Significant unmet medical needs profoundly affect the lives of hundreds of millions of women worldwide. Women have more than their fair share of healthcare needs for a variety of reasons, including:
- Women’s healthcare needs vary substantially over the life cycle, from childhood and adolescence through the childbearing years and menopause; this increases the challenge for medical researchers in understanding and addressing a diverse and evolving set of health issues.
- Several chronic diseases disproportionately affect women, including type 2 diabetes, lupus, multiple sclerosis and depression.
- Because women often live longer than men, they are more likely to experience geriatric conditions such as osteoarthritis and Alzheimer’s disease.
- Diagnosis of some women’s health conditions, including ovarian cancer, requires invasive procedures that tend to delay detection and treatment and exacerbate outcomes.
- Therapeutics for some common women’s health conditions are lacking in efficacy, durability or tolerability.
As a leading CRO in women’s health, Health Decisions is using Women’s Health Week as an occasion to highlight a few unmet needs in women’s health that present substantial opportunities to improve the well-being and quality-of-life of the female population. These unmet needs also represent substantial business opportunities for developers of drugs, diagnostics and medical devices. Health Decisions looks forward to planning, designing and managing clinical trials for products to address women’s significant unmet medical needs in areas including but not limited to those listed below.
A Selection of Significant Unmet Needs in Women’s Health
Increased Availability of Noninvasive Diagnostics
Noninvasive diagnostics for women’s health conditions, especially conditions such as ovarian and cervical cancer that are often diagnosed when it is too late for effective treatment, represent a significant unmet need in women’s health and an opportunity for the diagnostics industry. There is also a need for improved diagnostics in other areas. For example, women are vocal about their displeasure with the experience of mammography and there is a need for noninvasive prenatal diagnostics for a greater range of hereditary health conditions.
Osteoporosis Therapeutics with a More Favorable Risk-Benefit Profile
While there has been substantial progress in therapeutics for osteoporosis, it is not rare for women to discontinue treatment if side effects are difficult to tolerate. New therapeutics that tilt the balance in favor of treatment benefits and against risks would find a vast and increasing market as the global population ages.
More Effective Therapeutics for Female Sexual Dysfunction
Female Sexual Dysfunction encompasses Female Sexual Interest/Arousal Disorder, Female Orgasmic Disorder and Genito-Pelvic Pain/Penetration Disorder. While therapeutics for female sexual dysfunction remain controversial in some circles, there were an estimated 4.1 million off-label prescriptions written in 2011 for testosterone as a treatment for women who seek assistance with this indication.1 This strongly suggests that a market opportunity exists for a treatment that demonstrates efficacy and has a more favorable side effect profile than dosing a female patient with a male hormone. FDA approval of flibanserin (Addyi®) was an important milestone but early market data suggests women unhappy with their sex lives are still awaiting a watershed event to rival the 1998 introduction of sildenafil (Viagra®) for male sexual dysfunction.
Endometriosis Therapeutics without Infertility and Menopausal Effects
Estimates of prevalence of endometriosis vary from 5%-20%, with incidence as high as 35% in women with severe menstrual cramps. A study in Germany found prevalence of diagnosed endometriosis to be approximately 8.1 percent, increasing to 12.8 percent for women aged 35-44.2 One thing is clear from disparate estimates: endometriosis affects millions of women worldwide. Endometriosis is estrogen-dependent and treatment typically involves suppression of the action of estrogen, with resulting effects on fertility and side effects like those of menopause. There is clearly a need for therapeutics with a more favorable risk-benefit balance.
Bacterial Vaginosis Therapeutics with More Durable Efficacy
Prevalence of bacterial vaginosis in the United States is approximately 29.2% among women aged 14-49. There are effective therapeutics but recurrence rates may be as high as 80%.3 Bacterial vaginosis represents a major health issue because it increases risks for pelvic inflammatory disease, sexually transmitted infections including HIV, postsurgical infection after gynecologic procedures, spontaneous abortion, preterm labor and low birth weight. Therefore, women need a therapeutic for bacterial vaginosis that not only cures bacterial vaginosis in the near term but also prevents recurrence.
Improved Therapeutic Options for Uterine Fibroids
Estimates of prevalence of uterine fibroids vary from 5-21 percent, with rates increasing substantially for women aged 35-49, with prevalence >80% among African American women by age 50 and >70% among Caucasian women.4 The majority of women are asymptomatic, and yet uterine fibroids are the leading cause of hysterectomies in the United States. Current treatment options include oral contraceptives or progestins, levonorgestrel-releasing intrauterine system (LNG-IUS) and GnRH-agonists. Surgical procedures include myomectomy, endometrial ablation and hysterectomy. Women would welcome improved interventions from the biopharma and medical-device industries.
Looking Forward to New Women’s Health Products and Possibilities
Along with our sponsors, Health Decisions looks forward to completing a variety of clinical development projects for women’s health products during the next year. By Mother’s Day and Women’s Health Week in 2017, we hope to celebrate the availability of improved therapeutics, diagnostics and medical devices in several indications where women’s medical needs are currently unmet. We even see new health options for women based on development of products for men! In addition to trials of investigational products for women, Health Decisions is managing clinical trials of investigational male hormonal contraceptives. This raises the possibility that men may someday have the option of relieving their female partners of the burden of hormonal contraception. If that day comes, millions of women would have additional cause for celebration in a future Women’s Health Week.
 Khera M. Testosterone therapy for female sexual dysfunction. Sex Med Rev 2015;3:137–144.
 Abbas S, Ihle P et al. Eur J Obstet Gynecol Reprod Biol. 2012 Jan;160(1):79-83.
 Marrazzo J, ed. Vaginitis. National Network of STD/HIV Prevention Training Centers. Available at: http://www.stdhivtraining.org/resource.php?id=55&ret=clinical_resources
 Day Baird D, Dunson DB, Hill MC, Cousins D, Schectman JM: High cumulative incidence of uterine leiomyoma in black and white women: ultrasound evidence. Am J Obstet Gynecol 2003, 188(1):100–107.