The women’s health paradox
Women make up half of the global population, yet they spend 25% more of their lives in poor health compared to men – and many of the conditions driving this disparity remain under researched and underserved. Closing the healthcare gap is estimated to add at least 1 trillion US dollars to annual global GDP by 2040, according to the McKinsey Health Institute.
Global awareness of female-specific health issues is rising, driving increased public and private focus on reproductive, endocrine, and general women’s health. This global movement is seen in the US, EU, Australia, Japan, other governments, as well as privately as described by McKinsey, Forbes, and BCG. This shift in perspective on women’s health is driven by an increased awareness regarding the lack of research, including a governmental focus on decreases in the global fertility rates caused by aging populations and health issues such as obesity.
We will use female and women interchangeably during this article. We acknowledge that gender and sex are not equivalent, especially regarding access and efficacy of healthcare. This is done to align with current dialogue around these diseases.
What is “women’s health” and why does the women’s health gap still exist?
The phrase “women’s health” is used to encapsulate a large span of diseases that affect those born as the female sex:
- differently, like Alzheimer’s disease;
- disproportionately, like osteoporosis or urinary tract infections;
- or exclusively, like menopause, endometriosis, or polycystic ovary syndrome (PCOS).
Many aspects of women’s health still have a significant unmet need, so a larger number of patients go without proper care. This healthcare gap exists across multiple markets, offering significant opportunities for investment and growth.
Where the pipeline stalls
In research and drug design
- Male-default models: Within biology labs, standard animal models are male. As research is built off past work, lack of experience with and lack of data from female mice slows current use of both sexes as it is more risky, expensive, and/or adds complexity to an experiment.
- Hidden biology: Researchers are working to include female and male animals in initial studies building the basic research foundation for future work within a myriad of disease fields. For translational research models for women’s health, suppliers and CROs can offer animal models and include female mice in PK/PD work to illuminate differences in sex response to new compounds. Starting early with sex as a variable allows for researchers to discover more specific disease phenotypes or compound responses.
In clinical trials:
- Lack of trial representation: Starting in 1993, according to the Office of Research on Women’s Health at the NIH, clinical trials in the United States legally had to include women. But it was only in 2016 that sex had to be analysed as a variable in preclinical and clinical data, as AAMC states. By not having this information on record, sex-specific differences in drug response were likely missed. The consequences of this are severe with a potentially therapies abandoned early due to confounded data from one sex or a therapy being offered to men or women that should not be used with their respective physiology.
- Treatment as a default: The opportunity for additional applications of current therapies is vast; medications approved for other indications could be repurposed for women’s health indications or dosages re-examined for women specifically. The market availability for novel medications is equally as large. Menopause, menstruation, PCOS, and other such female-specific diseases have limited to no dedicated medicines, with primarily lifestyle changes being the only option. However, patients and clinicians are looking for medical solutions.
In medical practice:
- Care gap: Women-specific conditions at the practice level are still under-diagnosed and poorly treated; providers often lack training, or the standard of care does not address the needs of patients. Additionally, within female healthcare patients’ self-reported pain is often dismissed, leading to delays of care and/or misdiagnoses. These concepts are reviewed in an article in Nature Communications and the Journal of Psychosomatic Research.
- Technological solutions: To bridge the healthcare gap while medical research and standard care catch up, virtual women’s-health—“FemTech”—platforms are now creating one-stop apps specializing in addressing female health issues. This is done by connecting users with specialist clinicians, tracking cycles and symptoms, and offering lifestyle changes to address menopausal transition and hormonal imbalances.
Opportunity and societal impact of addressing women’s health
By focusing on developing treatments for women, there is an exponential amplification of the positive impact addressing these diseases as future generations depend on the health of current individuals. Current understanding is there is a decrease of 1000s of disability adjusted life years to be had by addressing female health issues, as reported by Silicon Valley Bank. By preventing further disability years of women, the McKinsey Health Institute states that there is an opportunity to increase economic impact $3 for every $1 invested.
Fertility, a subsection of the area of women’s health, also has an increased need to be addressed as global fertility rates decrease. Individuals looking to have children are facing increased fertility barriers. One example of this is as more children survive childhood cancer, more individuals are losing their supply of oocytes, so later in life they are unable to conceive. Preventing oocyte loss, promoting maturation of oocytes, and retention of pregnancies are important sectors for those who are having children later in life or while dealing with other difficulties.
Any movement in this field can have a significant impact on the economy, society, and future health of generations to come.
How CROs accelerate progress in women’s health research
CROs, like Gubra, are uniquely positioned to supply women’s health expertise, allowing for rapid innovation and growth within pipelines without needing to invest internally in expensive models and resources. As the field of women’s health continues to grow, establishing standardized models in mouse, rats, and beyond is crucial. In addition, honing quantifiable endpoints will expedite drug development. Both standardized models and defined endpoints allow drug developers to produce IND-enabling data with more confidence and speed.
Gubra is growing our expertise in conditions that specifically effect women, such as polycystic ovary syndrome and primary ovary insufficiency. We have fully developed whole ovary imaging and quantification of follicles utilizing light-sheet microscopy. This technique, while being extremely informative, requires a highly specialized skill set, limiting most drug developers from performing these assays internally at the scale needed to make strong conclusions.
We hope to be one of many to contribute to filling the health disparity gap by providing the resources for our partners to develop much needed, novel therapies for female-specific diseases. If you are interested in working with Gubra within the realm of women’s health, contact our experts here.
