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March 2024 Newsletter: Women's History Month Edition

Hello friends and colleagues,  

 

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: 

 

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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  


Unmet needs: Non-invasive diagnostics, non-hormonal DMTs; better understanding of pathophysiology 

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As we reflect on the critical need for advancements in women's health, the statistics reveal a stark reality: there are limited treatment options available for diseases that exclusively affect women, despite their significant prevalence and impact on quality of life. Based on the investments that some of our clients and colleagues in the industry are making in women's health, coupled with the Biden administration's newly announced initiative to expand women's health research, we are optimistic that there will be meaningful strides toward addressing the unmet needs of women's health in the coming years.  

 

Thank you for joining us this month as we shed light on the challenges surrounding women’s health. Stay tuned for more exciting updates in the next edition of our monthly newsletter as we continue to provide best-in-class services for commercial (strategic new product planning), corporate development, and R&D strategy.   

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