Despite high unmet need across many conditions, the pipeline is sparse

According to GlobalData’s Pharma Intelligence Center, as of February 18, 2021, 287 drugs are in development for various women’s health-related conditions*. Among these pipeline candidates, 42 per cent are in Phase II development stage or beyond.  Approximately 31 per cent of the overall women’s health pipeline is assessing candidates for female infertility followed by 22 per cent for cervical intraepithelial neoplasia (CIN) and 14 per cent for endometriosis.

Considering the overall research and development activities within this space, there were a minimal number of women’s health company acquisitions by Big Pharma in the last few years. In August 2020, Bayer acquired KaNDy Therapeutics for a sum of $875 million to expand its drug development pipeline in women’s healthcare.

Genericisation: A barrier to entry of novel therapies

One of the major drivers is the growing incidence of female health conditions. Infertility is becoming more prevalent as women are postponing pregnancy until a reproductively older age when fertility has decreased. Endometriosis and uterine fibroids are receiving increased disease awareness and earlier diagnoses. There is also an increasing need for contraceptives as certain government initiatives aim to curb population growth.

The current treatment of many female health conditions is highly genericised which represents a barrier to the entry of novel therapies. Hesitancy also remains for use of hormonal contraceptives due to potential unwanted side-effects and cultural or religious reasons. Despite the high unmet need across many conditions, the pipeline is sparse and the female population ages 12–54 is projected to decrease across certain markets.

Significant unmet needs remain

Several novel products, many with improved routes of administration, have recently launched across the female health space. Multiple competing companies have entered the space with their own oral GnRH antagonist attempting to capture market share for endometriosis and uterine fibroid indications.

New forms of contraceptives will offer more options for women.

The infertility drug paradigm has largely remained unchanged, although improved versions of the original fertility drugs have made their way into the market.

Digital technologies are advancing female health

Femtech includes digital technologies that aim to improve women’s health, with menstrual health and reproductive health trackers being two of its fastest-growing sectors.

Despite major progress in treating patients, significant unmet needs remain such as improving the poor side-effect profiles and low patient compliance of contraceptives, sufficiently addressing the underlying pathology of conditions such as endometriosis and uterine fibroids and novel treatment options for menopausal symptoms, preterm birth, post-partum haemorrhage and vulvar and vaginal atrophy.

* Female-specific cancer indications like breast, cervical, and ovarian cancer are classified under the oncology space by pharma companies and are thus not considered within the scope of the women’s health indications.

Continued investment in women’s health will enhance health outcomes, quality of life and gender equality

Women’s health has oft been a neglected area, and COVID-19 disruptions further exacerbated limitations in women’s access to healthcare services and infrastructure. Thus, there is an urgent need to invest in providing access to health information, services and preventative tools.

Globally, Bayer continues to invest in breakthrough innovation in healthcare by continuing to build a strong development pipeline advancing more than 50 projects through the clinical development phases with women’s health as a key focus area. A recent attractive asset addition through the acquisition of KaNDy Therapeutics supports the investment in women’s health advancements, with interventions for menopause symptoms currently in development.

Providing women evidence-based solutions to empower them to take charge of their health is the need of the hour. Continued investment in women’s health will promote enhanced health outcomes, quality of life and gender equality, with these effects cascading across other areas of women’s lives.

Plugging gaps with digitalisation

‘Bayer For Women’, a dedicated social media platform and ‘Bare your Pain’ application are some of the key digital interventions that have empowered women by equipping them with more information about managing their health. In 2020, Bayer also partnered with The Federation of Obstetric and Gynaecological Societies of India (FOGSI) to drive awareness of its digital chatbot service ‘Ask Tanu,’ which provides round-the-clock, credible information and advice on contraception and family planning. Such solutions can bridge knowledge gaps in sexual and reproductive health, thus overcoming traditional barriers such as stigma.

Several barriers to women’s health persist, including social and cultural taboos that lead to reduced conversations on sexual and reproductive health. Moreover, decreased in-person access to healthcare practitioners due to the prevailing circumstances in 2020 has posed an additional challenge, contributing to worrying trends of increased maternal and child mortality and miscarriage. There is a crucial need to drive new and innovative ways for women to access health solutions at scale, so they can make informed decisions and get the care they need. Advancing digitisation has thus emerged as a key growth driver in the sector, enabling accessible support, as well as remote consultation and care services.

Now, more than ever, a holistic health and wellness approach is central to delivering care. That is why Bayer has invested in digital solutions to empower women to manage their health.

Need to approach women’s health holistically

2020 marked the 60th anniversary of the contraceptive pill, which has opened a world of opportunity by giving women and couples the right to have a child by choice, not chance. But it was also the year when access to sexual and reproductive health services was interrupted, thus threatening gains to women’s health outcomes made over decades. Restoring access to these vital services, while also ensuring the deployment of technology-enabled solutions will help ensure continued progress on the fronts of sexual and reproductive health. Such solutions also promote increased transparency and dialogue on contraceptive and family planning options.

There is also an emerging focus on managing disease conditions holistically, with greater personalisation to address women’s unique needs. Here too, digital resources such as chatbots or apps can play a vital role. By approaching women’s health holistically and complementing the journey of care with trusted, sustainable solutions, we can help women put their health needs first and get the care they deserve.

There are stringent regulations in place for approval of drugs against women’s diseases

One of Lupin’s differentiators has been the branded portfolio as an engine for growth. This includes building a world-class Women’s Health portfolio in the US, India and the EU.

A growing portfolio

Lupin’s Specialty portfolio in the US is 100 per cent focused on Women’s Health. Introduced back in 2000, Lupin’s Suprax (cefixime) oral suspension today is an established antibiotic to effectively treat UTIs and other bacterial infections.

With the acquisition of Gavis Pharmaceuticals LLC in the US, Lupin added Methergine to its Women’s Health portfolio. In 2016, Lupin announced the re-introduction of Methergine for the prevention and management of postpartum haemorrhage (PPH). The next year, the company acquired Symbiomix Therapeutics LLC to obtain its brand Solosec and launched it in 2018 for the treatment of Bacterial Vaginosis (BV).

The company also enjoys a considerable market share in the women’s oral contraceptive segment in the US ($40 million) and EU.

Lupin was the first company to introduce a medication for cervical erosion before which surgical intervention was the only mode of treatment. In 2020, the company also launched a non-hormonal product to support women transitioning to menopause.

Lupin’s iron supplement is the fourth largest prescription brand in its category in India. It also introduced India’s first small-sized calcium tablet which, market survey reveals, is especially preferred by women during pregnancy.

Lucrative opportunities galore

The global women’s healthcare market is projected to grow primarily driven by factors such as the growing incidence of chronic health conditions among women, growing demand for novel products and increased government spending on healthcare.

While the market has significant potential, the competition is also intense as there are numerous players competing for market share. There are also stringent regulations in place for the approval of drugs against women’s diseases, especially for treatments aimed at hormonal disorders.

However, a growing women’s population and geriatric population globally, coupled with the potential demand for advanced products offer lucrative opportunities for the industry to invest in.

– A spokesperson from Lupin

Women’s health therapeutics have established strong presence in global pharma market

Women’s health therapeutics have a strong presence in the global pharma market, and that presence is expected to increase significantly. In today’s times, pharma companies in the women’s healthcare space are expanding their R&D base and increasing the efforts to expand beyond reproductive health into key women’s health areas, such as endometriosis, polycystic ovary syndrome and the symptoms of menopause.

Challenges and growth drivers

One of the challenges has been women’s healthcare subjects especially those related to fertility, menstruation, intimate hygiene, birth control and sexual wellness are considered taboo to even discuss. While rising endeavours by government to encourage people about the adoption of safety in women healthcare is indirectly contributing to the growth of women healthcare market, the investment in women health continues to be limited considering the risks and expenses associated with it. There are several side-effects believed to have associated with women intensive surgeries and drugs. Producers are trying to come up with solutions that mitigate side-effects and are less cumbersome, which could offer lucrative opportunities for the growth of women’s health market.

Prevention is the key to women’s health

Women are demanding equal access to safety, health, and opportunities for empowerment. It is no secret that women today are overcoming barriers and are leading busier lives than ever before. Times are changing, and various women-centric movements around the globe have undulated the pharma industry. In addition to fertility and reproductive conditions, which are typically associated with women’s health, there are many other diseases, such as post-menopausal osteoporosis, osteoarthritis, Alzheimer’s disease, depression, urinary incontinence, multiple sclerosis, etc., that disproportionately affect women compared with men. Many of the large pharma companies have units or divisions that focus on these diseases that disproportionately affect women’s health.

Overall, women’s health therapeutics have established a strong presence in the global pharma market over the last few decades and the market is expected to grow moderately. Innovations coupled with technology focusing on correct nutrition and safety i.e. prevention is the key to Women’s health.

There is a lot of potential in women’s healthcare segment in India

Pharma majors are massively investing in the women’s health segment. For instance, Cipla last year had announced the acquisition of four brands – CPink, CDense, Productiv and Folinine, from Wanbury, to increase its presence in women’s health. The products sold under these brands would address health issues arising due to nutritional deficiencies or insufficiencies. Another key deal is Ahmedabad-based Torrent Pharma’s acquisition of women healthcare brands Regestrone and Pregachieve from Swiss pharma major Novartis AG, with an estimated deal size of Rs 500 crores. These brands are prescribed by gynaecologists for addressing multiple health issues. It is notable that Torrent Pharma had also acquired key brands like Shelcal and Deviry from Elder Pharma, in the women’s healthcare segment. All this demonstrates pharma investments made to benefit from the potential for growth in the women’s healthcare segment.

Drivers and restraints

It is expected that the women’s health market will grow at 4.96 per cent by 2026. Key drivers in this segment would include:

(a) Government’s increased focus on healthcare

(b) Rise in R&D activities of pharma manufacturers for providing better healthcare to women

(c) Lifestyle challenges

(d) Potential to provide qualitative healthcare services for women.

On the flip side, key restraints would be

(a) expiry of certain patents of pharma products; huge financial costs associated with clinical services; inadequate healthcare infrastructure and comparatively low levels of awareness.

Femtech is a key focus area

With 50 per cent of the population as target customers, and with the women’s healthcare market expected to reach $50 billion by 2025, Femtech (female technology) is the key focus area in the women’s health market, and this is the right time for pharma companies to increase presence in this sector. Femtech refers to software and products that use technology to improve women’s health and manage women’s health issues. In this tech-dominated scenario, connected devices and mobile applications will provide key and timely solutions to women. New business models such as telemedicine and remote monitoring platforms will emerge and are expected to play a key role in the women’s health segment. There is a lot of potential in the women’s healthcare segment in India, and this will attract top global investors.

Increased demand for high quality, safer alternative therapy options that offer reliable outcomes

Indian fertility market is more than 120 million EUR market growing rapidly with 9 per cent-12 per cent annual growth. Market once limited to metro and tier-I cities sees a lot of expansion in tier-II, III markets with more than 1500 centres coming from clinic chains as well as a stand-alone segment. There is increased demand for high quality, safer alternative therapy options that offer reliable outcomes.

As per E&Y report (2015), there are an estimated 27.5 million infertile couples in India (approx. 10-15 per cent married couples). With more and more women prioritising education and career, marriage and motherhood age is getting pushed. Coupled with lifestyle changes, it has led to increase in cases of infertility. Being the leaders in the field of Infertility, Merck strives not only to provide top quality drugs for the treatment but works in all the allied fields like Lab technology, digital tools to enable compliance and awareness etc and bring better clinical outcomes. Our partnerships with Philips and Genea Biomedx are an indication of our commitment to the field of women’s infertility.

Awareness and access are propelling progress

The growth drivers of this segment are increasing awareness around women’s health in India, working women professionals in certain key pockets of India, eradicating the stigma faced by women in society due to infertility, busting myths and superstitions surrounding the treatment of infertility and strong catchy marketing initiatives, better understanding/diagnosis, openness of talking about problems related to fertility etc., support groups for women suffering from infertility and those embarking on the journey of treatment.

Likewise, improved access due to fertility centres opening up in tier-2 and 3 cities of the country, more gynaecologists getting trained in ART for treatment of infertility is also adding to the segment’s progress

Challenges for this segment are low penetration in rural markets due to less awareness of infertility, couples hesitant to restart IVF treatment post-pandemic – economic impact and fear of infection, overall treatment cycle and lifestyle changes that need to be incorporated, non-medical treatments for infertility delaying the women reaching IVF centres and thus losing out on valuable time and decreasing the success rates, as well as patient drop-outs from the treatment due to various socio-economic reasons.

Working towards novel solutions

Merck continues to be continued to bringing joy to the life of childless couples seeking parenthood through drugs and technology. Towards this, Merck Healthcare India plans to introduce a new combination drug (first time and only such combination) which will help certain section of patients who will benefit from it. Also, Merck will work towards innovative and novel digital health solutions for improving patient compliance, adherence to treatment to improve success rates

– Spokesperson from Merck Healthcare India