9 Female-Specific Conditions

Female gynecological health conditions, such as PCOS, endometriosis, adenomyosis, fibroids, and heavy menstrual bleeding, affect a significant portion of the population worldwide. Endometriosis alone is estimated to affect 10 percent of women and girls of reproductive age globally, or 190 million people. These conditions are poorly understood. At the same time, the diagnosis and treatment of gynecological conditions cost billions due to high prevalence and expensive interventions—often long-term medication use or invasive surgery. An opportunity exists to advance the basic science for gynecological conditions and to support the development of less invasive, more effective, and higher-medical value options for diagnosis, monitoring, and treatment.

The vaginal microbiome is a dynamic community of microorganisms that is crucial to a woman’s overall health. The vaginal microbiome not only serves as a critical line of defense against the negative impacts of infections on the reproductive tract, but can also impact well-being when an abnormal vaginal microenvironment causes discomfort, odor, or unusual discharge. Stigma and limited investment in vaginal health research have posed barriers to developing prevention, diagnostic and therapeutic strategies to support the vaginal microbiome. Prioritizing research in this field could lead to improved diagnostics, personalized treatments, and preventive strategies that could benefit billions of women worldwide.

Maternal morbidity and mortality, stillbirths, and adverse neonatal outcomes are all interconnected. Thus, investing in maternal health positively impacts the range of adverse perinatal outcomes. Global progress in reducing maternal and newborn deaths as well as stillbirths has slowed down in the past decade; the rate of progress achieved between 2000 and 2010 exceeded the pace observed in subsequent years. Increased investment and research into developing new drugs, devices, and tools is required to address the significant factors that contribute to adverse maternal outcomes, as limited research exists to date into medicines or techniques for prevention and control. Maternal and perinatal conditions cause 7 percent of the global disease burden, but innovations for obstetrics only account for an estimated 1 to 5 percent of the drug pipeline. An opportunity exists to increase knowledge of the risk factors and causes of adverse maternal health conditions and develop new tools and treatments to improve maternal and infant health.

Women of reproductive age in LMIC and low-resource settings often have concurrent deficiencies of multiple micronutrients due to inadequate dietary intake and limited choices in fruits, vegetables, animal proteins, and fortified foods. In pregnancy and lactation, the burden and severity of micronutrient deficiencies are worsened by the increased demand, leading to potentially adverse effects on both the mother and baby. To address the issue of multiple and concurrent micronutrient deficiencies, the United Nations Children’s Fund, United Nations University, and the WHO developed a multiple micronutrient tablet called UNIMMAP (United Nations International Multiple Micronutrient Antenatal Preparation). However, the WHO does not yet universally recommend multiple micronutrient supplements for pregnant women over the current practice of prenatal supplementation with iron and folate, except in the context of rigorous research. As such, WHO recommends further research on the use of multiple micronutrient supplementation over iron and folic acid supplementation alone for pregnant women in low-resource settings.

Information about the impact of medication use in pregnancy on babies is often lacking; even less information is available on the transfer of medication from mother to child when breastfeeding. Closing this knowledge gap will promote the protection of mothers’ and babies’ health and ensure timely post-market updates about drug safety are disseminated to patients. Globally 200 million women get pregnant each year. A study of pregnant women in 28 countries found that 81 percent reported taking medication during pregnancy.

Breastfeeding women face a comparable situation, where many suffer from a chronic disease as well as postnatal health issues that require medication use. A study observed that of newly FDA-approved drugs, one-third of medications were not adequately labeled for safety during pregnancy and lactation and less than 20 percent included human data on pregnancy and lactation. New biobanks with linked milk and blood samples could enable knowledge generation of interactions between medications and pregnancy and breastfeeding. They could also be used in a variety of other research, such as nutritional or immunologic studies focused on pregnancy and breastfeeding. Safe, ethical inclusion of pregnant and lactating women in these biobanks will require strict adherence to local regulations, consent processes, and cultural norms.

From a business perspective, the contraceptive market appears robust—a market research firm estimated the market size at US$28 billion in 2022 and growing at 6 percent annually. Yet, innovations in contraceptive technology have slowed within the pharmaceutical industry; most recent industry-funded clinical trials focus on incremental revisions to existing hormonal products. New partnerships between academic institutions, nonprofits, small biotechnology companies, philanthropy, and government could help fill the gap in contraception innovation.

Many women choose not to use available methods of contraception, often to avoid unwanted side effects or due to cost. In the US for example, approximately 50 percent of contraceptive options on the market are not fully covered by insurance, despite federal mandates that insurers cover contraception at no cost. These barriers to contraceptive use drive high rates of unplanned pregnancies and lead more women to die unnecessarily from pregnancy and childbirth. Lack of contraception access also decreases women’s educational attainment, workforce participation, and autonomy. Women need more and better options to ensure parenthood is a choice, including more options available for male partners. With payors and innovators in place, potential exists for millions of women to uptake new methods that elicit fewer side effects.

Increased advocacy and funding for research on reproductive care policy in diverse settings can broaden the evidence base for potential implications of these policies on women’s quality of life and how policies may hinder or support the development of new reproductive care methods.. Key focus areas for development include safe and effective methods for facilitating completion of non-viable pregnancies that preserve the health of the pregnant individual due to complications or worsening disease, or when the embryo or fetus has lethal anomalies; these include inevitable or incomplete miscarriage—particularly those in the second trimester, ectopic pregnancies, preterm premature rupture of the membranes, and stillbirths.

The incidence of pregnancy loss in the second trimester is not well known and estimates range from 0.4 percent to 3 percent. While strong evidence exists supporting methods for managing pregnancy loss in the first trimester, data is limited for treatment options for pregnancy loss in the second trimester. For example, one systematic review of medical treatments for incomplete miscarriage found no randomized control trials that specifically studied the treatment of miscarriage between 13- and 24-weeks gestation. Research is needed to generate evidence on the best treatment modalities for second trimester miscarriages to guide improved care for women.

Ectopic pregnancies—which occur in one to two percent of pregnancies—are pregnancies outside of the uterus, which are nonviable and risk the mother’s health without prompt treatment. The most common treatments for ectopic pregnancies—surgical intervention and provision of methotrexate—are associated with unwanted side effects and adverse outcomes. Alternative pharmacological methods are promising, but additional research is needed to test these methods to ensure safety and efficacy across the array of presentations and patient populations.

Family planning is more than pregnancy prevention—fertility care is a key component that can help families have children when they want them. The global lifetime prevalence of infertility is estimated to be 17.5 percent; inequities in fertility care exist due to limited availability of services and high costs. In 2009 a panel of experts estimated that only 24 percent of the need for assisted reproductive technologies, including in-vitro fertilization (IVF), in the US was being met. Unmet need for infertility treatment may be significant in other countries as well. In China, for example, the number of assisted reproductive technology centers per citizen is estimated to be 1 for every 7.5 million people, compared to 1 for every 700,000 in the US. Equity and ethical concerns also abound, as those with the fewest resources are the least likely to have access to fertility care. A market research firm forecasts that the global infertility treatment market will grow by 8 percent annually. Industry should be ready to meet demand with innovations that can be applied in both high- and low-resource settings.

Stress urinary incontinence (SUI) and pelvic organ prolapse (POP) are conditions with growing burden and negative impacts on the overall health and quality of life for millions of women globally. POP is estimated to affect 40 percent of women at some point in their lives, and SUI is estimated to affect up to 35 percent. Pessaries are a non-surgical method to manage female POP and SUI. Traditionally placed in the vagina for extended periods of time, pessaries have few side effects but may be difficult for the patient to insert and remove. Issues with comfort and convenience may also limit widespread use of the devices. Although surgical solutions such as the placement of mesh can ameliorate symptoms associated with SUI and POP, they present risks of complications. Some biomaterials, including pelvic mesh implants, were recalled because of poor patient outcomes.

Most in-vitro biomaterials studies do not report the sex of the cells, which leads to a gap in understanding of sex-specific cell interactions with biomaterials. Efforts to ensure SABV is applied across R&D efforts and modalities (i.e. therapeutics, devices, and digital platforms), are critical first steps to improving the value of findings and innovations, and globalizing these efforts is vital. Greater knowledge about critical differences in response to devices between sexes, such as the immune or biomechanical responses to biomaterials, will support development and scaling of devices that fit the needs of women.

Women’s health research has traditionally focused on maternal and reproductive health, even though women aged 50 or over account for 26 percent of all women and girls globally. Millions of women, typically between the ages of 45 and 55, experience menopause each year. The burden of menopause symptoms represents significant personal and societal costs. Globally, vasomotor symptoms are responsible for over US$800 billion in healthcare costs and productivity losses. Perceptions of menopause as an inevitable unpleasant physiological process contribute to limited help-seeking behaviors and a dearth of innovation. However, FemTech companies are emerging to revolutionize peri- and post-menopause care. The growing, multi-billion dollar menopause market has the potential to increase understanding of risk factors for menopause symptoms and develop new tools and treatments for early detection, symptom prevention, and alleviation.