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Market Spotlight: Endometriosis

  • Report

  • 38 Pages
  • June 2021
  • Region: Global
  • Citeline
  • ID: 4421388
Endometriosis is an estrogen-dependent condition that affects approximately 10% of women of reproductive age, and may lead to chronic pelvic pain, infertility, or both. It is estimated that endometriosis is present in 24-50% of women with infertility, and in over 20% of those with chronic pelvic pain. Information gathered by the American Congress of Obstetricians and Gynecologists indicates that in approximately 60% of adult endometriosis patients, symptoms start before the age of 20 years.

Key Takeaways
  • The publisher estimates that in 2019, there were 191.0 million prevalent cases of endometriosis in women aged 15-49 years worldwide, and forecasts that number to increase to 201.8 million prevalent cases by 2028.
  • Endometriosis affects an estimated one in 10 women in the reproductive age group of 15-49 years. The approved drugs in the endometriosis space target the gonadotropin-releasing hormone (GnRH) receptor, progesterone receptor, follicle-stimulating hormone (FSH), gonadotropin-releasing hormone (GnRH), and androgen receptors. The majority of marketed drugs are administered via the subcutaneous route, while the remainder are oral and intramuscular formulations.
  • The majority of industry-sponsored drugs in active clinical development for endometriosis are in Phase II, with two drugs in Phase III.
  • Therapies in development for endometriosis focus on targets such as the gonadotropin-releasing hormone (GnRH) receptor, progesterone receptor, luteinizing hormone receptor (LHR), androgen receptors, and follicle-stimulating hormone (FSH). The majority of pipeline drugs are administered via the oral route, with only one product being tested as a topical formulation.
  • High-impact upcoming events for drugs in the endometriosis space comprise topline Phase III trial results for Trelstar and Yselty. The overall likelihood of approval of a Phase I gynecology asset is 11.9%, and the average probability a drug advances from Phase III is 70%. Drugs, on average, take 11.8 years from Phase I to approval, compared to 13.0 years in the overall obstetrics/gynecology space.
  • The distribution of clinical trials across Phase I-IV indicates that the majority of trials for endometriosis have been in the early and mid-phases of development, with 73% of trials in Phase I-II, and only 27% in Phase III-IV.
  • The US has a substantial lead in the number of endometriosis clinical trials globally. Germany leads the major European markets, while Japan has the top spot in Asia.
  • Clinical trial activity in the endometriosis space is dominated by completed trials. Bayer has the highest number of completed clinical trials for endometriosis, with 45 trials.
  • Bayer leads industry sponsors with the highest overall number of clinical trials for endometriosis, followed by AbbVie and Takeda.

Table of Contents

OVERVIEWKEY TAKEAWAYSDISEASE BACKGROUND
TREATMENT
  • GnRH analogs
  • Progestins
  • Combined oral contraceptives
  • Non-steroidal anti-inflammatory drugs
  • Danocrine
  • Surgery

EPIDEMIOLOGYMARKETED DRUGSPIPELINE DRUGS
RECENT EVENTS AND ANALYST OPINION
  • Orgovyx for Endometriosis (January 26, 2021)
  • Orgovyx for Endometriosis (June 23, 2020)
  • Orgovyx for Endometriosis (April 22, 2020)

KEY UPCOMING EVENTSPROBABILITY OF SUCCESS
LICENSING AND ASSET ACQUISITION DEALS
  • Genexine, Turret Capital Ink License For Immunosuppressant

REVENUE OPPORTUNITY
CLINICAL TRIAL LANDSCAPE
  • Sponsors by status
  • Sponsors by phase

BIBLIOGRAPHYAPPENDIX
LIST OF FIGURES
Figure 1: Trends in prevalent cases of endometriosis, 2019–28
Figure 2: Overview of pipeline drugs for endometriosis in the US
Figure 3: Pipeline drugs for endometriosis, by company
Figure 4: Pipeline drugs for endometriosis, by drug type
Figure 5: Pipeline drugs for endometriosis, by classification
Figure 6: Orgovyx for Endometriosis (June 23, 2020): Phase III - SPIRIT 1
Figure 7: Orgovyx for Endometriosis (April 22, 2020): Phase III - SPIRIT 2
Figure 8: Key upcoming events in endometriosis
Figure 9: Probability of success in the gynecology pipeline
Figure 10: Clinical trials in endometriosis
Figure 11: Top 10 drugs for clinical trials in endometriosis
Figure 12: Top 10 companies for clinical trials in endometriosis
Figure 13: Trial locations in endometriosis
Figure 14: Endometriosis trials status
Figure 15: Endometriosis trials sponsors, by phase
LIST OF TABLES
Table 1: Prevalent cases of endometriosis, 2019–28
Table 2: Marketed drugs for endometriosis
Table 3: Pipeline drugs for endometriosis in the US
Table 4: Orgovyx for Endometriosis (January 26, 2021)
Table 5: Orgovyx for Endometriosis (June 23, 2020)
Table 6: Orgovyx for Endometriosis (April 22, 2020)
Table 7: Historical global sales, by drug ($m), 2016–20
Table 8: Forecasted global sales, by drug ($m), 2021–25