Women's Health: innovations, discoveries and gaps

The year 2024 may be the beginning of a new moment for the women's health market. This is because companies and research institutes have begun to open space for new studies focusing exclusively on the female body, in addition to more robust attempts to improve the representation of women in clinical trials.

After science discovered that exclusively female organs can impact other areas of the body and influence the clinical outcome of various diseases (even if it is one affecting both sexes), scientists realized the need to better understand what happens in women's bodies. Within this, there is also the beginning of a wave of studies that go beyond reproductive health.

But before talking about the market, it is worth considering some essential data and information.

Disease in the female vs male body

Despite having many elements in common, the existence of organs exclusive to each sex implies different possibilities of the impact of a disease on the body, in addition to different absorption and/or efficacy rates of medications and other treatments.

Even so, when developing new therapies for diseases, many studies fail to study the performance of these treatments in the female body. According to McKinsey, a review of more than 650 academic articles on 183 popular interventions for the treatment of 64 health conditions — of which 90% mainly affect women — showed that half of the studies did not present data separated by sex.

And when finally there were data separated by gender, it was observed that 64% of treatments were less advantageous for women. This was sometimes due to the drop in efficacy, and in other cases, access to treatment was limited. In some situations, both motives influenced. On the other hand, the same only happened with 10% of men.

To better illustrate the possibilities of clinical outcomes influenced by gender particularities, a report of McKinsey also suggests that we look at two examples, one referring to asthma and another one about diseases cardiovascular and cerebrovascular:

• “Asthma it is a common respiratory disease affecting men and women at similar prevalence rates. Acute asthma exacerbations present as symptoms such as shortness of breath, wheezing, coughing, or chest tightness. The basis of treatment is inhalation therapy with bronchodilators and corticosteroids, but studies indicate that this treatment is about 20 percentage points less effective in reducing exacerbations in women than in men,” the analysts point out.

• “Cardiovascular and cerebrovascular diseases — particularly ischemic heart disease and stroke — are the biggest individual contributors to the global burden of disease for both men and women, accounting for 16% of DALYS (acronym for Disability-Adjusted Life Year, a metric used to measure the overall burden of the disease) globally for men and 14% for women. A German study found that, despite the identical technical success of a percutaneous cardiac intervention for men and women, the age-adjusted risk of death or cardiac events was 20% higher in women than in men.”

In other words, treatments could be more assertive, if women were represented in greater numbers in the studies.

According to this study, from 2000 to 2022, female representation in oncology clinical trials generally improved. Even so, women are still underrepresented in surgical research against head and neck cancer, of bladder, stomach and gullet. In addition, the fact that a disease affects more women does not guarantee that they are adequately represented in research, as is the case of studies in neurology.

Another important factor for improving women's health is the encouragement of studies on diseases with a higher prevalence among women.

A mapping from Nature, published in 2023, reveals that diseases that affect more women than men receive less research funding compared to those that affect mostly men.

Among the examples, the data highlight that conditions such as migraine, migraines and anxiety disorders, affect women much more and yet attract much less funding - in proportion to the burden they exert on the American population - than other conditions. Other conditions that exclusively affect women, such as endometriosis, are also on that list.

In addition, data from the US National Cancer Institute show that, between 2007 and 2017, points out that gynecological cancers received less support than other types of cancer. In terms of lethality (measured in years of life lost per diagnosis), ovarian cancer ranks 5th out of 19 cancer types, but is only in 12th place when considering funding in relation to lethality.

Science and the woman's body

The development of medical treatments begins when researchers carry out preclinical studies In vitro and in animal models. By testing treatments on animals, scientists can observe effects involving multiple organs and body systems, such as immune, metabolic, and toxicological reactions, allowing for a more realistic assessment of the efficacy and safety of new therapies.

In addition, these studies help identify possible adverse effects and adjust dosages more precisely. Ultimately, this reduces the risk of unwanted effects when treatments move to clinical trials with human volunteers.

And what does this have to do with women's health? Well, according to the analyses by researchers Irving Zucker and Annaliese Beery, published in Nature in 2010, most studies used males for animal modeling.

According to Zucker and Beery's study, out of 10 study areas, at least 8 were male-biased. Among the examples, they cite the pharmacology, neuroscience and physiology. Already in immunology, 75% of the most cited studies, found in three journals, did not specify the sex of the animals used. Female bias only appeared in the segment of reproduction.

A possible explanation for this situation is the increased hormonal variability in the female body, primarily due to hormones associated with reproductive organs. As a result, using female animal models may have been deemed inadequate as a research baseline. However, precisely because of these biological differences between genders, the absence of female representation in studies leaves significant gaps in the health sector.

The understanding of these differences is relatively recent. It wasn't until 1993 that the american health regulatory agency, Food and Drug Administration (FDA), issued orientations about gender differences for clinical evaluation of medications.

New scientific discoveries

Although we are still far from ideal levels, the first results of this innovative impetus have begun to appear.

For example, last year two researches made important discoveries about menstrual pads.

• For the first time, a study decided to test the absorption capacity of these products with blood, rather than with saline solution. With the results published in BMJ Sexual & Reproductive Health, the study indicates that there are large disparities in absorption between the liquid capacity indicated on the package and the actual capacity. For women with heavy flows, this can represent leaks and difficulty analyzing whether the flow is at healthy levels.

• The second relevant discovery came through another new study in the category: for the first time, scientists analyzed the amount of toxic metals in tampons. And the results pointed to presence of arsenic and lead, components that may increase the risk of dementia, infertility, diabetes, and cancer — in addition to impacting the brain, liver, kidneys, and other body systems.
• The researchers at the University of Berkeley decided to investigate the issue because they took into account two pieces of information in particular: the fact that vaginal skin has a greater potential for chemical absorption than the rest of the body; and that 50% to 80% of people who menstruate use tampons.

In addition to this, there are also other researches that provide new information related to menopause and to pregnancy. Below, we will show four of the six scientific novelties presented in a report from National Geographic earlier this year.

When it comes to menopause, for example:

• A recent study opens up new possibilities for treating hot flashes that come with menopause. This symptom, experienced by approximately 80% of women during this phase, can occur several times a day for a period of at least four years and is often accompanied by symptoms such as dizziness, anxiety, fatigue and palpitations, among others.

       New research has revealed that the drop in estrogen affects a specific group of neurons in the hypothalamus - the brain region responsible for controlling body temperature - causing those neurons to be activated inappropriately. In response, companies are developing drugs that block these neurons, in order to permanently eliminate hot flashes.

• Another finding refers to the influence of menopause on frozen shoulder syndrome, a condition in which the connective tissue of the shoulders becomes inflamed, painful, and immobile. It is a poorly studied syndrome and 75% of the public is a woman. Current research investigates whether a drop in estrogen in the body is associated with joint pain.

As far as it relates to maternity:

• Scientists are investigating hyperemesis gravidarum (HG) in greater depth. The condition causes nausea and vomiting at dangerous levels, which can lead to weight loss and dehydration. What current research suggests is that a specific hormone may lead to this condition.

• The second discovery, on the other hand, refers to strategies that can help reduce maternal mortality, since pregnancy or childbirth complications cause around 800 people to die every day worldwide. On this list are conditions such as preeclampsia, anemia, and sepsis.

            For the cases of preeclampsia, the first blood test capable of predicting which patients are susceptible to developing the condition was approved by the FDA in 2023.

           As for anemias, the new strategy for curbing heavy bleeding during childbirth is the intravenous administration of iron. That's because researchers found that 15 minutes of intravenous treatment provides the equivalent of four pills a day for four weeks.

           Finally, a single dose of the antibiotic azithromycin during a vaginal delivery can reduce the risk of postpartum sepsis.

The women's health market

According to an analysis of Deloitte, based on data collected by PitchBook, even though investments in health technology in general fell 27% between the years 2022 and 2023, companies focusing on women's health saw a growth of 5% in the same period.

In addition, more than 60% of companies focused on women's health were founded in the six years prior to 2022. In fact, in general, the last decade has seen a 1000% increase in the number of companies in this segment, according to research by FemHealth Insights.

In a more detailed perspective, Deloitte points out that health-focused health technology companies peaked in 2021, reaching US$ 629 million through 39 businesses.

And, according to analyses from Dealroom, the women's health segment represents a market with the potential to move 36 billion dollars. However, according to data from PitchBook, of the US$ 41.2 billion invested in health investments in the USA in 2023, only 2% of that amount was directed to women's health.

With that in mind, some large companies are beginning to direct their market strategies to this area. For example, the Google Ventures led a Series A funding round for Midi Health, a virtual clinic for women's midlife health needs.

Another favorable sign for the women's health market occurred in July of this year, when the app Flo, an application for monitoring the menstrual cycle and ovulation, reached the Valuation (market value) of 1 billion dollars.

Among other movements to follow, the rival app called Rosy, announced in May the expansion of services to treat other clinical conditions, such as menopause, endometriosis, and fibroids.

Another popular application in this medium is Clue; In September, the company launched perimenopause mode, so that users could register symptoms such as hot flashes, changes in sleep and mood.

Among other relevant movements, Deloitte also highlights:

• Mass General Brigham Health Plan — launched a broad portfolio focused exclusively on women's health, expanding access to targeted care and promoting health equity for women.
• Atrium Health — created the Sanger Heart & Vascular Institute Center for Women's Cardiovascular Health, with a specialized focus on more prevalent heart conditions among women, including fibromuscular dysplasia. The center also offers cardiovascular care during pregnancy and postpartum, through the Cardio-Obstetrics Clinic.
• Medtronic — expanded its scope to include a division specialized in gynecology and women's health, focusing on clinical studies that consider factors of diversity in gender, race, and ethnicity.
• Organon — founded in 2020, the pharmaceutical company specializes in women's health, offering a line of products ranging from reproductive health to oncology and cardiovascular diseases.

Finally, one of the most recent movements took place in the last edition of HLTH, one of the largest health innovation events in the world.

At the time, the First Lady of the United States, Jill Biden, announced that the Advanced Health Research Projects Agency (ARPA-H) will allocate 110 million dollars to 23 initiatives focusing on women's health. Among the selected startups, there are various theses such as: cancer, endometriosis, menopause, obstetrics, pain control, neurological conditions, ovarian health, gynecological care, and cardiovascular diseases.

To help us think about some of the possibilities for innovation in this area, it is worth considering examples of the projects of the selected companies:

• the Gamete, for example, aims to develop ovarian therapy to interrupt menopausal diseases;
• Already Vanderbilt University Medical Center was the one chosen to develop a medication for conditions associated with risks in premature births.

And, as the First Lady pointed out, “the potential is too great to be ignored. In 2021, the Boston Consulting Group (BCG) estimated that the women's health market could jump from US$ 9 billion to US$ 29 billion in eight years, due to the growing impetus of funders and founders to address women's unmet health needs,” concluded Jill Biden.