Poland approves world-first OTC switch of tadalafil

We continue with the theme of Rx-to-OTC switch this week with news from Poland, where the Office for Registration of Medicinal Products, Medical Devices & Biocidal Products (URPL) has approved Adamed’s Tadalafil MaxOn ED treatment (tadalafil 10mg; film-coated tablets; 2- and 4-count SKUs) as an OTC medicine, effective 1st February 2022. This will join Adamed’s sildenafil options MaxOn Active (25mg) and MaxOn Forte (50mg), which launched in May 2016 and April 2020, respectively. Tadalafil is claimed to get to work within 30 minutes for up to 36 hours, vs claims for sildenafil that it works within 30-60 minutes for up to five hours.

Poland was again one of the most active Rx-to-OTC switch markets in 2021, with only China ahead of it last year in terms of number of launched products reclassified from prescription to OTC status. Three of the six products launched post-switch in Poland in 2021 were erectile dysfunction treatments, including Hasco-Lek’s Mensil Max, Aflofarm’s Inventum Max and Polpharma’s Maxigra Max (all sildenafil 50mg). In addition, there were two digestive health switches – Teva’s antidiarrhoeal Gastrolit and Polpharma’s antacid Famotydyna Ranigast – and Polpharma’s cold sore treatment Heviran Comfort Max.

Source: Nicholas Hall’s CHC New Products Tracker

Nicholas Hall’s Touchpoints: Last week our lead story was the likely switch of HRT in the UK, which we singled out as a pioneer. The latest news this week is from Poland, another switch centre of excellence and where the ED treatment tadalafil will be available in a non-prescription version for the first time anywhere in the world. Tadalafil was launched as a prescription medicine under the trademark Cialis, and Sanofi later acquired the CHC rights from Lilly, but the switch application in the USA has been held up for many years by the FDA.

My colleague Maryna Marriott of the CHC Insight Europe team tells me: “Poland continues to lead the way in switch innovation. The tadalafil approval follows a number of sildenafil 25mg and 50mg switches, with the Polish ED category totalling US$27.7mn in MAT Q3 2021, according to DB6, an increase of 28.5% vs the year-ago period. Men’s health clearly remains high on the consumer health agenda, and it seems likely a number of other tadalafil switches will follow in Poland.”

Switch is an expensive process in the USA, which is why it is subdued there at present. On the other hand, there has been renewed switch activity in Europe and parts of Asia. The problem for the CHC industry has always been that the benefits given to US companies gaining switch status – the cost to the patient-as-consumer drops substantially and there is often three years marketing exclusivity, whereas the ingredient can no longer be prescribed for the same indication – are not available to marketers in the rest of the world. That leads to the curious situation of some switches being regulatory wins but commercial failures. Let’s hope that Adamed is blessed with decent sales for its latest innovation.

Find solutions for success in this competitive CHC landscape with Nicholas and the team in Athens on 4-6 May 2022 for our 32nd European CHC Conference & Action Workshop! Meet with peers and hear from industry experts, including sessions from Bayer, Teva, J&J and many others face-to-face! For more information, or to reserve your seat, please contact elizabeth.bernos@NicholasHall.com.

Estradiol to switch to OTC in UK?

The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) has launched a consultation on proposals to reclassify Danish-based Novo Nordisk’s Gina (estradiol 10mcg) vaginal tablets. This would mean that for the first time, women in the UK could access a local hormone replacement therapy at a pharmacy without a prescription. The tablets treat vaginal atrophy, which can cause dryness, soreness, itching, burning and painful intercourse. It affects around half of post-menopausal women, but many do not discuss the problem with their doctor.

The consultation seeks views from general practitioners, pharmacists and the public on making Gina available OTC to women aged 50+ years who have not had a period for at least one year. The MHRA stressed that as this is the first time such a change has been considered, it is important that as many opinions as possible are heard.

Proposed labelling for Gina. Source: MHRA

Nicholas Hall’s Touchpoints: When I read this story, my first reaction was concern about the safety profile of a consumer version of this formulation. I’m reassured by the Commission on Human Medicine’s statement that “it is safe for this product to be made available as a Pharmacy (P) medicine”, but I can fully understand why the MHRA is consulting widely. In fact, there seems to be a decent measure of consumer and professional support for the switch as far as I can tell.

Coming hard on the heels of last year’s switch of the daily oral contraceptive in the UK, Novo Nordisk’s Gina – if approved – will be launched into an important intersection of sexual and women’s health. Women are responsible for 60% of CHC consumption globally, but with relatively few specific products designed for them, and account for about 85% of purchasing. It also reminds us that the UK is now the premier switch market in the world, at a time when our industry’s interest in switch is at an all-time low.

For a more detailed consideration of the consultation process and the pro’s and con’s of this switch, please read CHC.NewDirections. The markets for contraception, intimate care, pregnancy and fertility products, among others, are also explored in our newly-published Sexual Health & Fertility report. For further details, or to place your order, please contact melissa.lee@NicholasHall.com.

NielsenIQ’s “Global Consumer Outlook”: Agility crucial in 2022

The pandemic may be entering its third year, but there are signs that governments are gearing up to living with Covid-19. NielsenIQ’s 2022 Global Consumer Outlook delves into consumer sentiment and spending, revealing how people will shop in the year ahead. With employment disruptions, supply chain breakdowns and varying recovery scenarios, the trends setting the tone for consumer behaviour in 2022 include:

  • Consumers will move towards an endemic mindset 
  • Virus variants will fuel different recovery trajectories
  • Inflation concerns will take a toll on consumers; prepare for continued global consumer spending constraints
  • New-found consumer priorities born out of the pandemic will not be compromised. Consumer prioritisation of health, wellbeing & financial security will take centre stage 
Source: NielsenIQ
  • Consumer spending intentions reflect a continued homebody lifestyle with cautious approaches intensified by inflationary pressures. Leisure & entertainment will continue to take a backseat against an ongoing Covid backdrop
  • Necessity will be a driving force. Consumers will bring added scrutiny on expenses that fall beyond priorities & necessities

For the full Outlook, click here.

Nicholas Hall’s Touchpoints: The NielsenIQ 2022 edition of “Global Consumer Outlook” is timely as we start to think again about a possible end of the pandemic. The NielsenIQ team concludes: “In the year ahead, agility will be critical. Retailers and brands that consider different trajectories and recovery scenarios will be better placed to address consumers’ changing priorities, states of cautiousness and increasingly constrained wallets. They must ensure their offerings can morph and resonate with how the landscape will continue to evolve in the years to come.”

One of the trends that we have observed in the USA, but not in other regions to the same extent, is a prioritisation of healthcare spend by consumers on products with tangible benefits. So for the first time in some years, we’ve seen more of the growth categories focusing on treatment than prevention. Is this a blip or the start of a longer-term trend? It’s too soon to tell!

An added complication is the weakness of the global economy and the predicted rise of inflation, which are putting more pressure on consumers, who in general will have to prioritise their shopping even more than in the past. So which consumer health products will they purchase in what may be a slimmed-down overall shopping basket? And a further knock-on effect may be a reduced interest in supporting sustainable products. The survey reported in our third lead story (below) is encouraging, but the practicality might be that consumers with less disposable income then before may not be able to prioritise these products, even though this remains their ideal.

These and many other issues are in the front of our minds at the moment as we begin to scope the 4th edition of our New Paradigms report (subtitled “A Return to the New Normal”) later in 2022.

Unilever still seeking expansion in CHC

Pressure has been building on Unilever over the weekend, with Nelson Peltz’s activist hedge fund Trian Partners reportedly taking a position in the UK group’s shares, adding to the challenges facing CEO Alan Jope. The Unilever boss is already facing brewing shareholder discontent after its attempted takeover of GSK Consumer Health, and now confronts a fierce activist fund known for demanding streamlining and governance reforms at consumer goods groups including P&G, Sysco and Mondelez.

Following a third unsolicited bid for GSK’s Consumer Healthcare business last week, Unilever brought forward an update setting out its strategic direction. An extensive review by the Board to reposition Unilever’s portfolio into higher-growth categories concluded that the FMCG player’s future strategic direction lies in “materially expanding its presence in health, beauty and hygiene”. The company added that consumer health was a “highly complementary category, with good potential for synergies and a number of routes to build scale”.

As our CHC New Products Tracker tool indicates, the priority brand for Unilever over the past two years has been supplement Olly, which has been expanded beyond its initial US launch market into the key growth market of China. Unilever has also invested in NPD for fellow supplements SmartyPants and Liquid I.V., since acquiring both brands in 2020, as well as Derma brands Vaseline and Lifebuoy, and there is clear scope for Unilever to expand its CHC portfolio further both geographically and in terms of category focus.

Nicholas Hall’s Touchpoints: Unilever’s latest offer for GSK CH, received in December 2021, was for a total value of £50bn (US$68bn), which the GSK Board unanimously concluded “fundamentally undervalued the business and its future prospects”. Following the publication of Unilever’s strategy update, it initially looked like the company would make a sweetened offer. It stated: “GSK CH would be a strong strategic fit; 45% is in oral care and VMS — categories in which Unilever already has presence and substantial capabilities. OTC would be an attractive adjacent category, with the ability to combine Unilever’s consumer and branding expertise with GSK CH’s technical OTC capabilities.”

However, Unilever faced a growing backlash from investors, with its shares falling and ratings agency Fitch warning it could downgrade the company’s “A” credit rating if it proceeded with the deal, which would likely raise debt. A few days later, the company announced: “We note the recently-shared financial assumptions from the current owners of GSK CH and have determined that it does not change our view on fundamental value. Accordingly, we will not increase our offer above £50bn (US$68bn).

Unilever has laid its cards on the table though and will no doubt be on the lookout for another CHC target. Meanwhile, GSK maintains that the “focus remains on executing the proposed demerger, which is on track to be achieved in mid-2022”, although analysts note that the MNC may consider a deal worth around £60bn (US$82bn). It remains to be seen whether other suitors, potentially thought to include Nestlé and private equity, will make a move.

Innovation trends by region will be analysed in the latest edition of Innovation in CHC from CHC New Products Tracker. This report will also take a look at delivery format trends, offer the Top 100 innovations from 2021, as well as innovation by leading marketers. To pre-order your copy and save with the pre-publication discount, or for further information, please contact melissa.lee@NicholasHall.com.

Japan birth rate in steep decline, femtech on the rise

The birth rate in Japan is declining faster than expected, with the number of babies born in the country in 2021 estimated to have fallen to around 805,000, a figure previously predicted for 2028, according to calculations by The Asahi Shimbun. Meanwhile, the latest government figures show the number of Japanese aged 20 years on 1st January 2022 fell 40,000 from 2021 to around 1.2mn, a record low.

The decline reflects Japan’s persistent inability to reverse the falling number of births. Worryingly in a country with a dwindling workforce, the “new adult” cohort now represents just 0.96% of the population. Several 20-year olds told the UK Financial Times that their main ambition was to join a company and avoid risk, while starting a business was a “terrifying leap into the unknown”. Studies show that this generation has grown up with slow growth, low inflation and a zero-interest financial policy, and above all desires stability in business and the workplace.

Projections by the United Nations already show a decline in fertility rates in Asia, with the regional rate forecast to fall from 2.12 live births per mothers in 2020 to 1.76 by the end of this century. A more dramatic decline in fertility rate is forecast for Africa – from 4.29 in 2020 to 2.13 in 2099 – while the outlook for Europe and North America is more stable.

Source: Our World In Data. United Nations, Department of Economic and Social Affairs, Population Division (2019). 

Meanwhile, the growing market for Femtech, with its increased focus on female empowerment and independence, is having direct benefits for the CHC market for sexual health & fertility, according to a new report from Nicholas Hall. Women’s health is becoming less of a “one size fits all” category as marketers increasingly recognise diversity within the demographic group. Female-led tech companies are avoiding the discreet and euphemistic marketing historically employed for intimate care, instead directly challenging taboos. A key benefit of FemTech is its ability to meet women’s health needs underserved by current services, such as existing health monitoring apps based on insufficiently diverse data or algorithms and values based on male norms. 

Comment from Nicholas Hall Reports Managing Editor, Ian Crook: Launches such as Natural Cycles, the first FDA-cleared birth control app, and menstrual aid Lunette have brought improved access to intimate health resources. Marketing for Lunette is typical of the FemTech concept, focusing on women with a variety of body types and highlighting diversity to expand the brand’s audience and challenge a historical lack of interest in the health needs of minorities. As technology improves and marketers increasingly recognise gaps in women’s healthcare, we are seeing targeted launches offering real solutions, from better menopause care to app-driven fertility sensors, giving women the tools needed to take their health into their own hands.

FemTech features in a dedicated chapter in the newly-published Sexual Health & Fertility report, alongside coverage of contraception, intimate care, pregnancy & fertility and much more. For further details, or to place your order, please contact melissa.lee@NicholasHall.com.

Global dementia cases set to triple

The number of people aged 40+ years with dementia could nearly triple worldwide from 57mn in 2019 to 153mn by 2050. This is according to a study of 195 countries funded by the Bill & Melinda Gates Foundation, published in The Lancet Public Health on 6th January 2022. The projected increase is largely owing to the ageing population and population growth.

However, the study also looks at four risk factors – smoking, obesity, high blood sugar and low education – and highlights their impact on future trends. While improvements in global education access are projected to reduce dementia prevalence by 6.2mn cases by 2050, this will be offset by anticipated trends in obesity, high blood sugar and smoking, which are expected to result in an additional 6.8mn cases.

Nicholas Hall’s Touchpoints: This study was conducted by the University of Washington, and to quote the lead author, Emma Nichols: “We need to focus more on prevention and control of risk factors before they result in dementia. Even modest advances in preventing dementia or delaying its progression would pay remarkable dividends. To have the greatest impact, we need to reduce exposure to the leading risk factors. For most, this means scaling up locally-appropriate, low-cost programmes that support healthier diets, more exercise, quitting smoking and better access to education.”

Is there a role for consumer healthcare here? I believe there is! Not least, it is noticeable that herbal products sold for memory & brain health have been growing consistently during the past five years, with a spike in demand in 2020. Taking all channels of distribution into account, this category is valued at over a billion dollars, with the USA accounting for about 50% of sales. In Prevagen, it has produced a mega-brand, which is why both Reckitt and P&G have entered the fray. At a time of continuing interest in M&A, it’s encouraging to see that there are a number of CHC categories delivering substantial organic growth.

Herbal memory and brain health supplements will be reviewed in our forthcoming report, Herbals & Naturals, which will track the leading H&N marketers, highlight developments, sales and success strategies. To pre-order your copy and save up to GB£2,100, or for further information, please contact melissa.lee@NicholasHall.com.

CRN survey shows sharp rise in US VMS usage in 2021

The Council for Responsible Nutrition has revealed initial findings from its 2021 Consumer Survey on Dietary Supplements, which was fielded by Ipsos in August and involved 3,089 adults aged 18+ years. Vitamin D usage has significantly increased (52% vs 42% in 2020), as has zinc (22% vs 15%) and vitamin C (40% vs 35%); all could be helpful for combatting Covid-19 and boosting overall immunity. Further, 50% of supplement users report a change to their supplement routine since the start of the pandemic; 55% of those indicated that this includes adding new supplements to their existing routine.

ClearCut Analytics Director of Sales Jake Bernstein told attendees of the CRN Annual Conference, where the findings were unveiled, that dietary supplement sales on Amazon have risen by 43% and predicted that 25% of sales will be purchased online by 2024. Ashwagandha and collagen were the Amazon star performers.

Nicholas Hall’s Touchpoints: This important research is another building block in helping us to understand how consumer attitudes have changed during the Covid-19 lockdown. As CRN’s Brian Wommack comments: “With 80% of Americans using supplements, these products are now mainstream and broadly accepted by the public. Just as important, 79% of Americans believe the dietary supplement industry is trustworthy, a jump of 5% from 2020.” This data and these comments will be taken into account in our ongoing evaluation of whether the CHC market is moving back to treatment and reversing the recent trend towards prevention & immunity. 

However this turns out, one clear learning emerges: consumer trends move slowly, accelerated only by mega-happenings such as the recent pandemic. By comparison, fashions in the pharmaceutical industry, including its CHC daughter, are highly volatile. 

Our Innovation in CHC 2021 report assesses 10 major trending ingredients, with a strong focus on VMS. Drawing from CHC New Products Tracker, this report also explores trends in NPD activity by company, reviews the best CHC innovations and much more. For more information or to order your copy, please contact melissa.lee@NicholasHall.com.

Nielsen IQ: OTC pack size trends 2019-21

In this week’s blog, we share some insights and research from one of our partners, Nielsen IQ, on how purchasing patterns for OTC medicines have evolved in the US market over the past 2-3 years.

In 2019, prior to the Covid pandemic, all size ranges of OTC medications were growing 2-5%, with the larger packs slightly outpacing the smaller pack sizes. As the outbreak began, wellness concerns and “stocking up” behaviours increased, leading to accelerated growth rates of the largest sizes. In the back half of 2020, many shoppers were able use their stockpiled OTC medication purchases from earlier in the year.

Additionally, cold and flu incidence was low owing to less social interaction and the wearing of masks. As the vaccine has become widely available in 2021, normal activities are resuming but all OTC medication sales are down compared to the unsustainable growth of a year ago.

Source: Nielsen IQ. *Pain Relief, Upper Respiratory, Gastrointestinal, Sleeping and Alertness Aids.

The importance of extra large and super size pack sizes has increased consistently since the start of the pandemic. This growth traces across all the top OTC categories and to all forms of pain relief and sleep. The GI extra / super size gains are from liquids, while tablets are driving the CCA / upper respiratory growth.

The upsizing is also seen in shopping patterns. While there were 5 million less OTC medication shopping trips in 2020 compared to 2019, the number of trips in which shoppers purchased an extra or super large pack increased by 10.4 million (+3%), while smaller size trips were down to 15.4 million (-3%).

NielsenIQ Client Director Anna Mayo discussed Healthier Growth for OTC during our recent North American e-Conference 2021. If you were unable to join, contact us to purchase a recording of the session. Next on the agenda is our APAC e-Conference 2021 on 23 November. To find out more about either meeting, please contact elizabeth.bernos@NicholasHall.com.

Spotlight on WBA, plus US and UK retail

In its latest results, Walgreens Boots Alliance announced that fiscal 2021 sales from continuing operations rose by 7.5% on a constant currency basis to US$132.5bn, exceeding expectations. In Q4 fiscal 2021 (June-August 2021), sales increased by 11.8% to US$34.3bn.

  • United States had Q4 sales of US$28.8bn, up by 6.6%. Retail sales grew by 6.5%. Comparable sales were up 8.1%, reflecting an 8.9% rise in comparable pharmacy sales and 6.2% growth in comparable retail sales. Excluding tobacco & e-cigarettes, sales increased by 7.2%, reflecting broad-based growth across all categories. In particular, health & wellness sales were 14% ahead, aided by cough / cold & flu, at-home Covid tests and vitamins.
  • International sales rose by 61.8% to US$5.5bn, including a favourable currency impact of 9.2%. Sales were up 52.6% (CC), including higher sales associated with the formation of the company’s wholesale j-v in Germany. Excluding this, sales rose by 9.3% (CC), reflecting the ongoing recovery in the UK market, where Covid restrictions were lifted in July 2021. Boots UK comparable retail sales were up by 15.0%, with footfall on the high street recovering although still below pre-Covid levels. Boots.com continued to perform ahead of expectations, with digital sales in Q4 more than doubling vs pre-Covid levels.

Both the US and UK CHC markets struggled for growth in the MAT Q2 2021 period – as per the chart below – but there were signs in the WBA results of a strong recovery in retail pharmacy sales in both markets in July and August 2021.

WBA has also announced its new consumer-centric healthcare strategy to drive sustainable, long-term growth. The plan features the launch of Walgreens Health, a technology-enabled care model powered by a nationally-scaled, locally-delivered healthcare platform. Walgreens Health will bring equitable, personalised, healthcare to communities across USA in-store, at home, in the doctor’s office and via a mobile app. WBA’s aim also includes reimagining retail through expanded health & wellness offerings and mass personalisation; accelerating WBA brands and digital offerings; and expanding the Transformational Cost Management programme.

In addition, WBA has increased its ownership stake in VillageMD from 30% to 63% to advance its strategic position in the delivery of value-based primary care, a fast-growing segment of the healthcare system. The US$5.2bn investment will accelerate the opening of at least 600 Village Medical at Walgreens primary care practices in 30+ US markets by 2025 and 1,000 by 2027, with more than half of those practices in medically underserved communities. 

Now is your final chance to enter our Nicholas Hall’s CHC Marketing Awardstaking place during our APAC e-Conference 2021 on 23 November! If you wish to put your brands in the spotlight, enter your campaign before 22 October. To find out more about this online meeting or awards criteria, please contact elizabeth.bernos@NicholasHall.com.

Macro Trends: Economic & Demographic Outlook

In this week’s blog, we look at two recent reports on macro trends that will have a future impact on the consumer healthcare market. The first looks at short-term economic trends and the second longer-term demographic trends.

Last week the International Monetary Fund has revised down its forecast for global economic growth in 2021 to slightly below its July 2021 forecast of 6%. At a virtual G20 event, IMF Managing Director Kristalina Georgieva said: “The most immediate obstacle is the ‘great vaccination divide’ – too many countries with too little access to vaccines, leaving too many people unprotected. At the same time, countries remain deeply divided in their ability to respond – in being able to support the recovery, and in their ability to invest for the future.”

“We face a global recovery that remains ‘hobbled’ by the pandemic and its impact. We are unable to walk forward properly — it is like walking with stones in our shoes.” Three of the most painful stones are divergence in economic growth, inflation and global public debt. As the chart below indicates, the sectors currently facing the largest inflationary pressures include transportation and food, whereas prices in the health sector remain stable.

As for demographic trends, according to a report in The Times newspaper last week there will be more Nigerians than Europeans in 60 years’ time. Some two-thirds of Africans are aged under-25 years (in Senegal the average age is 19 years) and many capitals and cities on the continent are unable to cope with this “youthquake”, with no time or money to build the basic infrastructure, often coupled with a high cost of living. While this youthful energy could be a good thing, the lack of opportunities – coupled with climate migration – is driving many of the younger generation to leave Africa, with Europe becoming a spill over zone.

Nicholas Hall Writes: “Many of these new consumers will rapidly become empowered, and although it is not a factor that will influence next year’s P&L, sensible companies will start to plan for much larger immigrant communities, which will have very determined views on the CHC products they buy (and anyone who doubts this has only to take a look at the very specialised products sold to the Hispanic community in North America by companies like Genomma). Indeed, some of these populations will be made up of ‘illegals’, who will not sign up to see community physicians and for whom CHC will be primary care and possibly much more. And for that, I fear, we are not at all prepared as countries or an industry.

You can save up to GB£2,500 when you pre-order our forthcoming Hot Topic report, Sexual Health & Fertility! This title will delve into key topics, such as home diagnostics, intimate care, ED and many others, as well as tracking NPD and Rx-to-OTC switch activity, plus much more. To pre-order your copy, or for further details, please contact melissa.lee@NicholasHall.com.