Feminine health and hygiene: an exciting category with a potential for growth

Feminine health is a personal care segment with an increased demand from consumers, who are taking a more active role in their health and wellbeing. Vaginal infections require medical treatment but the preventative role of personal care is on-trend, in particular around the menopause. This segment is also of interest to translational research that can leverage our understanding of biofilms and similar forms of microbial growth, as the presence of sessile microbial communities on the vaginal epithelium is associated with both health and disease.

The UK feminine hygiene market has reached £451m in 2020, expected to grow annually by 1.8% (CAGR 2020-2025). The market comprises of two categories: feminine protection and intimate care. The former are tissue and hygiene paper products such as sanitary pads, tampons and panty liners. The latter are intimate cleansers and sprays, vaginal medicated treatment, personal lubricants and douches used by women to maintain personal hygiene. Due to the health consciousness of women, there is an increasing demand for natural materials. The high-end of intimate care products are popular primarily in the developed markets of North America and Western Europe[i]. [ii]

Changing consumer attitudes: no longer taboo

Intimate care has a large consumer base of women with diverse needs, across all age groups. An ageing population with larger disposable income and caring about their health drives this category. There is a shift toward awareness and openness to discuss once taboo and delicate topics from both manufacturers and consumers.

‘A survey conducted by Combe Incorporated’s Vagisil Women’s Health CenterSM found that about 43% women are comfortable discussing their genital issues as well as comfortable with referring to the genital area as ‘vagina’.’ [iii]

This is good news for new product development; it allows for consumer education and products addressing functional and emotional needs as well as inconveniences due to ageing e.g. vaginal dryness with discomfort and increased risk of infection. [iv]

Vaginal microbiome in health and disease

The vaginal microbiome plays an essential role in a woman’s health across her life span. Microbial imbalance (dysbiosis) can potentially affect sexual health and pregnancies (in terms of pre-term birth or low birth weight), increasing risk of pelvic inflammatory disease, infertility, and postpartum endometritis. Later on, via mother-child microbial transfer, it can impact the health of a baby.[v] The rapidly expanding research of the vaginal microbiome is largely based on 16S ribosomal ribonucleic acid (rRNA) amplicon sequencing and cpn60 gene sequencing, with only a few studies accounting for spatial microbiota organization. Biofilm microbial communities are implicated in vaginal infections such as bacterial vaginosis and vulvovaginal candidiasis, where vaginal biofilms decrease susceptibility to antimicrobials, may increase  tolerance to treatment regimens, leading to treatment failures and recurrence.[vi] [vii]

‘The pathogenic biofilm formation over the vaginal epithelium can provide a defensive barrier against anti-infective agents. Gardnerella vaginalis is the primary organism associated with bacterial vaginosis but is clearly modulated by other organisms in the vaginal microbiome’.[viii]

The healthy vaginal microbiome maintains ecological balance (homeostasis) to prevent imbalance (dysbiosis) or infection. Hallmarks of a healthy reproductive tract vary across racial and socioeconomic borders, affected by sexual health, changing hormones, hygiene, menstrual cycle, etc. Generally thought of as being dominated largely by Lactobacillus strains, it is becoming increasingly obvious that the healthy vaginal microbiome can be complex, forming a sessile communities on the vaginal mucosa. These have a beneficial effect of inhibiting growth, adhesion and spread of other microorganisms. It has been suggested that Lactobacilli control the environment by mechanisms that include secretion of organic acids, production of antimicrobial substances e.g. hydrogen peroxide, bacteriocins and bio-surfactants, competition for nutrients and receptors in terms of adhesion to the epithelium, etc. This ecological balance can be disturbed by medication (such as antibiotics and local contraceptives) or by devices (tampons, intrauterine devices).[ix] Given the importance Candia albicans in infection, the composition and diversity of mycobiome component of the microbiome in the vagina is important to consider. Lactobacilli dominance is protective but changes throughout life as well as the menstrual cycle.

There is still a widely accepted theory that Lactobacilli dominant microbiome is healthier than a taxonomically diverse microbiome. However, every woman is different and the same microbiome can be asymptomatic for one yet troublesome for others.[x] Also, conditions like diabetes can lead to vaginal dysbiosis. In healthy postmenopausal women, research reiterates the protective role of Lactobacillus species and changes in vaginal microbiome diversity as low levels of circulating estrogen affect the vaginal epithelium. Hormone replacement therapy can resolve vaginal symptoms, and probiotic administration of Lactobacilli have shown a promise in reinstating vaginal homeostasis in menopause.[xi] Dr Julie Thornton, Director of Centre for Skin Sciences at University of Bradford comments on the changes in vaginal epithelium in menopause impacting the microbiome,

“The thickness of the vaginal epithelium, its ability to synthesise glycogen and the development of a stratum corneum is significantly enhanced by reproductive hormones, specifically oestrogen. The glycogen stores support the vaginal microbiome, which is crucial in lowering the pH to yield an inhospitable microenvironment for many pathogens, and thereby reducing susceptibility to infection of the reproductive tract. A significant and permanent reduction in circulating oestrogen, a consequence of the menopause, or anti-oestrogen therapies such as aromatase inhibitors commonly used in breast cancer treatment, leads to vaginal atrophy that is characterised by thinning of the vaginal epithelium and diminished glycogen stores. This in turn causes disruption of the microbiome and the opportunity for growth of bacteria that can trigger urinary tract infections. Since the hormonal regulation of the vaginal epithelium and its associated microbiome is currently not well understood, a greater appreciation of its role will help develop more effective topical treatments capable of restoring/maintaining vaginal health and reducing the incidence of infections”.

‘Vaginal dysbiosis is characterized by a perturbed or imbalanced microbiota, where dominant Lactobacillus species are overwhelmed by exogenous or minority ones, and associated with a significant negative impact on self-esteem, sexual relationships and quality of life.’ [xii]

Vaginal dysbiosis can lead to bacterial vaginosis, yeast infections (vaginal thrush or vulvovaginal candidiasis due to Candida albicans) and increase chances of a Urinary Tract Infection (UTI). Bacterial vaginosis can increase microbiome diversity and elevation of pH above 4.5 can reduce the protective Lactobacilli, also preventing yeast infections. Bacterial vaginosis, the most common cause of vaginal infection, is clinically associated with an unpleasant odor, discharge, discomfort, itching. In Bacterial vaginosis, the Lactobacilli concentration decreases while the presence of other anaerobic bacteria increases with a polymicrobial biofilm forming on vaginal epithelial cells. The roles of bacterial species are not fully understood, nor are the triggers of biofilm formation.[xiii] Research has determined the existence of 13 different species within the genus Gardnerella vaginalis – with virulent strains being implicated in the  condition, as well as Prevotella bivia and Atopobium vaginae.[xiv] UTIs are more common in women and  often not caused by the same bacteria that cause vaginal infections. The healthy vaginal biota the urinary tract.

The future of intimate care in femtech

The interest in the feminine health sector is growing. Companies including DuPont, the personal care brand Gallinee, the Urinary Tract Infections focused BrightCure and Juno Bio (working to decode the vaginal microbiome by at-home screening Vaginal Microbiome Test), are investing into understanding the vaginal microbiome profile in terms of consumer wellness. [xv][xvi] The regulatory pathways for non-pharma technologies are unclear and companies are likely to enter into a dialogue with regulatory agencies. Biofilm assays that monitor therapeutic efficacy of treatments, e.g. inhibition of in vitro biofilm formation will be required to substantiate new claims. Professor Andrew McBain from the University of Manchester, known for his expertise in in vitro models explains,

“Microbial communities representing those occurring in the vagina can be grown in a range of In vitro models with and without the involvement of host cells. As is often the case, however, selection of the appropriate model and the way it is applied to a given research question is key to obtaining predictive preclinical data”.

Probiotics in feminine health

At present, antibiotics in capsules or vaginal pessaries are treating recurring infections. Some probiotic strains showed antimicrobial properties, linked to their ability to produce bacteriocins, lactic acid or hydrogen peroxide. Lactobacillus acidophilus is the most-researched strain when it comes to establishing and maintaining a healthy vaginal balance, followed by Lactobacillus rhamnosus and Lactobacillus reuteri.  These strains help maintain vaginal balance by attaching to vaginal surfaces and making it more challenging for harmful bacteria to grow. Lactobacillus may also adhere directly to harmful bacteria, killing them and preventing them from colonisation.[xvii] As research advances to differentiate the ‘normal’ versus ‘disease-prone, dysbiotic’ vaginal microbiome and specific strains of Lactobacilli that confer the most benefits, new probiotic approaches will provide preventative, restorative and therapeutic options.[xviii]

In vitro studies have suggested that this may be possible by applying single strains of probiotic lactobacilli that penetrate and disrupt biofilms.[xix] The most effective approach would be to provide probiotics directly into the vagina. Lactobacilli‐containing vaginal probiotics have shown promise for bacterial vaginosis. However, the regulatory landscape is complex as vaginal probiotics have not been approved as drugs for human use. The detection of probiotic strains has never lasted long beyond the dosing period, suggesting inadequate engraftment in the vagina.[xx] [xxi][xxii]

Vaginal microbiota transplant incurs the challenge of lacking suitable animal models, microbiome personalisation, inoculum harvesting from the donor and immunological assessment.[xxiii] Preventative and treatment effects on vaginal imbalance have been confirmed after eating probiotic yogurt[xxiv], using an oral probiotic alone[xxv] or augmenting treatment with antibiotics[xxvi]. Roelmi HPC have developed a probiotic multi-strain supplement to reduce the recurrence of bacterial vaginosis and re‐populate the native healthy Lactobacillus by oral probiotics supplementation. Having screened a number of probiotic strains, the best three strains inhibit a wide range of biofilm-forming pathogens, selectively colonizing  the vaginal epithelium after oral administration.

The Vienna-based biotech company PhagoMed Biopharma GmbH has discovered a novel alternative to antibiotics for the treatment of bacterial vaginosis and the re-stabilization of the vaginal microbiome, based on a recombinant phage enzyme (endolysin) that Gardnerella bacteria. Endolysins can specifically attack the bacteria that cause the disease – without harming the rest of the microbiome – and also destroy bacteria that are resistant to any antibiotics. PhagoMed has filed a patent application for this class of recombinant endolysins and established a dedicated team focused on the development of phages at the company’s headquarter at the Vienna Biocenter. The Austrian Research Promotion Agency (FFG) has awarded a grant of EUR 1 million under its Early Stage program to further develop this technology, also in Urinary Tract Infection.[xxvii] Also, Swiss Ferring Pharmaceuticals, the USA based Eliava Foundation and Intralytix have formed a research collaboration that focuses on developing bacteriophage-based products to target the vaginal microbiome.[xxviii]

Daily intimate care with gentle surfactants is beneficial, as rinsing vagina with soap and water can disrupt its natural balance. Professor Andrew McBain from the University of Manchester reflects on the opportunity for growth in the feminine health sector,

“Host-associated microbial communities in the vagina are clearly important in both health and disease and as our understanding of their composition and activities increase, so do the opportunities to promote health and combat disease”.

Mild, soap-free formulas solve consumer need for freshness and lack of odour, even during menstruation. Acidic environment ensures a balanced protective flora, brands like Lactacyd and Gallinee add lactic acid to the formulations to address fluctuation of vaginal dryness, swelling, redness, itching, burning sensation, odor and discharge. Czech based company Pharmaceutical Biotechnology has developed sanitary pads with stabilized probiotics which contain live Lactobacillus cultures. [xxix] 

Working with the Cosmetics Cluster UK (CCUK), NBIC would like to appeal for SMEs to contact us to discuss their R&D needs in feminine health and hygiene. We are in a process of reviewing vaginal in vitro modelling and clinical research capabilities of our academic partners at 52 UK Universities.

References

[i] https://www.alliedmarketresearch.com/feminine-hygiene-market

[ii] https://www.statista.com/study/48853/tissue-and-hygiene-paper-report-feminine-hygiene/

[iii] https://www.marketresearch.com/Consumer-Goods-c1596/Consumer-Goods-Retailing-c80/Feminine-Hygiene-c1548/

[iv] https://www.marketresearch.com/Consumer-Goods-c1596/Consumer-Goods-Retailing-c80/Feminine-Hygiene-c1548/

[v] https://pubmed.ncbi.nlm.nih.gov/28844447/

[vi] https://academic.oup.com/cid/article/61/4/601/330070

[vii] https://pubmed.ncbi.nlm.nih.gov/28358585/

[viii] https://www.nature.com/articles/s41396-018-0337-0

[ix] https://pubmed.ncbi.nlm.nih.gov/12379833/

[x] https://pubmed.ncbi.nlm.nih.gov/31992328/

[xi] https://www.sciencedirect.com/science/article/abs/pii/S0378512216301244

[xii] https://www.roelmihpc.com/news/roelmi-hpc-12th-international-scientific-conference-on-probiotics-prebiotics-gut-microbiota-and-health-ipc-2018/

[xiii] https://pubmed.ncbi.nlm.nih.gov/28232119/

[xiv] https://pubmed.ncbi.nlm.nih.gov/31369673/

[xv] https://www.giievent.jp/gel917952/catalog.pdf?20200214

[xvi] https://www.womenofwearables.com/new-blog/wow-woman-in-femtech-hana-janebdar-co-founder-ceo-juno-bio

[xvii] https://www.healthline.com/health/vaginal-health/probiotic-vaginal-health#when-to-see-a-doctor

[xviii] https://www.tandfonline.com/doi/pdf/10.1080/08910600601072415

[xix] https://pubmed.ncbi.nlm.nih.gov/21497071/

[xx] https://obgyn.onlinelibrary.wiley.com/doi/10.1111/1471-0528.15870

[xxi] https://pubmed.ncbi.nlm.nih.gov/1523530/

[xxii]https://www.researchgate.net/publication/6205796_Probiotics_for_treatment_of_women_with_bacterial_vaginosis

[xxiii] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5904725/

[xxiv] https://pubmed.ncbi.nlm.nih.gov/8930233/

[xxv] https://pubmed.ncbi.nlm.nih.gov/11750220/

[xxvi] https://pubmed.ncbi.nlm.nih.gov/16697231/

[xxvii] https://www.microbiometimes.com/phage-lysin-stabilizes-vaginal-microbiome-phagomed-accelerates-rd-program-against-bacterial-vaginosis/

[xxviii] https://www.nutraingredients.com/Article/2019/06/26/Ferring-join-Intralytix-and-the-Eliava-Foundation-in-vaginal-microbiome-R-D-pact

[xxix] https://pharmabiotech.cz/vyroba_damskehygieny_en.php

 

 

Dr Katerina Steventon, NBIC Senior Innovation Consultant

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