Currently, the health of women and girls appears to be a pertinent issue that the pharma industry is addressing, as women’s health became one of the top ten therapy areas being investigated in clinical trials in January 2024. This is the first time women’s health has held a spot in the top ten since 2020. Data obtained from GlobalData’s Trials Intelligence platform reveals that women’s infertility is the women’s health indication leading the clinical trial count this month. This follows a record year in 2023, which saw the largest number of female infertility clinical trials since 2019 (Figure 1). If this momentum continues, 2024 has the potential to exceed pre-pandemic figures.

Infertility is a disease of the male or female reproductive system, defined by the failure to achieve pregnancy after 12 months or more of regular unprotected sexual intercourse. The World Health Organization (WHO) reported that infertility
rates are rising and one in six people are affected globally, which means that by 2025, almost ten million couples will encounter problems with conceiving. Despite the magnitude of the issue, solutions remain underfunded and inaccessible to millions due to high costs and poor availability. Although infertility does not discriminate, there are significant disparities in access to fertility care. Within the US, fertility treatment is generally not covered by public or private insurers and the high cost of treatment has resulted in most clinics selecting high-net-worth locations.

Mate Fertility reported that 80% of all US clinics are in New York, with 30% specifically in Manhattan. This highlights the urgent need to increase access to affordable, innovative, high-quality fertility care. The Centers for Disease Control and Prevention (CDC) claim that 11% of women, compared to 9% of men of childbearing age, have infertility, explaining the surge in female-focused infertility trials.

The causes behind increasing infertility are multi-faceted. Research from The National Institute of Child Health and Human Development (NICHD) has linked influences such as obesity, excessive exercise, substance abuse, and heavy drinking to an increase in infertility. Additionally, advances in technology, medicine, and education, have provided women more options and control over their fertility, which has seen the average age that most women have their first child increase from 21 to closer to 27. This naturally results in women having fewer children, as corroborated by figures released by the CDC that show the worldwide average of children per woman has fallen from five in 1950 to two in 2020.

Historically, the pipeline for female infertility treatments has been sparse. However, recent years have provided valuable insights regarding the use of mesenchymal stem cells and even the naturally occurring substance inositol for infertility. GlobalData’s trials intelligence platform indicates that studies planned for 2024 appear conscious of the astronomical price of treatments, as sponsors such as Batterjee Medical College are investigating cost-effective treatments for women’s infertility such as Viagra.

The issue of infertility is unavoidable and the increase in clinical trial activity is indicative of this. GlobalData predicts that the infertility drug market will be worth $2.5 billion in 2028 as pharma begins to understand the clinical necessity and opportunities available from investing within this sector.