Alli granted final marketing approval in Japan

Following the recommendation of orlistat for direct-to-OTC approval in Japan, anti-obesity drug Alli has been granted final marketing approval by the Ministry of Health, Labour & Welfare. Taisho, which gained the rights to develop and market orlistat in Japan from GSK in 2009, is yet to announce the product’s release date.

Victoria Blake, head of Competitive Intelligence & Market Analysis (CIMA), writes: The World Health Organisation reports that worldwide obesity has almost tripled since 1975 – in 2016, almost 2bn adults were overweight. However, a report in 2020 found that across 7 major markets (France, Germany, Italy, Spain, UK, Japan and USA), Japan had the lowest total prevalence of obesity at 4%. While orlistat is a welcome innovation to the self-care market as a scientifically-proven solution to weight loss, it is notable that the target audience appears to be significantly smaller than in some Western markets (prevalence was reported at 40% for the USA). Nevertheless, serious government concerns regarding the economic healthcare impact of obesity in Japan’s older population led to the Metabo Law in 2008, which attempts to address obesity concerns through regular monitoring of waist size in those aged 40-74 years. Alli was switched in the USA in 2007 and in the EU in 2009 (the first drug to go through the EU Centralised procedure). Lack of repeat purchases was a key factor behind limited growth for the brand, consumers prone to expecting “miracle cures” and rapid results when it comes to weight loss vs faith in longer-term, proven regimen. We watch with interest to see how Taisho’s strategy unfolds for orlistat in this new market.

Nicholas Hall Writes: I wanted to lead with this story this week, not because Alli is a wonder brand – sadly, it failed in the consumer market – but because of the huge unmet demand for effective weight loss products, which is rightly pointed out by my colleague Victoria Blake. In fact, there is no other sector in consumer health where demand is so high and delivery so poor. In all other sectors we have great products and the job is communicating their benefits to consumers. This is the exact reverse, where demand is almost unlimited among an increasingly overweight population, but where we just don’t have safe and effective products in consumer health or indeed in the prescription market. So no one who reads this column will be surprised that weight loss and obesity is to be a major topic covered in my signature report, New Paradigms 2023 – the Future Resumed. 

One of the problems that Alli faced was honesty. The brand was marketed in terms of delivering major benefits, but those benefits could only be achieved if consumers modified their lifestyle as well. This they were largely unwilling to do, and there is a great deal of anecdotal evidence that consumers taking a weight loss product feel empowered to consume more of their favourite foods and drinks, even though contrary to the necessary changes that enable it to be effective. And, of course, weight loss brands stress simplicity, not the complex set of lifestyle changes necessary to deliver benefits.

We are delighted to announce that Nicholas will explore “The Future Resumed” in the upcoming 2023 edition of his signature New Paradigms report! Offering insights into unmet consumer needs, demographic drivers, emerging markets and more, this report will provide an essential strategic review of key factors impacting the CHC industry. To pre-order your copy at a discounted rate, or for more 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.

Rx-to-OTC switch drivers

Allergy and sexual health are two areas of the global CHC market that continue to expand in sales thanks to Rx to non-prescription switch activity in various markets. In Japan, the Ministry of Health, Labour & Welfare’s Evaluation (MHLW) Review Conference will discuss the potential Rx-to-OTC switch of emergency hormonal contraceptives at a meeting this week.

According to CHC Insight Asia-Pacific Senior Editor, Nicola Allan: “In June 2019, an MHLW steering committee permitted pharmacists to dispense EHCs during a face-to-face transaction after the consumer has had an online consultation with a doctor. Previously, the patient had to see a doctor face-to-face to obtain a prescription to give to the pharmacist. More than 9,000 pharmacists have undertaken training that allows them to participate in the new scheme, which has prompted the MHLW to consider further liberalisation of EHC sales.”

Meanwhile, in the UK, following an application from Sanofi, the Medicines & Healthcare products Regulatory Agency last week reclassified Nasacort Allergy Relief (triamcinolone acetonide 55mcg / dose) nasal spray from Pharmacy medicine to General Sales List. The suspension can be used for the relief of symptoms associated with seasonal allergic rhinitis, including sneezing, itchy and runny nose, itchy red or watery eyes, nasal congestion or sinus discomfort in adults aged 18+ years.

In terms of switch drivers, governments seeking to reduce healthcare costs remains a primary factor, but also important is the empowerment of consumers as they increasingly use digital solutions to improve and monitor their health, a trend that is being leveraged into test & treat models. Commenting on the just-published Rx-to-OTC Switch Hot Topic Report, CIMA Senior Market Analyst Victoria Blake said the report “considers the impact of Covid on struggling healthcare systems, and the increased burden on the undertreated population. While traditional mechanisms have proved too slow in recent years, the next generation of switches – such as statins, triptans, oral contraceptives and CBD – require new thinking and a different approach.”

According to Nicholas Hall, “we could be entering a Golden Age. Voltaren Arthritis Pain Relief Gel’s successful US launch; OTC approval for low-dose cannabis in Australia; the possibility of OTC oral contraceptives in a major Western market for the first time; plus recent statements by Sanofi on the likely switches of the antiviral Tamiflu and the erectile dysfunction treatment Cialis. These are just the tonic this industry needs as the recovery from Covid gets underway.”

Our hot topic report Rx-to-OTC Switch is now published! Written by Nicholas Hall’s CIMA team in association with switch expert Joe McGovern of Biograph Inc, you can access information on the historic and current switch environments in key global markets, including an overview of pipeline and strategic considerations. For more information, or to purchase your copy, please contact melissa.lee@NicholasHall.com

Market Movers in MAT Q2 2020

To mark the publication of our latest Market Movers update, which picks out 6 brands driving growth in the global CHC market in the MAT Q2 2020 period, as well as 6 brands in fast decline, our blog this week examines the trends that are driving these exceptional changes.

Among the fastest-growing brands, one common thread is immunity positioning, with at least four of the six products highlighted below – Dabur Chyawanprash (India), Yiling Lianhua Qingwen (China), Airborne (USA) and Arbidol (Russia) – boosted by heightened demand for products that boost immunity during the pandemic.

TCM Yiling Lianhua Qingwen, available in China as capsules and granules, was listed in 2020 in the country’s Novel Coronavirus Pneumonia Diagnosis and Treatment Scheme, while in April 2020, the National Medical Products Administration of China approved a new indication for “mild and common Covid-19” to be added on the basis of its originally approved indications. Sales for the brand in the MAT Q2 2020 period were up 68%.

Ayurvedic formulation Dabur Chyawanprash (Dabur) saw sales more than double (+169%) in MAT Q2 2020, driven by strong Covid-related demand and the launch of Dabur Immunity Kit in Q2 2020, to become India’s No.1 CHC brand. Likewise, umifenovir-based medicine Arbidol (OTCPharm), which is positioned for flu as well as acute respiratory and viral infections, also saw sales more than double (+103%) in the MAT Q2 2020 period and the brand now ranks in the Top 5 in Russia.

As for products that suffered falling sales in MAT Q2 2020, notable examples were tonics & cure alls in China – such as Dong-e E-Jiao – hit by rising raw material costs and falling demand, as well as ranitidine-based antacids – such as Sanofi’s Zantac 150 – owing to concerns around NDMA and Takeda’s Alinamin EX vitamin B supplement in Japan, affected by demographic changes and a fall in tourist spending.

If you would like to review the latest launches and NPD surrounding all the leading brands in the global CHC market, take a look at CHC New Products Tracker, the ultimate competitive intelligence tool! Featuring 26,000+ launches and innovations, products are graded with a star rating, and you can search according to your specific requirements. Please contact waisan.lee@NicholasHall.com to set up your demo.

Focus on Japan: Q2 results point to further CHC decline

According to government data released today, GDP in Japan fell 7.8% quarter on quarter in Q2 2020 (April to June), with Covid-19 having an impact both on domestic consumer spending and exports. Japan’s economy is heavily dependent on exports, especially to China, and demand there has remained subdued during Q2. This downturn does not bode well for the world’s No.3 CHC market, which had already failed to match the boost in OTC spending seen in Europe and North America in Q1, with Japan recording flat sales in MAT Q1 2020 owing to the loss of in-bound tourists from China and Taiwan.

Japan’s OTC market has not outperformed the wider economy, as has been the case in other regions during Covid-19, with several key local marketers reporting Q2 declines in line or in excess of Japan’s 7.8% GDP fall. Daiichi Sankyo saw OTC revenues decrease by 7.3% in fiscal Q1 2020 (Apr-Jun 2020), owing to the impact of Covid-19, while Taisho reported an even more dramatic fall in its Q2 domestic Self-Medication sales, with its OTC portfolio in Japan down 16.4% in fiscal Q1 2020 (Apr-Jun 2020). Tonic drink Lipovitan and CCA range Pabron both led the decline, impacted by Covid-19.

Takeda outlined size of OTC divestitures still to come

While Takeda no longer reports on the performance of its Self-Medication business in its quarterly results, it did reveal in its Q2 results presentation the value of the various regional portfolios of non-core and OTC products that it plans to divest in the near future. In late 2019, Takeda sold a portfolio of non-core OTC and Rx products to Swiss-based Acino, covering what the describes as its North Europe, Middle East & Africa (NEMEA) region, as well as a larger portfolio to Stada, covering Russia / CIS. Takeda now intends to complete even larger divestments in Latin America and Europe.

In late July, it was announced that Taisho is reportedly in advanced talks to acquire Takeda’s Consumer Healthcare unit in Japan, according to people familiar with the matter. Blackstone, Bain Capital and CVC Capital Partners were also understood to be among the final bidders. If Taisho does secure the deal for Takeda’s CHC portolio in Japan – which DB6 valued at US$571mn in the MAT Q1 2020 period – it will extend its domestic dominance as Japan’s No.1 CHC marketer but still remain the global No.7 behind P&G. Either way, Taisho will be looking to move beyond the business uncertainty caused by Covid-19 and M&A, with a view to reviving growth in Japan’s CHC market in H2 2020.

If you are interested in making an acquisition, or need licensing or business development support, Nicholas Hall’s Consultancy team is available to give confidential advice. We work with a number of strategic and financial partners to evaluate potential opportunities for buyers and sellers in the M&A, licensing and fundraising space. To find out more contact kayleigh.griffinhooper@NicholasHall.com

CHC trends in 2020

In Nicholas Hall’s recent signature New Paradigms report, there were 15 Infinity Zones identified as offering substantial growth opportunities for the consumer healthcare market over the next decade, against a backdrop of uncertainty in the industry caused by the recent wave of mega-mergers. These include the development of new CHC products for diabetes and food intolerance, as well as a further uptick in activity for probiotics, MedTech and e-Commerce. In this week’s blog, we look at three trends that may boost the consumer healthcare market in 2020.

CBD and beyond

2019 was the year of CBD, as evidenced by our CHC New Products Tracker service, which logged over 300 new CBD products in the US market alone last year. A recent article in US pharmacy trade publication, Drug Store News, suggests that CBD is just the tip of the cannabinoid iceberg, with various other cannabinoids set to take off over the coming year. These include cannabigerol (CBG), which is said to produce a stimulant effect, cannabinol (CBN), claimed to show benefits as a sleep aid, and cannabichromene (CBC), claimed to be an effective pain reliever.

Veganism on the rise

A UK-based campaign that has received a lot of celebrity endorsements, Veganuary, is encouraging people to try veganism in the month of January. One of the benefits of the rise in veganism for VMS marketers is increased awareness of the nutrients we require, many of which can be lacking in a vegan diet. For instance, several leading proponents of veganism like The Vegan Society recommend taking vitamin B12 supplements while adopting a vegan diet. Our CHC New Products Tracker service has also recorded a strong rise in vegan-friendly supplements in the past two years, a trend that looks set to accelerate in 2020.

Uptick in switch activity?

One of the trends responsible for the slowdown in global CHC market growth these past 3-4 years is the drop-off in Rx-to-OTC switch activity, especially in the world’s No.1 market, USA. There are signs this is about to change – for example, Viagra is due to lose its final patents in the USA in 2020. In Japan, the world’s No.3 CHC market, there has been a similar falling off in switch activity, with just two ingredients approved for reclassification in 2018 and 2019. However, 2019 saw the first ingredient to be switched under a new system set up by Japan’s drugs agency, MHLW, which has nominated over 30 ingredients as eligible for switch. With the Tokyo Olympics also on the horizon in summer 2020, this year could see a revival in Japan’s sluggish CHC market.

With options available for complete access to all 20 markets covered by CHC New Products Tracker, or a subscription for selected categories or countries, contact waisan.lee-gabell@NicholasHall.com today to find out more or set up a free trial!

Alibaba and Walmart report strong Q2

Our blog this week rounds up the latest retail news, including recent Q2 results from Walmart and Alibaba, and a focus on M&A activity in Asia-Pacific. China’s Alibaba trumped analysts’ expectations with a 42% year-on-year jump in quarterly revenues to Rmb114.92bn (US$16.3bn), contrasting with its rival Tencent which one day earlier disappointed the market by falling short with a more modest quarterly growth (though Tencent did report a 26% year-on-year increase in profit).

Alibaba’s CEO, Daniel Zhang, said the company “had a great quarter, expanding our user base to 674mn annual active consumers, and demonstrating our superior user experience. We will continue to expand our customer base, increase operating efficiency and deliver robust growth. With strong cashflow from our core e-commerce business, we will continue to invest in technology and bring digital transformation to millions of businesses globally.” 

Alibaba is also reportedly looking to acquire Kaola’s cross-border online shopping platform from rival NetEase, according to two people familiar with the matter, as China’s highly competitive US$2tn e-commerce market takes early steps towards consolidation.  

Meanwhile, Walmart has raised its outlook for the USA and said US consumers were in “solid” financial health as it shrugged off the Trump administration’s trade war with Beijing and turmoil elsewhere in bricks-and-mortar retail. Walmart revenues rose by 1.8% in fiscal Q2 2020 to US$130bn (+2.9% on a constant currency basis). USA sales were US$85.2bn (+2.9%) and the retailer noted that it is gaining market share in key categories, including health & wellness; e-commerce sales grew by 37%. International sales fell by 1.1% to US$29.1bn (+3.3% excluding currency impacts). Strength in Mexican subsidiary Walmex and China were offset by softness in UK and Canada. 

In Brazil, No.1 drugstore chain RaiaDrogasil (RD) reported better than expected results, seeing its national share rise to 13% in Q2 2019 (up 1.6% vs Q2 2018). Another drugstore chain quickly gaining share in Brazil is Farmarcas, which looks set to become the No.4 ranked chain by end-2019 after reporting even stronger results than RD, putting pressure on established players Drogaria DPSP and Pague Menos.

As for M&A activity:

• In Japan, drugstore operator Cocokara Fine is pursuing a merger with rival Matsumotokiyoshi in a deal that could create a market leader with sales of around ¥1tn (US$9.4bn)

• Amazon, which is looking to boost its bricks & mortar presence in the fast-growing Indian market, is reportedly in advanced talks to acquire up to 10% of Future Retail, the country’s No.2 retailer

• AS Watson (an affiliate of CK Hutchison Holdings) is in talks with potential partners in UAE with a view to introducing its health & beauty stores there

Take a look at the evolution of Pharmacy and Pharmacy Point-of-Care in the Distribution chapter in our new report, Nicholas Hall’s New Paradigms for CHC 2019: Over the Horizon, written by Nicholas himself! Other chapters will include Healthcare Trends, Regulation, Digital engagement amongst many others. Nicholas will also unveil the 15 “Infinity Zones” he has identified as being crucial to the future growth of the industry. You can 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 pre-order your copy, please contact melissa.lee@NicholasHall.com.

OTCs in Action Episode 62: Countries claiming climbing CAGRs!

This week, OTCs are in Action all over the world as we post the top-performing markets in terms of compound annual growth rates. First, kudos to my colleagues on the DB6 OTC database team. Thanks to their amazing expertise and hard work, Nicholas Hall Companies has just published the DB6 global OTC database, which tracks sales at the brand level in 64 countries.

The leading OTC market in the world is the USA, with turnover of $31bn, while the smallest market is Slovenia, with OTC sales generating $61mn. Both are mature markets, with the US posting a CAGR of 3.3% from 2011-2015 — Slovenian OTCs were close behind, achieving growth of 3.2%.

Looking at the Emerging Markets, China’s performance was strong with CAGR of 7% and sales of $21.6bn last year. Russia’s CAGR was 12%, reaching $3.3bn in 2015. Brazil performed a point better with growth of 13% to achieve sales of $2.7bn, whilst India’s CAGR was significantly slower at 9% to generate sales of $2.6bn last year.

Turning to more mature markets, Japan’s OTC CAGR for the period was flat with sales of $7.1bn in 2015, while the $4.9bn Germany OTC cart sputtered forward with a CAGR of 2.3%. In France, CAGR was negative 1% to $3.9bn. The UK and Canada drifted equally with a 2.3% posted in both markets, with sales of $2.9bn and $2.1bn, respectively, in 2015.

Which markets were stimulated by Rx-to-OTC switches? Where in the Emerging Markets did Lifestyle OTCs outpace other categories? DB6 subscribers know the answers. Visit the DB6 OTC database 2016 website to learn more about this valuable service, used by leading OTC players around the world.

DB6 Global OTC Database

OTCs in Action Episode 54: Japan’s First Food for Cognitive Function

This week OTCs are in Action in Japan, where Otsuka has introduced Nature Made Ginkgo Biloba, Japan’s first Food with Function Claim for cognitive function. Research has shown that flavonoid glycosides and terpene lactones extracted from ginkgo biloba can improve perception and recall of perceived objects.

According to Otsuka: “Traditionally prized in Europe for its health benefits, ginkgo biloba has also been recognized as a health food in Japan for many years. A systematic review of research results for flavonoid glycosides and terpene lactones extracted from ginkgo biloba leaves led to notification and acceptance of this supplement as Japan’s first Food with Function Claim for cognitive function.” Nature Made Gingko Biloba is delivered in tablet form.

The Food with Function regulatory classification was introduced in April 2015 and allows food supplements to be supported by nutrient claims, as long as scientific evidence has been provided to the Consumer Affairs Agency, reports the December issue of Nicholas Hall’s OTC INSIGHT Asia-Pacific. Unlike Foods for Specified Health Use, these products are not subject to case-by-case review by the agency.

Another recent innovation from Otsuka offers heart health benefits to Japanese consumers. In November, the company expanded claims for Nature Made Super Fish Oil in Japan with the specific health benefit of “inhibition of triglyceride levels in the blood”.

OTCs in Action Episode 52: Japanese tax tweak to raise OTC spending

This week, OTCs are in Action in Japan, where the government plans to reward self-medicating consumers with a tax deduction. Under current tax codes, Japanese consumers can deduct medical expenses over US$800 or so per year from taxable income, but OTC expenses are often not high enough to meet this threshold. A recently proposed tax incentive will require a minimum OTC expenditure of only about us$80 to qualify for the deduction – a benefit the government is hoping will nudge consumers with minor ailments away from expensive hospitals, and toward drugstores.

According to Nikkei Asian Review: “The health ministry expects more than 10mn households to qualify for the deduction. If the break changes patient behaviour, the resulting drop in government medical spending could outweigh the expected tens of billions of yen in lost tax revenue. Reining in social insurance expenditures is also crucial to achieving the government’s goal of a primary surplus by fiscal 2020.”

Nichols Hall’s DB6 database shows that the US$7bn Japanese OTC market has been ailing with sales declines for the past several years – encouraging people to put OTCs in Action for financial rewards will be therapeutic for consumers, manufacturers and government.