features a unique technology that allows the product to adapt to various skin tones. Sold as a 30ml liquid, this latest addition to the Asepxia line is positioned to reduce acne and even skin tone, as well as mattify the skin and cover blemishes. New technology and innovation hold the key to unlocking future growth in this important OTC subcategory.

Birgit Schuhbauer, VP Global Franchise OTC and EMEA Region at J&J will take to the stage at Nicholas Hall’s OTC.NewDirections Executive Conference to explore how, with new consumer marketing opportunities with digital tools, we are Getting Closer to the Consumer than Ever. Taking place in London on 14 November 2019, the meeting will ultimately focus on the latest CHC Innovations and Technologies with presentations from companies also including Bayer, Prohibition Partners and Mundipharma. Save when you reserve your place now at the early bird booking rate. For more information, or to book your place, please contact elizabeth.bernos@NicholasHall.com.

Tracker hits 20,000 innovations

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Our sister product OTC New Products Tracker has hit a significant milestone – 20,000 innovations added to a database that tracks consumer healthcare launch activity all the way back to the start of 2013, across 20 key markets. In this week’s blog, we look back at some of the highest-ranked innovations added to the archive over the past year.

A recent 4-star innovation is medical device Flow from Flow Neuroscience, a first of its kind home treatment on the European market. Positioned as a non-medicated alternative treatment for depression, the medical device comprises a brain stimulation headset and a therapy app. While stimulation is in use, the app acts as a virtual therapist that the user can interact with. Available in the UK since summer 2019, Flow retails for £399.

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Adjacent OTC categories have been fuelling the fire of consumer healthcare innovation in recent years, with medical cannabis / CBD and probiotics two of the most active categories in terms of launch activity. US marketer CBDfx is arguably the most pioneering innovator among the new wave of medical cannabis companies, launching several new delivery formats over the past two years, including vaping pens (January 2018), “chill shot” drinks for anxiety (March 2019), sublingual hemp strips (April 2019) and acne face masks (June 2019).

Like CBD, probiotics have also enjoyed high levels of innovation in terms of delivery formats and positioning. Two examples of probiotics targeting a new consumer healthcare niche include Elebiotic, a recent Recordati launch in Spain positioned to manage recurrent acute otitis media in infants, and Khan’s Morning, a probiotic launched in South Korea in early 2019 that is claimed to help break down the alcohol and acetaldehyde that causes hangovers.

Review 20,000+ launches and innovations with OTC New Products Tracker, the ultimate competitive intelligence tool! Products are graded with a star rating, from 1* (essentially “me too” and generics) up to 4* (1st Rx-to-OTC switches in a category, creation of a new OTC class or other major leaps in innovation). 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, please contact waisan.lee-gabell@NicholasHall.com.

OTC Innovation Report 2018

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Lamenting the fact that Scott Gottlieb is stepping down as FDA Commissioner, Nicholas Hall commented in Friday’s OTC.Newsflash that: “Although producing few tangible results so far, FDA under Gottlieb has displayed a greater openness to finding new switch models at a lower cost and with shorter lead times, including the use of new technologies.” Nicholas Hall also said that “government support is vital to our industry” and that “more liberal regulations are at the heart of a successful self-care sector”.

A drop-off in switch activity over the past year is part of the explanation for lower levels of high-quality OTC innovation. In 2018, OTC New Products Tracker awarded just six products with 4 stars – eye care brands Lumify (USA) and Zabak Eye Drops (Poland), antacid Reza Band (USA) and antispasmodic Scopolan Compositum (Poland), plus Viagra Connect (UK) and allergy remedy Talerc (Brazil). Compared to previous years, this marked a falling-off in terms of 4-star innovations.

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The number of total OTC innovations (3,747) in 2018 was roughly in line with the previous year, and still much higher compared to 2014, 2015 and 2016. However, the number of 2* (528), 3* (94) and 4* (6) innovations was much lower, while the number of 1* innovations (3,119) was at an all-time high.

VMS continues to be a major source of innovation, with three of the Top 5 subcategories in 2018 – probiotics, multivitamins and hair & beauty supplements. Derma is another key source of innovation, with three of the Top 10 – acne remedies, eczema & psoriasis and lip care. The three other innovative subcategories which complete the Top 10 are sedatives & sleep aids, topical analgesics and sore throat.

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Please contact us for the full report. You can also review 17,000+ new launches and innovations 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 requirements, now is the ideal time to set up your free trial. For a demo or more information, contact waisan.lee-gabell@NicholasHall.com.