J.Andrew McKee shares a recent company newsletter and update on women’s healthcare challenges.
As we reflect on Women’s History Month, we would like to take the opportunity to shine a spotlight on women’s health and diseases that exclusively affect women. As a consulting firm that is at gender parity, we recognize the importance of advancing women’s healthcare and addressing the unique challenges and disparities in treatment options for diseases primarily impacting women.
Did you know…
There are only ~35 clinical-stage assets for women’s health indications in development, across ~20 non-oncology diseases
There are only 43 FDA-approved new molecular entities (NME) for all non-oncology women’s health indications, of which ~80% have hormonal mechanisms of action
Female-specific diseases are often chronic conditions with high market potential due to prevalence, for example, uterine fibroids affect > 50% of women of reproductive age, endometriosis affects > 10% of women of reproductive age, adenomyosis affects ~30% of women of reproductive age, and pre-eclampsia impacts ~5% of all pregnancies
Many highly prevalent female-specific diseases remain poorly understood resulting in significant unmet medical needs. Women with these conditions often experience a substantial burden of disease and have limited options for non-hormonal disease-modifying therapies (DMT). We’ve highlighted two examples below of women’s health diseases with no FDA-approved DMTs:
Uterine fibroids
Disease overview & burden: Uterine fibroids are benign tumors that arise from smooth muscle cells of the uterus and can lead to heavy menstrual bleeding, pelvic pain, and infertility, with an increased risk of pregnancy complications
Prevalence: ~33M women of reproductive age in the United States, 2-3x higher prevalence in black women than white women
Diagnosis and treatment: Diagnosed via pelvic ultrasound and ~70% of patients use pharmacotherapy including gonadotropin-releasing hormone (GnRH) agonists/antagonists and IUDs, and 30% seek surgical treatment
Unmet needs: Non-hormonal DMTs
Endometriosis
Disease overview & burden: Chronic disease that commonly affects women of reproductive age, characterized by endometrial implantation outside of the endometrial cavity, resulting in chronic pelvic pain and/or infertility
Prevalence: ~7.5M women of reproductive age in the United States, impacts ~10% of women aged 14-49
Diagnosis and treatment: ~60% of cases are diagnosed in the US and current medical therapies only manage pain, with >60% of patients treated with NSAIDs, oral contraceptives, or GnRH analogs.
Key points include:
- Female specific diseases
- Unmet needs
- Diagnoses and treatment
Access the newsletter, March 2024 Newsletter: Women’s History Month Edition, on HeadlandStrategy.com.