Uterine fibroids are characterized by heavy menstrual bleeding (menorrhagia), pelvic pressure due to increased uterine bulk, abdominal and back pain, and fertility issues. Disease management may include procedures for fibroid removal (e.g., laparoscopic, myomectomy, hysterectomy) or pharmacological approaches to manage more-disruptive symptoms like menorrhagia (e.g., hormonal contraceptives like progestin-only birth control pills). Owing to reproductive concerns, some patients avoid procedures and rely solely on pharmacological options. Although these pharmacotherapies are effective in reducing menorrhagia, they fail to reduce fibroid tumor volume or resolve bulk symptoms. Over the next ten years, we expect that the launch of several gonadotropin-releasing hormone (GnRH) antagonists, including Myovant/Takeda’s relugolix, ObsEva/Kissei’s linzagolix, and AbbVie’s elagolix, will offer a new class of therapies for the long-term management of uterine fibroids.

Questions Answered:

  • How will the launches of GnRH antagonists affect the use of traditional pharmacological treatments and procedures in patients with symptomatic uterine fibroids?
  • What clinical role will second-generation, oral GnRH antagonist therapies play in the management of uterine fibroids?
  • How have recent concerns regarding selective progesterone receptor modulators like ulipristal (Esmya) affected physicians’ prescription of them?
  • What are the greatest remaining unmet needs, and how well will emerging therapies address these needs?

Market covered: United States, France, Germany, Italy, Spain, and United Kingdom.

Primary research: Six country-specific interviews with thought-leading gynecologists specializing in uterine fibroids and supported by survey data collected for this study.

Epidemiology: Total prevalent, diagnosed prevalent, and drug-treated cases of uterine fibroids by country.

Market forecast: Drug-level sales and patient share of key uterine fibroids therapies in 2028.

Emerging therapies: Phase III/PR: 3; Phase II: 1; coverage of select preclinical and Phase I products.

Key companies: Allergan, Gedeon Richter, Bayer HealthCare, AbbVie, Myovant, ObsEva.

Key drugs: Ulipristal, telapristone, vilaprisan, elagolix, relugolix, linzagolix.

Table of contents

  • Uterine Fibroids - Landscape & Forecast - Disease Landscape & Forecast
    • Commercial Outlook
      • Key Findings
        • Regional Sales of Key Therapies to Treat Uterine Fibroids: 2018 and 2028
        • Uterine Fibroids SWOT Analysis
      • COVID-19: Areas of Potential Forecast Impact
        • Drivers and Constraints
          • What Factors Are Driving Sales in Uterine Fibroids?
          • What Factors Are Constraining Sales in Uterine Fibroids?
        • Selective Progesterone Receptor Modulator-Specific Trends
          • Gonadotropin-Releasing Hormone Antagonists-Specific Trends
          • Forecast
            • Sales of Key Therapies in Uterine Fibroids
          • Etiology and Pathophysiology
            • Disease Overview
              • Etiology
                • Pathophysiology
                  • Clinical Presentation of Uterine Fibroids
                    • Types of Uterine Fibroid by Location
                    • Key Clinical Features of Uterine Fibroids
                    • Location of Uterine Fibroids
                  • Key Pathways and Drug Targets
                  • Epidemiology Overview
                    • Key Findings
                      • Epidemiology Populations
                        • Disease Definition
                        • Methods
                        • Sources Used for Total Prevalence of Uterine Fibroids
                        • Number of Total Prevalent Cases of Uterine Fibroids in the Major Pharmaceutical Markets: 2018-2028 (thousands)
                        • Methods
                        • Sources Used for Diagnosed Prevalence of Uterine Fibroids
                        • Number of Diagnosed Prevalent Cases of Uterine Fibroids in the Major Pharmaceutical Markets: 2018-2028 (thousands)
                        • Drug-Treated Prevalent Cases of Uterine Fibroids: 2018-2028 (thousands)
                    • Current Treatment
                      • Key Findings
                        • Diagnosis
                          • Tests Used for Diagnosis of Uterine Fibroids
                          • Treatment Providers and Referral Patterns
                          • Expert Insight: Diagnosis of Uterine Fibroids
                        • Treatment Goals
                          • Key End Points Used in Clinical Trials for Uterine Fibroids
                        • Key Current Therapies
                          • Overview
                          • Mechanism of Action of Key Current Drug Classes Used for Uterine Fibroids
                          • Current Treatments Used for Uterine Fibroids
                          • Clinical Trial Outcomes for Ulipristal
                          • Advantages and Disadvantages of Ulipristal
                          • Key Results from Select Clinical Trials Investigating Ulipristal for the Treatment of Uterine Fibroids
                          • Expert Insight: Ulipristal
                          • Clinical Trial Outcomes for Gonadotropin-Releasing Hormone Agonists
                          • Advantages and Disadvantages of Gonadotropin-Releasing Hormone Agonists
                          • Expert Insight: Gonadotropin-Releasing Hormone Agonists
                          • Advantages and Disadvantages of Hormonal Contraceptives
                          • Expert Insight: Hormonal Contraceptives
                          • Advantages and Disadvantages of Tranexamic Acid
                          • Expert Insight: Tranexamic Acid
                          • Advantages and Disadvantages of NSAIDs
                          • Hysterectomy
                          • Myomectomy
                          • Uterine Artery Embolization
                          • Myolysis
                          • Endometrial Ablation
                        • Medical Practice
                          • Overview
                          • Country and/or Regional Uterine Fibroids Treatment Guidelines
                          • Region-Specific Treatment
                          • Generalized Treatment Decision Tree for Uterine Fibroids
                      • Unmet Need Overview
                        • Current and Future Attainment of Unmet Needs in Uterine Fibroids
                        • Top Unmet Needs in Uterine Fibroids: Current and Future Attainment
                        • Expert Insight: Unmet Need in Uterine Fibroids
                      • Emerging Therapies
                        • Key Findings
                          • Pipeline Trends for Uterine Fibroids
                        • Key Emerging Therapies
                          • Key Therapies in Development for Uterine Fibroids
                          • Estimated Market Authorization Dates of Key Emerging Therapies for the Treatment of Uterine Fibroids
                          • Vilaprisan Profile
                          • Expectations for Launch and Sales Opportunity of Vilaprisan in Uterine Fibroids
                          • Telapristone Profile
                          • Expectations for Launch and Sales Opportunity of Telapristone in Uterine Fibroids
                          • Expert Insight: Gonadotropin-Releasing Hormone Antagonists
                          • Elagolix Profile
                          • Key Ongoing Clinical Trials of Elagolix for the Treatment of Uterine Fibroids
                          • Expectations for Launch and Sales Opportunity of Elagolix in Uterine Fibroids
                          • Relugolix Profile
                          • Key Ongoing Clinical Trials of Relugolix for the Treatment of Uterine Fibroids
                          • Expectations for Launch and Sales Opportunity of Relugolix in Uterine Fibroids
                          • Linzagolix Profile
                          • Key Ongoing Clinical Trials of Linzagolix for the Treatment of Uterine Fibroids
                          • Expectations for Launch and Sales Opportunity of Linzagolix in Uterine Fibroids
                        • Early-Phase Pipeline Analysis
                          • Select Compounds in Early-Phase Development for Uterine Fibroids
                        • Patient Registries
                          • Uterine Fibroids Patient Registries
                          • Prominent Patient Organizations
                      • Access & Reimbursement Overview
                        • Region-Specific Reimbursement Practices
                          • Key Market Access Considerations in Uterine Fibroids: United States
                          • General Reimbursement Environment: United States
                          • Key Market Access Considerations in Uterine Fibroids: EU5
                          • General Reimbursement Environment: EU5
                        • Looking for More?
                      • Appendix
                        • Key Abbreviations Related to Uterine Fibroids
                        • Brands, Marketers, and Generic Availability of Key Therapies for Uterine Fibroids by Market
                        • Uterine Fibroids Bibliography

                    Author(s): Laura Darnieder; Ema Rodrigues, DSc, MPH

                    Laura Darnieder is a Business Insights Analyst on the Infectious, Niche, and Rare Diseases team at Decision Resources Group, where she is focused on providing market forecasts within the niche biopharmaceutical space.

                    Prior to joining DRG, Laura earned a Ph.D. in Neuroscience from Tufts University Sackler School of Graduate Biomedical Sciences. Her research focused on the role of stress neuropeptides and inhibitory signaling in alcohol dependence and drug addiction. She also holds a B.S., summa cum laude, in Psychobiology and Linguistics from Binghamton University (SUNY).

                    Ema is an epidemiologist with expertise in forecasting incident and prevalent populations within oncology, as well as some cardiovascular indications such as venous thromboembolism. She has significant experience with statistical methods such as multivariate linear regression, conditional logistic regression, principal components analysis, mixed models, hierarchical modeling, and path analysis to account for the complex relationships among various predictors of health outcomes, particularly correlated variables.

                    She completed her master’s and doctoral degree (MPH, D.Sc.) in Environmental Health at Boston University School of Public Health, where she worked on projects investigating significant predictors of various health outcomes including central nervous system cancer, cognitive function, and birth outcomes.


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