Switch: 2020 Review and 2021 Prospects

According to our CHC New Products Tracker tool, which covers 20 key markets globally, 2020 was a relatively good year for Rx-to-OTC switch activity, not quite at the level of particularly active years like 2018, but above average in terms of switch-related launch developments, and with some notable breakthroughs such as GSK’s switch of Voltaren Arthritis Pain (diclofenac) in the USA and Glenmark’s Momate Rhino Advance Nasal Spray (mometasone + azelastine) switch in Russia.

Thanks to the Rx-to-OTC reclassification of Voltaren Arthritis Pain, as well as eye allergy itch relief range Pataday (Alcon), the US market led the way in terms of switch developments in 2020, along with Poland, Germany and China. As for category switch trends, looking at Tracker data for the past 8 years (2013 to 2020), allergy remedies has been by far the most active OTC subcategory in producing new products following switch activity, with double the amount of NPD activity as the next nearest subcategory, cough remedies.

Looking ahead to 2021, one of the first switch developments this year will again be an allergy remedy. The UK’s Medicines & Healthcare products Regulatory Agency granted GSL status to Sanofi’s Allevia tablets for seasonal allergic rhinitis (fexofenadine 120mg; 12+ years; 1 tablet per day) in late December 2020. Once Allevia and other OTC fexofenadine products are launched, they will enjoy mass market distribution from the outset (it is more common in the UK for switched ingredients to be granted pharmacy-only OTC status). This is the second Rx-to-GSL UK allergy remedy switch in as many months, following approval for J&J’s Rhinocort Aqua budesonide 64mcg nasal spray in November 2020 (to be marketed as Benacort Hayfever Relief).

In addition, Poland remains at the forefront of global switch activity, with the country’s medicines agency (URPL) recently approving the Rx-to-OTC switch of Famotydyna Ranigast film-coated tablets (Polpharma; famotidine 20mg). Claimed to relieve indigestion, heartburn and hyperacidity for up to 12 hours, this is the first famotidine option available OTC in Poland. Meanwhile, Australia’s TGA is seeking comments until 27th January 2021 on proposed amendments to the Poisons Standard, which will be discussed at the March 2021 meeting of the Advisory Committee on Medicines Scheduling, including adding the following pharmacist-only medicines to Appendix H to permit consumer advertising: prochlorperazine and metoclopramide for the treatment of nausea associated with migraine; and chloramphenicol for ophthalmic use.

We are delighted to announce that our annual European e-Conference 2021 will take place online on 28 & 29 April! With options for individual and corporate site or global access, take the chance to keep up with what’s happening in consumer healthcare today and contact elizabeth.bernos@NicholasHall.com

Allergy: NPD, switch & naturals power growth

While many of the leading CHC marketers reported declines for their cough & cold portfolios in Q3 2020, the performance of allergy remedies was more mixed, with notable variability by region. For example, Bayer reported rising sales for its Allergy & Cold portfolio in North America in Q3, partly driven by increasing sales for key allergy brand Claritin, which was boosted in early 2020 by the US launch of Claritin Non-Drowsy Chewables in a new cool mint flavour.

Likewise, Perrigo reported a strong performance for its Consumer Self-Care Americas unit in Q3, with increased OTC demand powered by allergy, pain and digestive health products. For Sanofi, while overall Allergy, Cough & Cold sales declined in Q3, portfolio sales were up in the USA, thanks to key allergy brands Allegra and Xyzal. Sanofi also launched its drug-free AllerLife range in the US market in early 2020, adding further fuel to the fast-growing naturals niche among allergy remedies.

Outside the USA, by far the world’s largest market for OTC allergy remedies, two countries that are performing very well are Germany and Brazil. Rx-to-OTC switch has been the driving factor in both markets, with various allergy ingredients – fexofenadine, ebastine and desloratadine – switched to OTC status in Brazil in recent years. As for Germany, after the switch of levocetirizine, which led to several OTC launches in April 2019, desloratadine was subsequently also approved for Rx-to-OTC switch in February 2020.

In October 2020, the EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending a change to the terms of the marketing authorisation for Ratiopharm’s desloratadine, potentially paving the way for an EU-centralised switch to non-Rx status for the allergy ingredient in the near future. Indications will be limited to adults only and the urticaria indication will be restricted to chronic idiopathic urticaria as initially diagnosed by a doctor.

Discover which marketers and brands stand out and how Covid-19 is impacting sales in our newly published Cough, Cold & Allergy report! Allergy remedies are just one of the many categories covered, alongside profiles of 10 major markets, forecasts and much more. For more information, or to order your copy, please contact melissa.lee@NicholasHall.com.

Perrigo to revive flagging OTC allergy sales?

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According to the latest MAT Q1 2018 data, global growth of OTC allergy remedies has slowed to just +0.2%, compared with a rate of +3.7% in the year-ago MAT Q1 2017 period, and +10.3% in the MAT Q1 2016 period. A drop-off in Rx-to-OTC switch activity has been a key factor, so last week’s news that Perrigo has signed an agreement with Merck & Co for exclusive rights to market, sell and distribute a non-prescription version of Nasonex (mometasone furoate monohydrate) in the US will be a welcome boost for the category.

Financial terms were not disclosed and the deal is subject to receipt of all necessary regulatory approvals. Nasonex is currently available on prescription only in USA, where it is marketed by Merck & Co. The corticosteroid anti-inflammatory nasal spray is indicated for the treatment of the symptoms of seasonal allergic or perennial allergic rhinitis in people aged 18+ years. In those markets where the product is available OTC, such as Australia, it is marketed by Bayer.

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Perrigo has often been first to launch private label equivalents of recently switched OTC brands – generic versions of Flonase and Zegerid OTC were launched in 2016, while a copy of Nexium 24HR was launched by the company last summer – but this deal marks a new phase for Perrigo into switching brands.

As Perrigo Executive VP & President, Consumer Healthcare Americas, Jeff Needham, commented: “This product in-licence is the first of its kind for Perrigo. As other similar products that have previously switched from prescription to OTC status, we are working diligently to bring this important product to consumers and customers more quickly than the average 5-year OTC switch timeframe. This strategic investment into the OTC category creates an innovative product offering for Perrigo. We expect to execute the Rx-OTC-switch, fully penetrate this market with a branded offering and provide a future store brand alternative.” 

Comment from Ian Crook, Managing Editor, Nicholas Hall’s Reports: Nasonex enjoys dynamic growth in the handful of markets where it has been switched to OTC by Bayer and generated sales of US$23mn in 2017 (+28% CAGR 2013-17). In the brand’s largest market, Australia (where it switched in 2014), award-winning advertising helped it build a strong presence among consumers; it ranked 4th with sales of US$10mn (+5%) in 2017, comfortably the No.1 in the nasal sprays segment. How the brand will fare in the USA — if and when Perrigo successfully navigates the switch process — remains to be seen. Nasal steroid switches in the USA have historically driven high growth among allergy remedies, but later arrivals like Nasonex are unlikely to make as big a splash as previous INS switches.

Perrigo is one of the Top 20 OTC players profiled in the 2018 version of our bestselling OTC YearBook. This essential annual report also gives an extensive, up-to-date overview of the OTC industry across the globe, including reviews of M&A activity, Top 15 markets and major OTC categories, plus much more. For more information or to order your copy, please contact melissa.lee@NicholasHall.com.

 

Nielsen-CHPA Survey on OTC Allergy Trends

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Coughing, sneezing, a runny nose and itchy eyes are just some of the symptoms of seasonal or chronic allergies, one of the most common ailments impacting the lives of Americans today, according to a new white paper on Rx-to-OTC allergy switches, produced by Nielsen and the US OTC industry association, Consumer Health Products Association (CHPA).

In 2015, 27.8% of Americans suffered from allergies, which translates to approximately 69 million adults, and 89 million people overall. Since 2009, a number of ingredients, including antihistamines and intranasal steroids that were only available Rx, have now switched to OTC, giving consumers more options to treat their allergies.

While there is abundant data to show that allergy OTC sales have grown significantly owing to the increasing number of brands available, there haven’t been many studies conducted to understand how these Rx-to- OTC switches have benefitted allergy sufferers.

Nielsen’s latest report assesses the consumer benefits of allergy Rx-OTC switches to help gain an understanding of allergy-suffering consumers and how having access to more oral and nasal OTC medications has contributed to their financial and personal wellbeing.

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The survey is made up of data based around allergy patient visits, the number of prescriptions written by month, the costs for each, and corresponding insurance-related costs. Nielsen also provided data on allergy sufferer penetration, their buying behaviour, and how each consumer treats their ailment. 
A survey was also fielded to 2,000 adult allergy sufferers to better understand their treatment routine and overall satisfaction with their medication options.

The report found that more and more Americans are suffering from allergies. Over the time period analysed, the number of individuals who stated that they suffer from allergies has increased. There are approximately 9.7mn more allergy sufferers today than there were
 in 2010.

There has also been a clear shift to OTCs. 
The number of allergy sufferers taking OTCs has increased, while 
at the same time the number of sufferers taking prescription medications has declined. Just as importantly, the report also found that allergy sufferers who take OTCs are highly satisfied with the medication options available to them.

The report is available to download here.

Editor’s Introduction to Cough, Cold & Allergy

Sneak peek at some highlights from Global OTC Cough, Cold & Allergy

With so much going on in the US allergy remedies category ­– from Allegra’s swift dash up the rankings to the switch of intranasal corticosteroid Nasacort, from new A+P campaigns to allergy extensions of blockbuster cough & cold brands Mucinex and Vicks – it is small wonder that it was the source of double-digit growth (+11%) in 2014. Not to mention 2015 developments like the February debut of Flonase and the planned launch of Rhinocort. Yet this was just one of a handful of strong performances around the globe in the past year, with the global CCA market responding positively to a spike in flu infections across several regions, switch activity, format innovation and other new launches.

A handful of highlights from around the globe include:

  • In Brazil the move to Rx status of vasoconstrictor-based nasal decongestants led to a significant downturn, but innovative launches subsequently revived topical decongestants sales
  • China’s cough and sore throat remedies benefited from A+P targeting smokers, both for treatment of respiratory conditions caused by smoking and for freshening breath
  • In France dereimbursement is gradually transforming CCA into a pure OTC market, with increasing numbers of semi-ethicals losing reimbursement and becoming pure OTCs – and so able to be advertised
  • CCA is Russia’s largest OTC category by a considerable margin, with over $400mn separating it from VMS (second largest category); CCA options are prominent on a proposed mass market list
  • In Turkey marketers are increasingly launching products classified as food supplements (particularly throat lozenges) and medical devices (notably saline topical decongestants) as these are less tightly controlled than registered medicines

For a comprehensive view of the Global OTC Cough, Cold & Allergy market, including in-depth coverage of the 15 leading CCA markets, check out our just-published report. For more information, download the brochure or contact Nino Hunter.

OTCs in Action Episode 29: Probiotic powers

OTCinActionheaderProbiotics are in action this week, effectively tackling the common cold, allergy and triglycerides, according to a recent edition of OTC.Newsflash, published by Nicholas Hall & Company:

Allergy attacked!  A Vanderbilt University (US) review of 23 studies found that probiotics were linked to improvement in at least one facet of a patient’s health – either rhinitis-specific quality of life or symptoms — in 17 of the studies. (International Forum of Allergy & Rhinology, April 20,2015).

Triglycerides tackled! Researchers at The Yonsei University (South Korea) found that dual probiotic strains Lactobacillus curvatus HY7601 + Lactobacillus plantarum KY1032 demonstrated triglyceride-lowering effects vs placebo in a 12-week study of 92 participants with hypertriglyceridaemia but without diabetes. (Nutrition, Metabolism & Cardiovascular Diseases, May 13, 2015)

Sick days shortened! The American Journal of Clinical Nutrition reports that in cases of influenza-like illness, the number of sick days was reduced to five for a group that consumed a daily beverage with 1bn live bacteria (Chr Hansen’s L.casei 431 probiotic strain) vs eight days in a placebo group. The proportion of subjects who required healthcare system support during the follow-up period fell from 28% to 22% with probiotic consumption. 

Global sales of probiotic dietary supplements have increased by $1bn to $2.7bn in the past five years, according to Nicholas Hall & Company’s global OTC sales database, DB6.