The pharmaceutical industry has progressed a long way from a ‘what’s sauce for the gander …’ attitude when it comes to women’s health needs. As summed up by John J Castellani, President and CEO, the Pharmaceutical Research and Manufacturers of America (PhRMA), “Our increasing knowledge of the less obvious differences between men and women is providing great promise for new and better treatments that will benefit both sexes.”
This was in May 2011, when Castellani was releasing a PhRMA report, according to which 851 medicines were in development for diseases that exclusively or disproportionately affect women. The number included 139 for cancers that affect women and 110 for autoimmune diseases, which strike women three times more often than men. The medicines were all either in human clinical trials or were awaiting review by the Food and Drug Administration (FDA).
The discovery that there are possible differences in the ways men and women metabolise certain substances, or react to stress helped researchers understand that treatments for some diseases needed to take this into account.
Besides the findings featured in PhRMA release, various research reports reveal attractive growth rates of the women-specific segment of the global pharma market.
GBI Research forecasts the women’s health therapeutics market to grow at a Compound Annual Growth Rate (CAGR) of 7.9 per cent between 2010 and 2017 to record a sales value of $24,671 million in 2017.
Similarly, a 2011 report from Business Insights (BI) valued the global women’s health market in 2010 at $23.3 billion, with a CAGR of 4.2 per cent (2005–10). It is forecast to reach $32.8 billion by 2016 at a CAGR of 5.9 per cent (2010–16).
According to the BI report, hormonal contraceptives was the largest selling drug class in 2010 and is projected to reach $15.2 billion by 2016, followed by osteoporosis treatment as the second largest drug class.
The top 10 brands in the women’s health market accounted for 39.5 per cent of total sales in 2010. Seven out of the top 10 brands are forecast to decline during the forecast period due to impending or expired patents.
Within India, CubeX, a division of Sorento Healthcare has recently released a report titled “Decoding the Better Half of India: Mapping the Health and Wellness Opportunity among Indian Women” which aims to understand the Indian woman’s health concerns and identifies unmet opportunities in the women health and wellness market. (See page 30 in this issue: Decoding the better half of India)
Broadly speaking, the five rapidly growing segments in the female health market are products dealing with anti-aging, reproductive health, tumours as well as dermatological and beauty products, and mental health treatments. Postmenopausal osteoporosis and menopause are the two major drivers of the women’s health market, according to a GBI Research report, which also points out that the endometriosis market is heavily genericised and lacks an effective and safe option for the treatment of endometriosis.
But even today, safety issues associated with some treatment regimens for these health issues remain a serious concern. For instance, the majority of these diseases are currently served by hormonal therapeutics and as hormones have been shown to be associated with significant safety issues such as risks of breast cancer and cardiovascular disease, the use of hormones has declined. Women are worried about resuming hormonal therapy for the treatment of menopause/osteoporosis and this translates into an unmet need.
Given the safety issues with existing products, pharma companies do seem to have sensed the opportunity to develop drugs with greater safety profiles at more competitive prices. These safety issues are of particular concern when such therapies are being used by pregnant and lactating women, as the unborn/newborn baby will also be adversely affected by such safety issues.
According to the GBI Research report, the women’s health therapeutics market R&D pipeline is moderately strong, with the majority of first-in-class drugs in late stages of development. These drugs are expected to drive market revenues and it is expected that, if they are approved and are shown to have better safety profiles, patients will comply with novel therapies. In particular, non-hormones are set to take over the conventional hormone therapeutics market, predicts the report.
NGEBNs in healthcare
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(Source: Suhas Wadwalkar, Vice President – Corporate Affairs, Premier Nutraceuticals) |
New age ‘nutras’
Suhas Wadwalkar VP – Corporate Affairs, Premier Nutraceuticals |
It is precisely these safety issues which has seen what Suhas Wadwalkar, Vice President – Corporate Affairs, Premier Nutraceuticals calls the “rediscovery” of the importance of certain dietary components in maintaining women’s health. This has in turn led to the rapid growth of women’s health ingredients market.
While the established safety of natural ingredients during pregnancy and lactation gives a special impetus to this category, Wadwalkar also points out that the increasing life span of women translates into a longer menopausal phase, which is another driver for the overall women’s health market.
Dietary and nutritional supplements have been part of our lives for at least the last five decades, more as a long-ingrained habit rather than for any specific health-related benefits.
Samantha Marie Izzy Scientist – Supplement Product Development, Nutrilite |
As Samantha Marie Izzy, Scientist, Supplement Product Development, Nutrilite, puts it, “Nutrition is like an insurance. You are secured when you take nutritional supplements and therefore its a long term investment for healthcare.” Amway India, which recently launched a range of women healthcare products in India, targeted at hair, skin and nail health, iron deficiency and for women experiencing menopause challenges, is but one of the many companies tapping into this market.
The natural ingredient market has evolved beyond the calcium-iron-zinc-multivitamin routine and in fact, Wadwalkar calls these products New Generation Evidence Based Nutraceuticals (NGEBN).
The terminology seems to have been coined with the sole aim of dealing with the scepticism of both consumers as well as the medical community, as there did not seem to be any scientific proof of the benefits of such nutraceutical ingredients.
As Wadwalkar avers, if nutraceuticals come armed with robust scientific studies, clinical trial data and standardisation of dosages, they are allowed to make certainhealth claims after regulatory approval. He claims that as newer and more advanced nutraceutical entities from the world over make their appearance, the ethical market is openly welcoming new entrants.
Quoting ORG IMS data, he says nutraceuticals enjoy the support of 70 per cent specialists, with one out of four prescriptions carrying a nutraceutical product.
Learning from the past, when supplements lost out to prescription products as the former did not have the evidence to back them up, Wadwalkar says there is a boom in research and development activities, robust scientific back-up and clinical trial and validation of new nutraceutical entities, all of which is paving the way for a major growth in the segment, especially in developing countries.
Izzy, for instance, specialises in research and technical evaluation of nutritional supplements designed to maintain optimal health with her primary focus of research for Nutrilite being omega-3 fatty acids, coenzyme Q10, multicarotene and women’s health.
It is not difficult to see why pharma companies, faced with depleting research pipelines and revenue dips due to blockbusters losing patent protection, want a slice of the natural ingredients pie.
Within the India market, Sanofi’s acquisition of Universal Medicare’s nutraceutical unit in 2011, shoring up its OTC presence in the country, could be see in this light.
Wadwalkar also draws attention to the changing demographics and increasing life span which is creating more demand for supportive products for women of all age groups, from puberty to menopause. An increase in disposable incomes and growth in aspirations to lead of better quality of life is also driving the demand for nutraceutical entities proven to add value to a healthy life style.
And regulators too are keeping up with customer demand and market trends. India has a relatively new regulatory regime under the Food Safety and Standards Authority of India (FSSAI) which monitors the segment.
The FSSAI recently pulled up several well known food companies, (ranging from Maggi multigrain noodles, Top Ramen, Nutrichoice biscuits, Horlicks, Complan, Heartcare biscuits, Bournvita Lil Champs and Pediasure food supplement) asking them to substantiate the health benefit claims made in their advertisements, proving that it is very much on the job. (See link to The Indian Express report dated February 20, 2013: http://www.indianexpress.com/news/food-authority-crackdown-on-ad-claims/910187/)
Alluding to the success of companies like Zydus Cadila (which launched Zydus Nutriva in March 2008 with two spearhead brands: GRD and Globac-Z), Sanofi’s 2011 buyout of Universal Medicare’s OTC nutraceutical unit, Tablets India, as well as his own company, Wadwalkar says that the growth of natural healthcare products for women will attract more players into the segment. He predicts that the next few years will see at least five-six pharma majors introducing a basket of nutraceuticals targeted at women’s health.
The super-segmentation of the nutra market into women-specific nutra ingredients is still a nascent trend in India. Whether these brands are able to capture the imagination of the increasingly empowered bharatiya nari and retain her as a long time customer/ consumer, remains to be seen.