Historically, the women’s health pharmaceutical market has been an attractive segment and an area of commercial opportunity for drug developers, with mostly a focus on women’s cancers and reproductive health. More recently, interest and drug development have expanded beyond these two areas, into indications such as hypoactive sexual desire disorder, postmenopausal conditions, benign gynecological conditions, and endometriosis, owing to persistent unmet needs. This blog is part of a 2-blog series, providing a snapshot of the current trends in the treatment and development of new therapeutics for select women’s health indications. Part 1 of the series will focus on two common gynecological disorders of the uterus and endometrium—uterine fibroids and endometriosis, while part 2 of the series will profile common types of women’s cancers— breast, ovarian, endometrial, and cervical cancer.

Uterine Fibroids: Uterine fibroids are the most common benign tumors in women, and a leading cause for hysterectomies in the United States and Europe. Over 70 percent of women will develop uterine fibroids in their lifetime, however less than half will suffer from symptoms related to the condition. Nonetheless, DRG’s recent epidemiological analysis has identified a large prevalent population in the mature markets, which will translate into a significant number of patients requiring drug treatment and surgical intervention to minimize the clinical manifestations of uterine fibroids.

  • The current treatment algorithm for the management of uterine fibroids involves gynecologists monitoring asymptomatic patients for any growth in tumor size and number, prescribing drug therapies to alleviate heavy menstrual bleeding and pelvic pain/pressure in symptomatic patients, and performing surgical procedures, such as hysterectomies and myomectomies in suitable patients.
  • While low-cost hormonal contraceptives, tranexamic acid, and non-steroidal anti-inflammatory drugs (NSAIDs) will remain the first-line drug therapies for controlling heavy menstrual bleeding associated with uterine fibroids, pharmacological options that can effectively control the bleeding and bypass the need for surgical procedures represent an area of very high unmet need in the uterine fibroids therapeutic market.
  • Multiple selective progesterone receptor modulators (SPRMs) and the second-generation, orally administered gonadotropin-releasing hormone (Gn-RH) antagonists are expected to launch over the next ten years and to become a key driver for the significant expansion of the uterine fibroids therapeutic market, allowing for long-term pharmacological management of symptomatic uterine fibroids. Below is a snapshot of the current late-phase pipeline for uterine fibroids:
Compound Status (US/EU5) Marketing Company
SPRMs
Ulipristal III/Marketed Allergan/Gedeon Richter
Vilaprisan II Bayer
Telapristone II Repros
Gn-RH antagonists
Elagolix III AbbVie
Relugolix III Myovant
OBE-2109 III ObsEva

 

Endometriosis: Endometriosis is a disorder caused by the growth of endometrial tissue outside of the uterus. Endometriosis is the one of the leading causes of female infertility, and has pelvic pain as its main clinical manifestation. Similar to the uterine fibroids market, DRG’s epidemiology analysis indicates a high prevalence of suspected and confirmed diagnosed cases of endometriosis in the mature markets. However, unlike the uterine fibroid space, where drug treatment is typically prescribed to bridge patients to menopause, onset of endometriosis-related symptoms and need for medical intervention occurs earlier in a patient’s life—as early as teenage years and during reproductive years, underscoring a high unmet need for therapies for the long-term management of this chronic disorder.

  • Pain relievers, hormonal contraceptives, androgenic agents, and Gn-RH agonists represent the current treatment paradigm to manage endometriosis-associated pelvic pain and other complications.
  • Although laparoscopic excision surgery has the potential to remove endometriosis, the surgery is complicated and requires expert skills; furthermore, the disease recurs if any ectopic tissue is overlooked or not completely removed. Hysterectomies, the more aggressive surgical option, are less commonly performed to treat endometriosis, given the age of disease onset; unlike in uterine fibroids, this approach is also less likely to result in a definitive cure for endometriosis.
  • Patients with diagnosed endometriosis long for pharmacological treatment options that are easily administered, efficacious, and safe for long-term use. Successful development and adoption of second-generation, orally administered Gn-RH antagonists will be key in driving growth of the endometriosis drug market. Below is a snapshot of the key late-stage pipeline for endometriosis:
Compound Status (US/EU5) Marketing Company
Gn-RH antagonists
Elagolix III AbbVie
Relugolix II Myovant
OBE-2109 II ObsEva
SPRMs
Telapristone II Repros
Vilaprisan II Bayer

 

 

A common theme in the drug pipeline for both the uterine fibroids and endometriosis markets is the development of second-generation Gn-RH antagonists and SPRMs. With the exception of ulipristal, developers are investigating the potential of these agents in both indications, underscoring developers’ strategy to capitalize on a significant commercial opportunity by bringing to market therapies that can be used across two highly prevalent gynecological disorders. These emerging drug classes are poised to address key unmet needs in both markets, but we expect them to perform differently. Our analysis predicts that SPRMs will outperform the Gn-RH antagonists in the uterine fibroids market, but will play a lesser role in the endometriosis market.

 

For a more in depth analysis of uterine fibroids therapies, please see our recent Niche & Rare Disease Landscape & Forecast report entitled Uterine Fibroids (US/EU5); a parallel analysis of endometriosis market and therapeutics will be published in the second half of 2017.

 

Coming up: Part 2 of DRG Perspective: A Snapshot into Current Trends and Development of New Therapeutics for Women’s Health – A Profile of Women’s Cancers

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